Otu esi eji NovoMix 30 Penfill nkwusioru

Aha mba ofesi - novomix 30 penfill

Ngwakọta na ụdị ntọhapụ.

Nkwụsị maka njikwa SC acha ọcha, ịkpa agwa (na-enweghị eriri, flakes nwere ike ịpụta na ihe nlere ahụ), mgbe stratified, ọ stratifies, na-akpụ ụcha ọcha na nke na-enweghị ụcha ma ọ bụ nke na-enweghị ụcha, na-akpachapụ anya ịgwakọta nke nkwusioru otu ụdị ga-etolite. 1 ml nwere insulin nke abụọ - asul - 100 IU (3.5 mg), insulin na - soluble aspart - 30%, insulin ọgwụ insulin dị ka aspro protamine - 70%.

Ndị pụrụ iche: glycerol - 16 mg, phenol - 1.5 mg, metacresol - 1.72 mg, zinc chloride - 19.6 μg, sodium chloride - 0.877 mg, sodium hydrogen phosphate dihydrate - 1.25 mg, protamine sulfate

0.33 mg sodium hydroxide

2.2 mg, hydrochloric acid

1.7 mg, mmiri d / i - ruo 1 ml.

Nkwusioru d / p / na ntinye nke 100 PIECES / 1 ml: katrized 3 ml 5 pcs.

3 ml (300 PIECES) - katrized (5) - blisters (1) - ngwugwu nke kaadiboodu.

Omume ọgwụ.

NovoMix 30 Penfill bụ ihe nnochi anya nke abụọ nke nwere ngwakọta nke insulin analogues: soluble insulin aspart (30% obere insulin analog) na kristal nke aspart protamine insulin (70% ọkara insulin analog).

NovoMix 30 Penfill na-arụ ọrụ bụ insulin aspart, nke usoro usoro ihe omimi nke DNA jiri ọgwụ Saccharomyces cerevisiae mepụtara.

Insulin aspart bụ ihe mmadụ na-agbanye insulin na-eme ka mmadụ sie ike dabere na ngosipụta oke.

Mbelata shuga dị n'ọbara na-ebilite n'ihi mmụba n'ụgbọ njem ya mgbe akwara insulin na-anabata ndị na-anabata insulin na akwara na abụba yana imeju n'otu oge na - egbochi imepụta glucose.

Mgbe nchịkwa subvoane nke NovoMix 30 Penfill gasịrị, mmetụta ahụ na-amalite n'ime nkeji 10-20. Oke
A na - ahụta mmetụta ahụ n’etiti 1 ruo 4 awa mgbe ịgba ọgwụ mgbochi ahụ gasịrị. Ogologo oge ọgwụ ahụ ruru awa 24.

N'ime ule nlele ọnwa atọ nke metụtara ndị ọrịa nwere ụdị shuga 1 na ụdị 2 ndị natara NovoMix 30 Penfill na insulin mmadụ mmadụ iri abụọ kwa ụbọchị tupu nri ụtụtụ na nri abalị, NovoMix 30 Penfill gosipụtara belata postprandial ọbara glucose karị ike (mgbe nri ụtụtụ na nri abalị).

Meta nyocha nke data sitere na ule itoolu metụtara ndị ọrịa nwere ọrịa shuga
1dị nke 1 na nke 2 gosipụtara na NovoMix 30 Penfill, mgbe a na-achịkwa ya tupu nri ụtụtụ na nri abalị, na-enye njikwa nke glucose postprandnal ọbara postprandnal (nkezi mmụba nke prandial glucose mgbe nri ụtụtụ, nri ehihie na nri abalị), ma e jiri ya tụnyere insulin biphasic mmadụ 30.

Ọ bụ ezie na glucose na-ebu ọnụ dị elu na ndị ọrịa na-eji NovoMix 30 Penfill, mkpokọta, NovoMix 30 Penfill nwere otu mmetụta na ntinye uche nke glycosylated haemoglobin (HbA)_1c) dika insulin nke mmadu dika insulin 30.

N'ime nyocha nke ụlọ ọgwụ metụtara ndị ọrịa 341 nwere ụdị ọrịa shuga 2, ndị ọrịa nwere usoro iche iche na ọgwụgwọ ọgwụgwọ naanị NovoMix 30 Penfill, NovoMix 30 Penfill na ngwakọta metformin na metformin na nchịkọta sitere na ụdị sulfonylurea.

HbA ịta_1c mgbe ọgwụgwọ iri na isii gasịrị dị iche na ndị ọrịa na-anata NovoMix 30 Penfill na metformin na ndị ọrịa na-anata metformin na mgbakwunye na usoro sulfonylurea. Na omumu a, 57% nke ndị ọrịa nwere ọnụọgụ HbA_1c dị elu karịa 9%, na ọgwụgwọ ndị a na NovoMix 30 Penfill na mgbakwunye na metformin butere mgbada dị ukwuu karịa ịta ahụhụ.
Hba_1ckaria na ndi oria na anata metformin na nchikota sulfonylurea.

N'ime ọmụmụ ihe ọzọ, ndị ọrịa nwere ụdị ọrịa shuga 2 nke na-adịghị mma nke na-achịkwa ọrịa glycemic nke na-ewere ọgwụ hypoglycemic ọgwụ na-abanye na otu ndị a: na-anata NovoMix 30 ugboro abụọ n'ụbọchị (ndị ọrịa 117) na ịnata insulin glargine otu ugboro kwa ụbọchị (ndị ọrịa 116). Mgbe izu 28 gasịrị iji ọgwụ ọjọọ eme ihe, mbelata nke ọkara na ịta HbA_1c n'ime otu NovoMix, 30 Penfill ruru 2.8% (uru mbụ ha ruru bụ 9.7%). Na 66% na 42% nke ndị ọrịa jiri NovoMix 30 Penfill na njedebe nke ọmụmụ ahụ, ụkpụrụ HbA_1c nọ n'okpuru 1% na 6.5%, n'otu n'otu. Igwe glucose plasma na-ebu ọnụ belatara ihe dika 7 mmol / L (site na 14.0 mmol / L na mbido ọmụmụ ahụ ruo 7.1 mmol / L).

Nsonaazụ nke nyocha nke meta nke data nwetara n’oge nnwale ụlọ ọgwụ metụtara ndị ọrịa nwere ụdị ọrịa shuga abụọ nke ọrịa shuga gosipụtara mbelata ọnụ ọgụgụ nke ọrịa nocturnal hypoglycemia na hypoglycemia siri ike na NovoMix 30 Penfill ma e jiri ya tụnyere insulin biphasic mmadụ 30. N’otu oge ahụ, enwere nnukwu ihe egwu ụbọchị Hypoglycemia na ndị ọrịa na-anata NovoMix 30 Penfill dị elu.

Childrenmụaka na ndị nọ n'afọ iri na ụma. Emere omumu ihe omumu nke izu iri isii na isii nke atụnyere glucose ọbara mgbe nrichara ya na NovoMix 30 (tupu nri), insulin / biphasic mmadụ mmadụ 30 (tupu nri) na isofan-insulin (nke a na-ahụ tupu oge ụra). Ọmụmụ ihe ahụ metụtara ndị ọrịa 167 dị afọ 10 ruo 18. HbA averages_1c ke otu mbiba emi ama aka iso odu uwem ke akpa ukpepn̄kpọ oro. Ọzọkwa, mgbe ị na-eji NovoMix 30 Penfill ma ọ bụ insulin nke mmadụ 30 na-eme ihe, enweghị ọdịiche dị n'etiti ọnọdụ hypoglycemia.

Emere ihe omumu nke nwere okpukpu abuo n’ime onu ogugu n’etiti ndi oria noo n’agbata afọ isii rue afọ iri na abụọ (ngụkọta ndị ọrịa 54, izu iri abụọ maka ụdị ọgwụgwọ ọ bụla) Ọnọdụ nke hypoglycemia na mmụba nke glucose mgbe nri n’etiti ndị ọrịa na-eji NovoMix 30 Penfill belatara nke ukwuu ma e jiri ya tụnyere ụkpụrụ dị n’òtù ndị ọrịa na-eji insulin nke mmadụ biapsic 30. ụkpụrụ HbA_1c na njedebe nke ihe omumu a, n'ime otutu insulin mmadu bi 30 na-adi ala karie na ndi otu ndi oria na-eji NovoMix 30 Penfill.

Ndị okenye na-arịa ọrịa. Mlọ ọgwụ Pharmacodynamics NovoMix 30 Penfill na ndị agadi na ndị ọrịa maara ọmụmụ. Agbanyeghị, n'ọmụmụ ihe nyocha gbara okpukpu abụọ nwere ụdị nyocha emere na ndị ọrịa 19 nwere ụdị ọrịa shuga 2 dị afọ 65-83 (afọ pụtara afọ 70), e jiri ọgwụ pharmacodynamics na pharmacokinetics nke insulin na -akpata ọgwụ mmadụ. Iche iche di iche na ọgwụ pharmacodynamics (ọnụego glucose dị elu - GIR_max na mpaghara dị n'okpuru usoro nke usoro mbulata ya maka minit 120 mgbe nchịkwa insulin insulin - AUC_{GIR, 0-120 min}) n'etiti insulin aspart na insulin mmadụ na ndị ọrịa mere agadi dị ka nke ndị ọrụ afọ ofufo siri ike na ndị ọrịa na-eto eto na-arịa ọrịa mellitus.

Mlọ ọgwụ

Na insulin aspart, nnọchi nke amino acid proline na ọnọdụ B28 maka aspartic acid na-ebelata ọchịchọ nke ụmụ irighiri ihe na-akpụ hexamers na mpekere nke NovoMix 30 Penfill, nke a na-ahụ na insulin na -akpata mmadụ. N'akụkụ a, a na-enweta insulin aspart (30%) site na abụba subcutaneous ngwa ngwa karịa insulin na -akari nwere insulin nke mmadụ. 70% fọdụrụnụ na-ada n'ụdị kristal, protamine-insulin aspart, ọnụego nnabata nke ya na nke insulin NPH nke mmadụ.

Oke nlebara anya nke insulin na ọbara ọbara mgbe nchịkwa NovoMix 30 Penfill bụ 50% karịa insulin nke mmadụ biphasic 30, oge ọ ga - ewe iji nweta ya bụ ihe dị mkpụmkpụ karịa nke insulin nke mmadụ bi 30.

N'ime ndị ọrụ afọ ofufo mara mma, mgbe nlekọta nchịkwa nke NovoMix 30 na ọnụego nke 0.20 U / n'arọ, oke ruru insulin aspart na ọbara ọbara ruru ka nkeji 60 wee ruo 140 ± 32 pmol / L. Oge T_1/2NovoMix 30, nke gosipụtara ọnụego nnabata nke ụmụ irighiri protamine, bụ awa 8-9. Ọbara insulin ọkwa laghachiri na isi 15-18 awa mgbe nchịkwa subcutaneous nke ọgwụ. N'ime ndị ọrịa nwere ụdị ọrịa mellitus nke ụdị 2, a na-etinyekarị uche kachasị ka nkeji iri ise na iteghete gachara ma jisie ike karịa ntọala 14 ọbụlagodi.

Ndị okenye na ndị okenye maara ọrụ. Emebeghị nnyocha banyere ọgwụ ọgwụ nke NovoMix 30 na ndị agadi na ndị ọrịa nwere nsogbu. Agbanyeghị, ọdịiche ndị dị na pharmacokinetics dị n'etiti insulin aspart na insulin nke mmadụ nwere ndị agadi nwere ọrịa shuga 2 (afọ 65-83, nkezi afọ - afọ 70) yiri nke ndị ọrụ afọ ofufo ahụike na ndị ọrịa obere ọrịa shuga mellitus. N’ime ndị ọrịa merela agadi, a chọpụtara mbelata nke mmịpụta, nke dugara na mbelata na T_max (Nkeji 82 (nkeji etiti: 60-120 nkeji)), ebe nkezi ịta (C_max) dị ka nke a chọpụtara na ndị okenye na-arịa ọrịa shuga 2dị nke Abụọ, ọ dị ntakịrị karịa na ndị ọrịa nwere ụdị shuga nke 1.

Ndị ọrịa nwere nsogbu gbasara akụrụngwa yana ọrụ ịba ọcha n'anya. Nnyocha ọmụmụ nke ọgwụ pharmacokinetics nke NovoMix 30 Penfill na ndị ọrịa nwere nsogbu gbasara akụrụngwa yana ọrụ ịba ọcha n'anya. Agbanyeghị, na mmụba na dose nke ọgwụ na ndị ọrịa nwere ịdị iche iche ogo nsogbu gbasara akụrụ na ọrụ ịba ọcha n'anya, enweghị mgbanwe mgbanwe ọgwụ ọgwụ nke ọgwụ insulin na-agagharị.

Childrenmụaka na ndị nọ n'afọ iri na ụma. Agụbeghị ụlọ ọgwụ ọgwụ nke NovoMix 30 Penfill na ụmụaka na ndị nọ n'afọ iri na ụma. Agbanyeghị

A muputara ọgwụ pharmacokinetic na pharmacodynamic nke soluble aspart insulin n’ime ụmụaka (afọ 6 ruo 12) na ndị nọ n’oge uto (afọ 13 ruo 17) nwere ọrịa shuga 1.

N'ime ndị ọrịa nọ n'afọ abụọ, insulin aspart mara nnabata ngwa ngwa na ụkpụrụ T_maxdika ndi okenye. Agbanyeghị, ụkpụrụ nke C_max n'afọ abụọ dị iche iche, nke na-egosi mkpa ịhọrọ insulin na -elekọta mmadụ kwa otu.

Nchebe imebi ime ụlọ n'oge agba tupu. N'ime usoro ọmụmụ ahụ, ọ nweghị ihe egwu dịịrị mmadụ, dabere na data niile a nabatara.

ọmụmụ nke nchekwa ọgwụ, jighachi toxicity, genotoxicity na nsí ọmụmụ.

N'ime nyocha nke vitro, nke gụnyere njikọta insulin na ndị na-anabata IGF-1 yana nsonaazụ uto mkpụrụ ndụ, egosiri na njirimara nke insulin insulin yiri nke insulin mmadụ. Nnyocha e mere egosiwo na ịhapụ njikọ nke insulin na-anabata ndị na-anabata insulin hà na nke insulin mmadụ.

Elldị ọrịa shuga mellitus nke 2. diabetesdị ọrịa shuga mellitus 2 (n'ihe banyere iguzogide ndị nnọchianya hypoglycemic nke nje, nguzogide ele mmadụ anya na ọgwụ ndị a n'oge ọgwụgwọ njikọta, ọrịa na-efe efe).

Usoro onunu ogwu na usoro nke ngwa ohuru mix 30 penfill.

NovoMix 30 Penfill ezubere maka nchịkwa subcutaneous. Can gaghị abanye NovoMix 30 Penfill intravenously, ebe nke a nwere ike ibute nnukwu hypoglycemia. NovoMix 30 Penfill maka ntụtụ insulin infusion (PPII) na nfuli insulin. Ọ bụ dọkịta ga-ekpebi ịgwọ NovoMix 30 Penfill n'otu n'otu n'ọnọdụ ọ bụla, dabere na mkpa nke onye ọrịa. Iji mezuo ọkwa glycemia zuru oke, a na-atụ aro ka ịchịkwa ịba ụba nke glucose na ọbara ma dozie ogo nke ọgwụ.

Enwere ike ịkọwa ndị ọrịa nwere ụdị ọrịa shuga 2, NovoMix 30 Penfill dị ka monotherapy yana yana ọgwụ hypoglycemic nke ọnụ na-achịkwa ebe enwere ọkwa nchịkwa ọbara glucose na-adịghị mma.

Mmalite ọgwụgwọ. Maka ndị ọrịa nwere ụdị shuga 2 nke na-ebu ụzọ nye ọgwụ insulin, ọgwụ mmalite a tụrụ aro ka NovoMix 30 Penfill bụ nkeji 6 tupu nri ụtụtụ yana nkeji 6 tupu nri abalị. Anabatakwa iwebata 12 nke NovoMix 30 Penfill otu ugboro n'ụbọchị mgbede (tupu nri abalị).

Nyefee onye ọrịa na ọgwụ insulin ndị ọzọ. Mgbe ị na-ebufe onye ọrịa site na insulin nke mmadụ bi na NovoMix 30 Penfill kwesịrị ịmalite site na otu

usoro na usoro nchịkwa. Mgbe ahụ dozie dose ahụ dabere na mkpa onwe onye nke onye ọrịa (lee ndụmọdụ ndị a maka otu ụzọ nke ọgwụ ahụ si chọọ). Dịka oge niile, mgbe ị na-ebufe onye ọrịa na ụdị insulin ọhụụ, nlekọta nlekọta ahụike dị mkpa n'oge mbufe onye ọrịa na izu mbụ nke iji ọgwụ ọhụrụ.

Intensification nke ọgwụ. Thenkwalite usoro ọgwụgwọ NovoMix 30 Penfill ga-ekwe omume site na ịgbanwee otu ugboro kwa ụbọchị gaa ugboro abụọ. A na-atụ aro ka ị rachara ọgwụ iri atọ ọgwụ ọgwụ gbanyere NovoMix 30 Penfill ugboro abụọ n'ụbọchị, kewaa ọgwụ ahụ ụzọ abụọ nha - ụtụtụ na mgbede (tupu nri ụtụtụ na nri abalị). Ntughari na ojiji NovoMix 30 Penfill ugboro atọ n'ụbọchị ga-ekwe omume site na ịkekọrịta ụtụtụ n'ụtụtụ na akụkụ abụọ na-elekọta ma na-elekọta akụkụ abụọ a n'ụtụtụ na nri ehihie (ugboro atọ kwa ụbọchị).

Dose ukpụhọde. Iji hazie dose nke NovoMix 30 Penfill, a na-eji mkpụkọ glucose na-ebu ọnụ nke edepụtara karịa ụbọchị atọ gara aga. Iji chọpụta izu ike dị na ọgwụ gara aga, jiri uru nke mkpokọ glucose dị n'ọbara tupu nri ọzọ. Imeghari Dose nwere ike ime otu ugboro n’izu rue mgbe eburu oke uru HbA ahụ rụzuru._1c. Emekwala elu nke ọgwụ a ma ọ bụrụ na a hụrụ hypoglycemia n'oge a. Imeghari dose nwere ike ịdị mkpa mgbe ị na-eme ka ahụ onye ọrịa dị, na-agbanwe nri ọ na-eri, ma ọ bụ nwee ọnọdụ na-apụ apụ. Iji dozie dose nke NovoMix 30 Penfill, a na-atụ aro iji ndụmọdụ ndị a maka itinye titration dose:

Ndị otu ọrịa pụrụ iche. Dị ka oge niile, mgbe ị na-eji nkwadebe insulin, na ndị ọrịa nke ìgwè pụrụ iche, a ga-eji nlezianya na-achịkọta glucose ọbara ma na-agbatị usoro ọgwụgwọ dị iche iche.

Ndị okenye na ndị okenye maara ọrụ. Enwere ike iji NovoMix 30 Penfill mee ihe na ndị ọrịa agadi, agbanyeghị, ahụmịhe ya na ojiji ya na ọgwụ hypoglycemic nke ọnụ na ndị ọrịa okenye karịa afọ 75 nwere mmachi.

Ndị ọrịa nwere nsogbu gbasara akụrụngwa yana ọrụ ịba ọcha n'anya. N'ime ndị ọrịa nwere akụrụ gbasara akwara ma ọ bụ ọrịa hepatic, enwere ike belata mkpa nke insulin.

Childrenmụaka na ndị nọ n'afọ iri na ụma. Enwere ike iji NovoMix 30 Penfill gwọọ ụmụaka na ndị nọ n'afọ iri n’agbata afọ 10 n’egwuregwu ebe a ka ahọrọ ọgwụ insulin gwakọtara. Enwere amachaghị banyere ụlọ ọgwụ dị afọ ole ụmụaka dị afọ 6-9 (lee ngalaba Nlekọta ọgwụ).

NovoMix 30 Penfill kwesịrị ka a ga - achịkwa subcutaneously na apata ụkwụ ma ọ bụ mgbidi akụkụ ihu. Ọ bụrụ na achọrọ, a ga-enye ọgwụ a n'ubu ma ọ bụ buttocks.

Okwesiri igbanwe ebe ogwu ngbanyere na mpaghara anatomical iji gbochie mmepe nke lipodystrophy.
Dị ka ọ dị na nhazi insulin ọ bụla, oge ihe NovoMix 30 Penfill na-adabere na ntinye, ebe nchịkwa, ike ọbara na-agba, okpomọkụ na ọkwa nke mmega ahụ.

E jiri ya tụnyere insulin nke mmadụ bi, NovoMix 30 Penfill na-amalite ime ngwa ngwa, yabụ, ekwesịrị inye ya ozugbo tupu nri. Ọ bụrụ na ọ dị mkpa, enwere ike ịhazi NovoMix 30 Penfill obere oge mgbe nri gasịrị.

Ntụziaka maka ndị ọrịa maka iji NovoMix 30 Penfill.

Cangaghị eji NovoMix 30 Penfill:

Ọ bụrụ na ị na-eme ihe nfụkasị (ị na-eme mmụọ) na insulin aspart ma ọ bụ ihe ọ bụla mejupụtara NovoMix 30 Penfill.

Y’oburu n’inwe hypoglycemia n’aru nso (shuga di ala).

Maka infulinaneous insulin infusion (PPII) dị na nfuli isisulin.

Ọ bụrụ na katriiki ma ọ bụ ngwa ntinye nke katoliki etinyere, etinyere, ma ọ bụ mebiri katrij ahụ ma ọ bụ mebie ya.

Ọ bụrụ na emebi emebi ọnọdụ nchekwa ọgwụ ma ọ bụ akpọnwụrụ.

Ọ bụrụ na insulin apụtaghị na-acha ọcha na urukpuru mgbe agwakọchara.

Ọ bụrụ na ogwe ọcha na-adịgide na nkwadebe mgbe agwakọta ma ọ bụ ọ bụrụ na ntụpọ ọcha na-arapara na ala ma ọ bụ mgbidi nke katriiki.

Tupu iji NovoMix 30 Penfill:

Lelee akara ahụ iji jide n'aka na ahọrọ ụdị insulin dị mma.

Lelee katriiki mgbe niile, tinyere piston roba. Ejila katriiki ma ọ bụrụ na enwere mmebi anya, ma ọ bụ ọ bụrụ na enwere oghere n'etiti piston na mpempe ọcha na bọọdụ ahụ. Maka ntuziaka ndị ọzọ, lee ntuziaka maka iji sistemụ insulin na-arụ ọrụ.

Jiri ogwu ojoo obula oge obula iji gbochie oria.

NovoMix 30 Penfill na agịga bu n'obi maka ojiji nkeonwe.

NovoMix 30 bụ maka ntụtụ subcutaneous. Achịkwala ọgwụ insulin n'ụzọ intraven ma ọ bụ intramuscularly.

Oge ọ bụla, gbanwee saịtị ịgba ntụtụ n'etiti mpaghara anatomical. Nke a ga - enyere aka belata ohere nke akàrà na ọnya n’ebe a na-agba ya. Ebe kachasị mma maka ịgba ntụtụ bụ mgbidi azụ, ihe aka ekpe, apata ụkwụ ma ọ bụ ubu. Insulin ga-eme ngwa ngwa ma ọ bụrụ na etinye ya n'azu ime. Na-elele oge ị na-atụle mkpokọta glucose ọbara.

Usoro maka ịgwakọta insulin.

Tupu i tinye katriiki n’usoro injection iji duzie insulin, jide ya n ’okpomoku ma gwakọta dika akwara n’okpuru:

Mgbe ị na-eji NovoMix 30 Penfill na nke izizi, were ọbụ aka gị kwọọ krieti ahụ ugboro iri - ọ dị mkpa na katriiki ahụ kwụ ọtọ. Ewelite ma wedata katriji ugboro iri wee gbadata ka bọọlụ dị n’ime katalọgụ ahụ si n'otu njedebe nke katrijị ahụ gaa na nke ọzọ. Megharịa ndị a ruo mgbe
ruo mgbe mmiri mmiri ahụ na-acha ọcha na urukpuru. Usoro ịgwakọta ga-adị mfe ma ọ bụrụ na ka ọ dị ugbu a, insulin erutela temprechọ nke ime ụlọ. Gbanye ozugbo.

Tupu ntụtụ ọ bụla sochi ya, kwanye ngwaọrụ ntụtụ ahụ na klọọkụ dị na ya ruo mgbe mmiri ahụ na-acha ọcha na igwe ojii, mana ọ dịkarịa ala ugboro iri. Gbanye ozugbo.

Lelee ma ọ dịkarịa ala nkeji 12 nke insulin na-anọdụ na katriiki iji hụ na ijikọ ọnụ otu. Ọ bụrụ na erughi nkeji iri na abụọ, jiri NovoMix 30 Penfill ọhụụ.

Otu esi edozi insulin.

Ekwesịrị itinye insulin n'okpuru anụahụ. Jiri usoro ịgba ọgwụ nke dọkịta gị ma ọ bụ nọọsụ tụrụ aro, soro ntuziaka maka ịhazi insulin dị ka akọwara na ntuziaka maka ngwaọrụ gị maka inye insulin.

Jide agịga n'okpuru anụ ahụ gị ma ọ dịkarịa ala 6 sekọnd. Mee ka mkpali ahụ pụta ruo mgbe ịpụpụrụ agịga n'okpuru anụahụ. Nke a ga - agba mbọ hụ na a na - echekwa insulin zuru ezu ma gbochie ọbara ịbanye na agịga ma ọ bụ katridge na insulin.

Mgbe nsị nke ọ bụla, jide n’aka na ị ga-ewepụ ma tụfuo agịga ahụ, echekwala NovoMix 30 Penfill na agịga ahụ. Ma ọ bụghị ya, mmiri nwere ike isi na pọpụlụ ahụ pụta, nke ahụ nwere ike ibute insulin nke na-adịghị mma.

Ejijula ​​insulin katriza jiri insulin.

Ezubere NovoMix 30 Penfill maka iji ya na usoro ntụtụ insulin Novo Nordisk yana agịga NovoFine ma ọ bụ NovoTvist.

Ọ bụrụ na a na-eji NovoMix 30 Penfill na insulin nke ọzọ na ngwugwu Penfill maka ọgwụgwọ n'otu oge, ọ dị mkpa iji usoro abụọ dị iche iche na-elekọta insulin, otu maka ụdị insulin ọ bụla.

Dịka ihe eji akpachapụ anya, na-ebu ihe mgbe mgbe maka nnyefe insulin ọ bụrụ na NovoMix 30 Penfill gị furu efu ma ọ bụ mebie.

Kpachara anya maka iji ya ngwakọta ọhụrụ 30 penfilla.

NovoMix 30 Penfill na agịga bụ maka onwe gị. Emejukwala kadi nke Penfill. Enweghi ike iji NovoMix 30 Penfill mee ihe ma ọ bụrụ na agwakọta ya na-acha ọcha na urukpuru. Ekwesiri ime ka onye ọrịa mara mkpa ịgwakọta nkwusioru NovoMix 30 Penfill ozugbo tupu ojiji. Cannotgaghị enwe ike iji NovoMix 30 Penfill ma ọ bụrụ na agbajikwala. E kwesiri ịdọ ndị ọrịa aka na ntị ka ha tufuo agịga mgbe ọ bụla.

Mmetụta akụkụ.

Mmeghachi omume ọjọọ na-achọpụta na ndị ọrịa na-eji NovoMix 30 bụ isi n'ihi mmetụta ọgwụ insulin na-akpata. Ihe omume kachasị njọ na insulin bụ hypoglycemia. Ugboro nke mmetụta ndị metụtara ya na iji NovoMix 30 dịgasị iche dabere na ọnụ ọgụgụ ndị ọrịa, usoro ịsụ ọgwụ, yana njikwa glycemic.

Na nmalite ọmụmụ ọgwụ insulin, njehie na-egbu azụ, edema na mmeghachi omume nwere ike ime na ntụtụ
ọgwụ (gụnyere mgbu, redness, urticaria, mbufụt, hematoma, ọzịza na itching na ebe ntụtụ). Mgbaàmà ndị a anaghị adịte aka. Mmezi ngwa ngwa na njikwa glycemic nwere ike ibute ọnọdụ nke "nnukwu ihe mgbu neuropathy," nke na-agbanwegharị. Enstụgharị uche na ọgwụ insulin na mmụba dị mma n'ịchịkwa metabolism metabolism nwere ike ibute ịbelata nwa oge na ọnọdụ nke ọrịa mamịrị, ebe nkwalite ogologo oge na njikwa glycemic na-ebelata ohere nke inwe ọrịa mamị retinopathy. Edepụtara ndepụta nke mmetụta ndị dị na tebụl.

Nsonaazụ niile ndị a gosipụtara n’okpuru, dabere na data nnwale, nyochara usoro nyocha dị n’usoro dịka usoro MedDRA na sistem. A na-akọwapụta ntụpọ nke mmetụta ndị ọzọ dịka: ọtụtụ mgbe (≥1 / 10), ọtụtụ mgbe (≥ 1/100 na ọgwụ ọjọọ, na-ebelata nri oriri.

Ọrịa concoitant, nke na-efe efe ma na-efe efe, na -emekarị ahụ insulin nwere ahụ. Ọ ga-adị mkpa imeghari dose ma ọ bụrụ na onye ọrịa ahụ nwere ọrịa ndị akụrụ, akụrụ, ọrụ akwara, pisis gland ma ọ bụ azụ gland.

Mgbe ị na-ebufe onye ọrịa na ụdị insulin ndị ọzọ, ihe mgbaàmà mbụ nke ebido hypoglycemia nwere ike gbanwee ma ọ bụ belata ịkpọ aha karịa ndị na-eji ụdị insulin mbụ.

Nyefee onye ọrịa na usoro insulin ndị ọzọ. A ga-ebufe onye ọrịa na ụdị insulin ọ bụla ma ọ bụ ịkwado insulin nke onye nrụpụta ọzọ n'okpuru nlekọta ahụike siri ike. Ọ bụrụ ngbanwe ịta, ụdị, onye na-emepụta ihe na ụdị (insulin mmadụ, analog nke insulin mmadụ) na nkwadebe insulin na / ma ọ bụ usoro imepụta, enwere ike ịchọrọ ịgbanwe dose. Ndị ọrịa na-agbanwe site na insulin ndị ọzọ na ọgwụgwọ na NovoMix 30 Penfill nwere ike ịbawanye ugboro nke injections ma ọ bụ gbanwee dose ahụ tụnyere usoro nke insulin na-emebu. Ọ bụrụ na ọ dị mkpa, ịhazigharị ọgwụ, enwere ike ịme ya na ntụtụ mbụ nke ọgwụ ma ọ bụ n’izu mbụ ma ọ bụ ọnwa mbụ ọgwụgwọ.

Mmeghachi omume na ebe ntụtụ. Dị ka ọ dị na ọgwụgwọ insulin ndị ọzọ, mmeghachi omume nwere ike ịmalite na ebe ntụtụ, nke ihe mgbu, redness, hives, ọnya, hematomas, ọzịza na itching na-egosipụta. Changinggbanwe saịtị ntụtụ mgbe niile na mpaghara otu ahụ nwere ike belata mgbaàmà ma ọ bụ gbochie mmepe nke mmeghachi omume ndị a. Mmeghachi omume na-apụkarị n'ime ụbọchị ole na ole ruo ọtụtụ izu. N'ọnọdụ ndị a na-adịghị ahụkebe, ọ nwere ike ịdị mkpa ịkagbu NovoMix 30 Penfill n'ihi mmeghachi omume na saịtị ịgba ahụ.

Ojiji nke otu ọgwụ thiazolidinedione na nhazi insulin.A kọwo ọrịa banyere mmepe nke obi nkụda mmụọ na ọgwụgwọ nke ndị ọrịa nwere thiazolidinediones yana njikọ insulin, ọkachasị ma ọ bụrụ na ndị ọrịa dị otú ahụ nwere ihe ọghọm maka mmepe nke ọrịa obi na-adịghị ala ala. Ekwesiri iburu n'uche eziokwu a mgbe ị na-edepụta ọgwụ njikọta na thiazolidinediones na nkwadebe insulin na ndị ọrịa. Mgbe ị na-edepụta usoro ọgwụgwọ dị otú a, ọ dị mkpa iji nyochaa nyocha ahụike nke ndị ọrịa iji chọpụta akara na akara nke obi na-adịghị ala ala, oke ibu na ọnụnọ edema. Ọ bụrụ na mgbaàmà nke nkụda obi na-akawanye njọ n'ime ndị ọrịa, a ga-akwụsị ịgwọ ya na thiazolidinediones.

Mmetụta ikike ịkwọ ụgbọ ala ma jiri usoro rụọ ọrụ.Ike nke ndị ọrịa itinye uche na ọnụego mmeghachi omume nwere ike ọfụma n'oge hypoglycemia, nke nwere ike ịdị ize ndụ n'ọnọdụ ebe ikike ndị a dị ezigbo mkpa (dịka ọmụmaatụ, mgbe ha na-anya ụgbọala ma ọ bụ jiri igwe na arụ ọrụ).

A dụrụ ndị ọrịa ọdụ ka ha mee ihe iji gbochie mmepe nke hypoglycemia mgbe ha na-anya ụgbọala. Nke a dị ezigbo mkpa maka ndị ọrịa na-enweghị ma ọ bụ belata ihe mgbaàmà nke ihe ndị na - ebilite hypoglycemia ma ọ bụ na - ata ahụhụ site na ọrịa hypoglycemia ugboro ugboro. N'ụdị ndị a, ekwesịrị ịtụle maka ịkwọ ụgbọala na ịrụ ụdị ọrụ ahụ.

Dodoụbiga ya ókè.

E guzobeghi otu ọgwụ insulin riri oke, ma hypoglycemia nwere ike ịmalite nke nta nke nta ma ọ bụrụ na enyere insulin oke oke n'ihe metụtara mkpa onye ọrịa.

Onye ọrịa ahụ nwere ike iwepụ hypoglycemia dị nwayọọ site na ị gluụ glucose ma ọ bụ nri nwere shuga. Ya mere, a na-atụ aro ka ndị ọrịa nwere ọrịa shuga na-ebu ngwaahịa nwere shuga mgbe niile.

N'ihe banyere nnukwu hypoglycemia, mgbe onye ọrịa amaghị, 0.5 mg ka 1 mg nke glucagon kwesịrị ịnwe intramuscularly ma ọ bụ subcutaneously (onye a zụrụ azụ nwere ike ịnyere nchịkwa) ma ọ bụ usoro glucose ọbara (dextrose) (naanị ọkachamara n'ọgwụ nwere ike inye gị). Ọ dịkwa mkpa inye ọgwụgwọ dextrose intravenly ma ọ bụrụ na onye ọrịa ahụ enwetaghị onwe ya oge nkeji iri na ise 10-15 ka nchịkwa glucagon gasịrị. Mgbe ọ nwetasịrị onwe ya, a na-adụ onye ọrịa ọdụ iri nri nwere carbohydrate iji gbochie nlọghachi hypoglycemia.

Mmekọrịta na ọgwụ ndị ọzọ.

Hypoglycemic mmetụta nke insulin dịkwuo onu hypoglycemic ọgwụ ọjọọ, Mao inhibitors, Ace inhibitors, carbonic anhydrase inhibitors, ndị na-abụghị nhọrọ beta-blockers, bromocriptine, octreotide, sulphonamides, anabolic Steroid, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, ọgwụ ọjọọ Li +, ọgwụ ethanol na ọgwụ ethanol nwere. Ihe mgbochi oral, corticosteroids, homonụ thyroid, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazole, clonidine, BMKK, diazoxide, morphine, phenytoin, nicotine na-ebelata ike hypoglycemic mmetụta nke insulin. N'okpuru mmetụta nke reserpine na salicylates, ma ike na-agwụ ike ma na-abawanye na ọrụ ọgwụ a ga-ekwe omume.

Ọnọdụ ezumike si ụlọ ahịa ọgwụ.

Usoro na ọnọdụ nchekwa.

Chekwaa n 'okpomoku okpukpu 2 Celsius rue 8 Celsius (na friji), ma obughi nso friza. Emela ifriizi. Maka mepere emepe: Echekwala na friji. Na-echekwa na okpomọkụ agaghị akarị 30 Celsius. Jiri n'ime izu anọ.

Debe katọn n'ime igbe kaadi ọ bụla iji chebe ọkụ.

Ekwesịrị ka echedo NovoMix 30 Penfill pụọ na oke ọkụ na ọkụ. Ekwela ka ụmụaka ghara iru ya.

Ndụ shelf bụ afọ 2.

Ojiji nke ọgwụ Novomix 30 penfill naanị dị ka dọkịta nyere, a na-enye ntuziaka ahụ maka akwụkwọ!

Ofzọ nke ngwa maka NovoMix 30 Penfill n'ụdị nkwụsị

NovoMix® 30 Penfill® ezubere maka nchịkwa subcutaneous. Edoghachila NovoMix® 30 Penfill® intravenia, ebe nke a nwere ike ibute nnukwu hypoglycemia. Ekwesịrị izere nchịkwa intramuscular nke NovoMix® 30 Penfill®. Ejila NovoMix® 30 Penfill® maka infulinaneous insulin infusion (PPII) na insulin nfuli.

Ọ bụ dibia nke NovoMix® 30 Penfill® ka dọkịta kpebiri n’otu n’otu n’otu, dabere na mkpa nke onye ọrịa. Iji mezuo ọkwa glycemia zuru oke, a na-atụ aro ka ịchịkwa ịba ụba nke glucose na ọbara ma dozie ogo nke ọgwụ.

Enwere ike ịkọwa ndị ọrịa nwere ụdị ọrịa shuga 2, NovoMix® 30 Penfill both dị ka monotherapy yana yana ọgwụ hypoglycemic nke ọnụ na-achịkwa n'ọnọdụ ebe ọkwa glucose ọbara na-adịghị edozi nke ọma site na ọgwụ hypoglycemic nke ọnụ.

Maka ndị ọrịa nwere ụdị shuga 2 nke na-ebu ụzọ nye ọgwụ insulin, usoro ọgwụgwọ a chọrọ maka NovoMix® 30 Penfill® bụ nkeji isii tupu nri ụtụtụ yana nkeji isii tupu nri abalị. Anabatakwa iwebata 12 maka NovoMix® 30 Penfill® otu ugboro n'ụbọchị mgbede (tupu nri abalị).

Nyefee onye ọrịa na ọgwụ insulin ndị ọzọ

Mgbe ị na-ebufe onye ọrịa site na insulin nke mmadụ bi na NovoMix® 30, Penfill® kwesịrị ịmalite site na otu usoro na usoro nchịkwa. Mgbe ahụ dozie dose ahụ dabere na mkpa onwe onye nke onye ọrịa (lee ndụmọdụ ndị a maka otu ụzọ nke ọgwụ ahụ si chọọ). Dịka oge niile mgbe ị na-ebufe onye ọrịa na ụdị insulin ọhụrụ, a chọrọ nlekọta ahụike siri ike n'oge ịnyefe onye ọrịa na izu mbụ nke iji ọgwụ ọhụrụ.

Nokwalite ọgwụgwọ NovoMix® 30 Penfill® ga-ekwe omume site na ịgbanwere otu ugboro kwa ụbọchị gaa ugboro abụọ. A na-atụ aro ka ị rachara ọgwụ iri atọ ọgwụ ọgwụ gbanyere NovoMix® 30 Penfill® ugboro abụọ n'ụbọchị, kewaa ọgwụ ahụ ụzọ abụọ nha - ụtụtụ na mgbede (tupu nri ụtụtụ na nri abalị). Ntughari na ojiji nke NovoMix® 30 Penfill® ugboro atọ n'ụbọchị ga-ekwe omume site na ịkekọrịta ụtụtụ ụtụtụ ụzọ abụọ na iwebata akụkụ abụọ a n'ụtụtụ na nri ehihie (ugboro atọ kwa ụbọchị).

Iji dozie dose nke NovoMix® 30 Penfill®, a na-eji mkpokọta ọbara glucose dị ala nke na-ebu ọnụ karịa ụbọchị atọ gara aga.

Iji chọpụta izu ike dị na ọgwụ gara aga, jiri uru nke mkpokọ glucose dị n'ọbara tupu nri ọzọ.

Enwere ike ịme mgbanwe dose otu ugboro n'izu ruo mgbe eburu oke ebumnuche HbA1c aka.

Emekwala elu nke ọgwụ a ma ọ bụrụ na a hụrụ hypoglycemia n'oge a.

Imeghari dose nwere ike ịdị mkpa mgbe ị na-eme ka ahụ onye ọrịa dị, na-agbanwe nri ọ na-eri, ma ọ bụ nwee ọnọdụ na-apụ apụ.

Iji hazie dose nke NovoMix® 30 Penfill®, a na-atụ aro ka ndị a

Ọbara glucose n’iru tupu nri

Ndị otu ọrịa pụrụ iche

Dị ka oge niile, mgbe ị na-eji nkwadebe insulin, na ndị ọrịa nke ìgwè pụrụ iche, a ga-eji nlezianya na-achịkọta glucose ọbara ma na-agbatị usoro ọgwụgwọ dị iche iche.

Ndị okenye na ndị okenye maara ọrụ

Enwere ike iji NovoMix® 30 Penfill® na ndị ọrịa meworo agadi, agbanyeghị, ahụmịhe ya na ojiji ya na ọgwụ hypoglycemic ọgwụ na ndị ọrịa okenye karịa afọ 75 nwere mmachi.

Ndị ọrịa nwere nsogbu gbasara akụrụngwa na arụ ọrụ:

N'ime ndị ọrịa nwere akụrụ gbasara akwara ma ọ bụ ọrịa hepatic, enwere ike belata mkpa nke insulin.

Childrenmụaka na ndị nọ n’oge uto:

Enwere ike iji NovoMix® 30 Penfill® gwọọ ụmụaka na ndị nọ n'afọ iri n’agbata afọ 10 n ’ebe ejiri mmasị insulin gwakọtara. Enwere amachaghị banyere ụlọ ọgwụ dị afọ ole ụmụaka dị afọ 6-9 (lee ngalaba Nlekọta ọgwụ).

Ekwesịrị ịnwe NovoMix® 30 Penfill sub subcutaneously na apata ụkwụ ma ọ bụ mgbidi akụkụ ihu. Ọ bụrụ na achọrọ, a ga-enye ọgwụ a n'ubu ma ọ bụ buttocks.

Okwesiri igbanwe ebe ogwu ngbanyere na mpaghara anatomical iji gbochie mmepe nke lipodystrophy. Dị ka ọ dị na nhazi insulin ọ bụla, oge ọrụ NovoMix® 30 Penfill® na-adabere na ntinye, ebe nchịkwa, ike ọbara na-agba, okpomọkụ na ọkwa nke mmega ahụ.

E jiri ya tụnyere insulin nke mmadụ bi, NovoMix® 30 Penfill® na-eme ngwa ngwa, yabụ, ekwesịrị inye ya ozugbo tupu nri. Ọ bụrụ na ọ dị mkpa, enwere ike ịhazi NovoMix® 30 Penfill® mgbe obere nri gachara.

Etu esi eji: usoro onunu ogwu na usoro ọgwụgwọ

S / c na apata ụkwụ ma ọ bụ mgbidi akụkụ ihu. Ọ bụrụ na ọ dị mkpa, na mpaghara ubu ma ọ bụ aka ekpe. Okwesiri igbanwe ebe ogwu ngbanyere na mpaghara anatomical iji gbochie mmepe nke lipodystrophy. A na-enye ọgwụ ahụ ozugbo tupu nri, ma ọ bụrụ na ọ dị mkpa, ozugbo nri. Okpomoku nke mmanu insulin kwesiri ino na okpomoku.

Ọ bụ dọkịta ga-ekpebi ọ̀tụ̀tụ̀ ọgwụ ahụ n’otu n’otu n’otu, dabere n’ịchịkọta glucose dị n’ọbara. Na nkezi, kwa ụbọchị NovoMix 30 Penfill bụ 0,5-1 U / n'arọ ahụ. N'ime ndị ọrịa nwere insulin na-eguzogide ọgwụ (gụnyere n'ihi oke ibu), enwere ike ịbawanyewanye mkpa insulin kwa ụbọchị, na ndị ọrịa nwere resingenous secretion nke insulin, enwere ike belata ya.

Insulin NovoMiks: dose nke ọgwụ maka ochichi, nyocha

Insulin NovoMiks bụ ọgwụ nke enwere ọgwụ analorọ nke homonụ na-ebelata mmadụ. A na-eme ya na ọgwụgwọ nke ọrịa mellitus, ma insulin na-adabere na ụdị ndị na-abụghị insulin. N'oge egwusi, ọrịa a na-agbasa n'akụkụ niile nke mbara ụwa, ebe 90% ndị ọrịa mamịrị na-arịa ụdị nke abụọ nke ọrịa ahụ, 10% fọdụrụ - site n'ụdị nke mbụ.

Inje in insulin dị mkpa, na enweghị nchịkwa zuru oke, mmetụta a na-agbanwe agbanwe na ahụ yana ọbụna ọnwụ na-eme. Ya mere, onye ọ bụla nwere ọrịa shuga mellitus, ezinụlọ ya na ndị enyi ya kwesịrị ka ha 'nwee ihe ọmụma' banyere ọgwụ hypoglycemic ọgwụ na insulin, yana iji ya eji eme ihe.

Denmark nọ na insulin nọ n'ụdị nkwusioru, nke dị na katriiki 3 ml (NovoMix 30 Penfill) ma ọ bụ pen pen 3 ml (NovoMix 30 FlexPen). Nkwụsị ahụ bụ agba ọcha, mgbe ụfọdụ ịkpụcha flakes ga-ekwe omume. Site na ntuzi nke ọcha na mmiri iyi n’elu ya, ịkwesịrị ịma jijiji ya, dị ka akọwara n’ime ntuziaka etinyere.

Ihe dị n'ime ọgwụ ahụ bụ insulin aspart (30%) na kristal, yana insulin aspart protamine (70%). Na mgbakwunye na mmiri ndị a, ọgwụ ahụ nwere obere glycerol, metacresol, sodium hydrogen phosphate dihydrate, zinc chloride na ihe ndị ọzọ.

Nkeji 10-20 mgbe iwebata ọgwụ n'okpuru anụ ahụ, ọ na-amalite nsonaazụ hypoglycemic ya. Nlekọta insulin na-ejikọ ya na ndị na-anabata homonụ, yabụ sel sel mmadụ na-abanye glucose ma na - egbochi mgbochi ya imeju. A na - ahụta mmetụta kachasị ukwuu nke nchịkwa insulin mgbe awa 1-4 gachara, nsonaazụ ya na-adịgidekwa ruo awa 24.

Ọmụmụ ọgwụ mgbe a na - ejikọ insulin na ọgwụ na - agbada shuga nke ụdị ọrịa shuga abụọ gosipụtara na NovoMix 30 na nchịkọta metformin nwere mmetụta hypoglycemic dị ukwuu karịa nchikota nke sulfonylurea na usoro metformin.

Agbanyeghị, ndị ọkà mmụta sayensị anwalebeghị mmetụta ọgwụ ahụ nwere n'ahụ ụmụaka na-eto eto, ndị agadi na-arịa ọrịa na-arịa ọrịa imeju ma ọ bụ akụrụ.

Naanị dọkịta nwere ikike ịkọpụta usoro insulin kwesịrị ekwesị, na-eburu n'uche ogo glucose n'ọbara onye ọrịa. Ekwesiri icheta na a na-enye ọgwụ ahụ ma ụdị ọrịa mbụ yana yana ọgwụgwọ na-adịghị ike nke ụdị nke abụọ.

Nyere na homonụ nke biphasic na-arụ ngwa karịa homonụ nke mmadụ, a na-enyekarị ya tupu eri nri, ọ bụ ezie na ọ ga-ekwe omume ịchịkwa ya n'oge na-adịghị anya nri.

Ngosiputa gosiputara onye choria mamiri na homonu, dabere na ibu ya (na kilo kilogram), bu ihe 0,5-1 nke ime ihe kwa ubochi. Sụ ọgwụ kwa ụbọchị nwere ike ịbawanye na ndị ọrịa anaghị eche banyere homonụ (dịka ọmụmaatụ, buru oke ibu) ma ọ bụ ibelata mgbe onye ọrịa ahụ nwere ụfọdụ ihe insulin mepụtara. Ọ kachasị mma ịgbanye na mpaghara apata ụkwụ, mana ọ ga-ekwe omume na mpaghara apata ụkwụ ma ọ bụ ubu. Ọ bụ ekwesighi ịkwụsi ike n'otu ebe, ọbụlagodi n'otu ebe.

Enwere ike iji insulin NovoMix 30 FlexPen na NovoMix 30 Penfill dị ka isi ngwaọrụ ma ọ bụ na njikọta ọgwụ hypoglycemic ndị ọzọ. Mgbe ejikọtara ya na metformin, ọgwụ izizi nke homonụ bụ 0.2 nkeji ihe kwa kilogram kwa ụbọchị. Dọkịta ga-enwe ike gbakọọ dose nke ọgwụ abụọ a dabere na ngosipụta nke glucose n'ọbara na njirimara onye ọrịa. Ekwesiri iburu n'uche na ezigharị ọbara nke akụrụ ma ọ bụ imeju nwere ike ịkpalite mbelata mkpa ị nwere ọrịa mamịrị na insulin.

A na-elekọta NovoMix naanị subcutaneously (karịa maka usoro algorithm maka ijikwa insulin subcutaneously), a machibidoro iwu ime injers n'ime akwara ma ọ bụ intravenously. Iji zere ịmalite nke infiltrates, ọ na-adịkarị mkpa ịgbanwe mpaghara ntụtụ. Enwere ike ịgba ntụtụ n'ebe niile ekwuputagogo na mbụ, mana nsonaazụ nke ọgwụ ahụ na-amalite n'oge tupu ịmalite ya na mpaghara ukwu.

A na-echekwa ọgwụ ahụ maka mmụọ nke afọ site na ụbọchị ahapụ. A na-echekwa ihe ngwọta ọhụrụ a na-ejighị ya na katalọgụ ma ọ bụ mkpịsị sirinji na friji site na ogo 2 ruo 8, ma jiri ya mee ihe na ụlọ okpomọkụ erughị ụbọchị iri atọ.

Iji gbochie ìhè anyanwụ ịbanye, a ga-eyiri okpu nchebe na sirinji.

NovoMix enweghị ihe mgbochi ọ bụla ma e wezụga maka mbelata shuga dị ngwa ma ọ bụ nwekwuru ike ịgbanye ihe ọ bụla dịnụ.

Ọ kwesiri iburu n'uche na mgbe nwa ahụ na-amụ nwa, ọ nweghị mmetụta ọ bụla dị n’ahụ nne na-atụ anya ya na nwa ya.

Mgbe ị na-enye nwa ara, enwere ike inye ya ọgwụ insulin, ebe ọ bụ na enyeghị ya mmiri ara ehi nye nwa ọhụrụ ahụ. Ma, tupu iji NovoMix 30, nwanyị kwesịrị ịga hụ dọkịta ga-edepụta usoro ọgwụgwọ ọ bụla.

Banyere ihe ọghọm dị na ọgwụ ahụ, ọ kachasị metụtara ogo nke usoro onunu ogwu. Ya mere, ọ dị ezigbo mkpa na ịhazi ọgwụ edepụtara, na-agbaso ndụmọdụ dọkịta. Nsonaazụ ndị enwere ike ịgụnye:

1. Ọnọdụ nke hypoglycemia (karịa ihe hypoglycemia dị na ọrịa shuga), bụ nke nsụhọ mmụọ na ọdịdọ wee soro.
2. Ahụike n ’anụ ahụ, urticaria, itching, sweating, anaphylactic reaction, angioedema, mụbara mkpụrụ-obi ma belata ọbara mgbali elu.
3. Mgbanwe na ntụgharị uche, oge ụfọdụ - mmepe nke retinopathy (nsị nke arịa nke retina).
4. Lipid dystrophy na ebe a na-agba ntụtụ, yana ọbara-ọbara na ọzịza na ntụtụ ahụ.

N'ọnọdụ ndị pụrụ iche, n'ihi akpachapụghị anya nke onye ọrịa, ị anụbiga ihe ókè nwere ike ime, mgbaàmà nke dị iche iche, dabere n'ịdị njọ nke ọnọdụ ahụ. Ihe ịrịba ama nke hypoglycemia bụ iro ụra, ọgba aghara, ọgbụgbọ, ọgbụgbọ, tachycardia.

N'ịdoụbiga mmanya ókè, onye ọrịa kwesịrị iri ngwaahịa nwere nnukwu shuga. Ọ nwere ike ịbụ kuki, swiiti, ihe ọ juiceụ sweetụ na-atọ ụtọ, ọ bụ ihe amamihe dị na ya ịnwe ihe na ndepụta a. Nnukwu nnukwute ọgwụ chọrọ nchịkwa glucagon ozugbo, ma ọ bụrụ na ahụ onye ọrịa anaghị anabata nsị glucagon, onye na-eweta ya ga-enyerịrị glucose.

Mgbe o mechara usoro ahụ, onye ọrịa ahụ kwesịrị ị toụ carbohydrates dị mfe ngwa ngwa iji gbochie hypoglycemia ugboro ugboro.

Mgbe ị na-a Noụ ọgwụ insulin NovoMix 30, ekwesịrị ịnye eziokwu na ụfọdụ ọgwụ nwere mmetụta hypoglycemic ya.

Mmanya na - abawanye na - eme ka ọ belata shuga nke insulin, ndị na - egbochi beta-adrenergic na - ekpuchi ihe ịrịba ama nke ọnọdụ hypoglycemic.

Dabere na ọgwụ ndị e jikọtara ya na insulin, ihe ọ na-arụ nwere ike ịbawanye elu ma belata.

A na-achọpụta mbelata nke ihe choro homonụ mgbe ị na-eji ọgwụ ndị a:

• ọgwụ n'ime hypoglycemic ọgwụ,
• monoamine oxidase inhibitors (MAO),
• angiotensin na - agbanwe enzyme (ACE)
• ndị na - abụghị nhọrọ beta-adrenergic,
• octreotide
• anabolic steroid
• salicylates,
• sulfonamides,
• mmanya na-egbu egbu.

Drugsfọdụ ọgwụ ọjọọ na-ebelata ọrụ insulin ma na-abawanye mkpa onye ọrịa nwere. Usoro dị otú a na - apụta mgbe eji:

1. homonụ thyroid
2. glucocorticoids,
3. nnabata ọmiko
4. danazole na thiazides,
5. contraceptives na-ewere n'ime.

Drugsfọdụ ọgwụ n’ozuzu adabaghị na insulin NovoMix. Nke a bụ, nke mbụ, ngwaahịa nwere thiols na sulfites. A machibidoro ọgwụ a ịgbakwunye na ngwakọta infusion. Iji insulin ya na ndị ọrụ a nwere ike ibute nsonaazụ dị oke njọ.

Ebe ọ bụ na emepụtara ọgwụ ahụ ná mba ọzọ, ọnụahịa ya dị oke elu. Enwere ike ịzụta ya na ndenye ọgwụ na ụlọ ahịa ọgwụ ma ọ bụ nye ya iwu n'ịntanetị na ebe nrụọrụ ere nke onye na-ere ahịa. Ọnụ ego ọgwụ a na-akwụ dabere ma ihe ngwọta dị na katriiki ma ọ bụ mkpịsị sirinji na nke nkwakọ ngwaahịa. Ọnụahịa ahụ dịgasị iche maka NovoMix 30 Penfill (katridges 5 kwa otu) - site na 1670 ruo 1800 rubles, na NovoMix 30 FlexPen (mkpụrụ ego sirinji 5 kwa mkpọ) nwere ọnụ ahịa na ọnụego site na 1630 ruo 2000 Russian rubles.

Nyocha nke ọtụtụ ndị ọrịa mamịrị na-agbanye na homonụ biphasic dị mma. Fọdụ na-ekwu na ha tụgharịrị na NovoMix 30 mgbe ha jisịrị ndị ọzọ ọgwụ insulins. N'akụkụ a, anyị nwere ike ịme ka uru ndị dị na ọgwụ ahụ dị ka mfe nke iji ya na mbelata ohere nke hypoglycemic ọnọdụ.

Na mgbakwunye, ọ bụ ezie na ọgwụ ahụ nwere ndepụta dị ukwuu nke mmeghachi omume na-adịghị mma, enwere ike ime. Ya mere, enwere ike ịtụle NovoMix dị ka ọgwụ nke ịga nke ọma.

N'ezie, enwere nyocha na n'ọnọdụ ụfọdụ ọ dabara na ya. Ma ọgwụ ọ bụla nwere contraindications.

N'ọnọdụ ebe ọgwụgwọ adịghị mma maka onye ọrịa ma ọ bụ kpatara nsonaazụ, dibịa na-aga ahụ nwere ike ịgbanwe usoro ọgwụgwọ. Iji mee nke a, ọ na-edozigharị ọgwụ nke ọgwụ ahụ ma ọ bụ kwetachaa iji ya. Ya mere, ọ dị mkpa iji ọgwụ nwere mmetụta hypoglycemic yiri ya.

O kwesiri iburu n’uche NovoMix 30 FlexPen na NovoMix 30 Penfill enweghị analogues n’ime akụrụngwa nọ n'ọrụ - insulin aspart. Dọkịta nwere ike inye gị ọgwụ nke nwere ụdị ihe ahụ.

A na-ere ọgwụ ndị a site na ndenye ọgwụ. Ya mere, ọ bụrụ na ọ dị mkpa, ọgwụ insulin, onye ọrịa ahụ ga-agakwuru dọkịta.

Ọgwụ ndị nwere mmetụta yiri ya:

1. Humalog Mix 25 bu ihe nlere anya nke homonụ nke aru mmadu mepụtara. Akụkụ bụ isi bụ insulin lispro. Ọgwụ nwekwara mmetụta dị mkpirikpi site na ịhazi ọkwa glucose na metabolism ya. Ọ bụ nkwụchi ọcha, a na-ewepụta ya n’akwụkwọ sirinji akpọrọ Ndenye Pen. Nkezi ego otu ogwu (ogwu drọ 5 nke 3 ml n’otu n’otu) bu 1860 rubles.
2. Himulin M3 bụ insulin na-arụ ọrụ na-arụ ọrụ nke ewepụtara na nkwusioru. Obodo imepụta ọgwụ bụ France. Ihe na-arụ ọrụ nke ọgwụ ahụ bụ insulin biosynthetic mmadụ. Ọ na - eme ka ịbawanye ụba nke glucose dị n'ọbara n'emeghị mmalite nke hypoglycemia. Na ahịa ọgwụ Russia, enwere ike ịzụta ụdị ọgwụ dị iche iche, dịka Humulin M3, Humulin Regular, ma ọ bụ Humulin NPH. Ọnụ ego ọgwụ ahụ (pensụ 5 pensụ nke 3 ml) na 1200 rubles.

Ogwu ọgbara ọhụrụ agbagola, ugbu a ọ dị mkpa ka agba ya insulin naanị ugboro ole na ole n'ụbọchị. Mpempe sirinji ndị adabara adaba usoro a ugboro ugboro. Ahịa ọgwụ na-enye ọtụtụ nhọrọ nke insulins sịntetik dịgasị iche iche. Otu n'ime ọgwụ ndị a ma ama bụ NovoMix, nke na-ebelata ọkwa shuga ka ọ dị ka ụkpụrụ kwesịrị ịdị ma ghara ibute hypoglycemia. Ojiji o kwesịrị, yana nri na mmega ahụ ga-eme ka ndụ ndị ọrịa mamịrị wee dị ogologo ma na-egbu mgbu.

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INSULINUM ASPARTUM A10A D05

Mmechi na ụdị ISE:

kwụsịtụ. d / n’ime. 100 Carter IU / ml 3 ml, akwu. n’ime mkpụrụ akwụkwọ sirinji, Nke 1, Nke 5

Nke UA / 4862/01/01 site na 02/15/2010 ruo 02/15/2015

hypoglycemia, hypersensitivity na insulin aspart ma ọ bụ ihe ọ bụla n’ime ọgwụ ahụ.

mmeghachi omume ọjọọ na-achọpụta na ndị ọrịa na-eji NovoMix 30 FlexPen na-ejikọ ọnụ na ogo nke ọgwụ a na-achịkwa ma bụrụ ngosipụta nke ọgwụ insulin. Ihe kachasị akpata mmetụta insulin na-arụ bụ hypoglycemia. Ọ nwere ike ime ma ọ bụrụ na dose ahụ karịrị mkpa nke insulin na-arịa ya. Nnukwu ọbara ọgbụgba nwere ike ibute nsụhọ na / ma ọ bụ ihe ọdịdọ, nke na-esote nkwarụ nwa oge ma ọ bụ nke na-adịgide adịgide nke ọrụ ụbụrụ yana ọnwụ. Dabere na nsonaazụ nke ọmụmụ ụlọ ọgwụ, yana data edekọtara mgbe ebubata ọgwụ ahụ n'ahịa, ọnọdụ nke nnukwu hypoglycemia dịgasị iche iche na ndị ọrịa yana usoro usoro onunu ogwu dị iche iche, ọnọdụ nke nnukwu hypoglycemia na ndị ọrịa na-anata insulin dị ka nke ahụ na ndị na-anata mmadụ. insulin
Ihe na-esote ya bụ ugboro ugboro nke mmeghachi omume na-emebi emebi na, dị ka ọmụmụ banyere ụlọ ọgwụ, enwere ike jikọta ya na ntinye nke ọgwụ NovoMix 30 Flexpen.
Dika ugboro ihe mere, a na-ekewa mmeghachi omume ndị a mgbe ụfọdụ (>1/1000, 1/10 000,

• Mkpado: Novo Nordisk, NOVOMIX 30 FLEXPEN, NOVOMIX 30 FLEXPEN

Omume ọgwụ

Ọrịa hypoglycemic, bụ analog nke insulin nke mmadụ.

Ọ na - emekọrịta otu onye na - anabata ihe na akpụkpọ ahụ dị na mpụta ahụ wee mepụta insulin-receptor complex nke na - akpali usoro intracellular, gụnyere njikọ nke ọtụtụ isi enzymes (hexokinase, pyruvate kinase, glycogen synthetase). Mbelata nke mkpokọta glucose na ọbara bụ n'ihi mmụba nke ụgbọ njem akwara ya, ịba ụba site na anụ ahụ, mkpali nke lipogenesis, glycogenogenesis, na mbelata ọnụego glucose mepụtara site na imeju.

Ọ nwere ụdị ọrụ insulin na-ahụ maka mmadụ. Igha nkpuru nke amino acid n’eburu n’onodu B28 ya na aspartic acid na –ebelata udiri umu irighiri ihe wee kee okpukpo ahu nke ogwu, bu nke a na - ahu n’ime insulin nke mmadu nwere. N'akụkụ a, a na-enweta insulin aspart na abụba dị n'okpuru ala karịa ngwa ngwa insulin na-adị n'ime insulin nke mmadụ. A na-etinye insulin aspart protamine ogologo oge.

Mgbe nchịkwa s / c nke NovoMix 30 Penfill, mmetụta ahụ na-etolite mgbe nkeji 10-20, mmetụta kachasị - na awa 1-4. Ogologo oge nke NovoMix 30 Penfill ruru awa 24 (dabere na dose, ebe nchịkwa, mmụba ọbara, oke ahụ, ogo ahụ na ọkwa nke mmega ahụ. )

Nhazi ọkwa nosological (ICD-10)

NOVOMIKS 30 Flexpen - ụdị ntọhapụ, ihe mejupụtara na nkwakọ

Nkwụsị maka njikwa SC dị ọcha, ịkpa agwa (na-enweghị eriri, flakes nwere ike ịpụta na ihe nlere ahụ), mgbe stratified, ọ stratifies, na-akpụ ụcha ọcha na nke enweghị agba ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ nke na-enweghị ụcha, jiri nlezianya na-akpali nkwusioru homogeneous kwesịrị ịmalite.

PRING glycerol, phenol, metacresol, zinc chloride, sodium chloride, sodium hydrogen phosphate dihydrate, protamine sulfate, sodium hydroxide, hydrochloric acid, mmiri d / i.

* Otu 1 kwekọrọ na 35 μg (ma ọ bụ 6 nmol) nke insulin insulin na-agba.

3 ml (300 PIECES) - katrized karama (1) - diski pensụl ọtụtụ ọgwụ ọnya maka ọtụtụ injections (5) - ngwugwu nke kaadiboodu.

Ihe analog nke insulin mmadu n’eji oge n’eji oge amalite.

NovoMix 30 Flexpen bụ nkwusioru nke abụọ nke mejupụtara insulin asrel so 30 (analog insulin insulin na-arụ ọrụ obere oge) na kristal aspart proulinine insulin (70% ọkara insulin analog).

Nlele insulin nwetara site na ihe omumu ihe omumu nke ihe omimi nke DNA site na iji aru nke Saccharomyces cerevisiae.

Insulin aspart bụ ihe mmadụ na-agbanye insulin na-eme ka mmadụ sie ike dabere na ngosipụta oke.

Mbelata mgbanye glucose n'ọbara na-apụta n'ihi mmụba nke ụgbọ njem intracellular mgbe njikọ insulin na-egbochi ndị na-anabata insulin nke uru ahụ na anụ abụba na mgbochi nke imeju na -emepụta site na umeji.

Mgbe nchịkwa ọgwụ ọgwụ NovoMix 30 Flexpen gasịrị, nsonaazụ ahụ na-amalite mgbe nkeji 10-20 gachara. A na - ahụkarị nsonaazụ kachasị elekere bụ elekere 1-4 mgbe a gbasesịrị.Ogologo oge ọgwụ ahụ ruru awa 24.

N'ime ule nlele ọnwa atọ nke metụtara ndị ọrịa nwere ọrịa shuga 1 na ụdị 2 ndị natara NovoMix 30 Flex Pen na insulin nke mmadụ 30 ugboro 2 / ụbọchị tupu nri ụtụtụ na nri abalị, NovoMix 30 FlexPen gosipụtara belata mkpụkọ glucose postprandial n'ọbara karịa. (mgbe nri ụtụtụ na nri abalị).

Ntụle meta nke data enwetara na nnwale 9 nke nyocha metụtara ndị ọrịa nwere ụdị 1 na ụdị ọrịa shuga gosiri na NovoMix 30 FlexPen, mgbe a na-achịkwa ya tupu nri ụtụtụ na nri abalị, na-enye njikwa mma karịa postprandial ịba uru glucose n'ọbara (nkezi nke mmụba nke prandial glucose ịta mgbe nri ụtụtụ, nri ehihie na nri abalị), ma e jiri ya tụnyere insulin nke biphasic 30. Ọ bụ ezie na ọnụ ọgụgụ glucose na-ebu ọnụ na ndị ọrịa na-anata Novo Mix 30 FlexPen dị elu, n'ozuzu NovoMix 30 FlexPen na-egosipụta otu ystvie ịta nke glycosylated haemoglobin (HbA_1C) dika insulin nke mmadu dika insulin 30.

N'ime nyocha nke ụlọ ọgwụ metụtara ndị ọrịa nwere ụdị ọrịa shuga 2 nke mellitus (n = 341), enwere ndị ọrịa na NovoMix 30 FlexPen, NovoMix 30 FlexPen na ngwakọta na metformin na metformin na nchịkọta nke sulfonylurea. HbA ịta_1C mgbe izu 16 gasịrị ọgwụgwọ adịghị iche na ndị ọrịa na-anata NovoMix 30 Flexpen na njikọ metformin na ndị ọrịa na-anata metformin na mgbakwunye na usoro sulfonylurea. Na omumu a, 57% nke ndị ọrịa nwere ọnụọgụ HbA_1C dị elu karịa 9%, na ọgwụgwọ ndị ọrịa a na NovoMix 30 FlexPen na mgbakwunye na metformin butere mgbadawanye ukwuu na mkpokọta HbA_1Ckaria na ndi oria na anata metformin na nchikota sulfonylurea.

N'ime ọmụmụ ihe ọzọ, ndị ọrịa nwere ụdị ọrịa shuga 2 nke na-adịghị mma nke na-achịkwa glycemic nke na-a oụ ọgwụ hypoglycemic ọgwụ na-enweghị usoro nye ndị otu a: NovoMix 30 FlexPen ugboro abụọ / ụbọchị (ndị ọrịa 117) na insulin glargine 1 oge / ụbọchị (ndị ọrịa 116). Mgbe izu 28 gasịrị iji ọgwụ ọjọọ eme ihe, ọnụego ọnụ na HbA_1C n'ime otu ngwa NovoMix, 30 Flexpen bụ 2.8% (uru ọkara mbụ bụ 9.7%). A kọwara 66% na 42% nke ndị ọrịa na-eji NovoMix 30 FlexPen site na ụkpụrụ HbA na njedebe nke ọmụmụ ahụ._1C n'okpuru 7% na 6.5% n'otu n'otu. Igwe glucose plasma na-ebu ọnụ belatara ihe dị ka 7 mmol / L (site na 14 mmol / L na mbido ọmụmụ ahụ ruo 7.1 mmol / L).

Nsonaazụ nke nyocha nke meta nke data enwetara site na nnwale ụlọ ọgwụ metụtara ndị ọrịa nwere ụdị ọrịa shuga abụọ nke ọrịa shuga gosipụtara mbelata ọnụ ọgụgụ nke ọrịa nocturnal hypoglycemia na hypoglycemia siri ike na NovoMix 30 FlexPen ma e jiri ya tụnyere insulin nke mmadụ bi 30. hypoglycemia na ndị ọrịa na-anata NovoMix 30 Flexpen dị elu.

Emere ọmụmụ banyere izu iri na isii n'ime ụmụaka na ndị nọ n'afọ iri na ụma nke jiri glucose ọbara tụnyere nri mgbe ọ nwụrụ na NovoMix 30 FlexPen (tupu nri), insulin / biphasic mmadụ na-elekọta mmadụ 30 (tupu nri) na insulin-isophan (nke a na-ebu tupu ụra). Ọmụmụ ihe ahụ metụtara ndị ọrịa 167 dị afọ 10 ruo 18. HbA averages_1C ke otu mbiba emi ama aka iso odu uwem ke akpa ukpepn̄kpọ oro. Ọzọkwa, mgbe ị na-eji NovoMix 30 Flexpen ma ọ bụ insulin nke mmadụ bi 30, ọ nweghị ọdịiche dị na ọnọdụ hypoglycemia. Emere ihe omumu nke nwere okpukpu abuo n’ime onu ogugu n’etiti ndi oria noo n’agbata afọ isii rue afọ iri na abụọ (ngụkọta ndị ọrịa 54, izu iri abụọ maka ụdị ọgwụgwọ ọ bụla)Ọnọdụ nke hypoglycemia na mmụba nke glucose mgbe o riri nri n’òtù ndị NovoMix 30 FlexPen mesoro belatara nke ukwuu ma e jiri ya tụnyere ụkpụrụ dị n’òtù ahụ site na iji insulin nke mmadụ na-arịa ọrịa biphasic 30. ụkpụrụ HbA_1C na njedebe nke ihe omumu a, n'ime otutu insulin nke mmadu bi 30 na-adi ala karie na otu ha jiri NovoMix 30 Flexpen.

Agụghị ọgwụ ọgwụ nke NovoMix 30 FlexPen na ndị agadi na ndị ọrịa maara. Agbanyeghị, n'ọmụmụ ihe nyocha gbara okpukpu abụọ nwere ụdị nyocha emere na ndị ọrịa 19 nwere ụdị ọrịa shuga 2 dị afọ 65-83 (afọ pụtara afọ 70), e jiri ọgwụ pharmacodynamics na pharmacokinetics nke insulin na -akpata ọgwụ mmadụ. Ndi iche iche di iche n’iche banyere ogwu nke ogwu (glucose infusion pressure - GIR)_max na mpaghara dị n'okpuru usoro nke usoro mbulata ya maka 120 min mgbe nchịkwa insulin insulin - AUC_{GIR, 0-120 min}) n'etiti insulin aspart na insulin mmadụ na ndị ọrịa mere agadi dị ka nke ndị ọrụ afọ ofufo siri ike na ndị ọrịa na-eto eto na-arịa ọrịa mellitus.

Na insulin aspart, nnọchi nke proino amino acid nọ n'ọnọdụ B28 maka aspartic acid na -ebelata ọchịchọ nke ụmụ irighiri ihe ịkpụkọ anụ ahụ na NovoMix F 30 FlexPen lu 30 FlexPen ®, nke a na-ahụta na insulin na -akpata mmadụ. N'akụkụ a, a na-enweta insulin aspart (30%) site na abụba subcutaneous ngwa ngwa karịa insulin na -akari nwere insulin nke mmadụ. 70% fọdụrụnụ na-ada n'ụdị crystalline nke protamine-ipsulin aspart, ọnụego nnabata nke ya na nke insulin NPH nke mmadụ.

Mgbe ị na-etinye NovoMix ® 30 FlexPen ® C_max insulin insulin dị nkezi 50% dị elu karịa mgbe ị na-eji insulin na-eme mmadụ ihe 30, ebe oge ị ga-eru C_max Ugboro abụọ obere na nkezi. Mgbe nchịkwa s / c nke ndị ọgwụ ahụ nyere ndị ọrụ afọ ofufo ahụike nwere ogo nke 0.2 U / n'arọ kilogram ogo C_max insulin aspart bụ 140 ± 32 pmol / L ma rụpụtara ya ka nkeji 60 gachara.

N'ime ndị ọrịa nwere ụdị ọrịa shuga mellitus nke 2_max mejupụtara nkeji iri itoolu na ise mgbe nchịkwa ma na-adịgide karịa nke mbụ ma ọ dịkarịa ala elekere 14

Ọgwụ insulin insulin na-alaghachi ọkwa mbụ ya ka ọ gachara awa iri na ise ruo awa iri na asatọ ka ọ gbasasịrị.

Ndi_1/2na-egosipụta ọnụọgụ nke nnabata nke mgbakwunye protamine bụ elekere 8-9

Pharmacokinetics n'ihe gbasara ọrịa

Emebeghị nnyocha banyere ọgwụ ọgwụ nke NovoMix ® 30 FlexPen ® na ndị ọrịa agadi. Agbanyeghị, ọdịiche ndị dị na pharmacokinetics dị n'etiti insulin aspart na insulin nke mmadụ nwere ndị agadi nwere ọrịa shuga 2 (afọ 65-83, nkezi afọ - afọ 70) yiri nke ndị ọrụ afọ ofufo ahụike na ndị ọrịa obere ọrịa shuga mellitus. N’ime ndị ọrịa merela agadi, a chọpụtara mbelata nke mmịpụta, nke dugara na mbelata na T_max (82 min (etiti etiti: 60-120 min)), ebe nkezi C_max dị ka nke a chọpụtara na ndị okenye pere mpe nwere ụdị ọrịa shuga 2, ọ dịkwa obere karịa na ndị ọrịa nwere ụdị shuga nke 1.

E duzighi nnyocha banyere ọgwụ pharmacookinetics nke NovoMix ® 30 FlexPen with n'ime ndị ọrịa nwere nnukwu akwara ọrịa na arụ ọrụ ọria ahụ. Agbanyeghị, na mmụba na dose nke ọgwụ na ndị ọrịa nwere ịdị iche iche ogo nsogbu gbasara akụrụ na ọrụ ịba ọcha n'anya, enweghị mgbanwe mgbanwe ọgwụ ọgwụ nke ọgwụ insulin na-agagharị.

Nyocha akụrụngwa ọgwụ nke NovoMix ® 30 FlexPen ® n'ime ụmụaka na ndị na-eto eto. Agbanyeghị, a na-amụ ọgwụ pharmacokinetic na pharmacodynamic nke insulin asrel na ụmụ nwere (afọ 6 ruo 12) na ndị nọ n’oge uto (afọ 13 ruo 17) nwere ọrịa shuga 1.N'ime ndị ọrịa nọ n'afọ abụọ, insulin aspart mara nnabata ngwa ngwa na ụkpụrụ T_maxdika ndi okenye. Agbanyeghị, ụkpụrụ nke C_max n'afọ abụọ dị iche iche, nke na-egosi mkpa ịhọrọ insulin na -elekọta mmadụ kwa otu.

NovoMix30 FlexPen bu n'uche maka nchịkwa sc. Enweghi ike inye ọgwụ ahụ iv. nke a nwere ike ibute nnukwu hypoglycemia. Ọ dịkwa mkpa iji zere nchịkwa intramuscular nke NovoMix30 FlexPen. Ejila NovoMix 30 FlexPen maka nnabata insulin na-abanye n'ime nfuli insulin.

Ọ bụ dibia NovoMix 30 FlexPen ka dọkịta kpebiri n’otu n’otu n’otu n’otu n’otu n’usoro si kwado onye ọrịa. Iji mezuo ọkwa dị mma nke glycemia, a na-atụ aro ka ị nyochaa oke nke glucose dị n'ọbara ma dozie ogo nke ọgwụ.

Enwere ike inye ndị ọrịa nwere ụdị ọrịa shuga 2 ọrịa mellitus NovoMix 30 FlexPen dị ka monotherapy yana yana ọgwụ hypoglycemic nke ọnụ na n'ọnọdụ ndị ahụ mgbe a na-achịkwa ọkwa glucose ọbara nke ọma site na ọgwụ ọnụ.

N'ihi na ụdị ndị ọrịa shuga 2dị nke Abụọ nke bu ụzọ nye ọgwụ insulin, usoro mmalite akwadoro nke NovoMix 30 FlexPen bụ nkeji 6 tupu nri ụtụtụ na nkeji 6 tupu nri abalị. Anabatakwa iwebata 12 maka NovoMix 30 Flexpen ka ọ bụrụ oge 1 / ụbọchị na mgbede (tupu nri abalị).

Nyefee onye ọrịa na ọgwụ insulin ndị ọzọ

Na na-ebufe onye ọrịa site na insulin nke mmadụ biapsic na NovoMix 30 Flexpen kwesịrị ịmalite site na otu usoro na ụdị nchịkwa. Mgbe ahụ dozie dose ahụ dabere na mkpa nke onwe onye ọrịa (lee tebụl maka ndụmọdụ maka ịtọ oke nke ọgwụ). Dịka oge niile mgbe ị na-ebufe onye ọrịa na ụdị insulin ọhụụ, nlekọta ahụike siri ike dị mkpa n'oge mbufe onye ọrịa na izu mbụ nke iji ọgwụ ọhụrụ.

Thenkwalite ọgwụgwọ nke NovoMix 30 FlexPen ga-ekwe omume site na ịgbanwee otu ugboro kwa ụbọchị ka okpukpu abụọ. A na-atụ aro ka ị rachara ọgwụ iri atọ ọgwụ ọgwụ gbanwere NovoMix 30 Flexpen ugboro abụọ / ụbọchị, kewaa dose ahụ n'ime akụkụ abụọ hà - ụtụtụ na mgbede (tupu nri ụtụtụ na nri abalị).

Ntughari na ojiji NovoMix 30 Flexpen ugboro atọ / ụbọchị ga - ekwe omume site na ịkekọrịta ụtụtụ n'ụtụtụ na akụkụ abụọ hà nhata ma na-achịkwa akụkụ abụọ a n'ụtụtụ na nri ehihie (ugboro atọ kwa ụbọchị).

Iji dozie dose nke NovoMix 30 FlexPen, a na-eji mkpụkọ glucose ọnụ ala kachasị ọnụ nke enwetara n'ime ụbọchị 3 ikpeazụ.

Iji chọpụta izu ike dị na ọgwụ gara aga, jiri uru nke mkpokọ glucose dị n'ọbara tupu nri ọzọ.

Enwere ike idozi dose otu ugboro n'izu ruo mgbe eburu oke HbA ahụ akara._1C.

Emekwala elu nke ọgwụ a ma ọ bụrụ na a hụrụ hypoglycemia n'oge a.

Imeghari dose nwere ike ịdị mkpa mgbe ị na-eme ka ahụ onye ọrịa dị, na-agbanwe nri ọ na-eri, ma ọ bụ nwee ọnọdụ na-apụ apụ.

Iji dozie dose nke NovoMix 30 FlexPen, a na-atụ aro ka ị jiri ntinye aha titition ndị edepụtara na tebụl:

Nkwụsịtụ nke Subcutaneous, Novo Nordisk

NovoMix® 30 Penfill®

Nkwụsị nke nchịkwa subcutaneous nke 1 ml ihe na-arụ ọrụ: insulin aspart - insulin aspart (30%) na kristal insulin aspart protamine (70%) 100 IU (3.5 mg) excipients: glycerol - 16 mg, phenol - 1.5 mg , metacresol - 1.72 mg, zinc (n'ụdị nke zinc chloride) - 19.6 μg, sodium chloride - 0.877 mg, sodium hydrogen phosphate dihydrate - 1.25 mg, protamine sulfate - ihe dị ka 0.32 mg, sodium hydroxide - banyere 2 , 2 mg, hydrochloric acid - ihe dị ka 1.7 mg, mmiri maka injection - ihe dị ka 1 ml 1 katrij (3 ml) nwere 300 PIECES

NovoMix® 30 FlexPen®

Nkwụsị nke nchịkwa subcutaneous nke 1 ml ihe na-arụ ọrụ: insulin aspart - insulin aspart (30%) na kristal insulin aspart protamine (70%) 100 IU (3.5 mg) excipients: glycerol - 16 mg, phenol - 1.5 mg , metacresol - 1.72 mg, zinc (n'ụdị nke zinc chloride) - 19.6 μg, sodium chloride - 0.877 mg, sodium hydrogen phosphate dihydrate - 1.25 mg, protamine sulfate - ihe dị ka 0.32 mg, sodium hydroxide - banyere 2 , 2 mg, hydrochloric acid - ihe dị ka 1.7 mg,mmiri maka ịgba ntụtụ - ihe ruru 1 ml 1 mkpụrụ ọgwụ eji ejupụta tupu mkpụrụ (3 ml) nwere 300 PIECES

Homogeneous ọcha akpụ-enweghị nkwusioru. Flakes nwere ike iputa n’omume.

Mgbe ọ na-eguzo ọtọ, nkwusioru ahụ na-akụda ya, na-akpụ ụsụụ ọcha na nke enweghị agba ma ọ bụ nke na-enweghị atụ.

Mgbe ị na-agwakọta ntụpọ dị ka usoro akọwara n'ime ntuziaka maka ojiji ahụike, nkwanye ugwu ga-etolite.

Na insulin aspart, nnọchi nke amino acid proline na ọnọdụ B28 maka aspartic acid na -ebelata ọchịchọ nke ụmụ irighiri ihe ịkpụkọ ọghọm nke NovoMix® 30 Penfill® / FlexPen®, nke a na-ahụ na insulin mmadụ na -akpata. N'akụkụ a, a na-enweta insulin aspart (30%) site na abụba subcutaneous ngwa ngwa karịa insulin na -akari nwere insulin nke mmadụ. 70% fọdụrụnụ na-ada n'ụdị crystalline nke protamine-insulin aspart, ọnụego nnabata nke ya na nke insulin NPH nke mmadụ.

Serum Cmax nke insulin mgbe nchịkwa NovoMix® 30 Penfill® / FlexPen® dị 50% karịa nke insulin mmadụ na-arịa ọrịa 30, Tmax dịkarịrị obere insulin nke mmadụ bi 30.

N'ime ndị ọrụ afọ ofufo ahụike, mgbe nlekọta nchịkwa nke NovoMix at 30 na ọnụego 0.2 U / n'arọ nke ịdị arọ Cmax nke insulin aspart na serum mezuru mgbe nkeji 60 gachara (140 ± 32) pmol / L. Ogologo oge T1 / 2 nke NovoMix® 30, nke gosipụtara ọnụego nnabata nke uru ahụ protamine, bụ awa 8-9 Ọkwa insulin na ọbara ọbara laghachiri na ọkwa mbụ 15-18 awa mgbe nchịkwa s / c nke ọgwụ gasịrị. N'ime ndị ọrịa nwere ụdị ọrịa mellitus nke 2 dị ka ọrịa, a ruru Cmax 95 minit mgbe nchịkwa gachara ma nọrọ n'elu ntọala maka opekata mpe 14.

Ndị okenye na ndị okenye maara ọrụ. Emebeghị nnyocha banyere pharmacokinetics nke NovoMix® 30 na ndị agadi na ndị ọrịa maara ọrụ. Agbanyeghị, ọdịiche ndị dị na pharmacokinetics dị n'etiti insulin aspart na insulin nke mmadụ nwere ndị agadi nwere ụdị ọrịa shuga 2 (afọ 65-83, afọ nke afọ 70) yiri nke ndị ọrụ afọ ofufo siri ike na ndị ọrịa na-eto eto nwere ọrịa mellitus. N’ime ndị ọrịa merela agadi, a chọpụtara mbelata nke mmịpụta, nke butere ọsụsọ na T1 / 2 (82 min interagbile nso - 60-120 min), ebe nkezi Cmax dị ka nke ahụ siri hụ na ndị ọrịa pere mpe nwere ụdị ọrịa shuga nke abụọ, dịkwa ntakịrị karịa Patientsdị ndị ọrịa shuga 1.

Ndị ọrịa nwere nsogbu gbasara akụrụngwa yana ọrụ ịba ọcha n'anya. Enwebeghị ọgwụ ọgwụ nke NovoMix® 30 Penfill® / FlexPen® na ndị ọrịa nwere nsogbu gbasara akụrụ na ọrịa ịba ọcha n'anya. Agbanyeghị, na mmụba na dose nke ọgwụ na ndị ọrịa nwere ịdị iche iche ogo nsogbu gbasara akụrụ na ọrụ ịba ọcha n'anya, enweghị mgbanwe mgbanwe ọgwụ ọgwụ nke ọgwụ insulin na-agagharị.

Childrenmụaka na ndị nọ n'afọ iri na ụma. Nyocha akụrụngwa ọgwụ nke NovoMix® 30 Penfill® / FlexPen in na ụmụaka na ndị na-eto eto. Agbanyeghị, a na-amụ ọgwụ pharmacokinetic na pharmacodynamic nke insulin na-agagharị n'ime ụmụaka (afọ 6 ruo 12) na ndị nọ n'afọ iri na atọ (afọ 13 ruo 17) na ndị nwere ọrịa shuga nke 1. N'ime ndị ọrịa nọ n'afọ abụọ, a na-amata insulin aspart na mmata ngwa ngwa na ụkpụrụ Tmax ndị yiri nke ahụ. n’ime ndị okenye. Agbanyeghị, ụkpụrụ Cmax dị na ọgbọ abụọ dị iche iche, nke na-egosi mkpa ịhọrọ insulin na -elekọta otu onye chọrọ.

NovoMix® 30 Penfill® / FlexPen® bụ nkwụghachi nkebi abụọ nke mejupụtara insulin aspart (30% analog insulin insulin) na kristal nke aspart protamine insulin (70% ọkara insulin analog). NovoMix® 30 Penfill® / FlexPen® nọ n'ọrụ arụ ọrụ bụ insulin aspart, nke usoro usoro ihe omimi nke DNA na - ejikọ site na iji usoro Sacvisromyces cerevisiae.

Insulin aspart bu ihe ndi mmadu na acho ka insulin na-aru.

Mbelata shuga dị n'ọbara na-ebilite n'ihi mmụba n'ụgbọ njem ya mgbe akwara insulin na-anabata ndị na-anabata insulin na akwara na abụba yana imeju n'otu oge na - egbochi imepụta glucose. Mgbe nchịkwa SC nke NovoMix® 30 Penfill® / FlexPen®, mmetụta ahụ na-amalite n'ime nkeji 10-20. Mmetụta kachasị enwere na-ahụ n’etiti site na 1 ruo 4 awa mgbe ọ gbasịrị. Ogologo oge ọgwụ ahụ ruru awa 24.

N'ime ule nlele ọnwa atọ nke metụtara ndị ọrịa nwere ọrịa shuga 1 na ụdị 2 ndị natara NovoMix® 30 Penfill® / FlexPen® na insulin nke mmadụ 30, ugboro 2 kwa ụbọchị, tupu nri ụtụtụ na nri abalị, NovoMix® 30 Penfill gosipụtara. ® / FlexPen® nwere ike iwepu ọkwa ọbara glucose postprandial (mgbe nri ụtụtụ na nri abalị).

Ntụle meta nke data enwetara na ọmụmụ nyocha 9 nke metụtara ndị ọrịa nwere ụdị 1 na ụdị oria 2 gosipụtara na NovoMix® 30 Penfill® / FlexPen® mgbe a na-elekọta tupu nri ụtụtụ na nri abalị na-enye njikwa nke ọbara glucose postprandial ọbara postprandial. ọkwa prandial glucose mgbe nri ụtụtụ, nri ehihie, na nri abalị) ma e jiri ya tụnyere insulin nke biphasic 30. Ọ bụ ezie na ọnụ ọgụgụ glucose na-ebu ọnụ na ndị ọrịa na-eji NovoMix® 30 Penfill® / FlexPen® dị elu, mkpokọta NovoMix® 30 Penfill® / FlexPen® sụgharịrị Ọ bụ otu mmetụta na ịta nke glycated haemoglobin (HbA1c), nakwa dị ka biphasic mmadụ insulin 30.

N'ime nyocha nke ụlọ ọgwụ metụtara ndị ọrịa 341 nwere ụdị ọrịa shuga 2, ndị ọrịa nwere usoro iche iche na ọgwụgwọ ọgwụgwọ naanị NovoMix® 30 Penfill® / FlexPen®, NovoMix® 30 Penfill® / FlexPen® na ngwakọta na metformin na metformin na nchịkọta nke usoro sulfonylurea. Ntinye uche nke HbA1c mgbe izu iri na isii nke ọgwụgwọ gasịrị adịghị iche na ndị ọrịa na-anata NovoMix® 30 Penfill® / FlexPen® na njikọta na metformin, yana ndị ọrịa na-anata metformin yana agwakọta na usoro sulfonylurea. Na omumu a, na 57% nke ndị ọrịa, ntinye uche nke HbA1c dị elu karịa 9%; n'ime ndị ọrịa a, ọgwụgwọ na NovoMix Pen 30 Penfill® / FlexPen® na mgbakwunye na metformin rụpụtara na mbelata nke HbA1c karịa karịa na ndị ọrịa e mesoro metformin na nchịkọta. sulfonylureas.

N'ọmụmụ ihe ọzọ, ndị ọrịa nwere ụdị ọrịa shuga 2 nke na-adịghị mma nke na-achịkwa ọrịa glycemic nke na-a oụ ọgwụ hypoglycemic ọgwụ na-abanye na otu ndị a: na-anata NovoMix® 30 ugboro abụọ n'ụbọchị (ndị ọrịa 117) na ịnata insulin glargine 1 oge kwa ụbọchị (ndị ọrịa 116). Mgbe izu iri abụọ na asatọ nke nchịkwa ọgwụ gasịrị, mbelata nke ọnụọgụ HbA1c na NovoMix® 30 Penfill® / FlexPen® otu bụ 2.8% (uru mbụ pụtara 9.7%). Na 66% na 42% nke ndị ọrịa na-eji NovoMix® 30 Penfill® / FlexPen®, na njedebe nke ọmụmụ ahụ, ụkpụrụ nke HbA1c dị n'okpuru 7 na 6.5%, n'otu n'otu. Igwe glucose plasma na-ebu ọnụ belatara ihe dị ka 7 mmol / L (site na 14 mmol / L na mbido ọmụmụ ahụ ruo 7.1 mmol / L).

Nsonaazụ nyocha nke meta nke data enwetara site na nnwale ụlọ ọgwụ metụtara ndị ọrịa nwere ụdị ọrịa shuga 2 nke ọrịa shuga gosipụtara mbelata ọnụ ọgụgụ nke ọrịa nocturnal hypoglycemia na hypoglycemia siri ike na NovoMix® 30 Penfill® / FlexPen® ma e jiri ya tụnyere insulin na-arịa mmadụ Biphsic 30. ọghọm nke hypoglycemia nke ehihie na ndị ọrịa na-anata NovoMix® 30 Penfill® / FlexPen® dị elu.

Childrenmụaka na ndị nọ n'afọ iri na ụma. Emere ụlọ nyocha izu iri na isii iji nyocha glucose ọbara mgbe nrichara ya na NovoMix® 30 (tupu nri), insulin / mmadụ insulin / biphasic mmadụ 30 (tupu nri) na isofan-insulin (nke a na-ahụ tupu oge ụra). Ọmụmụ ihe ahụ metụtara ndị ọrịa 167 site na 10 ruo afọ 18. Ogo nke HbA1c na otu abụọ ahụ ka nọgidesiri ike na ụkpụrụ mbụ n'oge ọmụmụ ihe ahụ. Ọzọkwa, mgbe ị na-eji NovoMix® 30 Penfill® / FlexPen® ma ọ bụ insulin nke mmadụ mmadụ 30, enweghị ọdịiche nke nnweta hypoglycemia.

Emere ọmụmụ ihe nwere akụkụ abụọ kpuchitekwara ọnụ ọgụgụ ndị ọrịa site na afọ 6 ruo afọ 12 (ndị ọrịa 54 na ngụkọta, izu 12 maka ụdị ọgwụgwọ ọ bụla). Ọnọdụ nke hypoglycemia na mmụba nke glucose mgbe nri dị na otu nke ndị ọrịa na-eji NovoMix® 30 Penfill® / FlexPen® dị ala ma e jiri ya tụnyere ụkpụrụ ndị otu ndị ọrịa na-eji insulin biphasic mmadụ 30. Kpamkpam HbA1c na njedebe nke ọmụmụ na otu biphasic nnwale insulin 30 dị ala karịa nke ndị ọrịa na-eji NovoMix® 30 Penfill® / FlexPen®.

Ndị okenye na-arịa ọrịa. Emebeghị nchọpụta ọgwụ nke NovoMix® 30 Penfill® / FlexPen® na ndị ọrịa merela agadi. Agbanyeghị, n'ọmụmụ ihe nyocha mmadụ abụọ kpuru ìsì gosipụtara na ndị ọrịa 19 nwere ụdị ọrịa shuga 2 dị afọ 65–83 (nke pụtara afọ 70), ọgwụ pharmododynamics na pharmacokinetics nke insulin na insulin na -akpata mmadụ. Uzo di iche na udiri onodu ogwu dika pacoliko (nke kachasi glucose na - GIRmax na mpaghara n'okpuru onyunyo nke okpukpo 120 min mgbe ochichi insulin - AUCGIR, 0-120 min) n’agbata insulin na ubara ndi mmadu n’ime ndi agadi agadi dika ndi ahu n’enwe oria. ndị ọrụ afọ ofufo na ndị ọrịa obere ọrịa shuga.

Data Nchekwa nke ime

Ihe omumu ihe omumu emere ekpughere mmadu ihe omuma, dabere na data sitere na omumu ihe omumu banyere nchekwa nke ogwu, ubara nke iji ya eme ihe mgbe ochie, oria mmuo na udiri omumu.

N'ime nyocha nke vitro, nke gụnyere njikọta insulin na ndị na-anabata IGF-1 yana nsonaazụ uto mkpụrụ ndụ, egosiri na njirimara nke insulin insulin yiri nke insulin mmadụ. Nnyocha e mere egosiwo na ịhapụ njikọ nke insulin na-anabata ndị na-anabata insulin hà na nke insulin mmadụ.

1. 
   Ọrịa Hisenko-Cushing: monograph. . - M .: Medicine, 1988 .-- 224 p.
2. 
   Dobrov, A. Ọrịa shuga - abụghị nsogbu / A. Dobrov. - M.: Akwụkwọ (lọ (Minsk), 2010 .-- 166 p.
3. 
   Efimov A.S. Ọrịa mamịrị na-arịa ọrịa shuga Moscow, ụlọ obibi akwụkwọ "Medicine", 1989, 288 pp.
4. Melnichenko G. A., Peterkova V. A., Tyulpakov A. N., Maksimova N. V. Eponymous syndromes na endocrinology, Omume - M., 2013. - 172 p.
5. Balabolkin M.I., Klebanova E.M., Kreminskaya V.M. Akụrụngwa na ọgwụ thyroidology, Medicine - M., 2013. - 816 p.

Ka m kọwaa onwe m. Aha m bụ Elena. Anọwo m na-arụ ọrụ dị ka ọkà mmụta endocrinologist ruo ihe karịrị afọ 10. Ekwenyere m na abụ m ọkachamara n'ọhịa m ugbu a, m chọrọ inyere ndị ọbịa niile nọ na saịtị ahụ aka idozi ihe dị mgbagwoju anya ọ bụghị ọrụ. A na-achịkọta ihe niile dị na saịtị ahụ ma jiri nlezianya hazie iji kọọ ozi niile dị mkpa. Tupu itinye ihe akowara na weebụsaịtị, itinye aka na ndị ọkachamara na-adị mkpa mgbe niile.

Nkọwa nke ụdị usoro onunu ogwu

Homogeneous ọcha akpụ-enweghị nkwusioru. Flakes nwere ike iputa n’omume.

Mgbe ọ na-eguzo ọtọ, nkwusioru ahụ na-akụda ya, na-akpụ ụsụụ ọcha na nke enweghị agba ma ọ bụ nke na-enweghị atụ.

Mgbe ị na-agwakọta ntụpọ dị ka usoro akọwara na Ntuziaka maka ojiji ahụike, nkwanye ugwu ga-etolite.

Mlọ ọgwụ

NovoMix ® 30 Penfill a bụ nkwusioru nke abụọ nke mejupụtara insulin aspart so 30 (analog insulin ana-arụ ọrụ obere oge) yana kristal nke asulin proulinine insulin (70% ọkara insulin analog). NovoMix ® 30 Penfill ® na-arụ ọrụ bụ insulin aspart, nke a na - ejikọ site na usoro nke njikọta akụ na ụba nke DNA site na iji eriri Saccharomyces cerevisiae.

Insulin aspart bu ihe ndi mmadu na acho ka insulin na-aru.

Mbelata shuga dị n'ọbara na-ebilite n'ihi mmụba n'ụgbọ njem ya mgbe akwara insulin na-anabata ndị na-anabata insulin na akwara na abụba yana imeju n'otu oge na - egbochi imepụta glucose. Mgbe usoro nchịkwa nke NovoMix ® 30 Penfill sub gasịrị, mmetụta ahụ na-amalite n'ime nkeji 10-20. Mmetụta kachasị enwere na-ahụ n’etiti site na 1 ruo 4 awa mgbe ọ gbasịrị. Ogologo oge ọgwụ ahụ ruru awa 24.

N'ime ọmụmụ nlele ọnwa atọ nke metụtara ndị ọrịa nwere ụdị ọrịa shuga 1 na ụdị 2 ndị natara NovoMix Pen 30 Penfill ® na insulin nke mmadụ 30 ugboro ugboro abụọ tupu nri ụtụtụ na nri abalị, egosipụtara na NovoMix Pen 30 Penfill ® na-ebelata ọkwa postprandial karịa. ọbara ọgbụgba (mgbe nri ụtụtụ na nri abalị).

Nchịkọta meta nke data sitere na nnwale 9 nke nyocha metụtara ndị ọrịa nwere ụdị 1 na ụdị shuga gosiri na NovoMix® 30 Penfill®, nke a na-elekọta tupu nri ụtụtụ na nri abalị, na-enye njikwa nke ọbara glucose postprandial ọbara oge (ogo a na-abawanye na ọkwa glucose prandial prandial mgbe nri ụtụtụ, nri ehihie na nri abalị), atụnyere insulin biphasic nke mmadụ 30. Ọ bụ ezie na ọnụ ọgụgụ glucose na-ebu ọnụ na ndị ọrịa na-eji NovoMix ® 30 Penfill ® dị elu, n'ozuzu, NovoMix ® 30 Penfill ® nwere otu mmetụta na nchịkọta gemocosylated ịba ọcha n'anya (HbA _1c ) dika insulin nke mmadu dika insulin 30.

N'ime nyocha nke ụlọ ọgwụ metụtara ndị ọrịa 341 nwere ụdị ọrịa shuga 2, ndị ọrịa nwere usoro iche iche na ọgwụgwọ ọgwụgwọ naanị NovoMix ® 30 Penfill ®, NovoMix Pen 30 Penfill ® na ngwakọta na metformin na metformin na nchịkọta nke usoro sulfonylurea. HbA ịta _1c mgbe izu 16 gasịrị ọgwụgwọ adịghị iche na ndị ọrịa na-anata NovoMix ® 30 Penfill ® yana njikọta na metformin yana ndị ọrịa na-anata metformin yana agwakọta nke sulfonylurea. Na omumu a, 57% nke ndị ọrịa nwere ọnụọgụ HbA _1c dị elu karịa 9%, na ọgwụgwọ ndị ọrịa a na NovoMix ® 30 Penfill ® na mgbakwunye na metformin butere mgbada dị ukwuu karịa mkpokọta HLA. _1s karia n’ebe ndi oria na anata metformin n’otu n’enye ogwu.

N'ime ọmụmụ ihe ọzọ, ndị ọrịa nwere ụdị ọrịa shuga 2 nke na-adịghị mma nke na-achịkwa ọrịa glycemic nke na-a oụ ọgwụ hypoglycemic ọgwụ na-abanye na otu ndị a: na-anata NovoMix ® 30 ugboro abụọ n'ụbọchị (ndị ọrịa 117) na ịnata insulin glargine 1 oge kwa ụbọchị (ndị ọrịa 116). Mgbe izu 28 gasịrị iji ọgwụ ọjọọ eme ihe, mbelata nke ọkara na ịta HbA _1c n'ime otu NovoMix ® 30, Penfill ® bụ 2.8% (uru mbụ ha ruru bụ 9.7%). Na 66% na 42% nke ndị ọrịa na-eji NovoMix ® 30 Penfill ®, na njedebe nke ọmụmụ ahụ, ụkpụrụ nke HbA _1c nọ n'okpuru 7 na 6.5%, n'otu n'otu. Igwe glucose plasma na-ebu ọnụ belatara ihe dị ka 7 mmol / L (site na 14 mmol / L na mbido ọmụmụ ahụ ruo 7.1 mmol / L).

Nsonaazụ nke nyocha nke meta nke data enwetara site na nnwale ụlọ ọgwụ metụtara ndị ọrịa nwere ụdị ọrịa shuga abụọ nke ọrịa shuga gosipụtara mbelata ọnụ ọgụgụ nke ọrịa nocturnal hypoglycemia na hypoglycemia siri ike na NovoMix ® 30 Penfill ® tụnyere insulin biphasic mmadụ 30. N'otu oge ahụ, enwere nnukwu ihe ize ndụ ihe omume nke ụbọchị hypoglycemia na ndị ọrịa na-anata NovoMix ® 30 Penfill ® dị elu.

Childrenmụaka na ndị nọ n'afọ iri na ụma. Emere ụlọ nyocha izu iri na isii iji nyocha glucose ọbara mgbe nrichara ya na NovoMix® 30 (tupu nri), insulin / mmadụ insulin / biphasic mmadụ 30 (tupu nri) na isofan-insulin (nke a na-ahụ tupu oge ụra).Ọmụmụ ihe ahụ metụtara ndị ọrịa 167 dị afọ 10 ruo 18. Ihe omuma HLA _1s ke otu mbiba emi ama aka iso odu uwem ke akpa ukpepn̄kpọ oro. Ọzọkwa, mgbe ị na-eji NovoMix ® 30 Penfill ® ma ọ bụ insulin nke mmadụ mmadụ 30, enweghị ọdịiche dị na ịba ụba hypoglycemia.

Emere ihe omumu nke nwere okpukpu abuo n’ime onu ogugu n’etiti ndi oria noo n’agbata afọ isii rue afọ iri na abụọ (ngụkọta ndị ọrịa 54, izu iri abụọ maka ụdị ọgwụgwọ ọ bụla). Ọnọdụ nke hypoglycemia na mmụba nke glucose mgbe nri n’otu n’etiti ndị ọrịa na-eji NovoMix ® 30 Penfill ® belatara nke ukwuu ma e jiri ya tụnyere ụkpụrụ ndị otu ndị ọrịa na-eji insulin nke mmadụ bipisic. _1c na njedebe nke ihe omumu a, n'ime akwukwo insulin nke mmadu bi 30 na-adi ala karie na ndi otu ndi oria na-eji NovoMix ® 30 Penfill ®.

Ndị okenye na-arịa ọrịa. Emebeghị nchọpụta Pharmacodynamics NovoMix ® 30 Penfill ® n'ime ndị ọrịa katarala ahụ. Agbanyeghị, n'ọmụmụ ihe nyocha mmadụ abụọ kpuru ìsì gosipụtara na ndị ọrịa 19 nwere ụdị ọrịa shuga 2 dị afọ 65–83 (afọ pụtara afọ 70), e jiri ọgwụ pharmacodynamics na pharmacokinetics nke insulin na insulin na-arịa ọrịa mmadụ. Iche iche di iche na ọgwụ pharmacodynamics (ọnụego glucose dị elu - GIR _max na mpaghara dị n'okpuru usoro nke ọnụego ya na-agbakọta maka 120 min mgbe nchịkwa insulin insulin - AUC _{GIR, 0-120 min} ) n'etiti insulin aspart na insulin mmadụ na ndị ọrịa mere agadi dị ka nke ndị ọrụ afọ ofufo siri ike na ndị ọrịa na-eto eto na-arịa ọrịa mellitus.

Data preclinical mana nchekwa

Ihe omumu ihe omumu emere ekpughere mmadu ihe omuma, dabere na data sitere na omumu ihe omumu banyere nchekwa nke ogwu, ubara nke iji ya eme ihe mgbe ochie, oria mmuo na udiri omumu.

Na ule in vitro Ejikọtara insulin na ndị na-anabata IGF-1 yana mmetụta na uto mkpụrụ ndụ, egosiri na ihe ndị dị na insulin na-arụ ọrụ yiri nke insulin mmadụ. Nnyocha e mere egosiwo na ịhapụ njikọ nke insulin na-anabata ndị na-anabata insulin hà na nke insulin mmadụ.

Mlọ ọgwụ

Na insulin aspart, nnọchi nke amino acid proline na ọnọdụ B28 maka aspartic acid na -ebelata ọchịchọ nke ụmụ irighiri ihe ịkpụpụta oke hexamers n'ụdị nke NovoMix® 30 Penfilllu, nke a na-ahụ na insulin nke mmadụ nwere ike ịnabata. N'akụkụ a, a na-enweta insulin aspart (30%) site na abụba subcutaneous ngwa ngwa karịa insulin na -akari nwere insulin nke mmadụ. A na-ahụta 70% fọdụrụnụ site na ụdị crystalline nke protamine-insulin aspart, ọnụego nnabata nke ya na nke insulin NPH nke mmadụ.

C _max ọbara ụbọ insulin mgbe nchịkwa NovoMix Pen 30 Penfill ® 50% dị elu karịa nke insulin na-arịa mmadụ nke ụbụrụ 30. a T _max Ugboro abụọ dị mkpụmkpụ ma e jiri ya tụnyere insulin mmadụ na-arịa 30.

N'ime ndị ọrụ afọ ofufo nwere ahụike mgbe nchịkwa subcutaneous nke ọgwụ NovoMix ® 30 na ọnụego 0.2 PIECES / kg C _max Emezuru insulin na nkeji n'ime nkeji iri isii wee bụrụ (140 ± 32) pmol / L. Oge T _1/2 NovoMix ® 30, nke gosipụtara ọnụego nnabata nke nta nke protamine, bụ awa 8-9 Ọkwa insulin na ọbara ọbara laghachiri na awa 15-18 mbụ ka nchịkwa ọgwụ ọgwụ gachara. N'ime ndị ọrịa nwere ụdị ọrịa shuga mellitus nke 2 _max mejuputara 95 minit mgbe ochichi gachara ma nọgide n’elu usoro ihe dịkarịa ala elekere 14

Ndị okenye na ndị okenye maara ọrụ. Emebeghị nnyocha banyere pharmacokinetics nke NovoMix ® 30 na ndị agadi na ndị ọrịa nwere nsogbu. Agbanyeghị, ọdịiche ndị dị na pharmacokinetics dị n'etiti insulin aspart na insulin nke mmadụ nwere ndị agadi nwere ụdị ọrịa shuga 2 (afọ 65-83, nkezi afọ - afọ 70) yiri nke ndị ọrụ afọ ofufo ahụike na ụmụ obere ọrịa nwere ọrịa mellitus.N’ime ndị ọrịa merela agadi, a chọpụtara mbelata nke mmịpụta, nke dugara na mbelata na T _1/2 (82 min (etiti etiti - 60-120 min), ebe nkezi C _max dị ka nke a chọpụtara na ndị okenye pere mpe nwere ụdị ọrịa shuga 2, ọ dịkwa obere karịa na ndị ọrịa nwere ụdị shuga nke 1.

Ndị ọrịa nwere nsogbu gbasara akụrụngwa yana ọrụ ịba ọcha n'anya. E duzighi nnyocha banyere ọgwụ pharmacookinetics nke NovoMix ® 30 Penfill ® na ndị ọrịa nwere nnukwu aha na arụ ọrụ hepatic. Agbanyeghị, na mmụba na dose nke ọgwụ na ndị ọrịa nwere ịdị iche iche ogo nsogbu gbasara akụrụ na ọrụ ịba ọcha n'anya, enweghị mgbanwe mgbanwe ọgwụ ọgwụ nke ọgwụ insulin na-agagharị.

Childrenmụaka na ndị nọ n'afọ iri na ụma. Agụbeghị ụlọ ọgwụ ọgwụ nke NovoMix ® 30 Penfill ® na ụmụaka na ndị na-eto eto. Agbanyeghị, a na-eji ọgwụ pharmacokinetic na pharmacodynamic nke insulin na-agwọ ọrịa na ụmụaka (6 ruo 12 afọ) na ndị nọ n'afọ iri na atọ (afọ 13 ruo 17) na ụdị ọrịa shuga nke 1. N'ime ndị ọrịa nke ọgbọ abụọ, a na-eji insulin aspart mara nnabata ngwa ngwa na ụkpụrụ T. _max dika ndi okenye. Agbanyeghị, ụkpụrụ nke C _max n'afọ abụọ dị iche iche, nke na-egosi mkpa ịhọrọ insulin na -elekọta mmadụ kwa otu.

Ime na lactation

Ahụmahụ na-adakarị site na iji NovoMix ® 30 Penfill ® n'oge afọ ime nwere oke.

Agbanyeghị, data sitere na nnwale ụlọ ọgwụ abụọ a na-achịkwa achịkwa (nke dị ka 157 na ụmụ nwanyị 14 dị ime nke natara insulin na usoro nke mbụ bolus) ekpughere mmetụta ọ bụla insulin na-enwe na ime ma ọ bụ ahụ nwa ebu n'afọ / ahụike nke nwa amụrụ ma e jiri ya tụnyere insulin na-arịa ọrịa mmadụ. Na mgbakwunye, na nyocha nke enweghị nsogbu gbasara ụmụ nwanyị 27 na-arịa ọrịa shuga bụ ndị natara insulin ma nweekwa insulin mmadụ (insulin aspart natara ụmụ nwanyị 14, insulin 13 mmadụ), profaịlụ nchekwa yiri nke ụdị insulin abụọ ahụ.

N'oge oge ọ ga-ekwe omume ịtụrụ ime, na oge ya niile, ọ dị mkpa iji nlezianya nyochaa ọnọdụ ndị ọrịa nwere ọrịa mellitus ma lelee oke glucose n'ọbara. Mkpa insulin, dị ka a na-achị, na-ebelata na ọkara nke mbụ wee jiri nwayọọ nwayọọ na-abawanye na nke abụọ na nke atọ nke afọ ime. N'oge na-adịghị anya a mụsịrị nwa, mkpa ọ dị insulin na-alaghachi ngwa ngwa dị ka ọ dị tupu ime ime.

N'ime oge inye ara, enwere ike iji NovoMix ® 30 Penfill without enweghị mmachi. Ijikwa insulin na-a motherụ ara na-eme nne abụghị ihe egwu nye nwa a. Agbanyeghị, ọ nwere ike ịdị mkpa idozi ọnụọgụ nke NovoMix ® 30 Penfill ®.

Nsonaazụ

Mmeghachi omume ọjọọ na-achọpụta na ndị ọrịa na-eji ọgwụ NovoMiks ® 30, n'ihi mmetụta ọgwụ insulin na-akpata. Ihe omume kachasị njọ na insulin bụ hypoglycemia. Ugboro nke nsonaazụ n'akụkụ ya na iji NovoMix ® 30 dịgasị iche dabere na ọnụ ọgụgụ ndị ọrịa, usoro ị doụ ọgwụ ahụ, yana njikwa glycemic.

Na nmalite ọmụmụ ọgwụ insulin, njehie na-egbu ume, edema na mmeghachi omume nwere ike ime na ntụtụ ahụ (gụnyere mgbu, redness, hives, mbufụt, ọnya ahụ, ọzịza na itching na saịtị injection). Mgbaàmà ndị a anaghị adịte aka. Mmezi ngwa ngwa na njikwa glycemic nwere ike ibute ọnọdụ nke neuropathy mgbu, nke na-agbanwegharị. Enstụgharị uche na ọgwụ insulin na mmụba dị mma n'ịchịkwa metabolism metabolism nwere ike ibute ịbelata nwa oge na ọnọdụ nke ọrịa mamịrị, ebe nkwalite ogologo oge na njikwa glycemic na-ebelata ohere nke inwe ọrịa mamị retinopathy.

Edepụtara ndepụta mmeghachi omume ọjọọ na tebụl.

A na-ekekọta mmeghachi omume ojoo niile dị n'okpuru ebe a, dabere na data nnwale, nyochara usoro mmepe dị ka MedDRA yana sistem. A na-akọwapụta mmeghachi omume dị njọ dị ka ndị a: mgbe mgbe (≥1 / 10), mgbe mgbe (≥1 / 100, ® 30 Penfill ®) agwaghị ọgwụ ndị ọzọ.

Usoro onunu ogwu na nhazi

NovoMix ® 30 Penfill ® ezubere maka s / c mmeghe. Emekwala NovoMix ® 30 Penfill ® iv, dị ka nke a nwere ike ibute nnukwu hypoglycemia. Ekwesịrị izere nchịkwa intramuscular nke NovoMix Pen 30 Penfill ®. Cannweghị ike iji NovoMix ® 30 Penfill ® maka infusion insulin infusion (PPII) na nfuli insulin.

Ọ bụ dọkịta ga-ekpebi ịgwọ NovoMix ® 30 Penfill determined n'otu n'otu n'ọnọdụ ọ bụla, dabere na mkpa nke onye ọrịa. Iji mezuo ọkwa glycemia zuru oke, a na-atụ aro ka ịchịkwa ịba ụba nke glucose na ọbara ma dozie ogo nke ọgwụ.

Enwere ike inye NovoMix ® 30 Penfill ® ka ndị ọrịa nwere ụdị ọrịa shuga mellitus abụọ dị ka monotherapy yana yana ọgwụ hypoglycemic nke ọnụ na-achịkwa ebe enwere oke nchịkwa glucose ọbara.

Maka ndị ọrịa nwere ụdị shuga 2 nke na-ebu ụzọ nye insulin ọgwụ ọnụ, ọgwụ mmalite a tụrụ aro ka NovoMix ® 30 Penfill units bụ nkeji 6 tupu nri ụtụtụ yana nkeji 6 tupu nri abalị. Anabatakwa iwebata 12 maka NovoMix ® 30 Penfill ® otu ugboro n'ụbọchị mgbede (tupu nri abalị).

Nyefee onye ọrịa na ọgwụ insulin ndị ọzọ

Mgbe ị na-ebufe onye ọrịa site na insulin nke mmadụ bi na NovoMix ® 30 Penfill ®, mmadụ kwesịrị ịmalite site na otu usoro na usoro nchịkwa. Mgbe ahụ dozie dose ahụ dabere na mkpa onwe onye nke onye ọrịa (lee ndụmọdụ ndị a maka otu ụzọ nke ọgwụ ahụ si chọọ). Dịka oge niile, mgbe ị na-ebufe onye ọrịa na ụdị insulin ọhụụ, nlekọta nlekọta ahụike dị mkpa n'oge mbufe onye ọrịa na izu mbụ nke iji ọgwụ ọhụrụ.

Strekwalite ọgwụgwọ nke NovoMix ® 30 Penfill ® ga-ekwe omume site na ịgbanwee otu ugboro kwa ụbọchị gaa ugboro abụọ. A na-atụ aro ka ị rachara ọgwụ iri atọ ọgwụ ọgwụ gbanyere NovoMix ® 30 Penfill ® ugboro abụọ kwa ụbọchị, kewaa ọgwụ ahụ ụzọ abụọ nha - ụtụtụ na mgbede (tupu nri ụtụtụ na nri abalị).

Ntughari na ojiji NovoMix ® 30 Penfill ® ugboro atọ kwa ụbọchị ga - ekwe omume site na ịkekọrịta ụtụtụ n'ụtụtụ n'ime akụkụ abụọ na iwebata akụkụ abụọ a n'ụtụtụ na nri ehihie (ugboro atọ kwa ụbọchị).

Iji dozie dose nke NovoMix ® 30 Penfill ®, a na-eji mkpokọta ọbara glucose dị ala nke na-ebu ọnụ karịa ụbọchị atọ gara aga.

Iji chọpụta izu ike dị na ọgwụ gara aga, jiri uru nke mkpokọ glucose dị n'ọbara tupu nri ọzọ.

Enwere ike idozi dose otu ugboro n'izu ruo mgbe eburu oke HbA ahụ akara. _1c . Emekwala elu nke ọgwụ a ma ọ bụrụ na a hụrụ hypoglycemia n'oge a.

Imeghari dose nwere ike ịdị mkpa mgbe ị na-eme ka ahụ onye ọrịa dị, na-agbanwe nri ọ na-eri, ma ọ bụ nwee ọnọdụ na-apụ apụ.

Iji hazie dose nke NovoMix ® 30 Penfill ®, n'okpuru bụ ntuziaka maka aha ya (lee okpokoro).

Ndị otu ọrịa pụrụ iche

Dị ka oge niile, mgbe ị na-eji nkwadebe insulin, na ndị ọrịa nke ìgwè pụrụ iche, a ga-eji nlezianya na-achịkọta glucose ọbara ma na-agbatị usoro ọgwụgwọ dị iche iche.

Ndị okenye na ndị okenye maara ọrụ. Enwere ike iji NovoMix ® 30 Penfill in na ndị ọrịa meworo agadi, agbanyeghị, ahụmịhe ya na ojiji ya na ọgwụ ọnụ nke hypoglycemic ọgwụ na ndị ọrịa karịrị afọ 75 nwere mmachi.

Ndị ọrịa nwere arụ ọrụ abalị na imeju. N'ime ndị ọrịa nwere akụrụ gbasara akwara ma ọ bụ ọrịa hepatic, enwere ike belata mkpa nke insulin.

Childrenmụaka na ndị nọ n'afọ iri na ụma. Enwere ike iji NovoMix ® 30 Penfill to na-emeso ụmụaka na ndị nọ n'afọ iri na ụma karịa afọ 10 n'ọnọdụ a ka ahọrọ ọgwụ insulin gwakọtara. Mụaka amachibidoro ụlọọgwụ dị maka ụmụaka afọ 6-9 (lee Pharmacodynamics).

Ekwesịrị inye NovoMix ® 30 Penfill ® subcutaneously na apata ụkwụ ma ọ bụ mgbidi akụkụ ihu. Ọ bụrụ na achọrọ, a ga-enye ọgwụ a n'ubu ma ọ bụ buttocks.

Okwesiri igbanwe ebe ogwu ngbanyere na mpaghara anatomical iji gbochie mmepe nke lipodystrophy.

Dịka ọ dị na nkwadebe insulin ọ bụla, oge ọrụ NovoMix ® 30 Penfill ® dabere na ntinye, ebe nchịkwa, ike ọbara na-agba, okpomọkụ na ọkwa nke mmega ahụ.

E jiri ya tụnyere insulin nke mmadụ bi, NovoMix Pen 30 Penfill ® na-amalite ime ngwa ngwa, yabụ, ekwesịrị inye ya ozugbo tupu iburu onye arịrịọ ahụ. Ọ bụrụ na ọ dị mkpa, enwere ike ịhazi NovoMix ® 30 Penfill ® obere oge gachara onye arịrịọ ahụ.

Dodoụbiga ya ókè

Ọrịa Edobeghi otu usoro insulin riri oke insulin, agbanyeghị hypoglycemia nwere ike ịmalite nke nta ma ọ bụrụ na onunu ogwu karịrị akarị na mkpa onye ọrịa.

Ọgwụgwọ. Onye ọrịa ahụ nwere ike iwepụ hypoglycemia dị nwayọọ site na ị gluụ glucose ma ọ bụ nri nwere shuga. Ya mere, a na-atụ aro ka ndị ọrịa nwere ọrịa shuga na-ebu ngwaahịa nwere shuga mgbe niile.

Bụrụ na oké hypoglycemia, mgbe onye ọrịa amaghị, ị kwesịrị ịbanye site na 0,5 mg ruo 1 mg nke glucagon na / m ma ọ bụ s / c (enwere ike ịchịkọta ya), ma ọ bụ na / na ngwọta nke glucose (dextrose) (naanị ndị ọkachamara n'ịgwọ ọrịa nwere ike ịbanye). Ọ dịkwa mkpa iji duzie dextrose iv bụrụ na onye ọrịa ahụ anaghị enwetaghachi mmụọ mgbe nkeji iri na ise gachara nchịkwa glucagon. Mgbe ọ nwetasịrị onwe ya, a na-adụ onye ọrịa ọdụ iri nri nwere carbohydrate iji gbochie nlọghachi hypoglycemia.

Nchedo nchekwa

NovoMix ® 30 Penfill ® na agịga bụ maka onwe gị. Emejukwala kadi nke Penfill ®.

Enweghị ike iji NovoMix ® 30 Penfill ® ma ọ bụrụ na agwakọtaghị na ọ na-acha ọcha na urukpuru.

Ekwesiri ime ka onye ọrịa ahụ mkpa ịgwakọta nkwusioru NovoMix® 30 Penfill® ozugbo tupu ojiji.

Ejila NovoMix ® 30 Penfill ® ma ọ bụrụ na ajriza. E kwesiri ịdọ ndị ọrịa aka na ntị ka ha tufuo agịga mgbe ọ bụla.

Ntụziaka pụrụ iche

Tupu ogologo njem metụtara mgbanwe oge mpaghara, onye ọrịa ahụ kwesịrị ịkpọtụrụ dọkịta ha, ebe ịgbanwe oge mpaghara pụtara na onye ọrịa ahụ ga-eri ya ma nyekwa ya insulin n'oge dị iche.

Hyperglycemia. Ọgwụ ezughị ezu ma ọ bụ ịkwụsị ọgwụgwọ, karịsịa na ụdị ọrịa shuga 1, nwere ike iduga mmepe nke hyperglycemia na ọrịa shuga ketoacidosis. Ọrịa hyperglycemia na-apụtakarị nwayọ nwayọ n'oge ọtụtụ awa ma ọ bụ ụbọchị. Ihe mgbaàmà nke hyperglycemia bụ mmetụta akpịrị ịkpọ nkụ, mmụba na mmụba a tọhapụrụ, ọgbụgbọ, ọgbụgbọ, ụra, akpịrị na akpịrị, akpịrị ịkpọ nkụ, agụụ, na ọdịdị nke acetone na ikuku nwere oke.Enweghị ọgwụgwọ kwesịrị ekwesị, hyperglycemia na ndị ọrịa nwere ọrịa shuga 1 nwere ike ibute ketoacidosis mamịrị, ọrịa na-egbu egbu.

Hypoglycemia. Izere nri ma ọ bụ imega ahụ siri ike na-enweghị nhazi nwere ike iduga hypoglycemia. Hypoglycemia nwekwara ike ịmalite ma ọ bụrụ na ọgwụ insulin dị oke na mkpa onye ọrịa ahụ (lee “Side side”, “overdose”).

E jiri ya tụnyere insulin nke mmadụ biburu, nchịkwa NovoMix Pen 30 Penfill ® nwere mmetụta hypoglycemic dị elu karịa n'ime awa 6 mgbe nchịkwa gasịrị. N'akụkụ a, n'ọnọdụ ụfọdụ, ọ nwere ike ịdị mkpa ịgbanwe nhazi insulin na / ma ọ bụ ụdị nri. Mgbe ha kwusịrị metabolism metabolism, dịka ọmụmaatụ, site na ọgwụgwọ insulin siri ike, ndị ọrịa nwere ike ịnwe mgbaàmà ndị na-ebute ụzọ nke hypoglycemia, nke a ga-agwa ndị ọrịa. Ihe mgbaàmà ịdọ aka na ntị na-adịkarị nwere ike ịnwe ọrịa shuga ogologo oge. Njikwa nlezianya nke glycemia na ndị ọrịa nwere ike ịbawanye n'ihe ize ndụ nke hypoglycemia, yabụ, a ga-ebuwanye mmụba nke NovoMix ® 30 Penfill ® n'okpuru nlekọta ahụike siri ike (lee "Usoro Ọgwụ na Nchịkwa").

Ebe ọ bụ na ekwesịrị iji NovoMix ® 30 Penfill ® na njikọta na nri oriri, mmadụ kwesịrị iburu n'uche oke ọsọ nke mmalite nke mmetụta ọgwụ nwere n'ịgwọ ndị ọrịa nwere ọrịa concomitant ma ọ bụ na-a drugsụ ọgwụ nke na-ebelata oriri.

Ọrịa concoitant, nke na-efe efe ma na-efe efe, na -emekarị ahụ insulin nwere ahụ. Ọ ga-adị mkpa imeghari dose ma ọ bụrụ na onye ọrịa ahụ nwere ọrịa ndị akụrụ, akụrụ, ọrụ akwara, pisis gland ma ọ bụ azụ gland.

Mgbe ị na-ebufe onye ọrịa na ụdị insulin ndị ọzọ, ihe mgbaàmà mbụ nke ebido hypoglycemia nwere ike gbanwee ma ọ bụ belata ịkpọ aha karịa ndị na-eji ụdị insulin mbụ.

Nyefee onye ọrịa na usoro insulin ndị ọzọ. A ga-ebufe onye ọrịa na ụdị insulin ọ bụla ma ọ bụ ịkwado insulin nke onye nrụpụta ọzọ n'okpuru nlekọta ahụike siri ike. Ọ bụrụ ngbanwe ịta, ụdị, onye na-emepụta ihe na ụdị (insulin mmadụ, analog nke insulin mmadụ) na nkwadebe insulin na / ma ọ bụ usoro imepụta, enwere ike ịchọrọ ịgbanwe dose. Ndị ọrịa na-agbanwe site na insulin ndị ọzọ na ọgwụgwọ na NovoMix ® 30 Penfill ® nwere ike ịbawanye ugboro nke injers ma ọ bụ gbanwee dose ahụ tụnyere usoro nke insulin na-emebu. Ọ bụrụ na ọ dị mkpa, ịhazigharị ọgwụ, enwere ike ịme ya na ntụtụ mbụ nke ọgwụ ma ọ bụ n’izu mbụ ma ọ bụ ọnwa mbụ ọgwụgwọ.

Mmeghachi omume na ebe ntụtụ. Dị ka ọ dị na ọgwụgwọ insulin ndị ọzọ, mmeghachi omume nwere ike ịmalite na ebe ntụtụ, nke ihe mgbu, redness, hives, ọnya, hematomas, ọzịza na itching na-egosipụta. Changinggbanwe saịtị ntụtụ mgbe niile na mpaghara otu ahụ nwere ike belata mgbaàmà ma ọ bụ gbochie mmepe nke mmeghachi omume ndị a. Mmeghachi omume na-apụkarị n'ime ụbọchị ole na ole ruo ọtụtụ izu. N'ọnọdụ ndị a na-adịghị ahụkebe, enwere ike ịkagbu NovoMix Pen 30 Penfill ® n'ihi mmeghachi omume na saịtị ịgba ahụ.

Ojiji nke otu ọgwụ thiazolidinedione na nhazi insulin. A kọwo ọrịa banyere mmepe nke obi nkụda mmụọ na ọgwụgwọ nke ndị ọrịa nwere thiazolidinediones yana njikọ insulin, ọkachasị ma ọ bụrụ na ndị ọrịa dị otú ahụ nwere ihe ọghọm maka mmepe nke ọrịa obi na-adịghị ala ala.Ekwesiri iburu n'uche eziokwu a mgbe ị na-edepụta ọgwụ njikọta na thiazolidinediones na nkwadebe insulin na ndị ọrịa. Mgbe ị na-edepụta usoro ọgwụgwọ dị otú a, ọ dị mkpa iji nyochaa nyocha ahụike nke ndị ọrịa iji chọpụta akara na akara nke obi na-adịghị ala ala, oke ibu na ọnụnọ edema. Ọ bụrụ na mgbaàmà nke nkụda obi na-akawanye njọ n'ime ndị ọrịa, a ga-akwụsị ịgwọ ya na thiazolidinediones.

Mmetụta ikike ịkwọ ụgbọ ala ma jiri usoro rụọ ọrụ. Ike nke ndị ọrịa itinye uche na ọnụego mmeghachi omume nwere ike ọfụma n'oge hypoglycemia, nke nwere ike ịdị ize ndụ n'ọnọdụ ebe ikike ndị a dị ezigbo mkpa (dịka ọmụmaatụ, mgbe ha na-anya ụgbọala ma ọ bụ jiri igwe na arụ ọrụ).

A dụrụ ndị ọrịa ọdụ ka ha mee ihe iji gbochie mmepe nke hypoglycemia mgbe ha na-anya ụgbọala. Nke a dị ezigbo mkpa maka ndị ọrịa na-enweghị ma ọ bụ belata ihe mgbaàmà nke ihe ndị na - ebilite hypoglycemia ma ọ bụ na - ata ahụhụ site na ọrịa hypoglycemia ugboro ugboro. N'ụdị ndị a, ekwesịrị ịtụle maka ịkwọ ụgbọala na ịrụ ụdị ọrụ ahụ.

Mpempe mwepụta

Nkwụsị nke nchịkwa subcutaneous, 100 PIECES / ml. Na katridges nke iko hydrolytic klas nke 1, ejiri roba roba kpuchie ya na akụkụ nke ọzọ, 3 ml nke ọ bụla, a na-etinye bọọlụ iko na katalọgụ iji mee ka agwakọta nke nkwusioru ahụ, na ngwungwu dị mbadamba ise, na mkpọ nke kaadiboodu 1 na-acha uhie uhie.

Mmetụta nke Novomix 30 penfill:

Mmetụta ndị metụtara ya na nsonaazụ metabolism: hypoglycemia (mmụba na-aba ụba, pallor nke anụ ahụ, ụjọ ma ọ bụ ịma jijiji, nchekasị, ike ọgwụgwụ pụrụ iche ma ọ bụ adịghị ike, mgbakasị ahụ, mwepu nke mkpocha, obi ilu, agụụ dị njọ, nhụjuanya anya nwa oge, isi ọwụwa. , ọgbụgbọ, tachycardia). Nnukwu ọbara ọgbụgba nwere ike ibute nsụhọ na / ma ọ bụ ụdọ, nkwụsị ụbụrụ nke ọnwụ na ọnwụ.

Mmeghachi omume nfụkasị ahụ: enwere ike - urticaria, ọnya ọnya, adịkarịghị - mmeghachi omume anaphylactic. Mmeghachi omume nfụkasị nke agbasa ozi nwere ike ịgụnye ọnya anụ ahụ, ọnụnọ ọsụsọ, ọsụsọ mụbara, nsogbu eriri afọ, angioedema, iku ume, tachycardia, na mbelata ọbara mgbali.

Mmeghachi omume mpaghara: mmeghachi omume nfụkasị (ọbara ọbara, ọzịza, itching nke anụ ahụ na ntụtụ), na-adịkarị nwa oge ma na-agafe ka ọgwụgwọ na-aga n'ihu, enwere ike lipodystrophy.

Ndị ọzọ: na mmalite ọgwụgwọ adịkarịghị - edema, enwere ike imebi refraction.

Jiri n'oge ime na lactation.

Ahụmahụ na -adakarị na insulin aspart na afọ ime nwere oke mmachi.

Na nyocha anụmanụ, a hụghị ọdịiche dị n’etiti ẹmbrayoxic na teratogenicity nke insulin aspart na insulin nke mmadụ. N'oge oge ọ ga-ekwe omume ịtụrụ ime yana oge ya niile, ọ dị mkpa iji nlezianya nyochaa ọnọdụ ndị ọrịa nwere ọrịa mellitus ma lelee ọkwa nke glucose n'ọbara. Mkpa insulin, dị ka a na-achị, na-ebelata na ọkara nke mbụ wee jiri nwayọọ nwayọọ na-abawanye na nke abụọ na nke atọ nke afọ ime. N'oge na mgbe amuchara nwa, ihe ndi choro insulin nwere ike igbadata nke ukwuu. N'oge na-adịghị anya a mụsịrị nwa, mkpa ọ dị insulin na-alaghachi ngwa ngwa dị ka ọ dị tupu ime ime.

Enwere ike iji insulin asprat mee ihe n'oge a na-enye nwa ara (na-enye nwa ara), enwere ike ịchọ nhazi insulin nke insulin.

Ntụziaka pụrụ iche maka iji Novomix 30 penfill.

Insuba insulin ma ọ bụ ịkwụsị ịgwọ ọrịa ezughi oke, nwere ụdị ọrịa shuga mellitus nke 1, nwere ike ibute mmepe nke hyperglycemia ma ọ bụ ketoacidosis mamịrị. Ọrịa hyperglycemia na-apụtakarị nwayọ nwayọ n'oge ọtụtụ awa ma ọ bụ ụbọchị. Ihe mgbaàmà nke hyperglycemia bụ ọgbụgbọ, ọgbụgbọ, ụra, ụrọ na akpọnwụ akpọnwụ, akpịrị ịkpọ nkụ, mmụba mmamịrị, akpịrị ịkpọ nkụ na agụụ, yana ọdịdị nke isi acetone na ikuku ekuru. Enweghị ọgwụgwọ kwesịrị ekwesị, hyperglycemia nwere ike ibute ọnwụ. Mgbe ha kwusịrị metabolism metabolism, dịka ọmụmaatụ, na ọgwụ insulin kpụ ọkụ n'ọnụ, ndị ọrịa nwere ike ịnwe mgbaàmà ndị na-ebute ụzọ nke hypoglycemia.

N'ime ndị ọrịa nwere ọrịa shuga nke nwere ezigbo metabolic njikwa, ọrịa ụkọ nri na-egbu oge na-ebute ma emesịa ma jiri nwayọ nwayọ nwayọ. N'akụkụ a, a na-atụ aro ka ọ rụọ ọrụ ndị kachasị maka njikwa metabolic, gụnyere ilele ọkwa glucose dị n'ọbara.

Ihe ga - esite na mmiri ọgwụ nke ike nke analogues na - eme insulin ngwa ngwa bụ na mmepe nke hypoglycemia mgbe ejiri ha na - ebido na mbụ site na iji insulin na-arụ ọrụ mmadụ.

O kwesiri iburu n'uche mmụba dị elu nke mmepe hypoglycemic na ọgwụgwọ nke ndị ọrịa nwere ọrịa concomitant ma ọ bụ na-a drugsụ ọgwụ ọjọọ nke na-ebelata oriri. Ọnụnọ nke ọrịa concomitant, karịsịa nke sitere na nje ọrịa, mkpa insulin, dịka iwu, na-abawanye. Ọkpụkpụ akụrụngwa na-arụ ọrụ ma ọ bụ ọrụ ịba ọcha n'anya nwere ike ibutelata insulin chọrọ.

Mgbe ị na-ebufe onye ọrịa na ụdị insulin ndị ọzọ, akara mmalite nke ebumnuche hypoglycemia nwere ike gbanwee ma ọ bụ belata akpọpụta ma e jiri ya tụnyere ndị na-eji ụdị insulin mbụ.

A ga-ebufe onye ọrịa na ụdị insulin ọ bụla ma ọ bụ ịkwado insulin nke onye nrụpụta ọzọ n'okpuru nlekọta ahụike siri ike. Ọ bụrụ n’ịgbanwe itinye uche, ụdị, onye na-emepụta ihe na ụdị (insulin mmadụ, insulin anụmanụ, ntụnyere insulin nke mmadụ) nke nkwadebe insulin na / ma ọ bụ usoro eji emepụta, enwere ike ịchọrọ ịgbanwe dose.

Enwere ike ịgbanwe mgbanwe insulin nwere ike iji gbanwee ụdị nri nri yana mgbatị ahụ siri ike. Mgbatị ahụ ozugbo ị rie nri nwere ike ịbawanye ohere ị nwere hypoglycemia. Izere nri ma ọ bụ mgbatị ahụ na-enweghị nhazi nwere ike iduga mmepe nke hypoglycemia.

Ọganihu dị ukwuu na steeti nkwụghachi ụgwọ maka metabolism metabolism nwere ike ibute ọnọdụ neuropathy mgbu, nke a na-atụgharịkarị.

Ọganiite ogologo oge na njikwa glycemic na-ebelata ohere ịbawanye ọrịa mamị retinopathy mamịrị. Agbanyeghị, ịbawanye uru nke ọgwụ insulin na-enwe ọganihu dị mma na njikwa glycemic nwere ike ịgbakwunye mbibi ọrịa mamịrị retinopathy nwa oge.

A akwadoghị maka iji ya na ụmụaka na-erubeghị afọ isii.

Mmetụta ikike ịkwọ ụgbọ ala na usoro nchịkwa

Ike nke ndị ọrịa itinye uche na ọnụego mmeghachi omume nwere ike ọfụma n'oge hypoglycemia na hyperglycemia, nke nwere ike ịdị ize ndụ n'ọnọdụ ebe ikike ndị a dị ezigbo mkpa (dịka ọmụmaatụ, mgbe ha na-anya ụgbọ ala ma ọ bụ na-arụ ọrụ na igwe na usoro). A dụrụ ndị ọrịa ọdụ ka ha mee ihe iji gbochie mmepe nke hypoglycemia na hyperglycemia mgbe ha na-anya ụgbọ ala ma jiri usoro rụọ ọrụ. Nke a dị ezigbo mkpa maka ndị ọrịa na-enweghị ma ọ bụ belata ihe mgbaàmà nke ihe ndị na - ebilite hypoglycemia ma ọ bụ na - ata ahụhụ site na ọrịa hypoglycemia ugboro ugboro. N'ụdị ndị a, a ga-atụle ohere nke ụdị ọrụ a.

Mmekọrịta nke Novomix 30 penfill na ọgwụ ndị ọzọ.

Hypoglycemic mmetụta nke insulin welie onu hypoglycemic ọgwụ ọjọọ, Mao inhibitors, Ace inhibitors, carbonic anhydrase inhibitors, nhọrọ beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic Steroid, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations nkwadebe nwere ethanol.

Ihe mgbochi oral, GCS, homonụ thyroid, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazole, clonidine, ndị na-egbochi calcium, diazoxide, morphine, phenytoin, nicotine na-ebelata ike hypoglycemic mmetụta nke insulin.

N'okpuru mmetụta nke reserpine na salicylates, ma ike na-agwụ ike ma na-abawanye na ọrụ ọgwụ a ga-ekwe omume.

Ọgwụ nwere thiol ma ọ bụ sulfite, mgbe etinye ya na insulin, na-akpata mbibi ya.

Ajuju, azịza, nyocha banyere ọgwụ NovoMix 30 Penfill

Ihe omuma a enyere ndi okacha amara n’ulo ogwu. Ihe omuma nke oma banyere ogwu a di na ntuziaka ndi emeputara na nkwakọ. Enweghị ozi edeputara na ibe a ma ọ bụ na saịtị ọ bụla ọzọ nwere ike ịnọchite anya arịrịọ nke onye ọkachamara.