NovoMix 30 Flexpen: tshuaj xyuas ntawm daim ntawv thov, cov lus qhia

Ib qho lus sib piv ntawm tib neeg cov tshuaj insulin ntawm nruab nrab ncua.
Npaj: NOVOMIX® 30 FlexPen®
Cov tshuaj nquag ntawm cov tshuaj: insulin aspart
ATX Encoding: A10AD05
KFG: Ib qho khoom sib piv ntawm tib neeg cov kua dej ntawm lub sijhawm nruab nrab nrog kev pib sai ntawm kev ua
Npe sau npe: P No. 015640/01
Hnub tso npe: 04/29/04
Tswv reg reg. acc .: NOVO NORDISK A / S

Daim ntawv tso tawm Novomiks 30 flekspen, ntim tshuaj thiab muaj pes tsawg leeg.

Kev ncua rau sc tswj hwm ntawm cov xim dawb, thaum stratified, tsim cov dej nag dawb thiab xim tsis tshua muaj xim lossis yuav luag tsis tau xim, nrog kev ua tib zoo nplawm, ib qho homogeneous kev ncua yuav tsum tsim.

1 ml
tshuaj insulin aspart biphasic
100 DAIM DUAB *

Cov kev zam: mannitol, phenol, metacresol, zinc chloride, sodium chloride, sodium hydrogen phosphate dihydrate, protamine sulfate, sodium hydroxide, hydrochloric acid, dej d / thiab.

* 1 koog raug rau 35 mcg ntawm anhydrous insulin aspart.

3 ml - ntau-koob syringe cwjmem nrog lub dispenser (5) - pob ntawm cardboard.

Cov lus piav qhia ntawm cov tshuaj yog ua raws cov lus qhia raug pom zoo rau kev siv.

Pharmacological ua Novomix 30 flekspen

Ib qho lus sib piv ntawm tib neeg cov tshuaj insulin ntawm nruab nrab ncua. Nws cuam tshuam nrog ib qho kev tshwj xeeb ntawm sab cytoplasmic membrane ntawm cov hlwb thiab tsim cov txheej txheem insulin-receptor complex uas txhawb cov txheej txheem intracellular, suav nrog synthesis ntawm cov naj npawb ntawm cov enzymes tseem ceeb (hexokinase, pyruvate kinase, glycogen synthetase). Cov nyhuv hauv lub qog nqaij hlav yog cuam tshuam nrog kev thauj mus los ntau ntxiv thiab kev nqus ntawm cov kua nplaum ntau ntxiv los ntawm cov ntaub so ntswg, txhawb kev ua haujlwm ntawm lipogenesis, glycogenogenesis, thiab qhov txo qis hauv cov ntshav qabzib ntau lawm los ntawm lub siab.

NovoMix 30 Flexpen yog ob lub caij raug ncua uas muaj kev tiv thaiv cov tshuaj insulin aspart (30%) thiab crystalline insulin aspart protamine (70%). Insulin aspart tau los ntawm biotechnology (hauv cov qauv tsim qauv ntawm cov kua dej, cov amino acid proline ntawm txoj haujlwm B28 yog hloov los ntawm aspartic acid).

Thaum siv rau hauv cov neeg mob uas muaj hom 1 thiab hom 2 mob ntshav qab zib mellitus, NovoMix 30 FlexPen muaj cov txiaj ntsig zoo ib yam ntawm qib glycosylated hemoglobin yog biphasic tib neeg insulin 30. Insulin aspart thiab tib neeg insulin muaj tib yam hauv cov hniav puas sib npaug.

Hauv cov tshuaj insulin aspart, kev hloov pauv ntawm cov amino acid proline nyob rau hauv txoj haujlwm B28 rau aspartic acid txo kev nyiam ntawm cov lwg me me los ua hexamers nyob rau hauv cov tshuaj tiv thaiv ntawm NovoMix 30 FlexPen, uas tau pom nyob hauv tib neeg lub cev cov kua dej. Hauv qhov no, insulin aspart yog nqus los ntawm subcutaneous rog sai dua li cov tshuaj insulin uas muaj nyob hauv tib neeg cov kua dej. Insulin aspart protamine, zoo li tib neeg insulin NPH, nqus tau ntev dua.

Piv nrog soluble tib neeg cov tshuaj insulin, insulin aspart (ua haujlwm sai ntawm tib neeg cov tshuaj insulin) pib ua ntau dua, yog li nws tuaj yeem siv tam sim ua ntej noj mov (los ntawm 0 txog 10 feeb ua ntej noj mov). Cov nyhuv ntawm crystalline insulin aspart protamine (nruab nrab lub sij hawm ntev ntawm tib neeg cov tshuaj insulin) zoo ib yam li tib neeg ntawm insulin NPH. Tom qab s / c tswj hwm ntawm cov tshuaj NovoMix 30 Flexpen, cov nyhuv tshwm sim tom qab 10-20 feeb. Qhov siab tshaj plaws tau pom yog 1-4 teev tom qab txhaj tshuaj. Lub sijhawm tiv thaiv ntawm cov tshuaj nce mus txog 24 teev.

Pharmacokinetics ntawm cov tshuaj.

Thaum siv NovoMix 30 FlexPen, Cmax ntawm cov tshuaj insulin hauv qhov dej yog qhov nruab nrab 50% siab dua thaum siv ob-theem ntawm tib neeg insulin 30, thaum lub sijhawm nce mus txog Cmax yog nruab nrab 2 lub sijhawm tsawg dua. Thaum cov tshuaj tau muab rau cov neeg tuaj yeem noj qab nyob zoo ntawm koob tshuaj 0.2 U / kg lub cev hnyav, qhov nruab nrab Cmax yog 140 ± 32 pmol / L thiab tau mus txog tom qab 60 feeb.

Qhov nruab nrab T1 / 2, xav txog qhov nqus tus nqi ntawm cov protamin-fraction feem, yog 8–9 teev. Ntsuas cov tshuaj insulin rov qab los rau nws thawj theem 15-18 teev tom qab s / c txhaj tshuaj.

Hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus, Cmax tau mus txog tom qab 95 feeb thiab tswj tau nyob rau theem qis dua 0 rau tsawg kawg 14 teev tom qab kev tswj hwm sc.

Qhov tos ntawm kev nqus ntawm NovoMix 30 FlexPen ntawm qhov chaw txhaj tshuaj tsis tau kawm.

Dosage thiab txoj hauv kev ntawm kev tswj hwm tshuaj.

Cov tshuaj yog npaj rau sc tswj hwm. Cov tshuaj NovoMix 30 FlexPen tsis tuaj yeem nkag rau hauv / hauv!

Cov koob tshuaj tau teeb tsa ib leeg zuj zus raws li ntsuas ntsuas ntshav qabzib. Qhov nruab nrab cov tshuaj txhua hnub nruab nrab ntawm 0.5 txog 1 U / kg lub cev hnyav. Nrog cov insulin tsis kam (piv txwv li, nyob rau hauv cov neeg mob rog), kev xav tau rau insulin txhua hnub yuav nce ntxiv, thiab hauv cov neeg mob uas muaj qhov endogenous insulin muaj zais cia, nws yuav txo qis.

NovoMix 30 FlexPen tuaj yeem siv rau cov neeg mob ntshav qab zib hom 2 mob ntshav qab zib mellitus xws li kev kho mob monotherapy lossis muab sib xyaw nrog metformin hauv qhov xwm txheej uas cov ntshav qabzib tsis txaus los ntawm metformin ib leeg. Qhov pom zoo pib koob tshuaj NovoMix 30 ua ke nrog metformin yog 0.2 U / kg / hnub. Qhov tshuaj yuav tsum tau kho nyob ntawm tus neeg xav tau cov tshuaj insulin, raws li cov ntsiab lus ntawm cov piam thaj hauv cov ntshav.

NovoMix 30 FlexPen yuav tsum tau tswj hwm ua ntej noj mov, yog tias tsim nyog tam sim tom qab noj mov. Qhov ntsuas kub ntawm cov tshuaj tso cai yuav tsum nyob ntawm chav sov.

Kev txhaj tshuaj yog ua s / c hauv tus ncej puab lossis sab hauv plab phab ntsa, yog qhov xav tau - nyob hauv xub pwg lossis lub pob tw. Nws yog ib qho tsim nyog yuav tsum hloov chaw txhaj tshuaj nyob rau thaj tsam anatomical thiaj li tiv thaiv kev txhim kho ntawm lipodystrophy.

Ib yam li lwm yam insulin npaj, lub sijhawm ntawm kev txiav txim siab ntawm NovoMix 30 FlexPen yog nyob ntawm qhov koob tshuaj, qhov chaw tswj, ntshav txaus, qhov kub thiab theem ntawm kev siv lub cev. Qhov tos ntawm kev nqus ntawm NovoMix 30 FlexPen ntawm qhov chaw txhaj tshuaj tsis tau kawm.

Cov kev cai rau kev siv tshuaj NovoMix® 30 FlexPen®

Flexpen yog kua cwj mem tsim los tswj cov tshuaj insulin. Flexpen yog siv nrog NovoFayn koob luv. Kev ntim ntawm NovoFine koob luv luv yog cim S.

Koj tsis tuaj yeem siv NovoMix 30 FlexPen yog tias, tom qab tshee, qhov kev ncua tsis dhau dawb thiab tauv huab.

Cov tshuaj yuav tsum tsis txhob siv yog tias cov qog dawb tshwm hauv nws lossis yog tias muaj cov thooj dawb lo rau hauv qab lossis rau ntawm phab ntsa ntawm daim cartridge, muab nws qhov tshwm sim ntawm ib qho khov.

Lub FlexPen Syringe Cwj mem yog rau kev siv tus kheej nkaus xwb thiab tsis tuaj yeem siv ntxiv.

Cov lus qhia ntxaws ntxaws rau kev siv FlexPen koob txhaj tshuaj yog muab rau hauv cov lus qhia kho mob rau NovoMix 30 FlexPen muab tso rau hauv txhua pob.

Cov kev mob tshwm sim ntawm Novomix 30 ua haujlwm:

Cov kev mob tshwm sim cuam tshuam nrog kev cuam tshuam ntawm cov metabolism hauv cov metabolism: feem ntau ntshav qab zib tsis txaus, cov tsos mob uas yuav muaj xws li pallor ntawm daim tawv nqaij, tawm hws txias, poob siab, tshee, ntxhov siab, txawv txawv lossis qaug zog, tsis meej pem, poob siab, poob siab, kiv taub hau, pom kev tsis taus ib ntus, mob taub hau, xeev siab, tachycardia. Kev mob ntshav nce siab ntau tuaj yeem ua rau tsis nco qab, ib ntus lossis tsis tuaj yeem cuam tshuam ntawm lub hlwb thiab tuag.

Kev tsis haum tshuaj: kev tawm tsam hauv zos (feem ntau yog ib ntus thiab ploj mus thaum kev kho mob txuas ntxiv) - tawv nqaij liab, o, khaus ntawm qhov chaw txhaj tshuaj, dav dav (tuag taus), tawv nqaij ua pob khaus, ua pob khaus tawv nqaij, nce hws, mob lub plab tsis sib haum, mob hlwb, nyuaj kev ua pa tawm, tachycardia, txo cov ntshav siab.

Lwm yam: kab mob edema, hnov ​​qab lub ntsej muag (feem ntau pom thaum pib kho mob insulin thiab yog ib ntus), kev txhim kho lipodystrophy ntawm qhov chaw txhaj tshuaj.

Contraindications rau cov tshuaj:

- nce ib tug neeg rhiab rau insulin aspart lossis lwm yam tshuaj.

Nws tsis raug nquahu kom siv cov tshuaj rau menyuam yaus thiab cov hluas hnub nyoog qis dua 18 xyoo, vim tias cov kev tshawb fawb soj ntsuam txog kev siv NovoMix 30 Flexpen hauv cov neeg mob ntawm cov pab pawg hnub nyoog no tsis tau ua tiav.

Siv thaum cev xeeb tub thiab lactation.

Cov kev paub txog kev kho mob nrog insulin aspart thaum cev xeeb tub yog qhov tsawg.

Nyob rau lub sijhawm ntawm qhov pib ua tau thiab thaum tag nrho lub sijhawm cev xeeb tub, ua tib zoo saib xyuas cov xwm txheej ntawm cov neeg mob ntshav qab zib mellitus thiab saib xyuas qib ntawm cov piam thaj hauv cov ntshav ntshav yog qhov tsim nyog. Qhov xav tau rau insulin, raws li txoj cai, txo qis hauv thawj peb hlis thiab maj mam nce ntxiv hauv qib thib ob thiab thib peb ntawm cev xeeb tub. Thaum lub sijhawm thiab yug tom qab yug, insulin yuav tsum poob ntau. Tsis ntev tom qab yug los, xav tau cov tshuaj insulin sai sai rau qib uas yog ua ntej cev xeeb tub.

Thaum lub sijhawm pub niam mis, cov tshuaj yuav siv tau yam tsis muaj kev txwv. Qhov kev coj ntawm cov tshuaj insulin rau leej niam noj mis tsis yog kev hem thawj rau tus menyuam. Txawm li cas los xij, nws yuav tsim nyog los kho qhov koob tshuaj NovoMix 30 FlexPen.

Hauv kev sim tsiaj, tsis muaj qhov sib txawv ntawm qhov pom ntawm embryotoxic thiab teratogenic cuam tshuam ntawm insulin aspart thiab tib neeg insulin.

Cov lus qhia tshwj xeeb rau kev siv Novomix 30 flekspen.

Qhov tsis txaus noj tshuaj lossis tsis ncua kev kho mob, tshwj xeeb tshaj yog nrog hom 1 mob ntshav qab zib mellitus (insulin-dependant), tuaj yeem ua rau kev loj hlob ntawm hyperglycemia lossis ntshav qab zib ketoacidosis.

Cov tsos mob ntawm hyperglycemia feem ntau pib maj mam dhau ob peb teev lossis hnub thiab suav nrog xeev ntuav, ntuav, nkees, liab thiab tawv nqaij ntawm daim tawv nqaij, lub qhov ncauj qhuav, tso zis tawm ntxiv, nqhis dej thiab tsis qab los noj mov, thiab cov tsos ntawm cov ntxhiab tsw ntxhiab hauv tshuab pa zoo heev. Yog tias tsis muaj kev kho mob uas tsim nyog, hyperglycemia tuaj yeem ua rau tuag taus.

Tom qab them nyiaj rau cov pluas noj carbohydrate, piv txwv li, nrog kev siv tshuaj insulin ntau dua, cov neeg mob yuav muaj cov tsos mob tshwm sim ua ntej ntawm hypoglycemia, uas cov neeg mob yuav tsum tau qhia txog. Hauv cov neeg mob ntshav qab zib uas muaj cov khoom siv tswj lub cev kom zoo rau lub cev, cov mob ntshav qab zib lig dhau los tom qab thiab nce qeeb dua. Hauv qhov no, nws raug nquahu kom ua haujlwm los tswj kev ua kom lub cev zom zaub mov zoo, nrog rau saib xyuas qib ntawm cov piam thaj hauv cov ntshav.

NovoMix 30 FlexPen yuav tsum tau siv nyob rau hauv kev sib txuas ncaj qha nrog kev noj zaub mov. Koj yuav tsum coj mus rau hauv qhov kev kub ceev ntawm qhov pib ntawm cov nyhuv ntawm cov tshuaj hauv kev kho mob ntawm cov neeg mob uas muaj kab mob concomitant lossis noj tshuaj uas ua rau qeeb qis dua qhov nqus ntawm cov khoom noj. Nyob rau hauv muaj cov kab mob concomitant, tshwj xeeb ntawm kev kis tus kab mob, xav tau cov tshuaj insulin nce ntxiv. Mob raum lossis siab mob muaj nuj nqi tuaj yeem ua rau txo qis hauv tshuaj insulin.

Tsis noj zaub mov ua si los yog kev tawm dag zog tsis npaj yuav tuaj yeem coj mus rau hauv hypoglycemia. Piv nrog biphasic tib neeg cov tshuaj insulin, txoj kev tswj hwm ntawm NovoMix 30 FlexPen muaj qhov ua kom tsis muaj zog nyob rau thawj 6 teev tom qab kev tswj hwm. Hauv qhov no, qee qhov xwm txheej, nws yuav tsim nyog yuav tau kho lub koob tshuaj insulin thiab / los yog hom xwm ntawm kev noj haus.

Hloov chaw ntawm tus neeg mob mus rau ib hom tshiab ntawm insulin lossis kev tsim tshuaj insulin ntawm lwm cov tuam txhab yuav tsum tau ua nyob ntawm kev saib xyuas mob nkeeg nruj. Yog tias koj hloov qhov kev xav, hom, chaw tsim khoom thiab hom (tib neeg insulin, tsiaj insulin, tib neeg insulin analogue) ntawm cov tshuaj insulin thiab / lossis cov qauv kev tsim tawm, yuav tsum tau hloov cov koob tshuaj. Cov neeg mob uas hloov mus rau NovoMix 30 FlexPen yuav xav tau hloov cov koob tshuaj ntau dua li piv rau cov tshuaj insulin uas tau siv yav dhau los. Yog tias tsim nyog, kev hloov kho tshuaj, nws tuaj yeem ua twb tau dhau los ntawm thawj kev txhaj tshuaj lossis thaum thawj lub limtiam lossis hli ntawm kev kho. Ib qho ntxiv, kev hloov pauv ntawm cov tshuaj yuav raug nrog kev hloov pauv ntawm kev noj zaub mov thiab nrog kev tawm dag zog lub cev. Kev tawm dag zog ua tam sim ntawd tom qab ib pluas noj yuav ua rau muaj kev txo ntshav qab zib hauv lub cev.

Tsis txhob siv NovoMix 30 FlexPen hauv cov twj tso kua mis.

Cuam tshuam rau kev muaj peev xwm tsav tsheb thiab tswj cov tshuab

Lub peev xwm ntawm cov neeg mob kom pom tseeb thiab qhov tshuaj tiv thaiv yuav ua rau lub sijhawm tsis muaj ntshav qab zib thiab hyperglycemia, uas tuaj yeem ua rau muaj xwm txheej nyob rau hauv cov xwm txheej uas cov peev xwm no tsim nyog tshwj xeeb (piv txwv li, thaum tsav tsheb lossis ua haujlwm nrog cov tshuab thiab tshuab). Cov neeg mob yuav tsum tau qhia rau kev ntsuas kom tiv thaiv kev txhim kho hypoglycemia thiab hyperglycemia thaum tsav tsheb thiab ua haujlwm nrog cov txheej txheem. Qhov no yog qhov tshwj xeeb tshaj yog rau cov neeg mob uas tsis muaj los yog ploj zuj zus ntawm cov tshwm sim ntawm kev muaj ntshav qab zib lossis kev txom nyem los ntawm kev pheej muaj ntshav tsis txaus. Hauv cov xwm txheej no, qhov ua tau ntawm cov haujlwm no yuav tsum raug txiav txim siab.

Kev siv tshuaj ntau dhau:

Cov tsos mob: hypoglycemia yuav tshwm sim.

Kev Kho Mob: tus neeg mob tuaj yeem nres kom tsis txhob mob ntshav qab zib tsawg los ntawm kev noj cov piam thaj, qab zib lossis tej zaub mov uas muaj carbohydrate. Yog li, cov neeg mob ntshav qab zib tau qhia kom pheej nqa cov suab thaj, qab zib, ncuav qab zib lossis kua txiv qab zib. Hauv cov xwm txheej loj, yog tias tsis nco qab, 40% kev daws teeb meem yog txhaj tshuaj rau lub cev, glucagon (0.5-1 mg) intramuscularly lossis subcutaneously. Tom qab nws rov qab nco qab, tus neeg mob tau pom zoo kom noj cov khoom noj uas muaj cov khoom noj carbohydrate kom tiv thaiv kev rov qab txhim kho hypoglycemia.

Kev sib cuam tshuam ntawm Novomix 30 flekspen nrog lwm cov tshuaj.

Hypoglycemic kev txiav txim ntawm cov tshuaj txhim khu qhov ncauj hypoglycemic tshuaj, Mao inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, xim beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium npaj ethanol-muaj npaj.

Cov nyhuv hauv lub ntsej muag hypoglycemic yog txo los ntawm kev tiv thaiv qhov ncauj, GCS, cov thyroid hormones npaj, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazole, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Hauv qab ntawm reserpine thiab salicylates, ob qho tib si qaug zog thiab txhim kho kev ua ntawm cov tshuaj NovoMix 30 FlexPen yog ua tau.

Cov nqe lus ntawm qhov kev mob cia ntawm cov tshuaj Novomix 30 flekspen.

Sau npe B. Tsis Siv NovoMix 30 FlexPen yuav tsum muab cia rau hauv tub yees ntawm qhov kub ntawm 2 ° txog 8 ° C (tsis txhob nyob ze rau lub tub yees txias), tsis txhob kom khov. Txee lub neej yog 2 xyoos.

Siv NovoMix 30 FlexPen yuav tsum khaws cia ntawm qhov kub tsis tshaj 30 ° C rau 4 lub lis piam. Txhawm rau tiv thaiv los ntawm lub teeb, NovoMix 30 FlexPen yuav tsum raug kaw nrog lub hau.

Kev taw qhia thiab contraindications rau kev siv tshuaj

NovoMix 30 Flexpen qhia rau cov ntshav qab zib. Pharmacokinetics tsis tau kawm hauv cov pawg no ntawm cov neeg mob:

• neeg laus neeg laus
• cov menyuam
• cov neeg mob uas muaj lub siab thiab lub raum tsis ua haujlwm.

Categorically, cov tshuaj yuav tsum tsis txhob siv rau hypoglycemia, ntau rhiab heev rau cov tshuaj aspart lossis lwm qhov tshuaj ntawm cov tshuaj teev tseg.

Cov lus qhia tshwj xeeb thiab cov lus ceeb toom rau kev siv

Yog tias qhov tshuaj tsis txaus siv lossis qhov kev kho mob tsis tu ncua (tshwj xeeb yog mob ntshav qab zib hom 1), cov hauv qab no yuav tshwm sim:

Ob qho xwm txheej no txaus ntshai tshaj plaws rau kev noj qab haus huv thiab tuaj yeem ua rau tuag taus.

NovoMix 30 FlexPen lossis nws rab qau hloov pauv yuav tsum tau ua haujlwm ua ntej noj mov. Nws yog ib qho tsim nyog yuav tsum tau coj mus rau hauv qhov pib thaum ntxov ntawm kev nqis tes ua ntawm cov tshuaj no hauv kev kho mob ntawm cov neeg mob uas muaj kab mob sib kis lossis noj tshuaj uas tuaj yeem txo qis qhov nqus ntawm cov khoom noj hauv lub plab zom mov.

Cov kab mob tsis haum (tshwj xeeb tshaj yog cov sib kis thiab cov tsiaj febrile) nce qhov xav tau ntxiv rau insulin.

Kev hloov pauv ntawm tus neeg mob mus rau lwm hom tshuaj insulin, qhov ua ntej ntawm kev pib ntawm kev txhim kho ntawm lub cev tsis tuaj yeem tuaj yeem hloov pauv thiab txawv ntawm cov uas tshwm sim los ntawm kev siv cov tshuaj ntshav qab zib ib txwm siv. Hauv kev pom txog qhov no, nws yog qhov tseem ceeb heev kom hloov tus neeg mob mus rau lwm cov tshuaj nyob rau hauv kev tswj hwm nruj ntawm tus kws kho mob.

Cov kev hloov pauv muaj xws li hloov kho qhov koob uas xav tau. Peb tab tom tham txog cov xwm txheej zoo li no:

• hloov nyob rau hauv cov tshuaj concentration,
• kev hloov ntawm hom lossis chaw tsim khoom,
• hloov pauv keeb kwm ntawm cov kua dej (tib neeg, tsiaj los yog tsiaj txuas ntawm tib neeg),
• txoj kev tswj hwm lossis kev tsim khoom.

Hauv cov txheej txheem ntawm hloov mus rau NovoMix 30 FlexPen cov tshuaj insulin los yog penfill analog txhaj tshuaj, cov neeg mob ntshav qab zib xav tau kev pab ntawm tus kws kho mob hauv kev xaiv cov tshuaj rau thawj cov thawj coj ntawm cov tshuaj tshiab rau lawv. Nws kuj tseem ceeb nyob hauv thawj lub lis piam thiab lub hlis tom qab hloov nws.

Piv nrog rau cov pa biphasic tib neeg cov tshuaj insulin, kev txhaj tshuaj ntawm NovoMix 30 FlexPen tuaj yeem ua rau mob ntshav qab zib ntau heev. Nws tuaj yeem kav ntev txog 6 teev, uas suav nrog kev txheeb xyuas cov tshuaj xav tau ntawm insulin lossis kev noj haus.

Kev tshem tawm cov tshuaj insulin tsis tuaj yeem siv hauv cov tshuaj insulin los txuas cov tshuaj hauv qab tawv.

Muaj peev xwm tswj cov tshuab

Yog tias, vim li cas rau ntau yam, hypoglycemia tshwm sim thaum noj cov tshuaj, tus neeg mob yuav tsis muaj peev xwm mloog tau zoo thiab muaj peev xwm teb tau qhov tshwm sim rau nws. Yog li ntawv, tsav tsheb los yog lub tshuab yuav tsum raug txwv. Txhua tus neeg mob yuav tsum paub txog kev ntsuas tsim nyog los tiv thaiv cov ntshav qab zib cov ntshav kom qis, tshwj xeeb yog tias koj yuav tsum tau tsav tsheb.

Hauv cov xwm txheej uas FlexPen lossis nws qhov tseeb ntawm lub ntsej muag siv, nws yuav tsum ua tib zoo ntsuas kev nyab xeeb thiab kev pom zoo ntawm kev tsav tsheb, tshwj xeeb tshaj yog nyob rau qee qhov xwm txheej ntawm cov ntshav qog ntshav tsis muaj zog lossis tsis tuaj.

Cov tshuaj sib cuam tshuam li cas nrog lwm cov tshuaj?

Muaj ntau cov tshuaj uas tuaj yeem cuam tshuam cov metabolism hauv cov piam thaj hauv lub cev, uas yuav tsum tau coj mus rau hauv kev suav thaum xam qhov yuav tsum tau noj.

Txhais tau tias kev txo qis qhov xav tau rau insulin hormone suav nrog:

• qhov ncauj hypoglycemic,
• MAO inhibitors
• octreotide
• ACE inhibitors
• salicylates,
• anabolics
• sulfonamides,
• cawv muaj
• tsis xaiv cov khoom blockers.

Nws kuj muaj cov cuab yeej uas ua rau kom qhov kev xav tau ntxiv rau kev siv NovoMix 30 FlexPen insulin lossis nws cov roj ntsha sib txawv:

1. tshuaj tiv thaiv qhov ncauj
2. danazol
3. cawv
4. thiazides,
5. GSK,
6. cov thyroid hormones.

Yuav thov li cas thiab koob tshuaj?

Dosage NovoMix 30 Flexpen yog tus neeg nruj me ntsis thiab muab rau kev teem caij ntawm tus kws kho mob, nyob ntawm seb pom tseeb qhov xav tau ntawm tus neeg mob. Vim tias cov tshuaj nrawm heev, nws yuav tsum tau ua haujlwm ua ntej noj mov. Yog tias tsim nyog, insulin, nrog rau penfill, yuav tsum tau muab tshuaj sai sai tom qab noj mov.

Yog tias peb tham txog cov ntsuas nruab nrab, ces NovoMix 30 FlexPen yuav tsum thov raws li qhov hnyav ntawm tus neeg mob thiab yuav los ntawm 0.5 txog 1 UNIT rau txhua qhov hnyav ib hnub. Qhov kev xav tau yuav nce ntxiv nyob rau hauv cov neeg mob ntshav qab zib uas muaj kev tiv thaiv insulin, thiab txo qis thaum muaj qee qhov tshwj tseg cov pa tawm ntawm lawv tus kheej lawm.

Flexpen feem ntau yog tswj xyuas subcutaneously hauv tus ncej puab. Los tseem muaj peev xwm ua tau hauv:

• tsam plab (sab xub ntiag phab ntsa),
• pob tw
• deltoid leeg ntawm lub xub pwg.

Lipodystrophy tuaj yeem zam tau tias cov chaw txhaj tshuaj yog cov kev hloov chaw.

Ua raws li cov piv txwv ntawm lwm yam tshuaj, lub sijhawm sib kis ntawm cov tshuaj kuj txawv. Qhov no yuav cia siab rau:

1. tsuas tshuaj
2. chaw txhaj tshuaj
3. ntshav txaus
4. theem ntawm kev siv lub cev
5. lub cev kub.

Qhov kev cia siab ntawm kev nqus ntawm cov tshuaj tso rau ntawm thaj chaw txhaj tshuaj tsis tau txheeb xyuas.

Cov neeg mob uas muaj ntshav qab zib hom 2, NovoMix 30 FlexPen (thiab mem tes ua piv txwv) tuaj yeem raug kho raws li kev kho mob tseem ceeb, nrog rau kev sib xyaw nrog metformin. Qhov tom kawg yog qhov tsim nyog nyob rau hauv cov xwm txheej uas tsis tuaj yeem txo qhov kev nqus ntawm cov ntshav qab zib los ntawm lwm txoj hauv kev.

Thawj qhov kev pom zoo ntawm cov tshuaj nrog metformin yuav yog 0.2 units ntawm ib phaus ntawm tus neeg mob lub cev ib hnub. Qhov ntim ntawm cov tshuaj yuav tsum tau kho nyob ntawm cov kev xav tau ntawm txhua kis.

Nws tseem yog ib qho tseem ceeb kom them rau qib ntawm cov piam thaj hauv ntshav cov ntshav. Ib qho ua tsis zoo lub raum lossis hepatic muaj nuj nqi yuav txo qhov kev xav tau cov tshuaj hormone.

NovoMix 30 Flexpen tsis tuaj yeem siv los kho menyuam yaus.

Cov tshuaj hauv cov lus nug tsuas yog siv tau rau ntawm kev txhaj tshuaj ib leeg xwb. Nws tsis tuaj yeem raug categorically txhaj rau hauv cov leeg nqaij lossis leeg ntshav.

Cov cim ntawm cov kev phiv tshuaj

Cov kev mob tsis zoo ntawm kev siv cov tshuaj tuaj yeem raug sau tseg tsuas yog thaum hloov pauv ntawm lwm tus insulin lossis thaum hloov txoj kev noj tshuaj. NovoMix 30 FlexPen (lossis nws qhov tseeb ntawm lub tog raj mis) tuaj yeem siv tshuaj rau hauv lub xeev kev noj qab haus huv.

Raws li txoj cai, hypoglycemia ua rau pom cov kev mob tshwm sim heev. Nws tuaj yeem tsim kho thaum qhov koob tshuaj ntau dua li qhov xav tau tiag tiag rau ib qho tshuaj hormones, uas yog, ntau tshaj ntawm insulin tshwm sim.

Cov neeg tsis muaj peev xwm txaus yuav ua rau tsis nco qab lossis ua kom mob plab, tom qab ntawd cuam tshuam tas li lossis ib ntus cuam tshuam rau lub hlwb lossis tuag taus.

Raws li cov txiaj ntsig ntawm kev tshawb fawb soj ntsuam thiab cov ntaub ntawv sau tseg tom qab tshaj tawm ntawm NovoMix 30 ntawm kev ua lag luam, nws tuaj yeem hais tias qhov xwm txheej ntawm ntshav nce siab ntau hauv ntau pawg neeg mob yuav sib txawv.

Raws li qhov xwm txheej ntawm qhov tshwm sim, kev tsis zoo tuaj yeem raug cais ua faib ua pawg:

• los ntawm kev tiv thaiv kab mob: anaphylactic tshua (tsis tshua muaj), urticaria, tawm pob rau ntawm daim tawv nqaij (qee zaum),
• cov kev tawm dav dav: khaus, tsis hnov ​​mob ntau dhau, tawm hws, cuam tshuam ntawm lub plab zom mov, txo qis ntshav siab, lub plawv dhia qeeb, angioedema (qee zaum),
• los ntawm lub paj hlwb: peripheral neuropathies. Kev txhim kho thaum ntxov hauv kev tswj cov piam thaj hauv ntshav tuaj yeem ua rau qhov mob ntawm cov mob neuropathy, dhau mus (tsis tshua muaj),
• teeb meem tsis pom kev: tsis meej pem (qee zaum). Nws yog qhov xwm yeem thiab tshwm sim thaum pib ntawm kev kho mob nrog insulin,
• kev kuaj mob ntshav qab zib (qee zaum). Nrog kev tswj zoo glycemic, qhov yuav muaj kev vam meej ntawm qhov kev cuam tshuam no yuav raug txo kom tsawg. Yog tias siv cov kev mob siab rau siv, yog li qhov no yuav ua rau muaj kev cuam tshuam ntawm qhov retinopathy,
• los ntawm cov nqaij mos subcutaneous thiab tawv nqaij, lipid dystrophy tuaj yeem tshwm sim (qee zaum). Nws tshwm sim hauv cov chaw uas tau txhaj tshuaj ntau zaus. Cov kws kho mob pom zoo hloov qhov chaw txhaj tshuaj ntawm NovoMix 30 FlexPen (lossis nws rab phom piv ua ke) hauv thaj chaw. Ntxiv mus, kev rhiab heev dhau los yuav pib. Nrog rau kev qhia ntawm cov tshuaj, kev txhim kho ntawm lub siab lub cev tsis muaj zog yog qhov ua tau: liab liab, khaus ntawm daim tawv nqaij, o ntawm thaj chaw txhaj tshuaj. Cov kev sib hloov no yog ua rau qhov tshwm sim thiab ploj mus nrog kev kho mob txuas ntxiv,
• lwm cov kev cuam tshuam thiab cuam tshuam (qee zaum). Pib thaum pib ntawm kev siv tshuaj insulin. Cov tsos mob tsuas yog ib ntus xwb.

Ntau tus neeg mob

Nrog kev tswj hwm ntev li ntawm cov tshuaj, txoj kev txhim kho ntawm lub xeev hypoglycemic yog tau.

Yog tias cov ntshav qab zib hauv cov ntshav qab zib tau poob qis me ntsis, ces kev noj ntshav qab zib kom tsawg yuav tsum nres los ntawm kev noj zaub mov qab zib lossis qabzib. Vim li ntawd, txhua tus neeg mob ntshav qab zib yuav tsum tau nqa me me ntawm cov khoom qab zib, piv txwv li, cov khoom qab zib uas tsis yog mob ntshav qab zib lossis dej qab zib.

Yog tias muaj qhov ua rau cov ntshav tsis dhau ntawm lub ntsej muag, thaum tus neeg mob poob mus rau hauv lub cev tsis nco qab, nws yog qhov yuav tsum tau muab nws los ua haujlwm rau cov ntshav ntawm lub cev ntawm glucagon hauv kev suav ntawm 0.5 txog 1 mg. Cov lus qhia rau cov kev ua no yuav tsum paub rau cov neeg nyob nrog ntshav qab zib.

Sai li tus neeg mob ntshav qab zib mob tawm los ntawm kev tsis xeev, nws yuav tsum tau noj me me ntawm carbohydrates hauv. Qhov no yuav muab ib txoj hauv kev los tiv thaiv qhov pib ntawm kev rov huam mob.

NovoMix 30 Flexpen yuav tsum khaws cia li cas?

Cov txheej txheem txee lub neej ntawm cov tshuaj yog 2 xyoos txij li hnub ntawm nws cov khoom siv. Phau ntawv qhia tau hais tias yuav tsum tau muaj ib rab cwj mem npaj tau siv nrog NovoMix 30 FlexPen (lossis nws qhov mem hluav) uas tsis tuaj yeem muab tso rau hauv tub yees. Nws yuav tsum tau nrog koj nyob hauv chaw cia thiab khaws cia tsis ntau tshaj 4 lub lis piam ntawm qhov kub tsis tshaj 30 degrees.

Ib qho tshuaj thaiv insulin uas siv ruaj khov yuav tsum khaws cia ntawm 2 txog 8 degrees. Categorically koj tuaj yeem tsis khov cov tshuaj!

Daim ntawv noj tshuaj:

Kev piav qhia
Homogeneous dawb lump-tsis pub muab ncua. Flakes tuaj yeem tshwm sim hauv tus qauv.
Thaum sawv ntsug, qhov kev ncua tawm delaminates, sib sau ua ib qho dawb nag lossis daus uas tsis muaj xim lossis yuav luag tsis muaj xim.
Thaum muab sib xyaw cov ntsiab lus ntawm cov kua roj pleev xim raws li tus txheej txheem tau piav qhia hauv Cov Lus Qhia rau kev siv tshuaj, ib qho kev ncua homogeneous yuav tsum tau ua.

Cov yam ntxwv Pharmacological:

Cov tshuaj insulin aspart yog equipotential soluble tib neeg insulin raws li nws cov molarity.

Kev poob qis hauv cov concentration ntawm cov piam thaj hauv cov ntshav tshwm sim vim yog qhov nce ntxiv hauv nws txoj kev thauj mus los tom qab kev khi ntawm insulin aspart rau insulin receptors ntawm cov leeg nqaij thiab cov nqaij rog thiab qhov tsis txaus siab rau cov piam thaj los ntawm lub siab.

Tom qab muab cov kev tswj hwm ntawm NovoMix® 30 FlexPen®, cov nyhuv loj zuj zus tsis pub dhau 10-20 feeb. Qhov siab tshaj plaws pom tau pom nyob hauv thaj tsam li 1 txog 4 teev tom qab kev txhaj tshuaj. Lub sijhawm tiv thaiv ntawm cov tshuaj nce mus txog 24 teev.

Hauv peb lub hlis sib piv kev tshawb fawb uas muaj feem cuam rau cov neeg mob ntshav qab zib hom 1 thiab ntshav qab zib hom 2 uas tau txais NovoMix® 30 FlexPen® thiab biphasic tib neeg insulin 30 ob zaug ib hnub ua ntej noj tshais thiab noj hmo, NovoMix® 30 FlexPen® tau pom tias txo qis tom qab tau txais kev xav ntau dua. ntshav piam thaj (tom qab noj tshais thiab noj hmo).

Kev ntsuas meta ntawm cov ntaub ntawv los ntawm cuaj lub chaw soj ntsuam uas muaj cov neeg mob ntshav qab zib hom 1 thiab ntshav qab zib hom 2 qhia tau tias NovoMix® 30 FlexPen®, muab rau noj ua ntej noj tshais thiab noj hmo, muab kev tswj tau zoo dua ntawm cov ntshav qabzib cov ntshav qabzib (nce ntxiv hauv thaj tsam ntshav qab zib kom zoo. tom qab noj tshais, noj su thiab noj hmo), piv nrog tib neeg biphasic insulin 30. Txawm hais tias cov kua nplaum ceev hauv cov neeg mob siv NovoMix® 30 FlexPen® tau siab dua, feem ntau, NovoMix® 30 FlexPen® muab t Tib cov txiaj ntsig ntawm kev saib xyuas ntawm glycosylated hemoglobin (HbA_1c), zoo li biphasic tib neeg cov insulin 30.

Hauv qhov kev tshawb fawb soj ntsuam koom nrog 341 cov neeg mob ntshav qab zib hom 2 mob ntshav qab zib, cov neeg mob tau tsim kho rau pawg kho mob tsuas yog NovoMix® 30 FlexPen®, NovoMix® 30 FlexPen® ua ke nrog metformin thiab metformin ua ke nrog sulfonylurea derivative. HbA concentration_1c tom qab 16 lub lim tiam ntawm kev kho mob tsis txawv hauv cov neeg mob tau txais NovoMix® 30 FlexPen® ua ke nrog metformin thiab hauv cov neeg mob uas tau txais metformin ua ke nrog sulfonylurea derivative. Hauv txoj kev tshawb fawb no, 57% ntawm cov neeg mob tau mob HbA concentration_1c tau siab dua 9%, hauv cov neeg mob txoj kev kho mob nrog NovoMix® 30 FlexPen® ua ke nrog metformin ua rau txo qis HbA concentration ntau dua_1cdua li nyob rau hauv cov neeg mob uas tau txais cov tshuaj metformin ua ke nrog ib qho sulfonylurea derivative.

Lwm txoj kev tshawb nrhiav, cov neeg mob hom 2 mob ntshav qab zib mellitus nrog kev tswj tsis zoo glycemic uas tau noj cov tshuaj hypoglycemic qhov ncauj tau txais kev xaiv rau cov pab pawg hauv qab no: tau txais NovoMix® 30 ob zaug ib hnub (117 tus neeg mob) thiab tau txais insulin glargine ib zaug ib hnub (116 cov neeg mob). Tom qab 28 lub lim tiam ntawm kev siv tshuaj, qhov nruab nrab txo HbA concentration_1c hauv NovoMix® 30 FlexPen® pawg, nws yog 2.8% (tus nqi nruab nrab tau pib yog 9.7%). Hauv 66% thiab 42% ntawm cov neeg mob siv NovoMix® 30 FlexPen®, qhov kawg ntawm kev kawm, HbA qhov tseem ceeb_1c nyob hauv qab 7% thiab 6.5%, feem. Qhov txhais tau tias yoo ntshav plasma qis dua li 7 mmol / L (los ntawm 14.0 mmol / L thaum pib ntawm kev kawm mus rau 7.1 mmol / L).

Cov txiaj ntsig ntawm kev ntsuas meta-tsom ntawm cov ntaub ntawv tau los ntawm kev soj ntsuam sim nrog cov neeg mob ntshav qab zib hom 2 qhia tau tias qhov qis ntawm tag nrho cov kev mob ntawm nocturnal hypoglycemia thiab mob ntshav qab zib tsawg nrog NovoMix® 30 FlexPen® piv nrog biphasic tib neeg insulin 30. Muaj kev pheej hmoo dav dav qhov tshwm sim ntawm nruab hnub lub qog ua ntshav hauv cov neeg mob uas tau txais NovoMix® 30 FlexPen® tau siab dua.

Cov menyuam yaus thiab tub ntxhais hluas: 16-lub lim tiam hauv kev soj ntsuam tau ua tiav uas sib piv cov ntshav qab zib tom qab noj mov nrog NovoMix® 30 (ua ntej noj mov), tib neeg insulin / biphasic tib neeg insulin 30 (ua ntej noj mov) thiab isofan-insulin (muab ua ntej ua ntej noj mov) pw). Txoj kev tshawb no koom nrog 167 cov neeg mob hnub nyoog 10 txog 18 xyoo. HbA nrab_1c hauv ob pawg neeg tseem nyob nrog qhov pib muaj nuj nqis thoob plaws qhov kev kawm. Tsis tas li, thaum siv NovoMix® 30 FlexPen® lossis biphasic tib neeg cov insulin 30, tsis muaj qhov sib txawv ntawm qhov tshwm sim ntawm cov ntshav qog ntshav qab zib.

Kev tshawb nrhiav pom ob sab ntawm qhov muag pom tau ua rau hauv cov neeg mob ntawm cov neeg mob hnub nyoog 6 txog 12 xyoo (tag nrho ntawm 54 tus neeg mob, 12 lub lis piam rau txhua hom kev kho mob). Qhov tshwm sim ntawm cov ntshav qog ntshav qab zib thiab qhov nce ntawm cov piam thaj tom qab noj mov hauv pab pawg ntawm cov neeg mob uas siv NovoMix® 30 FlexPen® tau qis dua piv rau cov txiaj ntsig hauv pab pawg ntawm cov neeg mob uas tau siv biphasic tib neeg insulin 30. HbA qhov tseem ceeb_1c qhov kawg ntawm txoj kev tshawb no, hauv pab pawg ntawm kev siv biphasic tib neeg cov insulin 30 tau qis dua qis dua li pawg pab neeg mob uas siv NovoMix® 30 FlexPen®.

Cov neeg laus laus: Cov chaw muag tshuaj ntawm NovoMix® 30 FlexPen® hauv cov neeg laus thiab cov neeg laus tsis tau raug tshawb fawb. Txawm li cas los xij, hauv kev tshawb nrhiav ob zaug pom ntawm kev tshawb nrhiav qhov tseeb rau 19 cov neeg mob ntshav qab zib hom 2 hnub nyoog 65-83 xyoo (txhais tau tias muaj hnub nyoog 70 xyoo), cov chaw muag tshuaj thiab pharmacokinetics ntawm insulin aspart thiab solulin tib neeg cov tshuaj insulin tau muab piv. Cov txheeb ze sib txawv ntawm cov chaw muag tshuaj (ntau tshaj qhov piam thaj infusion rate - GIR_max thiab thaj chaw hauv qab nkhaus ntawm nws qhov kev txaum rau 120 min tom qab kev tswj hwm ntawm insulin npaj - AUC_Girgir, 0-120 min) ntawm insulin aspart thiab insulin tib neeg hauv cov neeg mob laus yog qhov zoo sib xws rau cov neeg ua haujlwm pab dawb thiab hauv cov neeg muaj hnub nyoog yau uas muaj ntshav qab zib mellitus.

Cov Tshuaj Pharmacokinetics
Hauv cov tshuaj insulin aspart, kev hloov pauv ntawm cov amino acid proline nyob rau hauv txoj haujlwm B28 rau aspartic acid txo kev nyiam ntawm cov lwg me me los ua hexamers hauv cov kuab tshuaj ntawm NovoMix® 30 FlexPen®, uas tau pom nyob hauv tib neeg cov kua dej. Hauv qhov no, insulin aspart (30%) yog nqus tau los ntawm cov rog subcutaneous sai dua li cov tshuaj solulin hauv cov neeg insulin biphasic. Qhov seem 70% poob rau ntawm daim ntawv crystalline ntawm cov tshuaj tiv thaiv-insulin aspart, qhov kev nqus ntawm uas yog tib yam li cov tib neeg ntawm insulin NPH.

Qhov siab tshaj plaws ntawm cov tshuaj insulin hauv cov ntshav ntshav tom qab kev tswj hwm ntawm NovoMix® 30 FlexPen® yog 50% ntau dua li ntawm biphasic tib neeg cov insulin 30, thiab lub sijhawm mus cuag nws yog ib nrab ntawm biphasic tib neeg cov insulin 30. Hauv cov neeg ua haujlwm noj qab haus huv, tom qab subcutaneous tswj ntawm NovoMix® 30 los ntawm kev txiav txim siab ntawm 0.20 IU / kg ntawm lub cev qhov hnyav, qhov siab tshaj plaws ntawm cov tshuaj insulin aspart hauv cov ntshav dej tau tiav tom qab 60 feeb thiab yog 140 ± 32 pmol / L. Ib nrab-lub neej (t_1/2) ntawm NovoMix® 30, uas qhia txog tus nqi ntawm kev nqus ntawm cov tshuaj tiv thaiv-cuam tshuam nrog ntu, yog 8-9 teev. Ntshav dej insulin qib rov qab rau hauv lub hauv paus 15-18 teev tom qab kev saib xyuas ntawm cov tshuaj ntawm cov tshuaj. Hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus, qhov siab tshaj plaws tau mus txog 95 feeb tom qab kev tswj hwm thiab nyob twj ywm saum toj saud tsawg kawg 14 teev

Cov neeg laus thiab cov neeg laus:
Kev tshawb fawb ntawm cov khw muag tshuaj ntawm NovoMix® 30 hauv cov neeg laus thiab cov neeg laus laus tsis tau ua. Txawm li cas los xij, cov sib txawv ntawm cov pharmacokinetics ntawm insulin aspart thiab insulin tib neeg cov kua dej hauv cov neeg laus uas muaj ntshav qab zib hom 2 (hnub nyoog 65-83 xyoo, hnub nyoog nruab nrab - 70 xyoo) zoo ib yam li cov neeg ua haujlwm pab dawb thiab cov neeg mob hluas muaj ntshav qab zib mellitus. Hauv cov neeg mob neeg laus, tau pom qhov txo qis hauv kev nqus, uas ua rau kev txo qis t_max (82 feeb (sib cuam tshuam ntau: 60-120 feeb)), thaum nruab nrab qhov nruab nrab ntau C_max tau zoo ib yam li tau pom nyob hauv cov neeg hluas uas muaj ntshav qab zib hom 2, thiab tsawg dua li cov neeg mob ntshav qab zib hom 1.

Cov neeg mob uas lub raum tsis zoo thiab lub siab ua haujlwm:
Ib txoj kev tshawb ntawm cov chaw muag tshuaj ntawm NovoMix® 30 FlexPen® hauv cov neeg mob uas tsis muaj mob raum thiab mob siab tsis ua haujlwm. Txawm li cas los xij, nrog kev nce ntxiv ntawm cov tshuaj rau hauv cov neeg mob uas muaj qhov txawv txav ntawm lub raum thiab cov hlab ntsws tsis ua haujlwm, tsis muaj kev hloov pauv hauv pharmacokinetics ntawm solulin insulin.

Cov menyuam yaus thiab cov hluas:
Cov chaw muag tshuaj ntawm NovoMix® 30 FlexPen® hauv cov menyuam yaus thiab cov tub ntxhais hluas tsis tau kawm. Txawm li cas los xij, pharmacokinetic thiab pharmacodynamic cov yam ntxwv ntawm soluble insulin aspart tau kawm hauv cov menyuam yaus (6 txog 12 xyoos) thiab cov hluas (13 txog 17 xyoo) uas muaj ntshav qab zib hom 1. Hauv cov neeg mob ntawm ob pawg hnub nyoog, insulin aspart tau pom los ntawm kev nqus sai thiab t muaj nuj nqis_maxzoo ib yam li cov laus. Txawm li cas los xij, txiaj ntsig ntawm C_max hauv ob pawg hnub nyoog tau sib txawv, uas qhia qhov tseem ceeb ntawm cov tib neeg xaiv cov tshuaj insulin aspart koob tshuaj.

Cov Ntaub Ntawv Muaj Kev Nyab Xeeb Ua Ntej
Preclinical cov kev tshawb fawb tsis tau qhia txog kev phom sij rau tib neeg, raws li cov ntaub ntawv los ntawm kev lees paub feem ntau ntawm kev nyab xeeb pharmacological, kev siv tshuaj lom ntawm rov qab siv dua, genotoxicity thiab deev tshuaj muaj yees.

Hauv kev kuaj hauv vitro, uas suav nrog kev khi rau insulin thiab IGF-1 receptors thiab cuam tshuam rau kev loj hlob ntawm tes, nws tau pom tias cov khoom ntawm aspart insulin zoo ib yam li cov insulin ntawm tib neeg. Cov kev tshawb fawb kuj tau qhia tias kev cuam tshuam ntawm kev khi ntawm insulin aspart rau insulin receptors yog sib npaug rau tib neeg cov insulin.

Cov Tshuaj Tiv Thaiv:

Siv thaum cev xeeb tub thiab thaum pub niam mis
Cov kev paub txog mob thaum siv NovoMix® 30 FlexPen® thaum cev xeeb tub muaj tsawg.

Cov kev tshawb fawb txog kev siv NovoMix® 30 FlexPen® hauv cov poj niam cev xeeb tub tsis tau ua. Txawm li cas los xij, cov ntaub ntawv los ntawm ob txoj kev tswj hwm kev soj ntsuam (feem, ntawm 157 thiab 14 tus poj niam cev xeeb tub uas tau txais insulin aspart hauv cov kab mob bolus) tsis tau qhia txog qhov tsis zoo ntawm insulin aspart ntawm cev xeeb tub lossis menyuam hauv plab / kev noj qab haus huv tshiab piv nrog soluble tib neeg insulin. Tsis tas li ntawd, kev soj ntsuam kab mob kev sib tw ntawm 27 tus poj niam muaj lub siab mob ntshav qab zib mellitus uas tau txais insulin aspart thiab soluble tib neeg insulin (14 tus poj niam tau txais insulin aspart, 13 tib neeg insulin) qhia txog kev nyab xeeb zoo sib xws rau ob hom insulin.

Nyob rau lub sijhawm ntawm kev pib ua kom cev xeeb tub thiab nyob rau tag nrho nws lub sijhawm, nws yuav tsum tau ua tib zoo saib xyuas cov neeg mob uas muaj ntshav qab zib mellitus thiab saib xyuas qhov kev nyeem ntawm cov piam thaj hauv cov ntshav. Qhov xav tau rau insulin, raws li txoj cai, txo qis hauv thawj peb hlis thiab maj mam nce ntxiv hauv qib thib ob thiab thib peb ntawm cev xeeb tub. Tsis ntev tom qab yug los, xav tau cov tshuaj insulin sai sai rau qib uas yog ua ntej cev xeeb tub.

Thaum lub sijhawm pub mis niam, NovoMix® 30 FlexPen® tuaj yeem siv tau yam tsis muaj kev txwv. Qhov kev coj ntawm cov tshuaj insulin rau leej niam noj mis tsis yog kev hem thawj rau tus menyuam. Txawm li cas los xij, nws yuav tsim nyog los kho qhov koob tshuaj NovoMix® 30 FlexPen®.

Muab thiab kev coj:

Cov koob tshuaj ntawm NovoMix® 30 FlexPen® tau txiav txim los ntawm tus kws kho mob tshwj xeeb rau txhua kis, raws li qhov xav tau ntawm tus neeg mob. Txhawm rau kom ua tiav qib siab ntawm glycemia, nws raug nquahu kom tswj cov concentration ntawm cov piam thaj hauv cov ntshav thiab kho qhov ntau ntawm cov tshuaj.

Cov neeg mob uas mob ntshav qab zib hom 2, ntshav qab zib NovoMix® 30 FlexPen®, tuaj yeem kho tau ob qho tib si xws li kev kho mob monotherapy thiab kev sib xyaw nrog cov tshuaj tiv thaiv ntshav qab zib hauv qhov ncauj uas cov ntshav qabzib tsis txaus txaus tsuas yog los ntawm cov tshuaj tiv thaiv ntshav qab zib hauv qhov ncauj.

Kev pib ntawm kev kho
Rau cov neeg mob ntshav qab zib hom 2 uas yog thawj zaug tau txhaj tshuaj insulin, kev pom zoo pib siv ntawm NovoMix® 30 FlexPen® yog 6 ntu ua ntej noj tshais thiab 6 chav ua ntej noj hmo. Kev qhia ntawm 12 chav ntawm NovoMix® 30 Flexpen® ib hnub ib zaug nyob rau yav tsaus ntuj (ua ntej noj hmo) tseem raug tso cai.

Hloov chaw ntawm tus neeg mob los ntawm lwm yam tshuaj insulin
Thaum hloov mus rau tus neeg mob los ntawm biphasic tib neeg cov tshuaj insulin rau NovoMix® 30 FlexPen®, ib qho yuav tsum pib nrog tib lub koob tshuaj thiab hom kev tswj hwm. Tom qab ntawv kho cov koob tshuaj raws li qhov xav tau ntawm tus neeg mob (saib cov lus qhia hauv qab no rau ib feem ntawm qhov tshuaj ntawm cov tshuaj). Raws li ib txwm muaj, thaum hloov tus neeg mob mus rau ib hom tshuaj insulin tshiab, kev saib xyuas kev kho mob nruj yog qhov tsim nyog thaum lub sijhawm hloov ntawm tus neeg mob thiab hauv thawj lub lis piam ntawm kev siv tshuaj tshiab.

Kev kho mob sib zog
Ntxiv dag zog rau txoj kev kho ntawm NovoMix® 30 FlexPen® tau muaj peev xwm los ntawm kev hloov los ntawm kev siv ib hnub rau ib zaug. Nws raug nquahu tias tom qab tau txais 30 koob ntawm cov tshuaj hloov mus rau kev siv NovoMix® 30 FlexPen® ib hnub ob zaug, faib cov koob rau hauv ob qhov sib luag - thaum sawv ntxov thiab yav tsaus ntuj (ua ntej noj tshais thiab noj hmo).

Txoj kev hloov mus rau kev siv NovoMix® 30 FlexPen® peb zaug hauv ib hnub yog tau los ntawm kev faib cov koob tshuaj thaum sawv ntxov ua ob ntu sib luag thiab qhia ob ntu no thaum sawv ntxov thiab thaum noj su (peb zaug noj ib hnub).

Koob tshuaj hloov kho
Txhawm rau kho qhov koob tshuaj NovoMix® 30 FlexPen®, qhov qis tshaj ntawm cov ntshav nrawm nyob hauv peb hnub dhau los yog siv.

Txheeb xyuas qhov tsim nyog ntawm cov koob tshuaj dhau los, siv tus nqi ntawm cov concentration ntawm cov piam thaj hauv cov ntshav ua ntej noj mov tom ntej.

Koob tshuaj yuav tau ua ib zaug nyob rau ib as thiv kom txog rau hom phiaj tus nqi HbA._1c.

Tsis txhob nce qhov koob tshuaj ntawm cov tshuaj yog tias lub ntsej muag hypoglycemia tau pom nyob hauv lub sijhawm no.

Kev hloov koob tshuaj yuav tsim nyog thaum ua kom tus neeg mob lub cev ua si, hloov nws li kev noj zaub mov kom zoo, lossis muaj lub ntsej muag comorbid. Yuav kom kho qhov koob tshuaj NovoMix® 30 FlexPen®, nws raug nquahu kom siv cov lus pom zoo koob tshuaj raws li hauv qab no:

Cov ntshav qabzib concentration ua ntej noj mov

NovoMix® 30 koob hloov kho 10 hli mm / l> 180 mg / dl+ 6 units

Cov pab pawg neeg tshwj xeeb
Raws li ib txwm muaj nrog kev siv cov tshuaj insulin, hauv cov neeg mob ntawm cov pab pawg tshwj xeeb, cov ntshav qabzib concentration yuav tsum ua tib zoo saib xyuas thiab cov tshuaj ntawm aspart ua rau tus kheej hloov kho.

Cov neeg laus thiab cov neeg laus:
NovoMix® 30 FlexPen® tuaj yeem siv rau cov neeg mob laus, txawm li cas los xij, kev paub nrog nws siv nrog kev siv tshuaj ntawm qhov ncauj hypoglycemic hauv cov neeg mob laus dua 75 xyoo tau txwv.

Cov neeg mob uas lub raum tsis zoo thiab lub siab ua haujlwm:
Hauv cov neeg mob uas lub raum lossis hepatic tsis txaus, qhov kev xav tau yuav tsum tau txo tshuaj insulin.

Cov menyuam yaus thiab cov hluas:
NovoMix® 30 FlexPen® tuaj yeem siv los kho cov menyuam yaus thiab cov tub ntxhais hluas hnub nyoog 10 xyoo nyob rau hauv rooj plaub uas siv cov tshuaj insulin ua ntej dua. Cov ntaub ntawv kho mob tsawg tsawg muaj rau cov menyuam yaus hnub nyoog 6–9 xyoo (saib hauv ntu ntu ntawm Tshuaj Kho Mob Khoom Muag).

NovoMix® 30 FlexPen® yuav tsum tau tswj hwm subcutaneously hauv tus ncej puab lossis phab ntsa plab xub ntiag. Yog tias qhov xav tau, cov tshuaj no tuaj yeem siv rau hauv xub pwg lossis pob tw.

Nws yog ib qho tsim nyog yuav tsum hloov chaw txhaj tshuaj nyob rau thaj tsam anatomical thiaj li tiv thaiv kev txhim kho ntawm lipodystrophy.

Ib yam li lwm yam insulin npaj, lub sijhawm ntawm kev txiav txim siab ntawm NovoMix® 30 FlexPen® nyob ntawm qhov koob tshuaj, qhov chaw tswj, ntshav txaus, qhov kub thiab theem ntawm lub cev.

Piv rau biphasic tib neeg cov tshuaj insulin, NovoMix® 30 FlexPen® pib ua kom nrawm dua, yog li nws yuav tsum tau siv tam sim ua ntej noj mov. Yog tias tsim nyog, NovoMix® 30 FlexPen® tuaj yeem muab sijhawm sai tom qab noj mov.

Sab sij huam:

Thaum pib theem ntawm kev siv tshuaj insulin, qhov rov ua kom yuam kev, qhov mob ntawm lub cev thiab tshuaj tiv thaiv tuaj yeem tshwm sim ntawm qhov chaw txhaj tshuaj (suav nrog qhov mob, liab liab, ua xua, mob o, doog, o thiab khaus ntawm qhov chaw txhaj tshuaj). Cov tsos mob no feem ntau yog ib ntus. Kev txhim kho sai ntawm kev tswj glycemic tuaj yeem ua rau lub xeev ntawm "mob mob neuropathy," uas feem ntau thim rov qab. Kev siv tshuaj insulin ntau dua nrog kev txhim kho ntse hauv kev tswj hwm ntawm cov metabolism hauv cov roj ntsha tuaj yeem ua rau muaj kev tsis txaus siab nyob rau hauv cov xwm txheej ntawm tus mob ntshav qab zib retinopathy, thaum lub sij hawm ntev txhim kho hauv kev tswj glycemic txo txoj kev pheej hmoo ntawm kev mob ntshav qab zib retinopathy.

Cov npe ntawm cov kev mob tshwm sim muaj nyob rau hauv lub rooj.

Txhua qhov kev mob tshwm sim hauv qab no, raws li cov ntaub ntawv sim saib mob, raug cais raws kev loj hlob raws li MedDRA thiab kab mob hauv lub cev. Qhov tshwm sim ntawm cov kev mob tshwm sim txhais tau hais tias: feem ntau (≥ 1/10), feem ntau (≥ 1/100 rau * Saib "Cov lus piav qhia txog kev phiv los ntawm cov tib neeg"

Kev piav qhia ntawm tus neeg qhov tsis zoo:
Anaphylactic kev xav
Cov kev tsis tshua muaj tshwm sim ntawm cov kev tiv thaiv kab mob siab tshaj plaws (suav nrog kev tawm pob ntawm daim tawv nqaij dav dav, khaus, tawm hws, mob plab, puas tsuaj, mob caj dab, ua pa nyuaj, mob plawv, mob ntshav qis), uas muaj feem yuav ua rau tuag taus, tau sau tseg.

Kev ntshav siab
Kev mob ntshav qab zib yog qhov tshwm sim feem ntau tshwm sim. Nws tuaj yeem tsim kho yog tias qhov koob tshuaj insulin ntau dhau lawm hauv kev sib txuas nrog qhov xav tau ntawm cov tshuaj insulin. Kev mob ntshav nce siab ntau dhau los tuaj yeem ua rau tsis nco qab thiab / lossis rov huam, ib ntus lossis tsis tuaj yeem ua haujlwm ntawm lub hlwb kom mus txog rau qhov ua rau muaj kev ploj tuag. Cov tsos mob ntawm tus mob hypoglycemia, raws li txoj cai, tshwm sim sai. Cov no suav nrog "tawm hws txias", pallor ntawm daim tawv nqaij, ua rau qaug zog, tshee lossis tshee tshee, ntxhov siab, nkees txawv lossis tsis muaj zog, tsis meej pem, poob siab, poob tsaug zog, tshaib plab heev, tsis pom kev, mob taub hau, xeev siab thiab lub plawv dhia. Cov.

Cov kev tshawb fawb soj ntsuam pom tau tias qhov tshwm sim ntawm kev mob ntshav qab zib tsawg txawv nyob ntawm cov neeg mob, noj tshuaj ntau ntxiv, thiab tswj glycemic. Hauv kev sim tshuaj, tsis muaj qhov sib txawv ntawm qhov tshwm sim tag nrho ntawm kev mob ntshav qab zib kom tsawg ntawm cov neeg mob tau txais tshuaj aspart insulin thiab cov neeg mob siv tib neeg cov tshuaj insulin.

Lipodystrophy
Tau muaj cov kab mob lipodystrophy tau hais qhia. Lipodystrophy tuaj yeem tsim kho ntawm thaj chaw txhaj tshuaj.

Noj ntau dhau

- Tus neeg mob tuaj yeem tshem tawm qhov mob ntshav qab zib me me los ntawm kev noj zaub mov qab zib lossis qab zib. Yog li, nws tau pom zoo rau cov neeg mob ntshav qab zib kom ua cov khoom qab zib tas li.
- Yog tias qhov mob ntshav nce siab ntau, thaum tus neeg mob tsis nco qab lawm, 0.5 mg rau 1 mg ntawm glucagon yuav tsum tau txhaj tshuaj intramuscularly lossis subcutaneously (tus neeg kawm ua haujlwm tuaj yeem tswj hwm) lossis tshuaj pleev ntshav qab zib (dextrose) (tsuas yog tus kws kho mob muaj peev xwm ua tau). Nws kuj yog qhov tseem ceeb rau kev tswj hwm dextrose txhaj tshuaj yog tias tus neeg mob tsis rov qab nco qab 10-15 feeb tom qab kev tswj hwm ntawm glucagon. Tom qab nws rov qab nco qab, tus neeg mob tau hais kom noj cov khoom noj carbohydrate-nplua nuj sau kom tiv thaiv kev rov qab qog ntawm hypoglycemia.

Kev cuam tshuam nrog lwm yam tshuaj

Hypoglycemic nyhuv ntawm insulin txhim khu qhov ncauj hypoglycemic agents, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, xim beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, tshuaj lithium salicylates Cov.

Cov nyhuv hauv lub cev puas muaj zog ntawm insulin tsis muaj zog los ntawm kev tiv thaiv hauv lub qhov ncauj, glucocorticosteroids, cov thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazole, clonidine, "qeeb" calcium channel blockers, diazhenotin, morphine.

Beta-blockers tuaj yeem npog cov tsos mob ntawm kev mob ntshav qab zib.

Octreotide / lanreotide tuaj yeem nce ntxiv thiab txo qis qhov kev xav tau ntawm lub cev.

Cawv yuav ua kom cov ntshav qis los tsis txaus.

Incompatibility.
Txij li cov kev tshawb fawb ua tsis tau coj los ua, NovoMix® 30 FlexPen® yuav tsum tsis txhob sib xyaw nrog lwm cov tshuaj.

Pharmacological thaj chaw ntawm cov tshuaj Novomix 30 flekspen

NovoMix 30 FlexPen yog ob-theem raug ncua uas muaj kev sib xyaw ntawm cov tshuaj insulin: insulin aspart (kev sib piv ntawm tib neeg lub cev luv luv insulin) thiab protamine-insulin aspart (ib qho lus qhia ntawm tib neeg ntev insulin). Kev poob qis hauv cov ntshav qab nyob rau hauv kev cuam tshuam ntawm insulin aspart tshwm sim tom qab kev khi rau cov insulin receptors, uas ua rau lub ntsej muag cov piam thaj los ntawm cov leeg nqaij thiab cov roj ntsha thiab ib txhij inhibits kev tso tawm ntawm cov piam thaj los ntawm nplooj siab. NovoMix 30 FlexPen yog ob-theem raug muab ncua nrog 30% soluble aspart insulin. Qhov no ua kom qhov ua tau sai ntawm kev ua dua li soluble tib neeg cov insulin thiab tso cai rau cov tshuaj kom sai ua ntej noj mov (ntawm 0 txog 10 feeb). Cov theem crystalline (70%) muaj cov tshuaj tiv thaiv-insulin aspart, cov kev ua ub no uas yog tib yam li tib neeg nruab nrab tiv thaiv-insulin Hagedorn (NPH).NovoMix 30 FlexPen pib ua yeeb yam li 10-20 feeb tom qab kev txhaj tshuaj sc. Qhov siab tshaj plaws ua tiav tau tiav 1-4 teev tom qab kev tswj hwm. Lub sijhawm tiv thaiv yog txog li 24 teev.
Qib ntawm glycosylated hemoglobin hauv cov neeg mob uas muaj hom 1 thiab hom 2 mob ntshav qab zib mellitus, uas tau muab tshuaj NovoMix 30 rau 3 lub hlis, yog tib yam li thaum tswj hwm biphasic tib neeg cov tshuaj insulin. Thaum tib cov koob tshuaj tiv thaiv hniav tau siv, insulin aspart sib raug rau cov kev ua ntawm tib neeg cov insulin. Hauv qhov kev tshawb fawb soj ntsuam, cov neeg mob uas mob ntshav qab zib hom mob ntshav qab zib hom (341 tus neeg), muab faib ua pawg raws li txoj cai ntawm kev siv, tau txais tsuas NovoMix 30 FlexPen, lossis NovoMix 30 FlexPen ua ke nrog metformin, lossis metformin ua ke nrog sulfonylurea. Tom qab 16 lub lim tiam ntawm kev kho mob, qhov tseem ceeb ntawm glycosylated hemoglobin НbА1c qib hauv cov neeg mob tau txais NovoMix 30 ua ke nrog metformin lossis metformin hauv kev sib xyaw nrog sulfonylurea tau zoo ib yam. Hauv qhov kev tshawb fawb no, hauv 57% ntawm cov neeg mob, HbA1c qib siab dua 9%. Hauv cov neeg mob no, kev sib koom ua ke ntawm NovoMix 30 FlexPen thiab metformin ua rau ntau dua qhov txo qis ntawm HbA1c piv nrog kev sib xyaw ntawm metformin thiab sulfonylurea.
Hauv kev kawm txog cov neeg mob ntshav qab zib hom II hauv kev tswj hwm
glycemia los ntawm qhov ncauj hypoglycemic tshuaj
ua pov thawj tsis muaj txiaj ntsig, kho nrog kev qhia ntawm cov tshuaj
NovoMix 30 ib hnub ob zaug (117 tus neeg mob) lossis los ntawm kev tswj hwm
insulin glargine ib hnub ib zaug (cov neeg mob 116). Tom qab 28 lub lis piam
kev kho mob nrog NovoMix 30, nrog
xaiv koob tshuaj, qib HbA1c txo qis los ntawm 2.8% (nruab nrab
HbA1c muaj nuj nqis thaum suav nrog hauv kev kawm = 9.7%). Thaum kho nrog NovoMix 30, HbA1c qib qis dua 7% mus txog 66% ntawm cov neeg mob, thiab qis dua 6.5% - 42% ntawm cov neeg mob,
qhov kev yoo plasma ntshav nrawm no txo ​​qis
kwv yees li 7 mmol / l (los ntawm 14.0 mmol / l ua ntej kev kho mob - txog 7.1
mmol / l).
Cov Tshuaj PharmacokineticsCov. Hauv cov tshuaj insulin, aspart, cov amino acid proline ntawm txoj hauj lwm 28 ntawm B txoj kab B ntawm cov kua dej tuaj yeem hloov los ntawm aspartic acid, uas txo cov kev tsim cov hexamers tsim hauv soluble tib neeg insulin npaj. Hauv theem soluble ntawm NovoMix 30 FlexPen, qhov sib piv ntawm insulin aspart yog 30% ntawm tag nrho cov tshuaj insulin. Nws yog nqus rau hauv cov ntshav los ntawm cov nqaij mos subcutaneous sai dua soluble insulin ntawm biphasic tib neeg cov kua dej. Qhov seem 70% yog suav los ntawm cov qauv sib xyaw ua ke ntawm cov tshuaj tiv thaiv-insulin aspart, uas ntev dua qhov nws nqus tau yog tib yam li qhov ntawm tib neeg insulin NPH.
Qhov siab tshaj plaws ntawm cov tshuaj insulin hauv cov ntshav ntshav tom qab kev tswj hwm ntawm NovoMix 30 Flexpen yog 50% ntau dua, thiab lub sijhawm mus cuag nws yog ib nrab ntawm biphasic tib neeg insulin 30. Hauv cov neeg ua haujlwm noj qab haus huv, tom qab sc tswj ntawm NovoMix 30 ntawm tus nqi ntawm 0.20 U / kg lub cev qhov siab tshaj plaws ntawm cov tshuaj insulin aspart hauv cov ntshav dej tau tiav tom qab 60 feeb thiab yog 140 ± 32 pmol / L. Ib nrab-lub neej ntawm NovoMix 30, uas qhia txog tus nqi ntawm kev nqus ntawm qhov tshuaj tiv thaiv feem, yog 8–9 teev. Theem ntawm insulin hauv cov ntshav cov ntshav rov qab mus rau thawj 15-18 teev tom qab s / c tswj hwm. Hauv cov neeg mob uas muaj yam mob ntshav qab zib hom 2, qhov siab tshaj plaws tau mus txog 95 feeb tom qab kev tswj hwm thiab tseem nyob siab dua thawj theem pib tsawg kawg 14 teev.
Menyuam yaus thiab tub ntxhais hluas.
Cov chaw muag tshuaj ntawm NovoMix 30 FlexPen hauv cov menyuam yaus thiab cov hluas tsis tau raug tshuaj ntsuam. Txawm li cas los xij, hauv cov menyuam yaus (6-12 xyoo) thiab cov hluas (13-17 xyoo) uas muaj ntshav qab zib hom 1, pharmacokinetics thiab pharmacodynamics ntawm soluble aspart insulin tau kawm. Nws tau txais txiaj ntsig sai hauv cov neeg mob ntawm ob pawg, thaum lub txiaj ntsig rau lub sijhawm kom ncav cuag kev siab tshaj plaws tau zoo ib yam rau cov neeg laus. Tib lub sijhawm, Cmax qhov tseem ceeb hauv pab pawg sib txawv tau sib txawv, uas qhia qhov tseem ceeb ntawm cov tib neeg xaiv cov tshuaj insulin aspart koob tshuaj.
Cov pharmacokinetics ntawm NovoMix 30 tsis tau kawm hauv tib neeg.
cov laus, menyuam yaus thiab cov neeg mob uas lub cev tsis taus
raum lossis mob siab.

Xaiv ib koob tshuaj NovoMix 30

141-180 mg / 100 ml

Koj yuav tsum mob siab rau kev noj cov piam thaj kom qis dua li peb hnub dhau los. Yog tias muaj kev cuam tshuam txog kev mob ntshav siab thaum lub sijhawm no, cov koob tshuaj insulin tsis nce ntxiv. Kev xaiv koob tshuaj yog ua ib zaug ib as thiv kom txog rau qib hom HbA1c tau mus txog. Qhov tseem ceeb ntawm cov piam thaj hauv kev ua ntej noj mov yuav tsum tau ntsuas qhov muaj txiaj ntsig ntawm cov koob tshuaj qub.
Lub siab ua haujlwm lossis lub raum tsis zoo ua haujlwm tuaj yeem txo tus neeg mob txoj kev xav tau cov tshuaj insulin.
NovoMix 30 Flexpen tuaj yeem siv rau cov menyuam yaus thiab cov tub ntxhais hluas hnub nyoog 10 xyoo thiab laus dua, thaum qhia cov tshuaj sib tov ntawm cov tshuaj insulin yog qhov zoo dua. Cov ntaub ntawv los ntawm kev tshawb fawb soj ntsuam txog kev siv tshuaj yeeb hauv cov menyuam yaus 6-9 xyoos yog txwv. Kev tshawb fawb rau cov menyuam yaus hnub nyoog qis dua 6 xyoo tsis tau ua.
NovoMix 30 FlexPen tuaj yeem siv rau hauv cov neeg mob laus, txawm li cas los xij, qhov kev paub ntawm nws txoj kev siv nrog kev sib xyaw nrog PSS hauv cov neeg uas muaj hnub nyoog 75 xyoo yog qhov tsawg.
Txawm tsis muaj NovoMix 30 FlexPen yuav siv tau iv.
Cov lus qhia rau kev siv tshuaj NovoMiks 30
Flexpen rau tus neeg mob
Qhov kev xav tau ntawm kev sib xyaw ua ke yuav tsum tau hais txog.
tshem tawm cov tshuaj insulin ua ntej siv. Tom qab nplawm
Txoj kev tshem tawm yuav tsum yog uniformly dawb thiab huab. NovoMix 30 FlexPen yog npaj rau ib leeg siv nkaus xwb.
Txhob sau NovoMix 30 FlexPen ntxiv.
NovoMix 30 FlexPen yog siv nrog NovoFine ® koob luv luv.
Ua ntej siv NovoMix 30
Flekspen: nws yog qhov yuav tsum tau kuaj xyuas ntawm daim ntawv lo rau qhov tseeb hom insulin siv. Txhua zaus yuav tsum siv rab koob tshiab rau txhua txoj kev txhaj tshuaj.
Tsis txhob siv NovoMix 30 FlexPen:

• hauv cov tshuaj insulin,
• yog tias FlexPen syringe cwj mem tau poob lawm, yog tias nws puas ntsoog los yog tsis ua haujlwm, zoo li hauv cov teeb meem insulin tuaj yeem yuav xau,
• yog cov xaum xaum xaum raug khaws cia tsis raug los yog khov, yog tias tom qab nplawm qhov kev ncua tsis pub hnav tsis dawb thiab huab, yog tias dawb clog lossis khoom dawb dawb tshwm sim hauv kev npaj, ua raws rau hauv qab lossis phab ntsa ntawm daim cartridge, muab nws qhov zoo li khov.

NovoMix 30 Flexpen yog tsim rau SC txhaj tshuaj.
Cov tshuaj tsis tuaj yeem nkag mus rau hauv / hauv lossis ncaj qha rau hauv cov leeg.
Txhawm rau kom tsis txhob tsim cov infiltrates, qhov chaw txhaj tshuaj yuav tsum tau hloov tas li. Cov chaw zoo tshaj plaws rau kev tswj hwm yog hauv ntej, phab ntsa plab, xub pwg, saum npoo ntawm ncej puab lossis xub pwg. Qhov kev ua ntawm cov tshuaj insulin tshwm sim sai dua thaum txhaj rau hauv lub duav.

Kev phiv tshuaj ntawm Novomix 30 flekspen

Cov kev phiv tshuaj tiv thaiv pom nyob rau hauv cov neeg mob siv NovoMix 30 FlexPen feem ntau cuam tshuam nrog qhov ntau ntawm kev muab tshuaj ntawm cov tshuaj thiab yog qhov tshwm sim ntawm pharmacological kev ua ntawm insulin. Feem ntau cov kev phiv los ntawm kev kho tshuaj insulin yog hypoglycemia. Nws tuaj yeem tshwm sim yog tias qhov koob tau tshaj tus neeg mob xav tau cov tshuaj insulin. Kev mob ntshav nce siab ntau tuaj yeem ua rau tsis nco qab thiab / lossis rov huam, ua raws li kev xiam hlwb ib ntus lossis tas mus li thiab ua rau tas sim neej. Raws li cov txiaj ntsig ntawm kev tshawb fawb soj ntsuam, nrog rau cov ntaub ntawv sau tseg tom qab cov tshuaj tau pib ua lag luam, qhov xwm txheej ntawm cov ntshav qog ntshav ntshav tsawg sib txawv hauv cov pab pawg sib txawv ntawm cov neeg mob thiab nrog cov tshuaj sib txawv, qhov tshwm sim ntawm mob ntshav qab zib tsawg nyob hauv cov neeg mob tau txais insulin aspart yog tib yam li cov neeg mob tau txais tib neeg tshuaj insulin
Cov hauv qab no yog qhov zaus ntawm qhov tshwm sim tsis zoo uas, raws li kev tshawb fawb soj ntsuam, tuaj yeem cuam tshuam nrog kev qhia ntawm cov tshuaj NovoMix 30 Flexpen.
Raws li qhov muaj ntau zaus ntawm cov tshwm sim, cov kev cuam tshuam no tau muab faib ua qee zaum (1/1000, ≤1 / 100) thiab tsis tshua muaj (1/10 000, ≤1 / 1000). Qee qhov xwm txheej tshwm sim raug rau tsis tshua muaj neeg pom (≤1/10 000).
Los ntawm lub cev tiv thaiv kab mob
Tsis tshua muaj: anaphylactic kev tsis haum.
Qee zaum: urticaria, khaus, tawv nqaij ua pob.
Cov teeb meem tsis haum rau lub ntsej muag yuav muaj xws li ua pob ua pob rau ntawm daim tawv nqaij, khaus, tawm hws, mob plab zom mov, mob caj dab, ua tsis taus pa, palpitations thiab ntshav siab poob qis. Cov kev tsis haum no muaj cuab kav ua tau kom lub neej tsis zoo.
Los ntawm lub paj hlwb tawg
Tsawg: ncu khoom neuropathies. Kev txhim kho sai ntawm cov ntshav qabzib tswj kev ua haujlwm tuaj yeem ua rau mob neuropathy mob hnyav, uas feem ntau hloov pauv.
Ua txhaum ntawm lub cev ntawm lub zeem muag
Qee zaum: kev ntxhov siab ntawm qhov tsis nco qab, tuaj yeem tshwm sim thaum pib ntawm kev kho tshuaj insulin thiab yog qhov xwm nyob hauv.
Qee zaum: uas yog kuaj ntshav qab zib. Lub sij hawm ntev txij nkawm ntawm kev tswj hwm zoo glycemic txo txoj kev pheej hmoo ntawm kev muaj mob ntawm cov ntshav qab zib retinopathy. Txawm li cas los xij, kev sib zog ntawm kev siv tshuaj insulin kom sai txhim kho glycemic tswj tuaj yeem ua rau ib ntus exacerbation ntawm tus mob ntshav qab zib retinopathy.
Ntawm feem ntawm daim tawv nqaij thiab cov nqaij mos
Qee zaum: lipodystrophy, tuaj yeem tshwm sim hauv qhov chaw txhaj tshuaj vim qhov tsis ua raws li kev pom zoo kom hloov qhov chaw txhaj tshuaj nyob hauv tib thaj chaw, qhov chaw tiv thaiv tsis tau tiv thaiv kab mob hauv ib cheeb tsam. Thaum cov tshuaj insulin raug txhaj tshuaj, qhov mob siab nyob hauv qhov chaw tuaj yeem tshwm sim (liab liab, o, thiab khaus ntawm qhov chaw txhaj tshuaj). Cov kev mob no feem ntau yog ua dhau thiab ploj mus nrog kev kho mob txuas ntxiv.
Kev tsis sib haum xeeb thiab kev hloov pauv ntawm cov chaw txhaj tshuaj
Qee zaum: Hauv lub zos qhov chaw mos, tuaj yeem pib thaum pib tsim cov tshuaj insulin. Cov tsos mob no feem ntau ua rau hloov.

Cov lus qhia tshwj xeeb rau kev siv cov tshuaj Novomix 30 flekspen

Kev noj tshuaj tsis txaus lossis tsis ua haujlwm ntawm kev kho mob (tshwj xeeb nrog hom I mob ntshav qab zib mellitus) tuaj yeem ua rau hyperglycemia thiab ntshav qab zib ketoacidosis, cov mob no muaj feem ua rau tuag taus.
Cov neeg mob uas tau txais kev tswjhwm zoo tshaj plaws ntawm cov ntshav qabzib, piv txwv vim yog kev kho mob hnyav, yuav pom tias muaj kev hloov pauv hauv lawv cov tsos mob ib txwm - cov mob ntshav sai ua ntej, uas cov neeg mob yuav tsum ceeb toom ua ntej.
NovoMix 30 FlexPen yuav tsum muab tswj tam sim ua ntej noj mov. Kev pib sai ntawm cov tshuaj yuav tsum raug txiav txim siab nyob rau hauv kev kho mob ntawm cov neeg mob uas muaj kabmob sib xyaw lossis siv cov tshuaj uas tuaj yeem txo qis kev nqus ntawm cov zaub mov hauv cov hnyuv. Cov kab mob tsis haum, tshwj xeeb tshaj yog kis mob thiab kub ib ce, ua kom tus neeg mob xav tau cov tshuaj insulin. Thaum hloov mus rau tus neeg mob mus rau lwm hom insulin, cov kev qhia ntxov yuav hloov lossis yuav tsis hais tshaj li thaum noj cov insulin uas ib txwm npaj. Kev hloov chaw ntawm tus neeg mob mus rau lwm hom lossis hom tshuaj insulin yog ua tiav los ntawm kev saib xyuas mob nkeeg nruj. Hloov pauv qhov kev xav, hom (chaw tsim khoom), hom, keeb kwm ntawm insulin (tsiaj, tib neeg lossis tib neeg cov tshuaj insulin) thiab / lossis cov txheej txheem ntau lawm yuav tsum tau hloov cov koob tshuaj. Thaum hloov mus rau kev txhaj tshuaj ntawm NovoMix 30 FlexPen, cov neeg mob yuav tau hloov pauv ntawm cov tshuaj insulin ib txwm muaj. Qhov kev xav tau ntawm kev xaiv koob tshuaj yuav tshwm sim ob qho tib si hauv thawj zaug kev siv tshuaj tshiab, thiab nyob rau thawj ob peb lub lis piam lossis lub hlis ntawm kev siv.
Tsis noj zaub mov, kev noj zaub mov sai, los yog pom qhov ua kom lub cev ua si tsis zoo yuav ua rau lub plawv tsis muaj ntshav qab zib. Piv nrog biphasic tib neeg cov tshuaj insulin, kev txhaj tshuaj ntawm NovoMix 30 FlexPen ua rau cov nyhuv ntshav qab zib ntau dua, uas tuaj yeem ntev txog 6 teev. Qhov no yuav tsum tau xaiv cov tshuaj insulin thiab / lossis kev noj haus.
Tej zaum yuav tsum tau xaiv koob tshuaj yuav tshwm sim nrog
kev siv dag zog kom ntau ntxiv lossis hloov kev noj haus. Kev tawm dag zog tam sim ntawd tom qab noj mov nce qhov kev pheej hmoo ntawm lub qog ntshav qab zib.
Kev ncua ntawm insulin yuav tsum tsis txhob siv cov tshuaj insulin twj rau kev tswj hwm cov tshuaj insulin tas mus li.
Lub sijhawm ntawm cev xeeb tub thiab lactation. Cov kev paub txog kev kho mob nrog insulin aspart thaum cev xeeb tub yog qhov tsawg. Cov kev tshawb fawb tsiaj tau qhia tias insulin aspart, zoo li tib neeg insulin, tsis muaj kev cuam tshuam embryotoxic thiab teratogenic. Kev tswj hwm ntau dua yog pom zoo hauv kev kho mob ntawm cov poj niam cev xeeb tub uas muaj ntshav qab zib txhua lub sijhawm ntawm cev xeeb tub, nrog rau cov neeg xav tias cev xeeb tub. Qhov xav tau rau cov tshuaj insulin feem ntau poob qis hauv thawj peb lub hlis thaum cev xeeb tub thiab nce hauv lub hlis thib ob thiab peb lub hlis. Tom qab yug los, xav tau cov tshuaj insulin sai sai rov qab rau hauv paus. Kuj tseem tsis muaj kev txwv rau kev kho mob ntshav qab zib mellitus nrog tshuaj insulin thaum pub niam mis, txij li kev kho tus niam mis tsis ua rau muaj kev pheej hmoo rau tus menyuam. Txawm li cas los xij, nws yuav tsim nyog los kho qhov koob tshuaj NovoMix 30 FlexPen.
Cuam tshuam rau kev muaj peev xwm tsav tsheb thiab tshuab. Tus neeg mob cov lus teb thiab nws lub peev xwm los mloog zoo yuav ua rau lub plawv tsis muaj ntshav qab zib. Qhov no tuaj yeem ua rau muaj kev pheej hmoo hauv cov xwm txheej uas cov peev xwm no muaj qhov tseem ceeb tshwj xeeb (piv txwv, thaum tsav tsheb lossis tswj lub tshuab).
Cov neeg mob yuav tsum qhia rau lawv kom ntsuas los tiv thaiv kom tsis txhob muaj ntshav qab zib ua ntej tsav tsheb. Qhov no yog qhov tshwj xeeb tshaj yog rau cov neeg uas tsis muaj zog lossis tsis muaj tsos mob sai sai - lub sijhawm ua ntej ntawm cov ntshav ntog ntshav lossis ntu kev kub siab ntawm ntshav tsis tshua muaj tshwm sim tsis tu ncua. Hauv cov xwm txheej zoo li no, qhov tsim nyog thiab kev nyab xeeb ntawm kev tsav tsheb yuav tsum ntsuas.

Kev sib cuam tshuam txog yeeb tshuaj Novomix 30 ua haujlwm

Tus naj npawb ntawm cov tshuaj cuam tshuam rau cov metabolism hauv cov piam thaj, uas yuav tsum tau txiav txim siab thaum txiav txim qhov koob tshuaj insulin.
Tshuaj uas txo qhov xav xav tau rau insulin: qhov ncauj hypoglycemic tus neeg sawv cev, octreotide, MAO inhibitors, tsis xaiv-ren-adrenoreceptor blockers, ACE inhibitors, salicylates, cawv, anabolic steroids thiab sulfonamides.
Cov tshuaj uas ua kom muaj kev xav tau ntxiv rau insulin: qhov ncauj tawm tsam, thiazides, corticosteroids, cov thyroid hormones, sympathomimetics thiab danazole. Ers-adrenergic blockers tuaj yeem npog cov tsos mob ntawm kev mob ntshav qab zib, haus dej cawv tuaj yeem txhim kho thiab ua kom ntev li cas ntawm qhov kev tiv thaiv hypoglycemic ntawm insulin.
Incompatibility. Qhov sib ntxiv ntawm qee yam tshuaj rau cov tshuaj insulin tuaj yeem ua rau nws rhuav tshem, piv txwv li, cov tshuaj uas muaj thiols lossis sulfites. NovoMix 30 Flexpen tsis tuaj yeem raug ntxiv rau txoj kev daws teeb meem.

Kev noj tshuaj ntau tshaj ntawm Novomix 30 ua haujlwm, cov tsos mob thiab kev kho mob

Txawm hais tias tsis muaj lub ntsiab lus tshwj xeeb ntawm kev noj tshuaj rau ntau tshaj rau cov tshuaj insulin, hypoglycemia yuav tshwm sim nrog kev tswj hwm ntau dhau ntawm nws.
Cov ntshav qog ntshav qis yuav nres los ntawm kev noj cov piam thaj lossis zaub mov qab zib. Yog li, cov neeg mob ntshav qab zib tau qhia kom pheej nqa cov piam thaj ntau, qab zib, ncuav qab zib lossis kua txiv qab zib.
Hauv cov ntshav khov ntau heev, thaum tus neeg mob tsis nco qab lawm, nws yog qhov yuav tsum tau nqa tawm v / m lossis s / c txhaj tshuaj ntawm glucagon (ntawm 0.5 txog 1 mg), los ntawm tus neeg uas tau txais cov lus qhia tsim nyog. Tus kws kho mob kuj tseem tuaj yeem xa cov ntshav qab zib rau lub cev rau tus neeg mob thiab yog tias tus neeg mob tsis teb rau kev tswj hwm glucagon tsis pub dhau 10-15 feeb.
Tom qab tus neeg mob rov qab nco qab, nws yuav tsum noj carbohydrates hauv sab hauv kom tiv thaiv kev rov qab ua kom tus mob ntshav qab zib tsawg.

Cia rau cov mob ntawm cov tshuaj Novomix 30 flekspen

Txee lub neej yog 2 xyoos.
Siv Tau rab koob txhaj tshuaj nrog NovoMix 30 FlexPen yuav tsum tsis txhob muab cia rau hauv tub yees. Cov xaum xaum hluav taws xob, uas siv los yog nqa nrog koj hauv cov chaw cia, yuav tsum khaws cia tsis tshaj 4 lub lis piam (ntawm qhov kub tsis tshaj 30 ° C).
Tsis Siv rab koob txhaj tshuaj nrog NovoMix 30 FlexPen yuav tsum muab cia rau hauv tub yees ntawm qhov kub li 2-8 ° C (tsis txhob nyob ze rau lub taub yees txias). Tsis khov. Txhawm rau tiv thaiv los ntawm kev cuam tshuam ntawm lub teeb, muab cov xias xaum xev nrog lub hau rau.

Sau cov chaw muag tshuaj qhov twg koj tuaj yeem yuav Novomix 30 flekspen:

Chaw tsim tshuaj paus:

Sawv Cev
Novo Nordisk A / S
119330, Moscow,
Lomonosovsky Prospekt 38, chaw ua haujlwm 11

Cov lus qhia rau cov neeg mob txog kev siv NovoMix® 30 FlexPen® Thov nyeem cov lus qhia no kom zoo zoo ua ntej siv NovoMix® 30 FlexPen®
NovoMix® 30 FlexPen® yog ib qho kev tsim tshwj xeeb insulin cwj mem nrog cov tshuaj dispenser. Muab koob tshuaj ntawm cov tshuaj insulin, txij li 1 txog 60 units, tuaj yeem hloov pauv hauv nce 1 ntu. NovoMix® 30 FlexPen® yog tsim rau kev siv nrog cov rab koob uas siv pov tseg NovoFayn® lossis NovoTvist® txog li 8 hli ntev. Raws li kev ceev faj, ib txwm nqa cov tshuaj insulin hloov pauv nrog koj thaum koj NovoMix® 30 FlexPen® ploj lossis puas lawm.

Npaj NovoMix® 30 FlexPen®
Kuaj daim ntawv lo txhawm rau xyuas kom koj lub FlexPen® muaj hom insulin txoj cai. Ua ntej txhaj thawj, muab cov tshuaj insulin:

A
Txhawm rau pab txhawb kev sib xyaw, cia cov tshuaj kom sov rau chav sov. Tshem lub hau tawm ntawm cwj mem syringe.

Hauv
Yob lub xaum xaum xaum ntawm xib teg 10 npaug - nws yog qhov tseem ceeb uas nws tau nyob hauv kab tav toj.

Nrog
Tsa tus cwj mem nce thiab nqis 10 zaug, raws li pom hauv daim duab C, kom lub khob pob txav los ntawm ib kawg ntawm tus cartridge mus rau lwm qhov. Rov ua dua cov haujlwm hauv cov ntsiab lus B thiab C kom txog thaum cov ntsiab lus ntawm daim cartridge tau dhau los ua dawb thiab huab.
Ua ntej txhua qhov kev txhaj tshuaj tom qab, sib xyaw cov ntsiab lus raws li pom hauv daim duab C tsawg kawg 10 zaug kom txog thaum cov ntsiab lus ntawm daim cartridge yog dawb paug thiab huab. Tom qab sib tov, tam sim ntawd muab ib qho kev txhaj tshuaj.

Nco ntsoov xyuas kom muaj tsawg kawg yog 12 units ntawm insulin nyob hauv daim cartridge kom paub meej sib tov sib xyaw. Yog tias qis dua 12 units tau sab laug, siv NovoMix® 30 FlexPen® tshiab.

Koob txuas

D
Tshem daim nplaum thaiv tawm ntawm rab koob pov tseg. Ntsia tus ntsia hlau rab koob thiab maj mam muab mus rau NovoMix® 30 FlexPen®.

E
Tshem tawm sab nraud ntawm rab koob, tab sis tsis txhob muab pov tseg.

F
Tshem tawm thiab pov tseg lub hau ntawm lub hauv rab koob.