Tsambali limapereka mndandanda wazonse za Insugen-30/70 analogues (Bifazik) mwakulemba komanso chisonyezo chogwiritsa ntchito. Mndandanda wama analogi otsika mtengo, mutha kuyerekezeranso mitengo muma pharmacies.

• Analogue yotsika mtengo kwambiri ya Insugen-30/70 (Bifazik):Kusakaniza Kwa Humalog
• Analog yotchuka kwambiri ya Insugen-30/70 (Bifazik):Kusakaniza Kwa Humalog
• Gulu la ATX: Insulin (munthu)
• Zosakaniza / yogwira: insulin yamunthu
  

Mukamawerengera mtengo wake zotupa zotsika mtengo Insugen-30/70 (Bifazik) mtengo wocheperako womwe umapezeka mumndandanda wamapulogalamu omwe amaperekedwa ndi ma pharmacies adaganiziridwa

Popeza mndandanda wamankhwala osokoneza bongo kutengera manambala a mankhwala omwe apemphedwa kwambiri

Analogs popanga ndi chisonyezo chogwiritsidwa ntchito

Mndandanda womwe uli pamwambapa wa analogies ya mankhwala, omwe akuwonetsa M'malo Insugen-30/70 (Bifazik), ndizabwino kwambiri chifukwa zimakhala ndi zinthu zomwe zimagwirizana ndipo zimagwirana molingana ndi chisonyezo chogwiritsidwa ntchito

Analogs mwa chisonyezo ndi njira yogwiritsira ntchito

Kuphatikizika kosiyanasiyana, kungagwirizane mukuwonetsa komanso momwe mungagwiritsire ntchito

Kodi mungapeze bwanji analogue yotsika mtengo ya mankhwala okwera mtengo?

Kuti mupeze analogue yotsika mtengo kwa mankhwala, a generic kapena ofanana, choyambirira timalimbikitsa kulabadira kapangidwe kake, zomwe ndi zinthu zomwezi zomwe zikugwiritsidwa ntchito ndikuwonetsa. Zomwe zimagwiritsidwanso mosiyanasiyana ndi mankhwalawa zimawonetsa kuti mankhwalawo ndi ofanana ndi mankhwalawo, monga mankhwala ena kapena mitundu ina. Komabe, musaiwale za zovuta zomwe zimagwiritsidwa ntchito ndi mankhwala ofanana, omwe angakhudze chitetezo ndi kugwiranso ntchito. Musaiwale za malangizo a madotolo, kudzipereka nokha kungawononge thanzi lanu, chifukwa chake onani dokotala wanu musanagwiritse ntchito mankhwala.

Kufotokozera za mankhwalawa

Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) - Mankhwala Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® ndi kuphatikiza kosakanikirana komwe kumapangitsa munthu kusungunuka kwa insulin kopitilira muyeso (insulin degludec) komanso njira yodziyimira yosungunuka ya insulin (insulin aspart) yopangidwa ndi sayansi ya insulin. DNA pogwiritsa ntchito mtundu wa Saccharomyces cerevisiae.

Insulin degludec ndi insulin aspart mwanjira inayake yomangiriza ku cholandirira cha amkati a insulin komanso kuyanjana nacho, zindikirani zochitika zam'magazi zofanana ndi mphamvu ya insulin yaumunthu. Mphamvu ya insoglycemic ya insulin imachitika chifukwa cha kugwiritsidwa ntchito kwa glucose pogwiritsa ntchito minofu pambuyo pomangiriza insulini kupita ku minofu ndi ma cell cell receptors, komanso kutsika kwamtundu womwewo kwa kuchuluka kwa shuga ndi chiwindi.

Zotsatira za pharmacodynamic zamagulu a mankhwalawa Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® penfill ® ndizosiyana kwambiri ndipo mbiri yonse ya mankhwalawa imawonetsa mbiri ya zomwe zimachitika pazinthu zomwe munthu amakhala nazo: kuthamanga kwa insulini ndi insulin.

Gawo loyambira la mankhwala a Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ®, yomwe imakhala ndi zochita zowonjezera nthawi yayitali (insulin degludec), pambuyo pofikira njira zobayira zosakanikirana zosungunuka zamagetsi, zomwe zimapangitsa kuti madzi azikhala pang'onopang'ono kulowa kwa insulin. mbiri yokhazikika yokhudzana ndi mawonekedwe osakhazikika a hypoglycemic. Izi zimasungidwa limodzi ndi insulini ndipo sizikhudza kuchuluka kwa mayamwidwe olimbikira a insulin.

Mankhwala Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® amayamba kuchita zinthu mwachangu, ndikupereka kufunika kwa insulini posachedwa pambuyo pobayidwa, pomwe oyambira ali ndi mawonekedwe, osasunthika komanso opitilira muyeso omwe amapereka zofunikira mu insulin. Kutalika kwa gawo limodzi la mankhwala a Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® ndi maola opitilira 24.

Chiyanjano chazaka zatsimikizika pakati pakukulitsa mlingo wa Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfnill ® ndi zotsatira zake zazikulu komanso zapamwamba za hypoglycemic. Mgwirizano wofanana wa mankhwalawa Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® imatheka pambuyo pa masiku atatu a kukhazikitsidwa kwa mankhwalawa.

Panalibe kusiyana mu pharmacodynamics of Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® mwa odwala okalamba komanso a senile ndi odwala achichepere.

Kuchita Mwachipatala ndi Chitetezo

Mayeso asanu apadziko lonse lapansi otsoguka omwe amayesedwa mosavomerezeka anachitidwa ndi mankhwala a Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® mu mankhwalawa mpaka zigawo 26 kapena 52 zotsekera zomwe zimaphatikizapo odwala 1360 omwe ali ndi matenda osokoneza bongo (362 odwala matenda a shuga) Odwala 1 ndi 998 odwala matenda amtundu 2). Kafukufuku awiri a helm adachitika pakamodzi ka Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® pophatikiza ndi mankhwala a hypoglycemic (PHGP) komanso muyezo umodzi wa insulin glargine wophatikizana ndi PHGP mwa odwala omwe ali ndi matenda a shuga 2. Kukhazikitsidwa kwa Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® kawiri pa tsiku kuphatikiza ndi PHGP kuyerekezedwa ndi kukhazikitsidwa kwa magawo awiri a insulin aspart 30 kawiri pa tsiku limodzi ndi PHGP m'maphunziro awiri mwa odwala omwe ali ndi matenda a shuga 2 . Kupanga mankhwala a insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® kamodzi patsiku limodzi ndi insulini aspart amawayerekezeranso ndi makulidwe a insulin kamodzi kapena kawiri pa tsiku palimodzi ndi insulin. .

Kuperewera kwakukulu kwa zinthu zofanizira kwatsimikiziridwa kuti kugwa ndi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® pokhudzana ndi kuchepa kwa HbA_1c mu maphunziro onse mothandizidwa ndi odwala mpaka cholinga.

Odwala omwe ali ndi matenda a shuga a mtundu wa 2 omwe sanalandire chithandizo cha insulin komanso odwala omwe adalandirapo chithandizo cha insulin, Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® kuphatikiza ndi PHGP imaperekanso kuwongolera kwa glycemic ofanana ndi insulin Glargin. Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® imapereka chiwongolero chokwanira cha gandcemic bwino poyerekeza ndi insulin glargine yokhala ndi pafupipafupi pa nocturnal hypoglycemia (yofotokozedwa monga magawo a hypoglycemia omwe adachitika pakati pa maola 0 ndi maola 6, akutsimikiziridwa ndi zotsatira zake kuyeza kuchuluka kwa shuga m'magazi osakwana 3.1 mmol / l kapena umboni woti wodwalayo amafunikira thandizo la anthu ena).

Kupanga mankhwala a Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® kawiri pa tsiku imapereka chiwonetsero chofanana cha glycemic (HbA_1c) poyerekeza ndi biphasic insulin aspart 30, yomwe imagwiritsidwanso ntchito kawiri pa tsiku. Mankhwala Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® imapereka mphamvu zabwino kwambiri pochepetsa kuchuluka kwa shuga mukusamba kwam'madzi mwa plasma. Mukamagwiritsa ntchito insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ®, ma plasma glucose ofunika a 5 mmol / L adakwaniritsidwa mwachangu poyerekeza ndi odwala omwe amachitidwa ndi biphasic insulin aspart *. (Insulin degludec + Insulin aspart *) ® imayambitsa kwambiri hypoglycemia (kuphatikiza nthawi yausiku). Odwala omwe ali ndi matenda amtundu wa 1 wodwala, chithandizo cha Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® kamodzi patsiku limodzi ndi insulin aspart musanadye zakudya zina adawonetsa mtundu wofanana wa glycemic control (HbA_1c ndi kusala shuga m'magazi) okhala ndi zovuta zina zaposachedwa za hypoglycemia poyerekeza ndi ndondomeko yoyambira ya insulin dstemir ndi insulin aspart pachakudya chilichonse.

Malinga ndikufufuza kwa meta kawiri-kawiri wama 26 mayeso otseguka omwe akukonzekera malinga ndi lingaliro la "kuchiritsa cholinga" lomwe limakhudza odwala omwe ali ndi matenda a shuga a 2, mankhwala a Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ®, omwe amaperekedwa kawiri patsiku, adawonetsa kuchepa kwa zigawo za hypoglycemia yotsimikizika mokwanira komanso zigawo za kutsimikizika kwa nocturnal hypoglycemia poyerekeza ndi biphasic insulin aspart 30. Zotsatira zinaonetsa kuti Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® itachepa ili ndi plasma glucose yothamanga yokhala ndi chiopsezo chocheperako cha hypoglycemia phunziroli komanso panthawi yokonza mlingo kuyambira masabata 16 (Gome 1)

Gome 1. Zotsatira za kusanthula kwa meta pazomwe zimatsimikizika za hypoglycemia pakagwiritsidwa ntchito kawiri patsiku panthawi yophunzira komanso panthawi yokonza mankhwalawa kuyambira milungu 16

Panalibe kupangika kwofunikira kwambiri kwa ma antibodies kupita ku insulin atalandira chithandizo ndi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® kwa nthawi yayitali.

Makhalidwe a zinthu Insulin degludec + Insulin aspart

Mankhwala osakanikirana okhala ndi insulin ya insulin ya insulin ya anthu osokoneza bongo (insulin degludec) komanso yolumikizira mwachangu ya insulin (insulin aspart) yopangidwa ndi recombinant DNA biotechnology pogwiritsa ntchito mtundu Saccharomyces cerevisiae.

Kuphatikiza kwa ma insulin analogues kumakhala ndi 70% yogwira insulin nthawi yayitali (insulin degludec) ndi 30% yogwira insulin (insulin aspart).

Degludec insulin imasiyana ndi insulin ya anthu chifukwa palibe threonine amino acid pamalo B30 ndi kukhalapo kwa chingwe cham'mbali chokhala ndi glutamic acid ndi C16 fatty acid, yopangidwa ndi tekinoloje ya DNA yomwe imagwiritsidwanso ntchito Saccharomyces cerevisiae. Degludec insulin imakhala ndi kulemera kwa 6103.97.

Insulin aspart ndi yopanda tanthauzo ku insulin ya anthu, kupatula kuti m'malo a proline amino acid pamalo B28 ndi asipilini acid, opangidwa ndi recombinant DNA technology pogwiritsa ntchito mavuto Saccharomyces cerevisiae, kulemera kwamankhwala 5825.8.

Insulin Aspart, Bifazik ndi Degludek: mtengo ndi malangizo

Matenda a shuga ndi matenda ofala omwe amafunikira chithandizo cha moyo wonse. Chifukwa chake, mu mtundu woyamba wa matenda komanso muzochitika zapamwamba ndi njira yachiwiri yamatenda, odwala amafunikira insulin mosalekeza, yomwe imathandizira kusintha shuga, posinthira mwachangu kukhala mphamvu.

Nthawi zambiri ndi shuga, insulin Aspart imagwiritsidwa ntchito. Ichi ndi mankhwala a ultrashort.

Chidacho ndi analogue of insulin ya anthu, yomwe imapangidwa ndi ukadaulo wa DNA wogwiritsa ntchito mtundu wa Saccharomyces cerevisiae, pomwe proline pamalo a B28 (amino acid) m'malo mwake ndi acid. Kulemera kwa maselo ndi 5825.8.

The zikuchokera, kumasulidwa mawonekedwe ndi pharmacological kwenikweni

Biphasic insulin imaphatikiza Aspart yosungunuka ndi crystalline insulin protamine muyezo wa 30 mpaka 70%.

Uku ndi kuyimitsidwa kwa kachitidwe ka sc, kokhala ndi khungu loyera. Mililita imodzi imakhala ndi mayunitsi 100, ndipo ED imodzi imafanana ndi 35 mcg wa insulin Aspart.

Mafuta a insulin omwe amapanga munthu amapanga insulin receptor zovuta ndi receptor panja la cytoplasmic cell membrane. Otsatirawa adayambitsa kaphatikizidwe ka glycogen synthetase, pyruvate kinase ndi hexokinase michere.

Kuchepa kwa shuga kumachitika ndikuwonjezereka kwa mayendedwe amkati komanso kusintha kwa minofu. Hypoglycemia imapezekanso pakuchepetsa nthawi yotulutsidwa kwa shuga ndi chiwindi, glycogenogeneis ndi kutsegula kwa lipogenesis.

Biphasic insulin aspart imapezeka kudzera mu kubwezeretsa kwachilengedwenso pamene molekyulu ya proline ya hormone imaloŵedwa m'malo ndi aspartic acid. Ma insulin a biphasic oterowo amakhala ndi vuto lofanananso ndi glycosylated hemoglobin, monga insulin yaumunthu.

Mankhwala onse awiriwa amagwira ntchito molingana molar. Komabe, Aspart insulin imagwira ntchito mwachangu kuposa mahomoni amtundu wa anthu. A crystalline aspart ya protamine imakhudzanso nthawi yayitali.

Zochita pambuyo pazoyang'anira wothandizirazo zimatheka pambuyo mphindi 15. Kuphatikiza kwakukulu kwa mankhwalawa kumachitika patatha maola 1-4 pambuyo pa kubayidwa. Kutalika kwa vutoli kuli mpaka maola 24.

Mu seramu Cmax, insulin ndi 50% kuposa mukamagwiritsa ntchito insulin ya anthu. Komanso, nthawi yayitali kuti afike ku Cmax ndi ochepera theka.

T1 / 2 - mpaka maola 9, amawonetsa kuthamanga kwa kuyamwa kwa kachidutswa kamene kamakhala ndi protamine. Msuzi insulin amawona pambuyo 15-18 pambuyo kukhazikitsa.

Koma ndi matenda a shuga a mtundu wachiwiri, kupezeka kwa Cmax kuli pafupifupi mphindi 95. Amakhala pamalo ochepera 14 komanso pamwamba 0 pambuyo pa sc. Kaya dera loyang'anira likukhudza malo omwe kunyamulidwa sikunaphunzire.

Pharmacology

Njira yamachitidwe. Insulin degludec ndi insulin aspart makamaka imamangiriza ku cholandilira cha anthu amkati a insulin ndipo, kumayanjana nawo, amazindikira pharmacological awo chimodzimodzi ndi mphamvu ya insulin yaumunthu. Hypoglycemic zotsatira za insulin imayamba chifukwa cha kugwiritsidwa ntchito kwa glucose pogwiritsa ntchito minofu pambuyo pomangiriza insulini kupita ku minofu ndi mafuta othandizira maselo komanso kuchepa kwa munthawi yomweyo.

Zotsatira za pharmacodynamic zamagulu osakanikirana a insulin degludec + insulin aspart ndizosiyana kwambiri, ndipo zochitika zonse za mankhwala zimawonetsa mbiri ya zomwe zimachitika pazinthu ziwirizi: kuthamanga kwambiri kwa insulini ndi insulini ya insulin.

Gawo loyambira la kuphatikiza kwa insulin degludec + insulin aspart, yomwe imakhala ndi chowonjezera pofupika (insulin degludec), pambuyo pa jekeseni wa sc, imapanga mashesa ambiri osungunuka mu deputeraneous depot, komwe kumakhala kosalekeza pang'onopang'ono kwa insulini Refludec mu kufalikira, ndikupereka mawonekedwe osunthika a zochita ndi kukhazikika kwa hypoglycemic. Izi zimasungidwa limodzi ndi insulini ndipo sizikhudza kuchuluka kwa mayamwidwe olimbikira a insulin.

Kuphatikiza kwa insulin degludec + insulin aspart imayamba kugwira ntchito mwachangu, ndikupereka kufunikira kwa insulin posakhalitsa jakisoni, pomwe gawo loyambira lili ndi mawonekedwe osasunthika komanso osasunthika omwe amapereka chofunikira cha insulin. Kutalika kwa gawo limodzi la kuphatikiza kwa insulini Refludec + insulin ndi kupitilira maola 24.

Ubale wolimba pakati pakuwonjezereka kwa kuchuluka kwa kuphatikiza kwa insulin degludec + insulin aspart ndi zotsatira zake zazikulu komanso zapamwamba za Cogogicc, C_ss akwanilitsa pambuyo 2-3 masiku makonzedwe.

Panalibe kusiyana mu pharmacodynamics yophatikizira insulin degludec + insulin aspart mwa odwala okalamba komanso achinyamata.

Kuchita Mwachipatala ndi Chitetezo

Mayeso asanu apadziko lonse lapansi omwe amayesedwa osadziwika bwino a mayesero a insulin degludec + insulin aspart mu "chithandizo cholinga" anali kuchitidwa kwa masabata 26 kapena 52 ndi odwala 1360 omwe ali ndi matenda ashuga (362 odwala matenda amtundu 1 komanso odwala 998 okhala ndi matenda a 2 ) Kafukufuku awiri wofanana wachitika wokhazikika kuphatikiza kwa insulin degludec + insulin aspart kuphatikiza mankhwala a hypoglycemic (PHGP) komanso makonzedwe amodzi a insulin glargine osakanikirana ndi PHGP odwala omwe ali ndi matenda amtundu wa 2. PHGP idayerekezedwa ndi makonzedwe a biphasic insulin aspart 30 kawiri tsiku lililonse kuphatikiza ndi PHGP mu maphunziro awiri mwa odwala omwe ali ndi matenda a shuga 2. insulin katsitsidwe kamodzi patsiku limodzi ndi insulin aspart anali kuyerekezera ndi makonzedwe a insulin 1 kapena 2 kawiri pa tsiku limodzi ndi insulin aspart odwala omwe ali ndi mtundu 1 matenda a shuga.

Kuperewera kwa kuphatikiza kwa mankhwala oyerekeza kuphatikiza kwa insulin degludec + insulin aspart pokhudzana ndi kuchepa kwa HbA_1c mu maphunziro onse mothandizidwa ndi odwala mpaka cholinga.

Odwala omwe ali ndi matenda a shuga a mtundu wa 2 omwe sanalandire chithandizo cha insulin komanso odwala omwe adalandira chithandizo cha insulin kale, kuphatikiza kwa insulin degludec + insulin aspart kuphatikiza ndi PHGP kumapereka chiwonetsero chofanana cha glycemic poyerekeza ndi insulin glargine. Kuphatikiza kwa insulin degludec + insulin aspart kumapereka chiwongolero chokwanira cha prandial glycemic poyerekeza ndi insulin glargine yotsika pafupipafupi ya nocturnal hypoglycemia (yofotokozedwera ngati episode ya hypoglycemia yomwe idachitika pakati pa 0 ndi 6 am, zomwe zimatsimikiziridwa ndi kuyeza plasma glucose osachepera 3.1 mmol / l kapena kufunika kothandizidwa ndi odwala omwe ali mgulu lachitatu).

Kukhazikitsidwa kwa kuphatikiza kwa insulini Refludec + insulin 2 kawiri patsiku kumapereka chiwonetsero chofananira cha glycemic (HbA_1c) poyerekeza ndi biphasic insulin aspart 30, yomwe imagwiritsidwanso ntchito kawiri pa tsiku. Kuphatikiza kwa insulin degludec + insulin aspart kumapereka mphamvu zabwino kwambiri pochepetsa kusala kwa glucose. Mukamagwiritsa ntchito kuphatikiza kwa insulin degludec + insulin aspart, phindu la plasma glucose 5 mmol / L limatheka mwachangu mwa odwala poyerekeza ndi odwala omwe amachitidwa ndi biphasic insulin aspart 30. Kuphatikiza kwa insulin degludec + insulin aspart nthawi zambiri kumayambitsa hypoglycemia (kuphatikiza nthawi yausiku) . Odwala omwe ali ndi matenda a shuga 1 a mtundu wa mellitus, mankhwala omwe amaphatikizana ndi insulin degludec + insulin 1 nthawi patsiku osakanikirana ndi insulin -_1c ndi kusala shuga m'magazi) okhala ndi zovuta zina zaposachedwa za hypoglycemia poyerekeza ndi maziko a insulin detemir komanso insulini aspart pachakudya chilichonse.

Malinga ndikuwunikira kwa mayeso awiri ovomerezeka a masabata a 26 omwe adapangidwa malinga ndi lingaliro la "kuchiritsa cholinga" lomwe limakhudza odwala omwe ali ndi matenda a shuga a 2, kuphatikiza kwa insulin degludec + insulin aspart, yoperekedwa kawiri pa tsiku, kunawonetsa kuchepa kwa magawo omwe atsimikizidwa hypoglycemia ponseponse komanso magawo a kutsimikizika kwa nocturnal hypoglycemia poyerekeza ndi insulin ya biphasic 30. Kuwunika kwa meta kunawonetsa kuti kuphatikiza kwa insulin degludec + insulin aspart kutsitsa plasma glucose kusala magazi ndi chiopsezo chocheperako cha hypoglycemia panthawi yonse yophunzira komanso pakukonza mlingo kuyambira masabata 16. Pafupipafupi wachibale (95% CI) ya kuchuluka kwathunthu kwa kutsimikizika kwa hypoglycemia kwa insulin degludec + insulin aspart (2 kawiri pa tsiku) / biphasic insulin aspart 30 (2 kawiri pa tsiku) panthawi yophunzira anali 0.81 (0.67, 0.98 ,, pokonza mlingo - 0.69 (0.55, 0.87), pafupipafupi wa nthawi yotsimikizika ya hypoglycemia - 0.43 (0.31, 0.59) munthawi yophunzira ndi 0.38 (0.25, 0.58) pa yokonza mlingo.

Panalibe kupangika kwofunikira kwambiri kwa ma antibodies kuti apange insulin pambuyo pa chithandizo chophatikizana ndi insulin degludec + insulin aspart kwa nthawi yayitali.

Mafuta Pambuyo pa jekeseni wa sc, kupangika kwa soluble khola la insuludec insulin multhexamers kumachitika, komwe kumayambitsa insulin depot mu subcutaneous adipose minofu ndipo osasokoneza kutulutsidwa msanga kwa insulin aspart monomers m'magazi. Ma Multihexamers amapatuka pang'onopang'ono, ndikumasulidwa kwa maukalidi a insludec insulin, chifukwa chomwe amalowetsa magazi pang'onopang'ono. C_ss gawo la superlong kanthu (insulin degludec) m'magazi amapezeka patatha masiku 2-3 atayambitsa kuphatikiza kwa insulin degludec + insulin.

Zizindikiro zodziwika bwino za kuyamwa mwachangu kwa insulin aspart zimasungidwa kuphatikiza kwa insulini desludec + insulin. Mbiri ya pharmacokinetic ya insulin aspart imawonekera mphindi 14 pambuyo pa jekeseni, C_max ikuwoneka pambuyo pa mphindi 72

Mafuta The ndende - kudalira nthawi pambuyo limodzi limodzi mlingo wa 0,4, 0,6, ndi 0,8 U / kg kuphatikiza kwa insulin degludec + insulin aspart odwala omwe ali ndi vuto 1 la shuga ndi mtundu 2 wodwala matenda ashuga awonetsa kuchuluka kwa chiwonetsero chambiri zonse ziwiri zophatikiza.

Insulin aspart adawonetsa kuchuluka kwa kuchuluka kwa C_max ndi kuchuluka kocheperako pang'ono kuposa kuchuluka kwa AUC_0–12 pambuyo limodzi sc makonzedwe a kuphatikiza insulin degludec + insulin katswiri wa odwala 1 mtundu wa matenda a shuga ndi mtundu 2 shuga.

Insulin degludec adawonetsa kuchuluka kwa kuchuluka kwa C_max ndi AUC_0–120 Ndi limodzi sc makonzedwe osakanikirana a insulin degludec + insulin katswiri wa matenda a 1 matenda a shuga ndi mtundu 2 matenda a shuga.

Kukhazikika kwa mphamvu ya kuphatikiza - insulin, - 14 min pambuyo pa jekeseni, C_max - mphindi 72 Serum C_ss kuphatikiza - insulin degludec - idakwaniritsidwa Masiku 3-4 Pambuyo makonzedwe a kuphatikiza insulin degludec + insulin.

Kugawa. Kuphatikizika kwa insludec insulin ya serum albin kumafanana ndi mphamvu yomanga ya mapuloteni a plasma (> 99%) m'madzi a m'magazi a anthu. Mu insulin aspart, mphamvu ya plasma yomangira imakhala yotsika (T_1/2 kuphatikiza kwa insulini degludec + insulini wa aspulin pambuyo pa jekeseni wa sc umatsimikiziridwa ndi kuchuluka kwa mayamwidwe a minofu ya subcutaneous. T_1/2 Degludec insulin pafupifupi maola 25 ndipo mlingo wodziimira pawokha.

Chotsogola. Zotsatira zonse za kuphatikiza kwa insulin degludec + insulin aspart ndi yolingana ndi mlingo womwe waperekedwa wa basal chigawo chimodzi (insulin degludec) ndi gawo la prandial (insulin aspart) la 1 ndi mtundu 2 shuga.

Magulu apadera a odwala

Palibe kusiyana komwe kunapezeka mu pharmacokinetic katundu wophatikizana ndi insulin degludec + insulin aspart kutengera mtundu wa odwala.

Okalamba okalamba, odwala mafuko osiyanasiyana, odwala omwe ali ndi vuto laimpso kapena kwa chiwindi. Panalibe kusiyana kwakukulu mu pharmacokinetics kuphatikiza kwa insulin degludec + insulin aspart pakati pa okalamba ndi achinyamata, pakati pa odwala amitundu yosiyanasiyana, pakati pa odwala omwe ali ndi vuto laimpso ndi kwa chiwindi ndi odwala athanzi.

Geriatrics Zotsatira za pharmacokinetic ndi pharmacodynamic pakuphatikizidwa kwa insulin degludec + insulin aspart anaphunziridwa mwa achinyamata 13 (achikulire zaka 18- 35) ndi odwala okalamba 15 (≥65 wazaka) wokhala ndi mtundu 1 wa shuga pambuyo 2 2 sc / 0/1 Imodzi ndi kuphatikiza kwa insulin degludec + insulin aspart ndipo imodzi ndi gawo la insulin. Kuwonetsedwa kwathunthu kwa insulin aspart kuphatikiza kwa insulin degludec + insulin aspart (yochokera ku AUC_0–12 insulin aspart) mu odwala okalamba ankakonda kuchuluka poyerekeza ndi akulu. Kuwonetsedwa kwathunthu kwa insulin degludec kuphatikiza kwa insulin degludec + insulin aspart (yochokera ku AUC_0–120 insulin degludec) ndi mayankho a pharmacodynamic osakanikirana a insulin degludec + insulin aspart (yochokera pa AUC_0–24 insulin degludec) anali ofanana pakati pa achinyamata ndi odwala okalamba omwe ali ndi matenda amtundu wa 1, ngakhale kusintha kosiyanasiyana kwa odwala okalamba kunali kwapamwamba.

Ana ndi achinyamata. Mankhwala a pharmacokinetic omwe amaphatikiza insulin degludec + insulin aspart mu kafukufuku wa ana (6 - 11 wazaka) ndi achinyamata (wazaka 12-18) wokhala ndi mtundu wa 1 matenda a shuga ndi ofanana ndi omwe ali ndi odwala omwe ali ndi jakisoni imodzi.

Chiwerengero chonse ndi C_max insulin aspart ndi yokwera kwambiri kwa ana kuposa achikulire, komanso chimodzimodzi kwa achinyamata ndi achikulire.

Mankhwala a pharmacokinetic a degludec insulin mwa ana ndi achinyamata omwe ali ndi matenda amtundu wa 1 amafanana ndi omwe ali ndi odwala akuluakulu. Poyerekeza ndi jekeseni imodzi yamadzi a shuga a insludec odwala omwe ali ndi matenda a shuga 1, zimawonetsedwa kuti kuchuluka kwa mankhwalawa kwa ana ndi achinyamata ndiokwera kuposa kumene kwa anthu akuluakulu.

Paulo Zotsatira zakugonana pa pharmacokinetics pazinthu zomwe zimagwiritsidwa ntchito pophatikizana ndi insulin degludec + insulin aspart adawunika pokambirana zamaphunziro osiyanasiyana a pharmacokinetic ndi pharmacodynamic. Pazonse, panalibe kusiyana kwakukulu pamachitidwe a pharmacokinetic a insulin degludec kapena insulin aspart pakati pa akazi ndi amuna.

Kunenepa kwambiri Zotsatira za kuchuluka kwa mafuta mthupi (BMI) pa pharmacokinetics pazinthu zomwe zimagwiritsidwa ntchito pophatikizana ndi insulin degludec + insulin aspart idawunikidwa pakuwunika kwa mtanda-pharmacokinetic ndi maphunziro a pharmacodynamic. Odwala omwe ali ndi mtundu woyamba wa matenda a shuga, palibe ubale uliwonse womwe umapezeka pakati pa kukhudzana ndi Refludec insulin ndi BMI. Odwala omwe ali ndi matenda a shuga a mtundu woyamba 1 kapena 2, chidwi cha kutsika kwa shuga m'magazi a insludec ndi kuwonjezeka kwa BMI chinaululidwa. Kwa insulin aspart, kunalibe kuyanjana pakati pa BMI ndikuwonetsedwa mwa odwala omwe ali ndi matenda amtundu wa 2 kapena matenda a shuga.

Mtundu ndi fuko. Zotsatira zamtundu ndi mafuko pa pharmacokinetics kuphatikiza kwa insulin degludec + insulin aspart sizinaphunzire. Chigawo choyambira cha kuphatikiza, insulin degludec, idaphunziridwa mu maphunziro a pharmacokinetic ndi pharmacodynamic ku American Americanans of Hispanic kapena Latino chiyambi (n = 18), anthu oyera khungu la Hispanic kapena Latino fuko (n = 22), ndi anthu oyera khungu la Hispanic kapena Latino fuko (n = 23) ndi lembani matenda a shuga 2: Palibe kusiyana kwakukulu pakati pa mafuko ndi mafuko omwe anaphunziridwa.

Mimba Zotsatira za pakati pa pharmacokinetics ndi pharmacodynamics kuphatikiza kwa insulin degludec + insulin aspart sizinaphunzire (onani. "Gwiritsani ntchito pakati pathupi ndi mkaka wa m'mawere").

Kulephera kwina. Mphamvu ya kulephera kwa impso pa pharmacokinetics ya kuphatikiza kwa insulin degludec + insulin aspart sichinaphunzire. Gawo loyambira la kuphatikiza - insulin degludec (ndikuyambitsa mtundu umodzi wa 0,4 U / kg) - adaphunziridwa m'maphunziro a pharmacokinetic mwa anthu 32 (n = 4-8 / gulu) ndi kulephera kwaimpso kapena kwabwinobwino kwaimpso . Kukanika kwa renal kunatsimikizika malinga ndi Cl creatinine: ≥90 ml / mphindi (yachibadwa), 60-89 ml / min (yofatsa), 30-59 ml / mphindi (zolimbitsa) ndi s / c Mlingo wa 0.08 U / kg insulin aspart (yomwe imagwira ntchito mwachangu kuphatikiza kwa insulin degludec + insulin aspart) idawunika mu kafukufuku wa anthu omwe ali ndi vuto laimpso, ofatsa, odziletsa kapena okhwima (koma osafunikira hemodialysis) aimpso ntchito. Phunziroli, palibe zotsatira zowoneka ngati chilengedwe cha creatinine chiloleze ku AUC ndi C_max insulin.

Kulephera kwa chiwindi. Zotsatira zakulephera kwa chiwindi pa pharmacokinetics kuphatikiza kwa insulin degludec + insulin aspart sizinaphunzire. Gawo loyambira la kuphatikiza - insulin degludec - linaphunziridwa mu kafukufuku wa pharmacokinetic mwa anthu a 24 (n = 6 / gulu) ndi chiwindi chokwanira kapena chobowoka chiwindi (ofatsa, odziletsa komanso osafunikira kwambiri kwa hepatic) atatha kugwiritsa ntchito limodzi la mankhwala a s / c (0,4 PIECES / kg) insulin degludec. Palibe kusiyana pakati pa pharmacokinetics of insulin degludec omwe adapezeka pakati pa anthu athanzi ndi anthu omwe ali ndi vuto la chiwindi (onani "Precautions").

Pakufufuza kwapadera kwa mlingo umodzi wa 0,06 U / kg wa insulin aspart (wopanga mwachangu mankhwala osakanikirana a insulin degludec + insulin aspart) adatumizidwa kwa sc kwa odwala 24 (n = 6 / gulu) omwe ali ndi magawo osiyanasiyana a chiwindi amalephera (ofatsa, odziletsa, oopsa). Phunziroli, palibe kuphatikizika komwe kunapezeka pakati pa kuchuluka kwa chiwindi cholephera ndi pharmacokinetics of insulin aspart.

Maphunziro Otetezeka

Zambiri zam'mbuyo zokhudzana ndi maphunziro a chitetezo chamatsenga, kuwopsa kwa Mlingo wobwereza, kuthekera kwazinthu zina, kuwopsa kwa ntchito yobereka, sizinawonetse vuto lililonse kwa anthu. Chiwerengero cha metabolic ndi mitogenic zochita za insludec insulin ndi chofanana ndi cha insulin ya anthu.

Mimba komanso kuyamwa

Kugwiritsa ntchito kuphatikiza kwa insulin degludec + insulin aspart pa nthawi ya pakati ndi kutsutsana, chifukwa palibe zochitika zachipatala ndi momwe zimagwiritsidwira ntchito panthawi yomwe muli ndi pakati. Kafukufuku wokhudzana ndi kubereka kwa nyama sikuwululira zakusiyana pakati pa insludec insulin ndi insulin yaumunthu potengera embryotoxicity ndi teratogenicity.

Kugwiritsa ntchito kuphatikiza kwa insulin degludec + insulin aspart nthawi yoyamwitsa ndi contraindicated, chifukwa Palibe chokuchitikira kuchipatala ndi akazi opaka mkaka.

Kafukufuku wazinyama adawonetsa kuti mu makoswe, degludec insulin imachotsedwa mkaka wa m'mawere, kuyika kwake m'mkaka wa m'mawere ndikotsika kuposa plasma yamagazi. Sizikudziwika ngati insulin degludec imachotsedwa mkaka wa amayi.

Chonde. Kafukufuku wazinyama sanapeze zovuta za degludec insulin pa chonde.

FDA Fetal Action Gulu - C.

Maphunziro okwanira komanso osamalitsa okhazikika ogwiritsira ntchito kuphatikiza kwa insulin degludec + insulin aspart mwa amayi apakati sanachitike. Pokonzekera kutenga pakati kapena kukhazikitsa, odwala ayenera kukambirana za kugwiritsa ntchito mankhwalawa ndi adokotala. Popeza maphunziro ochulukitsa nyama sangathe kulosera mavuto omwe amabwera mwa anthu, kuphatikiza kwa insulini woduludec + insulini ayenera kugwiritsidwa ntchito panthawi yomwe ali ndi pakati pokhapokha ngati chiyembekezo chakuchipatala chipitilira chiwopsezo cha mwana wosabadwayo. Kwa odwala omwe ali ndi mbiri ya matenda ashuga kapena gestational shuga, kusamalira bwino kagayidwe kachakudya musanatenge pathupi komanso panthawi ya pakati ndikofunikira. Kufunika kwa insulini kumatha kuchepa panthawi yoyambirira ya kubereka, monga lamulo, kumawonjezeka panthawi yachiwiri komanso yachitatu ndipo kumachepera msanga pambuyo pobadwa mwana. Kuwunikira mosamala kuchuluka kwa shuga ndikofunikira mwa odwalawa.

Sizikudziwika ngati insludec / aspart insulin imachotsedwa mkaka wa m'mawere. Popeza zinthu zambiri, kuphatikiza insulin ya anthu, zimapukusidwa mkaka wa m'mawere, kusamala kuyenera kuchitika pakamagwiritsira ntchito insulin degludec + insulin aspart mwa amayi oyamwitsa. Amayi omwe ali ndi matenda ashuga panthawi ya mkaka wa m'mawere angafunike kusintha kwa mapiritsi a insulin, kaperekedwe ka chakudya, kapena zonse ziwiri.

Zotsatira zoyipa za zinthu Insulin degludec + Insulin aspart

Zotsatira zoyipa zomwe zimanenedwa nthawi ya mankhwala ndi hypoglycemia (onani Kufotokozera kwamomwe munthu amachitikira mosiyana).

Zotsatira zonse zoyipa zomwe zafotokozedwa pansipa, kutengera deta kuchokera ku mayeso azachipatala, zimagawidwa malinga MedDRA ndi ziwalo zamagulu. Zowopsa zazotsatira zimafotokozedwa ngati nthawi zambiri (≥1 / 10), nthawi zambiri (≥1 / 100 kwa mankhwala osokoneza bongo, zingathe kuwopseza moyo wa wodwalayo.

Mukamagwiritsa ntchito kuphatikiza kwa insulin degludec + insulin aspart, kusintha kwa hypersensitivity (kuphatikizapo kutupa kwa lilime kapena milomo, kutsegula m'mimba, kunyansidwa, kutopa ndi kuyabwa pakhungu) ndi urticaria sizinali zachilendo.

Thupi lawo siligwirizana. Pogwiritsa ntchito insulin iliyonse, kuphatikizapo kuphatikiza kwa insulin degludec + insulin aspart, moyo wosafunikira wowopsa ungayambike, kuphatikizapo anaphylaxis, mawonekedwe a khungu, angioedema, bronchospasm, hypotension ndi mantha, izi zimatha kukhala zoopsa m'moyo (onani "Chenjerani") .

Hypersensitivity (yowonetsedwa ndi kufalikira kwa lilime ndi milomo, kutsekula m'mimba, mseru, kutopa ndi kuyamwa) ndi urticaria pa 0,5% Odwala omwe amalandira kuphatikiza kwa insulin degludec + insulin.

Hypoglycemia. Hypoglycemia imatha kukhala ngati mlingo wa insulin ndiwokwera kwambiri poyerekeza ndi kufunikira kwa wodwala. Hypoglycemia yayikulu imatha kuwononga chikumbumtima ndi / kapena kukhudzika, kusokonezeka kwakanthawi kapena kosasintha kwa ubongo kugwira ntchito mpaka pakufa. Zizindikiro za hypoglycemia, monga lamulo, zimayamba mwadzidzidzi. Izi zimaphatikizapo thukuta lozizira, kutsekeka kwa khungu, kutopa kwambiri, manjenje kapena kunjenjemera, nkhawa, kutopa kosazolowereka kapena kufooka, kusokonezeka, kuchepa kwa chidwi, kugona, kugona kwambiri, kusawona bwino, kupweteka mutu, nseru, mtima.

Lipodystrophy. Lipodystrophy (kuphatikiza lipohypertrophy, lipoatrophy) imatha kukulira pamalo opangira jekeseni. Kutsatira Malamulo osintha jakisoni mkati mwanu momwemo kumathandizira kuti muchepetse chiopsezo chokhala ndi vuto ili.

Lipodystrophy. Kugwiritsa ntchito insulin kwakanthawi kochepa, kuphatikizapo kuphatikiza kwa insulin degludec + insulin aspart, kumatha kubweretsa lipodystrophy pamalo opangira jakisoni mobwerezabwereza. Lipodystrophy imaphatikizapo lipohypertrophy (kukula kwa adipose minofu) ndi lipoatrophy (kuwonda kwa adipose minofu) ndipo ingakhudze kuyamwa kwa insulin. Muyenera nthawi zonse kusintha jakisoni wa insulin mkati mwake momwemo kuti muchepetse vuto la lipodystrophy. Pulogalamu yachipatala idati lipodystrophy mu 0.1% ya odwala, kuchitira limodzi ndi insulin degludec + insulin aspart.

Zokhudza malo jakisoni. Odwala omwe adalandira kuphatikiza kwa insulin degludec + insulin aspart, zimachitika zimadziwika pamalo operekera jakisoni (hematoma, ululu, hemorrhage, erythema, minyewa yolumikizana, kutupa, kusinthasintha kwa khungu, kuyabwa, kuyambitsa khungu ndikukhazikika pamalowo. Zambiri zomwe zimachitika jekeseni malo ndizochepa, zosakhalitsa, ndipo nthawi zambiri zimatha pomapitilira chithandizo.

Zokhudza malo jakisoni. Odwala omwe amalandiridwa ndi insulin degludec + insulin aspart kuphatikiza amatha kukhala ndi vuto m'malo a jakisoni, kuphatikizapo hematoma, kupweteka, kutuluka kwa magazi, erythema, timinofu, kutupa, kusintha kwa khungu, kuyabwa, kumva kutentha, ndi kulimba pamalo a jekeseni. Mu pulogalamu yachipatala, zomwe zimachitika jakisoni wambiri zimawonedwa mu 2% ya odwala, kuchitira limodzi ndi insulin degludec + insulin aspart.

Kulemera. Kulemera kumawoneka ndi insulin, kuphatikiza mukamagwiritsa ntchito kuphatikiza kwa insulin degludec + insulin, ndipo muwonetse zotsatira za insulin. Mu pulogalamu yachipatala, odwala omwe ali ndi matenda amtundu wa 1 omwe adalandira insulin degludec + insulin aspart osakanikirana anali ndi kulemera kwapakati pa 2.8 kg, ndipo odwala omwe ali ndi matenda a shuga a 2 omwe amalandira insulin degludec + insulin aspart amalandira pafupifupi 1 , 6 kg.

Peripheral edema. Insulin, kuphatikiza kuphatikiza kwa insulin degludec + insulin aspart, kungayambitse kusungidwa kwa sodium ndi edema. Mu pulogalamu yachipatala, zotumphukira edema zinaonedwa mu 2.2% ya odwala omwe ali ndi matenda a shuga 1 ndi 1.8% ya odwala omwe ali ndi matenda a shuga 2 omwe adalandira kuphatikiza kwa insulin degludec + insulin.

Ana ndi achinyamata. Mankhwala a chemacokinetic ophatikizira insulin degludec + insulin aspart amaphunziridwa mwa ana ndi achinyamata osakwana zaka 18 (onani. Pharmacokinetics). Kafukufuku wothandiza ndi chitetezo cha ana ndi achinyamata sichinachitike.

Magulu apadera a odwala. Panthawi ya mayesero azachipatala, palibe kusiyana komwe kunapezeka pakadutsa kawirikawiri, mtundu, kapena kusokonezeka kwapakati pakati pa okalamba, odwala omwe ali ndi vuto laimpso kapena kwa chiwindi, komanso odwala ambiri.

Zochitika Zakufufuza Kwachipatala

Popeza mayesero azachipatala amayendetsedwa ndi machitidwe osiyanasiyana, zomwe zimachitika m'maphunzirowa sizingafanane mwachindunji ndi pafupipafupi pamayeso ena azachipatala ndikuwonetseratu zotsatira zoyipa m'machitidwe azachipatala.

Chitetezo pakuphatikizidwa kwa insulin degludec + insulin aspart mwa odwala omwe ali ndi mtundu woyamba 1 ndi mtundu wa 2 matenda a shuga adawunika m'mayesero 5 omwe anakonzedwa pamaziko a "kuchitira zomwe mukufuna", miyezi 6-12.

Kafukufuku wokhudzana ndi chitetezo cha kuphatikiza kwa insulin degludec + insulin aspart mwa odwala omwe ali ndi matenda a shuga 1 amaphatikizapo odwala 362, nthawi yayitali yowonekera inali masabata 43. Avereji ya odwala anali ndi zaka 41, ndipo 1% ya odwala anali oposa zaka 75. Makumi asanu ndi anayi mphambu ziwiri anali amuna, 91% anali oyera khungu, 3% anali Achiafrika-Amereka, ndipo 3% anali a ku Spain. BMI wamba inali 26 kg / m 2. Nthawi yayitali ya matenda ashuga inali zaka 17, ndipo HbA wamba_1c kumayambiriro kwa kafukufukuyu - 8.3%. Mbiri ya neuropathy, ophthalmopathy, nephropathy, ndi matenda amtima kumayambiriro kwa kafukufukuyo inanenedwa mu milandu ya 19, 25, 6, ndi 4%, motsatana. Kutanthauza GFR kumayambiriro kwa kafukufukuyu kunali 88 ml / mphindi / 1.73 m 2, ndipo 6% ya odwala anali ndi GFR osakwana 60 ml / mphindi / 1.73 mm 2.

Kafukufuku wina wokhudzana ndi chitetezo cha kuphatikiza kwa insulin degludec + insulin aspart adaphatikizira odwala 998 omwe ali ndi mtundu wa 2 shuga mellitus, nthawi yayitali yowonekera inali masabata 24. Avereji ya odwala anali ndi zaka 58, ndipo 3% anali opitilira 75 zaka. Makumi asanu ndi anayi mphambu anayi anali amuna, 44% anali oyera khungu, 4% African-American, ndipo 6% anali Hispanic. BMI yapakati inali 29 kg / m 2. Nthawi yayitali ya matenda ashuga ndi zaka 12, HbA wamba_1c kumayambiriro kwa kafukufukuyu - 8.5%. Mbiri ya neuropathy, ophthalmopathy, nephropathy, ndi matenda amtima kumayambiriro kwa kafukufukuyo inanenedwa mu milandu ya 15, 21, 10, ndi 1%, motsatana. Poyamba, kutanthauza kuti GFR inali 84 ml / mphindi / 1.73 m 2 ndipo mwa 11% ya odwala osakwana 60 ml / min / 1.73 m 2.

Zotsatira zoyipa zambiri (kupatula hypoglycemia) zimawonedwa pamayesero azachipatala odwala omwe ali ndi mtundu 1 ndi mtundu wa 2 wodwala mellitus omwe amathandizidwa ndi insulin avludec + insulin aspart amaperekedwa pansipa. Zotsatira zoyipa zambiri zimafotokozedwa ngati zomwe zimachitika mu ≥5% ya odwala mu kafukufuku. Hypoglycemia siyikusonyezedwa ndipo ikukambidwa mu gawo lapadera pansipa.

Zotsatira zoyipa zomwe zimawonedwa mu ≥5% ya odwala omwe ali ndi matenda a shuga 1 amodzi a mankhwalawa amachititsa kuti insuludec + insuludec + insulin iperekedwe (N = 362)

Mutu 9.7%.

Kupumitsa kwa thirakiti la matenda oyatsira matenda a 9.1%.

Zotsatira zoyipa zomwe zimawonedwa mu ≥5% ndi mtundu wachiwiri wa matenda ashuga mellitus pochizira insuludec + insulin - Nulin 998

Wapamwamba kupuma thirakiti matenda 5.7%.

Mutu 5.6%.

Hypoglycemia ndimomwe zimachitika kawirikawiri chifukwa chodwala omwe ali ndi insulin, kuphatikizapo kuphatikiza kwa insulin degludec + insulin aspart (onani "Precautions"). Kukula kwa hypoglycemia yozikidwa kumadalira tanthauzo la hypoglycemia, monga matenda a shuga, insulin, mphamvu ya kuwongolera shuga, chithandizo cham'mbuyo komanso zinthu zina zamkati ndi zakunja kwa wodwalayo. Pazifukwa izi, kuyerekezera komwe kumachitika mu hypoglycemia m'mayesero azachipatala omwe amaphatikizidwa ndi insulin degludec + insulin aspart ndi zochitika za hypoglycemia wogwiritsa ntchito othandizira ena akhoza kukhala akusocheretsa ndipo mwina sangakhale oimira kuwunika kwa hypoglycemia yomwe imadziwika muzochitika zamankhwala.

Otsatirawa ndi omwe amapezeka mu hypoglycemia mu maphunziro a odwala omwe ali ndi mtundu woyamba wa 2 ndi mtundu wa 2 omwe adalandira kuphatikiza kwa insulin degludec + insulin aspart. Hypoglycemia yayikulu imatanthauzidwa monga gawo lomwe limafuna kuti munthu wina athandize jakisoni wa shuga, glucagon, kapena kutulutsa kwinanso.

M'mayesero azachipatala, kuphatikiza kwa insulin degludec + insulin aspart hypoglycemia kumatanthauzidwa ngati gawo la hypoglycemia (1), kapena gawo lomwe labotale kapena kudzipima kwa plasma glucose kunali kochepera 56 mg / dl kapena glucose wathunthu wamagazi anali ochepera 50 mg / dl (i.e. ndi kapena wopanda hypoglycemic) - (2).

Peresenti ya odwala omwe ali ndi matenda amtundu wa 1 omwe akumana ndi gawo limodzi la hypoglycemia (1) kapena hypoglycemia (2) pamavuto azachipatala

Mu Phunziro A, odwala adalandira kuphatikiza kwa insulin degludec + insulin aspart (1 nthawi patsiku) kuphatikiza insulin aspart (2 kawiri pa tsiku) kwa masabata 52 (N = 362).

Hypoglycemia (1) 13.3%.

Hypoglycemia (2) 95%.

Peresenti ya odwala omwe ali ndi matenda a shuga a 2 omwe akumana ndi gawo limodzi la hypoglycemia (1) kapena hypoglycemia (2) pamavuto azachipatala

Pophunzira B, odwala adalandira kuphatikiza kwa insulin degludec + insulin aspart (1 nthawi patsiku), insulini yosavuta komanso kale 2 kapena kupitila PHGP (N = 265).

Mu Phunziro C, odwala adalandira kuphatikiza kwa insulin degludec + insulin aspart (1 nthawi patsiku), insal-insulin (1 nthawi patsiku), ndi 1 kapena kuposa PHGP (N = 230).

Mu kuphunzira D, odwala adalandira kuphatikiza kwa insulin degludec + insulin aspart (2 kawiri pa tsiku), m'mbuyomu nthawi 1-2 patsiku, chisanadze / chokha chosakanikirana, ndi / popanda PHGP (N = 224).

Mu Phunziro E, odwala adalandira kuphatikiza kwa insulin degludec + insulin aspart (2 kawiri pa tsiku), m'mbuyomu masiku 1-2 patsiku basal / pre / kudzisakaniza nokha, ndi / opanda PHGP (N = 279).

Hypoglycemia (1) 0.4, 0, 3.1 ndi 1.4%.

Hypoglycemia (2) 49.8, 52.6, 66.1 ndi 73.5%.

Kuchita

Pali mankhwala angapo omwe amakhudza kufunika kwa insulin.

Kufunika kwa insulini kungachepe: mankhwala amkamwa a hypoglycemic, glucagon-peptide-1 receptor agonists (GLP-1), Ma inhibitors a MAO, osagwiritsa ntchito beta-blockers, ma inhibitors a ACE, salicylates, anabolic steroids ndi sulfonamides.

Kufunika kwa insulin kungakulitse: njira yolerera ya pakamwa ya mahomoni, thiazide diuretics, corticosteroids, mahomoni a chithokomiro, sympathomimetics, somatropin ndi danazole.

Beta-blockers amatha kufinya zizindikiro za hypoglycemia.

Octreotide / lanreotide imatha kuwonjezeka ndikuchepetsa kufunikira kwa insulin.

Ethanol imatha kukulitsa ndikuchepetsa mphamvu ya insulin.

Mankhwala ena, akawonjezeredwa kuphatikiza kwa insulin degludec + insulin aspart, angayambitse kuwonongeka kwa insulin degludec ndi / kapena insulin aspart. Kuphatikiza kwa insulin degludec + insulin aspart sikuyenera kuwonjezeredwa ku mayankho a kulowetsedwa. Simungasakanize mankhwalawa ndi mankhwala ena.

Matenda ofunikira kwambiri ophatikizana ndi insulin degludec + insulin

Mankhwala omwe angapangitse chiwopsezo cha hypoglycemia:mankhwala antidiabetes ACE zoletsa angiotensin II receptor blockers, disopyramides, fibrate, fluoxetine, Mao zoletsa pentoxifylline, pramlintide, propoxyphenesalicylates somatostatin analogues (mwachitsanzo, octreotide), sulfonamides, GLP-1 zolandila olandila, dipeptidyl peptidase-4 zoletsa;; sodium-based glucose transporter mtundu 2 inhibitors (SGLT-2 inhibitors).

Pogwiritsa ntchito kuphatikiza kwa insulin degludec + insulin aspart ndi mankhwalawa, kuchepetsedwa kwa mlingo ndi kuwonjezeka kwa pafupipafupi kwa kuwunika kuchuluka kwa shuga kungafunike.

Mankhwala omwe amatha kuchepetsa mphamvu ya kuphatikiza kwa insulin degludec + insulin aspart (kutsitsa glucose wamagazi):atypical antipsychotic (olanzapine ndi clozapine), corticosteroids, danazol diuretics, estrogens, glucagon, isoniazid, nikotini acid, kulera kwamlomo phenothiazines, progesterones (kuphatikizapo gawo la njira zakulera zamkamwa), protease inhibitors, somatropin, sympathomimetics (kuphatikizapo salbutamol, epinephrine, terbutaline), mahomoni a chithokomiro.

Pogwiritsa ntchito kuphatikiza kwa insulin degludec + insulin aspart ndi mankhwalawa, kuwonjezeka kwa mlingo komanso pafupipafupi kuyang'anira kuchuluka kwa glucose kungafunike.

Mankhwala omwe amatha kuwonjezeka ndikuchepetsa mphamvu ya kuphatikiza kwa insulin degludec + insulin aspart (kutsitsa glucose wamagazi): mowa beta-blockers, clonidine, mchere wa lithiamu. Pentamidine zimayambitsa hypoglycemia, yomwe nthawi zina imatha kutsagana ndi hyperglycemia.

Ndi kuphatikiza kwa kuphatikiza kwa insulin degludec + insulin aspart ndi mankhwalawa, kusintha kwa mankhwalawa komanso kuwonjezeka kwa pafupipafupi kuyang'anira kuchuluka kwa shuga kungafunike.

Mankhwala omwe amatha kupaka zizindikiro ndi hypoglycemia: beta blockers, clonidine, guanethidine ndi reserpine. Pogwiritsa ntchito kuphatikiza kwa insulin degludec + insulin aspart ndi mankhwalawa, kuwonjezereka kwa pafupipafupi kuyang'anira kuchuluka kwa glucose kungafunike.

Bongo

Mlingo wapadera womwe umayambitsa kuchuluka kwa insulini sunakhazikitsidwe, koma hypoglycemia imatha kukula pang'onopang'ono ngati mlingo wa mankhwalawa ndiwokwera kwambiri poyerekeza ndi zomwe wodwala amafunikira (onani "Precautions"). Wodwala amatha kuthetseratu hypoglycemia potenga shuga kapena mankhwala okhala ndi shuga mkamwa. Chifukwa chake, ndikulimbikitsidwa kwa odwala omwe ali ndi matenda ashuga kuti azisenza mankhwala okhala ndi shuga nthawi zonse.

Ngati hypoglycemia yavuta kwambiri, wodwalayo atakomoka, amayenera kuvulazidwa ndi glucagon (0,5 mpaka 1 mg) i / m kapena s / c (amatha kuyendetsedwa ndi munthu wophunzitsidwa bwino kapena mu / dextrose (glucose) solution (ingagwiritsidwe ntchito kokha) wogwira ntchito zachipatala). M'pofunikanso kuyang'anira dextrose iv ngati wodwalayo asadzayambenso chikumbumtima cha mphindi 10-15 atatha kugwiritsa ntchito shuga. Pambuyo podzikanso, wodwalayo amalangizidwa kuti azidya zakudya zokhala ndi mchere wambiri kuti muchepetse kubwerezanso kwa hypoglycemia.

Chenjezo la zinthu Insulin degludec + Insulin aspart

Hypoglycemia. Ngati mungadumphe chakudya kapena musakonzekere kuchita masewera olimbitsa thupi, wodwala amatha kuyamba kudwala matenda ena. Hypoglycemia imatha kukhazikikanso ngati mlingo wa insulin ndiwokwera kwambiri poyerekeza ndi zosowa za wodwala (onani "Zotsatira zoyipa" ndi "Overdose").

Atalipiritsa chakudya cha metabolism (mwachitsanzo, insulin Therapy), zizindikiro za odwala zomwe zimadziwika kwa iwo zimatha kusintha - otsogola a hypoglycemia, omwe odwala amafunikira kudziwa. Zizindikiro zofala - am'mbuyomu amatha kuzimiririka ndi njira yayitali ya matenda a shuga.

Matenda okhala ndi vuto limodzi, makamaka opatsirana komanso kutentha thupi, nthawi zambiri amalimbikitsa kufunika kwa insulin. Kusintha kwa magazi kungafunikenso ngati wodwala ali ndi vuto la impso, chiwindi, kapena adrenal gland, pituitary, kapena chithokomiro.

Monga momwe zimakhalira ndi insulin kukonzekera kapena kukonzekera ndi chigawo choyambira, kuchira pambuyo pa hypoglycemia kuphatikiza kwa insulin degludec + insulin aspart kuchedwa.

Zomwe zimayambitsa hypoglycemia. Chiwopsezo cha hypoglycemia chimawonjezeka ndi kuwongolera kwambiri glycemic. Kuopsa kwa hypoglycemia pambuyo pa jakisoni kumalumikizidwa ndi nthawi yayitali ya insulini ndipo nthawi zambiri imakhala yotalika kwambiri pamene kutsika kwa glucose kumapangitsa kuti insulin ikhale yayitali. Monga momwe akukonzekera insulin yonse, kutsitsa kwa glucose-kuphatikiza kwa kuphatikiza kwa insulin degludec + insulin aspart imatha kusintha m'malo osiyanasiyana mwa anthu osiyanasiyana kapena nthawi zosiyanasiyana mwa anthu omwewo ndipo zimatengera magawo ambiri, kuphatikiza malo a jekeseni, komanso magazi ndi kutentha kwa malo opaka jakisoni .

Zina zomwe zingakulitse chiopsezo cha hypoglycemia zimaphatikizapo kusintha kwa zakudya (mwachitsanzo, zomwe zimakhala ndi macronutrients kapena nthawi yakudya), kusintha pamlingo wolimbitsa thupi, kapena kusintha mukamamwa ndi mankhwala ena (onani "Kuchita"). Odwala omwe ali ndi vuto laimpso kapena chiwindi amatha kukhala pachiwopsezo chachikulu cha kukhala ndi hypoglycemia.

Njira zochepetsera chiopsezo cha hypoglycemia. Odwala komanso omwe akuwasamalira ayenera kuzindikira zizindikiro za hypoglycemia ndikuchita zoyenera. Kudziyang'anira wekha wamagazi kumatenga gawo lofunikira popewa matenda a hypoglycemia. Odwala omwe ali ndi chiopsezo chowonjezereka cha hypoglycemia ndi odwala omwe ali ndi kuchepetsedwa kuti athe kumva zizindikiro za hypoglycemia, kuwonjezereka kwa pafupipafupi kwa kuwunika kwa shuga kwamagazi kumalimbikitsidwa.

Hyperglycemia. Mlingo wosakwanira kapena kutha kwa mankhwalawa kungayambitse kukula kwa hyperglycemia kapena matenda ashuga a ketoacidosis. Kuphatikiza apo, matenda ophatikizika, makamaka opatsirana, amatha kuthandizira kukulitsa mikhalidwe ya hyperglycemic ndipo, motero, kukulitsa kufunika kwa insulini.

Monga lamulo, zizindikiro zoyambirira za hyperglycemia zimawonekera pang'onopang'ono, kwa maola angapo kapena masiku. Zizindikiro zake zimaphatikizaponso ludzu, kukodza mwachangu, kusanza, kusanza, kugona komanso kuyanika pakhungu, pakamwa pouma, kusowa chilimbikitso, kununkhira kwa acetone mumlengalenga wotuluka. Mtundu woyamba wa matenda a shuga 1 mellitus, popanda chithandizo choyenera, hyperglycemia imatsogolera pakupanga matenda ashuga a ketoacidosis ndipo amatha kupha.

Zochizira kwambiri za hyperglycemia, insulin yolimbikira imalimbikitsidwa.

Tumizani wodwala kuchokera kukonzekera kwina kwa insulin. Kusamutsa wodwala kupita ku mtundu wina kapena kukonzekera kwa insulin yatsopano kapena wopanga wina kuyenera kuchitika moyang'aniridwa ndi achipatala. Mukamasulira, kusintha kwa mankhwala kungafunikire.

Hyperglycemia kapena hypoglycemia kusintha kwa insulin regimen. Zosintha pamachitidwe a insulin, wopanga, mtundu kapena njira yothandizira ingakhudze kuwongolera kwa glycemic komanso kudziwikiratu kwa hypoglycemia kapena hyperglycemia. Kusintha uku kuchitike mosamala ndipo kuyang'aniridwa ndi dokotala, pafupipafupi kuyeza magazi m'magazi kuyenera kuchuluka. Kwa odwala omwe ali ndi matenda a shuga a mtundu wachiwiri, kusintha kwa mlingo kungafunike ndi chithandizo chofanana cha PHGP. Mukasintha kuchokera ku mankhwala ena a insulini kupita kuchipatala limodzi ndi insulin degludec + insulin, mungafunikebe kusintha mankhwalawo.

Kugwiritsa ntchito munthawi yomweyo mankhwala a gulu la thiazolidinedione komanso kukonzekera insulin. Milandu yokhudzana ndi kukhazikika kwa kulephera kwa mtima inanenedwa pakuchiza kwa odwala omwe ali ndi thiazolidinediones kuphatikiza ndi kukonzekera kwa insulin, makamaka ngati odwala oterewa ali ndi chiopsezo chotukuka mtima. Izi zimayenera kukumbukiridwa pamene odwala adayikidwa kuphatikiza mankhwala ndi thiazolidatediones komanso kuphatikiza kwa insulin degludec + insulin. Ndi mankhwala osakanikirana oterowo, ndikofunikira kuyeserera kwa odwala kuti azindikire zizindikiro ndi kuchepa kwa mtima, kuwonjezera thupi ndi kukhalapo kwa edema. Ngati zizindikiro za kulephera kwa mtima zikuchulukirachulukira kwa odwala, chithandizo ndi thiazolidatediones ziyenera kusiyidwa.

Kusungidwa kwamphamvu ndi chitukuko cha mtima kulephera ndi kugwiritsa ntchito kwa masewera a gamma receptor agonists opangidwa ndi peroxisome proliferator (peroxisome proliferator-activated receptor-gamma, PPAR gamma). Thiazolidinediones omwe agonists PPARgamma ingayambitse kuchuluka kwa madzimadzi makamaka akamagwiritsa ntchito limodzi ndi insulin. Kusungidwa kwamphamvu kumatha kubweretsa kukulitsa kapena kuchulukitsa kwa maphunziro a mtima kulephera. Odwala omwe amalandira insulin, kuphatikizapo kuphatikiza kwa insulin degludec + insulin, ndi agonists PPARgamma iyenera kuyang'aniridwa chifukwa cha zizindikiro ndi kulephera kwa mtima. Ngati CHF ikukula, ndikofunikira kuchitira chithandizo motsatira malingaliro omwe alipo azachipatala ndikuganizira kusiya kapena kuchepetsa mlingo wa agonist PPARmasewera.

Kuphwanya gawo la masomphenyawo. Kulimbitsa kwa insulin mankhwala ndikusintha kolimba kwa mphamvu ya kagayidwe kazakudya kungayambitse kuwonongeka kwakanthawi mu matenda a shuga, pomwe kusintha kwakanthawi kwakanthawi ka glycemic kumachepetsa chiopsezo cha kupitirira kwa matenda ashuga retinopathy.

Kupewa mwangozi kusokonezeka kwa insulin kukonzekera. Wodwalayo ayenera kulangizidwa kuti azilembera zilembo chilichonse chovomerezeka pamaso pa jekeseni iliyonse kuti apewe kusokoneza mwangozi kuphatikiza kwa insulin degludec + insulin aspart ndi kukonzekera kwina kwa insulin. Odwala amayenera kudziwa kuti ali bwanji pa jakisoni wa jakisoni. Ndikofunikira kudziwitsa odwala omwe ali ndi vuto lakhungu kapena anthu omwe ali ndi vuto lowonera kuti nthawi zonse amafunikira thandizo la anthu omwe alibe mavuto ammaso ndipo amaphunzitsidwa kugwira ntchito ndi jakisoni.

Ma antibodies kupita ku insulin. Mukamagwiritsa ntchito insulin, mapangidwe a antibody ndiwotheka. Nthawi zina, mapangidwe a antibody angafunikire kusintha kwa insulin kuti mupewe milandu ya hyperglycemia kapena hypoglycemia.

Immunogenicity Monga momwe zimakhalira ndi mapuloteni onse achire, kuyambitsa insulini kungapangitse kupanga kwa ma insulin. Kuzindikira kwa antibody kumadalira kwambiri kumvetsetsa komanso kutsimikiza kwa njira yosanthula ndipo zitha kukhala chifukwa cha zinthu zingapo, monga njira ya njira yowunikira, kuyesa kwachitsanzo, nthawi yosonkhanitsa zitsanzo, chithandizo chogwirizana, komanso matenda oyamba. Pazifukwa izi, kufananitsa kuchuluka kwa ma antibodies osakanikirana ndi insulin degludec + insulin aspart ndi mulingo wa ma antibodies m'maphunziro ena kapena zinthu zina kumatha kusocheretsa.

M'maphunziro a odwala omwe ali ndi vuto la matenda a shuga 1, 95.9% ya odwala omwe amalandila insuludec + insulin aspart kamodzi patsiku anali ndi mayeso abwino a insulin antibodies kamodzi pa nthawi yophunzirira, kuphatikizapo 89% ya odwala omwe zotsatira zabwino, pomwe 13% ya odwala osachepera nthawi imodzi panthawi yophunzirayo adapereka zotsatira zabwino zama antibodies ku insulin aspart, kuphatikizapo 6.4% ya odwala omwe anali ndi zotsatira zoyambira. M'maphunziro a odwala omwe ali ndi matenda a shuga 2, 67,5% ya odwala omwe amalandiridwa ndi insulin degludec + insulin aspart kamodzi patsiku anali ndi zotsatira zabwino za kusanthula kwa ma antibodies kuti apange insulini osachepera 1 nthawi yamaphunziro, kuphatikiza 45.4% ya odwala omwe adakhala ndi zotsatira zoyambitsa kumayambiriro kwa kafukufukuyu, pomwe 17.1% ya odwala omwewo nthawi 1 nthawi yophunzirayi adayesa kuti ali ndi antibodies a insulin aspart, kuphatikizapo 12,3%, yomwe idakhala ndi zotsatira zoyambira. Mankhwala osokoneza mankhwalawa omwe ali ndi matenda a shuga 2 amatha kuchepetsedwa chifukwa cha kusokonezeka kwa kusanthula chifukwa cha kupezeka kwa insulin mwa insulini mu odwala. Kukhalapo kwa ma antibodies omwe amakhudza kukhudzika kwachipatala kungafune kusintha kwa mlingo kuti muthane ndi chizolowezi cha hyper- kapena hypoglycemia. Kupezeka kwa ma antibodies a degludec insulin sikunakhazikitsidwe.

Hypersensitivity ndi thupi lawo siligwirizana. Mankhwala osokoneza bongo owopsa omwe akupha anthu ambiri, kuphatikizapo anaphylaxis, amatha kukhala ndi ntchito ya insulin, kuphatikiza kuphatikiza kwa insulini degludec + insulin. Pankhani ya kukhudzika kwa hypersensitivity, ndikofunikira kusiya kugwiritsa ntchito insulin degludec + insulin aspart, khalani ndi chithandizo mogwirizana ndi muyezo wa chisamaliro chachipatala ndikuwunikira mpaka zizindikiro ndi zizindikiro zitathetsedwa. Kugwiritsa ntchito kuphatikiza kwa insulin degludec + insulin aspart kumakhudzana ndi odwala omwe ali ndi vuto la hypersensitivity ku insulin degludec kapena insulin aspart (onani "Contraindication").

Hypokalemia. Ma insulin onse, kuphatikizapo kuphatikiza kwa insulin degludec + insulin aspart, amachititsa kusintha kwa potaziyamu kuchokera kumalo ena akunja kulowa cell, komwe kungayambitse hypokalemia. Hypokalemia yopanda mawonekedwe imatha kupundula, kupumirana kwamitsempha, ndi kufa. Ndikofunikira kuyang'anira kuchuluka kwa potaziyamu mwa odwala omwe ali pachiwopsezo cha hypokalemia, ngati akuwonetsedwa (mwachitsanzo, odwala omwe amagwiritsa ntchito mankhwala omwe amachepetsa potaziyamu, komanso odwala omwe amamwa mankhwala omwe amakhala ndi chidwi ndi kuchuluka kwa potaziyamu).

Magulu apadera a odwala

Okalamba okalamba (woposa zaka 65). Kuphatikiza kwa insulin degludec + insulin aspart ingagwiritsidwe ntchito mwa odwala okalamba. Magazi a shuga wamagazi amayenera kuyang'aniridwa mosamala ndikuwonetsetsa kuti insulini ikusintha payekhapayekha (onani "Pharmacokinetics").

Gwiritsani ntchito mu geriatrics. M'mayesero azachipatala, odwala 9 (2,5) onse a 362 omwe ali ndi matenda amtundu 1 omwe adalandira insulin degludec + insulin aspart osakaniza anali azaka 65 kapena kupitirira ndipo 4 (1.1%) anali ndi zaka 75 ndipo kwatha. 256 (25,7%) mwa odwala 998 omwe ali ndi matenda amtundu wa 2 omwe adagwiritsa ntchito insulin degludec + insulin aspart anali azaka 65 kapena kupitilira ndipo 32 (3.2%) anali ndi zaka 75 kapena kupitilira. Kupenda koyerekeza sikunawonetse kusiyana pakutetezeka kapena kuchita bwino kwa odwala azaka zopitilira 65 poyerekeza ndi odwala achichepere.

Komabe, mukamagwiritsidwa ntchito ngati odwala matenda a geriatric, muyenera kusamala kwambiri, chifukwa kudziwa zambiri za kuphatikiza kwa insulin degludec + insulin aspart mwa anthu ena okalamba sikungaletsedwe. Mlingo woyambirira, mlingo wokulirapo ndi kukonza ziyenera kuchepetsedwa popewa hypoglycemia. Hypoglycemia ikhoza kukhala yovuta kwambiri kuzindikira mwa okalamba.

Odwala ndi mkhutu aimpso ndi kwa chiwindi ntchito. Kuphatikiza kwa insulin degludec + insulin aspart ingagwiritsidwe ntchito kwa odwala omwe ali ndi vuto laimpso ndi kwa chiwindi ntchito. Magazi a shuga wamagazi amayenera kuyang'aniridwa mosamala ndikuwonetsetsa kuti insulini ikusintha payekhapayekha (onani "Pharmacokinetics").

Kulephera kwina. M'mayesero azachipatala, odwala 18 (5%) omwe ali ndi matenda amtundu woyamba 1 omwe adalandira kuphatikiza kwa insulin degludec + insulin aspart anali ndi GFR ya osakwana 60 ml / min / 1.73 m 2 kapena ochepera mwa 1 (0.3%) wodwala GFR inali yochepera 30 ml / min / 1.73 m 2 kapena mochepera. Chiwerengero chonse cha 111 (11%) mwa odwala 998 omwe ali ndi matenda a shuga 2 omwe adalandira kuphatikiza kwa insulin degludec + insulin aspart anali ndi GFR yochepera 60 ml / min / 1.73 m 2, ndipo palibe wodwala aliyense yemwe anali ndi GFR wosakwana 30 ml / mphindi / 1.73 m 2.

Panalibe kusiyana kwama pharmacokinetics aomwe amodzi a kaphatikizidwe ka insulin degludec + insulin aspart mu maphunziro odziyimira pawokha poyerekeza ndi anthu athanzi komanso anthu omwe ali ndi vuto laimpso. Komabe, monga ndi ma insulin onse, mwa odwala omwe ali ndi kuperewera kwa impso, kuwunika kwa shuga kuyenera kukonzedwa, ndipo mlingo wa insulin degludec + insulin aspart osinthika uyenera kusinthidwa payekhapayekha.

Kulephera kwa chiwindi. Panalibe kusiyana kwama pharmacokinetics aumwini a kuphatikiza kwa insulin degludec + insulin aspart mu maphunziro odziyimira pawokha poyerekeza ndi maphunziro athanzi ndi maphunziro ndi kulephera kwa chiwindi (kufatsa, kufatsa komanso kufooka kwambiri kwa chiwindi). Komabe, monga ndi ma insulin onse, kuwunika kwa glucose kuyenera kukulitsidwa ndipo mulingo wa insulin degludec + insulin aspart wosinthika pawokha mwa odwala omwe ali ndi vuto la chiwindi.

Ana ndi achinyamata. Zambiri zomwe zapezeka mu pharmacokinetic zimawonetsedwa mu gawo la Pharmacokinetics, komabe, kufunikira ndi chitetezo cha kuphatikiza kwa insulin degludec + insulin aspart mwa ana ndi achinyamata osakwana zaka 18 sizinaphunziridwe, malingaliro a kuchuluka kwa mankhwalawa kwa ana sanapangidwe.

Osasunthanso cholembera kwa odwala ena. Cholembera sichimasamutsidwira wina, ngakhale singano isinthidwa. Kugwiritsira ntchito cholembera cha wodwala wina kumakhala pachiwopsezo chotenga kachilombo ka hemato native.

Kukopa pa luso loyendetsa magalimoto ndi zida. Kuthekera kwa odwala kulolera komanso kuchuluka kwa zomwe angachite kungayambitse vuto la hypoglycemia, zomwe zimatha kukhala zowopsa nthawi zomwe luso limafunikira makamaka (mwachitsanzo, poyendetsa magalimoto kapena kugwira ntchito ndi makina).

Odwala ayenera kulangizidwa kuti achitepo kanthu popewa kukulitsa kwa hypoglycemia poyendetsa.Izi ndizofunikira kwambiri kwa odwala omwe alibe kapena kuchepa kwa zizindikiro - zotsogola za kukhala ndi hypoglycemia kapena zochitika zapafupipafupi za hypoglycemia. Muzochitika izi, kuyenera koyendetsa galimoto kuyenera kuganiziridwanso.