Apidra - umarnin don amfani

Hanyar sashi na Apidra shine mafita ga gudanarwar subcutaneous (sc): kusan ruwa mai launin mara launi ko mara launi (10 ml a cikin kwalabe, kwalba 1 a cikin kwali na kwali, 3 ml a cikin katako, a cikin fakitin boge: 5 katako don maganin sirinji “OptiPen” ko manyan hotuna 5 da aka sanya a cikin sikirin da za'a iya sakin bayanan "OptiSet", ko kuma tsarin katako 5 "OptiClick").

A cikin 1 ml na bayani ya ƙunshi:

• abu mai aiki: glulisin insulin - 3.49 mg (daidai yake da 100 IU na insulin ɗan adam),
• abubuwan taimako: trometamol, m-cresol, polysorbate 20, chloride sodium, acid hydrorated, acid sodium hydroxide, ruwa don allura.

Contraindications

• hawan jini,
• shekarun yara har zuwa shekaru 6 (bayanin asibiti game da amfani yana da iyaka),
• hypersensitivity to insulin glulisin ko zuwa wani bangaren maganin.

Tare da taka tsantsan, ana shawarar Apidra don amfani yayin daukar ciki.

Marasa lafiya da rashin wadatuwar hepatic na iya buƙatar ƙaramin insulin saboda raguwar gluconeogenesis da raguwar yanayin aiki na insulin.

Rage buƙatar insulin kuma ana iya faruwa tare da gazawar renal kuma a cikin tsufa (saboda aiki na keɓaɓɓiyar aiki).

Sashi da gudanarwa

Ana gudanar da insulin na Apidra nan da nan kafin cin abinci (na minti 0-15) ko kuma nan da nan bayan cin abinci ta allurar s.c. ko ci gaba da jiko cikin ƙwayar mai ƙira ta amfani da tsarin aikin famfo.

Ana zaɓi kashi da yanayin gudanarwar miyagun ƙwayoyi daban-daban.

Ana amfani da maganin ta Apidra a cikin hadadden hanyoyin kwantar da hankali tare da insulin-matsakaici na aiki ko tare da insalin insulin / analog na analog na lokaci mai tsawo; ana amfani da haɗe tare da magungunan baka na hancin jini.

Yankin wuraren da aka ba da shawarar ga gwamnatin magani:

• s / c allurar - wanda aka samar a kafada, cinya ko ciki, yayin gabatarwar cikin bango na ciki yana ba da motsin sauri,
• cigaban jiko - wanda aka yi a cikin kitse mai ƙyalli a cikin ciki.

Ya kamata ku canza wuraren jiko da allura tare da kowane tsarin aikin magani na gaba.

Tunda nau'in sashi na Apidra shine mafita, ba a buƙatar sake tsaruwa kafin amfani da shi.

Yawan sha kuma, gwargwadon haka, farawa da tsawon lokacin da miyagun ƙwayoyi na iya bambanta ƙarƙashin ƙarfin aikin jiki, ya danganta da allurar mafita da sauran abubuwan canzawa.

Dole ne a kula sosai yayin gudanar da maganin don cire yiwuwar ta shiga kai tsaye cikin tasoshin jini. Bayan hanyar, ba za a tausa yankin allura ba.

Ana buƙatar koya wa marasa lafiya dabarun allura.

Lokacin gudanar da miyagun ƙwayoyi ta amfani da tsarin famfo don jiko na insulin, mafita ba zai iya haɗuwa tare da wasu abubuwan magunguna / wakilai ba.

Maganin Apidra baya cakuda shi da wasu magunguna banda isofan-insulin na mutum. A wannan yanayin, ana zana Apidra cikin sirinji na farko, kuma ana yin allurar nan da nan bayan an gauraya. Bayanai game da amfanin mafita hade da dogon lokaci kafin allurar ba ta samuwa.

Dole ne a yi amfani da katakan katako tare da alkalami na instiin OptiPen Pro1 ko kuma wasu naúrori a cikin ƙa'idodin umarnin mai ƙira don ɗaukar kicin, saka allura, da allurar insulin. Kafin amfani da katun, ya kamata ku gudanar da bincike na gani game da miyagun ƙwayoyi. Don allura, kawai bayyananne, ba tare da ƙarancin launi ba wanda ya ƙunshi ingantaccen abubuwan da ake iya gani. Kafin shigarwa, dole ne a fara ajiye katako na tsawon awanni 1-2 a zazzabi a dakin, kuma kafin gabatar da mafita, tilas a cire kumburin iska daga cikin kayan.

Ba za a iya cika kwantena da aka yi amfani da su ba. Ba za a iya amfani da maɓallin sirinji na OptiPen Pro1 mai lalacewa ba.

Idan ana cikin matsala na alƙalami mai narkewa, ana iya jawo mafita daga kicin a cikin sirinji na filastik wanda ya dace da insulin a cikin taro na 100 IU / ml, sannan a gudanar da shi ga mai haƙuri.

Ana amfani da alkalami mai sake iya amfani da allurar don kawai mai haƙuri ɗaya (don guje wa kamuwa da cuta).

Dukkanin shawarwari da ka'idoji na sama ya kamata kuma a lura dasu yayin amfani da tsarin katako da OptiKlik syringe pen don gudanar da maganin Apidra, waɗanda ke cikin katun gilashin tare da kayan piston na haɗe, waɗanda aka gyara a cikin akwati na filastik amintacce kuma suna dauke da 3 ml na glulisin insulin bayani.

Side effects

Yawancin sakamako wanda ba a ke so shi ba na maganin insulin shine hypoglycemia, wanda yawanci yakan faru lokacin amfani da insulin a allurai sosai sama da yadda ake buƙata.

Rashin halayen mara kyau waɗanda ke da alaƙa da gudanar da miyagun ƙwayoyi ta gabobin da tsarin marasa lafiya da aka yi wa rajista a lokacin gwaji na asibiti (ana ba da jerin ta amfani da waɗannan gradation na mita na faruwar abin: fiye da 10% - sau da yawa, fiye da 1%, amma ƙasa da 10% - sau da yawa, ƙari 0.1%, amma kasa da 1% - wani lokacin, sama da 0.01%, amma ƙasa da 0.1% - da wuya, ƙasa da 0.01% - da wuya):

• metabolism: sau da yawa - hypoglycemia, tare da waɗannan alamun ba zato ba tsammani: gumi mai sanyi, pallor na fata, gajiya, damuwa, rawar jiki, tashin hankali, rauni, rikicewa, matsananciyar damuwa, wahalar damuwa, damuwa na gani, tashin zuciya, matsanancin yunwar, ciwon kai, ciwo mai zafi, sakamakon hauhawar hauhawar jini zai iya zama: asarar hankali da / ko raunin hankali, ɓarna na ɗan lokaci ko na dindindin na aikin kwakwalwa, a cikin matsanancin yanayi, m sakamako
• fata da subcutaneous nama: sau da yawa - bayyanar rashin lafiyan, kamar kumburi, hyperemia, itching a wurin allurar, yawanci ci gaba a kan kansu tare da ci gaba da jiyya, da wuya lipodystrophy, akasari saboda cin zarafin canza wurare na wuraren insulin a cikin kowane yanki / sake sarrafawa na miyagun ƙwayoyi zuwa wuri guda
• halayen kwanciyar hankali: wani lokacin - shaƙa, shaƙatar ƙarfi a cikin kirji, cutar urticaria, itching, rashin lafiyar dermatitis, a cikin manyan maganganun halayen halayen ƙwayar cuta (ciki har da anaphylactic), barazanar rayuwa tana yiwuwa.

Babu takamaiman bayanai game da alamun insulin overdose na glulisin, amma saboda tsawaita amfani da babban allurai na Apidra, yanayin digo mai yawa na rashin ƙarfi na hypoglycemia mai yiwuwa ne.

Farjin yanayin yana dogara da matsayin cutar:

• sassan abubuwa masu saurin motsa jiki - tsayawa tare da amfani da abubuwan glucose ko samfuran da ke dauke da sukari, dangane da abin da ake bada shawarar marasa lafiya da masu ciwon sukari koda yaushe suna da cookies, wainar alade, gishirin ingantaccen sukari, ruwan 'ya'yan itace mai zaki,
• abubuwa masu raunin hypoglycemia mai ƙarfi (tare da asarar hankali) - dakatar da intramuscularly (intramuscularly) ko sc ta hanyar gudanarwar 0.5-1 mg na glucagon, ko iv (ciki) na glucose (dextrose) in babu martani ga aikin glucagon zuwa na minti 10-15 Bayan ya dawo da hankali, an shawarci mara lafiya ya ba da carbohydrates a cikin ciki don hana sake fadawa cikin yawan cutar mahaifa, bayan hakan, don kafa sanadin bullar cutar mahaifa, da kuma hana ci gaban irin wadannan abubuwan da ke tattare da mara lafiyar, ya zama dole a lura har zuwa wani lokaci a asibiti.

Umarni na musamman

Game da canza mai haƙuri zuwa insulin daga wani masana'anta ko wani sabon insulin, tsananin kulawa na likita ya zama dole, tunda ana iya buƙatar gyaran farjin gabaɗaya.

Arancin insulin da bai dace ba ko dakatar da rashin hankali a hankali, musamman a cikin marasa lafiya da ke dauke da ciwon sukari na 1, na iya haifar da cututtukan fata da ketoacidosis masu ciwon sukari - mai yuwuwar yanayin barazanar rayuwa. Lokaci na yiwuwar haɓakar hypoglycemia kai tsaye ya dogara da saurin aiwatar da insulin da aka yi amfani dashi don haka ya canza tare da gyara tsarin kulawa.

Babban yanayin da zai iya canzawa ko sanya alamun ci gaban haɓakar haila:

• tsawanta gaban ciwon sukari a cikin haƙuri,
• mai ciwon sukari mai ciwon sukari
• ƙaruwa na insulin far,
• amfani da wasu magunguna lokaci guda, misali, blo-blockers,
• canzawa zuwa insulin mutum daga insulin asalin dabbobi.

Hakanan gyaran allurar insulin na iya zama dole idan anyi wani canji a tsarin ayyukan motsi ko abinci mai gina jiki. Ara yawan aiki na jiki wanda aka samu nan da nan bayan cin abinci na iya ƙara yawan yiwuwar haɓakar haɓakar jini. Idan aka kwatanta da aikin insulin ɗan adam mai narkewa, hypoglycemia zai iya haɓaka da wuri bayan gudanar da aikin analogues na insulin-sauri.

Abubuwan da ba a san adadinsu ba ko kuma maganganun rashin daidaituwa na iya haifar da asarar hankali, ko na ciki, ko mutuwa.

Cututtuka masu rikitarwa ko ɗimbin yawa na tunanin mutum zai iya canza buƙatar haƙuri ga insulin.

Hulɗa da ƙwayoyi

Babu wani binciken da aka yi game da hulɗa da magunguna na Apidra, amma dangane da bayanan da ake bayarwa na magungunan makamancin wannan, ana iya ƙarara da cewa hulɗar magani a likitancin ba zai yuwu ba.

Wasu magunguna / magunguna na iya shafar metabolism na metabolism, wanda na iya buƙatar daidaita insulin glulisin allurai da kuma sa ido sosai game da far da yanayin haƙuri.

Don haka lokacin amfani dashi tare da maganin Apidra:

• magunguna na bakin jini, angiotensin yana canza enzyme inhibitors, sabawa, sunadarai, fibrates, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, sulfonamide antimicrobials, salicylates - na iya haɓaka tasirin hypoglycemic na insulin kuma ƙara haɓaka jini,
• glucocorticosteroids, diuretics, danazol, diazoxide, isoniazid, somatropin, sinadarin phenothiazine, sympathomimetics (epinephrine / adrenaline, terbutaline, salbutamol), estrogens, hormones thyroid, progesins (maganin hana haihuwa), antipsychotin, antiynchotin, sami damar rage girman tasirin insulin,
• Clonidine, β-blockers, ethanol, salts na litium - mai da ƙarfi ko raunana tasirin rashin lafiyar insulin,
• pentamidine - na iya haifar da hauhawar jini, daga biyo baya,
• kwayoyi tare da ayyukan juyayi (β-blockers, guanethidine, clonidine, reserpine) - tare da hypoglycemia, za su iya rage tsananin ko rufe alamun bayyanar kunnawar adrenergic reflex.

Ba a gudanar da nazari game da karfin jarin insulin glulisin ba, saboda haka, bai kamata a haɗar da APidra tare da sauran magunguna ba, banda shine isofan-insulin na ɗan adam.

Game da gabatarwar mafita ta amfani da famfon jiko, Apidra bai kamata a hade shi da wasu kwayoyi ba.

Misalin Apidra sune: Vozulim-R, Actrapid (NM, MS), Gensulin R, Biosulin R, Insuman Rapid GT, Insulin MK, Insulin-Fereyn CR, Gansulin R, Humalog, Pensulin (SR, CR), Monosuinsulin (MK, MP ), Humulin Regular, NovoRapid (Penfill, FlexPen), Humodar R, Monoinsulin CR, Insuran R, Rinsulin R, Rosinsulin R.

Sharuɗɗan da yanayin ajiya

Adana a cikin kayan kwali na kansu, ba tare da samun damar yin amfani da haske ba, a zazzabi na 2-8 ° C. Kar a daskare. Ku yi nesa da isa ga yara!

Bayan buɗe kunshin, ajiye a wurin da aka kare daga haske a yanayin zafi har zuwa 25 ° C. Rayuwar shiryayye na miyagun ƙwayoyi bayan farkon amfani da shi shine makonni 4 (yana da kyau a yi alamar ranar farawar mafita ta farko akan alamar).

Kayan magunguna

Babban mahimmancin aikin insulin da analogues na insulin, gami da insulin glulisin, shine ƙa'idar aiki na glucose. Insulin yana rage yawan glucose a cikin jini, yana karfafa shaye-shayen glucose ta kasusuwa na waje, musamman tsokoki na kasusuwa da tsotse nama, da kuma hana samuwar glucose a cikin hanta. Insulin yana hana lipolysis a cikin adipocytes, yana hana proteolysis kuma yana haɓaka haɗarin furotin. Nazarin da aka gudanar a cikin masu ba da agaji da lafiya da marasa lafiya tare da masu ciwon sukari mellitus sun nuna cewa tare da sc አስተዳደር insulin glulisin ya fara aiki da sauri kuma yana da ɗan gajeren lokacin aiki fiye da insulin ɗan adam mai narkewa. Tare da gudanarwa na subcutaneous, ragewar yawan glucose a cikin jini, aikin insulin glulisin yana farawa a cikin minti 10-20. Lokacin da aka gudanar dashi cikin ƙwayar cuta, tasirin hypoglycemic na insulin glulisin da insulin ɗan adam mai narkewa daidai suke da ƙarfi. Unitaya daga cikin yanki na insulin glulisin yana da aiki iri ɗaya na rage yawan glucose kamar ɗaya ɓangare na insulin ɗan adam mai narkewa.

A cikin lokaci na yi nazari a cikin marasa lafiya da ke da nau'in 1 na ciwon sukari, ana ba da bayanan martaba na glucose na insulin glulisin da insulin ɗan adam a cikin ƙananan kashi 0.15 U / kg a lokuta daban-daban dangane da daidaitaccen abinci na mintina 15. Sakamakon binciken ya nuna cewa insulin glulisin ana gudanar da shi na mintina 2 kafin cin abincin ya samar da maganin glycemic iri iri bayan cin abinci kamar yadda insulin ɗan adam ke sarrafawa mintina 30 kafin cin abinci. Lokacin da aka gudanar da mintina 2 kafin cin abinci, insulin glulisin ya samar da mafi kyawun sarrafa kwayar cuta bayan cin abinci fiye da insulin ɗan adam mai narkewa 2 mintuna kafin cin abinci. Glulisin insulin yana daukar mintina 15 bayan fara abincin ya ba da izinin sarrafa glycemic iri ɗaya bayan abincin kamar yadda insulin ɗan adam mai narkewa, ana gudanar da mintina 2 kafin cin abincin.

Wani rukuni da nayi nazari tare da insulin glulisin, insulin lispro da insulin mutum a cikin gungun marasa lafiya sun nuna cewa a cikin wadannan marassa lafiya, insulin glulisin yana rike sifofin sa da sauri. A cikin wannan binciken, lokacin da ya isa zuwa kashi 20% na jimlar AUC shine 114 min don insulin glulisin, 121 min don insulin lispro da 150 min don insulin mutum mai narkewa, da AUQ_{(0-2 a)}Har ila yau, yana nuna aikin rage yawan glucose a farkon, bi da bi, ya kasance 427 mg / kg don glulisin insulin, 354 mg / kg don insis lispro, da 197 mg / kg don insulin ɗan adam mai narkewa.

Karatun asibiti
Type 1 ciwon sukari.
A cikin gwajin asibiti na 26-mako na kashi na III, wanda aka kwatanta insulin glulisin tare da insulin lispro, ana gudanar da subcutaneously jim kaɗan kafin abinci (mintina 0-15), ga marasa lafiya waɗanda ke da nau'in ciwon sukari na 1 na mellitus ta amfani da gulingine insulin na basal, glulisin insulin tare da insulin lispro don sarrafa glycemic, wanda aka kimanta ta da canji a cikin taro na hawan jini (HbA)_1s) a lokacin ƙarshen binciken yayin kwatanta da ƙimar farko. Tare da gudanar da insulin, glulisin, sabanin magani tare da lyspro insulin, bai buƙatar haɓaka kashi na insulin basal ba.

Nazarin asibiti na 12-mako na III a cikin marasa lafiya da masu ciwon sukari na 1 wanda suka karɓi insulin glargine a matsayin maganin basal ya nuna cewa tasiri na insulin glulisin yana nan da nan bayan cin abinci yana daidai da na insulin glulisin nan da nan kafin abinci (na 0 -15 min) ko insulin ɗan adam (30-45 min kafin abinci).

A cikin rukuni na marasa lafiya waɗanda suka karbi insulin glulisin kafin abinci, an lura da raguwa mai girma a cikin HbA_1s idan aka kwatanta da gungun marasa lafiya da ke karbar insulin na mutum.

Type 2 ciwon sukari
An gudanar da gwajin asibiti na 26-mako na III wanda ya biyo bayan biyun makonni 26 a cikin hanyar nazarin aminci don kwatanta insulin glulisin (mintuna 0-15 kafin abinci) tare da insulin ɗan adam mai narkewa (minti 30-45 kafin abinci), waɗanda aka allurar cikin ƙasa a cikin marasa lafiya da keɓaɓɓen nau'in ciwon sukari na 2, ƙari da amfani da insulin-isophan a matsayin insulin basal. An nuna insulin glulisin ya zama daidai da insulin na ɗan adam mai narkewa dangane da canje-canje a cikin ƙwayoyin HbA_1s bayan watanni 6 da bayan watanni 12 na jiyya idan aka kwatanta da ƙimar farko.

Yayin ci gaba da ƙarancin sc insulin na insulin ta amfani da nau'in nau'in famfo (don nau'in cutar sukari na 1 na sukari) a cikin marasa lafiya 59 da aka bi da Apidra ® ko insulin a cikin rukuni biyu na kulawa, an lura da ƙananan abin da ke faruwa na catheter occlusion (0.08 eclicions a watan wata lokacin amfani da miyagun ƙwayoyi Apidra ® da abubuwan 0.15 na wata daya lokacin amfani da insulin aspart), da kuma irin maimaitawar halayen da aka yi a wurin allurar (10.3% lokacin amfani da Apidra ® da 13.3% lokacin amfani da insulin aspart).

A cikin yara da matasa tare da nau'in 1 mellitus na ciwon sukari, wanda ya karɓi insulin na yau da kullun sau ɗaya a maraice, insulin glargine, ko sau biyu kowace rana da safe da maraice, isulin insulin, lokacin gwada inganci da amincin magani tare da insulin glulisin da insulin lispro tare da don gudanarwa na mintina 15 kafin cin abinci, an nuna cewa sarrafa glycemic, da haɗarin hauhawar jini, wanda ya buƙaci shiga tsakanin ɓangarori na uku, kazalika da haifar da mummunan tashewar hypoglycemic ya kasance daidai a cikin rukuni biyu na jiyya. Bugu da ƙari, bayan makonni 26 na jiyya, marasa lafiya waɗanda ke karbar insulin tare da glulisin don cimma ikon glycemic mai kama da lispro insulin sun buƙaci ƙara girman ƙara a cikin abubuwan yau da kullun na insulin basal, yin aiki insulin cikin hanzari da jimlar insulin.

Nasihu da jinsi
A cikin gwaji na asibiti da aka sarrafa a cikin manya, bambance-bambance a cikin aminci da tasiri na insulin glulisin ba a nuna su ba a cikin binciken ƙungiyar ƙungiyoyi da aka rarrabe ta jinsi da jinsi.

Pharmacokinetics
A cikin insulin, glulisin, maye gurbin amino acid asparagine na ɗan adam insulin a matsayin B3 tare da lysine da lysine a matsayi B29 tare da acid glutamic yana haɓaka ɗaukar sauri.

Kasancewa da Bioavailability
Lokaci na maida hankali akan magunguna a cikin masu sa kai masu lafiya da marasa lafiya da nau'in 1 da nau'in ciwon sukari guda 2 wanda ya nuna cewa yawan shan insulin glulisin idan aka kwatanta shi da insulin mutum wanda yake narkewa shine kusan sau 2 cikin sauri kuma mafi girman yawan plasma da aka samu (Cmax) ya kusan 2 sau more.

A cikin binciken da aka gudanar a cikin marasa lafiya da nau'in ciwon sukari na 1 na mellitus, bayan sc gwamnatin insulin glulisin a cikin kashi 0.15 U / kg, T_max (lokacin farawa da mafi girman fifiko plasma) minti 55 ne, kuma C_max ya kasance 82 ± 1.3 μU / ml idan aka kwatanta da T_maxhada minti 82, da C_maxna 46 ± 1.3 mcU / ml don insulin ɗan adam mai narkewa. Lokacin zama a cikin tsari na yaduwar insulin glulisin ya yi guntu (minti 98) fiye da na insulin dan adam mai narkewa (minti 161).

A cikin bincike a cikin marasa lafiya da nau'in ciwon sukari na 2 na sukari bayan sc gwamnatin insulin glulisin a cikin kashi 0.2 PIECES / kg C_max ya kasance 91 μED / ml tare da tsakiyar nesa na 78 zuwa 104 μED / ml.

Lokacin da aka gudanar da s / c na insulin, glulisin a cikin yanki na bangon ciki, cinya, ko kafada (a cikin yankin tsoka), shawa yana da sauri lokacin da aka gabatar da shi a cikin yankin bangon ciki na ciki idan aka kwatanta da gudanar da miyagun ƙwayoyi a yankin cinya. Yawan sha daga yankin da aka kera ya kasance tsaka-tsaki. Cikakken bayanin bioavailability na insulin glulisin bayan aikin sc shine kusan 70% (73% daga bangon ciki na ciki, 71 daga ƙwayar tsoka da 68% daga kwatangwalo) kuma yana da ɗan bambanci kaɗan a cikin marasa lafiya daban-daban.

Rarraba da Sacewa
Rarraba da kewayon insulin glulisin da mai narkewa na mutum bayan gudanarwar jijiyoyin jini iri daya ne, tare da yawan rarraba lita 13 da lita 21 da rabin rayuwar mintuna 13 da 17 bi da bi. Bayan sc gudanar da insulin, glulisin yana fitowa da sauri fiye da insulin na mutum mai narkewa, yana da rabin rabin rayuwa na mintina 42, idan aka kwatanta shi da rabin rayuwa mai narkewa na ɗan adam na minti 86. A cikin binciken giciye-bincike na insulin glulisin cikin duka mutane masu lafiya da wadanda ke da nau'in 1 da nau'in ciwon sukari na 2, bayyanar rabin rabin rayuwar daga mintuna 37 zuwa 75.

Pharmacokinentics a cikin rukunin masu haƙuri na musamman
Marasa lafiya tare da gazawar koda
A cikin binciken asibiti da aka gudanar a cikin marasa lafiya ba tare da cutar sankara ba tare da yawan yanayin aikin kodan (keɓaɓɓen kashi (80) / 80 ml / min, 30-50 ml / min, ® a cikin mata masu ciki. Iyakataccen adadin data samu akan amfanin insulin glulisin mata masu ciki (kasa da sakamako na ciki 300 da aka ruwaito), baya nuna illar tasirin sa ga ciki, ci gaban tayin ko jariri. Nazarin haifuwa a cikin dabbobi bai bayyana wani lichy tsakanin insulin glulisine da mutum insulin game da ciki, amfrayo / fetal ci gaba, haihuwa da kuma post-Natal ci gaba.

Yin amfani da Apidra ® a cikin mata masu juna biyu na bukatar yin taka tsan-tsan. Ana buƙatar kulawa da hankali game da tattarawar glucose a cikin jini da kuma kula da isasshen kulawar glycemic.

Marasa lafiya da ke da juna biyu kafin masu juna biyu ko ciwon suga na cikin jiki dole ne su sami isasshen ikon kula da ƙwayar cuta kafin haihuwa da kuma cikin duk cikin su. A cikin lokacin farko na ciki, bukatar insulin na iya raguwa, kuma a lokacin karo na biyu da na uku, yawanci yana iya ƙaruwa. Nan da nan bayan haihuwa, bukatar insulin ya ragu da sauri.

Marasa lafiya da ciwon sukari yakamata su sanar da likitan su idan suna da juna biyu ko kuma suna shirin yin juna biyu.

Lokacin shayarwa
Ba'a sani ba ko insulin glulisin ya wuce cikin madara, amma gabaɗaya, insulin ɗin baya wucewa cikin madara kuma maganin baka ya sha.

A cikin mata yayin shayarwa, ana iya buƙatar gyaran insulin na tsarin insulin da abinci.

Sashi da gudanarwa

Ya kamata a yi amfani da Apidra in a magungunan da suka haɗa da insulin na matsakaici, ko insulin da ke aiki na dogon lokaci, ko analog na yin aiki na dogon lokaci. Bugu da kari, Apidra ® za a iya amfani dashi a hade tare da magunguna na baki na hypoglycemic (PHGP).

Zaɓin tsarin magani na Apidra ® an zaɓi shi daban-daban dangane da shawarar likitan dangane da bukatun mai haƙuri. An shawarci duk masu cutar da ciwon sukari da su sanya idanu a cikin tattarawar glucose din jininsu.

Yi amfani a cikin rukunin masu haƙuri na musamman
Yara da matasa
Ana iya amfani da Apidra ® a cikin yara sama da 6 da matasa. Bayanai na asibiti game da amfani da miyagun ƙwayoyi a cikin yara 'yan ƙasa da shekaru shida yana da iyaka.

Tsofaffi marasa lafiya
Ana samun bayanan pharmacokinetics a cikin tsofaffi marasa lafiya da masu ciwon sukari mellitus basu isa ba.
Arancin aikin haya na tsufa na iya haifar da raguwar buƙatun insulin.

Marasa lafiya tare da gazawar koda
Bukatar insulin a cikin maye na iya raguwa.

Marasa lafiya tare da raunin hanta
A cikin marasa lafiya da ke fama da aikin hanta, buƙatar insulin na iya raguwa saboda rage ƙarfin gluconeogenesis da raguwa a cikin aikin metabolism.

Abun ciki da nau'i na saki

a cikin kwalabe na milim 10 ko a cikin kwantena na mil 3, a cikin fakitin kwali 1 kwalba ko a cikin ɗaukar hoto ta kunshi 5 katako na alli na OptiPen alkalami ko kuma katuwar katako da aka sanya a cikin alkalami na OptiSet wanda za'a iya zubar dashi ko kuma tare da tsarin talanti na OptiClick .

Pharmacodynamics

Insulin glulisin wani abu ne wanda yake cike da insulin na mutum, wanda yake daidai da karfin insulin na mutane. Insulin glulisin yana fara aiki da sauri kuma yana da ɗan gajeren lokacin aiki fiye da insulin ɗan adam mai narkewa. Babban mahimmancin aikin insulin da analogues na insulin, gami da insulin glulisin, shine ƙa'idar aiki na glucose. Insulin yana rage yawan glucose a cikin jini, yana karfafa shaye-shayen glucose ta kasusuwa na waje, musamman tsokoki na kasusuwa da tsotse nama, da kuma hana samuwar glucose a cikin hanta. Insulin yana hana lipolysis adipocyte da proteolysis kuma yana haɓaka haɗarin furotin. Nazarin da aka gudanar a cikin masu ba da agaji da lafiya da marasa lafiya tare da masu ciwon sukari mellitus sun nuna cewa tare da sc አስተዳደር insulin glulisin ya fara aiki da sauri kuma yana da ɗan gajeren lokacin aiki fiye da insulin ɗan adam mai narkewa. Lokacin da s / ya gabatar da ƙaramin matakin glucose a cikin jini, aikin insulin glulisin yana farawa a cikin minti 10-20. Tare da gudanarwa na iv, sakamakon rage ƙananan matakan glucose na jini na insulin glulisin da insulin ɗan adam yana daidai da ƙarfi. Unitaya daga cikin yanki na insulin glulisin yana da aiki iri ɗaya na rage yawan glucose kamar ɗaya ɓangare na insulin ɗan adam mai narkewa.

A cikin wani rukuni na yi nazari a cikin marasa lafiya da ke da nau'in ciwon sukari na 1 na sukari, ana ƙididdige bayanan bayanan glucose na insulin glulisin da insulin ɗan adam mai narkewa, ana gudanar da su s.c. a cikin adadin kashi 0.15 / kg a lokuta daban-daban dangane da daidaitaccen abinci na mintina 15.

Sakamakon binciken ya nuna cewa glulisin insulin, wanda aka gudanar da mintina 2 kafin cin abinci, ya samar da sarrafawar glycemic iri daya bayan cin abinci kamar yadda insulin dan adam mai narkewa, ana gudanar da mintina 30 kafin cin abinci. Lokacin da aka gudanar da mintina 2 kafin cin abinci, insulin glulisin ya samar da mafi kyawun sarrafa kwayar cuta bayan cin abinci fiye da insulin ɗan adam mai narkewa 2 mintuna kafin cin abinci. Glulisin insulin, ana gudanar da shi na mintina 15 bayan fara abincin, ya ba da izinin sarrafa glycemic iri ɗaya bayan abinci kamar yadda insulin ɗan adam mai narkewa, ana gudanar da mintina 2 kafin cin abincin.

Kiba Wani rukuni da na yi nazari tare da insulin glulisin, insulin lispro da insulin mutum a cikin rukunin marasa lafiya ya nuna cewa a cikin wadannan marassa lafiya, insulin glulisin yana rike sifofin sa da sauri. A cikin wannan binciken, lokacin da ya isa zuwa 20% na jimlar AUC shine 114 min don insulin glulisin, 121 min don insulin lispro da 150 min don insulin mutum, kuma AUC (0-2 hours), wanda shima yana nuna farkon rage yawan glucose, ya kasance 427 mg · kg -1 - don insulin glulisin, 354 mg · kg -1 - don insulin lispro da 197 mg · kg -1 - don narkewar ɗan adam, bi da bi.

Type 1 ciwon sukari. A cikin gwajin asibiti na 26-mako na kashi III, wanda aka kwatanta insulin glulisin tare da insulin lispro, ana gudanar dashi s.c. jim kadan kafin abinci (mintuna 0-15), marasa lafiya masu dauke da nau'in ciwon sukari na 1 na mellitus, ta yin amfani da gulingine insulin, glulisin insulin kamar basal ya kasance daidai da insulin lyspro dangane da sarrafawar glycemic, wanda aka kimanta da canji a cikin taro na hawan glycosylated (HbA_1C) a ƙarshen ƙarshen binciken a kwatankwacin sakamako. Kwatanta darajar glucose na jini an lura, ta hanyar kulawa da hankali. Tare da gudanar da insulin glulisin, ya bambanta da magani tare da insulin, lyspro bai buƙatar haɓaka kashi na insulin basal ba.

Nazarin asibiti na 12-mako na III a cikin marasa lafiya da ke da nau'in ciwon sukari na 1 wanda ya karɓi insulin glargine a matsayin maganin basal ya nuna cewa tasiri na insulin glulisin yana da kyau bayan abinci ya kasance daidai da na insulin glulisin nan da nan kafin abinci (na 0 –15 min) ko insulin ɗan adam mai narkewa (30-45 mint kafin abinci).

A cikin yawan marasa lafiyar da suka kammala yarjejeniya na binciken, a cikin rukuni na marasa lafiya waɗanda suka karbi insulin glulisin kafin abinci, an lura da raguwa mai girma a cikin HbA_1C idan aka kwatanta da gungun marasa lafiya da ke karbar insulin na mutum.

Type 2 ciwon sukari. An gabatar da gwajin asibiti na 26-mako na III wanda ya biyo bayan biyun makonni 26 a cikin hanyar binciken aminci don kwatanta insulin glulisin (0-15 mintuna kafin abinci) tare da insulin ɗan adam mai narkewa (30-45 mintuna kafin abinci) da aka gudanar sc a cikin marasa lafiya da nau'in ciwon sukari na 2 na sukari guda biyu, ban da yin amfani da insulin-isophan as basal. Matsakaicin matsakaiciyar ƙoshin jikin mutum shine 34.55 kg / m 2. An nuna insulin glulisin ya zama daidai da insulin na ɗan adam mai narkewa dangane da canje-canje a cikin ƙwayoyin HbA_1C bayan watanni 6 na magani idan aka kwatanta da sakamako (-0.46% don glulisin insulin da -0.30% don insulin ɗan adam mai narkewa, p = 0.0029) da kuma bayan watanni 12 na magani idan aka kwatanta da sakamakon (-0.23% - don insulin glulisin da -0,13% na narkewar ɗan adam, bambanci ba shi da mahimmanci). A cikin wannan binciken, yawancin marasa lafiya (79%) sun haɗu da insulin-ɗan gajeran lokaci tare da isulin insulin nan da nan kafin allura. A lokacin rarrabuwar, marasa lafiya 58 sun yi amfani da magunguna na maganin hypoglycemic na baki da karɓar umarni don ci gaba da amfani da su a daidai wannan matakin.

Asalin launin fata da jinsi. A cikin gwaji na asibiti da aka sarrafa a cikin manya, bambance-bambance a cikin aminci da tasiri na insulin glulisin ba a nuna su ba a cikin binciken ƙungiyar ƙungiyoyi da aka rarrabe ta jinsi da jinsi.

Pharmacokinetics

A cikin insulin glulisine, maye gurbin amino acid asparagine na ɗan adam insulin a matsayin B3 tare da lysine da lysine a matsayi B29 tare da acid glutamic yana haɓaka ɗaukar sauri.

Kasancewa da kuma bioavailability. Lokaci na maida hankali akan Pharmacokinetic a cikin masu sa kai masu lafiya da marasa lafiya da ke da nau'in 1 da 2 na ciwon sukari mellitus sun nuna cewa yawan ƙwayar insulin glulisin idan aka kwatanta da insulin ɗan adam mai narkewa kusan sau 2 cikin sauri, har zuwa sau biyu mafi girma C_max .

A cikin binciken da aka gudanar a cikin marasa lafiya da nau'in ciwon sukari na 1 na mellitus, bayan sc gwamnatin insulin glulisin a cikin kashi 0.15 u / kg T_max (lokacin aukuwar C_max ) ya kasance 55 min da C_max a cikin plasma ya kasance (82 ± 1.3) μed / ml idan aka kwatanta da T_max kafa 82 min da C_max sashi (46 ± 1.3) μed / ml, don narkewar ɗan adam mai narkewa. Lokacin zama a cikin tsari na yaduwar insulin glulisin ya yi guntu (98 min) fiye da na insulin na mutane (161 min).

A cikin binciken a cikin marasa lafiya da nau'in ciwon sukari na 2 na ciwon sukari bayan sc gwamnatin insulin glulisin a cikin kashi 0.2 u / kg C_max ya kasance 91 μed / ml tare da tsakiyar nesa na 78 zuwa 104 μed / ml.

Tare da subcutaneous management na insulin glulisin a cikin bangon ciki na ciki, cinya ko kafada (yanki na deltoid tsoka), sha yana da sauri lokacin da aka gabatar dashi a bangon ciki na ciki idan aka kwatanta da gudanarwar miyagun ƙwayoyi a cinya. Yawan sha daga yankin da aka kera ya kasance tsaka-tsaki. Cikakken bioavailability na insulin glulisin (70%) a wuraren allura iri ɗaya yana da bambanci kuma yana da ɗan rarrabewa tsakanin marasa lafiya daban-daban. Ba a iya amfani da shi (CV) - 11%.

Rarraba da karba. Rarraba da kewayon insulin glulisin da mai narkewa na mutum bayan aikin iv sun yi kama, tare da rarraba juzu'ai 13 da 22 L, da T_1/2 hada 13 da 18 min, bi da bi.

Bayan sc insulin na insulin, glulisin yana fitowa da sauri sama da insulin na mutum mai narkewa, yana da alamun T_1/2 Mintuna 42 idan aka kwatanta da na T_1/2 insulin ɗan adam mai narkewa, wanda ya ƙunshi 86 min. A cikin binciken giciye-bincike na binciken glulisin insulin a duka mutane masu lafiya da wadanda ke da nau'in 1 da nau'in ciwon sukari na 2, bayyananniyar T_1/2 jere daga minti 37 zuwa 75.

Rukunin Masu haƙuri na Musamman

Rashin wahala. A cikin binciken asibiti da aka gudanar a cikin mutane ba tare da ciwon sukari tare da matsayi mai yawa na kodan (creatinine Cl> 80 ml / min, 30-50 ml / min, T_max da C_max kama da waɗanda ke cikin manya. Kamar yadda yake a cikin manya, lokacinda aka gudanar dashi kai tsaye gabanin gwajin abinci, glulisin insulin yana samarda mafi kyawun sarrafa glucose na jini bayan abinci fiye da insulin na mutum. Thearin yawan haɗarin glucose na jini bayan cin abinci (AUC 0-6 h - yanki a ƙarƙashin ɓoye na maida hankali na glucose jini - lokaci daga 0 zuwa 6 h) shine 641 mg · h · dl -1 - don insulin glulisin da 801 mg · h · dl -1 - don insulin mutum.

Haihuwa da lactation

Ciki Babu isasshen bayani game da amfani da insulin glulisin a cikin mata masu juna biyu.

Karatuttukan dabbobi na dabbobi basu bayyana wani bambance-bambance tsakanin insulin glulisin da insulin mutum dangane da ciki, ci gaban tayin / tayi, haihuwa da kuma bayan haihuwa.

Lokacin da aka tsara magunguna ga mata masu juna biyu, ya kamata a kula. Ana buƙatar kulawa da hankali akan matakan glucose na jini.

Marasa lafiya da ke da juna biyu kafin masu juna biyu ko masu ciwon sukari suna buƙatar kula da ingantaccen iko na rayuwa a duk lokacin da suke cikin ciki. A cikin lokacin farko na ciki, bukatar insulin na iya raguwa, kuma a lokacin karo na biyu da na uku, yawanci yana iya ƙaruwa. Nan da nan bayan haihuwa, bukatar insulin ya ragu da sauri.

Lactation. Ba'a sani ba ko insulin glulisin ya wuce cikin madara, amma a gaba ɗaya insulin ba ya shiga cikin madara nono kuma ƙwaƙwalwar ƙwaƙwalwar ƙwayar cuta ba ta tunawa da shi.

Iyayen mata masu shayarwa na iya buƙatar daidaita sashin insulin da abinci.

Yawan damuwa

Kwayar cutar tare da wuce haddi na insulin dangane da buƙatarsa, wanda aka ƙaddara ta hanyar abinci da yawan kuzari, hauhawar jini zai iya haɓaka.

Babu takamammen bayanai da ke akwai dangane da yawan ƙwayar insulin glulisin. Koyaya, tare da yawan abincinta, hypoglycemia na iya haɓaka cikin sauƙi ko mai rauni.

Jiyya: sassan abubuwa masu saurin motsa jiki za a iya tsayar dasu tare da glucose ko abinci mai ɗauke da sukari. Saboda haka, an ba da shawarar cewa marasa lafiya da ciwon sukari koyaushe suna ɗaukar sukari, alewa, kukis ko ruwan 'ya'yan itace mai zaki.

Abubuwan da ke faruwa na rashin ƙarfi na hypoglycemia, a lokacin da haƙuri ke rasa hankali, za a iya dakatar da shi ta hanyar intramuscular ko sc of 0.5-1 mg na glucagon, wanda mutumin da ya karbi umarnin da ya dace, ko iv of dextrose (glucose) ta ƙwararren likita. Idan mai haƙuri bai amsa aikin glucagon na mintina 10-15 ba, to lallai ma yana da damar sarrafa iv dextrose.

Bayan dawo da hankali, ana bada shawara a ba wa marassa lafiyar ciki don hana sake dawowa daga cututtukan jini.

Bayan gudanar da glucagon, ya kamata a lura da mai haƙuri a asibiti don kafa dalilin wannan mummunan cutar hypoglycemia kuma ya hana ci gaba da waɗannan alamomin irin wannan.

Tasiri kan iya tuka motoci da injinan

Ya kamata a shawarci marassa lafiya su yi hankali su kuma guji haɓaka ƙarancin ƙwaƙwalwa yayin tuki motoci ko na inji. Wannan yana da mahimmanci musamman a cikin marasa lafiya waɗanda suka rage ko ikon rashi don gane alamun da ke nuna ci gaban hypoglycemia, ko kuma suna da yawan sassan jiki na rashin ƙarfi. A cikin irin waɗannan marasa lafiya, tambayar yiwuwar korar su da motocin ko wasu injina yakamata a yanke hukunci daban-daban.

Umarnin don amfani da shi

Vials
Abubuwan da aka yiwa Apidra ® viidra ® ana nufin amfani dasu tare da sirinji insulin tare da ma'aunin ɓangaren da ya dace kuma don amfani dashi tare da tsarin famfon insulin.

Duba kwalban kafin amfani. Ya kamata ayi amfani dashi idan mafita a bayyane, mara launi kuma baya dauke da kwayoyin halitta bayyananne.

Ci gaba sc jiko ta amfani da tsarin famfo.

Ana iya amfani da Apidra ® don ci gaba da ƙarancin ins na insulin (NPII) ta amfani da tsarin famfo wanda ya dace da jiko insulin tare da catheters da suka dace da kuma wuraren ajiya.

Ya kamata a maye gurbin saiti da jigilar kowane sa'o'i 48 a cikin bin ka'idodin aseptic.

Marasa lafiya waɗanda ke karɓar Apidra ® ta hanyar NPI yakamata su sami insulin na dabam a cikin yanayin idan sun gaza tsarin famfon.

Kayan katako
Ya kamata a yi amfani da katako tare da alkalami na insulin, AllStar, kuma ya dace da shawarwarin da ke cikin Umarni don Amfani da masana'anta na wannan na'urar. Bai kamata a yi amfani dasu da wasu alkawuran sirinji mai warware warkarwa ba, tunda an kafa daidaiton dosing ne kawai tare da wannan alkairin sirinji.

Umarnin mai masana'anta don amfani da alkalami na allStar game da loda katako, saka allura, da allura ta insulin daidai. Binciken katun kafin amfani. Yakamata a yi amfani da shi idan mafita a bayyane, mara launi, ba dauke da abubuwan daskararren da ake gani. Kafin shigar da katun a cikin alkairin da za'a iya warwarewa, katifar yakamata ya kasance cikin zafin jiki a cikin awa 1-2. Kafin allurar, yakamata a cire kumburin iska daga kicin ɗin (duba umarnin don amfani da alkairin sirinji). Umarnin amfani da alkalami na syringe dole a bi shi sosai. Ba za a iya cike kwandishan fanko ba. Idan sirinji na "OlStar" (AllStar) ya lalace, ba za a iya amfani da shi ba.

Idan alkalami bai yi aiki yadda yakamata ba, za a iya zazzage maganin daga kicin a cikin sirinji filastik wanda ya dace da insulin a yawan 100 PIECES / ml kuma an kula dashi ga mai haƙuri.

Don hana kamuwa da cuta, dole ne a yi amfani da alkalami na reusable a cikin haƙuri ɗaya kawai.