natgillin/translations-raw huggingface dataset:
Each vial contains 10 ml of solution for injection, equivalent to 1000 Units.
Vsaka viala vsebuje 10 ml raztopine za injiciranje, kar ustreza 1. 000 enotam.
These units are exclusive to Apidra and are not the same as IU or the units used to express the potency of other insulin analogues.
Te enote veljajo izključno za zdravilo Apidra in niso enake mednarodnim enotam (i. e.) ali enotam, ki se uporabljajo za izražanje jakosti drugih insulinskih analogov.
See section 5.1 (Pharmacodynamics).
Glejte poglavje 5. 1 (Farmakodinamika).
Apidra should be given shortly (0-15 min) before or soon after meals.
Zdravilo Apidra je treba uporabiti tik (0– 15 minut) pred obroki ali kmalu po njih.
Apidra should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents.
Zdravilo Apidra je treba uporabljati v shemah, ki vključujejo srednjedolgo - ali dolgodelujoč insulin ali bazalni insulinski analog; zdravilo je mogoče uporabljati tudi s peroralnimi antidiabetiki.
The dosage of Apidra should be individually adjusted.
Odmerjanje insulina Apidra mora biti prilagojeno individualno.
Apidra should be given by subcutaneous injection or by continuous subcutaneous pump infusion.
Apidra se uporablja v subkutani injekciji ali stalni subkutani infuziji s črpalko.
Injection sites and infusion sites within an-injection area (abdomen, thigh or deltoid) should be rotated from one injection to the next.
Mesto injiciranja oz. infundiranja na posameznem predelu (trebuh, stegno, deltoidni predel) je treba od injekcije do injekcije krožno menjati.
Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2).
Absorpcija je po subkutani injekciji v trebušno steno nekoliko hitrejša kot z drugih mest injiciranja (glejte poglavje 5. 2).
2 Mixing with insulins
2 Mešanje z insulini
In the absence of compatibility studies, insulin glulisine must not be mixed with other medicinal products except NPH human insulin.
Zaradi pomanjkanja študij kompatibilnosti, insulina glulisin ne smemo mešati z drugimi zdravili razen s humanim insulinom NPH.
When used with an insulin infusion pump, Apidra must not be mixed with diluents or any other insulin.
Kadar se insulin Apidra uporablja v insulinski infuzijski črpalki, se ga ne sme mešati z razredčili ali kakšnim drugim insulinom.
For further details on handling, see section 6.6.
Za dodatne podrobnosti o ravnanju glejte poglavje 6. 6.
Renal impairment The pharmacokinetic properties of insulin glulisine are generally maintained in patients with renal impairment.
Okvara ledvic Farmakokinetične lastnosti insulina glulisin se pri bolnikih z okvaro ledvic praviloma ohranijo.
However, insulin requirements may be reduced in the presence of renal impairment (see section 5.2).
Lahko pa se pri okvari ledvic zmanjša potreba po insulinu (glejte poglavje 5. 2).
Hepatic impairment The pharmacokinetic properties of insulin glulisine have not been investigated in patients with decreased liver function.
Okvara jeter Farmakokinetične lastnosti insulina glulisin pri bolnikih z zmanjšanim delovanjem jeter niso raziskane.
Elderly Limited pharmacokinetic data are available in elderly patients with diabetes mellitus.
Starejši Na voljo so le omejeni podatki o farmakokinetiki pri starejših bolnikih z diabetesom mellitusom.
Children and adolescents There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Otroci in mladostniki Ni zadostnih kliničnih podatkov o uporabi zdravila Apidra pri otrocih mlajših od 6 let.
Transferring a patient to a new type or brand of insulin should be done under strict medical supervision.
Prehod na novo vrsto ali znamko insulina je treba opraviti pod strogim zdravniškim nadzorom.
Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species (animal) and/ or method of manufacturing may result in a change in dosage.
Spremembe v jakosti, znamki (izdelovalec), vrsti (navadni, NPH, lente itn.), izvoru (živalski) in/ ali načinu izdelave lahko povzročijo spremembo v odmerjanju.
The use of inadequate dosages or discontinuation of treatment, especially in insulin-dependent diabetic, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are potentially lethal.
Uporaba nezadostnih odmerkov ali prekinitev zdravljenja lahko, zlasti pri diabetikih, odvisnih od insulina, povzroči hiperglikemijo in diabetično ketoacidozo; obe sta lahko usodni.
Switching a patient to another type or brand of insulin should be done under strict medical supervision and may require change in dose.
Na drugo vrsto ali znamko insulina sme bolnik preiti le pod strogim zdravniškim nadzorstvom; potrebna utegne biti sprememba odmerka.
Hypoglycaemia The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed.
Hipoglikemija Čas pojava hipoglikemije je odvisen od profila delovanja uporabljenih insulinov, zato se ob spremembi sheme zdravljenja lahko spremeni.
3 Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease, medicinal products such as beta blockers or after transfer from animal-source insulin to human insulin.
Med stanji, ki lahko spremenijo zgodnje opozorilne simptome hipoglikemije ali zmanjšajo njihovo izrazitost, so dolgotrajen diabetes, intenzivirano zdravljenje z insulinom, diabetična nevropatija, zdravila, kakršna so zaviralci adrenergičnih receptorjev beta, ali prehod z insulina živalskega izvora na humani insulin.
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.
3 Prilagoditev odmerjanja utegne biti potrebna tudi, če je bolnik telesno bolj dejaven ali spremeni običajni razpored obrokov.
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Nekorigirane hipo - ali hiperglikemične reakcije lahko povzročijo nezavest, komo ali smrt.
Substances that may enhance the blood-glucose-lowering activity and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamide oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Med zdravili, ki lahko stopnjujejo učinek znižanja glukoze v krvi in zvečajo nagnjenost k hipoglikemiji, so peroralni antidiabetiki, zaviralci angiotenzinske konvertaze (ACE), dizopiramid, fibrati, fluoksetin, zaviralci monoaminooksidaze (MAO), pentoksifilin, propoksifen, salicilati in sulfonamidni antibiotiki.
Substances that may reduce the blood-glucose-lowering activity include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, estrogens, progestins (e. g. in oral contraceptives), protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Med zdravili, ki lahko zmanjšajo učinek znižanja glukoze v krvi, so kortikosteroidi, danazol, diazoksid, diuretiki, glukagon, izoniazid, derivati fenotiazina, somatropin, simpatikomimetiki (npr. adrenalin, salbutamol, terbutalin), ščitnični hormoni, estrogeni, progestini (npr. v peroralnih kontraceptivih), zaviralci proteaz in atipični antipsihotiki (npr. olanzapin in klozapin).
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose- lowering activity of insulin.
Zaviralci adrenergičnih receptorjev beta, klonidin, litijeve soli ali alkohol lahko učinek znižanja glukoze v krvi pri insulinu bodisi stopnjujejo ali oslabijo.
There are no adequate data on the use of insulin glulisine in pregnant women.
Ni zadostnih podatkov o uporabi insulina glulisin pri nosečnicah.
Animal reproduction studies have not revealed any differences between insulin glulisine and human insulin regarding pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije reprodukcije pri živalih niso pokazale razlik med insulinom glulisin in humanim insulinom, kar zadeva nosečnost, embrionalni in fetalni razvoj, porod in poporodni razvoj (glejte poglavje 5. 3).
Insulin requirements may decrease during the first trimester and generally
V prvem trimesečju se lahko potreba po insulinu zmanjša, v drugem in tretjem trimesečju pa se praviloma zveča.
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
To je lahko nevarno v okoliščinah, v katerih sta ti zmožnosti posebno pomembni (npr. pri vožnji avtomobila ali upravljanju s stroji).
Hypoglycaemia, the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
Hipoglikemija, ki je najpogostejši neželeni učinek zdravljenja z insulinom, se pojavi, če je odmerek insulina prevelik glede na potrebo po insulinu.
The following related adverse reactions from clinical investigations were listed below by system organ class and in order of decreasing incidence (very common: ≥ 1/ 10; common: ≥ 1/ 100 to < 1/ 10; uncommon: ≥ 1/ 1,000 to < 1/ 100; rare: ≥ 1/ 10,000 to < 1/ 1,000; very rare: < 1/ 10,000), not known (cannot be estimated from the available data).
Naslednji povezani neželeni učinki, ugotovljeni v kliničnih raziskavah, so navedeni spodaj po organskem sistemu in razvrščeni po padajoči incidenci (zelo pogosti: ≥ 1/ 10; pogosti: ≥ 1/ 100 do < 1/ 10; občasni: ≥ 1/ 1. 000 do < 1/ 100; redki: ≥ 1/ 10. 000 do < 1/ 1. 000; zelo redki: < 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Hypoglycaemia Symptoms of hypoglycaemia usually occur suddenly.
Presnovne in prehranske motnje Zelo pogosti: hipoglikemija Simptomi hipoglikemije se ponavadi pojavijo nenadoma.
Hypoglycaemia can become severe and may lead to unconsciousness and/ or convulsions and may result in temporary or permanent impairment of brain function or even death.
Hipoglikemija lahko postane huda in povzroči nezavest in/ ali konvulzije ter prehodno ali trajno okvaro delovanja možganov ali celo smrt.
Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Bolezni kože in podkožja Pogosti: reakcije na mestu injiciranja in lokalne preobčutljivostne reakcije Med zdravljenjem z insulinom se lahko pojavijo lokalne preobčutljivostne reakcije (pordelost, oteklost in srbenje na mestu injiciranja).
Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Redki: lipodistrofija Lipodistrofija na mestu injiciranja se lahko pojavi, če bolnik mest injiciranja na posameznem predelu ne menja krožno.
Systemic hypersensitivity reactions Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnea, allergic dermatitis and pruritus.
Splošne težave Občasni: sistemske preobčutljivostne reakcije Sistemske preobčutljivostne reakcije lahko vključujejo urtikarijo, tiščanje v prsih, dispnejo, alergijski dermatitis in srbenje.
Severe cases of generalized allergy, including anaphylactic reaction, may be life- threatening.
Hudi primeri generaliziranih alergij, vključno z anafilaktičnimi reakcijami, so lahko smrtno nevarni.
5 4.9 Overdose
4. 9 Preveliko odmerjanje
There are no specific data available concerning overdose with insulin glulisine.
Specifičnih podatkov o prevelikem odmerjanju insulina glulisin ni.
However, hypoglycaemia may develop over sequential stages:
A hipoglikemija se lahko razvije v dveh zaporednih stopnjah:
Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
5 Blage hipoglikemije je mogoče zdraviti z zaužitjem glukoze ali sladkih izdelkov.
Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated by glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a person who has received appropriate instruction, or by glucose given intravenously by a medical professional.
Hude hipoglikemije, ko je bolnik nezavesten, je mogoče zdraviti z intramuskularno ali subkutano injekcijo glukagona (0, 5 do 1 mg), ki jo da ustrezno usposobljena oseba, ali z intravensko injekcijo glukoze, ki jo da zdravstveni delavec.
Pharmacotherapeutic group: insulin and analogues, fast-acting.
Farmakoterapevtska skupina: insulini s hitrim delovanjem in analogi.
When insuline glulisine is injected subcutaneously, the glucose lowering activity will begin within 10 – 20 minutes.
Po subkutanem injiciranju insulina glulisin se učinek na zniževanje glukoze pojavi v 10 do 20 minutah.
In a study with 18 male subjects with diabetes mellitus type 1 aged 21 to 50 years, insulin glulisine displayed dose-proportional glucose lowering effect in the therapeutic relevant dose range 0.075 to 0.15 U/ kg, and less than proportional increase in glucose lowering effect with 0.3 U/ kg or higher, like human insulin.
Pri odmerku 0, 3 enot/ kg ali več je bilo povečanje učinka na znižanje glukoze manjše od sorazmernega, podobno kot pri humanem insulinu.
Insulin glulisine takes effect about twice as fast as regular human insulin and completes the glucose lowering effect about 2 hours earlier than regular human insulin.
Njegov učinek na znižanje glukoze se konča približno 2 uri prej kot pri navadnem humanem insulinu.
Data indicated that insulin glulisine
Študija faze I pri bolnikih z diabetesom mellitusom tipa 1 je ocenjevala znižanje glukoze z insulinom glulisin in navadnim humanim insulinom, apliciranima subkutano v odmerku 0, 15 e. / kg ob različnih časih glede na 15- minutni standardni obrok.
6 administered 2 minutes before the meal gives similar postprandial glycemic control compared to regular human insulin given 30 minutes before the meal.
Podatki kažejo, da insulin glulisin, apliciran 2 minuti pred obrokom, povzroči podobno postprandialno urejenost glikemije kot navadni humani insulin, uporabljen 30 minut pred obrokom.
GLUCOSE - mg/ dL
GLUKOZA V KRVI - mg/ dl GLUKOZA V KRVI - mg/ dl GLUKOZA V KRVI - mg/ dl
GLULISINE - pre REGULAR - pre
GLULISIN - po
2 3 4 5 6
234 5
6
234 5 6
2 3 4 5 6 TIME - hour
234 5 ČAS - ure
Figure 1 A
slika 1 A
Average glucose-lowering effect over 6 hours in 20 patients with type 1 diabetes mellitus.
Povprečni učinek na znižanje glukoze v 6 urah pri 20 bolnikih z diabetesom mellitusom tipa 1.
Insulin glulisine given 15 minutes (GLULISINE post) after start of a meal compared to regular human insulin given 2 minutes (REGULAR pre) before start of the meal (figure 1C).
Insulin glulisin, uporabljen 15 minut (GLULISIN - po) po začetku obroka, v primerjavi z navadnim humanim insulinom, uporabljenim 2 minuti (NAVADNI - pred) pred začetkom obroka (slika 1C).
On the x-axis, zero (arrow) is the start of a 15-minute meal.
Na osi x označuje ničla (puščica) začetek 15- minutnega obroka.
In this study, the time to 20% of total AUC and the AUC (0-2h) representing the early glucose lowering activity were respectively of 114 minutes and 427mg. kg-1 for insulin glulisine, 121 minutes and 354mg. kg-1 for lispro, 150 minutes and 197mg. kg-1 for regular human insulin (see figure 2).
V tej študiji sta bila čas do 20% celotne AUC in AUC (0– 2h), ki predstavljata zgodnji učinek na znižanje glukoze, pri insulinu glulisin 114 minut in 427 mg. kg- 1, pri insulinu lispro 121 minut in 354 mg. kg- 1 in pri navadnem humanem insulinu 150 minut in 197 mg. kg- 1 (slika 2).
10 GLULISINE LISPRO GIR - mg/ kg/ min
10 GLULISIN HIG - mg/ kg/ min
REGULAR
NAVADNI
7 Figure 2:
Slika 2:
Glucose infusion rates after subcutaneous injection of 0.3 U/ kg of insulin glulisine (GLULISINE) or insulin lispro (LISPRO) or regular human insulin (REGULAR) in an obese population.
Hitrost infundiranja glukoze po subkutani injekciji 0, 3 enot/ kg insulina glulisin (GLULISIN) ali insulina lispro (LISPRO) ali navadnega humanega insulina (NAVADNI) pri debelih preiskovancih.
Another phase I study with insulin glulisine and insulin lispro in a non-diabetic population in 80 subjects with a wide range of body mass indices (18-46 kg/ m²) has demonstrated that rapid action is generally maintained across a wide range of body mass indices, while total glucose lowering effect decreases with increasing obesity.
Druga študija faze I, izvedena z insulinom glulisin in insulinom lispro pri skupini 80 oseb brez diabetesa s širokim razponom indeksov telesne mase (18- 46 kg/ m²) je pokazala, da se hitro delovanje običajno ohrani preko širokega razpona indeksov telesne mase, medtem ko se skupni učinek na znižanje glukoze z večanjem telesne mase zmanjšuje.
The average total GIR AUC between 0– 1 hour was 102±75 mg/ kg and 158±100 mg/ kg with 0.2 and 0.4 U/ kg insulin glulisine, respectively, and was 83.1±72.8 mg/ kg and 112.3±70.8 mg/ kg with 0.2 and 0.4 U/ kg insulin lispro respectively.
Pri odmerku 0, 2 enot/ kg insulina lispro je bila 83, 1 ± 72, 8 mg/ kg, pri odmerku 0, 4 enot/ kg insulina lispro pa 112, 3 ± 70, 8 mg/ kg.
A phase I study in 18 obese patients with type 2 diabetes mellitus (BMI between 35 and 40 kg/ m2) with insulin glulisine and insulin lispro [90% CI:0.81, 0.95 (p= < 0.01)]has shown that insulin glulisine effectively controls diurnal post-prandial blood glucose excursions.
0, 81; 0, 95 (p = < 0, 01)] je pokazala, da insulin glulisin učinkovito nadzira dnevno postprandialno nihanje glukoze v krvi.
Type 1 diabetes mellitus-Adults In a 26-week phase III clinical study comparing insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in patients with type 1 diabetes mellitus using insulin glargine as basal insulin, insulin glulisine was comparable to insulin lispro for glycemic control as reflected by changes in glycated haemoglobin (expressed as HbA1c equivalent) from baseline to endpoint.
Glikemična urejenost je bila z insulinom glulisin primerljiva tisti z insulinom lispro, kot kažejo spremembe glikiranega hemoglobina (izraženega z ekvivalentom HbA1c) od izhodišča do končne točke.
A 12-week phase III clinical study performed in patients with type 1 diabetes mellitus receiving insulin glargine as basal therapy indicate that the immediate postmeal administration of insulin glulisine provides efficacy that was comparable to immediate premeal insulin glulisine (0-15 minutes) or regular insulin (30-45 minutes).
12- tedenska klinična študija faze III pri bolnikih z diabetesom mellitusom tipa 1, ki so kot bazalno terapijo dobivali insulin glargin, kaže, da apliciranje insulina glulisin takoj po obroku zagotavlja primerljivo učinkovitost kot uporaba insulina glulisin tik (0– 15 minut) pred obrokom ali navadnega humanega insulina 30– 45 minut pred obrokom.
In the per protocol population there was a significantly larger observed reduction in GHb in the premeal glulisine group compared with the regular insulin group.
V populaciji po- protokolu so v skupini, ki je uporabljala glulisin pred obrokom, ugotovili značilno večje znižanje vrednosti glikiranega hemoglobina kot v skupini, ki je uporabljala navadni insulin.
Type 1 diabetes mellitus-Paediatric A 26-week phase III clinical study compared insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in children (4-5 years: n=9; 6-7 years: n=32 and 8-11 years: n=149) and adolescents (12-17 years: n=382) with type 1 diabetes mellitus using insulin glargine or NPH as basal insulin.
Insulin glulisin oz. lispro je bil injiciran subkutano kratek čas (0– 15 minut) pred obrokom.
Type 2 diabetes mellitus-AdultsA 26-week phase III clinical study followed by a 26-week extension safety study was conducted to compare insulin glulisine (0-15 minutes before a meal) with regular human insulin (30-45 minutes before a meal) injected subcutaneously in patients with type 2 diabetes mellitus also using NPH insulin as basal insulin.
Diabetes mellitus tipa 2 - odrasli 26- tedenska klinična študija faze III, kateri je sledila 26- tedenska nadaljevalna študija varnosti, je primerjala insulin glulisin (0– 15 minut pred obrokom) z navadnim humanim insulinom (30– 45 minut pred obrokom), injiciranima subkutano, in sicer pri bolnikih z diabetesom mellitusom tipa 2, ki so uporabljali tudi insulin NPH kot bazalni insulin.
The average body mass index (BMI) of patients was 34.55 kg/ m2.
Povprečni indeks telesne mase (ITM) bolnikov je bil 34, 55 kg/ m2.
Insulin glulisine was shown to be comparable to regular human insulin with regard to glycated haemoglobin (expressed as HbA1c equivalent) changes from baseline to the 6-month endpoint (-0.46% for insulin glulisine and -0.30% for regular human insulin, p=0.0029) and from baseline to the 12-month endpoint (-0.23% for insulin glulisine and -0.13% for regular human insulin, difference not significant).
Insulin glulisin je primerljiv navadnemu humanemu insulinu, kar zadeva spremembo glikiranega hemoglobina (izraženo kot ekvivalent HbA1c) od izhodišča do končne točke po 6- ih mesecih (- 0, 46% za insulin glulisin in - 0, 30% za navadni humani insulin, p = 0, 0029) in od izhodišča do končne točke po 12- ih mesecih (- 0, 23% za insulin glulisin in - 0, 13% za navadni humani insulin, razlika ni značilna).
In this study, the majority of patients (79%) mixed their short acting insulin with NPH insulin immediately prior to injection and 58% of subjects used oral hypoglycemic agents at randomization and were instructed to continue to use them at the same dose.
Večina bolnikov (79%) v tej študiji je kratkodelujoči insulin tik pred injiciranjem zmešala z insulinom NPH, 58% preiskovancev pa je ob randomizaciji uporabljalo peroralne antidiabetike in so dobili navodilo, naj jih v enakem odmerku uporabljajo še naprej.
8 Race and Gender In controlled clinical trials in adults, insulin glulisine did not show differences in safety and efficacy in subgroup analyses based on race and gender.
Rasa in spol V kontroliranih kliničnih preizkušanjih pri odraslih se varnost in učinkovitost insulina glulisin v analizah podskupin po starosti in spolu nista razlikovali.
5.2 Pharmacokinetic properties
8 5. 2 Farmakokinetične lastnosti
In a study with 18 male subjects with diabetes mellitus type 1 aged 21 to 50 years, insulin glulisine displays dose-proportionality for early, maximum and total exposure in the dose range 0.075 to 0.4U/ kg.
V študiji z 18 osebami moškega spola z diabetesom mellitusom tipa 1, starimi od 21 do 50 let, je bila zgodnja, največja in skupna izpostavljenost insulinu glulisin v razponu odmerkov od 0, 075 do 0, 4 enot/ kg sorazmerna z odmerkom.
In a study in patients with type 1 diabetes mellitus after subcutaneous administration of 0.15 U/ kg, for insulin glulisine the Tmax was 55 minutes and Cmax was 82 ± 1.3 µU/ ml compared to a Tmax of 82 minutes and a Cmax of 46 ± 1.3 µU/ ml for regular human insulin.
V študiji pri bolnikih z diabetesom mellitusom tipa 1 sta bila po subkutani uporabi insulina glulisin v odmerku 0, 15 enot/ kg, tmax 55 minut in Cmax 82 ± 1, 3 µenot/ ml, po subkutani uporabi navadnega humanega insulina v enakem odmerku pa tmax 82 minut in Cmax 46 ± 1, 3 µenot/ ml.
The mean residence time of insulin glulisine was shorter (98 min) than for regular human insulin (161 min) (see figure3).
Povprečni rezidenčni čas je bil pri insulinu glulisin krajši (98 minut) kot pri navadnem humanem insulinu (161 minut) (slika 3).
Pharmacokinetic profile of insulin glulisine and regular human insulin in type 1 diabetes mellituspatients after a dose of 0.15 U/ kg.
Farmakokinetične značilnosti insulina glulisin in navadnega humanega insulina pri bolnikih z diabetesom mellitusom tipa 1 po odmerku 0, 15 enot/ kg.
In a study in patients with type 2 diabetes mellitus after subcutaneous administration of 0.2 U/ kg insulin glulisine, the Cmax was 91 µU/ ml with the interquartile range from 78 to 104 U/ ml.
V študiji pri bolnikih z diabetesom mellitusom tipa 2 je bil Cmax po subkutani aplikaciji 0, 2 enot/ kg insulina glulisin 91 µenot/ ml; interkvartilni razpon je bil od 78 do 104 µenot/ ml.