natgillin/translations-raw huggingface dataset:
Absorption from deltoid sites was in-between (see section 4.2).
Absorpcija z mest v deltoidnem predelu je bila vmes (glejte poglavje 4. 2).
The absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra- subject variability (11%CV).
Absolutna biološka uporabnost (70%) insulina glulisin je bila med mesti injiciranja podobna in je imela majhno intraindividualno variabilnost (11% KV).
9 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 absorption and total exposure is generally maintained across a wide range of body mass indices.
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 hitra absorpcija in celotna izpostavljensot običajno ohranita preko širokega razpona indeksov telesne mase.
The time to 10% of total INS exposure was reached earlier by approximately 5– 6 min with insulin glulisine.
Z insulinom lispro je bila 10% skupna INS izpostavljenost dosežena približno 5- 6 minut hitreje.
Distribution and elimination
9 Porazdelitev in izločanje
After subcutaneous administration, insulin glulisine is eliminated more rapidly than regular human insulin with an apparent half-life of 42 minutes compared to 86 minutes.
86 minut).
Renal impairment In a clinical study performed in non-diabetic subjects covering a wide range of renal function (CrCl > 80 ml/ min, 30-50 ml/ min, < 30 ml/ min), the rapid-acting properties of insulin glulisine were generally maintained.
Okvara ledvic V klinični študiji pri nediabetičnih preiskovancih z zelo različnim delovanjem ledvic (očistek kreatinina > 80 ml/ min, 30– 50 ml/ min, < 30 ml/ min) se je hitro delovanje insulina glulisin praviloma ohranilo.
Children and adolescents The pharmacokinetic and pharmacodynamic properties of insulin glulisine were investigated in children (7-11 years) and adolescents (12-16 years) with type 1 diabetes mellitus.
Otroci in mladostniki Farmakokinetične in farmakodinamične lastnosti insulina glulisin so raziskali pri otrocih (7– 11 let) in mladostnikih (12– 16 let) z diabetesom mellitusom tipa 1.
Insulin glulisine was rapidly absorbed in both age groups, with similar Tmax and Cmax as in adults (see section 4.2).
V obeh starostnih skupinah se je insulin glulisin hitro absorbiral. tmax in Cmax sta bila podobna kot pri odraslih (glejte poglavje 4. 2).
Administered immediately before a test meal, insulin glulisine provided better postprandial control than regular human insulin, as in adults (see section 5.1).
Insulin glulisin, apliciran tik pred testnim obrokom, je zagotovil boljšo postprandialno urejenost kot navadni humani insulin, tako kot pri odraslih (glejte poglavje 5. 1).
The glucose excursion (AUC 0-6h) was 641 mg. h. dl-1 for insulin glulisine and 801mg. h. dl-1 for regular human insulin.
Ekskurz glukoze (AUC 0- 6h) je bil pri insulinu glulisin 641 mg. h. dl- 1 in pri navadnem humanem insulinu 801 mg. h. dl- 1.
Metacresol Sodium chloride Trometamol Polysorbate 20 Hydrochloric acid, concentrated Sodium hydroxide Water for injections
Metakrezol, natrijev klorid, trometamol, polisorbat 20, koncentrirana klorovodikova kislina, natrijev hidroksid, voda za injekcije.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except NPH human insulin.
10 Zaradi pomanjkanja študij kompatibilnosti, tega zdravila ne smemo mešati z drugimi zdravili razen s humanim insulinom NPH.
Shelf life after first use of the vial The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C zaščiteno pred neposredno toploto ali svetlobo.
It is recommended that the date of the first use from the vial be noted on the label.
Priporočljivo je na nalepko vpisati datum prve uporabe viale
Unopened vials Store in a refrigerator (2°C - 8°C)
Neodprte viale Shranjujte v hladilniku (2 ºC - 8 ºC).
Opened vials For storage precautions, see section 6.3.
Odprte viale Za navodila za shranjevanje glejte poglavje 6. 3.
10 ml solution in a vial (type I colourless glass) with a stopper (flanged aluminium overseal, elastomeric rubber) and a tear-off cap.
10 ml raztopine v viali (iz brezbarvnega stekla tipa 1) z zaporko (prekriti prirobljen aluminij, elastomerna guma) in s pokrovčkom, ki se odtrga.
Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with an insulin pump system (see section 4.2).
Viale zdravila Apidra so namenjene za uporabo z insulinskimi brizgami z ustreznim merilom enot in za uporabo v sistemu z insulinsko črpalko (glejte poglavje 4. 2).
11 Mixing with insulins
Mešanje z insulini
Apidra may be used for Continuous Subcutaneous Insulin Infusion (CSII) in pump systems suitable for insulin infusion with the appropriate catheters and reservoirs.
Insulin Apidra se lahko za stalno subkutano infundiranje insulina (SSII) uporablja v sistemih s črpalko, primernih za infundiranje insulina z ustreznimi katetri in rezervoarji.
Patients using CSII should be comprehensively instructed on the use of the pump system.
Bolnike, ki uporabljajo SSII, je treba izčrpno poučiti o uporabi sistema s črpalko.
The infusion set and reservoir should be changed every 48 hours using aseptic technique.
Infuzijski komplet in rezervoar je treba zamenjati na 48 ur; menjava mora biti opravljena aseptično.
Patients administering Apidra by CSII must have alternative insulin available in case of pump system failure.
Bolniki, ki zdravilo Apidra uporabljajo v SSII, morajo vedno imeti na voljo še drug insulin za primer, da sistem s črpalko odpove.
Sanofi-Aventis Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Germany.
Sanofi- Aventis Deutschland GmbH, Brueningstrasse 50, D- 65926 Frankfurt am Main, Nemčija.
Apidra 100 Units/ ml, solution for injection in a cartridge.
Apidra 100 enot/ ml raztopina za injiciranje v vložku
13 Mixing with insulins
13 Mešanje z insulini
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.
Prilagoditev odmerjanja utegne biti potrebna tudi, če je bolnik telesno bolj dejaven ali spremeni običajni razpored obrokov.
When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid acting analogues, it may occur earlier.
14 Po injiciranju hitrodelujočih analogov se lahko hipoglikemija, če do nje pride, pojavi bolj zgodaj kot po topnem humanem insulinu.
14 Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Nekorigirane hipo - ali hiperglikemične reakcije lahko povzročijo nezavest, komo ali smrt.
15 4.7 Effects on ability to drive and use machines
15 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Hypoglycaemia Symptoms of hypoglycaemia usually occur suddenly.
Hipoglikemija Simptomi hipoglikemije se ponavadi pojavijo nenadoma.
16 4.9 Overdose
4. 9 Preveliko odmerjanje
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.
16 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.
A phase I study in patients with type 1 diabetes mellitus assessed the glucose lowering profiles of insulin glulisine and regular human insulin administered subcutaneously at a dose of 0.15 U/ kg, at different times in relation to a 15-minute standard meal.
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.
Data indicated that insulin glulisine administered 2 minutes before the meal gives similar postprandial glycemic control compared to
Podatki kažejo, da insulin glulisin, apliciran 2 minuti pred obrokom, povzroči podobno postprandialno urejenost glikemije kot navadni humani insulin, uporabljen 30 minut pred obrokom.
18 Figure 2:
Slika 2:
19 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
19 5. 2 Farmakokinetične lastnosti
Pharmacokinetic profile of insulin glulisine and regular human insulin in type 1 diabetes mellitus patients 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 µU/ 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.
20 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 absorption and total exposure is generally maintained across a wide range of body mass indices.
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 hitra absorpcija in celotna izpostavljensot običajno ohranita preko širokega razpona indeksov telesne mase.
The time to 10% of total INS exposure was reached earlier by approximately 5– 6 min with insulin glulisine.
20 Z insulinom lispro je bila 10% skupna INS izpostavljenost dosežena približno 5- 6 minut hitreje.
Insulin glulisine was rapidly absorbed in both age groups, with similar Tmax and Cmax as in adults (see section 4.2).
V obeh starostnih skupinah se je insulin glulisin hitro absorbiral, tmax in Cmax sta bila podobna kot pri odraslih (glejte poglavje 4. 2).
The glucose excursion (AUC 0-6h) was 641 mg. h. dl-1 for insulin glulisine and 801mg. h. dl-1 for regular human insulin.
Ekskurz glukoze (AUC 0– 6h) je bil pri insulinu glulisin 641 mg. h. dl- 1 in pri navadnem humanem insulinu 801 mg. h. dl- 1.
Metacresol Sodium chloride Trometamol Polysorbate 20 Hydrochloric acid, concentrated Sodium hydroxide Water for injections
Metakrezol, natrijev klorid, trometamo, l polisorbat 20, koncentrirana klorovodikova kislina, natrijev hidroksid, voda za injekcije.
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products except NPH human insulin.
21 Zaradi pomanjkanja študij kompatibilnosti, tega zdravila ne smemo mešati z drugimi zdravili razen s humanim insulinom NPH.
Shelf life after first use of the cartridge The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light The pen containing a cartridge must not be stored in the refrigerator.
Rok uporabnosti po prvi uporabi vložka Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C zaščiteno pred neposredno toploto ali svetlobo.
The pen cap must be put back on the pen after each injection in order to protect from light.
Injekcijskega peresnika z vstavljenim vložkom ne shranjujte v hladilniku.
Unopened cartridges Store in a refrigerator (2°C - 8°C).
Neodprti vložki Shranjujte v hladilniku (2 °C - 8 °C).
In use cartridges For storage precautions, see section 6.3.
Vložki, ki jih uporabljate Za navodila za shranjevanje glejte poglavje 6. 3.
3 ml solution in a cartridge (type I colourless glass) with a plunger (elastomeric rubber) and a flanged cap (aluminium) with a stopper (elastomeric rubber).
3 ml raztopine v vložku (iz brezbarvnega stekla tipa 1) z batom (iz elastomerne gume) in s prirobljeno zaporko (iz aluminija) z zamaškom (iz elastomerne gume).
The cartridges are to be used in conjunction with an insulin pen such as OptiPen and other pens suitable for Apidra cartridges, and as recommended in the information provided by the device manufacturer.
Vložke je treba uporabljati z insulinskim injekcijskim peresnikom kot je OptiPen in drugimi primernimi injekcijskimi peresniki za vložke zdravila Apidra, in po navodilih izdelovalca injekcijskega peresnika.
The manufacturer’ s instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
Natančno je treba upoštevati izdelovalčeva navodila za uporabo injekcijskega peresnika, kar zadeva vstavljanje vložka, nameščanje igle in injiciranje insulina.
Air
Pred vstavitvijo v injekcijski peresnik za večkratno uporabo mora biti vložek od 1 do 2 uri na sobni temperaturi.
22 bubbles must be removed from the cartridge before injection (see instruction for using pen).
Pred injiciranjem je treba iz vložka odstraniti zračne mehurčke (glejte navodilo za uporabo injekcijskega peresnika).
If the pen malfunctions (see instructions for using the pen), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 Units/ ml) and injected. If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.
Če je injekcijski peresnik poškodovan ali ne deluje pravilno (zaradi mehanskih poškodb), ga zavrzite in uporabite nov injekcijski peresnik.
When mixed with NPH human insulin, Apidra should be drawn into the syringe first.
22 V primeru mešanja s humanim insulinom NPH, je treba insulin Apidra v brizgo potegniti najprej.
24 In the absence of compatibility studies, insulin glulisine must not be mixed with other medicinal products except NPH human insulin.
24 Mešanje z insulini
25 Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
25 Nekorigirane hipo - ali hiperglikemične reakcije lahko povzročijo nezavest, komo ali smrt.
26 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
26 Bolnikom je treba svetovati, naj upoštevajo ustrezne varnostne ukrepe, da bi se izognili hipoglikemiji med upravljanjem vozila.
Severe cases of generalized allergy, including anaphylactic reaction, may be life threatening.
Hudi primeri generaliziranih alergij, vključno z anafilaktičnimi reakcijami, so lahko smrtno nevarni.
27 4.9 Overdose
4. 9 Preveliko odmerjanje
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
27 Ko se bolnik spet zave, je priporočljivo, da za preprečitev ponovitve peroralno dobi ogljikove hidrate.
A phase I study in patients with type 1 diabetes mellitus assessed the glucose lowering profiles of insulin glulisine and regular human insulin administered subcutaneously at a dose of 0.15 U/ kg, at
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 enot/ kg ob različnih časih glede na 15- minutni standardni obrok.
REGULAR - 30 min
NAVADNI - 30 min
2 3
234 5 ČAS - ure
4 5 6
6
TIME - hour TIME - hour
ČAS - ure
Average glucose-lowering effect over 6 hours in 20 patients with type 1 diabetes mellitus.
Povprečni učinek na znižanje glukoze
29 Figure 2:
Slika 2:
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.
Clinical studies
29 Klinične študije
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-Adults A 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.
30 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.
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.
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.
Pharmacokinetic profiles in healthy volunteers and diabetes patients (type 1 or 2) demonstrated that absorption of insulin glulisine was about twice as fast with a peak concentration approximately twice as high as compared to regular human insulin.
30 Farmakokinetične značilnosti pri zdravih prostovoljcih in bolnikih z diabetesom (tipa 1 ali 2) kažejo, da je absorpcija insulina glulisin približno dvakrat tako hitra, najvišja koncentracija pa približno dvakrat tako visoka kot pri navadnem humanem insulinu.
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 U/ ml compared to a Tmax of 82 minutes and a Cmax of 46 ± 1.3 U/ 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
Absorpcija z mest v deltoidnem predelu je bila vmes (glejte poglavje 4. 2).
31 absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra- subject variability (11%CV).
Absolutna biološka uporabnost (70%) insulina glulisin je bila med mesti injiciranja podobna in je imela majhno intraindividualno variabilnost (11% KV).
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 absorption and total exposure is generally maintained across a wide range of body mass indices.
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 hitra absorpcija in celotna izpostavljensot običajno ohranita preko širokega razpona indeksov telesne mase.
After subcutaneous administration, insulin glulisine is eliminated more rapidly than regular human insulin with an apparent half-life of 42 minutes compared to 86 minutes.
V analizi prečne študije insulina glulisin pri
In an across study analysis of insulin glulisine in either healthy subjects or subjects with type 1 or type 2 diabetes mellitus the apparent half-life ranged from 37 to 75 minutes (interquartile range).
31 zdravih preiskovancih ali preiskovancih z diabetesom mellitusom tipa 1 ali tipa 2 je bil navidezni razpolovni čas od 37 do 75 minut (interkvartilni razpon).
Shelf life after first use of the cartridge The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Rok uporabnosti po prvi uporabi vložka Zdravilo lahko shranjujete največ 4 tedne pri temperaturi do 25 °C zaščiteno pred neposredno toploto ali svetlobo.
The pen containing the cartridge must not be stored in the refrigerator.
Po
The pen cap must be put back on the pen after each injection in order to protect from light.
32 vsakem injiciranju dajte pokrovček injekcijskega peresnika nazaj na injekcijski peresnik za zagotovitev zaščite pred svetlobo.
3 ml solution in a cartridge (type I colourless glass cartridge) with a plunger (elastomeric rubber) and a flanged cap (aluminium) with a stopper (elastomeric rubber).
3 ml raztopine v vložku (iz brezbarvnega stekla tipa 1) z batom (iz elastomerne gume) in s prirobljeno zaporko (iz aluminija) z zamaškom (iz elastomerne gume).
The manufacturer’ s instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
Dosledno spoštujte izdelovalčeva navodila za uporabo injekcijskega peresnika glede nameščanja vložka in igle ter injiciranja insulina.
33 If OptiClik is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new OptiClik has to be used.
Če je OptiClik poškodovan ali ne deluje pravilno (zaradi mehanskih poškodb), ga zavrzite in uporabite nov OptiClik.
If the pen malfunctions, (see instructions for using the pen) the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 Units/ ml) and injected.
Če se injekcijski peresnik pokvari, je raztopino mogoče potegniti iz vložka v injekcijsko brizgo (primerno za insulin s 100 enotami/ ml) in jo injicirati.
Apidra 100 Units/ ml, solution for injection in a pre-filled pen.
Apidra 100 enot/ ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
OptiSet.
Raztopina za injiciranje v napolnjenem injekcijskem peresniku OptiSet.
35 In the absence of compatibility studies, insulin glulisine must not be mixed with other medicinal products except NPH human insulin.
35 Mešanje z insulini
Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully (see section 6.6).
Pred uporabo OptiSeta natančno preberite navodila za ravnanje z Optisetom v navodilu za uporabo (glejte poglavje 6. 6).
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 in mladostnikih.
36 When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid acting analogues, it may occur earlier.
36 Po injiciranju hitrodelujočih analogov se lahko hipoglikemija, če do nje pride, pojavi bolj zgodaj kot po topnem humanem insulinu.