qanastek/EMEA-V3 huggingface dataset:
A phase I study carried out with insulin glulisine, lispro and regular human insulin in an obese population has demonstrated that insulin glulisine maintains its rapid-acting properties.
Studju fil fażi I fuq l- insulina glulisine, lispro u l- insulina regolari umana fi grupp ta ’ pazjenti obeżi, wera li l- insulina glulisine iżżomm l- abbiltà li taħdem malajr.
0
0 19
TIME - hour
TIME - hour Figura 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.
Ir- rati ta ’ l- infużjoni tal- glukosju wara injezzjoni taħt il- ġilda ta ’ 0. 3 U/ kg ta ’ l- insulina glulisine (GLULISINE) jew l- insulina lispro (LISPRO) jew l- insulina regolari umana (REGULAR) fi grupp ta ’ pazjenti li jbatu minn obeżità.
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.
Studju ieħor fil- fażi I bejn l- insulina glulisine u l- insulina lispro, fi grupp ta ’ nies mhux dijabetiċi fi 80 – il individwu li kellhom firxa wiesgħa fl- indiċi tal- piż tal- ġisem (18– 46 kg/ m2), wera li l- azzjoni mgħaġġla hija ġeneralment mantenuta f’ firxa wiesgħa fl- indiċi tal- piż tal- ġisem, waqt li l- effett totali fuq it- tnaqqis fil- livell tal- glukosju jonqos ma ’ żieda fil- livell ta ’ l- obeżità.
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.
Dijabete mellitus tat- tip 1 - Adulti Fi studju komparattiv, fil- fażi III, tul ta ’ 26 ġimgħa, fejn l- insulina glulisine u l- insulina lispro ingħataw taħt il- ġilda ftit ħin (0 sa 15- il minuta) qabel ikla, f’ pazjenti bid- dijabete tat- tip I, fil- waqt li l- insulina glargine intużat bħala insulina bażika, l- insulina glulisine kienet komparabbli ma ’ l- insulina lispro fil- kontroll taz- zokkor fid- demm, kif rifless fil- bidliet ta ’ l- emoglobina glycated (espressa bħala l- ekwivalenti ta ’ HbA1c), mil- linja bażi sat- tmiem.
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).
Studju kliniku, fil- fażi III, tul ta ’ 12- il ġimgħa, magħmul fuq pazjenti bid- dijabete mellitus tat- tip I, li kienu qed jingħataw l- insulina glargine bħala terapija bażika, wera, li meta l- insulina glulisine ingħatat immedjatament wara l- ikel, din kellha effikaċja komparabbli ma’ dik ta ’ l- insulina glulisine li ngħatat immedjatament (0 sa 15- il minuta) qabel l- ikel, jew ma ’ dik ta ’ l- insulina regolari (30 sa 45 minuta).
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.
Dijabete mellitus tat- tip 1 – Pedjatriċi Fi studju kliniku, fil- fażi III, ta ’ 26 ġimgħa, ġew imqabbla l- insulina glulisine u l- insulina lispro li ingħataw taħt il- ġilda ftit ħin (0 sa 15- il minuta) qabel ikla, fi tfal (4- 5 snin: n=9; 6- 7 snin: n=32 u 8- 11 snin: n=149) u adoloxxanti (12- 17 – il sena: n=382) bid - dijabete mellitus tat- tip 1, fil- waqt li l- insulina glargine jew NPH intużaw bħala insulina bażika.
Insulin glulisine was comparable to insulin lispro for glycaemic control as reflected by changes in glycated haemoglobin (GHb expressed as HbA1c equivalent) from baseline to endpoint and by self-monitored blood glucose values.
L- insulina glulisine kienet komparabbli ma ’ l - insulina lispro fil- kontroll taz- zokkor fid- demm, kif rifless fil- bidliet ta ’ l- emoglobina glycated (GHb espressa bħala l- ekwivalenti ta ’ HbA1c), mil- linja bażi sat- tmiem u l- livelli ta ’ glukosju fid- demm fl - immonitorjar mill- pazjent innifsu.
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).
L- insulina glulisine intweriet li kienet komparabbli ma ’ l - insulina regolari umana fir- rigward tal- bidliet mil- linja bażi ta ’ l- emoglobina glycated (espressa bħala l- ekwivalenti ta ’ HbA1c) sa tmiem il- perijodu ta ’ 6 xhur (- 0. 46% għall- insulina glulisine u - 0. 30% għall- insulina regolari umana, p=0. 0029), u mil- linja bażi sa tmiem il- perijodu ta ’ 12- il xahar (- 0. 23% għall- insulina glulisine u - 0. 13% għall- insulina regolari umana; id- differenza mhix statistikament
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.
Razza u Sess maskil/ femminil Fi provi kliniċi ikkontrollati fl- adulti, l- insulina glulisine ma urietx differenzi fis- sigurtà u l- effikaċja, meta saret l- analiżi f’ sottogrupp, imqassma fuq bażi ta ’ razza u s- sess.
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.
Fi studju fuq pazjenti bid- dijabete mellitus tat- tip I, wara li ngħatat l- insulina taħt il- ġilda f’ doża ta ’ 0. 15 U/ kg, it- Tmax kien ta ’ 55 minuta u ċ- Cmax kien 82 ± 1. 3 µU/ ml għall- insulina glulisine, fil- waqt li t - Tmax kien ta ’ 82 minuta u ċ- Cmax kien 46 ± 1. 3 µU/ ml għall- insulina regolari umana.
Pharmacokinetic profile of insulin glulisine and regular human insulin in type 1 diabetes mellitus patients after a dose of 0.15 U/ kg.
Il- profili farmakokinetiċi ta ’ l- insulina glulisine u l- insulina regolari umana f’ pazjenti bid - dijabete mellitus tat- tip I, wara doża ta ’ 0. 15 U/ 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.
21 F’ studju f’ pazjenti bid- dijabete mellitus tat- tip 2, wara li ngħatat l- insulina glulisine taħt il- ġilda, f’ doża ta ’ 0. 2 U/ kg, iċ- Cmax kien 91 µU/ ml fil- medda interquartile minn 78 sa 104 U/ 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.
Studju ieħor fil- fażi I bejn l- insulina glulisine u l- insulina lispro, fi grupp ta ’ nies mhux dijabetiċi fi 80 – il individwu li kellhom firxa wiesgħa fl- indiċi tal- piż tal- ġisem (18– 46 kg/ m2), wera li l- assorbiment mgħaġġel u l- espożizzjoni totali huwa ġeneralment mantenut fuq firxa wiesgħa fl- indiċi tal- piż tal - ġisem.
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).
F’ studju wiesa ’ u analitiku fuq l- insulina glulisine, kemm f’ individwi b’ saħħithom kif ukoll f’ dawk bid- dijabete mellitus tat- tip 1 jew 2, il- half- life apparenti kienet minn 37 minuta sa 75 minuta (interquartile range).
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.
Indeboliment renali Fistudju kliniku magħmul fuq individwi mhux dijabetiċi, li mess firxa wiesa ’ ta ’ livell tal- funzjoni renali (CrCl > 80 ml/ min, 30- 50 ml/ min, < 30 ml/ min), il- karatteristiċi ta ’ l- insulina glulisine li taħdem malajr ġeneralment jinżammu.
Insulin glulisine was rapidly absorbed in both age groups, with similar Tmax and Cmax as in adults (see section 4.2).
L- insulina glulisine kienet assorbita malajr fiż- żewġ gruppi ta’ etajiet, b’ Tmax u Cmax l- istess bħall- adulti (ara sezzjoni 4. 2).
Non-clinical data did not reveal toxicity findings others than those linked to the blood glucose lowering pharmacodynamic activity (hypoglycemia), different from regular human insulin or of clinical relevance for humans.
22 Informazzjoni li mhiex klinika m’ urietx effetti tossiċi, ħlief għal dawk marbuta ma ’ l- attività farmakodinamika tat- tnaqqis fil- livelli tal- glukosju fid- demm (l- ipogliċemija), li kienu differenti minn dawk ta ’ l- insulina regolari umana jew li għandhom xi relevanza klinika għal bniedem.
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products except NPH human insulin.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief għall- insulina umana 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.
Il- pinna li fiha skartoċċ m’ għandhiex tinħażen fi friġġ.
Do not freeze.
Skartoċċi mhux miftuħa Aħżen fi friġġ (2°Ċ - 8°Ċ). Tagħmilhomx fil- friża.
In use cartridges For storage precautions, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna, ara sezzjoni 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 soluzzjoni fi skartoċċ (ħġieġ mingħajr kulur, tat- tip I) bi planġer (lastku elastomeriku) u għatu bi flanġ (ta ’ l- aluminju) b’ tapp (lastku elastomeriku).
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.
23 L- iskartoċċi għandhom jintużaw flimkien ma ’ pinna ta ’ l- insulina bħal Optipen u pinen oħrajn li jaqblu ma ’ l- iskartoċċi ta ’ Apidra u skond kif inhu irrakkomandat fl- informazzjoni mgħotija mill - manifattur fil- letteratura li tiġi mal- pinna.
The manufacturer’ s instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
L- istruzzjonijiet tal- manifattur dwar l- użu tal- pinna għandhom ikunu segwiti bir- reqqa meta jiddaħħal l- iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni ta ’ l- insulina.
It must only be used if the solution is clear, colourless, with no solid particles visible.
Għandu jintuża biss jekk is- soluzzjoni hija ċara, mingħajr kulur, u m’ għandhiex frak viżibbli.
Air
Qabel ma jiddaħħal l- iskartoċċ fil- pinna li terġa ’ tintuża, l- iskartoċċ għandu jinżamm f’ temperatura tal- kamra għal minn siegħa sa sagħtejn.
22 bubbles must be removed from the cartridge before injection (see instruction for using pen).
Il- bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel l - injezzjoni (ara l- istruzzjonijiet dwar l- użu tal- pinna).
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.
Jekk il- pinna ta ’ l - insulina għandha l- ħsara jew m’ hijiex taħdem tajjeb (minħabba xi difetti mekkaniċi) għandha tintrema u tintuża pinna ta ’ l- insulina ġdida.
To prevent any kind of contamination, the re-usable pen should be used by a single patient only.
Biex tkun evitata kull xorta ta ’ kontaminazzjoni, il- pinna li terga ’ tintuża għandha tintuża minn pazjent wieħed biss.
Mixing with insulins
Taħlit ma ’ insulini
Sanofi-Aventis Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Germany.
Sanofi- Aventis Deutschland GmbH, Brueningstrasse 50, D- 65926 Frankfurt am Main, il- Ġermanja.
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.
Dawn l- unitajiet huma esklussivament għal Apidra u m’ humiex l- istess bħal IU jew dawk l- unitajiet użati biex tkun stmata il- qawwa ta ’ analogi oħra ta ’ l - insulina oħra.
Injection sites and infusion sites within an-injection area (abdomen, thigh or deltoid) should be rotated from one injection to the next.
Il- postijiet ta ’ l- injezzjoni u l- infużjoni f’ parti partikolari (iż- żaqq, il- koxxa few id- deltoid), għandhom jinbidlu minn injezzjoni għall- oħra.
The rate of absorption, and consequently the onset and duration of action, may be affected by the injection site, exercise and other variables.
Ir- rata ta ’ assorbiment, u konsegwentement it- tul ta ’ ħin biex is- sustanza tibda taħdem u kemm iddum taħdem, jistgħu jiġu effetwati mil- post ta ’ l- injezzjoni, l- eżerċizzju u fatturi oħra li jistgħu jinbiddlu.
Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2).
L - injezzjoni taħt il- ġilda taż- żaqq tassigura assorbiment ftit aktar mgħaġġel minn siti oħrajn ta ’ injezzjoni (ara sezzjoni 5. 2).
Care should be taken to ensure that a blood vessel has not been entered.
25 Wieħed irid joqgħod attent li l- injezzjoni ma ssirx ġo vina jew arterja.
Patients must be educated to use proper injection techniques.
Il- pazjenti għandhom jiġu mgħallma dwar il- mod korrett ta ’ kif tingħata l- injezzjoni..
Mixing with insulins
It- taħlit ma ’ l- insulini
24 In the absence of compatibility studies, insulin glulisine must not be mixed with other medicinal products except NPH human insulin.
Fin- nuqqas ta ’ studji dwar il- kompatibiltà, l- insulina glulisine m’ għandhiex titħallat ma ’ sustanzi mediċinali oħra, ħlief għall- insulina umana NPH.
Elderly Limited pharmacokinetic data are available in elderly patients with diabetes mellitus.
Anzjani Il- karateristiċi farmakokinetiċi disponibbli hija limitata f’ pazjenti anzjani bid- dijabete mellitus.
Children and adolescents There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
Tfal u adoloxxenti M’ hemmx biżżejjed informazzjoni klinika adegwata dwar l- użu ta ’ Apidra fit- tfal taħt 6 snin.
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.
26 L- aġġustament tad- dożaġġ jista ’ jkun meħtieġ ukoll f’ dawk il- pazjenti li jżidu attività fiżika jew jibdlu l- ħin tas- soltu meta jieklu.
Exercise taken immediately after a meal may increase the risk of hypoglycaemia.
L- eżerċizzju magħmul immedjatament wara l- ikel jista ’ jżid ir- riskju ta ’ l - ipogliċemija.
25 Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death.
Reazzjonijiet ta ’ ipogliċemija u ipergliċemija li ma jiġux ikkoreġuti jistgħu jikkaġunaw it- telf mis - sensi, koma jew mewt.
Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
L- ammonti ta ’ insulina meħtieġa jistgħu jonqsu waqt l - ewwel trimestru tat- tqala u ġeneralment jiżdiedu waqt it- tieni u t- tielet trimestri.
Lactation
27 Treddigħ
26 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
Dan jista ’ jwassal għal riskju f’ sitwazzjonijiet meta dawn l- abbiltajiet huma ta ’ importanza speċjali (is- sewqan ta ’ karozza jew fit - tħaddim ta’ magni).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa ghandhom jitniżżlu skond is- serjetà tagħhom.
Severe cases of generalized allergy, including anaphylactic reaction, may be life threatening.
Każijiet severi ta ’ allerġija ġeneraliżżata, li jinkludu r- reazzjoni anafilattika, jistgħu jkunu fatali.
27 4.9 Overdose
28 4. 9 Doża eċċessiva
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.
29 L- insulina glulisine tibda taħdem darbtejn aktar malajr mill- insulina regolari umana u ttemm l- effett fuq it- tnaqqis tal- livell tal- glukosju madwar sagħtejn aktar kmieni mill- insulina regolari umana.
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
Studju fil- fażi I, f’ pazjenti li għandhom id- dijabete mellitus tat- tip I, assessja l- profili ta ’ l- insulina glulisine u dik regolari umana għall- kapaċita tagħhom biex iniżżlu l- livell tal- glukosju, meta dawn ingħataw taħt il- ġilda f’ doża ta ’ 0. 15 U/ kg, f’ ħinijiet varji relatati ma ’ ikla standardiżżata ta ’ 15- il minuta.
Data indicated that insulin glulisine administered 2 minutes before the meal gives similar postprandial glycemic control compared to regular human insulin given 30 minutes before the meal.
Id- data indikat li meta l- insulina glulisine tingħata 2 minuti qabel l- ikla din tagħti l- istess kontroll tal- glukosju wara li jittieħed l- ikel, daqs l- insulina regolari umana meta din ingħatat 30 minuta qabel l- ikla.
2 3 4
234 5 TIME - hour ĦIN - siegħa
2 3
2 3 4 5 6 TIME -- siegħa ĦIN hour
A phase I study carried out with insulin glulisine, lispro and regular human insulin in an obese population has demonstrated that insulin glulisine maintains its rapid-acting properties.
F’ dan l- istudju, il- ħin ta ’ 20% ta ’ l- AUC
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).
totali u l- AUC (0 sa sagħtejn), li jirrappreżentaw l- attività bikrija ta ’ tnaqqis fil- livell tal- glukosju, kienu rispettivament 114- il minuta u 427 mg. kg- 1 għall- insulina glulisine, 121 minuta u 354 mg. kg- 1 għall- lispro, 150 minuta and 197 mg. kg- 1 għall- insulina regolari umana (ara figura 2).
12
ĦIN - 30 siegħa 12
10 GLULISINE LISPRO GIR - mg/ kg/ min
10 GLULISINE LISPRO
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.
Dijabete mellitus tat- tip1 – - Adulti i Fi studju komparattiv, fil- fażi III, tul ta ’ 26 ġimgħa, fejn l- insulina glulisine u l- insulina lispro ingħataw taħt il- ġilda ftit ħin (0 sa 15- il minuta) qabel ikla, f’ pazjenti bid- dijabete tat- tip I, fil- waqt li l- insulina glargine intużat bħala insulina bażika, l- insulina glulisine kienet komparabbli ma ’ l- insulina lispro fil- kontroll taz- zokkor fid- demm, kif rifless fil- bidliet ta ’ l- emoglobina glycated (espressa bħala l- ekwivalenti ta ’ HbA1c), mil- linja bażi sat- tmiem.
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.
Dijabete mellitus tat- tip 1 – Pedjatriċi Fi studju kliniku, fil- fażi III, ta ’ 26 ġimgħa, ġew imqabbla l- insulina glulisine u l- insulina lispro li ingħataw taħt il- ġilda ftit ħin (0 sa 15- il minuta) qabel ikla, fi tfal (4- 5 snin: n=9; 6- 7 snin: n=32 u 8- 11 snin: n=149) u adoloxxanti (12- 17 – il sena: n=382) bid - dijabete mellitus tat- tip 1, fil- waqt li l- insulina
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.
Id- dijabete mellitus tat- tip 2 - Adulti Sar studju kliniku, fil- fażi III, fuq tul ta ’ żmien ta ’ 26 ġimgħa, segwit minn studju ieħor ta ’ 26 ġimgħa dwar is- sigurtà, biex jikkompara l- insulina glulisine (0 sa 15- il minuta qabel ikla) ma ’ l- insulina regolari umana (30- 45 minuta qabel ikla), injettata taħt il- ġilda, f’ pazjenti bid- dijabete mellitus tat- tip 2, li kienu ukoll qed jużaw l- insulina NPH bħala l- insulina bażika.
In this study, the majority of patients (79%) mixed their short acting insulin with NPH insulin immediately
F’ dan l- istudju, il- maġġoranza tal- pazjenti (79%) ħalltu l- insulina tagħhom, li taħdem fuq perijodu qasir, ma ’ l- insulina NPH immedjatament qabel l- injezzjoni, u 58% ta ’ individwi, mingħajr ma ’ saret l- għazla, użaw is- sustanzi orali ipogliċemiċi; dawn ingħataw struzzjonijiet biex jibqgħu jużawhom fl- istess doża.
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.
Razza u Sess maskil/ femminil Fi provi kliniċi ikkontrollati fl- adulti, l- insulina glulisine ma urietx differenzi fis- sigurtà u l- effikaċja, meta saret l- analiżi f’ sottogrupp, imqassma fuq bażi ta ’ razza u s- sess.
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.
Fi studju fuq 18- il individwu maskil b ’ dijabete mellitus tat- tip 1 ta ’ età minn 21 sa 50 sena, l- insulina glulisine turi proporzjonalità fid- doża għall- espożizzjoni kmieni, massima u totali fil- firxa tad- doża minn 0. 075 sa 0. 4 U/ kg.
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.
Fi studju fuq pazjenti bid- dijabete mellitus tat- tip I, wara li ngħatat l- insulina taħt il- ġilda f’ doża ta ’ 0. 15 U/ kg, it- Tmax kien ta ’ 55 minuta u ċ- Cmax kien 82 ± 1. 3 µU/ ml għall- insulina glulisine, fil- waqt li t - Tmax kien ta ’ 82 minuta u ċ- Cmax kien 46 ± 1. 3 µU/ ml għall- insulina regolari umana.
The mean residence time of insulin glulisine was shorter (98 min) than for regular human insulin (161 min) (see figure3).
Il- ħin medju kemm iddum l- insulina glulisine kien iqsar (98 minuta) minn dak ta ’ l- insulina regolari umana (161 minuta) (ara figura 3).
Pharmacokinetic profile of insulin glulisine and regular human insulin in type 1 diabetes mellitus patients after a dose of 0.15 U/ kg.
32 KONĊ TA ’ L- INSULINA – μU/ mL 80 GLULISINE REGULAR
31 absolute bioavailability (70%) of insulin glulisine was similar between injection sites and of low intra- subject variability (11%CV).
Il- bijodisponibilità assoluta (70%) ta ’ l- insulina glulisine kienet l- istess fis- siti ta ’ l - injezzjoni u kellha varjabilità baxxa fl- istess individwi (11% CV).
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.
Studju ieħor fil- fażi I bejn l- insulina glulisine u l- insulina lispro, fi grupp ta ’ nies mhux dijabetiċi fi 80 – il individwu li kellhom firxa wiesgħa fl- indiċi tal- piż tal- ġisem (18– 46 kg/ m2), wera li l- assorbiment mgħaġġel u l- espożizzjoni totali huwa ġeneralment mantenut fuq firxa wiesgħa fl- indiċi tal- piż tal - ġisem.
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.
Indeboliment renali Fi studju kliniku magħmul fuq individwi mhux dijabetiċi, li mess firxa wiesa ’ ta ’ livell tal- funzjoni renali( CrCl > 80 ml/ min, 30- 50 ml/ min, < 30 ml/ min), il- karatteristiċi ta ’ l- insulina glulisine li taħdem
Hepatic impairment The pharmacokinetic properties have not been investigated in patients with impaired liver function.
Indeboliment Epatiku Il- karatteristiċi farmakokinetiċi ma ġewx investigati f’ pazjenti li għandhom indeboliment tal- fwied.
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.
Il- prodott jista ’ jinħażen għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
The pen containing the cartridge must not be stored in the refrigerator.
Il- pinna li fiha l- iskartoċċ m’ għandhiex tinħażen fil- friġġ.
Do not freeze.
Skartoċċi mhux miftuħa Aħżen fi friġġ (2°Ċ - 8°Ċ) Tagħmilhomx fil- friża.
Keep the cartridge in the outer carton in order to protect from light.
34 Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
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 soluzzjoni f’ skartoċċ (ħġieġ mingħajr kulur, tat- tip I) bi planġer (lastku elastomeriku) u għatu bi flanġ (ta ’ l- aluminju) b’ tapp (lastku elastomeriku).
The glass cartridge is irreversibly integrated in a transparent container and attached to a plastic mechanism by a threaded rod at one extremity.
L- iskartoċċ tal- ħġieġ, li hu integrat b’ mod irreversibbli f’ kontenitur trasparenti, huwa mqabbad permezz ta ’ virga b’ kamin ma ’ mekkaniżmu tal- plastik f’ tarf tiegħu.
Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges for OptiClik are available.
Pakketti ta ’ 1, 3, 4, 5, 6, 8, 9 u 10 skartoċċi huma disponibbli għall- użu ma ’ l- OptiClik.
The cartridges for OptiClik are to be used in conjunction with OptiClik only, and as recommended in the information provided by the device manufacturer.
L- iskartoċċi għall- OptiClik għandhom jintużaw flimkien mal- OptiClik biss, u skond kif inhu irrakkomandat fl- informazzjoni mgħotija mill- manifattur fil- letteratura li tiġi magħha.
The manufacturer’ s instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.
L- istruzzjonijiet li jiġu mal- pinna mill- manifattur għandhom ikunu segwiti bir- reqqa meta jiddaħħal l - iskartoċċ, titwaħħal il- labra, u tingħata l- injezzjoni ta ’ l- 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.
Jekk l- OptiClik tkun bil- ħsara jew mhix taħdem sew (dovut għal difetti mekkaniċi), din trid titwarrab u għandha tintuża OptiClik ġdida.
Before insertion of the cartridge into the reusable pen, the cartridge must be stored at room temperature for 1 to 2 hours.
Qabel ma jiddaħħal l- iskartoċċ fil- pinna li terġa ’ tintuża, l- iskartoċċ għandu jinżamm f’ temperatura tal- kamra għal minn siegħa sa sagħtejn.
It must only be used if the cartridge is intact and the solution is clear, colourless, with no solid particles visible.
Għandu jintuża biss jekk l - iskartoċċ huwa intatt, u s- soluzzjoni hija ċara, mingħajr kulur, u m’ għandhiex frak viżibbli.
Air bubbles must be removed from the cartridge before injection (see instruction for using pen).
Il- bżieżaq ta ’ l- arja għandhom jitneħħew mill- iskartoċċ qabel l- injezzjoni (ara l- istruzzjonijiet dwar l- użu tal - pinna).
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.
Jekk il- pinna ma taħdimx sew, (ara l- istruzzjonijiet dwar l- użu tal- pinna) is- soluzzjoni tista ’ tinġibed lura mill- iskartoċċ f’ siringa (adatta għal insulina ta ’ 100 Unità/ ml) u tiġi njettata.
To prevent any kind of contamination, the re-usable pen should be used by a single patient only.
Biex tkun evitata kull xorta ta ’ kontaminazzjoni, il- pinna li terga ’ tintuża għandha tkun riservata għall - użu minn pazjent wieħed biss.
Apidra 100 Units/ ml, solution for injection in a pre-filled pen.
Apidra 100 Unità/ ml, soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest
Each pen contains 3 ml of solution for injection, equivalent to 300 Units.
Kull pinna fiha 3 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għall- 300 Unità.
Apidra should be given by subcutaneous injection or by continuous subcutaneous pump infusion.
Apidra għandu jingħata b’ injezzjoni taħt il- ġilda jew permezz ta ’ pompa għall- infuzjoni kontinwa taħt il- ġilda.
Apidra should be administered subcutaneously in the abdominal wall, thigh or deltoid or by continuous infusion in the abdominal wall.
Apidra għandu jingħata taħt il- ġilda taż- żaqq, tal- koxxa jew fil- parti tad- deltoid tad- driegħ, jew permezz ta ’ infuzjoni kontinwa taħt il- ġilda taż- żaqq.
Subcutaneous injection in the abdominal wall ensures a slightly faster absorption than other injection sites (see section 5.2).
L - injezzjoni taħt il- ġilda taż- żaqq tassigura assorbiment ftit aktar mgħaġġel minn postijiet oħrajn ta ’ injezzjoni (ara sezzjoni 5. 2).
Care should be taken to ensure that a blood vessel has not been entered.
37 Wieħed irid joqgħod attent li l- injezzjoni ma ssirx ġo vina jew arterja.
35 In the absence of compatibility studies, insulin glulisine must not be mixed with other medicinal products except NPH human insulin.
Fin- nuqqas ta ’ studji dwar il- kompatibiltà, l- insulina glulisine m’ għandhiex titħallat ma ’ sustanzi mediċinali oħra, ħlief għall- insulina umana NPH.
Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully (see section 6.6).
Qabel ma tintuża OptiSet, l- Istruzzjonijiet Għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif għandhom jinqraw b’ attenzjoni (ara sezzjoni 6. 6).
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.
38 L- aġġustament tad- dożaġġ jista ’ jkun meħtieġ ukoll f’ dawk il- pazjenti li jżidu l- attività fiżika jew jibdlu l- ħin tas- soltu meta jieklu.
36 When compared with soluble human insulin, if hypoglycaemia occurs after an injection with rapid acting analogues, it may occur earlier.
Meta mqabbla ma ’ l- insulina solubbli umana, jekk l- ipogliċemija tiġri wara injezzjoni ta ’ analogi ta ’ l- insulina analoga li jaħdmu malajr, din tista ’ titfaċċa aktar kmieni.
Handling of the pen Before using OptiSet, the Instructions for Use included in the Package Leaflet must be read carefully.
L- immaniġġar tal- pinna Qabel ma jintuża OptiSet, l- Istruzzjonijiet Għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif għandhom jinqraw b’ attenzjoni.
OptiSet has to be used as recommended in these Instructions for Use (see section 6.6).
OptiSet għandu jintuża kif irrakkomandat f’ dawn l- Istruzzjonijiet għall- Użu (ara sezzjoni 6. 6).
Studies on pharmacokinetic interactions have not been performed.
Ma sarux studji fuq interazzjonijiet farmakokinetiċi.
Careful monitoring of glucose control is essential.
Wiehed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal. L- immoniteraġġ bil- ħsieb tal- kontroll tal- livelli tal- glukosju huwa essenzjali.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
39 Huwa essenzjali li jinżamm kontroll metaboliku tajjeb tul it- tqala kollha fil- pazjenti li żviluppaw id - dijabete qabel jew waqt it- tqala innifisha.
37 It is unknown whether insulin glulisine is excreted in human milk, but in general insulin does not pass into breast milk and is not absorbed after oral administration.
Mhux magħruf jekk l- insulina glulisine toħroġx fil- ħalib tas- sider fil- bniedem, iżda normalment l - insulina ma tgħaddix fil- ħalib tas- sider u m’ hix assorbita wara li tingħata oralment.
General disorders Uncommon:
40 Disturbi ġenerali Mhux komuni:
Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnea, allergic dermatitis and pruritus.
Reazzjonijiet sistemiċi ta ’ sensittività eċċessiva Reazzjonijiet sistemiċi ta ’ sensittività eċċessiva jistgħu jinkludu l- urtikarja, tagħfis fis- sider, qtugħ ta ’ nifs, dermatite allerġika u ħakk.
38 There are no specific data available concerning overdose with insulin glulisine.
M’ hemmx data speċifika disponibbli dwar dożaġġ eċċessiv bl- insulina glulisine.
Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular human insulin.
L- insulina glulisine hija analogu ta ’ insulina rikombinanti tal- bniedem li hija ekwipotenti ma ’ l - insulina regolari umana.
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.
41 Fi studju fuq 18- il individwu maskil b’ dijabete mellitus tat- tip 1 ta ’ età minn 21 sa 50 sena, l- insulina glulisine uriet proporzjonalità bejn id- doża u l- effett fit- tnaqqis tal- livell tal- glukosju f’ doża terapewtika rilevanti ta ’ firxa minn 0. 075 sa 0. 15 U/ kg, u anqas minn żieda proporzjonali fuq l- effett fit- tnaqqis tal- livell tal- glukosju b’ 0. 3 U/ kg jew ogħla, bħall- insulina umana.
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.
Studju fil- fażi I, f’ pazjenti li għandhom id- dijabete mellitus tat- tip I, assessja l- profili ta ’ l- insulina glulisine u dik regolari umana għall- kapaċita tagħhom biex iniżżlu l- livell tal- glukosju, meta dawn ingħataw taħt il- ġilda f’ doża ta ’ 0. 15 U/ kg, f’ ħinijiet varji relatati ma ’ ikla standardiżżata ta ’ 15- il minuta.
When given 2 minutes prior to meal, insulin glulisine provided better postprandial control than regular human insulin given 2 minutes before the
Meta l- insulina glulisine ingħatat 2 minuti qabel l- ikla, din ipprovdiet kontroll ta ’ wara l - ikel aħjar mill- insulina regolari umana li ngħatat 2 minuti qabel l- ikla.
GLUCOSE - mg/ dL
GLUKOSJU – mg/ dl GLUCOSE - mg/ dL GLUCOSE - mg/ dL
GLUCOSE - mg/ dL 180 GLUCOSE - mg/ dL
180 GLUCOSE - mg/ dL
2 3 4 5 6
234 5 TIME - hour ĦIN - siegħa
2 3 4 TIME - hour
2 3 4 5 6 TIME -- siegħa ĦIN hour
Obesity A phase I study carried out with insulin glulisine, lispro and regular human insulin in an obese population has demonstrated that insulin glulisine maintains its rapid-acting properties.
Studju fil fażi I fuq l- insulina glulisine, lispro u l- insulina regolari umana fi grupp ta ’ pazjenti obeżi wera li l- insulina glulisine iżżomm l- abbiltà li taħdem malajr.
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).
F’ dan l- istudju, il- ħin ta ’ 20% ta ’ l- AUC totali u l- AUC (0 sa sagħtejn), li jirrappreżentaw l- attività bikrija ta ’ tnaqqis fil- livell tal- glukosju, kienu rispettivament 114- il minuta u 427 mg. kg- 1 għall- insulina glulisine, 121 minuta u 354 mg. kg- 1 għall- lispro, 150 minuta and 197 mg. kg- 1 għall- insulina regolari umana (ara figura 2).
12
42 12
40 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.
Studju ieħor fil- fażi I bejn l- insulina glulisine u l- insulina lispro, fi grupp ta ’ nies mhux dijabetiċi fi 80 – il individwu li kellhom firxa wiesgħa fl- indiċi tal- piż tal- ġisem (18– 46 kg/ m2), wera li l- azzjoni mgħaġġla hija ġeneralment mantenuta f’ firxa wiesgħa fl- indiċi tal- piż tal- ġisem, waqt li l- effett totali fuq it- tnaqqis fil- livell tal- glukosju jonqos ma ’ żieda fil- livell ta ’ l- obeżità.
0.81, 0.95 (p= < 0.01)] has shown that insulin glulisine effectively controls diurnal post-prandial blood glucose excursions.
Studju fil- fażi I fi 18 il- pazjent obeżi li għandhom id- dijabete mellitus tat- tip 2 (BMI bejn 35 u 40 kg/ m2) bl- insulina glulisine u l- insulina lispro [90% CI: 0. 81, 0. 95( p= < 0. 01)] wera li l- insulina glulisine tikkontrolla effettivament iċ- ċaqlieq fil- livell tal- glukosju fid- demm wara l- ikel, tul il - ġurnata.
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).
Studju kliniku, fil- fażi III, tul ta ’ 12- il ġimgħa, magħmul fuq pazjenti bid- dijabete mellitus tat- tip I, li kienu qed jingħataw l- insulina glargine bħala terapija bażika, wera, li meta l- insulina glulisine ingħatat immedjatament wara l- ikel, din kellha effikaċja komparabbli ma ’ dik ta ’ l- insulina glulisine li ngħatat immedjatament (0 sa 15- il minuta) qabel l- ikel, jew ma ’ dik ta ’ l- insulina regolari (30 sa 45 minuta).
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.
43 Fi studju kliniku, fil- fażi III, ta ’ 26 ġimgħa, ġew imqabbla l- insulina glulisine u l- insulina lispro li ingħataw taħt il- ġilda ftit ħin (0 sa 15- il minuta) qabel ikla, fi tfal (4- 5 snin: n=9; 6- 7 snin: n=32 u 8- 11 snin: n=149) u adoloxxanti (12- 17 – il sena: n=382) bid - dijabete mellitus tat- tip 1, fil- waqt li l- insulina glargine jew NPH intużaw bħala insulina bażika.
41 In controlled clinical trials in adults, insulin glulisine did not show differences in safety and efficacy in subgroup analyses based on race and gender.
Razza u Sess maskil/ femminil Fi provi kliniċi ikkontrollati fl- adulti, l- insulina glulisine ma urietx differenzi fis- sigurtà u l- effikaċja, meta saret l- analiżi f’ sottogrupp, imqassma fuq bażi ta ’ razza u s- sess.
Pharmacokinetic profile of insulin glulisine and regular human insulin in type 1 diabetes mellitus patients after a dose of 0.15 U/ kg.
insulina glulisine u l- insulina regolari umana f’ pazjenti bid- dijabete mellitus tat- tip I, wara doża ta ’ 0. 15 U/ 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.
F’ studju f’ pazjenti bid- dijabete mellitus tat- tip 2, wara li ngħatat l- insulina glulisine taħt il- ġilda, f’ doża ta ’ 0. 2 U/ kg, iċ- Cmax kien 91 µU/ ml fil- medda interquartile minn 78 sa 104 U/ ml.
When insulin glulisine was injected subcutaneously into abdomen, deltoid and thigh, the concentration-time profiles were similar with a slightly faster absorption when administered in the abdomen compared to the thigh.
Meta l- insulina glulisine kienet injettata taħt il- ġilda fiż- zaqq, il- parti tad- deltoid tad- driegħ u l- koxxa, il- profili tal- konċentrazzjoni u l- ħin kienu xorta, b’ assorbiment ftit aktar mgħaggel meta ngħatat fiż - zaqq komparata mal- koxxa.
42 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.
Studju ieħor fil- fażi I bejn l- insulina glulisine u l- insulina lispro, fi grupp ta ’ nies mhux dijabetiċi fi 80 – il individwu li kellhom firxa wiesgħa fl- indiċi tal- piż tal- ġisem (18– 46 kg/ m2), wera li l- assorbiment mgħaġġel u l- espożizzjoni totali huwa ġeneralment mantenut fuq firxa wiesgħa fl- indiċi tal- piż tal - ġisem.
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.
Fi studju wiesa ’ u analitiku
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).
45 fuq l- insulina glulisine, kemm f’ individwi b’ saħħithom kif ukoll f’ dawk bid- dijabete mellitus tat- tip 1 jew 2, il- half- life apparenti kienet minn 37 minuta sa 75 minuta (interquartile range).
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.
Indeboliment renali Fi studju kliniku magħmul fuq individwi mhux dijabetiċi, li mess firxa wiesa ’ ta ’ livell tal- funzjoni renali (CrCl > 80 ml/ min, 30- 50 ml/ min, < 30 ml/ min), il- karatteristiċi ta ’ l- insulina glulisine li taħdem malajr ġeneralment inżammu.
Metacresol Sodium chloride Trometamol Polysorbate 20 Hydrochloric acid, concentrated
Metacresol Sodium chloride Trometamol Polysorbate 20 Hydrochloric acid, ikkonċentrat Sodium hydroxide Ilma għall- injezzjonijiet
The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
46 Żmien kemm iddum tajba l- pinna wara l- ewwel użu.; Il- prodott jista ’ jinħażen għal massimu ta ’ 4 ġimgħat f’ temperatura mhux ’ il fuq minn 25°Ċ ’ il bogħod mis- sħana diretta jew mid- dawl dirett.
Not in-use pens Store in a refrigerator (2°C - 8°C).
Pinen mhux fl- użu:
In use pens For storage precautions, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna, ara sezzjoni 6. 3.
3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric rubber) and a flanged cap (aluminium) with a stopper (elastomeric rubber).
3 ml soluzzjoni fi skartoċċ (ħġieġ mingħajr kulur) bi planġer (lastku elastomeriku) u għatu bi flanġ (ta ’ l- aluminju) b’ tapp (lastku elastomeriku).
The cartridge is sealed in a disposable pre-filled pen.
L- iskartoċċ huwa ssiġillat f’ pinna mimlija għal- lest li tintrema meta tinħela.
Before first use, the pen must be stored at room temperature for 1 to 2 hours.
Qabel ma tintuża għall- ewwel darba, il- pinna għandha tinżamm fit- temperatura tal- kamra għal bejn siegħa sa sagħtejn.
It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Għandu jintuża biss jekk is- soluzzjoni hija ċara u bla kulur, mingħajr frak viżibbli u ta ’ konsistenza bħal dik ta ’ l- ilma.
Since Apidra is a solution, it does not require resuspension before use.
Peress li Apidra huwa soluzzjoni, ma teħtieġx li tagħmilha f’ soluzzjoni qabel l- użu.
Empty pens must never be used and must be properly discarded.
Pinen vojta m’ għandhom qatt jintużaw u għandhom jintremew kif jixraq.
To prevent any kind of contamination, the use of the pre-filled pen should remain strictly for a single patient use.
Biex tkun evitata kull tip ta ’ kontaminazzjoni, l- użu ta ’ pinna mimlija għal- lest għandha tkun ristretta għall- użu minn pazjent wieħed biss.
Handling of the pen The Instructions for Use included in the Package Leaflet must be read carefully before using OptiSet.
47 L- immaniġġar tal- pinna L- Istruzzjonijiet għall- Użu li jinsabu fil- Fuljett ta ’ Tagħrif għandhom jinqraw bir- reqqa qabel tintuża l- OptiSet.
Important information for use of OptiSet: • Always attach a new needle before each use.
Tagħrif importanti għall- użu ta ’ OptiSet: • Dejjem waħħal labra ġdida qabel kull darba li tintuza.
It must not be shared with anyone else. • If the injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
Uża biss labar li huma konpatibbli ma ’ l - uzu ta ’ OptiSet. • Dejjem agħmel it- test ta ’ sigurtà qabel kull injezzjoni. • Jekk ser tintuża OptiSet ġdida, it- test inizjali ta ’ sigurtà għandu jsir bit- 8 unità issettjati minn qabel mill- manifattur. • Il- mekkaniżmu għas- selezzjoni tad- dożaġġ jista ’ jdur f’ direzzjoni waħda. • Qatt m’ għandek iddawwar dan il- mekkaniżmu (tibdel id- doża) wara li l- buttun ta ’ l- injezzjoni jkun inġibed ’ il barra. • Din il- pinna hija intiża għall- użu mill- pazjent biss.
45 • Never use OptiSet if it is damaged or if you are not sure that it is working properly. • Always have a spare OptiSet in case your OptiSet is lost or damaged.
M’ għandhiex tintuża minn ħaddieħor. • Jekk l- injezzjoni tingħata minn persuna oħra, din ta ’ l- aħħar għandha tieħu l- kawtela kollha biex tevita li tweġġa ’ aċċidentalment bil- labra u tkun trasmessa l- infezzjoni. • Qatt tuża OptiSet jekk tkun bil- ħsara jew m’ intix ċert li qed taħdem sew. • Dejjem żomm miegħek OptiSet żejjda f’ każ li tintilef jew jiġrilha l- ħsara.
If OptiSet is in cool storage, it should be taken out 1 to 2 hours before injection to allow it to warm up.
Jekk OptiSet tkun maħżuna fil- kesħa, trid toħroġha minn siegħa sa sagħtejn qabel l- injezzjoni biex tilħaq tisħon.
Step 1
Pass Nru.
Check the Insulin
Iċċekkja l- Insulina
After removing the pen cap, the label on the pen and the insulin reservoir should be checked to make sure it contains the correct insulin.
Wara li tneħħi l- kappa tal- pinna, iċċekkja t- tikketti tal- pinna u r- riżervwar biex tiżgura li għandha t- tip korrett ta’ insulina.
The appearance of insulin should also be checked: the insulin solution must be clear, colourless, with no solid particles visible, and must have a water-like consistency.
48 għandha tkun ċara, mingħajr kulur, b’ ebda frak solidi u viżibbli u għandu jkollha konsistenza bħal dik ta ’ l- ilma.
Step 2
Pass Nru.
Step 3
Pass Nru.
For a new and unused OptiSet, a dose of 8 units is already preset by the manufacturer for the first safety test.
Għal OptiSet ġdida u mhux użata, doża ta ’ 8 unità hija diġà issettjata mill- manifattur għall- ewwel test ta ’ sigurtà.
In-use OptiSet, select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2.
Għal OptiSet fl- użu, agħżel doża ta ’ 2 unitajiet billi ddawwar ’ il quddiem il- mekkaniżmu li jagħżel d - dożaġġ, sakemm il- vleġġa li tindika d- doża tipponta lejn “ 2 ”.
Never turn the dosage selector after injection button has been pulled out.
Qatt m’ għandek iddawwar il- mekkaniżmu li jagħżel id- dożaġġ wara li tkun ġbidt il- buttun ’ il barra.