qanastek/EMEA-V3 huggingface dataset:
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
L- abbiltà tal- pazjent li jikkonċentra u jirreaġixxi tista ’ tonqos bħala riżultat ta ’ l- ipogliċemija jew l - ipergliċemija jew, per eżempju, bħala riżultat ta ’ indeboliment tal- vista.
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).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Il- pazjenti għandhom ikunu avżati biex jieħdu l- prekawzjonijiet biex jevitaw l- ipogliċemija waqt is - sewqan.
This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia.
Dan hu speċjalment importanti f’ dawk li jbatu minn tnaqqis jew l- assenza tas- sintomi bikrija ta ’ l- ipogliċemija jew ikollhom attakki spissi ta ’ l- ipogliċemija.
The advisability of driving should be considered in these circumstances.
Il- parir dwar is- sewqan irid jiġi ikkunsidrata f’ tali ċirkustanzi.
Hypoglycaemia, the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
L- ipogliċemija, li hi l- aktar komuni mill- effetti mhux mixtieqa tat- terapija bl- insulina, tista ’ tiġri jekk id- doża ta ’ l- insulina hija ogħla minn dik meħtieġa.
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).
Mill- istudji kliniċi, ir- reazzjonijiet avversi, li huma relatati li ġejjin huma mniżżla hawn isfel skond is - sistema tal- klassifika ta ’ l- organi u fl- ordni ta ’ frekwenza dejjem tonqos (komuni ħafna: ≥ 1/ 10; komuni: ≥ 1/ 100 sa < 1/ 10; mhux komuni: ≥ 1/ 1, 000 sa < 1/ 100; rari: ≥ 1/ 10, 000 sa < 1/ 1, 000; rari ħafna: < 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
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. L - effetti li huma l- aktar serji ghandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
Metabolism and nutrition disorders Very common:
Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni ħafna:
Hypoglycaemia Symptoms of hypoglycaemia usually occur suddenly.
L- ipogliċemija Ġeneralment, is- sintomi ta ’ l- ipogliċemija jiġru f’ daqqa.
They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Dawn jistgħu jinkludu għaraq kiesaħ, il- ġilda pallida u kiesħa, għeja, in- nervożiżmu jew ir- rogħda, l- anzjetà, l- għeja mhux tas- soltu jew id - debbulizza, il- konfużjoni mentali, id- diffikultà biex tikkonċentra, il- ħeddla, l- ġuħ eċċessiv, bdil fil - vista, uġigħ ta ’ ras, dardir u palpitazzjonijiet.
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.
L- ipogliċemija tista ’ ssir severa u twassal għat- telf miss - sensi u/ jew l- aċċessjonijiet u tista ’ tikkaġuna indeboliment temporanju jew dak permanenti fil- funzjoni tal- moħħ u anki l- mewt.
Skin and subcutaneous tissue disorders Common: injection site reactions and local hypersensitivity reactions.
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni: reazzjonijiet fil- post ta ’ l- injezzjoni u reazzjonijiet lokali ta ’ sensittività eċċessiva.
Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin.
Reazzjonijiet lokali ta ’ sensittività eċċessiva (ħmura, nefħa u ħakk fil- post ta ’ l- injezzjoni) jistgħu jiġru waqt it- trattament bl- insulina.
These reactions are usually transitory and normally they disappear during continued treatment.
Dawn ir- reazzjonijiet huma x’ aktarx transitorji u normalment jisparixxu waqt il- kontinwazzjoni tat- trattament.
Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
5 Il- lipodistrofija tista ’ tiġri fil- post ta ’ l- injezzjoni bħala konsegwenza tan- nuqqas fil- bdil tal- postijiet ta ’ l- injezzjoni f’ żona partikulari.
General disorders Uncommon:
Disturbi ġenerali Mhux komuni:
Systemic hypersensitivity reactions 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.
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.
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
l- ipogliċemija tista ’ tiġri bħala riżultat ta ’ attività eċċessiva ta ’ l- insulina meta mqabbla ma ’ l- ammont ta ’ ikel li jittiekel u l- użu ta ’ l- enerġija.
There are no specific data available concerning overdose with insulin glulisine.
M’ hemmx data speċifika disponibbli dwar dożaġġ eċċessiv bl- insulina glulisine.
However, hypoglycaemia may develop over sequential stages:
Madankollu, l - ipogliċemija tista ’ tiżviluppa fi gradi sekwenzjali:
Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Ġrajjiet ta ’ l- ipogliċemija ħafifa jistgħu jiġu ittrattati bit- teħid orali tal- glukosju jew sustanzi ta ’ zokkor.
It is therefore recommended that the diabetic patient constantly carries some sugar lumps, sweets, biscuits or sugary fruit juice.
Għalhekk, huwa irrakkomandat li l- pazjent dijabetiku jżomm dejjem fuqu xi dadi taz- zokkor, ħelu, gallettini jew meraq tal- frott li fih iz- zokkor.
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.
Grajjiet ta ’ l- ipogliċemija severa, meta l- pazjent ikun mitluf minn sensih, jistgħu jkunu ittrattati bil - glukagon (0. 5 sa milligramma 1), li tingħata fil- muskoli jew taħt il- ġilda minn persuna li rċeviet struzzjonijiet xierqa, jew permezz ta ’ injezzjoni ta ’ soluzzjoni tal- glukosju ġol- vina, mogħtija minn professjonista fil- qasam tas- saħħa.
Glucose must also be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Il- glukosju għandu jingħata ukoll ġol- vina, jekk il- pazjent ma jirrispondix għall- glukagon fi żmien 10 minuti sa 15- il minuta.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Wara li l- pazjent jiġi lura f’ sensih, it- teħid orali ta ’ karboidrat huwa irrakkomandat biex wieħed jevitata li jerġa ’ jiġri l- istess.
After an injection of glucagon, the patient should be monitored in a hospital in order to find the reason for this severe hypoglycaemia and prevent other similar episodes.
Wara injezzjoni ta ’ glukagon, il- pazjent għandu jkun immonitorjat fl- isptar biex tinsab ir- raġuni għal dan l- attakk qawwi ta ’ ipogliċemija u biex jiġu evitati attakki oħra simili.
Pharmacotherapeutic group: insulin and analogues, fast-acting.
Kategorija farmakoterapewtika: insulina u l- analogi tagħha, li jaħdmu malajr.
Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular human insulin.
L- insulina glulisine hija analogu ta ’ l - insulina rikombinanti tal- bniedem li hija ekwipotenti ma ’ l - insulina regolari umana.
Insulin glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin.
L- insulina glulisine tibda taħdem aktar malajr u ddum taħdem għal perijodu iqsar mill- insulina regolari umana.
The primary activity of insulins and insulin analogues, including insulin glulisine, is regulation of glucose metabolism.
L- attività ewlenija ta ’ l- insulini u l- analogi tagħhom, inkluża l- insulina glulisine, hija l- kontroll tal - metaboliżmu tal- glukosju.
Insulins lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
L- insulini jbaxxu l- livelli tal- glukosju fid- demm billi jistimulaw il- ġbir tal - glukosju mit- tessuti periferali, speċjalment mil- muskoli skeletrali u x- xaħam, u billi jinibixxu l - produzzjoni tal- glukosju mill- fwied.
Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
L- insulina tinibixxi l- lipolisi fiċ- ċelluli tax- xaħam, tinibixxi l - proteolisi u ttejjeb is- sintesi tal- proteini.
Studies in healthy volunteers and patients with diabetes demonstrated that insulin glulisine is more rapid in onset of action and of shorter duration of action than regular human insulin when given subcutaneously.
Studji f’ individwi voluntiera b’ saħħithom u f’ pazjenti dijabetiċi, urew li l- insulina glulisine tibda taħdem aktar malajr u ddum taħdem għal perijodu iqsar meta mqabbla ma ’ l- insulina regolari umana, meta dawn jingħataw taħt il- ġilda.
When insuline glulisine is injected subcutaneously, the glucose lowering activity will begin within 10 – 20 minutes.
Meta l- insulina glulisine tkun injettata taħt il- ġilda, tibda tbaxxi l - livell tal- glukosju fi żmien 10 minuti sa 20 minuta.
The glucose-lowering activities of insulin glulisine and regular human insulin are equipotent when administered by intravenous route.
L- insulina glulisine u dik regolari umana huma ekwipotenti biex iniżżlu l- livell tal- glukosju, meta jingħataw ġol- vina.
One unit of insulin glulisine has the same glucose-lowering activity as one unit of regular human insulin.
Unità waħda ta ’ insulina glulisine għandha l- istess qawwa biex tbaxxi l- livell tal- glukosju daqs unità waħda ta ’ insulina regolari umana.
Dose proportionality
6 Proporzjonalità tad- doża
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.
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.
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.
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.
Data indicated that insulin glulisine
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.
6 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.
When given 2 minutes prior to meal, insulin glulisine provided better postprandial control than regular human insulin given 2 minutes before the meal.
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.
Insulin glulisine administered 15 minutes after starting the meal gives similar glycemic control as regular human insulin given 2 minutes before the meal (see figure 1).
L- insulina glulisine mogħtija 15- il minuta wara li tibda tittiekel l- ikla, tipprovdi l- istess kontroll tal- livelli tal- glukosju fid- demm daqs l- insulina regolari umana mogħtija 2 minuti qabel l- ikla (ara figura 1).
GLUCOSE - mg/ dL
GLUKOSJU – mg/ dl
GLUCOSE - mg/ dL 180
180 GLUCOSE - mg/ dL
2 3 4 TIME - hour
234 5 TIME - hour ĦIN - siegħa
2 3 4 5 6 TIME - hour
2 3 4 5 6 TIME -- siegħa ĦIN hour
TIME - hour
ĦIN - siegħa TIME - hour
Figure 1C
Figura 1Ċ
Average glucose-lowering effect over 6 hours in 20 patients with type 1 diabetes mellitus.
Il- medja ta ’ l- effett fuq it- tnaqqis fil- livelli tal- glukosju fuq tul ta ’ ħin ta ’ 6 sigħat f’ 20 pazjent bid- dijabete mellitus tip I.
Insulin glulisine given 2 minutes (GLULISINE pre) before the start of a meal compared to regular human insulin given 30 minutes (REGULAR 30 min) before the start of the meal (figure 1A) and compared to regular human insulin given 2 minutes (REGULAR pre) before a meal (figure 1B).
L- insulina glulisine, mogħtija 2 minuti (GLULISINE pre) qabel il - bidu ta ’ ikla mqabbla ma ’ insulina regolari umana mogħtija 30 minuta (REGULAR 30 min) qabel il - bidu ta ’ l- ikla (figura 1A), u mqabbla ma ’ l- insulina regolari umana mogħtija 2 minuti (REGULAR pre) qabel l- ikla (figura 1B).
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).
L- insulina glulisine mogħtija 15- il minuta (GLULISINE post) wara l - bidu ta ’ l- ikla, mqabbla ma ’ l- insulina regolari umana mogħtija 2 minuti (REGULAR pre) qabel il - bidu ta ’ l- ikla (figura 1Ċ).
On the x-axis, zero (arrow) is the start of a 15-minute meal.
Fuq l- assi x, iż- żero (immarkat bi vleġġa) jirrappreżenta l- bidu ta ’ l- ikla ta ’ 15- il minuta.
Obesity
Obeżità
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.
7 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).
TIME - hour
TIME - hour ĦIN - siegħa
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 obeżi.
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.
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.
Il- medja totali ta ’ GIR AUC bejn 0 sa siegħa waħda kien 102±75 mg/ kg u 158±100 mg/ kg b’ 0. 2 u 0. 4 U/ kg insulina glulisine, rispettivament, u kien 83. 1±72. 8 mg/ kg u 112. 3±70. 8 mg/ kg b’ 0. 2 u 0. 4 U/ kg insulina lispro, rispettivament.
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.
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.
Clinical studies
Studji Kliniċi
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 I - 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.
Comparable self-monitored blood glucose values were observed.
Kienu osservati livelli komparabbli ta ’ glukosju fid - demm fl- immonitorjar mill- pazjent innifsu.
No increase in the basal insulin dose was needed with insulin glulisine, in contrast to insulin lispro.
Ma kienetx meħtieġa żieda fid- doża bażika ta ’ l- insulina glulisine, meta mqabbla ma ’ dik ta ’ l- insulina lispro.
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 8 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).
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.
Skond il- protokoll, fil- grupp ta ’ pazjenti studjati, kien hemm tnaqqis akbar u sinifikanti fil- GHb, f’ dawk li ħadu l- glulisine qabel l- ikel, meta mqabbel ma ’ dawk li kienu fuq l- insulina regolari.
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.
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 ngħataw 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 – il sena: 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. 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.
There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years.
M’ hemmx biżżejjed informazzjoni klinika dwar l- użu ta ’ Apidra fit- tfal taħt 6 snin.
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.
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.
The average body mass index (BMI) of patients was 34.55 kg/ m2.
L- indiċi medju tal- piż tal- ġisem (BMI) tal- pazjenti kien ta ’ 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).
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 sinifikanti).
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.
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 ’ l- individwi, mingħajr ma ’ saret l- għazla, użaw is- sustanzi orali ipogliċemiċi; dawn ingħataw struzzjonijiet biex jibqgħu jużawhom fl- istess doża.
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.
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 insulin glulisine the replacement of the human insulin amino acid asparagine in position B3 by lysine and the lysine in position B29 by glutamic acid favors more rapid absorption.
Fl- insulina glulisine, is- sostituzzjoni ta ’ l- aċidu amminiku asparagine ta ’ l- insulina umana f’ pożizzjoni B3 b’ lysine, u l- lysine f’ pożizzjoni B29 sostitut bl- aċidu glutamiku, jiffavorixxu l- assorbiment aktar mgħaġġel.
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.
Absorption and bioavailability
L- assorbiment u l- bijodisponibilità
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.
Il- profili farmakokinetiċi f’ voluntiera b’ saħħithom u l- pazjenti dijabetiċi (tip 1 jew 2) urew li l - assorbiment ta ’ l- insulina glulisine kien darbtejn aktar mgħaġġel b’ konċentrazzjoni massima ta ’ madwar id- doppju meta mqabbel ma ’ l- insulina regolari umana.
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 mellituspatients 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 U/ ml.
Fi 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 mgħaġġel meta ngħatat fiż - zaqq komparata mal- koxxa.
Absorption from deltoid sites was in-between (see section 4.2).
Il- grad ta ’ l- assorbiment mis- siti tad- deltoid kien jaqa ’ bejniethom (ara sezzjoni 4. 2).
The 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).
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.
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.
The time to 10% of total INS exposure was reached earlier by approximately 5– 6 min with insulin glulisine.
Il- ħin ta ’ 10% ta ’ l- espożizzjoni totali ta ’ l- INS intleħaq aktar kmieni b’ madwar 5- 6 minuti bl- insulina glulisine.
Distribution and elimination
Distribuzzjoni u tneħħija
The distribution and elimination of insulin glulisine and regular human insulin after intravenous administration is similar with volumes of distribution of 13 l and 22 l and half-lives of 13 and 18 minutes, respectively.
Id- distribuzzjoni u t- tneħħija ta ’ l- insulina glulisine u l- insulina regolari umana, wara li jingħataw ġol - vina, huma l- istess, b’ volum ta ’ distribuzzjoni ta ’ 13 l u 22 l u half- life ta ’ 13 u 18- il minuta, rispettivament.
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.
Wara li l- insulina tingħata taħt il- ġilda, l- insulina glulisine titneħħa aktar malajr mill- insulina regolari umana, b’ half- life apparenti ta ’ 42 minuta meta mqabbla ma ’ 86 minuta.
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).
Fi 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).
Insulin glulisine shows low plasma protein binding, similar to human insulin.
L- insulina glulisine turi qabda baxxa mal- proteini tal- plażma, simili għall- insulina umana.
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.
10 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.
However, insulin requirements may be reduced in the presence of renal impairment.
Madankollu, l- ħtieġa għall- insulina tista ’ tonqos fil- preżenza ta ’ indeboliment renali.
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.
Elderly Very limited pharmacokinetic data are available for elderly patients with diabetes mellitus.
Anzjani Id- data disponibbli hija limitata ħafna fil- pazjenti anzjani li għandhom id- dijabete mellitus.
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.
Tfal u adolexxenti Il- karatteristiċi farmakokinetiċi u farmakodinamiċi ta ’ l- insulina glulisine kienu studjati fit- tfal (7snin sa 11- il sena) u l- adolexxenti (12- 16- il sena) li kellhom id- dijabete mellitus tat- tip I.
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).
Administered immediately before a test meal, insulin glulisine provided better postprandial control than regular human insulin, as in adults (see section 5.1).
L- insulina glulisine meħuda immedjatament qabel ikla waqt prova, ipprovdiet kontroll aħjar tal- livell taz- zokkor fid- demm, wara l- ikel, mill- insulina regolari umana, kif inhu fl- adulti (ara sezzjoni 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.
Il- ħarġa tal- glukosju (AUC 0- 6h) kien ta ’ 641 mg. h. dl- 1 għall- insulina glulisine u 801 mg. h. dl- 1 għall- insulina regolari umana.
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.
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.
Metacresol Sodium chloride Trometamol Polysorbate 20 Hydrochloric acid, concentrated Sodium hydroxide Water for injections
Metacresol Sodium chloride Trometamol Polysorbate 20 Hydrochloric acid, ikkonċentrat Sodium hydroxide Ilma għall- injezzjonijiet
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.
When used with an insulin infusion pump, Apidra must not be mixed with other medicinal products.
Meta Apidra jintuża f’ pompa ta ’ l- insulina għall- infużjoni, m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
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.
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.
It is recommended that the date of the first use from the vial be noted on the label.
Huwa rakkomandat li d- data ta ’ l- ewwel użu mill- kunjett tkun imniżżla fuq it- tikketta.
Unopened vials Store in a refrigerator (2°C - 8°C)
Kunjetti mhux miftuħa Aħżen fi friġġ (2°Ċ - 8°Ċ)
Do not put Apidra next to the freezer compartment or a freezer pack.
Apidra m’ għandux jitpoġġa viċin il- kompartiment tal- friża jew viċin xi pakkett tal- friża.
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 soluzzjoni f’ kunjett (ħġieġ mingħajr kulur, tat- tip I) b’ tapp (siġillat bi flanġ ta ’ l- aluminju, lastku elastomeriku) u għatu li jiċċarrat.
Packs of 1, 2, 4 and 5 vials are available.
Pakketti ta ’ 1, 2, 4 u 5 kunjetti huma disponibbli.
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).
Il kunjetti ta ’ Apidra huma għall- użu bis- siringi ta ’ l- insulina li għandhom l- iskala korrispondenti ta ’ l - unità u għall- użu ma ’ sistema ta ’ pompa ta ’ l- insulina (ara sezzjoni 4. 2).
Inspect the vial before use.
Eżamina l- kunjett qabel l- użu.
It must only be used if the solution is clear, colourless, with no solid particles visible.
Jista ’ jintuża biss jekk is- soluzzjoni hija ċara, mingħajr kulur, u m’ għandhiex frak viżibbli.
Since Apidra is a solution, it does not require resuspension before use.
Peress li Apidra hija soluzzjoni, ma teħtieġx li tagħmilha f’ soluzzjoni qabel l- użu.
11 Mixing with insulins
Taħlit ma ’ insulini
When mixed with NPH human insulin, Apidra should be drawn into the syringe first.
Meta titħallat ma ’ l- insulina umana NPH, Apidra għandu jittella ’ l- ewwel fis- siringa.
Injection should be given immediately after mixing as no data are available regarding the mixtures made up a significant time before injection.
L- injezzjoni għandha tingħata immedjatament wara li titħallat għax m’ hemmx data disponibbli rigward it- taħlitiet magħmulin f’ tul ta ’ ħin sinifikanti qabel l- injezzjoni.
Continuous subcutaneous infusion pump
Pompa għall- infużjoni kotinwa taħt il- ġilda
Apidra may be used for Continuous Subcutaneous Insulin Infusion (CSII) in pump systems suitable for insulin infusion with the appropriate catheters and reservoirs.
Apidra jista ’ jintuża għall- infużjoni kontinwa ta ’ l- insulina taħt il- ġilda (CSII) f’ sistemi li jutiliżżaw pompa xierqa għall- infużjoni ta ’ l- insulina b’ kateter u riżervwar xierqa.
Patients using CSII should be comprehensively instructed on the use of the pump system.
Il- pazjenti li jużaw CSII għandhom jiġu mħarrġa sew dwar l- użu tas- sistema fejn tintuża pompa.
The infusion set and reservoir should be changed every 48 hours using aseptic technique.
Is - sett ta ’ l- infużjoni u r- riżervwar għandhom jinbidlu kull 48 siegħa bl- użu ta ’ teknika asettika.
Patients administering Apidra by CSII must have alternative insulin available in case of pump system failure.
Il- pazjenti li qed jieħdu Apidra b’ CSII għandu jkollhom insulina alternattiva fil- każ li l- pompa jiġrilha l- ħsara.
Sanofi-Aventis Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Germany.
Sanofi- Aventis Deutschland GmbH, Brueningstrasse 50, D- 65926 Frankfurt am Main, Ġermanja.
27 September 2004
27 ta ’ Settembru 2004
Apidra 100 Units/ ml, solution for injection in a cartridge.
Apidra 100 Unità/ ml, soluzzjoni għall- injezzjoni fi skartoċċ
Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Kull ml fih 100 Unità ta’ insulina glulisine (ekwivalenti għal 3. 49 mg).
Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units.
Kull skartoċċ fih 3 ml ta ’ soluzzjoni għall- injezzjoni, ekwivalenti għall- 300 Unità.
Solution for injection in a cartridge.
Soluzzjoni għall- injezzjoni fi skartoċċ
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.
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 jew 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 mis- sit 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 postijiet oħrajn ta’ injezzjoni (ara sezzjoni 5. 2).
Care should be taken to ensure that a blood vessel has not been entered.
14 Wieħed irid joqgħod attent li l- injezzjoni ma ssirx ġo vina jew arterja.
13 Mixing with insulins
It- taħlit ma ’ l- insulini
Hepatic impairment The pharmacokinetic properties of insulin glulisine have not been investigated in patients with decreased liver function.
Indeboliment Epatiku Il- karateristiċi farmakokinetiċi ta ’ l- insulina glulisine ma kienux studjati f’ pazjenti bi tnaqqis fil - funzjoni tal- fwied.
Deterioration of renal function may lead to a decrease in insulin requirements.
Id - deterjorament fil- funzjoni tal- kliewi jista ’ jwassal għat- tnaqqis fil- ħtieġa ta ’ l- insulina.
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 u taħt 6 snin.
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.
Ipogliċemija Il- ħin meta tiġri l- ipogliċemija jiddependi fuq il- profil ta ’ kif jaħdmu l- insulini użati u, għalhekk, jista ’ jinbidel meta jinbidel il- kors tat- trattament.
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.
Il- kundizzjonijiet li jistgħu jibdlu s- sintomi bikrija ta ’ twissija ta ’ l- ipogliċemija jew jagħmluhom anqas prominenti, jinkludu ż- żmien twil ta’ dijabete, terapija qawwja bl- insulina, marda fin- nervituri minħabba d- dijabete, l- użu ta ’ sustanzi mediċinali bħall- imblokkaturi tar- riċetturi beta, jew wara l - bidla ta ’ insulina derivata mill- annimali għal waħda li ġejja mill- bniedem.
Adjustment of dosage may be also necessary if patients undertake increased physical activity or change their usual meal plan.
15 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.
14 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.
Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.
Studji fuq interazzjonijiet farmakokinetiċi ma sarux. Mit- tagħrif empiriku dwar prodotti mediċinali simili, interazzjonijiet farmakokinetiċi klinikament rilevanti mhux probabbli li jiġru.
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.
Sustanzi li jistgħu jżidu l- attività biex jonqos il- livell tal- glukosju fid- demm u jżidu s- suxxettibilità għall- ipogliċemija jinkludu s- sustanzi orali anti- dijabetiċi, inibituri ta ’ l- enzima li tikkonverti angiotensin (ACE), disopyramide, fibrates, fluoxetine, inibituri ta ’ monamine oxidase (MAOIs), pentoxifylline, propoxyphene, salicylates and l- antibijotiċi sulfonamides.
Caution should be exercised when prescribing to pregnant women.
Wiehed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal.
It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Huwa essenzjali li jinżamm kontroll metaboliku tajjeb tul it- tqala kollha fil- pazjenti li żviluppaw id - dijabete qabel jew waqt it- tqala innifisha.
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
16 Treddigħ
15 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 - thaddim ta’ magni).
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).
Mill- istudji kliniċi, ir- reazzjonijiet avversi, li huma relatati li ġejjin huma mniżżla hawn isfel skond is - sistema tal- klassifika ta ’ l- organi u fl- ordni ta ’ frekwenza dejjem tonqos (komuni ħafna: ≥1/ 10; komuni: ≥1/ 100 sa < 1/ 10; mhux komuni: ≥1/ 1, 000 sa < 1/ 100; rari: ≥1/ 10, 000 sa < 1/ 1, 000; rari ħafna: < 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli).
Hypoglycaemia Symptoms of hypoglycaemia usually occur suddenly.
L- ipogliċemija Ġeneralment is- sintomi ta ’ l- ipogliċemija jiġru f’ daqqa.
Lipodystrophy Lipodystrophy may occur at the injection site as a consequence of failure to rotate injection sites within an area.
Lipodistrofija Il- lipodistrofija tista ’ tiġri fil- post ta ’ l- injezzjoni bħala konsegwenza tan- nuqqas fil- bdil tal- postijiet ta ’ l- injezzjoni f’ żona partikulari.
Severe cases of generalized allergy, including anaphylactic reaction, may be life- threatening.
Każijiet severi t’ allerġija ġeneraliżżata, li jinkludu r- reazzjoni anafilattika, jistgħu jkunu fatali.
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure.
17 l- ipogliċemija tista ’ tiġri bħala riżultat t’ attività eċċessiva ta ’ l- insulina meta mqabbla ma ’ l- ammont ta ’ ikel li jittiekel u l- użu ta ’ l- enerġija.
Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products.
Ġrajjiet ta ’ l- ipogliċemija ħafifa jistgħu jiġu ittrattati bit- teħid orali tal- glukosju jew sustanzi taz - zokkor.
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.
Grajjiet ta ’ l- ipogliċemija severa, meta l- pazjent ikun mitluf minn sensih, jistgħu jkunu ittrattati bil - glukagon (0. 5 sa milligramma 1), li tingħata fil- muskoli jew taħt il- ġilda, minn persuna li rċeviet struzzjonijiet xierqa, jew permezz ta ’ injezzjoni ta ’ soluzzjoni tal- glukosju ġol- vina, mogħtija minn professjonista fil- qasam tas- saħħa.
Upon regaining consciousness, administration of oral carbohydrate is recommended for the patient in order to prevent relapse.
Wara li l- pazjent jiġi lura f’ sensih, it- teħid orali ta ’ karboidrat huwa irrakkomandat biex wieħed jevita li jerġa jiġri l- istess.
Insulin glulisine is a recombinant human insulin analogue that is equipotent to regular human insulin.
L- insulina glulisine hija analoga ta ’ l- insulina rikombinanti tal- bniedem li hija ekwipotenti ma ’ l - insulina regolari umana.
Dose proportionality
Proporzjonalità tad- doża
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.
18 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
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.