FrancophonIA/ELRC3.0 huggingface dataset:
English: There were no clinically significant differences in the incidence of hypoglycaemic episodes in the immediate-release exenatide compared to the placebo group (25% and 29% respectively).
Maltese: Ma kienx hemm differenzi klinikament sinifikanti fl-inċidenza ta' episodji ta' ipogliċemija fil-grupp ta' exenatide b'rilaxx immedjat meta mqabbel mal-grupp ta' plaċebo (25% u 29% rispettivament).
English: No clinically relevant effects on Cmax or AUC were observed.
Maltese: Ma ġie osservat l-ebda effett klinikament relevanti fuq Cmax jew AUC.
English: Clinical studies with immediate-release exenatide have indicated improved beta-cell function, using measures such as the homeostasis model assessment for beta-cell function (HOMA-B) and the proinsulin to insulin ratio.
Maltese: Studji kliniċi b'exenatide b'rilaxx immedjat indikaw titjib fil-funzjoni taċ-ċelluli beta, dokumentat permezz ta'indikaturi bħall-valutazzjoni tal-mudell tal-omejostażi (HOMA-B) għall-funzjoni taċċelluli beta u l-proporzjon ta' proinsulina għal insulina.
English: Type I glass cartridge with a (bromobutyl) rubber plunger, rubber disc, and aluminium seal.
Maltese: Skartoċċ tal-ħġieġ tat-tip I b'planġer tal-lasktu (bromobutyl), disk tal-lasktu u siġill tal-aluminju.
English: • Pull off the blue pen cap.
Maltese: • Neħħi l-kappa blu tal-pinna.
English: Concomitant medicinal products included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, nonsteroidal anti-inflammatory medicinal products and diuretics.
Maltese: Prodotti mediċinali li ttieħdu flimkien kienu jinkludu inibituri talenzimi li jikkonvertu l-anġjotensin, antagonisti ta' anġjotensin-II, prodotti mediċinali antinfjammatorji li m'humiex sterojdi u dijuretiċi.
English: Hepatic impairment No dosage adjustment is necessary in patients with hepatic impairment (see section 5.2).
Maltese: Indeboliment epatiku M'hemmx bżonn ta' aġġustament fid-doża f'pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: In patients with mild (creatinine clearance 50 to 80 ml/min) or moderate renal impairment (creatinine clearance 30 to 50 ml/min), exenatide clearance was mildly reduced compared to clearance in individuals with normal renal function (13% reduction in mild and 36% reduction in moderate renal impairment).
Maltese: F'pazjent b'indeboliment renali ħafif (tneħħija ta' krejatinina 50 sa 80 ml/min) jew moderat (tneħħija ta' krejatinina 30 sa 50 ml/min), it-tneħħija ta' exenatide naqset bi ftit meta mqabbla mat-tneħħija f'individwi b'funzjoni renali normali (tnaqqis ta' 13 % f'indeboliment renali ħafif u 36 % f'indeboliment renali moderat).
English: In a 24-week study, where either insulin lispro protamine suspension or insulin glargine was added to existing therapy of immediate-release exenatide and metformin or metformin plus thiazolidinedione the incidence of patients with at least one minor hypoglycaemic episode was 18% and 9% respectively and one patient reported major hypoglycaemia.
Maltese: Fi studju li dam għaddej għal 24 ġimgħa, fejn ġie miżjud jew insulin lispro protamine f'suspensjoni jew insulin glargine flimkien ma' terapija eżistenti ta' exenatide b'rilaxx immedjat u metformin jew metformin u thiazolidinedione, l-inċidenza ta' pazjenti li kellhom mill-anqas episodju wieħed ta' ipogliċemija minuri kienet 18% u 9% rispettivament u pazjent wieħed irrapporta ipogliċemija maġġuri.
English: The concurrent use of immediate-release exenatide with D-phenylalanine derivatives (meglitinides), alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied and cannot be recommended.
Maltese: L-użu fl-istess ħin ta' exenatide b'rilaxx immedjat ma' derivattivi ta' D-phenylalanine (meglitinides), inibituri ta' alpha-glucosidase, inibituri ta' dipeptidyl peptidase-4 jew agonisti oħra tar-riċettur GLP-1 ma ġiex studjat u ma jistax jiġi rrakkomandat.
English: Severe allergic reactions (anaphylaxis) have been reported rarely (may affect up to 1 in 1,000 people).
Maltese: Reazzjonijiet allerġiċi gravi (anafilassi) ġew irrappurtati b'mod rari (jistgħu jiġu affettwati sa 1 minn kull 1,000 persuna).
English: Exenatide increases, on a glucose-dependent basis, the secretion of insulin from pancreatic beta cells.
Maltese: Exenatide iżid, b'mod dipendenti fuq glucose, is-sekrezzjoni ta' insulina miċ-ċelluli beta tal-frixa.
English: Nonclinical studies have shown that exenatide is predominantly eliminated by glomerular filtration with subsequent proteolytic degradation.
Maltese: Studji mhux kliniċi wrew li exenatide huwa fil-biċċa l-kbira eliminat permezz ta' filtrazzjoni glomerulari u sussegwentement b'degradazzjoni proteolitika.
English: Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine
Maltese: Ħakk u/jew urtikarja Edima anġjonewrotika Disturbi fil-kliewi u fissistema urinarja Kambjament fil-funzjoni renali, li jinkludi insuffiċjenza renali akuta, insuffiċjenza renali kronika li tmur għall-agħar, indeboliment renali, żieda fil-krejatinina fisserum
English: Immediate-release exenatide is not expected to have any clinically relevant effects on the pharmacokinetics of metformin or sulphonylureas.
Maltese: Mhux mistenni li exenatide b'rilaxx immedjat jkollu effetti klinikament relevanti fuq ilfarmakokinetika ta' metformin jew sulphonylureas.
English: Byetta contains metacresol Metacresol may cause allergic reactions.
Maltese: Byetta fih il-metacresol Il-metacresol jista' jikkawża reazzjonijiet allerġiċi.
English: - Each dose of Byetta 5 micrograms solution for injection (injection) contains 5 micrograms exenatide in 20 microlitre.
Maltese: - Kull doża ta' Byetta 5 mikrogrammi soluzzjoni għall-injezzjoni (injezzjoni) fiha 5 mikrogrammi mcexenatide f'20 mikrolitru.
English: Injection needles are not included.
Maltese: mikrobi li jikkaġunaw infezzjonijiet.
English: Acute pancreatitis (see section 4.4)
Maltese: Nefħa addominali Pankreatite akuta (ara sezzjoni 4.4) Tfewwiq
English: In insulin-comparator studies immediate-release exenatide (5 mcg BID for 4 weeks, followed by 10 mcg BID) in combination with metformin and sulphonylurea significantly (statistically and clinically) improved glycaemic control, as measured by decrease in HbA1c.
Maltese: F'studji bl-insulina bħala komparatur, exenatide b'rilaxx immedjat (5 mcg BID għal 4 ġimgħat, segwit b'10 mcg BID) użata flimkien ma' metformin u sulphonylurea tejbet b'mod sinifikanti (statistikament u klinikament) il-kontroll gliċemiku, imkejjel permezz tat-tnaqqis fl'HbA1c.
English: Byetta is used with other diabetic medicines called metformin, sulphonylureas, thiazolidinediones and basal or long acting insulins.
Maltese: Byetta tintuża ma' mediċini dijabetiċi oħra msejħa metformin, sulphonylureas, thiazolidinediones u insulini bażilari jew li jaħdmu fit-tul .
English: The clinical experience in patients with moderate renal impairment is very limited (see section 4.2).
Maltese: L-esperjenza klinika f'pazjenti b'indeboliment renali moderat hija limitata ħafna (ara sezzjoni 4.2).
English: Each dose contains 5 micrograms exenatide.
Maltese: Kull doża fiha 5 mikrogrammi ta' exenatide
English: Immediate-release exenatide-treated patients in the open-label extension studies at 82 weeks experienced similar types of adverse events observed in the controlled trials.
Maltese: Fl-istudji ta' estensjoni open-label, pazjenti fuq kura ta' exenatide b'rilaxx immedjat esperjenzaw fi 82 ġimgħa avvenimenti avversi simili għal dawk osservati fl-istudji kkontrollati.
English: Where should I inject Byetta?
Maltese: Fejn għandi nagħmel l-injezzjoni ta' Byetta?
English: In female rats given exenatide for 2 years, an increased incidence of benign thyroid C-cell adenomas was observed at the highest dose, 250 mcg/kg/day, a dose that produced an exenatide plasma exposure 130-fold the human clinical exposure.
Maltese: Fil-firien nisa li ġew mgħotija exenatide għal sentejn, ġiet osservata żieda fl-inċidenza ta' adenomi beninni fiċ-celluli C tat-tirojde mad-doża l-iżjed għolja, 250 mcg/kg/ġurnata, doża li tagħti espożizzjoni ta' exenatide fil-plażma ta' 130-il darba iżjed minn espożizzjoni klinika fil-bniedem.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jistgħu jiġu affettwati sa 1 minn kull 100 persuna):
English: • decreased in kidney function
Maltese: • indeboliment fil-funzjoni tal-kliewi
English: This treatment effect was comparable to that of insulin glargine in a 26-week study (mean insulin dose 24.9 IU/day, range 4-95 IU/day, at the end of study) and biphasic insulin aspart in a 52-week study (mean insulin dose 24.4
Maltese: IU/ġurnata, medda ta' 4-95 IU/ġurnata, fi tmiem l-istudju) u insulin aspart bifażiku f'studju ta' 52
English: In patients with moderate renal impairment (creatinine clearance 30-50 ml/min), dose escalation from 5 mcg to 10 mcg should proceed conservatively (see section 5.2).
Maltese: F'pazjenti b'indeboliment renali moderat (tneħħija tal-krejatinina 30 - 50 ml/min), żieda fid-doża minn 5 mcg għal 10 mcg għandha tingħata b'mod kawt (ara sezzjoni 5.2).
English: In the immediate-release exenatide arm the insulin dose increased by 13 units/day compared to 20 units/day on the placebo arm. Immediate-release exenatide reduced fasting serum glucose by 1.3 mmol/l and placebo by 0.9 mmol/l.
Maltese: Meta l-pazjent kien sajjem, exenatide b'rilaxx immedjat naqqas il-livell tal-glucose fid-demm b'1.3 mmol/l u l-plaċebo naqqas il-livell ta' glucose fid-demm b'0.9mmol/l .
English: A delay in tmax of about 2 h was observed when digoxin, lisinopril or warfarin was administered 30 min after exenatide.
Maltese: Ġie osservat dewmien ta' madwar sagħtejn f'tmax meta digoxin, lisinopril jew warfarin ingħataw 30 minuta wara exenatide.
English: In use pen: Store below 25 ºC.
Maltese: Waqt l-użu Aħżen f'temperatura taħt 25°C.
English: In clinical studies the mean apparent clearance of exenatide is 9 l/h and the mean terminal half-life is 2.4 h. These pharmacokinetic characteristics of exenatide are independent of the dose.
Maltese: F'studji kliniċi t-tneħħija apparenti medja ta' exenatide hi ta' 9 l/h u l-half-life terminali medju hu ta' 2.4 sigħat.
English: Immediate-release exenatide 10 mcg BID
Maltese: Exenatide b'rilaxx immedjat 10 mcg BID
English: See Commonly Asked Questions, number 5, in Section 4 of this user manual.
Maltese: Ara Mistoqsijiet Magħmula Ta' Spiss, numru 5, f'Sezzjoni 4 ta' dan il-manwal.
English: Cartridge Byetta Liquid
Maltese: Kif taħżen Byetta
English: STEP 4 Inject the Dose
Maltese: PROĊEDURA 4 Injetta d-Doża
English: Administration of the oral contraceptive 30 minutes after immediate-release exenatide did not affect AUC but resulted in a reduction of the Cmax of ethinyl estradiol by 45%, and Cmax of levonorgestrel by 27-41%, and a delay in tmax by 2-4 h due to delayed gastric emptying.
Maltese: It-teħid tal-kontraċettiv orali 30 minuta wara exenatide b'rilaxx immedjat ma ġabx tibdil fl-AUC iżda kien hemm tnaqqis fis- Cmax ta' ethinyl estradiol b'45 % u fis-Cmax ta' levonorgestrel b'27-41 % u żieda biex jintlaħaq it-tmax ta' bejn sagħtejn u 4 sigħat minħabba li kien hemm dewmien biex jitbattal l-istonku.
English: Immediate-release exenatide lowered HbA1c by 1.1% from a baseline of 8.3% and insulin lispro lowered HbA1c by 1.1% from a baseline of 8.2% and noninferiority of immediate-release exenatide to titrated lispro was demonstrated.
Maltese: Exenatide b'rilaxx immedjat baxxa HbA1c b'1.1% minn linja bażi ta' 8.3% u insulin lispro baxxa HbA1c b'1.1% minn linja bażi ta' 8.2% u ntwera n-nuqqas ta' inferjorità ta' exenatide b'rilaxx immedjat għal lispro titrat.
English: Hypoglycaemia was reported in 11% and 7% of patients treated with exenatide and placebo respectively.
Maltese: L-ipogliċemija ġiet irrapportata fi 11 % u fi 7 % tal-pazjenti kkurati b'exenatide u bi plaċebo rispettivament.
English: The signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
Maltese: Is-sinjali u s-sintomi ta' livell baxx ta' zokkor fid-demm jistgħu jinkludu uġigħ ta' ras, ħedla, għeja, sturdament, konfużjoni, irritabilità, ġuħ, tħabbit mgħaġġel tal-qalb, li tkun għarqan u li tħossok nervuż.
English: Two placebo-controlled studies were conducted: one of 16 and one of 26 weeks duration, with 121 and 111 immediate-release exenatide and 112 and 54 placebo treated patients respectively, added to existing thiazolidinedione treatment, with or without metformin.
Maltese: Ġew magħmula żewġ studji kkontrollati bil-plaċebo: wieħed li dam 16-il ġimgħa u ieħor li dam 26 ġimgħa, li rispettivament kellhom 121 u 111-il pazjent ikkurat b'exenatide b'rilaxx immedjat u 112 u 54 pazjent ikkurati bil-plaċebo, miżjuda mal-kura eżistenti ta' thiazolidinedione, b'metformin jew mingħajru.
English: Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' agonisti tar-riċettur GLP-1 ġie assoċjat mar-riskju li tiżviluppa pankreatite akuta.
English: Immediate-release exenatide 5 mcg BID
Maltese: Exenatide b'rilaxx immedjat 5 mcg BID
English: Severe gastrointestinal disease
Maltese: Mard gastro-intestinali sever
English: The mean apparent volume of distribution of exenatide following subcutaneous administration of a single dose of exenatide is 28 l.
Maltese: Il-volum apparenti medju ta' distribuzzjoni ta' exenatide wara li tingħata doża waħda ta' exenatide taħt il-ġilda hu ta' 28 l.
English: Weight loss of 1.8 kg from a baseline of 95 kg was observed with immediate-release exenatide whereas a weight gain of 1.0 kg from a baseline of 94 kg was observed with placebo.
Maltese: Kien hemm telf ta' piż ta' 1.8 kg mil-linja bażi ta' 95kg b'exenatide b'rilaxx immedjat waqt li kien hemm żieda fil-piż ta' 1.0 kg mil-linja bażi ta' 94 kg bilplaċebo.
English: In a 30-week study, when immediate-release exenatide or placebo was added to existing basal insulin therapy (insulin glargine), the dose of basal insulin was decreased by 20% in patients with an HbA1c ≤ 8.0%, per protocol design in order to minimize the risk of hypoglycaemia.
Maltese: Fi studju li dam għaddej għal 30 ġimgħa, meta exenatide b'rilaxx immedjat jew plaċebo ngħata flimkien mat-terapija eżistenti ta' insulina bażilari (insulin glargine), id-doża ta' insulina bażilari ġiet imnaqqsa b'20% f'pazjenti b'HbA1c ≤ 8.0 %, skont il-pjan tal-protokoll sabiex jitnaqqas ir-riskju ta' ipogliċemija.
English: Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults who have not achieved adequate glycaemic control with these medicinal products.
Maltese: Byetta hija wkoll indikata bħala terapija oħra miżjuda ma' insulina bażilari, b'metformin jew mingħajru u/jew pioglitazone f'adulti li ma kisbux kontroll gliċemiku xieraq b'dawn il-prodotti mediċinali.
English: Once you see several drops or a stream of liquid coming out of the tip of the needle, the setup is complete.
Maltese: Malli tara li mill-ponta tal-labra ħerġin diversi qtar jew nixxiegħa ta' likwidu, it tħejija tkun kompleta.
English: Treatment differences (immediate-release exenatide minus comparator) were -4.1 kg in the 26-week study and -5.4 kg in the 52-week study.
Maltese: Id-differenzi minħabba l-kura (exenatide b'rilaxx immedjat mingħajr komparatur) kienu -4.1 kg fl-istudju ta' 26 ġimgħa u -5.4 kg fl-istudju ta' 52 ġimgħa.
English: In patients where existing therapy also included a sulphonylurea the incidence of patients with at least one minor hypoglycaemic episode was 48% and 54% respectively and one patient reported major hypoglycaemia.
Maltese: F'pazjenti fejn it-terapija eżistenti kienet tinkludi xi sulphonylurea wkoll, l-inċidenza ta' pazjenti li kellhom mill-anqas episodju wieħed ta' ipogliċemija kien 48% u 54% rispettivament u pazjent wieħed irrapporta ipogliċemija maġġuri.
English: In the 30-week placebo-controlled clinical trials, concomitant use of immediate-release exenatide and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).
Maltese: Fl-istudji kliniċi kkontrollati bil-plaċebo li damu 30 ġimgħa, l-użu fl-istess waqt ta' exenatide b'rilaxx immedjat u inibituri ta' HMG CoA reductase ma ġiex assoċjat ma' tibdil konsistenti fil-profili tal-lipidi (ara sezzjoni 5.1).
English: The experience in patients > 65 years and in patients with impaired renal function is limited.
Maltese: L-esperjenza f'pazjenti >65 sena u f'pazjenti b'indeboliment tal-funzjoni renali hija limitata.
English: Clearance was significantly reduced by 84% in patients with end-stage renal disease receiving dialysis (see section 4.2).
Maltese: Kien hemm tnaqqis b'mod sinifikanti ta' 84 % fit-tneħħija f'pazjenti b'mard renali fl-aħħar stadju u li qegħdin fuq dijalisi (ara sezzjoni 4.2).
English: • Remove paper tab from outer needle shield.
Maltese: • Is-selettur tad-doża ma ġiex imdawwar kollu.
English: Overall, the percentage of antibody positive patients was consistent across clinical trials.
Maltese: B'mod ġenerali l-persentaġġ ta' pazjenti li kienu posittivi għall-anti-korpi kien konsistenti fuq firxa ta' studji kliniċi.
English: The clinical experience in patients > 75 years is very limited.
Maltese: L-esperjenza klinika f'pazjenti >75 sena hija limitata ħafna.
English: STEP 3 Dial the Dose
Maltese: PROĊEDURA 3 Isselezzjona d-Doża
English: Weight loss greater than 1.5 kg per week has been observed in approximately 5% of clinical trial patients treated with exenatide.
Maltese: Ġie osservat li kien hemm telf ta' piż ta' iżjed minn 1.5 kg fil-ġimgħa f'kważi 5 % tal-pazjenti f'studju kliniku li kienu kkurati b'exenatide.
English: Most episodes of hypoglycaemia were mild to moderate in intensity, and resolved with oral administration of carbohydrate.
Maltese: Il-biċċa l-kbira tal-episodji ta' ipogliċemija kienu ħfief jew moderati fl-intensità, u waqfu mat-teħid ta' karboidrat b'mod orali.
English: • Byettais injected twice a day,the pen contains enough medicine for 30 days.
Maltese: • Byetta tiġi njettata darbtejn kuljum; il-pinna fiha biżżejjed mediċina għal 30 jum.
English: Since immediate-release exenatide has been marketed, acute pancreatitis has been reported with a frequency not known and acute renal failure has been reported uncommonly (see section 4.4).
Maltese: Mit-tqegħid fis-suq ta' exenatide b'rilaxx immedjat, ġiet irrapportata pankreatite akuta bi frekwenza mhux magħrufa u insuffiċjenza renali akuta ġiet irrapportata b'mod mhux komuni (ara sezzjoni 4.4).
English: As blood glucose concentrations decrease, insulin secretion subsides.
Maltese: Kif il-konċentrazzjonijiet ta' glucose fid-demm jonqsu, tonqos is-sekrezzjoni ta' insulina.
English: There have been uncommon, spontaneously reported events of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring hemodialysis.
Maltese: Ġew irrapportati avvenimenti mhux komuni u spontanji ta' kambjament fil-funzjoni renali li jinkludu żieda fil-krejatinina fis-serum, indeboliment renali, insuffiċjenza renali kronika li tmur għall-agħar u insuffiċjenza renali akuta li xi kultant teħtieġ l-emodijalisi.
English: The most common adverse events leading to withdrawal for immediate-release exenatide-treated patients were nausea (4% of patients) and vomiting (1%).
Maltese: L-aktar avvenimenti avversi komuni li wasslu għat-twaqqif f'pazjenti fuq kura ta' exenatide b'rilaxx immedjat kienu tqalligħ (4 % tal-pazjenti) u rimettar (1 %).
English: Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4).
Maltese: Exenatide m'huwiex irrakkomandat għall-użu f'pazjenti b'mard renali fl-aħħar stadju jew b'indeboliment renali qawwi (tneħħija tal-krejatinina: <30 ml/min) (ara sezzjoni 4.4).
English: • heartburn
Maltese: • tifwiq
English: In patients at increased risk of hypoglycaemia reducing the dose of basal insulin should be considered (see section 4.8).
Maltese: F'pazjenti li għandhom riskju akbar ta' ipogliċemija, għandu jiġi kkunsidrat tnaqqis fid-doża tal-insulina bażilari (ara sezzjoni 4.8).
English: A trend for a decrease in triglycerides has been observed with weight loss.
Maltese: Mat-tnaqqis fil-piż ġiet osservata tendenza ta' tnaqqis fit-trigliċeridi.
English: If you are over 70 years old or have problems with your kidneys it may take longer than 30 days to tolerate the Byetta 5 micrograms dose and so your doctor may not increase your dose.
Maltese: Jekk għandek iżjed minn 70 sena jew għandek problemi bil-kliewi, tista' ddum iżjed minn 30 ġurnata biex tittollera d-doża ta' 5 mikrogrammi ta' Byetta u għalhekk it-tabib jista' ma jżidlekx id-doża.
English: Paracetamol was used as a model medicinal product to evaluate the effect of exenatide on gastric emptying.
Maltese: Paracetamol ġie użat bħala prodott mediċinali mudell biex jiġi valutat l-effett ta' exenatide fuq ittbattil gastriku.
English: In clinical trials, background therapies included metformin, a sulphonylurea, a thiazolidinedione, or a combination of oral glucose-lowering medicinal products.
Maltese: Fi provi kliniċi, terapiji ta' sfond li kienu qed jintużaw ukoll kienu jinkludu metformin, sulphonylurea, thiazolidinedione jew taħlita ta' prodotti mediċinali li jbaxxu l-livelli ta' glucose.
English: In use pen: 30 days
Maltese: Pinna waqt l-użu: 30 ġurnata
English: STEP D Prepare the Pen
Maltese: PROĊEDURA D Ipprepara l-Pinna
English: Do not repeat Section 2 for routine use, if you do, you will run out of Byetta before 30 days of use.
Maltese: Għall-użu ta' rutina tirrepetix sezzjoni 2, jekk toqgħod tirrepetiha, tispiċċa mingħajr Byetta qabel ma jkunu għaddew it-30 ġurnata ta' użu.
English: Label Dose Window
Maltese: Selettur tad-Doża
English: Your Byetta pen is suitable for use with Becton, Dickinson and Company pen injection needles.
Maltese: Il-pinna Byetta tiegħek hija tajba biex tintuża mal-labar ta' injezzjoni għall-pinen, Becton, Dickinson u Company.
English: The incidence of withdrawal due to adverse events was 8% for immediate-release exenatide-treated patients, 3% for placebo-treated and 1% for insulin-treated patients in the long-term controlled trials (16 weeks or longer).
Maltese: L-inċidenza tat-twaqqif tal-kura minħabba avvenimenti avversi kienet ta' 8 % għal pazjenti fuq kura ta' exenatide b'rilaxx immedjat, 3 % għal dawk fuq plaċebo u 1 % għal pazjenti fuq kura ta' insulina fl-istudji kkontrollati fit-tul (16-il ġimgħa jew aktar).
English: Macular and papular rash
Maltese: Raxx makulari u papulari
English: • Check pen label to make sure it is your 5 microgram pen.
Maltese: • Iċċekkja t-tikketta tal-pinna biex tkun żgur li hija l-pinna ta' 5 mikrogrammi tiegħek.
English: Of the immediate-release exenatide patients, 12% were treated with a thiazolidinedione and immediate-release exenatide and 82% were treated with a thiazolidinedione, metformin and immediate-release exenatide.
Maltese: Mill-pazjenti fil-grupp exenatide b'rilaxx immedjat, 12 % ġew ikkurati b'thiazolidinedione u exenatide b'rilaxx immedjat u 82 % ġew ikkurati b'thiazolidinedione, metformin u exenatide b'rilaxx immedjat.
English: • burping
Maltese: • sturdament
English: Patients who develop antibodies to exenatide tend to have more injection site reactions (for example: redness of skin and itching), but otherwise similar rates and types of adverse events as those with no antiexenatide antibodies.
Maltese: ħmura fil-ġilda u ħakk) iżda altrimenti kellhom rati u tipi ta' avvenimenti avversi simili għal dawk mingħajr anti-korpi kontra exenatide.
English: In a single-dose pharmacokinetic study in 13 patients with type 2 diabetes and between the ages of 12 and 16 years, administration of exenatide (5 mcg) resulted in slightly lower mean AUC (16% lower) and Cmax (25% lower) compared to those observed in adults.
Maltese: F'studju farmakokinetiku b'doża waħda f'13-il pazjent bid-dijabete tat-tip 2 b'etajiet bejn 12 u 16-il sena, l-għoti ta' exenatide (5 mcg) irriżulta f'tnaqqis żgħir fil-medja tal-AUC (tnaqqis ta' 16%) u tasCmax (tnaqqis ta' 25%) meta mqabbla ma dawk osservati fl-adulti.