FrancophonIA/ELRC3.0 huggingface dataset:
English: Thyroid tumours have been observed in rats and mice with long acting GLP-1 receptor agonists.
Maltese: Ġew osservati tumuri tat-tirojde f'firien u fi ġrieden b'agonisti tar-riċettur ta' GLP-1 li jaġixxi fit-tul.
English: In a single-dose pharmacokinetic study of immediate-release exenatide 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: Fi studju farmakokinetiku ta' exenatide li jerħi l-mediċina b'mod immedjat fi 13-il pazjent biddijabete tat-tip 2 b'etajiet bejn 12 u 16-il sena, l-għoti ta' exenatide (5 µg) irriżulta fi tnaqqis żgħir fil medja tal-AUC (tnaqqis ta' 16%) u tas-Cmax (tnaqqis ta' 25%) meta mqabbla ma' dawk osservati fladulti.
English: • skin reactions at the injection site following injection of exenatide.
Maltese: • reazzjonijiet fil-ġilda fis-sit tal-injezzjoni wara injezzjoni ta' exenatide.
English: In a 28-week open-label study, Bydureon BCise was compared to immediate-release exenatide in subjects on a diet and exercise programme alone or with a stable regimen of oral glucose-lowering medicinal products.
Maltese: Fi studju open-label ta' 28 ġimgħa, Bydureon BCise ġie mqabbel ma' exenatide li jerħi l-mediċina b'mod immedjat f'individwi fuq programm ta' dieta u eżerċizzju biss jew ma' reġimen stabbli ta' prodotti mediċinali orali li jbaxxu l-glukożju.
English: The finished medicinal product is comprised of the suspension-filled cartridge assembled into the pen device.
Maltese: Il-prodott mediċinali komplut jikkonsisti minn kartriġġ mimli bis-sospensjoni armat fl-apparat tal-pinna.
English: Pack size of 4 single-dose pre-filled pens (BCise) and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens (BCise).
Maltese: Daqs tal-pakkett ta' 4 pinen mimlijin għal-lest (BCise) ta' doża waħda u pakkett multiplu li fih 12 (3 pakketti ta' 4)-il pinna mimlija għal-lest ta' doża waħda (BCise).
English: B. Check the expiration date (labelled EXP) printed on the pen label.
Maltese: JIS) stampata fuq it-tikketta tal-pinna.
English: AstraZeneca Pharma Poland Sp. z o.o.
Maltese: Italia AstraZeneca S.p.A.
English: Prolonged-release exenatide did not increase the cardiovascular risk in patients with type 2 diabetes mellitus compared to placebo when added to current usual care (HR:0.91; 95% CI: 0.832, 1.004; P<0.001 for non-inferiority) see Figure1.
Maltese: 91; 95% CI: 0.832, 1.004; P<0.001 għal nuqqas ta' inferjorità) ara Figura 1.
English: Mean change from baseline in fasting plasma glucose (mmol/l) (±SE)
Maltese: It-tibdil fil-livell tal-glukożju fil-plażma meta wieħed ikun sajjem (mmol/l) ( ± SE)
English: SE = standard error, CI = confidence interval, * p < 0.05
Maltese: SE = devjazzjoni standard, CI = intervall ta' kunfidenza), * p <0.05
English: A study of 26-week duration has been conducted, in which prolonged-release exenatide 2 mg is compared to insulin glargine once daily.
Maltese: Sar studju li dam 26 ġimgħa, li fih exenatide 2 mg li jerħi l-mediċina bil-mod tqabbel ma' insulina glargine darba kuljum.
English: It's normal if you see air bubbles in the liquid.
Maltese: Huwa normali li jkun hemm bżieżaq tal-arja fil-pinna.
English: Angioneurotic oedema Injection site abscesses and cellulitis
Maltese: Imbagħad agħżel sit tal-injezzjoni differenti u temm it-teħid tal-injezzjoni.
English: Severe allergic reactions (anaphylaxis) have been reported rarely (may affect up to 1 in 1,000 people).
Maltese: Reazzjonijiet allerġiċi serji (anafilassi) ġew irrapportati b'mod rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000).
English: In clinical studies of prolonged-release exenatide, acute pancreatitis occurred in 0.3% of patients.
Maltese: Fl-istudji kliniċi ta' exenatide li jerħi l-mediċina bil-mod, pankreatite akuta ġiet osservata f'0.3% tal-pazjenti.
English: Figure 1: Time to First Adjudicated MACE (intent to treat patients)
Maltese: Figura 1: Ħin għall-Ewwel MACE aġġudikat (intenzjoni li jiġu kkurati l-pazjenti)
English: Reversibility of altered renal function has been observed with supportive treatment and discontinuation of potentially causative medicinal products, including exenatide.
Maltese: Ġie osservat li t-tibdil fil-funzjoni renali huwa riversibbli b'kura ta' sosteniment u t-twaqqif tal-prodotti mediċinali li wisq probabbli kienu l-kawża ta' kollox, inkluż exenatide.
English: Immediate-release exenatide 10 mcg BID
Maltese: Exenatide 10 mcg li jerħi lmediċina b'mod immedjat darbtejn kuljum
English: Single-dose pre-filled pen
Maltese: Pakkett tal-konnekter tal-kunjett
English: Bydureon BCise demonstrated superiority to immediate-release exenatide in reducing HbA1c from baseline to Week 28 (Table 2).
Maltese: Kemm pazjenti fuq Bydureon BCise kif ukoll fuq exenatide li jerħi l-mediċina b'mod immedjat kisbu tnaqqis fil-piż f'Ġimgħa 28 meta mqabbel mal-linja bażi (Tabella 2).
English: Prolonged-release exenatide 2 mg QW
Maltese: Kull kunjett fih 2 mg exenatide
English: Analyses exclude measurements post rescue therapy and post premature discontinuation of study medication.
Maltese: L-analiżijiet jeskludu kejliet wara t-terapija ta' salvataġġ u wara twaqqif prematur tal-mediċina talistudju.
English: Background therapies included diet and exercise alone or with metformin, a sulphonylurea, a thiazolidinedione or a combination of oral glucose-lowering medicinal products.
Maltese: It-terapiji ta' sfond kienu jinkludu dieta u eżerċizzju biss jew ma' metformin, sulphonylurea, thiazolidinedione jew taħlita ta' prodotti mediċinali orali li jbaxxu l-glukożju.
English: 1 Getting started
Maltese: Tikketta bi Strixxi
English: Adjusted LS means and treatment group difference(s) in the change from baseline values at Week 28 are modeled using a mixed model with repeated measures (MMRM) including treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), baseline SU-use stratum (yes vs. no), week, and treatment by week interaction as fixed factors, and baseline value as a covariate.
Maltese: Medji aġġustati tal-inqas kwadrati (Medji LS) u differenza/differenzi fil-grupp ta' kura fit-tibdil mill-valuri fillinja bażi fit-28 Ġimgħa huma mmudellati permezz ta' mudell imħallat b'kejliet ripetuti (MMRM) inklużi lkura, ir-reġjun, l-istrat HbA1c fil-linja bażi (<9.0% or ≥ 9.0%), il-ġimgħa, u l-kura skont l-interazzjoni talġimgħa bħala fatturi fissi, u valur fil-linja bażi bħala kovarjant.
English: Prolonged-release exenatide demonstrated superiority to placebo in reducing HbA1c from baseline to Week 28 (Table 8).
Maltese: Exenatide li jerħi l-mediċina bil-mod wera superjorità għal plaċebo fittnaqqis ta' HbA1c mil-linja bażi sal-Ġimgħa 28 (Tabella 8).
English: QW=once weekly, QD=once daily, SE = standard error, CI= confidence interval, N=number of patients.
Maltese: QW=darba fil-ġimgħa, QD=darba kuljum, SE=devjazzjoni standard, CI=intervall ta' kunfidenza, N=numru ta' pazjenti.
English: INNER CARTON, MULTIPACK OF 3 X (4 SINGLE-DOSE KITS) - WITH NO BLUE BOX
Maltese: KARTUNA TA' ĠEWWA, PAKKETT MULTIPLU TA' 3 x (4 settijiet ta' doża waħda)mingħajr il-kaxxa blu
English: p-values are all adjusted p-values for multiplicity.
Maltese: 001 (aġġustat għall-multipliċità).
English: One study was of 24 weeks in duration (n = 252) and the other of 30 weeks (n = 295) followed by an open-labelled extension where all patients were treated with prolonged-release exenatide 2 mg once weekly for a further 7 years (n = 258).
Maltese: Studju wieħed dam 24 ġimgħa (n= 252) u l-ieħor dam 30 ġimgħa (n= 295) segwit minn estensjoni open-labelled fejn ilpazjenti kollha ġew ikkurati b'exenatide 2 mg li jerħi l-mediċina bil-mod darba fil-ġimgħa għal 7 snin oħra (n= 258).
English: Clinically and statistically significantly more subjects on prolonged-release compared to immediate-release exenatide patients achieved an HbA1c reduction of ≤ 7 % or < 7 % in the two studies (p <0.05 and p ≤0.0001, respectively).
Maltese: Fiż-żewġ studji, kemm klinikament u kemm statistikament kien hemm b'mod sinifikanti iżjed pazjenti fuq exenatide li jerħi l-mediċina bil-mod meta mqabbel ma' exenatide li jerħi l-mediċina b'mod immedjat kisbu tnaqqis fl-HbA1c ta' ≤7% jew <7% (p <0.05 u p=<0.
English: Solvent: carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections sodium hydroxide
Maltese: Solvent: carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate ilma għall-injezzjonijiet sodium hydroxide
English: The powder is packaged in a 3 ml Type I glass vial sealed with a chlorobutyl rubber stopper and an aluminium seal with a plastic flip-off cap.
Maltese: It-trab jiġi f'kunjett tal-ħġieġ tat-tip I ta' 3 ml issiġillat b'tapp tal-gomma tal-chlorobutyl u b'siġill talaluminju b'għatu tal-plastik tat-tip flip-off.
English: Bydureon BCise demonstrated superiority to both sitagliptin and placebo in reducing HbA1c from baseline to Week 28 (Table 3).
Maltese: Kemm il-pazjenti fuq Bydureon BCise kif ukoll fuq sitagliptin kisbu tnaqqis fil-piż f'Ġimgħa 28 meta mqabbel mal-linja bażi (Tabella 3).
English: In two studies prolonged-release exenatide 2 mg once weekly has been compared to immediate-release exenatide 5 mcg given twice daily for 4 weeks followed by immediate-release exenatide 10 mcg given twice daily.
Maltese: F'żewġ studji, exenatide li jerħi l-mediċina bil-mod 2 mg darba fil-ġimgħa ġie mqabbel ma' exenatide li jerħi l-mediċina b'mod immedjat 5 mcg li jingħata darbtejn kuljum għal 4 ġimgħat segwit minn exenatide 10 mcg li jingħata darbtejn kuljum.
English: Each pre-filled pen delivers 2 mg of exenatide in a volume of 0.85 ml.
Maltese: Kull pinna mimlija għal-lest tagħti 2 mg ta' exenatide f'volum ta' 0.85 ml.
English: Front
Maltese: LISTA
English: Table 8: Results of one 28-week study of prolonged-release exenatide versus placebo in combination with insulin glargine alone or with metformin (intent to treat patients)
Maltese: Tabella 8: Riżultati ta' studju wieħed ta' 28 ġimgħa ta' exenatide li jerħi l-mediċina bil-mod meta mqabbel ma' plaċebo f'kombinazzjoni mal-insulina glargine waħdu jew mal-metformin (pazjenti fil-grupp bl-intenzjoni tal-kura)
English: Pack size of 4 single-dose kits and a multipack consisting of 12 (3 packs of 4) single-dose kits.
Maltese: Daqs ta' pakkett hu ta' 4 settijiet ta' doża waħda u pakkett multiplu fih 12 (3 pakketti x 4) settijiet ta' doża waħda.
English: Exenatide has been shown to bind to and activate the known human GLP-1 receptor in vitro, its mechanism of action mediated by cyclic AMP and/or other intracellular signalling pathways.
Maltese: Ġie muri li in vitro exenatide jingħaqad u jattiva r-riċettur GLP-1 uman u l-mekkaniżmu ta' azzjoni tiegħu huwa permezz tal-AMP ċikliku u/jew mekkaniżmi oħra ta' sinjali intraċellulari.
English: In a 28-week, double-blind study, the combination of prolonged-release exenatide and dapagliflozin was compared to prolonged-release exenatide alone and dapagliflozin alone in subjects also using metformin.
Maltese: Fi studju double-blind, ta' 28 ġimgħa, il-kombinazzjoni ta' exenatide li jerħi l-mediċina bil-mod u dapagliflozin tqabblet ma' exenatide li jerħi l-mediċina bil-mod waħdu u dapagliflozin waħdu f'individwi li jużaw ukoll metformin.
English: Prolonged-release exenatide demonstrated superiority to placebo in reducing HbA1c from baseline to Week 28 (Table 6).
Maltese: Exenatide li jerħi l-mediċina bil-mod wera superjorità għal plaċebo fittnaqqis ta' HbA1c mil-linja bażi sal-Ġimgħa 28 (Tabella 6).
English: 4 single-dose pre-filled pens (BCise).
Maltese: 4 pinen mimlijin għal-lest ta' doża waħda (BCise).
English: Following weekly administration of 2 mg Bydureon BCise, mean exenatide concentrations exceeded minimal efficacious concentrations (~ 50 pg/ml) in 2 weeks with gradual increase in the average plasma exenatide concentration up to Week 8.
Maltese: Wara dożi ta' kull ġimgħa ta' 2 mg Bydureon BCise, il-konċentrazzjonijiet medji ta' exenatide jaqbżu l-konċentrazzjonijiet minimi ta' effikaċja (~ 50 pg/ml) f'ġimagħtejn b'żieda gradwali filkonċentrazzjoni medja ta' exenatide fil-plażma fuq Ġimgħa 8.
English: Solvent carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections
Maltese: Solvent carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate ilma għall-injezzjoni
English: Vial
Maltese: Wara
English: In addition, a double-blind, placebo-controlled cardiovascular outcome study (EXSCEL) enrolled 14,752 subjects with type 2 diabetes and any level of CV risk when added to the current usual care.
Maltese: Barra minn hekk, studju tar-riżultat kardjo-vaskulari double-blind, ikkontrollat bi plaċebo (EXSCEL) irreġistra 14,752 individwu b'dijabete tat-tip 2 u kwalunkwe livell ta' riskju kardjovaskulari meta miżjud mal-kura normali attwali.
English: HR (active/placebo) and CI are based on Cox proportional hazards regression model, stratified by prior CV event, with treatment group only as explanatory variable.
Maltese: HR (attiv/plaċebo) u CI huma bbażati fuq mudell ta' rigressjoni ta' perikli proporzjonali Cox, stratifikati skont l-episodju CV preċedenti, bil-grupp ta' kura biss bħala varjabbli ta' spjegazzjoni.
English: - In the solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, water for injection and sodium hydroxide (for pH adjustment).
Maltese: - Fis-solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, ilma għall-injezzjonijiet u sodium hydroxide
English: Baseline
Maltese: Siringa
English: Prolonged-release exenatide in combination with basal insulin showed no clinically significant differences in the incidence of hypoglycaemic episodes compared to insulin.
Maltese: Exenatide li jerħi l-mediċina bil-mod flimkien mal-insulina bażi ma wera l-ebda diferenza klinikament sinifikanti fl-inċidenza ta' episodji ipogliċemiċi meta mqabbel mal-insulina.
English: The mean apparent volume of distribution of exenatide following subcutaneous administration of a single dose of exenatide is 28 l.
Maltese: Wara t-teħid minn taħt il-ġilda ta' doża waħda ta' exenatide, il-volum medju ta' distribuzzjoni evidenti ta' exenatide huwa ta' 28 l.
English: One needle is a spare.
Maltese: Ma jimpurtax jekk ikun hemm bżieżaq talarja.
English: • hypoglycaemia (low blood sugar) when taken with an insulin
Maltese: • ipogliċemija (zokkor baxx fid-demm) meta jittieħed ma' insulina
English: Table 7: Results of one 28-week study of prolonged-release exenatide and dapagliflozin versus prolonged-release exenatide alone and dapagliflozin alone, in combination with metformin (intent to treat patients)
Maltese: Riżultati ta' studju wieħed ta' 28 ġimgħa ta' exenatide li jerħi l-mediċina bil-mod u dapagliflozin kontra exenatide li jerħi l-mediċina bil-mod waħdu u dapagliflozin waħdu u, f'kombinazzjoni ma' metformin (intenzjoni li jikkura l-pazjenti)
English: Hold for 10 seconds to make sure you get the full dose.
Maltese: TKOMPLIX sakemm il-mediċina tiegħek tkun imħallta sew.
English: Table 6: Results of one 28-week study of prolonged-release exenatide versus placebo in combination with insulin glargine alone or with metformin (intent to treat patients)
Maltese: Tabella 6: Riżultati ta' studju wieħed ta' 28 ġimgħa ta' exenatide li jerħi l-mediċina bil-mod meta mqabbel ma' plaċebo f'kombinazzjoni mal-insulina glargine waħdu jew mal-metformin (pazjenti fil-grupp bl-intenzjoni tal-kura)
English: The medicine is injected into your skin (subcutaneously).
Maltese: Il-mediċina tiġi injettata fil-ġilda tiegħek (taħt il-ġilda).
English: CARTON (PACK OF 4 SINGLE-DOSE PRE-FILLED PENS)
Maltese: KARTUNA (Pakkett ta' 4 pinen mimlijin għal-lest ta' doża waħda)
English: Abdominal distension Abdominal pain
Maltese: • Diffikultà biex tibla'
English: Mean change from baseline in fasting plasma glucose (mmol/l) (± SE)
Maltese: Il-medja tat-tibdil mil-linja bażi fil-glukożju fil-plażma sagħtejn wara l-ikel (mmol/l) (SE)
English: Solvent carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections sodium hydroxide (for pH adjustment)
Maltese: Solvent carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate ilma għall-injezzjonijiet sodium hydroxide (għall-aġġustament tal-pH)
English: Bydureon 2 mg prolonged-release suspension for injection exenatide
Maltese: Bydureon 2 mg suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod exenatide
English: Dose Line
Maltese: -il Sekond
English: 1 pre-filled syringe of 0.65 ml solvent 1 vial connector
Maltese: Kull sett ta' doża waħda fih: kunjett ta' 2 mg exenatide siringa mimlija għal-lest ta' 0.65 ml solvent konnekter għall-kunjett
English: EXSCEL was a pragmatic cardiovascular (CV) outcome study in patients with type 2 diabetes and any level of CV risk.
Maltese: EXSCEL kien studju tar-riżultat kardjovaskulari (CV) pragmatiku f'pazjenti b'dijabete tip 2 u bi kwalunkwe livell ta' riskju CV.
English: Compared with insulin glargine treatment, prolonged-release exenatide demonstrated a superior change in HbA1c, significantly lowered mean body weight and was associated with fewer hypoglycaemic events (Table 3).
Maltese: Meta mqabbla mal-kura b'insulin glargine, exenatide li jerħi l-mediċina bil-mod wera tibdil superjuri f'HbA1c, ġab tnaqqis sinifikanti fil-piż medju tal-ġisem u kien assoċjat ma' inqas avvenimenti ipogliċemiċi (Tabella 3).
English: Minutes
Maltese: Astenja
English: QW = once weekly, QD = once daily, N = number of patients per treatment group, SE = standard error, CI = confidence interval.
Maltese: N=numru ta' pazjenti f'kull grupp ta' kura, SE = devjazzjoni standard, CI= intervall ta' kunfidenza, *valur-p <0.
English: Prolonged-release suspension for injection in pre-filled pen (BCise).
Maltese: Suspensjoni bajda għal bajda fil-griż.
English: Solvent: carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections
Maltese: Solvent: carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate ilma għall-injezzjonijiet
English: Injection site erythema
Maltese: Suġġerimenti siewja
English: Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen exenatide
Maltese: Bydureon 2 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod exenatide
English: Each single-dose kit contains one vial of 2 mg exenatide, one pre-filled syringe of 0.65 ml solvent, one vial connector, and two injection needles (one spare).
Maltese: Kull kitt b'doża waħda fih kunjett wieħed b'2 mg trab ta' exenatide, siringa waħda mimlija għal-lest b'0.65 ml ta' solvent, konnekter wieħed tal-kunjett, u żewġ labriet tal-injezzjonijiet.
English: Subsequently, exenatide concentrations of approximately 151-265 pg/ml were maintained indicating that steady state was achieved.
Maltese: Wara, ilkonċentrazzjonijiet ta' exenatide baqgħu sostnuti fuq livell ta' madwar 151-265 pg/ml li jindika li jkun ntlaħaq l-istat fiss.
English: Helpful hints
Maltese: Mhux imsakkra
English: Table 4: Results of two studies of prolonged-release versus immediate-release exenatide in combination with diet and exercise alone, metformin and/or sulphonylurea and metformin and/or thiazolidinedione (intent to treat patients)
Maltese: Tabella 4: Ir-riżultati ta' żewġ studji ta' exenatide li jerħi l-mediċina bil-mod kontra exenatide li jerħi l-mediċina b'mod immedjat flimkien ma' dieta u eżerċizzju waħidhom, metformin u/jew sulphonylurea u metformin u/jew thiazolidinedione (pazjenti b'intenzjoni ta' kura)
English: Place the needle, vial connector package, vial, and syringe on a clean, flat surface.
Maltese: Poġġi l-labra, il-pakkett tal-konnekter tal-kunjett, il-kunjett, u s-siringa fuq wiċċ nadif u ċatt.
English: Twist the orange connector onto the syringe until snug.
Maltese: Dawwar il-konnekter oranġjo mas-siringa sakemm jissikka.
English: No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50 to 80 ml/min).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża għal pazjenti b'indeboliment renali ħafif (tneħħija talkreatinina ta' 50 sa 80 ml/min).
English: Change from baseline (± SE) Mean difference in change from baseline between treatments (95% CI) Patients (%) achieving HbA1c ≤7% Mean body weight (kg) Baseline
Maltese: Il-medja tad-differenza fit-tibdil mil-linja bażi bejn iż-żewġ kuri (95% CI) Il-pazjenti (%) li kisbu HbA1c ≤7% It-tibdil fil-livell tal-glukożju fil-plażma meta wieħed ikun sajjem (mmol/l) ( ± SE)
English: Each carton contains 4 single-dose kits:
Maltese: Kull kartuna fiha 4 settijiet ta' doża waħda:
English: In a proportion of these the glycaemic response to prolonged-release exenatide was absent at the end of the controlled period of studies; 2.6% of patients showed no glucose improvement with higher titre antibodies whereas 1.6% showed no improvement while antibody negative.
Maltese: F'numru minn dawn, ir-rispons gliċemiku għal exenatide li jerħi l-mediċina bil-mod kien nieqes fl-aħħar tal-perijodu kkontrollat tal-istudji; 2.6% tal-pazjenti ma wrew ebda titjib fil-glukożju b'ammonti ogħla ta' antikorpi waqt li 1.6% ma wrew ebda titjib fil-glukożju bil li kienu negattivi għall-presenza tal-antikorpi.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: In a 28-week double-blind study, prolonged-release exenatide added to insulin glargine alone or with metformin was compared to placebo added to insulin glargine alone or with metformin.
Maltese: Fi studju double blind ta' 28 ġimgħa, exenatide li jerħi l-mediċina bil-mod miżjud mal-insulina glargine waħdu jew ma' metformin tqabbel ma' plaċebo miżjud mal-insulina glargine waħdu jew ma' metformin.
English: Each vial contains 2 mg of exenatide.
Maltese: Kull kunjett fih 2 mg ta' exenatide.
English: Mean difference in change from baseline between combination and single active medicinal product (95%CI)
Maltese: Il-medja tad-differenza fittibdil mil-linja bażi bejn ilkombinazzjoni u l-prodott mediċinali attiv uniku (95% CI)
English: There have been uncommon events of altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring haemodialysis.
Maltese: B'exenatide kien hemm avvenimenti mhux komuni ta' tibdil fil-funzjoni renali li jinkludu żieda talkreatinina fis-serum, indeboliment renali, insuffiċjenza renali kronika li tmur għall-agħar u insuffiċjenza renali akuta fejn xi kultant tkun meħtieġa l-emodijalisi.
English: • STOP taking this medicine and contact your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you could have an inflamed pancreas (pancreatitis).
Maltese: • TIBQAX TIEĦU din il-mediċina u kkuntattja lit-tabib tiegħek minnufih jekk tesperjenza uġigħ qawwi u persistenti fl-istonku, bl-irrimettar jew mingħajru, għaliex jista' jkollok frixa infjammata (pankreatite).
English: Vial connector package
Maltese: Pakkett multiplu:
English: The prolonged-release exenatide and dapagliflozin treatment group showed superior reductions in HbA1c from baseline compared to prolonged-release exenatide alone and dapagliflozin alone (Table 5).
Maltese: Ħafna drabi, pazjenti li jiżviluppaw antikorpi kontra exenatide jkollhom iżjed reazzjonijiet fis-sit talinjezzjoni (pereżempju: