FrancophonIA/ELRC3.0 huggingface dataset:
English: Papendorpseweg 83, 3528 BJ Utrecht
Maltese: Papendorpseweg 83, 3528 BJ Utrecht L-Olanda
English: There were 3,114 (31.5 %) patients with established CV disease.
Maltese: Kien hemm 3,114 (31.5 %) -il pazjent b'mard CV stabbilit.
English: Name and address of the manufacturers of the biological active substance Eli Lilly Kinsale Limited
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Eli Lilly Kinsale Limited
English: Severe side effects
Maltese: Effetti sekondarji severi
English: Magyarország Lilly Hungária Kft. Tel: + 36 1 328 5100
Maltese: Lilly Hungária Kft. Tel: + 36 1 328 5100
English: Placebo (n=141)
Maltese: Plaċebo (n=141)
English: Placebo (n= 177)
Maltese: Plaċebo (n= 177)
English: The GLP-1 analog portion of dulaglutide is approximately 90 % homologous to native human GLP-1 (7-37).
Maltese: huwa madwar 90 % omologu għal GLP-1 (7-37) uman nattiv.
English: 3 INJECT
Maltese: 3 INJETTA
English: Date of latest renewal: 23 August 2019
Maltese: Data tal-aħħar tiġdid: 23 Awwissu 2019
English: Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V.
Maltese: Eli Lilly Benelux S.A./N.V.
English: What Trulicity contains The active substance is dulaglutide.
Maltese: Is-sustanza attiva hi dulaglutide.
English: Eesti Tel: +372 6 817 280
Maltese: Tel: +372 6 817 280
English: Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: +371 67364000
Maltese: S.A Pārstāvniecība Latvijā Tel: +371 67364000
English: United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
Maltese: Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: UNCAP 2.
Maltese: L-GĦATU 2.
English: Trulicity contains sodium
Maltese: Trulicity fih sodium
English: 1500-2000 mg/day (n=268)
Maltese: Metformin 1500-2000 mg/kulju m (n=268)
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda.
English: EU/1/14/956/004 EU/1/14/956/005 EU/1/14/956/009 EU/1/14/956/010
Maltese: EU/1/14/956/005 EU/1/14/956/009 EU/1/14/956/010
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 21 Novembru 2014
English: Figure 2: Forest plot of analyses of individual cardiovascular event types, all cause death, and consistency of effect across subgroups for the primary endpoint
Maltese: Figura 2: Dijagramma t'analiżi ta' tipi individwali ta' avvenimenti kardjovaskulari, mewt minn kwalunkwe kawża, u l-konsistenza tal-effett fost is-sottogruppi għall-punt finali primarju
English: The mean age was 66.2 years, the mean BMI was 32.3 kg/m², and 46.3 % of patients were female.
Maltese: L-età medja kienet ta' 66.2 snin, il-medja ta' BMI kienet ta' 32.3 kg/m², u 46.3 % tal-pazjenti kienu nisa.
English: Dulaglutide is not a substitute for insulin.
Maltese: Dulaglutide mhuwiex sostitut għall-insulina.
English: First degree AV block/PR interval prolongation
Maltese: Imblokk AV tal-ewwel grad /titwil tal-intervall PR
English: The results showed that there was no increase in CV risk with dulaglutide compared with control therapies (HR: 0.57; CI: [0.30, 1.10]).
Maltese: b'dulaglutide meta mqabbel ma' terapiji ta' kontroll (HR: 0.57; CI: [0.30, 1.10]).
English: INFORMATION IN BRAILLE TRULICITY 1.5 mg
Maltese: TRULICITY 1.5 mg
English: INFORMATION IN BRAILLE TRULICITY 0.75 mg
Maltese: TRULICITY 0.75 mg
English: A significant and sustained reduction in HbA1c levels from baseline to month 60 was observed with Trulicity vs placebo, in addition to standard of care (-0.29 % vs 0.22 %; estimated treatment difference -0.51 % [-0.57; -0.45]; p < 0.001).
Maltese: Ġie osservat tnaqqis sinifikanti u sostnut fil-livelli ta' HbA1c mil-linja bażi sax-xahar 60 b'Trulicity vs placebo, flimkien ma' kura standard (-0.29 % vs 0.22 %; stima ta' differenza fit-trattament -0.51 % [0.57; -0.45]; p < 0.001).
English: Statistically significant reductions in Cmax of 26 % and 13 % and delays in tmax of 2 and 0.30 hours were observed for norelgestromin and ethinyl estradiol, respectively.
Maltese: Tnaqqis sinifikanti b'mod statistiku ta' 26 % u 13 % fis-Cmax u dewmien ta' sagħtejn u 0.30 sigħat fit-tmax kienu osservati għal norelgestromin u ethinyl estradiol, rispettivament.
English: The mean t1/2 of atorvastatin and o-hydroxyatorvastatin were increased by 17 % and 41 %, respectively, following dulaglutide administration.
Maltese: Il-medja tat-t1/2 ta' atorvastatin u o-hydroxyatorvastatin żdiedu bi 17 % u 41 %, rispettivament, wara għoti ta' dulaglutide.
English: Change in FBG
Maltese: Bidla flFBG
English: Of these, 1,206 were ≥ 65 years of which 119 were ≥ 75 years.
Maltese: Minn dawn, 1,206 kellhom ≥ 65 sena li minnhom 119 kellhom ≥ 75 sena.
English: Trulicity was superior in preventing MACE compared to placebo (Figure 1).
Maltese: Trulicity kien superjuri fil-prevenzjoni ta' MACE meta mqabbel ma' plaċebo (Figura 1).
English: The median study follow-up time was 5.4 years.
Maltese: Iż-żmien medjan ta' segwitu ta' studju kien ta' 5.4 snin.
English: Sitagliptin can produce up to 80 % inhibition of DPP-4 over a 24-hour period.
Maltese: Sitagliptin jista' jipproduċi inibizzjoni sa 80 % ta' DPP-4 fuq perjodu ta' 24 siegħa.
English: Slovenská republika Eli Lilly Slovakia s.r.o.
Maltese: Eli Lilly Slovakia s.r.o.
English: At baseline, overall mean eGFR was 38 mL/min/1.73 m2, 30% of patients had eGFR < 30 mL/min/1.73 m2.
Maltese: Fil-linja bażi, il-medja in ġenerali tal-eGFR kienet ta' 38 mL/min/1.73 m2, 30% tal-pazjenti kellhom eGFR < 30 mL/min/1.73 m2.
English: Dulaglutide exhibits several antihyperglycaemic actions of GLP-1.
Maltese: Dulaglutide juri diversi azzjonijiet kontra l-ipergliċemija ta' GLP-1.
English: LIST OF EXCIPIENTS Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections
Maltese: Sodium citrate, citric acid anhydrous, mannitol, polysorbate 80, ilma għall-injezzjonijiet
English: There was no difference in diastolic blood pressure (DBP).
Maltese: Ma kien hemm l-ebda differenza fil-pressjoni tad-demm dijastolika (DBP - diastolic blood pressure).
English: Insulin glargine+ once daily (n=194)
Maltese: Insulin glargine+ darba kuljum (n=194)
English: * Documented, symptomatic hypoglycaemia with blood glucose ≤ 3.9 mmol/L † Dulaglutide 1.5 mg dose only.
Maltese: * Ipogliċemija bis-sintomi, ddokumentata bil-glukożju fid-demm ≤ 3.9 mmol/L
English: Native GLP-1 has a half-life of 1.5-2 minutes due to degradation by DPP-4 and renal clearance.
Maltese: 1.5-2 minuti minħabba degradazzjoni minn DPP-4 u tneħħija mill-kliewi.
English: Air bubbles are normal.
Maltese: Bżieżaq tal-arja huma normali.
English: Coadministration of dulaglutide with an oral contraceptive (norgestimate 0.18 mg/ethinyl estradiol 0.025 mg) did not affect the overall exposure to norelgestromin and ethinyl estradiol.
Maltese: 0.025 mg) m'affettwax l-espożizzjoni totali għal norelgestromin u ethinyl estradiol.
English: and patients with mild (n = 2,435), moderate (n = 1,031) or severe (n = 50) renal impairment.
Maltese: ≥ 75 years (n = 484), u pazjenti b'indeboliment renali ħafif (n = 2,435), moderat (n = 1,031) jew sever (n = 50).
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni ta' PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista taddati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Treatment with dulaglutide provided reductions in systolic blood pressure (SBP) (-2.8 mmHg difference compared to placebo) at 16 weeks.
Maltese: Kura b'dulaglutide ipprovdiet tnaqqis fil-pressjoni tad-demm sistolika (SBP - systolic blood pressure) (differenza ta' -2.8 mmHg meta mqabbel mal-plaċebo) fis-16-il ġimgħa.
English: Insulin glargine+ once daily (n=262)
Maltese: Insulina glargine+ darba kuljum (n=262)
English: Clinical studies with dulaglutide have indicated enhanced beta-cell function as measured by homeostasis model assessment (HOMA2-%B).
Maltese: Funzjoni taċ-ċellula beta Studji kliniċi bi dulaglutide indikaw funzjoni aħjar taċ-ċellula beta kif imkejla bl-istima tal-mudell tal omeostasi (HOMA2-%B - by homeostasis model assessment).
English: Small mean increases in heart rate of 2 to 4 beats per minute (bpm) and a 1.3% and 1.4 % incidence of sinus tachycardia, with a concomitant increase from baseline ≥ 15 bpm, were observed with dulaglutide 0.75mg and 1.5 mg, respectively.
Maltese: Medja ta' żidiet żgħar ta' 2 sa 4 taħbitiet kull minuta (bpm - beats per minute) fir-rata ta' taħbit talqalb u inċidenza ta' takikardija tas-sinus ta' 1.3 % u 1.4 %, b'żieda konkomittanti ta' ≥ 15-il bpm mill linja bażi, ġew osservati b'dulaglutide 0.75mg u 1.5 mg, rispettivament.
English: Statistically significant delays in lisinopril tmax of approximately 1 hour were observed on Days 3 and 24 of the study.
Maltese: Dewmien b'mod statistikament sinifikanti ta' madwar siegħa fit-tmax ta' lisinopril kien osservat fil-Jiem 3 u 24 tal-istudju.
English: In clinical trials, acute pancreatitis has been reported in association with dulaglutide (see section 4.8).
Maltese: Fi provi kliniċi, pankreatite akuta kienet irrappurtata b'rabta ma' dulaglutide (ara sezzjoni 4.8).
English: When a single dose of dulaglutide and metoprolol were coadministered, the AUC and Cmax of metoprolol increased by19 % and 32 %, respectively.
Maltese: dulaglutide u metoprolol ingħataw flimkien, l-AUC u s-Cmax ta' metoprolol żdiedu f'19 % u 32 %, rispettivament.
English: Combination therapy with metformin
Maltese: Terapija flimkien ma' metformin
English: Insulin glargine+ once daily (n=296)
Maltese: Insulina glargine+ darba kuljum (n=296)
English: Table 1: The frequency of adverse reactions of dulaglutide
Maltese: Tabella 1: Il-frekwenza tar-reazzjonijiet avversi ta' dulaglutide
English: Combination therapy with SGLT2 inhibitor with or without metformin The safety and efficacy of dulaglutide as add-on to sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy (96% with and 4% without metformin) were investigated in a placebo controlled study of 24 weeks duration.
Maltese: Is-sigurtà u l-effikaċja ta' dulaglutide bħala żieda fit-terapija ma' inibitur tal-kotrasportatur 2 tas sodium u l-glucose (SGLT2i) (96% b'metformin u 4% mingħajru) ġew investigati fi studju kkontrollat bi plaċebo li dam 24 ġimgħa.
English: The most frequent adverse reactions leading to discontinuation for 0.75 mg and 1.5 mg dulaglutide, respectively, were nausea (1.0%, 1.9 %), diarrhoea (0.5%, 0.6 %), and vomiting (0.4%, 0.6 %), and were generally reported within the first 4-6 weeks.
Maltese: L-aktar reazzjonijiet avversi frekwenti li wasslu għal twaqqif tal-kura għal 0.75 mg u 1.5 mg dulaglutide, rispettivament, kienu nawsja (1.0%, 1.9 %), dijarea (0.5%, 0.6 %), u rimettar (0.4%, 0.6 %), u b'mod ġenerali ġew irrappurtati fl-ewwel
English: Cumulative reporting of gastrointestinal events up to 104 weeks with dulaglutide 0.75mg and 1.5 mg, respectively, included nausea (12.9% and 21.2 %), diarrhoea (10.7% and 13.7 %) and vomiting (6.9% and 11.5 %).
Maltese: rispettivament, kien jinkludi nawsja (12.9% u 21.2 %), dijarea (10.7% u 13.7 %) u rimettar (6.9% u
English: Effects of overdose with dulaglutide in clinical studies have included gastrointestinal disorders and hypoglycaemia.
Maltese: Effetti ta' doża eċċessiva b'dulaglutide fi studji kliniċi kienu jinkludu disturbi gastrointestinali u ipogliċemija.
English: Elderly No dose adjustment is required based on age (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża abbażi tal-età (ara sezzjoni 5.2).
English: Rare: may affect up to 1 in 1,000 people - Severe allergic reactions (anaphylactic reactions, angioedema).
Maltese: Rari: jistgħu jaffettwaw sa persuna waħda minn kull 1,000 - Reazzjonijiet allerġiċi severi (reazzjonijiet anafilattiċi,anġjoedima)
English: Changes in body weight with Trulicity 0.75 mg ranged from 0.86 kg to -2.63 kg.
Maltese: Tibdil fil-piż tal-ġisem bi Trulicity 0.75 mg kien fuq firxa bejn 0.86 kg sa -2.63 kg.
English: The risk of hypoglycaemia may be lowered by a reduction in the dose of sulphonylurea or insulin (see sections 4.2 and 4.8).
Maltese: Ir-riskju ta' ipogliċemija jista' jitbaxxa bi tnaqqis fid-doża tas-sulphonylurea jew tal-insulina (ara sezzjonijiet 4.2 u 4.8).
English: AUCINR increased by 2 %, which is unlikely to be clinically significant, and there was no effect on maximum international normalised ratio response (INRmax).
Maltese: L-AUCINR żdied bi 2 %, li x'aktarx mhuwiex sinifikanti b'mod kliniku, u ma kien hemm l-ebda effett fuq ir-rispons tal-proporzjon normalizzat internazzjonali massimu (INRmax - maximum international normalised ratio).
English: Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' agonisti tar-riċettur ta' GLP-1 ġie assoċjat ma' riskju ta' żvilupp ta' pankreatite akuta.
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu,
English: Trulicity 1.5 mg was associated with sustained weight reduction over the duration of studies (from baseline to final time point -0.35 kg to -2.90 kg).
Maltese: Trulicity 1.5 mg ġie assoċjat ma' tnaqqis sostnut fil-piż għat-tul ta' żmien kollu tal-istudji (mill-linja bażi sal-punt ta' żmien finali -0.35 kg sa -2.90 kg).
English: the syringe.
Maltese: s-siringa.
English: Tel: + 34-91 663 50 00
Maltese: Lilly S.A. Tel: + 34-91 663 50 00
English: Thu
Maltese: T
English: The other ingredients are sodium citrate (see section 2 under ‘Trulicity contains sodium citrate' for further information); citric acid, anhydrous; mannitol; polysorbate 80 and water for injections.
Maltese: Is-sustanzi l-oħra huma sodium citrate (ara sezzjoni 2 taħt ‘Trulicity fih sodium citrate' għal aktar informazzjoni), citric acid anhydrous, mannitol, polysorbate 80 u ilma għall-injezzjonijiet.
English: Similar results for SBP and DBP were demonstrated at the final 26 week time point of the study.
Maltese: Riżultati simili għall-SBP u d-DBP intwerew fil-punt finali taż-żmien tal-istudju fis-26 ġimgħa.
English: atrioventricular block (AVB)
Maltese: Takikardija tassinus, imblokk atrioventrikulari tal-ewwel grad (AVBatrioventricular block)
English: Dulaglutide 1.5 mg once weekly and insulin glargine (n=150)
Maltese: Dulaglutide 1.5 mg darba fil-ġimgħa u insulina glargine (n=150)
English: The most frequently reported adverse reactions in clinical trials were gastrointestinal, including nausea, vomiting and diarrhoea.
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti fi provi kliniċi kienu gastrointestinali, inkluż nawsja, rimettar u dijarea.
English: The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and Trulicity 0.75 mg, and insulin glargine were 4.44, 4.34, and 9.62 episodes/patient/year, respectively.
Maltese: Ir-rati ta' ipogliċemija sintomatika ddokumentata b'Trulicity 1.5 mg u Trulicity 0.75 mg, u insulin glargine kienu 4.44, 4.34, u 9.62 episodji/pazjent/sena, rispettivament.
English: The safety profile of Trulicity in patients with renal impairment was similar to that observed in other studies with Trulicity.
Maltese: Il profil ta' sigurtà ta' Trulicity f'pazjenti b'indeboliment renali kien simili għal dak osservat f'studji oħra b'Trulicity.
English: Treatment with dulaglutide resulted in significant reductions in mean post prandial glucose from baseline (changes from baseline to primary time point -1.95 mmol/L to -4.23 mmol/L).
Maltese: (tibdiliet mill-linja bażi sal-punt ta' żmien primarju -1.95 mmol/L sa -4.23 mmol/L).
English: The time of international normalised ratio response (tINRmax) was delayed by 6 hours, consistent with delays in tmax of approximately 4 and 6 hours for S- and R-warfarin, respectively.
Maltese: Il-ħin għar-rispons tal proporzjon normalizzat internazzjonali (tINRmax) ġie mdewwem b'6 sigħat, li huwa konsistenti ma' dewmien fit-tmax ta' madwar 4 u 6 sigħat għal warfarin S u R, rispettivament.
English: The pharmacokinetics of dulaglutide were evaluated in a clinical pharmacology study, where subjects with hepatic impairment had statistically significant decreases in dulaglutide exposure of up to 30 % to 33 % for mean Cmax and AUC, respectively, compared to healthy controls.
Maltese: Il-farmakokinetika ta' dulaglutide ġiet stmata fi studju farmakoloġiku kliniku, fejn individwi b'indeboliment tal-fwied kellhom tnaqqis sinifikanti b'mod statistiku fl-espożizzjoni għal dulaglutide sa 30 % u 33 % għal medja ta' Cmax u l-AUC, rispettivament, meta mqabbla ma' kontrolli f'saħħithom.
English: Each MACE component contributed to the reduction of MACE, as shown in Figure 2.
Maltese: Kull komponent ta' MACE ikkontribwixxa għat tnaqqis ta' MACE, kif muri fi Figura 2.
English: Combination therapy with sulphonylurea
Maltese: Terapija flimkien ma' metformin u sulphonylurea
English: The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and insulin glargine were 1.67, 1.67, and 3.02 episodes/patient/year, respectively.
Maltese: Ir-rati ta' ipogliċemija bis-sintomi ddokumentata bi Trulicity1.5 mg u 0.75 mg u insulina glargine kienu 1.67, 1.67, u 3.02 episodji/pazjent/sena, rispettivament.
English: Insulin glargine+ once daily (n=194) † 1-sided p-value < 0.025, for non-inferiority of dulaglutide to insulin glargine ## p < 0.001 dulaglutide treatment group compared to insulin glargine + Insulin glargine doses were adjusted utilizing an algorithm with a fasting plasma glucose target of
Maltese: Insulin glargine+ darba kuljum (n=194) † 1-sided p-value < 0.025, għan-non-inferjorità ta' dulaglutide għal insulin glargine ## p < 0.001 il-grupp ta' trattament ta' dulaglutide meta mqabbel ma' insulin glargine
English: I'm not sure my pen worked correctly.
Maltese: Neħħi l-pinna minn mal-ġilda.
English: Small mean increases from baseline in PR interval of 2 to 3 msec and a 1.5% and 2.4 % incidence of first-degree AV block were observed with dulaglutide 0.75 mg and 1.5 mg, respectively.
Maltese: Medja ta' żidiet żgħar ta' 2 sa 3 msek mill-linja bażi fl-intervall PR u inċidenza ta' 1.5% u 2.4 % fl imblokk AV tal-ewwel grad, ġew osservati b'dulaglutide 0.75 mg u 1.5 mg, rispettivament.
English: # p < 0.05 dulaglutide treatment group compared to liraglutide.
Maltese: # p < 0.05 grupp ta' kura ta' dulaglutide mqabbel ma' liraglutide.
English: 50019, Sesto Fiorentino
Maltese: Via Gramsci 731/733 50019, Sesto Fiorentino Firenze (FI) L-Italja
English: Dulaglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist.
Maltese: Dulaglutide huwa agonist tar-riċettur ta' peptide 1 li jixbah lil glucagon (GLP-1 - glucagon-like peptide 1) u li jaħdem fit-tul.
English: Sitagliptin 100 mg once daily (n=315)
Maltese: Sitagliptin 100 mg darba kuljum (n=315)
English: 10 mcg twice daily (n=276)
Maltese: Exenatide+ 10 mcg darbtejn kuljum (n=276)
English: After coadministration with up to 3 mg of dulaglutide at steady state, there were no statistically significant differences on AUC(0-12), Cmax or tmax of paracetamol.
Maltese: Wara għoti flimkien ma' massimu ta' 3 mg ta' dulaglutide fi stat fiss, ma kien hemm l-ebda differenzi sinifikanti b'mod statistiku fuq l-AUC(0-12), is-Cmax jew it-tmax ta' paracetamol.
English: The mean peak (Cmax) and total (AUC) exposures were approximately 114 ng/ml and 14,000 ngh/ml, respectively, after multiple subcutaneous 1.5 mg doses of dulaglutide in patients with type 2 diabetes.
Maltese: Il-medja tal-ogħla (Cmax) u tat-total (AUC) tal-espożizzjoni kienu madwar 114 ng/ml u 14,000 ngsiegħa/ml, rispettivament, wara dożi multipli taħt il-ġilda ta' 1.5 mg ta' dulaglutide f'pazjenti b'dijabete tat-tip 2.
English: Therefore, dulaglutide does have a high degree of protection against DPP-4 inactivation (see section 5.1, Mechanism of action).
Maltese: Għalhekk, dulaglutide għandu grad għoli ta' protezzjoni kontra inattivazzjoni minn DPP-4 (ara sezzjoni 5.1, Mekkaniżmu ta' azzjoni).
English: Consistent with the pharmacokinetic profile, dulaglutide has a pharmacodynamic profile suitable for once weekly administration (see section 5.2).
Maltese: B'mod konsistenti mal-profil farmakokinetiku, dulaglutide għandu profil farmakodinamiku adattat għall-għoti ta' darba fil-ġimgħa (ara sezzjoni 5.2).
English: Belgique/België/Belgien Eli Lilly Benelux S.A./N.V.
Maltese: Belgique/België/Belgien
English: Dulaglutide coadministration with sitagliptin increased dulaglutide exposure and Cmax by approximately 38 % and 27 %, respectively, and median tmax increased approximately 24 hours.
Maltese: L-għoti ta' dulaglutide flimkien ma' sitagliptin żied l-espożizzjoni għal dulaglutide u s-Cmax b'madwar 38 % u 27 %, rispettivament, u l-medjan tat-tmax żdied madwar 24 siegħa.
English: Treatment with Trulicity 0.75 mg or Trulicity 1.5 mg in combination with SGLT2i therapy resulted in a statistically significant reduction in HbA1c compared to placebo with SGLT2i therapy at 24 weeks.
Maltese: Trattament bi Trulicity 0.75 mg jew Trulicity 1.5 mg flimkien ma' terapija b'SGLT2i wasslet għal tnaqqis statistikament rilevanti fl-HbA1c meta mqabbel ma' plaċebo b'terapija b'SGLT2i fl-24 ġimgħa.
English: The severe hypoglycaemia event incidences were 2.4% and 3.4%, and rates were 0.05 and 0.06 events/patient/year.
Maltese: L-inċidenzi ta' każ ta' ipogliċemija qawwija kienu 2.4% u 3.4%, u r-rati kienu 0.05 u 0.06 każijiet/pazjent/sena.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 1.5 mg dose, i.e. essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża ta' 1.5 mg, i.e. huwa essenzjalment ‘ħieles mis-sodium'.
English: The incidences of documented symptomatic hypoglycaemia when dulaglutide 0.75 mg and 1.5 mg, respectively, were used in combination with a sulphonylurea and metformin were 39.0% and 40.3% and the rates were 1.67 and 1.67 events/patient/year.
Maltese: L-inċidenzi ta' ipogliċemija bis-sintomi ddokumentati meta dulaglutide 0.75 mg u 1.5 mg, rispettivament, intużaw flimkien ma' xi sulphonylurea u metformin kienu 39.0% u 40.3% u r-rati kienu 1.67 u 1.67 każijiet/pazjent/sena.
English: Pancreatic enzymes
Maltese: Enzimi tal-frixa
English: When it is added to existing therapy of a sulphonylurea or insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see sections 4.4 and 4.8).
Maltese: Meta jiżdied ma' terapija diġà eżitenti ta' xi sulphonylurea jew ta' xi insulina, jista' jitqies tnaqqis fid-doża tas sulphonylurea jew l-insulina biex jitnaqqas ir-riskju ta' ipogliċemija (ara sezzjonijiet 4.4 u 4.8).
English: In studies of 26 weeks duration, the incidence of discontinuation due to adverse events was 2.6% (0.75 mg) and 6.1% (1.5 mg) for dulaglutide versus 3.7 % for placebo.
Maltese: Fi studji li damu 26 ġimgħa, l-inċidenza ta' twaqqif tal-kura minħabba każijiet avversi kienet 2.6% (0.75 mg) u 6.1% (1.5 mg) għal dulaglutide versus 3.7 % għall-plaċebo.
English: 100 mg once daily (n=315)
Maltese: 100 mg darba kuljum (n=315)
English: A similar percentage of patients achieved HbA1c targets of < 8.0 % at 26 and 52 weeks with both dulaglutide doses as well as insulin glargine.
Maltese: Persentaġġ simili ta' pazjenti laħqu l-miri ta' HbA1c ta' < 8.0 % wara 26 u 52 ġimgħa kemm biż-żewġ dożi ta' dulaglutide kif ukoll b'insulin glargine.
English: The incidence of acute pancreatitis in Phase II and III clinical studies was 0.07% for dulaglutide compared to 0.14% for placebo and 0.19% for comparators with or without additional background antidiabetic therapy.
Maltese: L-inċidenza ta' pankreatite akuta fi studji kliniċi tal-Fażi II u III kienet 0.07% għal dulaglutide meta mqabbel ma' 0.14% għall-plaċebo u 0.19% għall-kumparaturi, b'terapija addizzjonali kontra d dijabete fl-isfond jew mingħajrha.