FrancophonIA/ELRC3.0 huggingface dataset:
English: There were significantly fewer patients in the Trulicity group who received an additional glycaemic intervention compared to placebo (Trulicity: 2,086 [42.2 %]; placebo: 2,825 [57.0 %]; p < 0.001).
Maltese: Kien hemm numru sinifikanti inqas ta' pazjenti fil-grupp ta' Trulicity li rċevew intervent gliċemiku ieħor meta mqabbel ma' plaċebo (Trulicity: 2,086 [42.2 %]; plaċebo:
English: The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and insulin glargine were 31.06, 35.66, and 40.95 episodes/patient/year, respectively.
Maltese: Ir-rati ta' ipogliċemija bis-sintomi ddokumentata bi Trulicity 1.5 mg u 0.75 mg u bl-insulina glargine kienu 31.06, 35.66, u 40.95 episodji/pazjent/sena, rispettivament.
English: This medicine contains less than 1 mmol sodium (23 mg) per 0.75 mg or 1.5 mg, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull 0.75 mg jew 1.5 mg, li fil-verità tista' tgħid li huwa ‘mingħajr sodium'.
English: Glass syringe (type I).
Maltese: Ħadt l-injezzjoni kollha?
English: In the presence of elevated glucose concentrations, dulaglutide increases intracellular cyclic AMP (cAMP) in pancreatic beta cells leading to insulin release.
Maltese: konċentrazzjonijiet għolja ta' glukożju, dulaglutide iżid l-AMP ċikliku (cAMP - cyclic AMP) intraċellulari fiċ-ċelluli beta tal-frixa li jwassal biex tintreħa l-insulina.
English: Postprandial glucose
Maltese: Kontroll gliċemiku
English: - Trulicity 0.75 mg: Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution.
Maltese: - Trulicity 0.75 mg: Kull pinna mimlija għal-lest fiha 0.75 mg ta' dulglutide f'0.5 ml ta' soluzzjoni.
English: Immunogenicity
Maltese: Monoterapija
English: In a 52 week study, Trulicity 1.5 mg and 0.75 mg were compared to titrated insulin glargine as add-on to prandial insulin lispro to evaluate the effect on glycaemic control and safety of patients with moderate to severe chronic kidney disease (eGFR [by CKD-EPI] <60 and ≥15 mL/min/1.73 m2).
Maltese: Fi studju li dam 52 ġimgħa, Trulicity 1.5 mg u 0.75 mg ġew imqabbla ma' insulin glargine ittitrat bħala żieda ma' insulin lispro mogħti mal-ħin tal-ikel sabiex jiġi evalwat l-effett fuq il-kontroll gliċemiku u s-sigurtà f'pazjenti b'mard kroniku tal-kliewi moderat għal sever (eGFR [permezz ta' CKD-EPI] <60 u ≥15-il mL/min/1.73 m2).
English: When Trulicity is added to existing metformin and/or sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose of metformin and/or SGLT2i can be continued.
Maltese: Meta Trulicity jiżdied ma' terapija diġà eżitenti b'metformin u/jew inibitur tal-kotrasportatur 2 tas-sodium u l-glucose (SGLT2i, sodium-glucose co transporter 2 inhibitor), id-doża attwali ta' metformin u/jew SGLT2i tista' titkompla.
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins, ATC code: A10BJ05
Maltese: Mediċini użati fid-dijabete, mediċini li jbaxxu l-livell tal-glukożju fiddemm, eskl. l-insulini, kodiċi ATC:
English: 1500-2000 mg/day (n=268) † multiplicity adjusted 1-sided p-value < 0.025, for noninferiority; †† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to metformin, assessed for HbA1c only # p < 0.05, ## p < 0.001 dulaglutide treatment group compared to metformin
Maltese: 1500-2000 mg/kulju m (n=268) † valur p 1-sided aġġustat għall-multipliċità < 0.025, fejn jidher li ma kienx inferjuri;†† valur p
English: 1 UNCAP
Maltese: 1 NEĦĦI
English: Trulicity 1.5 mg and 0.75 mg were superior to metformin (1500-2000 mg/day) in the reduction in HbA1c and a significantly greater proportion of patients reached an HbA1c target of < 7.0 % and ≤ 6.5 % with Trulicity 1.5 mg and Trulicity 0.75 mg compared to metformin at 26 weeks.
Maltese: fit-tnaqqis ta' HbA1c u proporzjon sinifikanti akbar ta' pazjenti laħqu l-mira ta' HbA1c ta' < 7.0 % u ta' ≤ 6.5 % bi Trulicity 1.5 mg u Trulicity 0.75 mg meta mqabbla ma' metformin fis-26 ġimgħa.
English: Following coadministration of multiple dose dulaglutide with steady state metformin (immediate release formula [IR]), metformin AUCτ increased up to 15 % and Cmax decreased up to 12 %, respectively, with no changes in tmax.
Maltese: Wara l-għoti flimkien ta' dożi multipli ta' dulaglutide ma' metformin fl-istat fiss (formula li terħi lmediċina b'mod immedjat [IR - immediate release]), l-AUCτ ta' metformin żdied sa 15 % u s-Cmax naqas sa 12 %, rispettivament, mingħajr l-ebda tibdil fit-tmax.
English: Elderly
Maltese: Ifli
English: Baseline HbA1c
Maltese: Bidla medja flHbA1c
English: Decreased appetite, dyspepsia, constipation, flatulence, abdominal distention, gastroesophageal reflux disease, eructation
Maltese: Tnaqqis fl-aptit, dispepsja, stitikezza, gass, nefħa fl-addome, mard ta' rifluss gastroesefagali, tifwiq
English: Dulaglutide dosing of male and female juvenile rats did not produce memory deficits at 91-fold the human exposure.
Maltese: Dożi ta' dulaglutide mogħtija lill-firien żgħar maskili u femminili ma kkawżawx nuqqasijiet fil-memorja f'espożizzjoni li kienet 91 darba dik umana.
English: The incidence of documented symptomatic hypoglycaemia when dulaglutide 1.5 mg was used in combination with insulin glargine was 35.3% and the rate was 3.38 events/patient/year.
Maltese: Meta dulaglutide 1.5 mg intuża flimkien mal-insulina glargine, l-inċidenza ta' ipogliċemija sintomatika ddokumentata kienet ta' 35.3% u r-rata kienet ta' 3.38 avvenimenti/pazjent/sena.
English: At the end of the 28 week treatment period the dose was 65 units/day and 51 units/day, for patients receiving placebo and Trulicity 1.5 mg, respectively.
Maltese: 28 ġimgħa ta' trattament, id-doża kienet ta' 65 unità/jum u 51 unità/jum, għall-pazjenti li qed jirċievu plaċebo u Trulicity 1.5 mg, rispettivament.
English: The pharmacokinetics of dulaglutide were evaluated in a clinical pharmacology study and were generally similar between healthy subjects and patients with mild to severe renal impairment (CrCl < 30 ml/min), including end stage renal disease (requiring dialysis).
Maltese: Il-farmakokinetika ta' dulaglutide ġiet stmata fi studju farmakoloġiku kliniku u b'mod ġenerali kienet tixxiebah bejn individwi f'saħħithom u pazjenti b'indeboliment minn ħafif sa moderat tal-kliewi (CrCl < 30 ml/min), inkluż mard tal-kliewi fl-aħħar stadju (li jkun jeħtieġ id-dijalisi).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (without Blue Box) component of a multipack - PRE-FILLED PEN
Maltese: KARTUNA INTERMEDJA (mingħajr il-Kaxxa Blu) komponent ta' pakkett multiplu - PINNA
English: Type 2 diabetes patients were randomly allocated to either Trulicity 1.5 mg (4,949) or placebo (4,952) both in addition to standards of care for type 2 diabetes (the 0.75 mg dose was not administered in this study).
Maltese: B'mod arbitrarju, pazjenti bid-dijabete ta' tip 2 ġew assenjati għal jew Trulicity 1.5 mg (4,949) jew plaċebo (4,952) it-tnejn flimkien ma' kura standard għad-dijabete tat-tip 2 (id-doża ta' 0.75 mg ma ngħatatx f'dan l-istudju).
English: The Trulicity long-term cardiovascular outcome study was a placebo-controlled, double-blind clinical trial.
Maltese: L-istudju fit-tul ta' Trulicity dwar l-effett kardjovaskulari kien prova klinika ,double-blind u kkontrollat bi plaċebo.
English: Instructions for use Trulicity 1.5 mg solution for injection in pre-filled syringe dulaglutide
Maltese: Trulicity 1.5 mg injezzjoni dulaglutide
English: Combination therapy with titrated basal insulin, with or without metformin In a 28 week placebo controlled study, Trulicity1.5 mg was compared to placebo as add-on to titrated basal insulin glargine (88% with and 12% without metformin) to evaluate the effect on glycaemic control and safety.
Maltese: Terapija flimkien ma' insulina bażali ttitrata, b'metformin jew mingħajru Fi studju kkontrollat bil-plaċebo li dam 28 ġimgħa, Trulicity1.5 mg ġie mqabbel ma' plaċebo bħala żieda fit-terapija ma' insulina glargine bażali ttitrata (88% b'metformin u 12% mingħajru) sabiex jiġi evalwat l-effett fuq il-kontroll gliċemiku u s-sigurtà.
English: For dulaglutide 0.75 mg, adverse reaction met frequency for next lower incidence grouping.
Maltese: Għal dulaglutide 0.75 mg, ir-reazzjoni avversa laħqet il frekwenza aktar baxxa tal-grupp tal-inċidenza li kien imiss.
English: The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and placebo were 0.90 and 0.04 episodes/patient/year, respectively.
Maltese: Ir-rati ta' ipogliċemija sintomatika ddokumentata b'Trulicity 1.5 mg u bi plaċebo kienu 0.90 u 0.04 episodji/pazjent/sena, rispettivament.
English: Instructions for use Trulicity 0.75 mg solution for injection in pre-filled syringe dulaglutide
Maltese: Trulicity 0.75 mg injezzjoni dulaglutide
English: How to store Trulicity
Maltese: X'fih Trulicity
English: Additionally, in a 52-week clinical study in patients with type 2 diabetes and moderate to severe renal impairment (eGFR [by CKD-EPI] <60 and ≥15 mL/min/1.73 m2), the pharmacokinetic profile of Trulicity 0.75 mg and 1.5 mg once weekly was similar to that demonstrated in previous clinical studies.
Maltese: Barra minn hekk, fi studju kliniku ta' 52 ġimgħa f'pazjenti bid-dijabete mellitus tat-tip 2 u b'indeboliment renali moderat għal sever (eGFR [permezz ta' CKD-EPI] <60 u ≥15-il mL/min/1.73 m2), il-profil farmakokinetiku ta' Trulicity 0.75 mg u 1.5 mg darba fil-ġimgħa kien simili għal dak stabbilit f'studji kliniċi preċedenti.
English: ABOUT TRULICITY PRE-FILLED PEN
Maltese: Trulicity kien superjuri fil-prevenzjoni ta'
English: In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis (see section 4.8).
Maltese: Fin-nuqqas ta' sinjali u sintomi oħra ta' pankreatite akuta, żidiet fil-livelli tal-enzimi tal-frixa waħedhom mhumiex tbassir ta' pankreatite akuta (ara sezzjoni 4.8).
English: When dulaglutide 0.75 mg and 1.5 mg were used as monotherapy or in combination with metformin alone or metformin and pioglitazone, the incidences of documented symptomatic hypoglycaemia were 5.9% to 10.9% and the rates were 0.14 to 0.62 events/patient/year, and no episodes of severe hypoglycaemia were reported.
Maltese: Meta dulaglutide 0.75 mg u 1.5 mg intużaw bħala monoterapija jew flimkien ma' metformin waħdu jew metformin u pioglitazone, l-inċidenzi ta' ipogliċemija bis-sintomi ddokumentata kienu 5.9% sa 10.9% u r-rati kienu 0.14 sa 0.62 każijiet/pazjent/sena, u ma kienu rrappurtati l-ebda episodji ta'
English: Hypoglycaemia* (when used as monotherapy or in combination with metformin plus pioglitazone)
Maltese: Ipogliċemija* (meta jintuża bħala monoterapija jew flimkien ma' metformin u pioglitazone)
English: The Trulicity treatment arm included patients ≥ 65 years (n = 2,619) and ≥ 75 years (n = 484),
Maltese: Il-fergħa ta' trattament ta' Trulicity kienet tinkludi pazjenti ≥ 65 sena (n = 2,619) u ≥ 75 years (n = 484), u pazjenti b'indeboliment renali ħafif (n = 2,435), moderat (n = 1,031) jew sever (n = 50).
English: The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and insulin glargine were 3.38 episodes/patient/year compared to placebo and insulin glargine 4.38 episodes/patient/year.
Maltese: 3.38 episodji/pazjent/sena meta mqabbla ma' plaċebo u insulina glargine b'4.38 episodji/pazjent/sena.
English: • When refrigeration is not possible, you can keep your pen at room temperature (below 30°C) for up to a total of 14 days.
Maltese: • Meta ma jkunx possibbli li tpoġġiha fil-friġġ, tista' żżomm il-pinna tiegħek f'temperatura tal kamra (inqas minn 30°C) sa total ta' 14-il ġurnata.
English: Placebo once weekly and insulin glargine (n=150) ‡‡ p < 0.001 for superiority of dulaglutide compared to placebo, overall type I error controlled ** p < 0.001 dulaglutide treatment group compared to placebo
Maltese: Plaċebo darba filġimgħa u insulina glargine (n=150) ‡‡ p < 0.001 għas-superjorità ta' dulaglutide meta mqabbel ma' plaċebo, bl-iżball in ġenerali ta' tip I (overall type I error) ikkontrollat
English: The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and exenatide twice daily were 0.19, 0.14, and 0.75 episodes/patient/year, respectively.
Maltese: Ir-rati ta' ipogliċemija bis-sintomi ddokumentata bi Trulicity 1.5 mg u 0.75 mg, u b'exenatide darbtejn kuljum kienu 0.19, 0.14, u 0.75 episodji/pazjent/sena, rispettivament.
English: Biotransformation
Maltese: L. Bijotransformazzjoni
English: To optimise the insulin glargine dose, both groups were titrated to a target fasting serum glucose of <5.6 mmol/L.
Maltese: insulina glargine, iż-żewġ gruppi ġew ittitrati biex jiksbu l-mira ta' livell ta' glukożju fis-serum fl-istat sajjem ta' <5.6 mmol/L.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Maltese: Il-pazjenti għandhom jiġu infurmati bis-sintomi karatteristiċi ta' pankreatite akuta.
English: Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism pathways.
Maltese: Wieħed jassumi li dulaglutide jiddiżintegra f'komponenti ta' amino acids li huwa magħmul minnhom permezz ta' rotot ġenerali ta' kataboliżmu tal-proteini.
English: Dulaglutide is associated with mean increases from baseline in pancreatic enzymes (lipase and/or pancreatic amylase) of 11 % to 21 % (see section 4.4).
Maltese: (lipase u/jew amylase tal-frixa) (ara sezzjoni 4.4).
English: Ten patients reported severe hypoglycaemia with Trulicity 1.5 mg, seven with Trulicity 0.75 mg, and fifteen with insulin glargine.
Maltese: Ebda pazjent ma rrapporta każ ta' ipogliċemija severa b'Trulicity 1.5 mg, sitta b'Trulicity 0.75 mg, u sbatax b'insulin glargine.
English: At 52 weeks, Trulicity 1.5 mg demonstrated superior lowering in HbA1c to insulin glargine which was maintained at 78 weeks; whereas lowering in HbA1c with Trulicity 0.75 mg was non-inferior to insulin glargine.
Maltese: Fit-52 ġimgħa, Trulicity 1.5 mg wera tnaqqis fl-HbA1c superjuri għall-insulina glargine li nżamm fil-ġimgħa 78; filwaqt li t-tnaqqis flHbA1c bi Trulicity 0.75 mg ma kienx inferjuri għal insulina glargine.
English: Handle it carefully.
Maltese: rispettivament.
English: Dulaglutide 0.75 mg once weekly (n=141)
Maltese: Dulaglutide 0.75 mg darba fil-ġimgħa (n=141)
English: The molecule consists of 2 identical disulfide-linked chains, each containing a modified human GLP-1 analogue sequence covalently linked to a modified human immunoglobulin G4 (IgG4) heavy chain fragment (Fc) by a small peptide linker.
Maltese: Il-molekula tikkonsisti f'żewġ katini identiċi maqgħuda b'disulfide, li kull waħda minnhom fiha sekwenza ta' analogu għal GLP-1 uman modifikat magħqud b'mod kovalenti, ma' biċċa mill-katina (Fc - chain fragment) tqila ta' immunoglobulina G4 (IgG4) umana modifikata, permezz ta' peptide żgħira li tgħaqqad.
English: - Trulicity 1.5 mg: Each pre-filled pen contains 1.5 mg of dulaglutide in 0.5 ml solution.
Maltese: - Trulicity 1.5 mg: Kull pinna mimlija għal-lest fiha 1.5 mg ta' dulglutide f'0.5 ml ta' soluzzjoni.
English: The mean apparent clearance of dulaglutide 0.75 mg and 1.5 mg at steady state was 0.111 L/h and 0.107 L/h with an elimination half-life of 4.5 and 4.7 days, respectively.
Maltese: 0.107 L/siegħa b'half-life ta' eliminazzjoni ta' 4.5 u 4.7 ijiem, rispettivament.
English: Pack sizes of 2, 4 or multipacks of 12 (3 packs of 4) pre-filled pens.
Maltese: Daqsijiet tal-pakketti ta' 2, 4 jew pakketti multipli ta' 12 (3 pakketti ta' 4) -il pinna mimlijin għal-lest.
English: In clinical studies, treatment with dulaglutide was associated with a 1.6 % incidence of treatment emergent dulaglutide anti-drug antibodies, indicating that the structural modifications in the GLP-1 and modified IgG4 parts of the dulaglutide molecule, together with high homology with native GLP-1 and native IgG4, minimise the risk of immune response against dulaglutide.
Maltese: Immunoġeniċità Fi studji kliniċi, kura b'dulaglutide ġiet assoċjata ma' inċidenza ta' 1.6 % ta' antikorpi kontra l mediċina għal dulaglutide li jfiġġu bil-kura, li tindika li l-modifikazzjonijiet strutturali fil-partijiet
English: - Trulicity 1.5 mg: Each pre-filled syringe contains 1.5 mg of dulaglutide in 0.5 ml solution.
Maltese: - Trulicity 1.5 mg: Kull siringa mimlija għal-lest fiha 1.5 mg ta' dulglutide f'0.5 ml ta' soluzzjoni.
English: Through the full study duration (up to 104 weeks), the incidence of discontinuation due to adverse events was 5.1% (0.75 mg) and 8.4 % (1.5 mg) for dulaglutide.
Maltese: Matul iż-żmien kollu li dam listudju (sa 104 ġimgħat), l-inċidenza ta' twaqqif tal-kura minħabba każijiet avversi kienet 5.1% (0.75 mg) u 8.4 % (1.5 mg) għal dulaglutide.
English: You may use the same area of your body, but be sure to choose a different injection site in that area.
Maltese: Iżda qis li f'dik iż-żona tagħżel sit tal injezzjoni differenti.
English: At 28 weeks, treatment with once weekly Trulicity 1.5 mg resulted in a statistically significant reduction in HbA1c compared to placebo and a significantly greater percentage of patients achieving HbA1c targets of < 7.0 % and ≤ 6.5 % (Table 9).
Maltese: Trulicity 1.5 mg irriżulta f'tnaqqis statistikament sinifikanti fl-HbA1c meta mqabbel ma' plaċebo u f'persentaġġ sinifikament ogħla ta' pazjenti li kisbu l-miri ta' HbA1c ta' < 7.0% u ≤ 6.5% (Tabella 9).
English: Inspect
Maltese: LISTA
English: Coadministration of dulaglutide with atorvastatin decreased Cmax and AUC(0-∞) up to 70 % and 21 %, respectively, for atorvastatin and its major metabolite o-hydroxyatorvastatin.
Maltese: Atorvastatin L-għoti ta' dulaglutide flimkien ma' atorvastatin naqqas is-Cmax u l-AUC(0-∞) sa 70 % u 21 %,
English: The safety and efficacy of dulaglutide was investigated in a placebo and active controlled (sitagliptin 100 mg daily) study of 104 weeks duration, all in combination with metformin.
Maltese: Is-sigurtà u l-effikaċja ta' dulaglutide ġiet investigata fi studju kkontrollat bi plaċebo u b'mod attiv (sitagliptin 100 mg kuljum) li dam sejjer 104 ġimgħat, kollha mogħtija flimkien ma' metformin.
English: Mon Tues
Maltese: TA' EĊĊIPJENTI
English: Multi-pack: 4 pre-filled syringes of 0.5 ml solution.
Maltese: Pakkett multiplu: 4 siringi mimlijin għal-lest b'0.5 ml ta' soluzzjoni.
English: The safety and efficacy of dulaglutide as add-on to a sulphonylurea was investigated in a placebo controlled study of 24 weeks duration.
Maltese: Is-sigurtà u l-effikaċja ta' dulaglutide bħala żieda fit-terapija ma' xi sulphonylurea ġew investigati f'studju kkontrollat bil-plaċebo u li dam 24 ġimgħa.
English: Sinus tachycardia, first degree
Maltese: Nawsja, dijarea,
English: the pen.
Maltese: l-pinna.
English: Multi-pack: 12 (3 packs of 4) pre-filled pens of 0.5 ml solution.
Maltese: Pakkett multiplu: 12-il pinna mimlijin għal-lest (3 pakketti ta' 4) b'soluzzjoni ta' 0.5 ml.
English: Patients at target HbA1c
Maltese: Bidla medja fl-HbA1c
English:  Unfold and lay flat 
Maltese: - Żomm dan il-fuljett.
English: Two cases of severe hypoglycaemia were observed with Trulicity 1.5mg and two cases of severe hypoglycaemia were observed with insulin glargine.
Maltese: Żewġ każijiet ta' ipogliċemija qawwija kienu osservati bi Trulicity 1.5mg u żewġ każijiet ta' ipogliċemija qawwija kienu osservati b'insulina glargine.
English: Multi-pack: 12 (3 packs of 4) pre-filled syringes of 0.5 ml solution.
Maltese: Pakkett multiplu: 12-il siringa mimlijin għal-lest (3 pakketti ta' 4) b'soluzzjoni ta' 0.5 ml.
English: Packs of 4 pre-filled syringes and multipack of 12 (3 packs of 4) pre-filled syringes.
Maltese: Pakketti ta' 4 siringi mimlijin għal-lest u pakkett multiplu ta' 12-il siringa (3 pakketti ta' 4) mimlijin għal-lest.
English: Multi-pack: 4 pre-filled pens of 0.5 ml solution.
Maltese: Pakkett multiplu: 4 pinen mimlijin għal-lest b'0.5 ml ta' soluzzjoni.
English: Uncommon: may affect up to 1 in 100 people - Injection site reactions (e.g. rash or redness) - Allergic reactions (hypersensitivity) (e.g. swelling, raised itchy skin rash (hives)) - Dehydration, often associated with nausea, vomiting and/or diarrhoea - Gallstones - Inflamed gallbladder
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna 1 waħda minn kull 100 - Reazzjonijiet fis-sit tal-injezzjoni (eż. raxx jew ħmura) - Reazzjonijiet allerġiċi (sensittività eċċessiva) (eż. nefħa, raxx bil-ħakk tal-ġilda li titla' bħal ħobż ħobż (ħorriqija)) - Deidratazzjoni, ħafna drabi assoċjata ma' dardir, rimettar u/jew dijarea - Ġebel fil-marrara
English: The rate of documented symptomatic hypoglycaemia with Trulicity 1.5 mg was 0.12 episodes/patient/year and with liraglutide was 0.29 episodes/patient/year.
Maltese: 12 episodji/pazjent/sena u b'liraglutide kienet 0.29 episodji/pazjent/sena.
English: In a meta-analysis of phase II and III registration studies, a total of 51 patients (dulaglutide: 26 [N = 3,885]; all comparators: 25 [N = 2,125]) experienced at least one cardiovascular (CV) event (death due to CV causes, nonfatal MI, nonfatal stroke, or hospitalisation for unstable angina).
Maltese: 3,885]; il-kumparaturi kollha: 25 [N = 2,125]) kellhom mill-anqas avveniment kardjovaskulari (CV
English: The adverse reactions are listed in Table 1 as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon:
Maltese: Ir-reazzjonijiet avversi huma elenkati f'Tabella 1 bit-terminu ppreferut ta' MedDRA skont il-klassi tas-sistemi u tal-organi u skont l-inċidenza tagħhom b'dawk li jseħħu l-aktar imniżżla l-ewwel (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 u mhux magħruf: ma tistax tittieħed stima mid-dejta disponibbli).
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Maltese: Għar-riżultati tal-istudji fir-rigward tat-teħid flimkien ma' mediċinali oħra, l-effetti fuq il-kontroll gliċemiku u l-avvenimenti kardjovaskulari u l-popolazzjonijiet studjati, ara sezzjonijiet 4.4,4.5 u 5.1.
English: Many of the reported adverse renal events occurred in patients who had experienced nausea, vomiting, diarrhoea, or dehydration.
Maltese: Ħafna mill-avvenimenti avversi renali li ġew irrapportati seħħew f'pazjenti li kellhom dardir, rimettar, dijarea, jew deidratazzjoni.
English: Cardiovascular Evaluation
Maltese: Evalwazzjoni kardjovaskulari
English: Age had no clinically relevant effect on the pharmacokinetic and pharmacodynamic properties of dulaglutide.
Maltese: L-età ma kellha l-ebda effett kliniku rilevanti fuq il-proprjetajiet farmakokinetiċi u farmakodinamiċi ta' dulaglutide.
English: Insulin glargine+ once daily (n=296) †† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to insulin glargine,
Maltese: Insulina glargine+ darba kuljum (n=262) † valur p 1-sided aġġustat għall-multipliċità < 0.025, fejn jidher li ma kienx inferjuri; †† valur p
English: 4 pre-filled syringes of 0.5 ml solution
Maltese: 4 siringi mimlijin għal-lest b'soluzzjoni ta' 0.5 ml
English: assessed for HbA1c only # p < 0.05, ## 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: # p < 0.05, ## p < 0.001 grupp ta' kura ta' dulaglutide mqabbel ma' insulina glargine
English: The rates of documented symptomatic hypoglycaemia with Trulicity 0.75 mg, Trulicity 1.5 mg, and placebo were 0.15, 0.16 and 0.12 episodes/patient/year, respectively.
Maltese: Ir-rati ta' ipogliċemija bis-sintomi ddokumentati bi Trulicity 0.75 mg, Trulicity 1.5 mg, u plaċebo kienu 0.15, 0.16 u 0.
English: Dulaglutide 0.75 mg once weekly (n=190)
Maltese: Dulaglutide 0.75 mg darba fil-ġimgħa (n=190)