FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: U metaanalizi ispitivanja faze II i III, ukupno je 51 bolesnik (dulaglutid: 26 [N = 3885]; svi usporedni lijekovi: 25 [N = 2125]) doživio najmanje jedan kardiovaskularni događaj (smrt zbog kardiovaskularnih uzroka, infarkt miokarda bez smrtnog ishoda, moždani udar bez smrtnog ishoda ili hospitalizacija zbog nestabilne angine).
English: Age had no clinically relevant effect on the pharmacokinetic and pharmacodynamic properties of dulaglutide.
Croatian: Dob nije imala klinički značajnog učinka na farmakokinetička ni farmakodinamička svojstva dulaglutida.
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.
Croatian: Sigurnost i djelotvornost dulaglutida ocijenjene su u placebom i aktivno (sitagliptin 100 mg na dan) kontroliranom ispitivanju u trajanju od 104 tjedna; svi su se primjenjivali u kombinaciji s metforminom.
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.
Croatian: Osim toga, u 52-tjednom kliničkom ispitivanju provedenom u bolesnika sa šećernom bolešću tipa 2 i umjerenim do teškim oštećenjem bubrežne funkcije (eGFR [prema CKD-EPI] < 60 i ≥ 15 ml/min/1,73 m2) farmakokinetički profil lijeka Trulicity 0,75 mg i 1,5 mg jedanput na tjedan bio je sličan onome viđenome u prethodnim kliničkim ispitivanjima.
English: Lower glucagon concentrations lead to decreased hepatic glucose output.
Croatian: Niže koncentracije glukagona dovode do smanjena lučenja glukoze u jetri.
English: Anti-hypertensives
Croatian: Antihipertenzivi
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.
Croatian: Tijekom cjelokupnog trajanja ispitivanja (do 104 tjedna), incidencija prekida liječenja zbog štetnih događaja na dulaglutid iznosila je 5,1% (0,75 mg) i 8,4% (1,5 mg).
English: Do not put the needle cover back on - this may result in an accidental needle stick injury to your hand.
Croatian: • Nemojte vraćati pokrov igle na štrcaljku - mogli biste se slučajno ubosti u šaku.
English: Inject your dose using another pen.
Croatian: Injicirajte dozu koristeći drugu brizgalicu.
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).
Croatian: Broj bolesnika koji su primili dodatnu intervenciju radi regulacije glikemijskih vrijednosti bio je značajno manji u skupini liječenoj lijekom Trulicity nego u onoj koja je primala placebo (Trulicity: 2086 [42,2%]; placebo: 2825 [57,0%]; p < 0,001).
English: The primary endpoint was the time from randomisation to first occurrence of any major adverse cardiovascular events (MACE): CV death, non-fatal myocardial infarction, or non-fatal stroke.
Croatian: Primarna mjera ishoda bilo je vrijeme od randomizacije do prvog nastupa bilo kojeg velikog kardiovaskularnog štetnog događaja (engl. major adverse cardiovascular events, MACE): smrti zbog kardiovaskularnog uzroka, infarkta miokarda bez smrtnog ishoda ili moždanog udara bez smrtnog ishoda.
English: In clinical trials, acute pancreatitis has been reported in association with dulaglutide (see section 4.8).
Croatian: U kliničkim je ispitivanjima prijavljen akutni pankreatitis povezan s primjenom dulaglutida (vidjeti dio 4.8).
English: Drops of liquid on the tip of the needle are not unusual and will not affect your dose.
Croatian: Kapljice tekućine na vrhu igle nisu neuobičajena pojava i neće utjecati na Vašu dozu.
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).
Croatian: Farmakokinetika dulaglutida ocijenjena je u kliničkom farmakološkom ispitivanju, a načelno je bila slična u zdravih ispitanika i bolesnika s blagim do teškim oštećenjem bubrežne funkcije (CrCl < 30 ml/min), uključujući bolesnike u terminalnoj fazi bubrežne bolesti (kojima je potrebna dijaliza).
English: Trulicity is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
Croatian: Trulicity je indiciran za liječenje odraslih osoba s nedovoljno dobro kontroliranom šećernom bolešću tipa 2, kao dodatak dijeti i tjelovježbi
English: If the syringe has been frozen, DO NOT USE.
Croatian: Ako je štrcaljka bila zamrznuta, NE SMIJETE JE UPOTRIJEBITI.
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).
Croatian: Tjelesna težina Trulicity od 1,5 mg povezivao se sa smanjenjem tjelesne težine koje se održalo tijekom trajanja ispitivanja (od početka ispitivanja do završne vremenske točke: -0,35 kg do -2,90 kg).
English: If you stop using Trulicity
Croatian: Ako prestanete primjenjivati Trulicity
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Trulicity if: - you are on dialysis as this medicine is not recommended.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Trulicity: - ako ste na dijalizi, jer se ovaj lijek ne preporučuje bolesnicima na dijalizi.
English: • Do not continue to use your syringe.
Croatian: • Nemojte nastaviti s uporabom štrcaljke.
English: Kaplan-Meier plot of time to first occurrence of the composite outcome: CV death, non-fatal myocardial infarction or non-fatal stroke, in the dulaglutide long-term cardiovascular outcome study
Croatian: Slika 1. Kaplan-Meierova krivulja vremena do prvog nastupa objedinjenog ishoda: smrti zbog kardiovaskularnog uzroka, infarkta miokarda bez smrtnog ishoda ili moždanog udara bez smrtnog ishoda u dugoročnom ispitivanju kardiovaskularnih ishoda kod primjene dulaglutida
English: At baseline, overall mean eGFR was 38 mL/min/1.73 m2, 30% of patients had eGFR < 30 mL/min/1.73 m2.
Croatian: Sveukupna srednja vrijednost eGFR-a na početku ispitivanja iznosila je 38 ml/min/1,73 m2, a 30% bolesnika imalo je eGFR < 30 ml/min/1,73 m2.
English: Last revised in Month YYYY
Croatian: Zadnji puta revidirano u mjesec GGGG
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).
Croatian: Kada se dodaje postojećoj terapiji sulfonilurejom ili inzulinom, može se razmotriti smanjenje doze sulfonilureje ili inzulina radi smanjenja rizika od hipoglikemije (vidjeti dijelove 4.4 i 4.8).
English: Do not use Trulicity if you are breast-feeding.
Croatian: Nemojte primjenjivati Trulicity ako dojite.
English: If pancreatitis is suspected, dulaglutide should be discontinued.
Croatian: Posumnja li se na pankreatitis, mora se prekinuti liječenje dulaglutidom.
English: A drop of liquid on the tip of the needle is not unusual and will not affect your dose.
Croatian: Kapljica tekućine na vrhu igle nije neuobičajena pojava i neće utjecati na Vašu dozu.
English: *Produced in CHO cells by recombinant DNA technology.
Croatian: *Proizvodi se tehnologijom rekombinantne DNK u stanicama jajnika kineskog hrčka.
English: Each MACE component contributed to the reduction of MACE, as shown in Figure 2.
Croatian: MACE događaja pridonijela je svaka pojedinačna sastavnica te objedinjene mjere ishoda, kao što je prikazano na Slici 2.
English: Trulicity contains sodium
Croatian: Trulicity sadrži natrij
English: The recommended dose is 1.5 mg once weekly.
Croatian: Preporučena doza je 1,5 mg jedanput na tjedan.
English: Patients at target HbA1c
Croatian: Bolesnici koji su postigli ciljni HbA1c
English: Following coadministration with 2 consecutive doses of dulaglutide, sitagliptin AUC(0-τ) and Cmax decreased by approximately 7.4 % and 23.1 %, respectively.
Croatian: Nakon istodobne primjene s 2 uzastopne doze dulaglutida, AUC(0-τ) sitagliptina smanjio se za približno 7,4%, a Cmax za približno 23,1%.
English: - Hypoglycaemia (low blood sugar) is very common when dulaglutide is used with medicines that contain metformin, a sulphonylurea and/or insulin.
Croatian: - Hipoglikemija (niska razina šećera u krvi) je vrlo česta kada se dulaglutid primjenjuje zajedno s lijekovima koji sadrže metformin, sulfonilureju i/ili inzulin.
English: • If you have any questions or problems with your Trulicity syringe, contact your doctor,
Croatian: • Ako imate bilo kakvih pitanja ili poteškoća s Trulicity štrcaljkom, obratite se svome liječniku,
English: A pharmacodynamic study with dulaglutide demonstrated, in patients with type 2 diabetes, a restoration of first phase insulin secretion to a level that exceeded levels observed in healthy subjects on placebo, and improved second phase insulin secretion in response to an intravenous bolus of glucose.
Croatian: Farmakodinamičko ispitivanje u bolesnika sa šećernom bolešću tipa 2 pokazalo je da uz dulaglutid dolazi do ponovne uspostave prve faze lučenja inzulina na razinu koja je nadmašivala razine primijećene u zdravih ispitanika koji su primali placebo, ali i do poboljšanja druge faze lučenja inzulina u odgovoru na intravensku bolusnu injekciju glukoze.
English: If less than 3 days (72 hours) remain before the next scheduled dose, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day.
Croatian: Ako je do sljedeće doze prema uobičajenom rasporedu preostalo manje od 3 dana (72 sata), propuštenu dozu mora se preskočiti, a sljedeću dozu primijeniti prema uobičajenom rasporedu.
English: INFORMATION IN BRAILLE TRULICITY 0.75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU TRULICITY 0,75 mg
English: Medicine
Croatian: LIJEKA
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.
Croatian: Nakon istodobne primjene višestrukih doza dulaglutida s metforminom u stanju dinamičke ravnoteže (formulacija s trenutnim oslobađanjem), AUCτ metformina povećao se za do 15%, Cmax se smanjio za do 12%, a tmax se nije promijenio.
English: If you forget to use Trulicity
Croatian: Ako ste zaboravili primijeniti Trulicity
English: The pre-filled syringe is for single-use only.
Croatian: Napunjena brizgalica namijenjena je samo za jednokratnu uporabu.
English: The dose can be administered at any time of day, with or without meals.
Croatian: Doza se može primijeniti u bilo koje doba dana, neovisno o obrocima.
English: Cardiovascular outcome study
Croatian: Ispitivanje kardiovaskularnih ishoda
English: If a dose is missed, it should be administered as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose.
Croatian: Ako bolesnik propusti dozu, mora je primijeniti što je prije moguće ako je do sljedeće doze prema uobičajenom rasporedu preostalo najmanje 3 dana (72 sata).
English: Too much Trulicity may make your blood sugar too low (hypoglycaemia) and can make you feel sick or be sick.
Croatian: Previše lijeka Trulicity može pretjerano sniziti razinu šećera u krvi (hipoglikemija) te uzrokovati osjećaj mučnine ili povraćanje.
English: No cases of severe hypoglycaemia with dulaglutide were observed.
Croatian: Nije zabilježen niti jedan slučaj teške hipoglikemije uz dulaglutid.
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.
Croatian: Farmakokinetika dulaglutida ocijenjena je u kliničkom farmakološkom ispitivanju u kojem su u ispitanika s oštećenjem jetrene funkcije zabilježena statistički značajna smanjenja izloženosti dulaglutidu, od čak 30% za srednji Cmax i do 33% za srednji AUC, u odnosu na zdrave kontrolne ispitanike.
English: Gently grasp a fold of skin at the injection site.
Croatian: • Nježno uhvatite nabor kože na mjestu injiciranja.
English: Trulicity should not be used if particles appear or if the solution is cloudy and/or discoloured.
Croatian: Trulicity se ne smije upotrijebiti ako sadrži čestice ili ako je otopina zamućena i/ili je promijenila boju.
English: When Trulicity is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued.
Croatian: Kada se Trulicity dodaje postojećoj terapiji metforminom i/ili pioglitazonom, može se nastaviti s primjenom dotadašnje doze metformina i/ili pioglitazona.
English: Results from the long-term cardiovascular outcome study with 4949 patients randomised to dulaglutide and followed for a median of 5.4 years were consistent with these findings.
Croatian: Tim su nalazima odgovarali i rezultati dugoročnog ispitivanja kardiovaskularnih ishoda, u kojem je 4949 bolesnika bilo randomizirano za primanje dulaglutida i praćeno tijekom medijana od 5,4 godine.
English: You should receive training from your doctor, pharmacist or nurse on the right way to prepare and inject your medicine.
Croatian: Liječnik, ljekarnik ili medicinska sestra trebali bi Vas obučiti o tome kako pravilno pripremiti i injicirati lijek.
English: The safety and efficacy of dulaglutide was also investigated in an active controlled study (liraglutide 1.8 mg daily) of 26 weeks duration, both in combination with metformin.
Croatian: Sigurnost i djelotvornost dulaglutida ocijenjene su i u aktivno kontroliranom ispitivanju (liraglutid 1,8 mg na dan) u trajanju od 26 tjedana; oba su se lijeka primjenjivala u kombinaciji s metforminom.
English: Patients with dulaglutide anti-drug antibodies generally had low titres, and although the number of patients developing dulaglutide anti-drug antibodies was low, examination of the phase III data revealed no clear impact of dulaglutide anti-drug antibodies on changes in HbA1c.
Croatian: Iako je broj bolesnika u kojih su se razvila protutijela na dulaglutid bio malen, pregled podataka iz ispitivanja faze III nije ukazao na jasan utjecaj protutijela na dulaglutid na promjene vrijednosti HbA1c.
English: Dulaglutide dosing of male and female juvenile rats did not produce memory deficits at 91-fold the human exposure.
Croatian: Primjena dulaglutida u juvenilnih mužjaka i ženki štakora nije uzrokovala poteškoće s pamćenjem pri razini izloženosti 91 puta većoj od one koja se postiže u ljudi.
English: # From post-marketing reports.
Croatian: # Prijavljeno nakon stavljanja lijeka u promet.
English: In addition, there was significantly lower perceived frequency of hyperglycaemia and hypoglycaemia compared to exenatide twice daily.
Croatian: Osim toga, primijećena učestalost hiperglikemije i hipoglikemije bila je značajno manja nego uz eksenatid dvaput na dan.
English: Following dulaglutide coadministration, S- and R-warfarin exposure and R-warfarin Cmax were unaffected, and S-warfarin Cmax decreased by 22 %.
Croatian: Nakon istodobne primjene s dulaglutidom, izloženost S- i R-varfarinu te Cmax R-varfarina ostali su nepromijenjeni, dok se Cmax S-varfarina smanjio za 22%.
English: What if there is a drop of liquid on the tip of the needle when I remove the needle cover?
Croatian: Što ako se na vrhu igle nalazi kapljica tekućine nakon što skinem zatvarač igle?
English: Steady-state plasma concentrations were achieved between 2 to 4 weeks of once-weekly administration of dulaglutide (1.5 mg).
Croatian: Stanje dinamičke ravnoteže plazmatskih koncentracija postignuto je između 2. i 4. tjedna primjene dulaglutida (1,5 mg) jedanput na tjedan.
English: These effects were not considered to be clinically relevant.
Croatian: Navedeni se učinci nisu smatrali klinički značajnima.
English: FRONT
Croatian: SPRIJEDA
English: Pancreatic enzymes
Croatian: Enzimi gušterače
English: There are no or limited amount of data from the use of dulaglutide in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni dulaglutida u trudnica ograničeni.
English: No cases of severe hypoglycaemia were observed for dulaglutide and two cases of severe hypoglycaemia were observed with exenatide twice daily.
Croatian: Uz dulaglutid nije zabilježen nijedan slučaj teške hipoglikemije, dok su uz eksenatid dvaput na dan primijećena dva slučaja teške hipoglikemije.
English: What if I see an air bubble in my Syringe?
Croatian: Što ako vidim zračni mjehurić u brizgalici?
English: Another person may give you the injection in your upper arm.
Croatian: • Neka druga osoba može Vam dati injekciju u nadlakticu.
English: It is not known if dulaglutide passes into human breast milk.
Croatian: Nije poznato izlučuje li se dulaglutid u majčino mlijeko.
English: Coadministration of multiple dulaglutide doses with steady state lisinopril caused no clinically relevant changes in the AUC or Cmax of lisinopril.
Croatian: Istodobna primjena višestrukih doza dulaglutida s lizinoprilom u stanju dinamičke ravnoteže nije uzrokovala klinički značajne promjene AUC-a ni Cmax-a lizinoprila.
English: How to use Trulicity
Croatian: Kako primjenjivati Trulicity
English: Dulaglutide improves glycaemic control through the sustained effects of lowering fasting, pre-meal and postprandial glucose concentrations in patients with type 2 diabetes starting after the first dulaglutide administration and is sustained throughout the once weekly dosing interval.
Croatian: U bolesnika sa šećernom bolešću tipa 2 dulaglutid poboljšava regulaciju glikemije dugotrajnim učincima na sniženje koncentracije glukoze natašte, prije obroka i nakon obroka, koji počinju nakon prve primjene dulaglutida, a održani su tijekom cijelog intervala doziranja jedanput na tjedan.
English: • The pen is a disposable, pre-filled delivery device that is ready to use.
Croatian: • Brizgalica je napunjena naprava za jednokratnu primjenu lijeka koja je spremna za korištenje.
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.
Croatian: Najčešće nuspojave koje su dovele do prekida liječenja dulaglutidom u dozi od 0,75 mg odnosno 1,5 mg bile su mučnina (1,0% odnosno 1,9%), proljev (0,5% odnosno 0,6%) i povraćanje (0,4% odnosno 0,6%), a u pravilu su se prijavljivale unutar prvih 4-6 tjedana.
English: The mean baseline dose of insulin glargine was 37 units/day for patients receiving placebo and 41 units/day for patients receiving Trulicity 1.5mg.
Croatian: Srednja vrijednost početne doze inzulina glargina bila je 37 jedinica/dan za bolesnike koji su primali placebo te 41 jedinica/dan za bolesnike koji su primali Trulicity 1,5 mg.
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.
Croatian: Kombinirana terapija s inhibitorom SGLT2, uz metformin ili bez njega Sigurnost i djelotvornost dulaglutida kao dodatka terapiji inhibitorom suprijenosnika natrija i glukoze 2 (SGLT2i) (96% uz metformin, 4% bez metformina) ispitivale su se u placebom kontroliranom ispitivanju u trajanju od 24 tjedna.
English: None of the patients with systemic hypersensitivity developed dulaglutide anti-drug antibodies.
Croatian: Niti u jednog bolesnika sa sistemskom preosjetljivošću nisu se razvila protutijela na dulaglutid.
English: 26 weeks
Croatian: 26 tjedana
English: Baseline HbA1c
Croatian: HbA1c
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).
Croatian: Kod primjene lijeka Trulicity kao dodatka standardnom liječenju opaženo je značajno i održano smanjenje vrijednosti HbA1c od početka ispitivanja do 60. mjeseca u odnosu na placebo (-0,29% naspram 0,22%; procijenjena razlika između liječenja: -0,51% [-0,57; -0,45]; p < 0,001).
English: 28 weeks
Croatian: 28 tjedana
English: Combination therapy with prandial insulin with or without metformin In this study, patients on 1 or 2 insulin injections per day prior to study entry, discontinued their prestudy insulin regimen and were randomised to dulaglutide once weekly or insulin glargine once daily, both in combination with prandial insulin lispro three times daily, with or without metformin.
Croatian: U ovom su ispitivanju bolesnici koji su prije uključivanja u ispitivanje primjenjivali 1 ili 2 injekcije inzulina na dan prekinuli dotadašnji režim liječenja inzulinom te su randomizirani na primanje dulaglutid jedanput na tjedan ili inzulin glargin jedanput na dan, oba u kombinaciji s prandijalnim inzulinom lispro triput na dan, uz metformin ili bez njega.
English: Also contact your local Lilly office listed in the Information for the patient for further instructions.
Croatian: Također se obratite lokalnom uredu tvrtke Eli Lilly čiji su podaci navedeni u Informacijama za bolesnika za daljnje upute, a brizgalicu u međuvremenu pohranite na sigurno kako biste izbjegli slučajnu ozljedu iglom.
English: * Documented, symptomatic hypoglycaemia with blood glucose ≤ 3.9 mmol/L † Dulaglutide 1.5 mg dose only.
Croatian: *Dokumentirana, simptomatska hipoglikemija uz razinu glukoze u krvi od ≤ 3,9 mmol/l.
English: BACK
Croatian: STRAGA
English: Dulaglutide suppresses glucagon secretion which is known to be inappropriately elevated in patients with type 2 diabetes.
Croatian: Dulaglutid potiskuje lučenje glukagona, čije su razine neprimjereno povišene u bolesnika sa šećernom bolešću tipa
English: Please read these Instructions for use and the Information for the patient carefully and completely before using your pre-filled syringe.
Croatian: Pažljivo pročitajte cijele Upute za uporabu i Informacije za bolesnike prije nego što upotrijebite napunjenu štrcaljku.
English: You may inject the medicine into your stomach (abdomen) or thigh.
Croatian: • Lijek možete injicirati u trbuh (abdomen) ili bedro.
English: Each syringe delivers only one dose.
Croatian: Jedna štrcaljka isporučuje samo jednu dozu.
English: No cases of severe hypoglycaemia were observed.
Croatian: Nije zabilježen niti jedan slučaj teške hipoglikemije.
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.
Croatian: Kada se dulaglutid u dozama od 0,75 mg i 1,5 mg primjenjivao u monoterapiji ili u kombinaciji sa samim metforminom ili metforminom uz pioglitazon, incidencije dokumentirane simptomatske hipoglikemije iznosile su 5,9% do 10,9%, dok su stope iznosile 0,14 do 0,62 događaja po bolesnikgodini, ali nije prijavljena nijedna epizoda teške hipoglikemije.
English: • Do not use your syringe.
Croatian: • Nemojte upotrijebiti štrcaljku.
English: Dulaglutide should not be used during breast-feeding.
Croatian: Dulaglutid se ne bi trebao primjenjivati tijekom dojenja.
English: If the pen has been frozen, DO NOT USE.
Croatian: Ako je brizgalica bila zamrznuta, NE SMIJETE JE UPOTRIJEBITI.