FrancophonIA/ELRC3.0 huggingface dataset:
English: No patients reported cases of severe hypoglycaemia with Trulicity 1.5 mg, six with Trulicity 0.75 mg, and seventeen with insulin glargine.
Croatian: Nije prijavljen nijedan slučaj teške hipoglikemije uz Trulicity 1,5 mg, ali ih je prijavljeno šest uz Trulicity 0,75 mg i sedamnaest uz inzulin glargin.
English: Cases of anaphylactic reaction have been rarely reported with marketed use of dulaglutide.
Croatian: Kod primjene dulaglutida nakon stavljanja lijeka u promet rijetko su prijavljeni slučajevi anafilaktičke reakcije.
English: No dose adjustment of paracetamol is necessary when administered with dulaglutide.
Croatian: Nije potrebno prilagođavati dozu paracetamola kada se primjenjuje istodobno s dulaglutidom.
English: Sitagliptin 100 mg once daily (n=315) †† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide compared to sitagliptin, assessed only for HbA1c at 52 and 104 weeks ‡‡ multiplicity adjusted 1-sided p-value < 0.001 for superiority of dulaglutide compared to placebo,
Croatian: Sitagliptin 100 mg jedanput na dan (n=315) †† jednostrana p-vrijednost prilagođena za multiplicitet < 0,025, za superiornost dulaglutida u usporedbi sa sitagliptinom, ocijenjena samo za HbA1c u 52. i 104. tjednu ‡‡ jednostrana p-vrijednost prilagođena za multiplicitet < 0,001, za superiornost dulaglutida u usporedbi s placebom, ocijenjena samo za HbA1c
English: Multi-pack: 12 (3 packs of 4) pre-filled syringes of 0.5 ml solution.
Croatian: Višestruko pakiranje: 12 (3 pakiranja s 4) napunjenih štrcaljki s 0,5 ml otopine.
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
Croatian: Placebo jedanput na tjedan i inzulin glargin (n=150) ‡‡ p < 0,001 za superiornost dulaglutida u usporedbi s placebom, uz kontroliranu ukupnu pojavnost pogreške tipa
English: OTHER SPECIAL WARNING(S), IF NECESSARY If seal is broken before first use, contact pharmacist.
Croatian: Ako je kutija otvorena prije prve uporabe, obratite se ljekarniku.
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.
Croatian: Stopa dokumentirane simptomatske hipoglikemije iznosila je 3,38 epizoda po bolesnik-godini uz Trulicity 1,5 mg i inzulin glargin u odnosu na 4,38 epizoda po bolesnik-godini uz placebo i inzulin glargin.
English: Cholelithiasis, cholecystitis
Croatian: Poremećaji jetre i žuči kolelitijaza, kolecistitis
English: What Trulicity looks like and contents of the pack Trulicity is a clear, colourless, solution for injection in a pre-filled syringe.
Croatian: Trulicity je bistra i bezbojna otopina za injekciju u napunjenoj štrcaljki.
English: Inspect
Croatian: Pregledajte
English: The mean t1/2 of atorvastatin and o-hydroxyatorvastatin were increased by 17 % and 41 %, respectively, following dulaglutide administration.
Croatian: Nakon primjene dulaglutida, srednja vrijednost t1/2 atorvastatina povećala se za 17%, a srednja vrijednost t1/2 o-hidroksiatorvastatina za 41%.
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
Croatian: Inzulin glargin+ jedanput na dan (n=194) † Jednostrana p-vrijednost < 0,025, za neinferiornost dulaglutida u odnosu na inzulin glargin ## p < 0,001 za skupinu liječenu dulaglutidom u usporedbi s inzulinom glarginom + Doze inzulina glargina prilagođavale su se na temelju algoritma s ciljnom vrijednošću glukoze u plazmi natašte od ≤ 8,3 mmol/l
English: 10 mcg twice daily (n=276)
Croatian: Eksenatid+ 10 µg dvaput na dan (n=276)
English: 2 pre-filled pens of 0.5 ml solution 4 pre-filled pens of 0.5 ml solution
Croatian: 2 napunjene brizgalice s 0,5 ml otopine 4 napunjene brizgalice s 0,5 ml otopine
English: At 26 weeks, both Trulicity 1.5 mg and 0.75 mg were non-inferior to insulin glargine in lowering of HbA1c and this effect was sustained at 52 weeks.
Croatian: U 26. tjednu su i Trulicity 1,5 mg i Trulicity 0,75 mg bili neinferiorni inzulinu glarginu s obzirom na smanjenje razine HbA1c, a taj je učinak bio održan i u 52. tjednu.
English: The severe hypoglycaemia event incidence was 0.7% and the rate was 0.01 events/patient/year.
Croatian: Incidencija događaja teške hipoglikemije iznosila je 0,7%, dok je stopa iznosila 0,01 događaja po bolesnik-godini.
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
Croatian: 1500-2000 mg/dan (n=268) † jednostrana p-vrijednost prilagođena za multiplicitet < 0,025, za neinferiornost; †† jednostrana p-vrijednost prilagođena za multiplicitet < 0,025, za superiornost dulaglutida u odnosu na metformin, ocijenjena samo za HbA1c # p < 0,05, ## p < 0,001 za skupinu liječenu dulaglutidom u usporedbi s metforminom
English: • Do not freeze your syringe.
Croatian: • Štrcaljka se ne smije zamrzavati.
English: METHOD OF ADMINISTRATION Once weekly
Croatian: Jedanput na tjedan
English: • The syringe is a disposable, pre-filled delivery device.
Croatian: • Štrcaljka je napunjena naprava za jednokratnu primjenu lijeka.
English: Table 1: The frequency of adverse reactions of dulaglutide
Croatian: Tablica 1: Učestalost nuspojava dulaglutida
English: STORAGE AND HANDLING
Croatian: ČUVANJE I RUKOVANJE
English: You can use your pen at any time of the day, with or without meals.
Croatian: Brizgalicu možete primijeniti u bilo koje doba dana, neovisno o obrocima.
English: Trulicity is used: - on its own if your blood sugar is not properly controlled by diet and exercise alone, and you can't take metformin (another diabetes medicine).
Croatian: - samostalno, ako se razina šećera u krvi ne može dovoljno dobro regulirati samo dijetom i tjelovježbom i ako ne možete uzimati metformin (drugi lijek za liječenje šećerne bolesti) - ili s drugim lijekovima za liječenje šećerne bolesti, kada oni nisu dovoljni za regulaciju razine šećera u krvi.
English: Table 11: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to insulin glargine (in patients with moderate to severe chronic kidney disease)
Croatian: Tablica 11: Rezultati 52-tjednog ispitivanja kontroliranog lijekom; dvije doze dulaglutida u usporedbi s inzulinom glarginom (u bolesnika s umjerenom do teškom kroničnom bubrežnom bolešću) Početni HbA1c
English: No dose adjustment is required for digoxin when administered with dulaglutide.
Croatian: Nije potrebno prilagođavati dozu digoksina kada se primjenjuje istodobno s dulaglutidom.
English: Table 3: Results of a 104 week placebo and active controlled study with two doses of dulaglutide in comparison to sitagliptin
Croatian: Tablica 3: Rezultati placebom i aktivno kontroliranog ispitivanja u kojem su se dvije doze dulaglutida uspoređivale sa sitagliptinom u trajanju od 104 tjedna Početni HbA1c
English: • Store the pen in the original package in order to protect from light.
Croatian: • Brizgalicu čuvajte u originalnom pakiranju radi zaštite od svjetlosti.
English: Hepatic impairment No dosage adjustment is required in patients with hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije jetre.
English: At 26 weeks, both Trulicity 1.5 mg and 0.75mg were superior to insulin glargine in lowering of HbA1c and this effect was sustained at 52 weeks.
Croatian: U 26. tjednu su i Trulicity 1,5 mg i Trulicity 0,75 mg bili superiorni u odnosu na inzulin glargin s obzirom na smanjenje razine HbA1c, a taj se učinak održao do 52. tjedna.
English: Each syringe contains one weekly dose of Trulicity (0.75 mg or 1.5 mg).
Croatian: Jedna štrcaljka sadrži jednu tjednu dozu lijeka Trulicity (0,75 mg ili 1,5 mg).
English: Monotherapy The recommended dose is 0.75 mg once weekly.
Croatian: Preporučena doza je 0,75 mg jedanput na tjedan.
English: What Trulicity looks like and contents of the pack Trulicity is a clear, colourless, solution for injection in a pre-filled pen.
Croatian: Trulicity je bistra i bezbojna otopina za injekciju u napunjenoj brizgalici.
English: • If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist or nurse.
Croatian: • Ako imate bilo kakvih pitanja ili poteškoća s Trulicity brizgalicom, obratite se svome liječniku,
English: ^ Patients who withdrew from randomized treatment before 24 weeks were considered as not meeting the target
Croatian: ** p < 0,001 za skupinu liječenu dulaglutidom u usporedbi s onom koja je primala placebo ^ Za bolesnike koji su isključeni iz randomiziranog liječenja prije 24. tjedna smatra se da nisu postigli cilj
English: Not known: the frequency cannot be estimated from the available data - Bowel obstruction - a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting.
Croatian: - začepljenje (opstrukcija) crijeva - težak oblik zatvora s dodatnim simptomima kao što su bol u trbuhu, nadutost ili povraćanje
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.
Croatian: Stopa dokumentirane simptomatske hipoglikemije uz Trulicity 1,5 mg i Trulicity 0,75 mg te inzulin glargin iznosila je 4,44, 4,34 odnosno 9,62 epizode po bolesnik-godini.
English: Dehydration, sometimes leading to acute renal failure or worsening renal impairment, has been reported in patients treated with dulaglutide, especially at the initiation of treatment.
Croatian: U bolesnika liječenih dulaglutidom prijavljena je dehidracija, posebice u početku liječenja, koja je ponekad dovela do akutnog zatajenja bubrega ili pogoršanja oštećenja bubrežne funkcije.
English: Fasting blood glucose
Croatian: Glukoza u krvi natašte
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.
Croatian: Stopa dokumentirane simptomatske hipoglikemije uz Trulicity 1,5 mg, Trulicity 0,75 mg odnosno inzulin glargin iznosila je 31,06, 35,66 odnosno 40,95 epizode po bolesnik-godini.
English: Mean change in HbA1c
Croatian: Početni HbA1c
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.
Croatian: Stopa dokumentirane simptomatske hipoglikemije uz Trulicity 1,5 mg, Trulicity 0,75 mg odnosno inzulin glargin iznosila je 1,67, 1,67 odnosno 3,02 epizode po bolesnik-godini.
English: Insulin glargine+ once daily (n=296) †† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to insulin glargine,
Croatian: Inzulin glargin+ jedanput na dan (n=296) †† jednostrana p-vrijednost prilagođena za multiplicitet < 0,025, za superiornost dulaglutida u odnosu na inzulin glargin, ocijenjena samo za HbA1c
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/006 2 pre-filled pens
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/956/006 2 napunjene brizgalice
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.
Croatian: Incidencija dokumentirane simptomatske hipoglikemije kada se dulaglutid u dozi od 1,5 mg primjenjivao u kombinaciji s inzulinom glarginom iznosila je 35,3%, dok je stopa iznosila
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 0.75 mg injection dulaglutide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Trulicity 0,75 mg injekcija dulaglutid s.c.
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.
Croatian: AV blok prvog stupnja/produljenje PR intervala Kod primjene dulaglutida u dozi od 0,75 mg odnosno 1,5 mg primijećena su male srednje vrijednosti produljenja PR intervala za 2 do 3 milisekunde u odnosu na početnu vrijednost te incidencija AV bloka prvog stupnja od 1,5% odnosno 2,4%.
English: No dose adjustment for metformin IR is recommended when given with dulaglutide.
Croatian: Ne preporučuje se prilagođavati dozu metformina u formulaciji s trenutnim oslobađanjem kada se primjenjuje istodobno s dulaglutidom.
English: Each pen contains one weekly dose of Trulicity (0.75 mg or 1.5 mg).
Croatian: Jedna brizgalica sadrži jednu tjednu dozu lijeka Trulicity (0,75 mg ili 1,5 mg).
English: Multi-pack: 4 pre-filled syringes of 0.5 ml solution.
Croatian: Višestruko pakiranje: 4 napunjene štrcaljke s 0,5 ml otopine.
English: Insulin glargine+ once daily (n=262) † multiplicity adjusted 1-sided p-value < 0.025, for noninferiority; †† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to insulin glargine, assessed for HbA1c only # p < 0.05, ## p < 0.001 dulaglutide treatment group compared to insulin glargine + Insulin glargine doses were adjusted utilising an algorithm with a fasting plasma glucose target of
Croatian: Inzulin glargin+ jedanput na dan (n=262) † jednostrana p-vrijednost prilagođena za multiplicitet < 0,025, za neinferiornost; †† jednostrana p-vrijednost prilagođena za multiplicitet < 0,025, za superiornost dulaglutida u odnosu na inzulin glargin, ocijenjena samo za HbA1c # p < 0,05, ## p < 0,001 za skupinu liječenu dulaglutidom u usporedbi s inzulinom glarginom
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.
Croatian: (0,75 mg) i 6,1% (1,5 mg) za dulaglutid naspram 3,7% za placebo.
English: Table 4: Results of a 26 week active controlled study of one dose of dulaglutide in comparison to liraglutide
Croatian: Tablica 4: Rezultati 26-tjednog aktivno kontroliranog ispitivanja u kojem se jedna doza dulaglutida uspoređivala s liraglutidom Početni HbA1c
English: Table 8: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to exenatide
Croatian: Tablica 8: Rezultati aktivno kontroliranog ispitivanja u kojem su se dvije doze dulaglutida uspoređivale s eksenatidom u trajanju od 52 tjedna
English: • Keep the pen out of sight and reach of children.
Croatian: • Brizgalicu čuvajte izvan pogleda i dohvata djece.
English: Each syringe contains one weekly dose of Trulicity (1.5 mg).
Croatian: Jedna štrcaljka sadrži jednu tjednu dozu lijeka Trulicity (1,5 mg).
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Trulicity Lijek čuvajte izvan pogleda i dohvata djece.
English: assessed for HbA1c only ** p < 0.001 dulaglutide treatment group compared to placebo ## p < 0.001 dulaglutide treatment group compared to sitagliptin
Croatian: ** p < 0,001 za skupinu liječenu dulaglutidom u usporedbi s placebom ## p < 0,001 za skupinu liječenu dulaglutidom u usporedbi sa sitagliptinom
English: Table 2: Results of a 52 week active controlled monotherapy study with two doses of dulaglutide in comparison to metformin
Croatian: Tablica 2: Rezultati aktivno kontroliranog ispitivanja u kojem se monoterapija dulaglutidom u dvije doze uspoređivala s metforminom u trajanju od 52 tjedna
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
Croatian: # p < 0,05, ## p < 0,001 za skupinu liječenu dulaglutidom u usporedbi s inzulinom glarginom + Doze inzulina glargina prilagođavale su se na temelju algoritma s ciljnom vrijednošću glukoze u plazmi natašte od < 5,6 mmol/l.
English: The incidences when dulaglutide 0.75 mg and 1.5 mg, respectively, were used in combination with prandial insulin were 85.3% and 80.0% and rates were 35.66 and 31.06 events/patient/year.
Croatian: Incidencija hipoglikemije kod primjene dulaglutida u kombinaciji s prandijalnim inzulinom bila je 85,3% za dozu od 0,75 mg, odnosno 80,0% za dozu od 1,5 mg, dok su stope iznosile 35,66 odnosno 31,06 događaja po bolesnik-godini.
English: Sitagliptin exposure was unaffected when coadministered with a single dose of dulaglutide.
Croatian: Istodobna primjena s jednom dozom dulaglutida nije utjecala na izloženost sitagliptinu.
English: Table 5: Results of a 78 week active controlled study with two doses of dulaglutide in comparison to insulin glargine
Croatian: Tablica 5: Rezultati aktivno kontroliranog ispitivanja u kojem su se dvije doze dulaglutida uspoređivale s inzulinom glarginom u trajanju od 78 tjedana
English: Each syringe contains one weekly dose of Trulicity (0.75 mg).
Croatian: Jedna štrcaljka sadrži jednu tjednu dozu lijeka Trulicity (0,75 mg).
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.
Croatian: Stopa dokumentirane simptomatske hipoglikemije uz Trulicity 0,75 mg, Trulicity 1,5 mg i placebo iznosila je 0,15, 0,16 odnosno 0,12 epizoda po bolesnik-godini.
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.
Croatian: Stopa dokumentirane simptomatske hipoglikemije uz Trulicity 1,5 mg iznosila je 0,12 epizoda po bolesnik-godini, a uz liraglutid 0,29 epizoda po bolesnik-godini.
English: Dulaglutide 0.75 mg once weekly (n=141)
Croatian: Dulaglutid 0,75 mg jedanput na tjedan (n=141)
English: 26 weeks Dulaglutide 1.5 mg once weekly (n=299) Liraglutide+ 1.8 mg daily (n=300) ‡ 1-sided p-value p < 0.001, for noninferiority of dulaglutide compared to liraglutide, assessed only for HbA1c.
Croatian: (n=299) Liraglutid+ 1,8 mg na dan (n=300) ‡ jednostrana p-vrijednost p < 0,001, za neinferiornost dulaglutida u usporedbi s liraglutidom,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/001 2 pre-filled pens
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/956/001 2 napunjene brizgalice
English: Dulaglutide 1.5 mg once weekly (n=304)
Croatian: Dulaglutid 1,5 mg jedanput na tjedan (n=304)
English: Nausea, diarrhoea, vomiting†, abdominal pain†
Croatian: - povraćanje - proljev - bol u trbuhu (abdomenu)
English: One patient reported severe hypoglycaemia with Trulicity 1.5 mg in combination with insulin glargine and none with placebo.
Croatian: Jedan bolesnik liječen lijekom Trulicity 1,5 mg u kombinaciji s inzulinom glarginom prijavio je tešku hipoglikemiju, dok uz placebo nije prijavljen nijedan takav slučaj.
English: Heart rate increase
Croatian: Ubrzanje srčane frekvencije
English: Dulaglutide coadministration with sitagliptin increased dulaglutide exposure and Cmax by approximately 38 % and 27 %, respectively, and median tmax increased approximately 24 hours.
Croatian: Istodobna primjena dulaglutida i sitagliptina povećala je izloženost dulaglutidu za približno 38%, a njegov Cmax za približno
English: + Patients randomised to liraglutide were initiated at a dose of 0.6 mg/day.
Croatian: # p < 0,05 za skupinu liječenu dulaglutidom u usporedbi s liraglutidom + Bolesnici randomizirani za primanje liraglutida liječenje su započeli dozom od 0,6 mg/dan.
English: • Store your pen in the refrigerator.
Croatian: • Brizgalicu čuvajte u hladnjaku.
English: Packs of 2 and 4 pre-filled pens and multipack of 12 (3 packs of 4) pre-filled pens.
Croatian: Pakiranja s 2 i 4 napunjene brizgalice i višestruko pakiranje s 12 (3 pakiranja s 4) napunjenih brizgalica.
English: Plunger Rod
Croatian: Spol i rasa
English: Table 10: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to insulin glargine
Croatian: Tablica 10: Rezultati aktivno kontroliranog ispitivanja u kojem su se dvije doze dulaglutida uspoređivale s inzulinom glarginom u trajanju od 52 tjedna
English: Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy, discoloured or has particles in it.
Croatian: Nemojte primijeniti lijek ako primijetite da je brizgalica oštećena ili ako vidite da je lijek mutan, da je promijenio boju ili da sadrži čestice.
English: Placebo (n=140) ‡‡ p < 0.001 for superiority of dulaglutide compared to placebo, with overall type I error controlled ** p < 0.001 for dulaglutide treatment group compared to placebo
Croatian: Placebo (n=140) ‡‡ p < 0,001 za superiornost dulaglutida u usporedbi s placebom, uz kontroliranu ukupnu pojavnost pogreške tipa
English: The severe hypoglycaemia event incidences were 0% and 0.7%, and rates were 0.00 and 0.01 events/patient/year for each dose, respectively.
Croatian: Incidencije događaja teške hipoglikemije za navedene dvije doze iznosile su 0% odnosno 0,7%, dok su stope iznosile 0,00 odnosno 0,01 događaja po bolesnik-godini.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 1.5 mg injection dulaglutide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Trulicity 1,5 mg injekcija dulaglutid s.c.
English: PLACE AND UNLOCK PRESS AND HOLD
Croatian: I OTKLJUČAJTE PRITISNITE I DRŽITE
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.
Croatian: Nakon višestrukih supkutanih doza dulaglutida od 1,5 mg u bolesnika sa šećernom bolešću tipa 2, srednja vršna izloženost (Cmax) iznosila je približno 114 ng/ml, a srednja ukupna izloženost (AUC) približno 14 000 mgh/ml.
English: - Trulicity 0.75 mg: Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution.
Croatian: − Trulicity 0,75 mg: Jedna napunjena štrcaljka sadrži 0,75 mg dulaglutida u 0,5 ml otopine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (without Blue Box) component of a multipack - PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU MEĐUPAKIRANJE (bez plavog okvira) - sastavni dio višestrukog pakiranja - NAPUNJENA ŠTRCALJKA
English: Placebo (n=60) ‡‡ p < 0.001 for superiority of dulaglutide compared to placebo, with overall type I error controlled ** p < 0.001 for dulaglutide treatment group compared to placebo
Croatian: Placebo (n=60) ‡‡ p < 0,001 za superiornost dulaglutida u usporedbi s placebom, uz kontroliranu ukupnu pojavnost pogreške tipa
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Trulicity 0.75 mg solution for injection in pre-filled pen dulaglutide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Trulicity 0,75 mg otopina za injekciju u napunjenoj brizgalici dulaglutid
English: With Trulicity 1.5 mg a significantly higher percentage of patients reached a target HbA1c of < 7.0 % or ≤ 6.5 % at 52 and 78 weeks compared to insulin glargine.
Croatian: Značajno veći postotak bolesnika postigao je ciljnu vrijednost HbA1c od < 7,0% ili ≤ 6,5% u 52. i 78. tjednu uz Trulicity 1,5 mg u usporedbi s inzulinom glarginom.
English: How to store Trulicity
Croatian: Moguće nuspojave Kako čuvati Trulicity
English: Dulaglutide 1.5 mg once weekly (n=142)
Croatian: Dulaglutid 1,5 mg jedanput na tjedan (n=142)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/956/010
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/956/010
English: Contact your doctor if you have any questions or concerns.
Croatian: Ako imate bilo kakvih pitanja ili ste zabrinuti, obratite se svom liječniku.
English: Angioedema#
Croatian: - mučnina
English: The rate of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and metformin were 0.62, 0.15, and 0.09 episodes/patient/year, respectively.
Croatian: Stopa dokumentirane simptomatske hipoglikemije uz Trulicity 1,5 mg, Trulicity 0,75 mg odnosno metformin iznosila je 0,62, 0,15 odnosno 0,09 epizoda po bolesnik-godini.