FrancophonIA/ELRC3.0 huggingface dataset:
English: • a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patientyears (p=0.021),
Croatian: • Značajno smanjenje apsolutnog rizika od ukupne smrtnosti: metformin 13,5 događaja/1000 bolesnik-godina naspram samo dijete 20,6 događaja/1000 bolesnik-godina, (p=0,011), i naspram skupina koje su liječene monoterapijom sulfonilurejom i inzulinom 18,9 događaja/1000 bolesnik-godina (p=0,021),
English: Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis.
Croatian: Pri akutnom pogoršanju funkcije bubrega dolazi do nakupljanja metformina, što povećava rizik od laktacidoze.
English: Iodinated contrast agents
Croatian: Jodirana kontrastna sredstva
English: In vivo assessment of interactions
Croatian: Procjena interakcija lijeka in vivo
English: • in patients inadequately controlled on their maximally tolerated dose of metformin alone
Croatian: • u bolesnika u kojih nije postignuta odgovarajućakontrola na njihovoj maksimalno podnošljivoj dozi samog metformina
English: - The active substances are linagliptin and metformin hydrochloride.
Croatian: - Djelatne tvari su linagliptin i metforminklorid.
English: Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat
Croatian: - povraćanje - bol u trbuhu (bol u abdomenu) - grčevi u mišićima - opće loše osjećanje uz jaki umor - otežano disanje - smanjena tjelesna temperatura i usporen rad srca
English: Metformin should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and
Croatian: Primjenu metformina treba prekinuti prije ili u vrijeme pretrage metodom oslikavanja i s njegovom primjenom smije se ponovno započeti tek 48 sati poslije, pod uvjetom da je funkcija bubrega bila ponovno procijenjena i da je potvrđeno da je stabilna, vidjeti dijelove 4.2 i 4.5.
English: Biotransformation Following a [
Croatian: Biotransformacija Nakon oralne doze [
English: Patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose of Jentadueto should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) plus the dose of metformin already being taken.
Croatian: Za bolesnike u kojih nije postignuta odgovarajuća kontrola metforminom kao monoterapijom, uobičajena početna doza Jentadueta mora osigurati linagliptin u dozi od 2,5 mg dvaput dnevno (5 mg ukupna dnevna doza) plus doza metformina koja se već uzima.
English: trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib).
Croatian: trimetoprim, vandetanib, izavukonazol, krizotinib, olaparib). - karbamazepin, fenobarbital ili fenitoin.
English: Oval, biconvex, light pink, film-coated tablet of 21.1 mm x 9.7 mm debossed with ”D2/1000" on one side and the company logo on the other.
Croatian: Jentadueto 2,5 mg/1000 mg filmom obložene tablete Ovalna, bikonveksna, svijetloružičasta filmom obložena tableta veličine 21,1 mm x 9,7 mm s utisnutom oznakom "D2/1000" na jednoj i logom tvrtke na drugoj strani.
English: The pharmacokinetics of linagliptin has been extensively characterised in healthy subjects and patients with type 2 diabetes.
Croatian: Farmakokinetika linagliptina je opsežno ispitana u zdravih ispitanika i bolesnika s dijabetesom tipa
English: The study population included 1211 (17.4%) patients ≥ 75 years of age and 4348 (62.3%) patients with renal impairment.
Croatian: ≥ 75 godina i 4348 (62,3%) bolesnika s oštećenjem bubrega.
English: Body mass index had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Croatian: Indeks tjelesne mase nije imao klinički značajan učinak na farmakokinetiku linagliptina na osnovi podataka farmakokinetičke analize skupina faze I i faze II.
English: Urticaria rare
Croatian: Urtikarija rijetko
English: Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
Croatian: Simptomi uključuju bol u trbuhu, ubrzano i duboko disanje, pospanost ili Vam dah ima neobičan voćni miris; - ako ste ikad imali dijabetičku pretkomu; - ako imate tešku infekciju kao što je infekcija koja pogađa pluća ili bronhe ili pak bubrege.
English: In the overall study observation period adjudicated acute pancreatitis was reported in 0.3% of patients treated with linagliptin and in 0.1% of patients treated with placebo.
Croatian: Tijekom ukupnog razdoblja promatranja u ispitivanju, ustanovljeni akutni pankreatitis prijavljen je u 0,3% bolesnika liječenih linagliptinom te u 0,1% bolesnika koji su primali placebo.
English: The mean HbA1c at baseline was 8.0%.
Croatian: Srednja vrijednost HbA1c na početku ispitivanja iznosila je 8,0%.
English: Blister Store in the original package in order to protect from moisture.
Croatian: Blister Čuvati u originalnom pakiranju radi zaštite od vlage.
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Croatian: OBLIK I SADRŽAJ 14 filmom obloženih tableta 60 filmom obloženih tableta 180 filmom obloženih tableta
English: - if you are taking insulin or an anti-diabetic medicine known as ‘sulphonylurea', your doctor may want to reduce your dose of insulin or sulphonylurea when you take either of them together with
Croatian: - uzimate inzulin ili antidijabetik poznat kao ‘sulfonilureja', liječnik će Vam možda sniziti dozu inzulina ili sulfonilureje ako neki od njih uzimate u kombinaciji s Jentaduetom kako bi se izbjegle pretjerano niske vrijednosti šećera u krvi (hipoglikemija).
English: Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm debossed with "D2/850" on one side and the company logo on the other.
Croatian: Jentadueto 2,5 mg/850 mg filmom obložene tablete Ovalna, bikonveksna, svijetlonarančasta filmom obložena tableta veličine 19,2 mm x 9,4 mm s utisnutom oznakom "D2/850" na jednoj i logom tvrtke na drugoj strani.
English: Some patients have had the following side effects while taking Jentadueto: - Common (may affect up to 1 in 10 people): diarrhoea, blood enzyme increase (lipase increase),
Croatian: Neki su bolesnici imali sljedeće nuspojave tijekom uzimanja Jentadueta: - Često (mogu se javiti u do 1 na 10 osoba): proljev, povišene vrijednosti enzima u krvi (povišena lipaza), mučnina - Manje često: upala nosa ili grla (nazofaringitis), kašalj, gubitak apetita (smanjeni apetit),
English: Linagliptin provided significant improvements in HbA1c (-0.64% change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%.
Croatian: Linagliptin je pokazao značajna poboljšanja u HbA1c (promjena od -0,64% u usporedbi s placebom nakon 24 tjedna), u odnosu na prosječnu početnu vrijednost HbA1c od 7,8%.
English: Twice Daily Metformin HCl 1,000 mg Twice Daily
Croatian: Metformin klorid 1000 mg dvaput dnevno
English: - The other ingredients are: - Tablet core: arginine, copovidone, magnesium stearate, maize starch, silica, colloidal anhydrous.
Croatian: - Pomoćne tvari su: jezgra tablete: arginin, kopovidon, magnezijev stearat, kukuruzni škrob, silicijev dioksid, koloidni, bezvodni film ovojnica: hipromeloza, titanijev dioksid (E171), talk, propilenglikol.
English: Metformin is contraindicated in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3).
Croatian: GFR je potrebno procijeniti prije početka liječenja i redovito nakon toga, vidjeti dio 4.2. Metformin je kontraindiciran u bolesnika s GFR<30 ml/min i njegovu je primjenu potrebno privremeno prekinuti ako su prisutna stanja koja mijenjaju funkciju bubrega, vidjeti dio 4.3.
English: This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Croatian: U tom slučaju, šećer (glukoza) se nakuplja u krvi, što može dovesti do ozbiljnih medicinskih problema poput bolesti srca, bolesti bubrega, sljepoće i amputacije.
English: Gender had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Croatian: Spol nije imao klinički značajan učinak na farmakokinetiku linagliptina na osnovi podataka farmakokinetičke analize skupina faze I i faze II.
English: Cardiovascular and renal outcomes by treatment group in the CARMELINA study Linagliptin 5mg
Croatian: Tablica 4 Kardiovaskularni i bubrežni ishodi prema terapijskim skupinama u ispitivanju CARMELINA
English: Age did not have a clinically relevant impact on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Croatian: Dob nije imala klinički značajan utjecaj na farmakokinetiku linagliptina na temelju podataka farmakokinetičke analize skupine faze I i faze II.
English: Number of Subjects
Croatian: Broj ispitanika
English: Administration of iodinated contrast agent
Croatian: Primjena jodiranih kontrastnih sredstava
English: Linagliptin provided significant improvements in HbA1c (-0.62% change compared to placebo), from a mean baseline HbA1c of 8.14%.
Croatian: Linagliptin je pokazao značajna poboljšanja u HbA1c (promjena od -0,62% u usporedbi s placebom), u odnosu na prosječan početni HbA1c od 8,14%.
English: • Diabetic pre-coma.
Croatian: • Dijabetička predkoma.
English: Risk of lactic acidosis.
Croatian: Rizik od laktacidoze
English: Linagliptin as add-on therapy in elderly (age ≥ 70 years) with type 2 diabetes The efficacy and safety of linagliptin in elderly (age ≥ 70 years) with type 2 diabetes was evaluated in a double-blind study of 24 weeks duration.
Croatian: Djelotvornost i sigurnost linagliptina kod starijih bolesnika (dob ≥ 70 godina) s dijabetesom tipa 2 ocjenjivana je u dvostruko slijepom ispitivanju u trajanju 24 tjedna.
English: In the CARMELINA study, bullous pemphigoid was reported in 0.2% of patients treated with linagliptin and in no patient treated with placebo.
Croatian: Tijekom ispitivanja CARMELINA, bulozni pemfigoid bio je prijavljen u 0,2% bolesnika na liječenju linagliptinom te ni u jednog bolesnika koji je primao placebo.
English: Linagliptin added to metformin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Croatian: Linagliptin dodan metforminu je pokazao značajna poboljšanja u HbA1c (-0,64% promjene u usporedbi s placebom) od prosječne početne vrijednosti HbA1c od 8%.
English: feeling sick (nausea) - Uncommon: inflamed nose or throat (nasopharyngitis), cough, loss of appetite (decreased appetite), being sick (vomiting), blood enzyme increase (amylase increase), itching (pruritus) - Rare: blistering of skin (bullous pemphigoid)
Croatian: povraćanje, povišene vrijednosti enzima amilaze u krvi (povišena amilaza), svrbež (pruritus) - Rijetko: stvaranje mjehura na koži (bulozni pemfigoid)
English: The decrease in body weight with the combination of linagliptin and metformin was similar to that observed for metformin alone or placebo; there was no change in weight from baseline for patients on linagliptin alone.
Croatian: Smanjenje tjelesne težine u skupini koja je primala kombinaciju linagliptina i metformina bilo je slično smanjenju opaženom u skupini koja je primala samo metformin ili placebo.
English: - Linagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4
Croatian: Sadrži dvije različite djelatne tvari, linagliptin i metformin. - linagliptin pripada skupini lijekova koji se nazivaju DPP-4 inhibitori (inhibitori dipeptidil peptidaze-4).
English: Pancreatitis rare #
Croatian: Pankreatitis rijetko
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 2.5 mg/850 mg FILM-COATED TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKA PAKIRANJA - SREDNJA KUTIJA BEZ PLAVOG OKVIRA - 2,5 MG/850 MG FILMOM OBLOŽENE TABLETE
English: Jentadueto 2.5 mg/850 mg are oval, biconvex, light orange, film-coated tablets (tablets).
Croatian: Jentadueto 2,5 mg/850 mg tablete su ovalne, bikonveksne, svijetlonarančaste filmom obložene tablete (tablete).
English: Linagliptin 24 month data, as add-on to metformin in comparison with glimepiride In a study comparing the efficacy and safety of the addition of linagliptin 5 mg or glimepiride (mean dose 3 mg) in patients with inadequate glycaemic control on metformin monotherapy, mean reductions in HbA1c were -0.16% with linagliptin (mean baseline HbA1c 7.69%) and -0.36% with glimepiride (mean baseline HbA1c 7.69%.)
Croatian: U ispitivanju koje je uspoređivalo djelotvornost i sigurnost dodavanja linagliptina 5 mg ili glimepirida (srednja doza od 3 mg) u bolesnika s nedostatnom kontrolom glikemije na monoterapiji metforminom, prosječna smanjenja HbA1c bila su -0,16% s linagliptinom (prosječna početna vrijednost HbA1c 7,69%) i -0,36% s glimeripidom (prosječna početna vrijednost HbA1c 7,69%) sa srednjom razlikom liječenja od 0,20% (97,5% CI: 0,09, 0,299).
English: if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Croatian: Nemojte uzimati Jentadueto - ako ste alergični na linagliptin ili metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.); - ako imate jako smanjenu funkciju bubrega; - ako imate nekontrolirani dijabetes uz, primjerice, tešku hiperglikemiju (visoka razina glukoze u krvi), mučninu, povraćanje, proljev, brz gubitak tjelesne težine, laktacidozu (vidjeti „Rizik od laktacidoze“ niže) ili ketoacidozu.
English: Jentadueto 2.5 mg/1,000 mg are oval, biconvex light pink film-coated tablets (tablets).
Croatian: Jentadueto 2,5 mg/1000 mg tablete su ovalne, bikonveksne, svijetloružičaste filmom obložene tablete (tablete).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/780/032 (120 (2 x 60 x 1) filmom obloženih tableta) EU/1/12/780/033 (180 (2 x 90 x 1) filmom obloženih tableta) EU/1/12/780/034 (200 (2 x 100 x 1) filmom obloženih tableta)
English: Jentadueto 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Croatian: Jentadueto 2,5 mg/850 mg filmom obložene tablete Svaka tableta sadrži 2,5 mg linagliptina i 850 mg metforminklorida.
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs) should be initiated with caution in metformin-treated patients.
Croatian: U bolesnika liječenih metforminom potreban je oprez kad se započinje s primjenom lijekova koji mogu akutno oštetiti funkciju bubrega (kao što su antihipertenzivi, diuretici i NSAIL-ovi).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/029 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/030 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/031 (200 (2 x 100 x 1) film-coated tablets)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/780/029 (120 (2 x 60 x 1) filmom obloženih tableta) EU/1/12/780/030 (180 (2 x 90 x 1) filmom obloženih tableta) EU/1/12/780/031 (200 (2 x 100 x 1) filmom obloženih tableta)
English: Twice Daily Metformin HCl 500 mg
Croatian: Metformin klorid 500 mg dvaput dnevno
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Croatian: Jentadueto 2,5 mg/1000 mg filmom obložene tablete Svaka tableta sadrži 2,5 mg linagliptina i 1000 mg metforminklorida.
English: Hepatobiliary disorders Liver function disorders uncommon
Croatian: Poremećaji jetre i žuči Poremećaji funkcije jetre manje često
English: Along with diet and exercise, this medicine helps to improve the levels and effects of insulin after a meal and lowers the amount of sugar made by your body.
Croatian: Dvije djelatne tvari djeluju zajedno u cilju kontrole vrijednosti šećera u krvi u odraslih osoba s oblikom dijabetesa koji se naziva dijabetes melitus tipa 2. Zajedno s dijetom i tjelovježbom, ovaj lijek pomaže u poboljšanju vrijednosti i učinaka inzulina nakon obroka te snižava količinu šećera koju proizvodi Vaše tijelo.
English: - Each Jentadueto 2.5 mg/850 mg film-coated tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Croatian: Svaka Jentadueto 2,5 mg/850 mg filmom obložena tableta sadrži 2,5 mg linagliptina i 850 mg metforminklorida.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - WRAPPED IN TRANSPARENT FOILINCLUDING THE BLUE BOX - 2.5 mg/1,000 mg FILM-COATED TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA - OMOTANO PROZIRNOM FOLIJOM - UKLJUČUJUĆI PLAVI OKVIR - 2,5 MG/1000 MG FILMOM OBLOŽENE TABLETE
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/026 14 film-coated tablets EU/1/12/780/027 60 film-coated tablets EU/1/12/780/028 180 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/780/026 14 filmom obloženih tableta EU/1/12/780/027 60 filmom obloženih tableta EU/1/12/780/028 180 filmom obloženih tableta
English: Jentadueto 2.5 mg / 850 mg film-coated tablets Jentadueto 2.5 mg / 1,000 mg film-coated tablets linagliptin/metformin hydrochloride
Croatian: Jentadueto 2,5 mg / 850 mg filmom obložene tablete Jentadueto 2,5 mg / 1000 mg filmom obložene tablete linagliptin/metforminklorid
English: Other adverse reactions
Croatian: Druge nuspojave
English: - if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties.
Croatian: Dehidracija može dovesti do problema s bubrezima što Vas može izložiti riziku od laktacidoze (vidjeti „Upozorenja i mjere opreza“); - ako se liječite zbog akutnog zatajenja srca ili ste nedavno imali srčani udar ili imate teške probleme s cirkulacijom (kao što je šok) ili imate poteškoće s disanjem.
English: België/Belgique/Belgien SCS Boehringer Ingelheim Comm.V Tél/Tel: +32 2 773 33 11
Croatian: België/Belgique/Belgien SCS Boehringer Ingelheim Comm.V
English: - if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row.
Croatian: Teške infekcije mogu dovesti do problema s bubrezima te Vas izložiti riziku od laktacidoze (vidjeti „Upozorenja i mjere opreza“); - ako ste izgubili puno vode iz tijela (dehidracija), npr. uslijed dugotrajnog ili teškog proljeva ili ako ste povraćali nekoliko puta uzastopce.
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg tablets Linagliptin/metformin HCl
Croatian: NAZIV LIJEKA Jentadueto 2,5 mg/850 mg tablete linagliptin/metforminklorid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 2.5 mg/1,000 mg FILM-COATED TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠESTRUKA PAKIRANJA - SREDNJA KUTIJA BEZ PLAVOG OKVIRA2,5 MG/1000 MG FILMOM OBLOŽENE TABLETE
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/1,000 mg tablets Linagliptin/metformin HCl
Croatian: NAZIV LIJEKA Jentadueto 2,5 mg/1000 mg tablete linagliptin/metforminklorid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - WRAPPED IN TRANSPARENT FOILINCLUDING THE BLUE BOX - 2.5 mg/850 mg FILM-COATED TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VANJSKOM OMOTU VIŠESTRUKOG PAKIRANJA - OMOTANO PROZIRNOM FOLIJOM -UKLJUČUJUĆI PLAVI OKVIR -2,5 MG/850 MG FILMOM OBLOŽENE TABLETE
English: - Each Jentadueto 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Croatian: Svaka Jentadueto 2,5 mg/1000 mg filmom obložena tableta sadrži 2,5 mg linagliptina i 1000 mg metforminklorida.
English: Patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea
Croatian: Bolesnici u kojih nije postignuta odgovarajuća kontrola na maksimalnoj podnošljivoj dozi monoterapije metforminom
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/012 14 film-coated tablets EU/1/12/780/013 60 film-coated tablets EU/1/12/780/014 180 film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/780/012 14 filmom obloženih tableta EU/1/12/780/013 60 filmom obloženih tableta EU/1/12/780/014 180 filmom obloženih tableta
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Jentadueto 2.5 mg/1,000 mg film-coated tablets
Croatian: Jentadueto 2,5 mg/850 mg filmom obložene tablete Jentadueto 2,5 mg/1000 mg filmom obložene tablete
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 2,5 mg linagliptina i 850 mg metforminklorida.
English: Secondary renal composite (renal death, ESRD, 40% sustained decrease in eGFR)
Croatian: Broj bolesnika Primarna KV kompozitna mjera (kardiovaskularna smrt, MI bez smrtnog ishoda, moždani udar bez smrtnog ishoda Sekundarna bubrežna kompozitna mjera (smrt zbog bubrežnih uzroka, ESRD, održano smanjenje eGFR-a za 40%)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka tableta sadrži 2,5 mg linagliptina i 1000 mg metforminklorida.
English: Respiratory, thoracic and mediastinal disorders Cough uncommon
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Kašalj manje često
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets EU/1/12/780/015 (10 x 1 film-coated tablets) EU/1/12/780/016 (14 x 1 film-coated tablets) EU/1/12/780/017 (28 x 1 film-coated tablets) EU/1/12/780/018 (30 x 1 film-coated tablets) EU/1/12/780/019 (56 x 1 film-coated tablets) EU/1/12/780/020 (60 x 1 film-coated tablets) EU/1/12/780/021 (84 x 1 film-coated tablets) EU/1/12/780/022 (90 x 1 film-coated tablets) EU/1/12/780/023 (98 x 1 film-coated tablets) EU/1/12/780/024 (100 x 1 film-coated tablets) EU/1/12/780/025 (120 x 1 film-coated tablets) EU/1/12/780/026 (14 film-coated tablets, bottle) EU/1/12/780/027 (60 film-coated tablets, bottle) EU/1/12/780/028 (180 film-coated tablets, bottle) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
Croatian: Jentadueto 2,5 mg/1000 mg filmom obložene tablete EU/1/12/780/015 (10 x 1 filmom obložena tableta) EU/1/12/780/016 (14 x 1 filmom obložena tableta) EU/1/12/780/017 (28 x 1 filmom obložena tableta) EU/1/12/780/018 (30 x 1 filmom obložena tableta) EU/1/12/780/019 (56 x 1 filmom obložena tableta) EU/1/12/780/020 (60 x 1 filmom obložena tableta) EU/1/12/780/021 (84 x 1 filmom obložena tableta) EU/1/12/780/022 (90 x 1 filmom obložena tableta) EU/1/12/780/023 (98 x 1 filmom obložena tableta) EU/1/12/780/024 (100 x 1 filmom obložena tableta) EU/1/12/780/025 (120 x 1 filmom obložena tableta) EU/1/12/780/026 (14 filmom obloženih tableta, bočica) EU/1/12/780/027 (60 filmom obloženih tableta, bočica) EU/1/12/780/028 (180 filmom obloženih tableta, bočica) EU/1/12/780/032 (120 (2 x 60 x 1) filmom obloženih tableta) EU/1/12/780/033 (180 (2 x 90 x 1) filmom obloženih tableta) EU/1/12/780/034 (200 (2 x 100 x 1) filmom obloženih tableta)