FrancophonIA/ELRC3.0 huggingface dataset:
English: Butylhydroxyanisole (E320), lactose monohydrate, sodium laurilsulfate, starch, pregelatinised (maize), docusate sodium, sucrose, citric acid monohydrate (E330), hypromellose (E464), crospovidone (E1202), magnesium stearate (E572), silicified microcrystalline cellulose (comprised of cellulose, microcrystalline and silica, colloidal anhydrous), ascorbic acid (E300).
Croatian: Butilhidroksianizol (E320), laktoza hidrat, natrijev laurilsulfat, prethodno geliran kukuruzni škrob, natrijev dokuzat, saharoza, citratna kiselina hidrat (E330), hipromeloza (E464), krospovidon (E1202), magnezijev stearat (E572), silicirana mikrokristalična celuloza (sastoji se od mikrokristalične celuloze i koloidnog, bezvodnog silicijevog dioksida), askorbatna kiselina (E300).
English: • you have an underactive thyroid gland (hypothyroidism)
Croatian: • ako imate smanjenu aktivnost štitnjače (hipotireoza)
English: • you are taking hepatitis C antiviral agents such as elbasvir or grazoprevir (used to treat hepatitis
Croatian: • ako uzimate antivirusne lijekove za hepatitis C kao što su elbasvir ili grazoprevir (koji se upotrebljavaju za liječenje infekcije virusom hepatitisa C)
English: Non-HDL-C (mmol/L)
Croatian: Ne-HDL-C (mmol/l)
English: • increase in blood platelets count
Croatian: • povećanje broja trombocita u krvi
English: The mechanism of the LDL lowering effect of simvastatin may involve both reduction of VLDL-C concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL-C. Apolipoprotein B also falls substantially during treatment with simvastatin.
Croatian: Mehanizam kojim simvastatin snižava LDL može uključivati i snižavanje koncentracije VLDL kolesterola (VLDL-C) i indukciju LDL receptora, što dovodi do smanjenog stvaranja i pojačane razgradnje LDL-C-a.
English: • If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o glecaprevir or pibrentasvir (used to treat hepatitis C virus infection) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression)
Croatian: • Ako već uzimate sljedeće lijekove:  danazol (sintetski hormon za liječenje endometrioze)  ciklosporin (lijek koji često uzimaju bolesnici s presađenim organom)  itrakonazol, ketokonazol, flukonazol ili posakonazol (lijekovi za gljivične infekcije)  inhibitore proteaze HIV-a kao što su indinavir, nelfinavir, ritonavir i sakvinavir (lijekovi koji se koriste kod HIV-infekcija i AIDS-a)  glekaprevir ili pibrentasvir (koji se upotrebljavaju za liječenje infekcije virusom hepatitisa C)  eritromicin, klaritromicin ili telitromicin (lijekovi za bakterijske infekcije)  nefazodon (lijek za depresiju)
English: • increase in “alkaline phosphatase” - produced by the bile system - shown in tests
Croatian: • povišenje “alkalne fosfataze" - koju stvara žučni sustav - vidljivo u pretragama
English: Concomitant administration of amiodarone, verapamil, amlodipine or diltiazem (see section 4.5) 4.4 Special warnings and precautions for use
Croatian: • Istodobna primjena amiodarona, verapamila, amlodipina ili diltiazema (vidjeti dio 4.5)
English: Blood creatine phosphokinase level increase rare
Croatian: Povišenje kreatin-fosfokinaze u krvi rijetko
English: Glitazones
Croatian: Glitazoni
English: Rare side effects (may affect up to 1 in 1,000 people):
Croatian: Rijetke nuspojave (mogu se javiti kod manje od 1 od 1000 osoba):
English: In elderly patients, the fenofibric acid apparent total plasma clearance is not modified.
Croatian: Prividni klirens fenofibrične kiseline iz plazme u starijih se osoba ne mijenja.
English: Tel: + 386 (0)123 63 180
Croatian: GSP Proizvodi d.o.o. Tel: + 386 (0)123 63 180
English: Photosensitivity reactions rare
Croatian: Fotosenzitivne reakcije rijetko Sindrom preosjetljivosti*** rijetko
English: The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of gemfibrozil with simvastatin.
Croatian: Rizik od miopatije i rabdomiolize značajno je povećan istodobnom primjenom gemfibrozila sa simvastatinom.
English: (see section 4.3).
Croatian: (vidjeti dio 4.3).
English: Therefore, the co-administration of Cholib with danazol is contraindicated (see section 4.3).
Croatian: Stoga je istodobna primjena Choliba s danazolom kontraindicirana (vidjeti dio 4.3).
English: Prescribing recommendations
Croatian: Preporuke za propisivanje
English: • increase in “creatine phosphokinase” - produced by the muscle - shown in tests
Croatian: • povišenje “kreatin-fosfokinaze" - koju stvaraju mišići - vidljivo u pretragama
English: Do not exceed one Cholib 145 mg/20 mg per day
Croatian: Ne smije se prekoračiti doza od jedne tablete Cholib 145 mg/20 mg dnevno.
English: Mylan Healthcare Sp. z o.o.
Croatian: Mylan Healthcare B.V.
English: CYP 3A4 inhibitors: fluconazole, verapamil, or diltiazem (see sections 4.3 and 4.4).
Croatian: Nužan je oprez kada se Cholib kombinira s određenim drugim manje potentnim inhibitorima CYP 3A4: flukonazol, verapamil, ili diltiazem (vidjeti dijelove 4.3 i 4.4).
English: Sexual dysfunction uncommon
Croatian: Seksualna disfunkcija manje često
English: Renal function Cholib is contraindicated in moderate to severe renal impairment (see section 4.3).
Croatian: Bubrežna funkcija Cholib je kontraindiciran kod umjerenog do teškog oštećenja bubrega (vidjeti dio 4.3).
English: • you have kidney disease
Croatian: • ako imate bolest bubrega
English: NA
Croatian: nd
English: TG
Croatian: K
English: Some cases of reversible paradoxical reduction of HDL-C have been reported during concomitant administration of fenofibrate and glitazones.
Croatian: Tijekom istodobne primjene fenofibrata i glitazona, prijavljeno je nekoliko slučajeva reverzibilnog paradoksalnog smanjenja HDL-C-a.
English: The primary efficacy criterion was superiority of the combination fenofibrate 145 and simvastatin 40 mg versus simvastatin 40 mg on TG and LDL-C decrease and HDL-C increase at 12 weeks.
Croatian: Primarni kriterij djelotvornosti bila je superiornost kombincije fenofibrata 145 i simvastatina 40 mg naspram simvastatina 40 mg u snižavanju TG-a i LDL-C-a te povišenju HDL-C-a u 12. tjednu.
English: The primary efficacy criterion was superiority of the combination fenofibrate 145 and simvastatin 20 mg versus simvastatin 40 mg on TG decrease and HDL-C increase and non-inferiority for LDL-C decrease at 12 weeks.
Croatian: Primarni kriterij djelotvornosti bila je superiornost kombinacije fenofibrata 145 i 20 mg simvastatina naspram 40 mg simvastatina u snižavanju TG-a i povišenju HDL-C-a te neinferiornost u snižavanju LDL-C-a u 12. tjednu.
English: In patients taking products containing elbasvir or grazoprevir concomitantly with Cholib the dose of simvastatin should not exceed 20 mg/day.
Croatian: U bolesnika koji istodobno s lijekom Cholib uzimaju lijekove koji sadrže elbasvir ili grazoprevir doza simvastatina ne bi smjela prelaziti 20 mg dnevno. (Vidjeti dijelove 4.4 i 4.5.)
English: Effects on the pharmacokinetics of other medicinal products Fenofibrate and simvastatin are not CYP 3A4 inhibitors or inducers.
Croatian: Fenofibrat i simvastatin nisu inhibitori ni induktori CYP 3A4.
English: Cholib is contraindicated in patients with moderate to severe renal insufficiency whose estimated glomerular filtration rate is < 60 mL/min/1.73 m
Croatian: Cholib je kontraindiciran u bolesnika s umjerenom do teškom insuficijencijom bubrega čija je procijenjena brzina glomerularne filtracije <60 ml/min/1,73 m
English: Adverse reactions observed with the co-administration of fenofibrate and simvastatin (Cholib)
Croatian: Nuspojave opažene kod istodobne primjene fenofibrata i simvastatina (Cholib) Klasifikacija organskih sustava
English: In addition, simvastatin moderately increases HDL-C and reduces plasma TG.
Croatian: Simvastatin, dodatno, umjereno povisuje razine HDL-C-a te snizuje TG u plazmi.
English: Cholib should be used with caution in patients with mild renal insufficiency whose estimated glomerular filtration rate is 60 to 89 mL/min/1.73 m
Croatian: Cholib se mora koristiti s oprezom u bolesnika s blagom insuficijencijom bubrega čija je procijenjena brzina glomerularne filtracije 60 do 89 ml/min/1,73 m
English: Musculoskeletal, connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: • If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression) o amiodarone (a medicine for an irregular heartbeat) or verapamil (a medicine for high blood pressure, chest pain associated with heart disease, or other heart conditions) o hepatitis C antiviral agents such as elbasvir, grazoprevir, glecaprevir or pibrentasvir (used to treat hepatitis C virus infection)
Croatian: • Ako već uzimate sljedeće lijekove:  danazol (sintetski hormon za liječenje endometrioze)  ciklosporin (lijek koji često uzimaju bolesnici s presađenim organom)  itrakonazol, ketokonazol, flukonazol ili posakonazol (lijekovi za gljivične infekcije)  inhibitore proteaze HIV-a kao što su indinavir, nelfinavir, ritonavir i sakvinavir (lijekovi koji se koriste kod HIV-infekcija i AIDS-a)  eritromicin, klaritromicin ili telitromicin (lijekovi za bakterijske infekcije)  nefazodon (lijek za depresiju)  amiodaron (lijek za nepravilne otkucaje srca) ili verapamil (lijek za povišeni krvni tlak, boli u prsima povezana s bolešću srca ili s drugim srčanim tegobama)
English: Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Cholib.
Croatian: Vaš liječnik Vas možda uputi na pretrage krvi radi provjere koliko dobro radi
English: The dose of simvastatin should not exceed 10 mg daily in patients taking danazol.
Croatian: U bolesnika koji uzimaju danazol, doza simvastatina ne smije prijeći 10 mg dnevno.
English: Fibrinogen* (g/L) Feno 145 + Simva 40
Croatian: UK (mmol/l) feno 145 + simva 40 simva 40
English: Potent CYP 3A4 inhibitors:
Croatian: Potentni inhibitori CYP 3A4: Itrakonazol
English: If treatment with fusidic acid is necessary, Cholib treatment should be discontinued throughout the duration of the fusidic acid treatment.
Croatian: Ako je neophodno liječenje fusidatnom kiselinom, liječenje Cholibom mora se prekinuti tijekom trajanja liječenja fusidatnom kiselinom. (također vidjeti dio 4.4).
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving a statin in combination with fusidic acid (see section 4.5).
Croatian: U bolesnika koji su primali statin u kombinaciji s fusidatnom kiselinom (vidjeti dio 4.5) prijavljena je rabdomioliza (uključujući nekoliko smrtnih ishoda).
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu se javiti kod manje od 1 od 100 osoba):
English: Poly (vinyl alcohol), partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), lecithin (derived from soya bean (E322)), xanthan gum (E415), iron oxide red (E172).
Croatian: Djelomično hidroliziran poli(vinilni alkohol) (E1203), titanijev dioksid (E171), talk (E553b), lecitin (iz soje (E322)), ksantanska guma (E415), crveni željezov oksid (E172).
English: There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins.
Croatian: Tijekom ili nakon liječenja nekim statinima vrlo rijetko je prijavljena imunološki posredovana nekrotizirajuća miopatija.
English: The geometric mean ratios and 90% CIs for the comparison of plasma exposure (AUC and AUC(0-t)) to simvastatin after administration of the fixed dose combination Cholib 145 mg/20 mg tablet and after co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were within the 80-125% bioequivalence interval.
Croatian: Omjeri geometrijske sredine i 90%-tni CI-evi za usporedbu izloženosti u plazmi (AUC i AUC(0-t)) simvastatinu nakon primjene tablete fiksne kombinacije doze Choliba 145 mg/20 mg i nakon istodobne primjene odvojenih tableta fenofibrata 145 mg i simvastatina 20 mg kao što je korišteno u kliničkom programu, bili su unutar bioekvivalentnog intervala od 80-125%.
English: Simva 40 Simva 40 Fibrinogen* (g/L) Feno 145 + Simva 40 Simva 40 *Treatment Comparison consists of the difference between the LS-means for Feno 145 + Simva 40 an d Simva 40, as well as the corresponding 95% CI.
Croatian: simva 40 *Usporedba liječenja sastoji se od razlike između srednjih vrijednosti LS za feno 145 + simva 40 i simva 40, kao i odgovarajući 95%-tni CI.
English: Interacting substances
Croatian: Lijekovi s interakcijama
English: Mean Percent Change from Baseline to 12 Weeks Full Analysis Subject Sample
Croatian: Srednja vrijednost postotka promjene nakon 12 tjedna od početne vrijednosti
English: The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax for fenofibric acid, simvastatin and simvastatin acid of the fixed dose combination Cholib 145 mg/40 mg tablet and the co-administration of the separate 145 mg fenofibrate and 40 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval.
Croatian: Omjeri geometrijske sredine i 90%-tni CI-evi za usporedbu AUC, AUC(0-t) i Cmax fenofibrične kiseline, simvastatina i simvastatinske kiseline tablete fiksne kombinacije doze Choliba 145 mg/40 mg i istodobne primjene odvojenih tableta fenofibrata 145 mg i simvastatina 40 mg kao što je korišteno u kliničkom programu, bili su svi unutar bioekvivalentnog intervala od 80-125%.
English: • elbasvir, grazoprevir, glecaprevir or pibrentasvir (used to treat hepatitis C virus infection)erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections)
Croatian: • elbasvir, grazoprevir, glekaprevir ili pibrentasvir (koji se upotrebljavaju za liječenje infekcije virusom hepatitisa C)
English: • colchicine (a medicine used to treat gout).
Croatian: • kolhicin (lijek za liječenje gihta).
English: Poly (vinyl alcohol), partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), lecithin (derived from soya bean (E322)), xanthan gum (E415), iron oxide red (E172), iron oxide yellow (E172), sunset yellow FCF (E110).
Croatian: Djelomično hidroliziran poli(vinilni alkohol) (E1203), titanijev dioksid (E171), talk (E553b), lecitin (iz soje (E322)), ksantanska guma (E415), crveni željezov oksid (E172), žuti željezov oksid (E172), bojilo sunset yellow FCF (E110).
English: The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax of the active metabolites, fenofibric acid and simvastatin acid, of the fixed dose combination Cholib 145 mg/20 mg tablet and the co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval.
Croatian: Omjeri geometrijske sredine i 90%-tni CI-evi za usporedbu AUC, AUC(0-t) i Cmax aktivnih metabolita, fenofibrične kiseline i simvastatinske kiseline, tablete fiksne kombinacije doze Choliba 145 mg/20 mg i nakon istodobne primjene odvojenih tableta fenofibrata 145 mg i simvastatina 20 mg kao što je korišteno u kliničkom programu, bili su svi unutar bioekvivalentnog intervala od 80-125%.
English: The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with simvastatin.
Croatian: Rizik od miopatije i rabdomiolize povećan je kada se istodobno primjenjuje danazol sa simvastatinom.
English: Nervous system disorders Headache uncommon
Croatian: Poremećaji živčanog sustava
English: N Means (SD) Treatment Comparison*
Croatian: Usporedba liječenja* P-vrijednost
English: Dizziness has been reported rarely in post-marketing experience with simvastatin.
Croatian: Nakon stavljanja lijeka u promet, rijetko je prijavljena omagalica.
English: TG (mmol/L)
Croatian: UK (mmol/l)
English: Common side effects (may affect up to 1 in 10 people):
Croatian: Česte nuspojave (mogu se javiti kod manje od 1 od 10 osoba):
English: • Concomitant administration of glecaprevir, pibrentasvir, elbasvir or grazoprevir (see section
Croatian: • Istodobna primjena glekaprevira, pibrentasvira, elbasvira ili grazoprevira (vidjeti dio 4.5)
English: One film-coated tablet contains 145 mg of fenofibrate and 20 mg of simvastatin.
Croatian: Jedna filmom obložena tableta sadrži 145 mg fenofibrata i 20 mg simvastatina.
English: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of ciclosporin with simvastatin.
Croatian: Rizik od miopatije/rabdomiolize povećan je istodobnom primjenom ciklosporina sa simvastatinom.
English: One film-coated tablet contains 145 mg of fenofibrate and 40 mg of simvastatin.
Croatian: Jedna filmom obložena tableta sadrži 145 mg fenofibrata i 40 mg simvastatina.
English: Cholib 145 mg/40 mg tablets fenofibrate/simvastatin
Croatian: Cholib 145 mg/40 mg tablete fenofibrat/simvastatin
English: Cholib 145 mg/20 mg tablets fenofibrate/simvastatin
Croatian: Cholib 145 mg/20 mg tablete fenofibrat/simvastatin
English: Cholib 145 mg/40 mg film-coated tablets
Croatian: Cholib 145 mg/40 mg filmom obložene tablete
English: Cholib 145 mg/20 mg film-coated tablets
Croatian: Cholib 145 mg/20 mg filmom obložene tablete
English: Galepharma Ltd. Tel: +356-21-22 14 22
Croatian: Tel: +356-21-22 14 22
English: Fenofibrate/Simvas tatin in combination
Croatian: Kombinacija fenofibrat / simvastatin
English: The film-coated tablet (tablet) is a, oval, biconvex, brick red coloured 19.3 x 9.3 mm tablet with bevelled edges and the inscription 145/40 on one side and the Abbott logo on the other side.
Croatian: Filmom obložena tableta (tableta) je ovalna, bikonveksna, ciglasto crvena tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/40 na jednoj strani i logotipom
English: The film-coated tablet (tablet) is a, oval, biconvex, tan coloured 19.3 x 9.3 mm tablet with bevelled edges and the inscription 145/20 on one side and the Abbott logo on the other side.
Croatian: Filmom obložena tableta (tableta) je ovalna, bikonveksna, žućkastosmeđa tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/20 na jednoj strani i logotipom
English: Stud y
Croatian: Ispitivanj e
English: Some patients have experienced the following side effects whilst taking Cholib, fenofibrate or simvastatin:
Croatian: Neki bolesnici imali su sljedeće nuspojave dok su uzimali Cholib, fenofibrat ili simvastatin: Vrlo česte nuspojave (mogu se javiti kod više od 1 od 10 osoba):
English: Oval, biconvex, brick red coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/40 on one side and the Abbott logo on the other side.
Croatian: Ovalna, bikonveksna, ciglasto crvena, filmom obložena tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/40 na jednoj strani i logotipom
English: Rash, pruritus, urticaria)
Croatian: Preosjetljivost kože (npr. osip, svrbež, urtikarija)
English: Cholib 145 mg/40 mg film-coated tablets fenofibrate/simvastatin
Croatian: Cholib 145 mg/40 mg filmom obložene tablete fenofibrat/simvastatin
English: % Change Mean (SD)
Croatian: Nakon 12 tjedana Srednja vrijednost (SD) % promjene TG
English: Cholib 145 mg/20 mg film-coated tablets fenofibrate/simvastatin
Croatian: Cholib 145 mg/20 mg filmom obložene tablete fenofibrat/simvastatin
English: There have been reports of myopathy and rhabdomyolysis with the concomitant administration of colchicine and simvastatin in patients with renal insufficiency.
Croatian: U bolesnika s insuficijancijom bubrega, pri istodobnoj primjeni kolhicina i simvastatina prijavljene su miopatija i rabdomioliza.
English: Immune system disorders Hypersensitivity rare
Croatian: Poremećaji imunološkog sustava
English: Each tablet contains 145 mg of fenofibrate and 20 mg of simvastatin
Croatian: Jedna tableta sadrži 145 mg fenofibrata i 20 mg simvastatina
English: Each tablet contains 145 mg of fenofibrate and 40 mg of simvastatin
Croatian: Jedna tableta sadrži 145 mg fenofibrata i 40 mg simvastatina
English: • Renal impairment
Croatian: • osjećaj omaglice
English: Each tablet contains 145 mg of fenofibrate and 20 mg of simvastatin.
Croatian: Jedna tableta sadrži 145 mg fenofibrata i 20 mg simvastatina.
English: Blood urea increased rare
Croatian: Povišenje ureje u krvi rijetko
English: • increase in “urea” - produced by the kidneys - shown in tests
Croatian: • povišenje “ureje” - koju stvaraju bubrezi - vidljivo u pretragama
English: Each tablet contains 145 mg of fenofibrate and 40 mg of simvastatin.
Croatian: Jedna tableta sadrži 145 mg fenofibrata i 40 mg simvastatina.
English: Hepatobiliary disorders Transaminases increased common
Croatian: Povišene transaminaze često
English: Oval, biconvex, tan coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/20 on one side and the Abbott logo on the other side.
Croatian: Ovalna, bikonveksna, žućkastosmeđa, filmom obložena tableta veličine 19,3 x 9,3 mm s kosim rubovima i oznakom 145/20 na jednoj strani i logotipom
English: Mylan Healthcare B.V. Tel: +31 (0)20 426 33 00
Croatian: Mylan Hrvatska d.o.o. Tel: + 385 (0)1 2350 599
English: Lecithin (derived from soya bean (E322)) Xanthan gum (E415) Iron oxide red (E172) Iron oxide yellow (E172) Sunset yellow FCF (E110)
Croatian: poli(vinilni alkohol), djelomično hidroliziran (E1203) titanijev dioksid (E171) talk (E553b) lecitin (iz soje (E322)) ksantanska guma (E415) željezov oksid, crveni (E172) željezov oksid, žuti (E172) sunset yellow FCF (E110)
English: Parameter
Croatian: BROJEVI
English: ANNEX III
Croatian: 13. BROJ SERIJE
English: Rhabdomyolysis with or without renal failure (see section 4.4),
Croatian: Rabdomioliza sa ili bez zatajenja bubrega (vidjeti rijetko
English: LIST OF EXCIPIENTS
Croatian: Potpuna analiza uzorka ispitanika
English: Brilique ticagrelor
Croatian: Brilique tikagrelor
English: They should take Brilique for a year unless the doctor asks them to stop it earlier.
Croatian: Takvi bolesnici trebaju uzimati Brilique godinu dana ako liječnik od njih ne zatraži da ranije prekine terapiju.
English: It is available as tablets (60 and 90 mg).
Croatian: Dostupan je u obliku tableta (60 i 90 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Brilique on 3 December 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Brilique na snazi u Europskoj uniji od 3. prosinca 2010.
English: The doctor may, for health reasons, tell them not to take aspirin.
Croatian: Liječnik može propisati da ne uzimaju aspirin iz zdravstvenih razloga.
English: It must also not be used in patients taking other medicines which have a strong blocking effect on one of the liver enzymes (CYP3A4).
Croatian: Ne smije se također primjenjivati u bolesnika koji uzimaju druge lijekove koji imaju znatan blokirajući utjecaj na jedan od jetrenih enzima (CYP3A4).
English: Other information about Brilique
Croatian: Ostale informacije o lijeku Brilique
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom taking Brilique should also be taking aspirin as directed by their doctor.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom je propisao liječnik.
English: What is Brilique?
Croatian: Što je Brilique?
English: What is the risk associated with Brilique?
Croatian: Koji su rizici povezani s lijekom Brilique?