FrancophonIA/ELRC3.0 huggingface dataset:
English: (3 h), days 1-4; Mitoxantrone 10 mg/m2 i.v.
Croatian: Ara-C 1000 mg/m2/12 h i.v.(3 h), dani 1-4; Mitoksantron 10 mg/m2 i.v. dani 3-5;
English: Imatinib Teva B.V. 100 mg film-coated tablets are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Croatian: 100 mg filmom obložene tablete dostupne su u veličinama pakovanja od 20x1, 60x1, 120x1 ili 180x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
English: See section 4.
Croatian: randomizirano ispitivanje faze II.
English: Traces of the dissolved tablets may be left behind in the glass.
Croatian: Ostatke otopljenih tableta možete
English: Hypertension, haematoma, subdural haematoma, peripheral coldness,
Croatian: Crvenilo uz osjećaj vrućine, hemoragija Hipertenzija, hematom, subduralni hematom, periferna hladnoća, hipotenzija,
English: MTX 1.5 g/m2 i.v.
Croatian: MTX 1,5 g/m2 i.v. (24 h), dan 1;
English: Methotrexate (5 g/m2 over 24 hours, IV): day 1
Croatian: MTX (5 g/m2 kroz 24 sata, i.v.): dan 1
English: CP 500 mg/m2 i.v.
Croatian: CP 500 mg/m2 i.v.(1 h) dan 1;
English: CP 1.2 g/m2 i.v.
Croatian: CP 1,2 g/m2 i.v. (3 h), dan 1;
English: If your daily dose is 800 mg (2 capsules), you should take one capsule in the morning and a
Croatian: Ako Vaša dnevna doza iznosi 800 mg (2 kapsule), trebate uzimati jednu kapsulu ujutro i drugu kapsulu navečer.
English: then resume treatment at 200 mg/m2.
Croatian: 200 mg/m2.
English: Imatinib Teva B.V. 100 mg film-coated tablets are available in pack sizes of 60 or 120 film-coated tablets in blisters.
Croatian: 100 mg filmom obložene tablete dostupne su u veličinama pakiranja od 60 ili 120 filmom obloženih tableta u blisterima.
English: In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Croatian: om je liječeno imatinibom u dozi od 100 mg do 1000 mg na dan.
English: (1 h), days 1-3; Vincristine 1.3 mg/m2 i.v., days 1, 8, 15, 21;
Croatian: Daunorubicin 60 mg/m2 i.v. (1 h), dani 1-3; Vinkristin 1,3 mg/m2 i.v., dani 1, 8, 15, 21; Prednizolon 60 mg/m2/dan peroralno
English: • Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
Croatian: omaglica ili nesvjestica zbog sniženog krvnog tlaka (znakovi problema s jajnicima ili
English: Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Croatian: Iritacija oka, bol u oku, orbitalni edem, krvarenje bjeloočnice, krvarenje mrežnice, blefaritis, makularni edem
English: G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44
Croatian: G-CSF (5 μg/kg, s.c.): dani 27-36 ili do porasta ANC >1500 nakon
English: The starting dose is 400 mg, to be taken as one tablet once a day.
Croatian: Početna doza je 400 mg, koja se uzima kao jedna tableta jednom na dan.
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one capsule of 400 mg once a day, depending on how you respond to treatment.
Croatian: Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao jedna kapsula jednom na dan.
English: Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended as
Croatian: U slučaju teške neutropenije i trombocitopenije preporučuje se dozu smanjiti ili prekinuti liječenje,
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day, depending on how you respond to treatment.
Croatian: Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, koja se uzima kao jedna tableta jednom na dan.
English: Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Croatian: Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati x 6 doza) iii: dani 2 i 3
English: Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP) Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and
Croatian: Sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS)* Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 400 mg film-coated tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU imatinib teva b.v. 400 mg filmom obložene tablete
English: - Each film-coated tablet of Imatinib Teva B.V. contains 100 mg imatinib (as mesilate).
Croatian: - Jedna filmom obložena tableta Imatiniba Teva B.V. sadrži 100 mg imatiniba (u obliku
English: Hyperbilirubinaemia, hepatitis, jaundice
Croatian: Hiperbilirubinemija, hepatitis, žutica Zatajenje jetre8, nekroza jetre
English: Figure 1 Kaplan-Meier estimates for primary recurrence-free survival endpoint (ITT
Croatian: Kaplan-Meierova procjena preživljenja bez recidiva bolesti kao primarnog
English: G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
Croatian: G-CSF (5 μg/kg, s.c.): dani 5-14 ili do porasta ANC >1500 nakon
English: Teva Italia S.r.l.
Croatian: Teva Pharma, S.L.U.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5;
Croatian: CP 200 mg/m2 i.v., dani 3, 4, 5;
English: The starting dose is 400 mg, to be taken as one capsule once a day.
Croatian: Početna doza je 400 mg, koja se uzima kao jedna kapsula jednom na dan.
English: • Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva B.V. or after you have stopped taking Imatinib Teva B.V.
Croatian: • Grčevi u mišićima ili bol u zglobovima, mišićima ili kostima, tijekom liječenja Imatinibom
English: The recommended dose of Imatinib Teva B.V. is 400 mg/day for adult patients with MDS/MPD.
Croatian: Za odrasle bolesnike s MDS/MPD-om preporučena doza Imatiniba Teva B.V. iznosi 400 mg/dan.
English: Maintenance
Croatian: Dojenje
English: The recommended dose of Imatinib Teva B.V. is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST.
Croatian: Za adjuvantno liječenje odraslih bolesnika nakon resekcije GIST-a preporučena doza Imatiniba Teva B.V. iznosi 400 mg/dan.
English: monthly for 13 months;
Croatian: 9 mjeseci.
English: The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients with Ph+ ALL.
Croatian: Za odrasle bolesnike s Ph+ ALL-om preporučena doza Imatiniba Teva B.V. iznosi 600 mg/dan.
English: This is because Imatinib Teva B.V.
Croatian: Kako uzimati Imatinib Teva B.V.
English: In the event of recurrence of ANC < 1.0 x 109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Croatian: 3. U slučaju da je ABN ponovno <1,0 x 109/l i/ili trombociti <50 x 109/l, treba ponoviti 1. korak i zatim nastaviti imatinib u smanjenoj dozi od 400 mg.
English: One open label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Croatian: Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) za ispitivanje imatiniba u raznim populacijama bolesnika koji pate od životno ugrožavajućih bolesti povezanih s
English: Imatinib Teva B.V. 400 mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blisters.
Croatian: 400 mg filmom obložene tablete dostupne su u veličinama pakiranja od 30 ili 90 filmom obloženih tableta u blisterima.
English: Imatinib Teva B.V. 100 mg hard capsules are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Croatian: 100 mg tvrde kapsule dostupne su u veličinama pakiranja od 20x1, 60x1, 120x1 ili 180x1 tvrdih kapsula u perforiranim blisterima djeljivim na jedinične doze.
English: • Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle
Croatian: • Grčevi mišića s vrućicom, crveno-smeđe obojena mokraća, bol ili slabost mišića (znakovi • Bol u zdjelici ponekad s mučninom i povraćanjem te neočekivanim krvarenjem iz rodnice,
English: MTX (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Croatian: MTX (5 g/m2 kroz 24 sata, i.v.): dan 1 Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati x 6 doza) iii: dani 2 i 3
English: G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2
Croatian: G-CSF = faktor stimulacije rasta granulocita, VP-16 = etoposid, MTX = metotreksat, i.v. = intravenski, SC = potkožno, i.t.
English: If any of these apply to you, tell your doctor before taking Imatinib Teva B.V.
Croatian: Obratite se svom liječniku prije nego uzmete Imatinib Teva B.V.:
English: Imatinib Teva B.V. 100 mg film-coated tablets Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Croatian: 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
English: ANC < 1.0 x 109/l and/or platelets < 50 x 109/l
Croatian: <1,0 x109/l i/ili trombociti
English: Imatinib Teva B.V. 100 mg film-coated tablets
Croatian: 100 mg filmom obložene tablete imatinib
English: • Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet derived growth factor receptor (PDGFR) gene re-arrangements.
Croatian: • Odraslih bolesnika s mijelodisplastičnim/mijeloproliferativnim bolestima (MDS/MPB)
English: (0.5 h), days 7, 8, 14, 15;
Croatian: IDA 8 mg/m2 i.v. (0,5 h), dani 7, 8, 14, 15;
English: Clinical studies in unresectable and/or metastatic GIST
Croatian: U ispitivanju kod bolesnika s inoperabilnim i/ili metastazirajućim GIST-om, u 7 (5%)
English: Imatinib Teva B.V. 400 mg film-coated tablets Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Croatian: 400 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
English: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Croatian: Metotreksat (5 g/m2 kroz 24 sata, i.v.): dan 1 Leucovorin (75 mg/m2 u 36. satu, i.v.; 15 mg/m2 i.v. ili p.o. svakih 6 sati
English: Imatinib Teva B.V. 400 mg film-coated tablets
Croatian: 400 mg filmom obložene tablete Imatinib
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4
Croatian: CPM (250 mg/m2/doza svakih 12 sati x 4 doze, i.v.): dani 3 i 4 PEG-ASP (2500 IU/m2, i.m.): dan 4
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Croatian: • Mučnina, nedostatak zraka, nepravilni otkucaji srca, zamućenje mokraće, umor i/ili osjećaj nelagode u zglobovima udruženi s poremećenim nalazima laboratorijskih pretraga (npr. visoke razine kalija, mokraćne kiseline i kalcija te niske razine fosfora u krvi).
English: Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Croatian: Indukcijsko-konsolidacijska terapija Hiper-CVAD režim: CP 300 mg/m2 i.v. (3 h, svakih 12 h), dani 1-3;
English: Triple IT therapy (age-adjusted): days 1 and 22 VP-16 (100 mg/m2/day, IV): days 22-26
Croatian: Metotreksat (20 mg/m2/tjedan, p.o.): dani 8, 15, 22 VP-16 (100 mg/m2, i.v.): dani 29-33
English: Therefore, caution should be exercised in patients with cardiac
Croatian: Zbog toga se u bolesnika s poremećenom srčanom funkcijom mora postupati s oprezom.
English: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis,
Croatian: melena, ezofagitis, ascites, želučani ulkus, hematemeza, heilitis, disfagija,
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
Croatian: Neutropenija, trombocitopenija, anemija Pancitopenija, febrilna neutropenija Trombocitemija, limfopenija, depresija koštane srži, eozinofilija,
English: Prephase
Croatian: Kod prvih
English: Absorption
Croatian: Plodnost
English: This will help protect you from stomach problems when
Croatian: To će Vam pomoći u zaštiti od želučanih problema prilikom uzimanja Imatiniba Teva B.V.
English: 2/day, PO): days 1-7 and 15-21
Croatian: 2/dan, i.v.): dani 1, 8 i 15
English: Ara-C 75 mg/m2 i.v.
Croatian: Ara-C 75 mg/m2 i.v. (1 h), dani 1-5;
English: A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
Croatian: Veliki odgovor je kombinacija potpunih i djelomičnih odgovora: potpuni (0% Ph+ metafaza), 3 Potpuni citogenetski odgovor potvrđen drugom citogenetskom procjenom koštane srži koja je provedena najmanje jedan mjesec nakon početnog ispitivanja koštane srži.
English: Etoposide 250 mg/m2 i.v.
Croatian: Etopozid 250 mg/m2 i.v. (1 h) dani 4-5;
English: Italia
Croatian: España
English: Tumour lysis syndrome
Croatian: Mijeloična blastična kriza
English: Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m2 i.v.
Croatian: Vinkristin 2 mg i.v., dani 4, 11;
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg hard capsules Imatinib Teva B.V. 400 mg hard capsules
Croatian: 100 mg tvrde kapsule Imatinib Teva B.V.
English: Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Croatian: 400 mg tvrde kapsule dostupne su u veličinama pakiranja od 30x1 ili 180x1 tvrdih kapsula u perforiranim blisterima s jediničnim dozama.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3-5;
Croatian: CP 200 mg/m2 i.v., dani 3-5;
English: At the time of the original analysis, three of the four patients with detected
Croatian: U tom kliničkom ispitivanju, 14 bolesnika s HES/KEL
English: Colitis, ileus, inflammatory bowel disease
Croatian: Kolitis, ileus, upalna bolest crijeva Ileus/intestinalna opstrukcija*, gastrointestinalna perforacija*,
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg film-coated tablets Imatinib Teva B.V. 400 mg film-coated tablets
Croatian: 100 mg filmom obložene tablete Imatinib Teva B.V.
English: What Imatinib Teva B.V. looks like and contents of the pack Imatinib Teva B.V. 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Croatian: 400 mg filmom obložene tablete su tamnožute do smećkasto narančaste okrugle filmom obložene tablete s urezom na jednoj strani.
English: The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients in blast crisis.
Croatian: Za odrasle bolesnike u blastičnoj krizi preporučena doza Imatiniba Teva B.V. iznosi 600 mg/dan.
English: The recommended dose of Imatinib Teva B.V. is 100 mg/day for adult patients with HES/CEL.
Croatian: Za odrasle bolesnike s HES/KEL-om preporučena doza Imatiniba Teva B.V. iznosi 100 mg/dan.
English: (24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20 Consolidation therapy II, IV Ara-C 75 mg/m2 i.v.
Croatian: Konsolidacijska terapija I, III, V MTX 500 mg/m2 i.v. (24 h), dani 1, 15; 6-MP 25 mg/m2 peroralno, dani 1-20
English: What you need to know before you take Imatinib Teva B.V. Imatinib Teva B.V. will only be prescribed to you by a doctor with experience in medicines to treat blood
Croatian: Što je Imatinib Teva B.V. i za što se koristi Imatinib Teva B.V. je lijek koji sadrži djelatnu tvar zvanu imatinib.
English: 100 vs. 100 97.8 vs. 100
Croatian: 64,0 80,7 vs. 46,6 NP
English: Teva Nederland B.V. Tel: +31 800 0228 400
Croatian: Pliva Hrvatska d.o.o. Tel: +385 1 37 20 000
English: G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir VCR (1.5 mg/m2/day, IV): days 1, 8, and 15
Croatian: ARA-C (3 g/m2/doza svakih 12 sati x 4, i.v.): dani 2 i 3 G-CSF (5 μg/kg, s.c.): dani 4-13 ili do porasta ANC >1500 nakon
English: Insomnia
Croatian: Imatinib Teva
English: Posology for CML in children
Croatian: Doziranje za KML u odraslih bolesnika
English: Bilirubin
Croatian: Nuspojave
English: RFS rates (%) 12 month 24 month Imatinib vs placebo
Croatian: -- (1) Imatinib 12 mj.:
English: Imatinib Teva B.V. 400 mg film-coated tablets are available in pack sizes of 30x1or 90x1 film-coated tablets
Croatian: 400 mg filmom obložene tablete dostupne su u veličinama pakiranja od 30x1 ili 90x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
English: Package leaflet: Information for the patient Imatinib Teva B.V. 400 mg film-coated tablets Imatinib
Croatian: Uputa o lijeku: Informacije za bolesnika Imatinib Teva B.V.
English: GIST.
Croatian: Norge
English: Confusional state Nervous system disorders Very common:
Croatian: Poremećaji reproduktivnog sustava i dojki Manje često
English: See section 4
Croatian: Studija ADE04
English: • Anaemia (low number of red blood cells).
Croatian: • anemija (nizak broj crvenih krvnih stanica).
English: • Feeling weak or lack of energy (asthenia).
Croatian: • slabost ili nedostatak energije (astenija).
English: You will take Exviera for either 12 or 24 weeks.
Croatian: Lijek Exviera uzimat ćete tijekom 12 ili 24 tjedna.
English: • More than 6 hours until your next dose - take the missed dose with food as soon as possible.
Croatian: • više od 6 sati do sljedeće doze - uzmite propuštenu dozu s hranom što je prije moguće.
English: Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
English: What Exviera is and what it is used for 2.
Croatian: Što je Exviera i za što se koristi 2.
English: Hepatitis B Virus Reactivation)
Croatian: Reaktivacija virusa hepatitisa B
English: Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX16 Mechanism of action
Croatian: Farmakoterapijska skupina: Antivirotici za sistemsku uporabu; antivirotici koji djeluju izravno, ATK oznaka: J05AX16
English: Table 15 shows SVR rates for these subjects.
Croatian: U Tablici 15 prikazane su stope SVR-a za te ispitanike.
English: There are some medicines you must not take with Exviera - see the previous table “Medicines you must not take with Exviera”.
Croatian: Postoje određeni lijekovi koje ne smijete uzimati s lijekom Exviera - pogledajte prethodnu tablicu 'Lijekovi koje ne smijete uzimati s lijekom Exviera'.
English: NS5A M28T M28V
Croatian: NS5A M28T M28Ve
English: The recommended dose of dasabuvir is 250 mg (one tablet) twice daily (morning and evening).
Croatian: Preporučena doza dasabuvira je 250 mg (jedna tableta) dvaput na dan (ujutro i navečer).
English: Changes for dasabuvir and ombitasvir, paritaprevir are the same as shown for paracetamol above
Croatian: Promjene za dasabuvir i ombitasvir, paritaprevir su iste kao što je prikazano iznad za paracetamol
English: 5 of 6 subjects with compensated cirrhosis in each arm achieved SVR12.
Croatian: Pet od 6 ispitanika s kompenziranom cirozom u svakoj skupini ostvarilo je SVR12.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Exviera, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Croatian: Kako bi se procijenilo ponovno pojavljivanje hepatocelularnog karcinoma povezanog s primjenom lijeka Exviera, nositelj odobrenja mora provesti i dostaviti rezultate prospektivnog ispitivanja sigurnosti, koristeći podatake koji proizlaze iz kohorte dobro definirane skupine bolesnika, na temelju dogovorenog protokola.
English: Exviera film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blister packs.
Croatian: Exviera filmom obložene tablete dostupne su u blister pakiranjima od PVC/PE/PCTFE aluminijske folije.
English: 67061 Ludwigshafen GERMANY
Croatian: 67061 Ludwigshafen
English: Q30R
Croatian: Q30Re
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcije glukoze i galaktoze ne smiju uzimati ovaj lijek.
English: Drug interaction studies have only been performed in adults.
Croatian: Pedijatrijska populacija Ispitivanja interakcija provedena su samo u odraslih.
English: Exviera must not be administered as monotherapy.
Croatian: Exviera se ne smije uzimati kao monoterapija.
English: If more than 6 hours have passed since Exviera is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule.
Croatian: Ako je prošlo više od 6 sati od uobičajenog vremena uzimanja doze lijeka Exviera, propuštena doza se NE smije uzeti nego bolesnik mora nastaviti sa sljedećom dozom prema uobičajenom rasporedu doziranja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/983/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/983/001
English: It is very important that you also read the package leaflets for the other antiviral medicines that you take with Exviera.
Croatian: Vrlo je važno da pročitate i Upute o lijeku za druge antivirusne lijekove koje uzimate s lijekom Exviera.
English: 800 mg once daily (given at the same time)
Croatian: 800 mg jedanput na dan (primjenjen u isto vrijeme)
English: It contains the active substance dasabuvir.
Croatian: Sadrži djelatnu tvar dasabuvir.
English: Treated subjects had a median age of 51 years (range: 26 to 64); 65.8% were male and 5.3% were Black.
Croatian: Medijan dobi liječenih ispitanika iznosio je 51 godinu (raspon: 26 - 64 godine); 65,8% bili su muškaraci, a 5,3% crnci.
English: What you need to know before you take Exviera 3.
Croatian: Što morate znati prije nego počnete uzimati lijek Exviera 3.
English: The safety and efficacy of dasabuvir in children below 18 years have not been established.
Croatian: Sigurnost i djelotvornost dasabuvira u djece mlađe od 18 godina nisu ustanovljene.
English: Because of the potential for adverse reactions from the medicinal product in breastfed infants, a decision must be made whether to discontinue breastfeeding or discontinue treatment with Exviera, taking into account the importance of the therapy to the mother.
Croatian: Budući da lijek može uzrokovati nuspojave u dojenčadi, mora se donijeti odluka hoće li se prekinuti dojenje ili obustaviti liječenje lijekom Exviera, uzimajući u obzir važnost terapije za majku.
English: carbamaze pine 10, 11epoxide dasabuvir
Croatian: karbamazepin 10, 11epoksid dasabuvir
English: • If you have severe liver problems other than hepatitis C.
Croatian: • ako osim hepatitisa C imate druge ozbiljne jetrene tegobe
English: 67061 Ludwigshafen Germany
Croatian: 67061 Ludwigshafen,
English: Contraceptive medicines that contains ethinylestradiol cannot be used in combination with Exviera.
Croatian: Kontraceptivi koji sadrže etinilestradiol ne smiju se uzimati u kombinaciji s lijekom Exviera.
English: R155K D168A D168V
Croatian: I132Vc R155K D168A D168V
English: 5 mg single dose and other vitamin K antagonists
Croatian: 5 mg pojedinačna doza i drugi antagonisti vitamina
English: As a precautionary measure, it is preferable to avoid the use of Exviera during pregnancy.
Croatian: Kao mjeru opreza poželjno je izbjegavati primjenu lijeka Exviera u trudnoći.