FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE granules that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE granules).
Croatian: U bolesnika u kojih je dobra regulacija već postignuta liječenjem deferoksaminom početna doza EXJADE granula može iznositi trećinu brojčane vrijednosti doze deferoksamina (npr. bolesnik koji prima 40 mg/kg/dan deferoksamina tijekom 5 dana na tjedan (ili ekvivalentno), može se prebaciti na početnu dnevnu dozu EXJADE granula od 14 mg/kg/dan).
English: • Kidney stones
Croatian: • Bubrežni kamenci
English: For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE film-coated tablets that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE film-coated tablets).
Croatian: U bolesnika u kojih je dobra regulacija već postignuta liječenjem deferoksaminom početna doza EXJADE filmom obloženih tableta može iznositi trećinu brojčane vrijednosti doze deferoksamina (npr. bolesnik koji prima 40 mg/kg/dan deferoksamina tijekom 5 dana na tjedan (ili ekvivalentno), može se prebaciti na početnu dnevnu dozu EXJADE filmom obloženih tableta od 14 mg/kg/dan).
English: • EXJADE 500 mg tablets are stamped “J 500” on one side and “NVR” on the other.
Croatian: • EXJADE 500 mg tablete na jednoj strani imaju otisnutu oznaku „J 500“, a na drugoj strani
English: EXJADE 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox.
Croatian: EXJADE 180 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 180 mg deferasiroksa.
English: OUTER CARTON OF MULTIPACK (including blue box)
Croatian: KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Croatian: KUTIJA VIŠESTRUKOG PAKIRANJA (uključujući plavi okvir)
English: While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with granule doses above 21 mg/kg cannot be excluded.
Croatian: Premda u kliničkim ispitivanjima nije bilo opaženo povećanje bubrežnih štetnih događaja nakon postupnog povećavanja doza EXJADE tableta za oralnu suspenziju iznad 30 mg/kg, ne može se isključiti povećani rizik bubrežnih štetnih događaja uz granule u dozama iznad 21 mg/kg.
English: Starting dose The recommended initial daily dose of EXJADE dispersible tablets is 20 mg/kg body weight.
Croatian: Početna doza Preporučena početna dnevna doza EXJADE tableta za oralnu suspenziju je 20 mg/kg tjelesne težine.
English: EXJADE 180 mg granules Each sachet contains 180 mg deferasirox.
Croatian: EXJADE 180 mg granule Svaka vrećica sadrži 180 mg deferasiroksa.
English: EXJADE 90 mg granules EU/1/06/356/020
Croatian: EXJADE 90 mg granule EU/1/06/356/020
English: Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 360 on the other).
Croatian: Tamno plava, ovalna, bikonveksna filmom obložena tableta ukošenih rubova s otisnutim oznakama (NVR na jednoj strani i 360 na drugoj strani).
English: EXJADE 360 mg granules Each sachet contains 360 mg deferasirox.
Croatian: EXJADE 360 mg granule Svaka vrećica sadrži 360 mg deferasiroksa.
English: While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with EXJADE dispersible tablet doses above 30 mg/kg cannot be excluded.
Croatian: Premda u kliničkim ispitivanjima nije bilo opaženo povećanje bubrežnih štetnih događaja nakon postupnog povećavanja doza EXJADE tableta za oralnu suspenziju iznad 30 mg/kg, ne može se isključiti povećani rizik bubrežnih štetnih događaja uz EXJADE tablete za oralnu suspenziju u dozama iznad 30 mg/kg.
English: EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
Croatian: EXJADE granule pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka EXJADE u obliku tableta za oralnu suspenziju.
English: EXJADE 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox.
Croatian: EXJADE 90 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 90 mg deferasiroksa.
English: • Each sachet of EXJADE 180 mg granules contains 180 mg deferasirox.
Croatian: • Svaka vrećica EXJADE 180 mg granula sadrži 180 mg deferasiroksa.
English: EXJADE 90 mg granules Each sachet contains 90 mg deferasirox.
Croatian: EXJADE 90 mg granule Svaka vrećica sadrži 90 mg deferasiroksa.
English: • Each sachet of EXJADE 360 mg granules contains 360 mg deferasirox.
Croatian: • Svaka vrećica EXJADE 360 mg granula sadrži 360 mg deferasiroksa.
English: <7 mg Fe/g dw or ≤2,000 µg/l
Croatian: <7 mg Fe/g težine ili
English: How to store EXJADE
Croatian: Kako čuvati EXJADE
English: Exjade 360 mg film-coated tablets deferasirox
Croatian: Exjade 360 mg filmom obložene tablete deferasiroks
English: Anxiety, sleep disorder
Croatian: anksioznost, poremećaj spavanja Poremećaji živčanog sustava Često:
English: Breast-feeding while taking EXJADE is not recommended.
Croatian: Tijekom primjene lijeka EXJADE ne preporučuje se dojenje.
English: Not all strengths may be available in your country.
Croatian: Na tržištu se ne moraju nalaziti sve jačine lijeka.
English: Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children and adolescents, receiving deferasirox.
Croatian: U bolesnika koji primaju deferasiroks, uključujući djecu i adolescente, prijavljene su ulceracije i
English: Exjade 180 mg film-coated tablets deferasirox
Croatian: Exjade 180 mg filmom obložene tablete deferasiroks
English: Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other).
Croatian: Svijetlo plava, ovalna, bikonveksna filmom obložena tableta ukošenih rubova s otisnutim oznakama (NVR na jednoj strani i 90 na drugoj strani).
English: The recommended initial daily dose of EXJADE film-coated tablets in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Croatian: Preporučena početna dnevna doza EXJADE filmom obloženih tableta u bolesnika sa sindromima talasemije neovisnim o transfuziji je 7 mg/kg tjelesne težine.
English: • Each sachet of EXJADE 90 mg granules contains 90 mg deferasirox.
Croatian: • Svaka vrećica EXJADE 90 mg granula sadrži 90 mg deferasiroksa.
English: EXJADE 125 mg dispersible tablets Each dispersible tablet contains 125 mg deferasirox.
Croatian: EXJADE 125 mg tablete za oralnu suspenziju Svaka tableta za oralnu suspenziju sadrži 125 mg deferasiroksa.
English: Nervous system disorders Common:
Croatian: Poremećaji probavnog sustava Često:
English: Gastrointestinal perforation 1, acute pancreatitis
Croatian: 1, akutni pankreatitis
English: EU/1/06/356/022 30 sachets
Croatian: EU/1/06/356/022 30 vrećica
English: Exjade 360 mg granules in sachet deferasirox
Croatian: Exjade 360 mg granule u vrećici deferasiroks
English: Exjade 180 mg granules in sachet deferasirox
Croatian: Exjade 180 mg granule u vrećici deferasiroks
English: Each dispersible tablet contains 125 mg of deferasirox.
Croatian: Svaka tableta za oralnu suspenziju sadrži 125 mg deferasiroksa.
English: As well as the requirements in the legislation, the following serious ADRs should be forwarded on an expedited basis to the appropriate competent authority as well as summarised in the above reports: o Increase in hepatic enzymes >10x ULN o Serious rise in creatinine o Results of renal biopsies, if available o Cataracts o Hearing loss o Gallstones
Croatian: o povišenje jetrenih enzima >10x GGN o ozbiljan porast kreatinina o rezultati biopsije bubrega, ako su dostupni o katarakte o gubitak sluha o žučni kamenci
English: The recommended initial daily dose of EXJADE granules in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Croatian: Preporučena početna dnevna doza EXJADE granula u bolesnika sa sindromima talasemije neovisnim o transfuziji je 7 mg/kg tjelesne težine.
English: Excipient with known effect: Each dispersible tablet contains 272 mg lactose.
Croatian: Svaka tableta za oralnu suspenziju sadrži 272 mg laktoze.
English: The recommended initial daily dose of EXJADE dispersible tablets in patients with non-transfusion-dependent thalassaemia syndromes is 10 mg/kg body weight.
Croatian: Preporučena početna dnevna doza EXJADE tableta za oralnu suspenziju u bolesnika sa sindromima talasemije neovisnim o transfuziji je 10 mg/kg tjelesne težine.
English: Each tablet contains 360 mg of deferasirox.
Croatian: Svaka tableta sadrži 360 mg deferasiroksa.
English: 10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l
Croatian: 10 mg/kg/dan ≥5 mg Fe/g težine suhog tkiva jetre ili
English: Multipack: 300 (10 packs of 30) film-coated tablets
Croatian: Filmom obložene tablete Višestruko pakiranje: 300 (10 pakiranja od 30) filmom obloženih tableta
English: Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, respectively.
Croatian: Zbog stvaranja pjene i sporog suspendiranja, ne preporučuje se priprema suspenzije u gaziranim napicima ni u mlijeku.
English: Exjade 90 mg film-coated tablets deferasirox
Croatian: Exjade 90 mg filmom obložene tablete deferasiroks
English: EXJADE 250 mg dispersible tablets Each dispersible tablet contains 250 mg deferasirox.
Croatian: EXJADE 250 mg tablete za oralnu suspenziju Svaka tableta za oralnu suspenziju sadrži 250 mg deferasiroksa.
English: EXJADE 125 mg dispersible tablets
Croatian: EXJADE 125 mg tablete za oralnu suspenziju
English: A food-effect study involving administration of the granules to healthy volunteers under fasting conditions and with a low-fat (fat content = approximately 30% of calories) or high-fat (fat content >50% of calories) meal indicated that the AUC and Cmax were slightly decreased after a low-fat meal (by 10% and 11%, respectively).
Croatian: = približno 30% kalorija) ili punomasni (sadržaj masti >50% kalorija) obrok ukazalo je na to da su AUC i Cmax bili blago povišeni nakon nemasnog obroka (za 10% odnosno 11%).
English: EXJADE 250 mg dispersible tablets
Croatian: EXJADE 250 mg tablete za oralnu suspenziju
English: EU/1/06/356/020 30 sachets
Croatian: EU/1/06/356/020 30 vrećica
English: EXJADE 125 mg dispersible tablets deferasirox
Croatian: EXJADE 125 mg tablete za oralnu suspenziju deferasiroks
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other).
Croatian: Bijele do žućkaste, okrugle, plosnate tablete ukošenih rubova s otisnutim oznakama (NVR na jednoj strani i J 500 na drugoj strani).
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).
Croatian: Bijele do žućkaste, okrugle, plosnate tablete ukošenih rubova s otisnutim oznakama (NVR na jednoj strani i J 125 na drugoj strani).
English: Excipient with known effect: Each dispersible tablet contains 136 mg lactose.
Croatian: Svaka tableta za oralnu suspenziju sadrži 136 mg laktoze.
English: An initial daily dose of 7 mg/kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells (approximately <2 units/month for an adult).
Croatian: Početna dnevna doza od 7 mg/kg može se razmotriti u bolesnika u kojih ne treba snižavati razine željeza u tijelu, a koji također primaju manje od 7 ml/kg/mjesec koncentrata eritrocita (približno <2 jedinice/mjesec za odraslog).
English: EXJADE 500 mg dispersible tablets Each dispersible tablet contains 500 mg deferasirox.
Croatian: EXJADE 500 mg tablete za oralnu suspenziju Svaka tableta za oralnu suspenziju sadrži 500 mg deferasiroksa.
English: EXJADE 125 mg dispersible tablets EU/1/06/356/001
Croatian: EXJADE 125 mg tablete za oralnu suspenziju EU/1/06/356/001
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).
Croatian: Bijele do žućkaste, okrugle, plosnate tablete ukošenih rubova s otisnutim oznakama (NVR na jednoj strani i J 250 na drugoj strani).
English: EXJADE 500 mg dispersible tablets EU/1/06/356/005
Croatian: EXJADE 500 mg tablete za oralnu suspenziju EU/1/06/356/005
English: Each tablet contains 180 mg of deferasirox.
Croatian: Svaka tableta sadrži 180 mg deferasiroksa.
English: Dispersible tablets
Croatian: Tablete za oralnu suspenziju
English: 30 mg/kg/day
Croatian: 30 mg/kg/dan
English: EU/1/06/356/021 30 sachets
Croatian: EU/1/06/356/021 30 vrećica
English: An initial daily dose of 21 mg/kg may be considered for patients who require reduction of elevated body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells (approximately >4 units/month for an adult).
Croatian: Početna dnevna doza od 21 mg/kg može se razmotriti u bolesnika u kojih treba sniziti povišene razine željeza u tijelu, a koji također primaju više od 14 ml/kg/mjesec koncentrata eritrocita (približno >4 jedinice/mjesec za odraslog).
English: EXJADE 250 mg dispersible tablets EU/1/06/356/003
Croatian: EXJADE 250 mg tablete za oralnu suspenziju EU/1/06/356/003
English: Each dispersible tablet contains 250 mg of deferasirox.
Croatian: Svaka tableta za oralnu suspenziju sadrži 250 mg deferasiroksa.
English: Each tablet contains 90 mg of deferasirox.
Croatian: Svaka tableta sadrži 90 mg deferasiroksa.
English: An initial daily dose of 30 mg/kg may be considered for patients who require reduction of elevated body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells (approximately >4 units/month for an adult).
Croatian: Početna dnevna doza od 30 mg/kg može se razmotriti u bolesnika u kojih treba sniziti povišene razine željeza u tijelu, a koji također primaju više od 14 ml/kg/mjesec koncentrata eritrocita (približno >4 jedinice/mjesec za odraslog).
English: An initial daily dose of 10 mg/kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells (approximately <2 units/month for an adult).
Croatian: Početna dnevna doza od 10 mg/kg može se razmotriti u bolesnika u kojih ne treba snižavati razine željeza u tijelu, a koji također primaju manje od 7 ml/kg/mjesec koncentrata eritrocita (približno <2 jedinice/mjesec za odraslog).
English: EXJADE 500 mg dispersible tablets
Croatian: EXJADE 500 mg tablete za oralnu suspenziju
English: Each sachet contains 360 mg of deferasirox.
Croatian: Svaka vrećica sadrži 360 mg deferasiroksa.
English: 10 mg/kg/day
Croatian: 10 mg/kg/dan
English: Exjade 90 mg granules in sachet deferasirox
Croatian: Exjade 90 mg granule u vrećici deferasiroks
English: • Each dispersible tablet of EXJADE 125 mg contains 125 mg deferasirox.
Croatian: Svaka EXJADE 125 mg tableta za oralnu suspenziju sadrži 125 mg deferasiroksa.
English: Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Croatian: gluhoća Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
English: • Each film-coated tablet of EXJADE 90 mg contains 90 mg deferasirox.
Croatian: Svaka EXJADE 90 mg filmom obložena tableta sadrži 90 mg deferasiroksa.
English: Each dispersible tablet contains 500 mg of deferasirox.
Croatian: Svaka tableta za oralnu suspenziju sadrži 500 mg deferasiroksa.
English: Excipient with known effect: Each dispersible tablet contains 544 mg lactose.
Croatian: Svaka tableta za oralnu suspenziju sadrži 544 mg laktoze.
English: • The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
Croatian: • Uobičajena dnevna doza EXJADE filmom obloženih tableta na početku liječenja za bolesnike koji primaju redovite transfuzije krvi je 14 mg po kilogramu tjelesne težine.
English: • Each dispersible tablet of EXJADE 250 mg contains 250 mg deferasirox.
Croatian: Svaka EXJADE 250 mg tableta za oralnu suspenziju sadrži 250 mg deferasiroksa.
English: • Dizziness
Croatian: • Svrbež
English: Each sachet contains 180 mg of deferasirox.
Croatian: Svaka vrećica sadrži 180 mg deferasiroksa.
English: • Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating,
Croatian: • Probavni poremećaji poput mučnine, povraćanja, proljeva, boli u trbuhu, nadutosti, zatvora i probavnih tegoba
English: • The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Croatian: • Uobičajena dnevna doza EXJADE filmom obloženih tableta na početku liječenja za bolesnike koji ne primaju redovite transfuzije krvi je 7 mg po kilogramu tjelesne težine.
English: EXJADE 500 mg dispersible tablets deferasirox
Croatian: EXJADE 500 mg tablete za oralnu suspenziju deferasiroks
English: • Each dispersible tablet of EXJADE 500 mg contains 500 mg deferasirox.
Croatian: Svaka EXJADE 500 mg tableta za oralnu suspenziju sadrži 500 mg deferasiroksa.
English: What EXJADE looks like and contents of the pack EXJADE is supplied as film-coated tablets.
Croatian: EXJADE se isporučuje u obliku filmom obloženih tableta.
English: EXJADE 250 mg dispersible tablets deferasirox
Croatian: EXJADE 250 mg tablete za oralnu suspenziju deferasiroks
English: • The usual daily dose for EXJADE granules at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Croatian: • Uobičajena dnevna doza EXJADE granula na početku liječenja za bolesnike koji ne primaju redovite transfuzije krvi je 7 mg po kilogramu tjelesne težine.
English: • The usual daily dose for EXJADE granules at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
Croatian: • Uobičajena dnevna doza EXJADE granula na početku liječenja za bolesnike koji primaju redovite transfuzije krvi je 14 mg po kilogramu tjelesne težine.
English: Each sachet contains 90 mg of deferasirox.
Croatian: Svaka vrećica sadrži 90 mg deferasiroksa.
English: • Each film-coated tablet of EXJADE 180 mg contains 180 mg deferasirox.
Croatian: Svaka EXJADE 180 mg filmom obložena tableta sadrži 180 mg deferasiroksa.
English: • Each film-coated tablet of EXJADE 360 mg contains 360 mg deferasirox.
Croatian: Svaka EXJADE 360 mg filmom obložena tableta sadrži 360 mg deferasiroksa.
English: • The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients receiving regular blood transfusions is 20 mg per kilogram body weight.
Croatian: • Uobičajena dnevna doza EXJADE tableta za oralnu suspenziju na početku liječenja za bolesnike koji primaju redovite transfuzije krvi je 20 mg po kilogramu tjelesne težine.
English: • The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients not receiving regular blood transfusions is 10 mg per kilogram body weight.
Croatian: • Uobičajena dnevna doza EXJADE tableta za oralnu suspenziju na početku liječenja za bolesnike koji ne primaju redovite transfuzije krvi je 10 mg po kilogramu tjelesne težine.
English: 1, alopecia
Croatian: 1, urtikarija multiformni eritem 1, alopecija
English: Optic neuritis
Croatian: zatajenje jetre
English: 10 mg/kg/day For adults not assessed and ≤2,000 µg/l
Croatian: 10 mg/kg/dan Za odrasle osobe
English: Exjade 180 mg granules deferasirox
Croatian: Exjade 180 mg granule deferasiroks Za primjenu kroz usta
English: Exjade 360 mg granules deferasirox
Croatian: Exjade 360 mg granule deferasiroks Za primjenu kroz usta
English: - if you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction, see also section 4 “Possible side effects”).
Croatian: povećane limfne čvorove (znakovi teške kožne reakcije, vidjeti također dio 4. „Moguće nuspojave”).
English: Hypromellose
Croatian: omaglica
English: • If you experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems),
Croatian: • Ako osjetite kombinaciju omamljenosti, bolova u gornjem desnom dijelu trbuha, požutite ili
English: Magnesium stearate Silica, colloidal anhydrous Poloxamer
Croatian: Jezgra tablete: celuloza, mikrokristalična krospovidon povidon magnezijev stearat silicijev dioksid, koloidni, bezvodni poloksamer
English: Lactose monohydrate Crospovidone type A Cellulose, microcrystalline Povidone
Croatian: 6.1 Popis pomoćnih tvari laktoza hidrat krospovidon tip A celuloza, mikrokristalična povidon natrijev laurilsulfat silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: Renal function
Croatian: Funkcija jetre
English: Granules in sachet
Croatian: Vid i sluh
English: Healthcare professionals will also receive a letter in the coming weeks reminding them of the problem.
Croatian: Također, zdravstveni radnici u idućim će tjednima primiti dopis s podsjetnikom na taj problem.
English: The CHMP opinion will now be sent to the European Commission for a legally binding decision applicable in all EU Member States.
Croatian: Mišljenje CHMP-a sada se šalje Europskoj komisiji koja treba donijeti pravno obvezujuću odluku primjenjivu u svim državama članicama EU-a.
English: More information about Noxafil can be found on the Agency's website: ema.europa.eu/Find_medicine.
Croatian: Više informacija o lijeku Noxafil dostupno je na internetskim stranicama Agencije: ema.europa.eu/Find_medicine.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Croatian: Tel: +44 (0)20 3660 8427 E-pošta: press@ema.europa.eu
English: This review was conducted by EMA's Committee for Medicinal Products for Human Use (CHMP) in the context of a procedure known as a ‘type II variation'.
Croatian: Ovo ocjenjivanje proveo je Odbor za lijekove za humanu uporabu (CHMP) pri EMA-i u kontekstu postupka koji je poznat kao „izmjena tipa II.”.
English: It contains the active substance posaconazole.
Croatian: Sadrži djelatnu tvar posakonazol.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016 EMA/425762/2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24. lipnja 2016.
English: • Patients who have any concerns about their medicine should speak to their pharmacist or the prescriber.
Croatian: • Bolesnici koji imaju bilo kakve nedoumice u pogledu lijeka trebaju se obratiti svojem ljekarniku ili liječniku koji im je propisao recept.
English: Noxafil is an antifungal medicine containing the active substance posaconazole, a member of the group of triazole antifungals.
Croatian: Noxafil je antifungalni lijek koji sadrži djelatnu tvar posakonazol koja pripada skupini antifungalnih triazola.
English: It is used when other medicines do not work or cannot be given, to treat adults with the serious fungal infections invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, or coccidioidomycosis.
Croatian: Primjenjuje se ako drugi lijekovi nisu djelovali ili se ne mogu primjenjivati, i to u odraslih osoba s teškim gljivičnim infekcijama kao što su invazivna aspergiloza, fuzarioza, kromoblastomikoza, micetom ili kokcidioidomikoza.
English: Noxafil, a medicine for serious fungal infections, is available by mouth as tablets (100 mg) and oral suspension (40 mg/ml), but the recommended doses for the two forms are different.
Croatian: Noxafil, lijek za liječenje teških gljivičnih infekcija, uzima se kroz usta u obliku tableta (od 100 mg) i oralne suspenzije (od 40 mg/ml), ali preporučene doze za ta dva oblika lijeka nisu jednake.
English: Prescriptions should indicate which dose form is intended
Croatian: U receptima treba naznačiti koji se farmaceutski oblik propisuje