FrancophonIA/ELRC3.0 huggingface dataset:
English: Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.
Croatian: Deferasiroks Mylan je indiciran za liječenje kroničnog preopterećenja željezom zbog čestih transfuzija krvi (≥ 7 ml/kg/mjesec koncentrata eritrocita) u bolesnika s beta-talasemijom major u dobi od 6 godina i starijih.
English: Exposure was increased 2.8-fold in one subject with severe hepatic impairment (Child-Pugh Class C) (see sections 4.2 and 4.4).
Croatian: U jednog ispitanika s teškim oštećenjem jetre (Child-Pugh stadij C), izloženost je bila povećana za 2,8 puta (vidjeti dijelove 4.2 i 4.4).
English: • The usual daily dose for Deferasirox Mylan 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 Deferasiroks Mylan filmom obloženih tableta na početku liječenja za bolesnike koji primaju redovite transfuzije krvi je 14 mg po kilogramu tjelesne težine.
English: Deferasirox Mylan is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.
Croatian: Deferasiroks Mylan se također koristi za liječenje kroničnog preopterećenja željezom kada je terapija deferoksaminom kontraindicirana ili neodgovarajuća u bolesnika s beta-talasemijom major s preopterećenjem željezom uzrokovanim rijetkim transfuzijama krvi, u bolesnika s ostalim vrstama anemija te u djece u dobi od 2 do 5 godina.
English: Deferasirox also comes as “dispersible” tablets.
Croatian: Deferasiroks je dostupan i u obliku tableta za „oralnu suspenziju”.
English: Deferasirox Mylan is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusiondependent thalassaemia syndromes aged 10 years and older.
Croatian: Deferasiroks Mylan je također indiciran za liječenje kroničnog preopterećenja željezom koje zahtijeva terapiju kelatorima željeza kad je terapija deferoksaminom kontraindicirana ili neodgovarajuća za bolesnike u dobi od 10 godina i starije sa sindromima talasemije neovisnim o transfuziji.
English: • If you get reduced hearing, tell your doctor as soon as possible.
Croatian: - Ako Vam se zamagli ili zamuti vid, - Ako Vam oslabi sluh, čim prije obavijestite svog liječnika.
English: Rash, pruritus
Croatian: osip, svrbež
English: The recommended initial daily dose of Deferasirox Mylan film-coated tablets in patients with nontransfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Croatian: Preporučena početna dnevna doza Deferasiroks Mylan filmom obloženih tableta u bolesnika sa sindromima talasemije neovisnim o transfuziji je 7 mg/kg tjelesne težine.
English: Post-marketing cases of severe forms of renal tubulopathy (such as Fanconi syndrome) and renal failure associated with changes in consciousness in the context of hyperammonaemic encephalopathy have been reported in patients treated with deferasirox, mainly in children.
Croatian: Nakon stavljanja lijeka u promet, u bolesnika liječenih deferasiroksom, uglavnom djece, bili su prijavljeni slučajevi teških oblika bubrežne tubulopatije (kao što je Fanconijev sindrom) te zatajenja bubrega povezani s promjenama svijesti u sklopu hiperamonemične encefalopatije.
English: ≥5 mg Fe/g dw or >800 µg/l
Croatian: ≥ 5 mg Fe/g težine suhog tkiva jetre ili > 800 µg/l
English: On average, liver iron concentration decreased by 3.80 mg Fe/g dw in patients treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 0.38 mg Fe/g dw in patients treated with placebo (p<0.001).
Croatian: Koncentracija željeza u jetri snizila se u prosjeku za 3,80 mg Fe/g težine suhog tkiva jetre u bolesnika liječenih deferasiroks tabletama za oralnu suspenziju (početna doza 10 mg/kg/dan), dok se u bolesnika koji su primali placebo (p<0,001) povisila za 0,38 mg Fe/g težine suhog tkiva jetre.
English: Cardiac function should be monitored in patients with severe iron overload during long-term treatment with Deferasirox Mylan.
Croatian: U bolesnika s teškim preopterećenjem željezom potrebno je, pri dugotrajnom liječenju lijekom Deferasiroks Mylan, pratiti funkciju srca.
English: Deferasirox Mylan 360 mg
Croatian: Deferasiroks Mylan 360 mg
English: Decrease 3.5 - 7 mg/kg/day
Croatian: Smanjenje 3,5 - 7 mg/kg/dan
English: Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)).
Croatian: U bolesnika s različitim vrstama anemije (npr. talasemijom, bolešću srpastih stanica ili mijelodisplastičnim sindromima (MDS)) može biti nužno provoditi ponovljene transfuzije krvi.
English: Deferasirox Mylan 90 mg
Croatian: Deferasiroks Mylan 90 mg
English: It is recommended that serum ferritin be monitored every month to assess the patient's response to therapy and to minimise the risk of overchelation (see section 4.4).
Croatian: Preporučuje se pratiti vrijednost serumskog feritina svaki mjesec kako bi se procijenio bolesnikov odgovor na terapiju te rizik od prekomjerne kelacije sveo na najmanju moguću mjeru (vidjeti dio 4.4).
English: Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulations.
Croatian: Deferasiroks filmom obložene tablete pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka deferasiroks u obliku tableta za oralnu suspenziju.
English: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Deferasirox Mylan (see section 4.4).
Croatian: Uz primjenu lijeka Deferasiroks Mylan prijavljene su teške kožne nuspojave, uključujući StevensJohnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i reakciju na lijek s eozinofilijom i sistemskim simptomima (DRESS) (vidjeti dio 4.4).
English: 21 mg/kg/day
Croatian: 21 mg/kg/dan
English: <7 mg Fe/g dw or ≤2,000 µg/l
Croatian: < 7 mg Fe/g težine suhog tkiva jetre ili ≤ 2000 µg/l
English: How long to take Deferasirox Mylan
Croatian: Koliko dugo uzimati Deferasiroks Mylan
English: Interruption of deferasirox therapy should be considered in patients who develop metabolic acidosis.
Croatian: U bolesnika koji razviju metaboličku acidozu mora se razmotriti prekid terapije lijekom deferasiroks.
English: Deferasirox Mylan 180 mg
Croatian: Deferasiroks Mylan 180 mg
English: Optic neuritis Ear and labyrinth disorders Uncommon:
Croatian: optički neuritis Poremećaji uha i labirinta Manje često:
English: Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulation (see section 5.2).
Croatian: Deferasiroks filmom obložene tablete pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka u obliku tableta za oralnu suspenziju (vidjeti dio 5.2).
English: Test
Croatian: Pretraga
English: Your eyesight and hearing will be tested each year during treatment as a precautionary measure.
Croatian: Kao mjeru opreza, svake ćete godine, sve dok se liječite, kontrolirati vid i sluh.
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba) - Omaglica - Vrućica
English: The patient information pack should contain:
Croatian: Informacijski paket za bolesnike mora sadržavati: - Uputu o lijeku - Vodič za bolesnike
English: Deferasirox Mylan is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.
Croatian: Deferasiroks Mylan se koristi za liječenje kroničnog preopterećenja željezom uzrokovanog čestim transfuzijama krvi u bolesnika s beta-talasemijom major u dobi od 6 godina i starijih.
English: As a consequence, treatment with Deferasirox Mylan is not recommended in these patients.
Croatian: Kao posljedica toga, u tih se bolesnika ne preporučuje liječenje lijekom Deferasiroks Mylan.
English: Deferasirox has been studied only in patients with baseline serum creatinine within the ageappropriate normal range.
Croatian: Deferasiroks je ispitivan samo u bolesnika čije su vrijednosti kreatinina u serumu na početku liječenja bile unutar granica normalnog raspona odgovarajućeg za dob.
English: 7 mg/kg/day
Croatian: 7 mg/kg/dan
English: Postmarketing cases of hepatic failure, sometimes fatal, have been reported in patients treated with deferasirox.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi zatajenja jetre, od kojih su neki bili fatalni, u bolesnika liječnih deferasiroksom.
English: Dizziness
Croatian: gluhoća
English: - if you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes
Croatian: (znakovi teške alergijske reakcije), - Ako primijetite kombinaciju bilo kojih od sljedećih simptoma: osip, crvenu kožu, mjehuriće na usnicama, očima ili u ustima, ljuštenje kože, vrućicu, simptome nalik gripi, povećane limfne čvorove (znakovi teških kožnih reakcija), - Ako primijetite izrazito smanjenje izlučivanja mokraće (znak bubrežnog problema), - Ako osjetite kombinaciju omamljenosti, bolova u gornjem desnom dijelu trbuha, požutite ili
English: Creatinine clearance
Croatian: Klirens kreatinina
English: Deferasirox Mylan 360 mg film-coated tablets are also available in blister pack of 300 tablets.
Croatian: Deferasiroks Mylan 360 mg filmom obložene tablete dostupne su i u blisterima s 300 tableta.
English: ≥7 mg Fe/g dw or >2,000 µg/l
Croatian: ≥ 7 mg Fe/g težine suhog tkiva jetre ili > 2000 µg/l
English: In a retrospective meta-analysis of 2,102 adult and paediatric beta-thalassaemia patients with transfusional iron overload treated with deferasirox dispersible tablets in two randomised and four open label studies of up to five years' duration, a mean creatinine clearance decrease of 13.2% in adult patients (95% CI: −14.4% to −12.1%; n=935) and 9.9% (95% CI: −11.1% to −8.6%; n=1,142) in paediatric patients was observed during the first year of treatment.
Croatian: U retrospektivnoj meta-analizi 2102 odrasla i pedijatrijska bolesnika s beta-talasemijom s preopterećenjem željezom izazvanim transfuzijama koji su liječeni deferasiroks tabletama za oralnu suspenziju u dva randomizirana i četiri otvorena ispitivanja u trajanju do pet godina, zapažena je srednja vrijednost smanjenja klirensa kreatinina od 13,2% u odraslih bolesnika (95% CI: −14,4% do
English: A food-effect study involving administration of the film-coated tablets to healthy volunteers under fasting conditions and with a low-fat (fat content <10% 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 11% and 16%, respectively).
Croatian: Ispitivanje učinka hrane koje je uključivalo primjenu filmom obloženih tableta u zdravih dobrovoljaca natašte te uz nemasni (sadržaj masti < 10% kalorija) ili punomasni (sadržaj masti > 50% kalorija)
English: Eye disorders Uncommon:
Croatian: Poremećaji oka Manje često:
English: 1, thrombocytopenia
Croatian: 1, trombocitopenija
English: Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets
Croatian: Deferasiroks Mylan 90 mg filmom obložene tablete Deferasiroks Mylan 180 mg filmom obložene tablete Deferasiroks Mylan 360 mg filmom obložene tablete
English: Hypromellose Titanium dioxide (E171) Macrogol/PEG (6000) Talc
Croatian: hipromeloza titanijev dioksid (E171) makrogol/PEG (6000) talk željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: <3 mg Fe/g dw or <300 µg/l
Croatian: < 3 mg Fe/g težine suhog tkiva jetre ili < 300 µg/l
English: Transfusional iron overload
Croatian: Preopterećenje željezom izazvano transfuzijama
English: Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets deferasirox
Croatian: Deferasiroks Mylan 90 mg filmom obložene tablete Deferasiroks Mylan 180 mg filmom obložene tablete Deferasiroks Mylan 360 mg filmom obložene tablete deferasiroks
English: Skin disorders
Croatian: Poremećaji kože
English: • Description of available deferasirox formulations on the market (e.g. dispersible tablets, filmcoated tablets and granules) ◦ Different posology regimen ◦ Different conditions of administration ◦ Dose conversion table when switching from one formulation to another
Croatian: Vodič za zdravstvene radnike mora sadržavati sljedeće ključne elemente: - opis dostupnih formulacija deferasiroksa na tržištu (npr. tablete za oralnu suspenziju, filmom obložene tablete i granule) ◦ različiti režimi doziranja ◦ različiti uvjeti primjene ◦ tablica za preračunavanje doze kod prelaska s jedne formulacije lijeka na drugu - preporučene doze i pravila za početak liječenja - potreba mjesečnog praćenja serumskog feritina
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 krvarenja u gornjem dijelu gastrointestinalnog trakta.
English: Deferasirox Mylan is also used when deferoxamine therapy is contraindicated or inadequate to treat patients aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who are not transfusion dependent.
Croatian: Deferasiroks Mylan se također koristi za liječenje bolesnika u dobi od 10 godina ili starijih u kojih je došlo do preopterećenja željezom povezanog sa sindromima talasemije neovisnim o transfuziji.
English: Each film-coated tablet contains 360 mg deferasirox
Croatian: Jedna filmom obložena tableta sadrži 360 mg deferasiroksa
English: Each film-coated tablet contains 90 mg deferasirox.
Croatian: Jedna filmom obložena tableta sadrži 90 mg deferasiroksa.
English: Breast-feeding while taking Deferasirox Mylan is not recommended.
Croatian: Tijekom primjene lijeka Deferasiroks Mylan ne preporučuje se dojenje.
English: Skin rashes may appear during Deferasirox Mylan treatment.
Croatian: Tijekom liječenja lijekom Deferasiroks Mylan moguća je pojava kožnih osipa.
English: How to take Deferasirox Mylan
Croatian: Kako uzimati Deferasiroks Mylan
English: Adverse reactions reported during post-marketing experience.
Croatian: Nuspojave prijavljene nakon stavljanja lijeka u promet.
English: What Deferasirox Mylan is
Croatian: Što je Deferasiroks Mylan
English: • Each film-coated tablet of Deferasirox Mylan 360 mg contains 360 mg deferasirox.
Croatian: - Svaka Deferasiroks Mylan 360 mg filmom obložena tableta sadrži 360 mg deferasiroksa.
English: Monitoring your Deferasirox Mylan treatment
Croatian: Praćenje liječenja lijekom Deferasiroks Mylan
English: Each film-coated tablet contains 180 mg deferasirox
Croatian: Jedna filmom obložena tableta sadrži 180 mg deferasiroksa
English: > age appropriate ULN
Croatian: > GGN-a prikladnog za godine i/ili smanjen < DGN-a
English: • Each film-coated tablet of Deferasirox Mylan 90 mg contains 90 mg deferasirox.
Croatian: - Svaka Deferasiroks Mylan 90 mg filmom obložena tableta sadrži 90 mg deferasiroksa.
English: Medicines called iron chelators are used to remove the excess iron and reduce the risk of it causing organ damage.
Croatian: Da bi se uklonio višak željeza i smanjio rizik od oštećenja organa, koriste se lijekovi koji se nazivaju kelatorima željeza.
English: • Each film-coated tablet of Deferasirox Mylan 180 mg contains 180 mg deferasirox.
Croatian: - Svaka Deferasiroks Mylan 180 mg filmom obložena tableta sadrži 180 mg deferasiroksa.
English: Deferasirox Mylan 180 mg film-coated tablets
Croatian: Deferasiroks Mylan 180 mg filmom obložene tablete
English: Deafness Respiratory, thoracic and mediastinal disorders Uncommon:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
English: Non-transfusion-dependent thalassaemia syndromes
Croatian: Sindromi talasemije neovisni o transfuziji
English: • The importance of measuring creatinine clearance • Brief overview of methods of measuring creatinine clearance
Croatian: Edukacijski materijal za liječnike mora sadržavati: - Sažetak opisa svojstava lijeka - Vodič za zdravstvene radnike
English: 90 film-coated tablets 300 film-coated tablets
Croatian: 90 filmom obloženih tableta 300 filmom obloženih tableta
English: How to store Deferasirox Mylan
Croatian: Kako čuvati Deferasiroks Mylan
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 1' on the other side.
Croatian: Bikonveksna filmom obložena tableta modificiranog oblika kapsule, boje breskve, s utisnutom oznakom „ ” na jednoj strani tablete i „DF 1” na drugoj strani.
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 2' on the other side.
Croatian: Bikonveksna filmom obložena tableta modificiranog oblika kapsule, boje breskve, s utisnutom oznakom „ ” na jednoj strani tablete i „DF 2” na drugoj strani.
English: Deferasirox Mylan 360 mg film-coated tablets
Croatian: Deferasiroks Mylan 360 mg filmom obložene tablete
English: Deferasirox Mylan 90 mg film-coated tablets
Croatian: Deferasiroks Mylan 90 mg filmom obložene tablete
English: 30 film-coated tablets 90 film-coated tablets
Croatian: 30 filmom obloženih tableta 90 filmom obloženih tableta
English: Liver function test elevations have been observed in patients treated with deferasirox.
Croatian: U bolesnika liječenih deferasiroksom opažena su povišenja vrijednosti testova jetrene funkcije.
English: A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF' on the other side.
Croatian: Bikonveksna filmom obložena tableta modificiranog oblika kapsule, boje breskve, s utisnutom oznakom „ ” na jednoj strani tablete i „DF” na drugoj strani.
English: 6 months)
Croatian: 6.3 Rok valjanosti
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) - Poremećaj testova funkcije bubrega.
English: Severe forms associated with changes in consciousness in the context of hyperammonaemic encephalopathy, may occur in patients treated with deferasirox, particularly in children.
Croatian: U bolesnika liječenih deferasiroksom, osobito djece, može doći do teških oblika povezanih s promjenama svijesti u sklopu hiperamonemične encefalopatije.
English: What Deferasirox Mylan is used for
Croatian: Za što se koristi Deferasiroks Mylan
English: 1, urticaria erythema multiforme1, alopecia1, toxic epidermal necrolysis (TEN)1 Renal and urinary disorders Very common:
Croatian: 1, toksična epidermalna nekroliza (TEN)
English: Deferasirox Mylan 360 mg film-coated tablets deferasirox
Croatian: Deferasiroks Mylan 360 mg filmom obložene tablete deferasiroks
English: Coating material:
Croatian: Ovojnica:
English: Psychiatric disorders Uncommon:
Croatian: metabolička acidoza Psihijatrijski poremećaji Manje često:
English: Interruption of treatment should be considered in patients who develop unexplained cytopenia.
Croatian: U bolesnika koji su razvili neobjašnjivu citopeniju treba razmotriti prekid liječenja.
English: Deferasirox Mylan 180 mg film-coated tablets deferasirox
Croatian: Deferasiroks Mylan 180 mg filmom obložene tablete deferasiroks
English: 30 film-coated tablets 90 film -coated tablets 300 film-coated tablets
Croatian: 30 filmom obloženih tableta 90 filmom obloženih tableta 300 filmom obloženih tableta
English: V.J.
Croatian: C.
English: Breast-feeding is not recommended during treatment with Deferasirox Mylan.
Croatian: Tijekom liječenja lijekom Deferasiroks Mylan ne preporučuje se dojenje.
English: Deferasirox Mylan 90 mg film-coated tablets deferasirox
Croatian: Deferasiroks Mylan 90 mg filmom obložene tablete deferasiroks
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: - Ako dobijete teški osip ili teškoće pri disanju i omaglicu ili oticanje uglavnom lica i grla
English: Up to 28 mg/kg/day Decrease
Croatian: Do 28 mg/kg/dan Smanjenje 3,5 - 7 mg/kg/dan
English: Laryngeal pain
Croatian: laringealna bol
English: Renal tubular disorder
Croatian: poremećaj bubrežnih tubula
English: Oral use.
Croatian: Način primjene Za peroralnu primjenu.
English: • If you experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems and lead to a change in your brain function),
Croatian: smanjenu pozornost ili svijest ili osjećaj izrazite pospanosti uz nisku razinu energiju (znakovi visoke razine amonijaka u Vašoj krvi, što može biti povezano s jetrenim ili bubrežnim tegobama te dovesti do promjene moždane funkcije), - Ako povraćate krv i/ili imate crne stolice, - Ako imate česte bolove u trbuhu, posebno nakon jela ili uzimanja lijeka Deferasiroks Mylan, - Ako imate česte žgaravice, - Ako imate djelomičan gubitak vida, - Ako osjetite jaku bol u gornjem dijelu trbuha (pankreatitis), prestanite uzimati ovaj lijek i odmah obavijestite svog liječnika.
English: Retreatment
Croatian: Ponovno liječenje
English: Renal or hepatic impairment
Croatian: Oštećenje bubrega ili jetre
English: 14 mg/kg/day
Croatian: Početna doza 14 mg/kg/dan
English: Close clinical monitoring is required when deferasirox is combined with these substances.
Croatian: Kada se deferasiroks kombinira s tim lijekovima nužno je pažljivo kliničko praćenje.
English: - if you experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems, see also section 4 “Possible side effects”).
Croatian: smanjenu pozornost ili svijest ili osjećaj izrazite pospanosti uz nisku razinu energije (znakovi visoke razine amonijaka u Vašoj krvi, što može biti povezano s jetrenim ili bubrežnim tegobama, vidjeti također dio 4. „Moguće nuspojave”) - ako povraćate krv i/ili imate crne stolice - ako imate česte bolove u trbuhu, posebno nakon jela ili uzimanja lijeka Deferasiroks Mylan - ako imate česte žgaravice - ako imate nizak broj krvnih pločica ili bijelih krvnih stanica u krvnoj pretrazi - ako imate zamagljen vid - ako imate proljev ili povraćate.
English: Tel: + 386 1 23 63 180
Croatian: Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180
English: Patients should be referred to a renal specialist, and further specialised investigations (such as renal biopsy) may be considered if the following occur despite dose reduction and interruption:
Croatian: Bolesnike treba uputiti nefrologu te razmotriti dodatne specijalističke preglede (poput biopsije bubrega) ukoliko, unatoč smanjenje doze ili prekidu liječenja, dođe do sljedećeg: - serumski kreatinin ostaje značajno povišen i - trajna abnormalnost drugog markera bubrežne funkcije (npr. proteinurija, Fanconijev sindrom).
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: Vam se pojača žutilo kože ili očiju i imate tamnu mokraću (znakovi jetrenih problema) - ako primijetite poteškoće u razmišljanju, pamćenju informacija ili rješavanju problema,
English: 15 OTHER INFORMATION
Croatian: 15 OSTALE INFORMACIJE
English: 4 INDICATIONS
Croatian: 4 INDIKACIJE
English: Add the following text in the relevant sections of the product information:
Croatian: Tekst u nastavku dodajte u odgovarajuće odjeljke informacija o proizvodu: