FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have any kidney problem, your doctor should check your kidney function regularly.
Croatian: Ako imate problema s bubrezima, Vaš liječnik treba redovito provjeravati funkciju Vaših bubrega.
English: Your doctor must have done a blood test to confirm that your disease is suitable for treatment with Translarna.
Croatian: Vaš je liječnik morao napraviti krvne pretrage kako bi potvrdio da je Vaša bolest prikladna za liječenje lijekom Translarna.
English: If you feel dizzy, do not drive, cycle or use machines.
Croatian: Ako osjetite omaglicu, ne upravljajte vozilom, biciklom ili strojevima.
English: Sachets should only be opened at the time of dose preparation.
Croatian: Vrećice se smiju otvoriti samo u trenutku pripreme doze.
English: Pharmacotherapeutic group:Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX03
Croatian: Farmakoterapijska skupina: Ostali lijekovi za poremećaje mišićno-koštanog sustava, ATK oznaka: M09AX03
English: The safety and efficacy of ataluren in patients aged 65 and older have not yet been established (see section 5.2).
Croatian: Sigurnost i djelotvornost atalurena u bolesnika u dobi od 65 godina i starijih nisu još ustanovljene (vidjeti dio 5.2).
English: Based on data in healthy volunteers, the relative bioavailability of ataluren is approximately 40% lower at steady-state than after the initial dose.
Croatian: Na temelju podataka prikupljenih u zdravih dobrovoljaca, relativna bioraspoloživost atalurena je otprilike 40% manja u stanju dinamičke ravnoteže nego nakon početne doze.
English: Based on data from subjects ranging in age from 2 years to 57 years, there is no apparent effect of age on ataluren plasma exposure.
Croatian: Na temelju podataka prikupljenih u ispitanika u dobi od 2 godine do 57 godina, nema očitog utjecaja dobi na izloženost atalurenu u plazmi.
English: Translarna is a medicine that contains the active substance ataluren.
Croatian: Translarna je lijek koji sadrži djelatnu tvar ataluren.
English: Hypertension with use of concomitant systemic corticosteroids
Croatian: Hipertenzija kod istovremene primjene sistemskih kortikosteroida
English: How does Translarna work?
Croatian: Kako Translarna djeluje?
English: Open the sachet only at the time you are taking the medicine and use the entire amount from the sachet.
Croatian: Vrećicu otvorite tek u trenutku kad uzimate lijek, te iskoristite cijeli sadržaj vrećice.
English: There was no difference between ataluren 80 mg/kg/day and placebo.
Croatian: Nije bilo razlike između atalurena 80 mg/kg/dan i placeba.
English: The values tended to stabilize early in the study and did not increase further with continued treatment.
Croatian: Vrijednosti su bile sklone stabilizaciji u ranoj fazi ispitivanja i nisu se dalje povećavale u nastavku liječenja
English: You or your child will have been tested by your doctor before starting treatment with Translarna, in order to confirm that your disease is suitable for treatment with this medicine.
Croatian: Vi ili Vaše dijete morate biti testirani od strane svojeg liječnika prije nego započnete liječenje lijekom Translarna kako bi se potvrdilo je li Vaša bolest pogodna za liječenje ovom lijekom.
English: Evening
Croatian: Večer
English: This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Croatian: Ovaj lijek je odobren po shemi takozvanog „uvjetnog odobrenja“.
English: Frequency not known (frequency cannot be estimated from the available data): - Increases in blood lipids - Increases in test for kidney function
Croatian: Učestalost nepoznata (učestalost se ne može procijeniti na temelju dostupnih podataka): - povišenje razine lipida u krvi - povišenja vrijednosti u testovima bubrežne funkcije
English: The significance for humans is not known.
Croatian: Značaj za ljude nije poznat.
English: In addition, one case of malignant hibernoma was found at the highest dose in a 2-year rat carcinogenicity study.
Croatian: Nadalje, jedan slučaj malignog hibernoma utvrđen je u najvišoj dozi u 2godišnjem ispitivanju karcinogenosti u štakora.
English: White to off-white granules.
Croatian: Bijele do gotovo bijele granule.
English: The maternal systemic exposure at the no observed effect level (NOEL) for neonatal toxicity was about 3 times human exposure.
Croatian: Sistemska izloženost u majki u razini bez uočenih učinaka (NOEL) za neonatalnu toksičnost iznosila je otprilike tri puta više od ljudske izloženosti.
English: Frequency not known
Croatian: Učestalost nije poznata
English: The efficacy of Translarna in children aged 2 - 5 years has been established on extrapolation from patients aged >5years.
Croatian: Djelotvornost lijeka Translarna u djece u dobi 2-5 godina ustanovljena je ekstrapolacijom iz podataka o bolesnicima u dobi > 5 godina.
English: Peak plasma levels of ataluren are attained approximately 1.5 hours after dosing in subjects who received medicinal product within 30 minutes of a meal.
Croatian: Vršne razine atalurena u plazmi postižu se otprilike 1,5 sat nakon doziranja u ispitanika koji su primili lijek unutar 30 minuta od obroka.
English: If you forget to take Translarna
Croatian: Ako ste zaboravili uzeti lijek Translarna
English: Healthy volunteers receiving a single oral dose of 200 mg/kg of ataluren experienced transient, low-grade symptoms of headache, nausea, vomiting, and diarrhoea.
Croatian: Zdravi dobrovoljci koji su primali jednu dozu od 200 mg/kg atalurena peroralno iskusili su prolazne simptome niskog stupnja poput glavobolje, mučnine, povraćanja i proljeva.
English: Patients who experience dizziness should use caution when driving, cycling or using machines.
Croatian: Bolesnici koji su iskusili omaglicu moraju oprezno upravljati automobilom, biciklom i raditi sa strojevima.
English: Exposure at the no observed adverse effect level (NOAEL) was similar to (rabbit) or 4 times (rat) the systemic exposure in humans (40 mg/kg/day).
Croatian: Izloženost na razini bez uočenih štetnih učinaka (NOAEL) bila je slična (kunić) ili 4 puta veća (štakor) od sistemske izloženosti u ljudi (40 mg/kg/dan).
English: The medicine is taken by mouth mixed in liquid or semi-solid food.
Croatian: Lijek se uzima kroz usta pomiješan u tekućinu ili polukrutu hranu.
English: Study 2 evaluated 230 male patients, ages 7 to 14 years.
Croatian: U Ispitivanju 2 procijenjeno je 230 muških bolesnika u dobi od 7 do 14 godina.
English: These data indicate no apparent drug-drug interaction between corticosteroids and ataluren, and no dose adjustments are required.
Croatian: Ovi podaci ukazuju da nema jasne interakcije lijekova između kortikosteroida i atalurena, te nisu potrebne prilagodbe doze.
English: Significance of the urinary bladder tumours for humans is considered unlikely.
Croatian: Značaj tumora mokraćnog mjehura za ljude smatra se malo vjerojatnim.
English: No serious adverse reactions were observed in these subjects.
Croatian: Ozbiljne nuspojave nisu uočene u ovih ispitanika.
English: Presence of radioactivity in pup plasma confirmed absorption from the milk by the pups.
Croatian: Prisutnost radioaktivnosti u plazmi mladunčadi potvrdila je apsorpciju iz mlijeka u mladunčadi.
English: Coadministration of corticosteroids (deflazacort, prednisone, or prednisolone) with ataluren did not affect the plasma concentrations of ataluren.
Croatian: Istovremena primjena kortikosteroida (deflazakort, prednizon ili prednizolon) s atalurenom nije utjecala na koncentracije atalurena u plazmi.
English: Safety data from 28 weeks of therapy showed a similar safety profile of ataluren in patients 2-5 years as compared with patients aged 5 years and older.
Croatian: Sigurnosni podaci prikupljeni tijekom 28 tjedana liječenja pokazali su sličan sigurnosni profil atalurena u bolesnika u dobi 2-5 godina u usporedbi s bolesnicima u dobi od 5 godina i starijima.
English: The table below provides information on which sachet strength(s) to use in the preparation of the recommended dose by body weight range.
Croatian: U niže prikazanoj tabeli navedene su informacije o tome koja(e) se jačina(e) vrećice treba koristiti u pripremi preporučene doze s obzirom na raspon tjelesne težine.
English: Study 1 evaluated 174 male patients, ages 5 to 20 years.
Croatian: U Ispitivanju 1 procijenjeno je 174 muških bolesnika u dobi od 5 do 20 godina.
English: Paediatric patients with body weight ≥12 kg are treated as per the dosing recommendations by body weight range (see above dosing table).
Croatian: Pedijatrijski bolesnici s tjelesnom težinom ≥ 12 kg liječeni su prema preporukama za doziranje s obzirom na raspon tjelesne težine (vidjeti tablicu za doziranje iznad).
English: Patients who do not have a nonsense mutation should not receive ataluren.
Croatian: Bolesnici koji nemaju besmislenu mutaciju ne smiju primiti ataluren.
English: In addition, at exposure much higher than in patients an increase of (rare) urinary bladder tumours was found.
Croatian: Nadalje, pri izloženosti mnogo većoj nego u bolesnika utvrđeno je povećanje broja (rijetkih) tumora mokraćnog mjehura.
English: This medicine does not require any special storage conditions.
Croatian: Ovaj lijek ne zahtijeva nikakve posebne uvjete čuvanja.
English: In a statistical based model the estimated mean difference was 13.0 meters (p=0.213), Figure 4.
Croatian: U statistički temeljenom modelu, procijenjena srednja razlika bila je 13,0 metara (p=0,213), Slika 4.
English: In both studies, 1/232 (0.43%) patients treated with ataluren discontinued due to an adverse reaction of constipation and 1/172 (0.58%) placebo patients discontinued treatment due to an adverse reaction of disease progression (loss of ambulation).
Croatian: U oba ispitivanja, 1/232 (0,43%) bolesnika liječenih atalurenom je prestao primati terapiju zbog nuspojave konstipacije, a 1/172 (0,58%) bolesnika liječenih placebom je prestao primati terapiju zbog nuspojave u vidu progresije bolesti (gubitak pokretljivosti).
English: One out of two 26-week rat repeat dose studies, initiated in 4-5 weeks old rats, showed a dose related increase of the incidence of malignant hibernoma, a rare tumour in rats.
Croatian: Jedno od dva ispitivanja ponovljene doze u trajanju od 26 tjedana u štakora započeto u 4-5 tjedana starih štakora pokazalo je povećanje incidencije malignog hibernoma, rijetkog tumora u štakora, povezano s dozom.
English: Concomitant use of intravenous aminoglycosides (see sections 4.4 and 4.5).
Croatian: Istovremena primjena intravenskih aminoglikozida (vidjeti dio 4.4 i 4.5).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of ataluren/metabolites in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazali su lučenje atalurena/metabolita u mlijeko (vidjeti dio 5.3).
English: Patients should maintain adequate hydration while taking ataluren (see section 4.4).
Croatian: Bolesnici moraju održavati primjerenu hidraciju dok uzimaju ataluren (vidjeti dio 4.4).
English: Therefore, if treatment with intravenous aminoglycosides is necessary the treatment with Translarna should be stopped and can be resumed 2 days after administration of the aminoglycoside has ended.
Croatian: Stoga, ako je potrebno liječenje intravenskim aminoglikozidima, liječenje lijekom Translarna treba prekinuti te ga se može nastaviti 2 dana nakon završetka primjene aminoglikozida.
English: General characteristics of ataluren after administration
Croatian: Opće karakteristike atalurena nakon primjene
English: Description of selected adverse reactions (laboratory abnormalities)
Croatian: Opis odabranih nuspojava (odstupanja u laboratorijskim nalazima)
English: Studies in animals have shown reproductive toxicity only at doses that resulted in maternal toxicity (see section 5.3).
Croatian: Ispitivanja provedena na životinjama pokazala su reproduktivnu toksičnost samo u dozama koje su uzrokovale toksičnost za majke (vidjeti dio 5.3).
English: If this is unavoidable (e.g. vancomycin to treat MRSA) careful monitoring of renal function is advised (see section 4.5).
Croatian: Ukoliko se ovo ne može izbjeći (primjerice vankomicin za liječenje MRSA), savjetuje se pažljivo praćenje funkcije bubrega (vidjeti dio 4.5).
English: The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing (see section 4.4).
Croatian: Prisutnost besmislene mutacije u distrofin genu treba utvrditi genetskim testiranjem (vidjeti dio 4.4).
English: Duchenne muscular dystrophy is caused by genetic changes that result in an abnormality in a muscle protein called dystrophin which is needed for muscles to work properly.
Croatian: Duchenneovu mišićnu distrofiju uzrokuju genetske promjene koje rezultiraju abnormalnošću mišićnog proteina nazvanog distrofin koji je potreban kako bi mišići ispravno radili.
English: You may experience mild headache, nausea, vomiting or diarrhoea.
Croatian: Možete osjetiti blagu glavobolju, mučninu, povraćanje ili proljev.
English: In a statistical based model the estimated mean difference was 31.7 meters (adjusted p=0.0367).
Croatian: U procjeni po statističkom modelu, srednja razlika je bila 31,7 metara (prilagođeno p=0,0367).
English: A higher frequency of malaise (7.1%), pyrexia (42.9%), ear infection (28.6%), and rash (21.4%) were reported in patients aged 2-5 years compared with patients 5 years of age and older.
Croatian: U bolesnika u dobi 2-5 godina zabilježena je veća učestalost malaksalosti (7,1 %), pireksije (42,9 %), infekcije uha (28,6 %) i osipa (21,4 %) u usporedbi s bolesnicima u dobi od 5 godina i starijima.
English: Ataluren plasma concentrations in patients from 2 to less than 5 years old were consistent with those seen in patients above the age of 5 years receiving the 10/10/20 mg/kg dose regimen.
Croatian: Koncentracije atalurena u plazmi bolesnika od 2 do manje od 5 godina starosti bile su u skladu s onima uočenima u bolesnika starijih od 5 godina koji su primali dozni režim 10/10/20 mg/kg.
English: In vivo, the only metabolite detected in plasma after oral administration of radio-labelled ataluren was the ataluren-O-1β-acyl glucuronide; exposure to this metabolite in humans was approximately 8% of the plasma AUC of ataluren.
Croatian: In vivo, jedini metabolit otkriven u plazmi nakon peroralne primjene radiološki označenog atalurena bio je ataluren-O-1β-acil glukuronid; izloženost ovom metabolitu u ljudi je bila otprilike 8% AUC atalurena u plazmi.
English: Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products (eg oseltamivir, aciclovir, captopril, furosemide, bumetanide, valsartan, pravastatin, rosuvastatin, atorvastatin, pitavastatin).
Croatian: Stoga je potreban oprez ako se ataluren primjenjuje istovremeno s lijekovima koji su supstrati OAT1 ili OATP1B3 zbog rizika od povećane koncentracije ovih lijekova (primjerice oseltamivira, aciklovira, kaptoprila, furosemida, bumetanida, valsartana, pravastatina, rosuvastatina, atorvastatina, pitavastatina).
English: Translarna enables the production of working dystrophin and helps muscles work properly.
Croatian: Translarna omogućuje stvaranje ispravnog distrofina i pomaže mišićima da ispravno rade.
English: - If you are receiving treatment with certain antibiotics, such as gentamicin, tobramycin, or streptomycin by injection into a vein.
Croatian: - Ako primate liječenje određenim antibioticima, poput gentamicina, tobramicina ili streptomicina injekcijom u venu.
English: In the clinical program investigating the efficacy and safety of monotherapy ataluren in patients with nonsense mutation cystic fibrosis, no statistically significant effect was observed in the primary and key secondary clinical outcome measures (ppFEV1 and pulmonary exacerbation rate) in adults and children aged 6 years and older.
Croatian: U kliničkom programu kojim su se ispitivale djelotvornost i sigurnost monoterapije atalurenom u bolesnika s cističnom fibrozom s besmislenom mutacijom, nije zabilježen statistički značajni učinak u primarnim i ključnim sekundarnim mjerama kliničkog ishoda (ppFEV1 i stopama egzacerbacije plućne bolesti) u odraslih i djece u dobi od 6 godina i starije.
English: Take each prepared dose immediately after preparation.
Croatian: Svaku pripremljenu dozu uzmite odmah nakon pripreme.
English: Translarna is used to treat Duchenne muscular dystrophy resulting from a specific genetic defect that affects normal muscle function.
Croatian: Translarna se koristi za liječenje Duchenneove mišićne distrofije koja je uzrokovana specifičnim genetskim defektom koji utječe na normalnu mišićnu funkciju.
English: Ataluren-treated patients experienced clinical benefit as measured by numerically favorable differences versus placebo across the primary and secondary efficacy endpoints.
Croatian: Bolesnici liječeni atalurenom imali su kliničku korist što je izmjereno numerički povoljnim razlikama u odnosu na placebo kroz mjere primarnog i sekundarnog ishoda djelotvornosti.
English: Usually prescribed for acyclovir treatment of chickenpox [varicella]
Croatian: Najčešće se propisuje za aciklovir liječenje vodenih kozica [varicella]
English: Ataluren plasma concentrations at steady state increase proportionally with increasing dose.
Croatian: Plazmatska koncentracija atalurena u stanju dinamičke ravnoteže povećava se proporcionalno s povećavanjem doze.
English: Also rat and dog studies showed changes in plasma lipid (cholesterol and triglycerides) suggestive of changes in fat metabolism.
Croatian: Također ispitivanja provedena u štakora i pasa pokazala su promjene u lipidima u plazmi (kolesterol i trigliceridi) koje ukazuju na promjene u metabolizmu masti.
English: It is unlikely that the pharmacokinetics of ataluren are significantly affected by UGT1A9 polymorphisms in a Caucasian population.
Croatian: Nije izgledno da na farmakokinetiku atalurena značajno utječe UGT1A9 polimorfizam u populacije bijelaca.
English: Kaplan-Meier Curve of Time to Persistent 10% 6MWD Worsening (Study 1)
Croatian: Slika 2. Kaplan-Meierova krivulja vremena do perzistentnog 10%-tnog pogoršanja udaljenosti prijeđene u 6 minuta (Ispitivanje 1)
English: Therefore, patients with severe renal impairment or end-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk, and should be closely monitored for possible metabolite toxicity and decrease in efficacy.
Croatian: Stoga, bolesnike s teškim oštećenjem funkcije bubrega ili završnim stadijem bubrežne bolesti treba liječiti atalurenom samo ako predviđena klinička korist nadmašuje potencijalni rizik i treba ih pažljivo pratiti u vezi s mogućom toksičnošću metabolita i smanjenjem djelotvornosti.
English: The most common adverse reactions in the 2 placebo-controlled studies were vomiting, diarrhoea, nausea, headache, upper abdominal pain, and flatulence, all occurring in ≥5% of all ataluren-treated patients.
Croatian: Najčešće nuspojave u 2 placebom kontrolirana ispitivanja bile su povraćanje, proljev, mučnina, glavobolja, bolovi u gornjem abdomenu i flatulencija i sve su se pojavile kod ≥ 5% svih bolesnika liječenih atalurenom.
English: The effect of ataluren on driving, on cycling, or on using machines has not been tested.
Croatian: Utjecaj atalurena na upravljanje automobilom, biciklom ili rad sa strojevima nije ispitan.
English: In a 48-week open-label extension study in patients with nmDMD patients who were ambulant or nonambulant demonstrated a similar safety profile.
Croatian: U 48-tjednom otvorenom nastavku ispitivanja bolesnika s DMD-om s besmislenom mutacijom, bolesnici koji su bili pokretni ili nepokretni pokazali su sličan sigurnosni profil.
English: It is hypothetised that the in vivo dose response relationship may also be bell-shaped, but in vivo data were too limited to confirm this hypothesis in a mouse model for nmDMD and in humans.
Croatian: Postavljena je hipoteza da in vivo odnos doze i odgovora može također imati oblik zvona, no in vivo podaci su bili previše ograničeni da bi se potvrdila ova hipoteza na mišjem modelu za Duchenneovu mišićnu distrofiju (DMD) s besmislenom mutacijom i na ljudima.
English: Patients were randomised in a 1:1 ratio and received ataluren 40 mg/kg/day (n=115) or placebo (n=115) 3 times per day (morning, midday, and evening).
Croatian: Bolesnici su randomizirani u omjeru 1:1 i primali su ataluren u dozi od 40 mg/kg/dan (n=115) ili placebo (n=115) 3 puta dnevno (ujutro, u podne i navečer).
English: Do not stop taking Translarna without talking to your doctor.
Croatian: Ako prestanete uzimati lijek Translarna Nemojte prestati uzimati lijek Translarna bez prethodnog savjetovanja s liječnikom.
English: Although ataluren is practically insoluble in water, ataluren is readily absorbed after oral administration as a suspension.
Croatian: Iako je ataluren praktički netopljiv u vodi, nakon peroralne primjene u obliku suspenzije lako se apsorbira.
English: Effect of ataluren on pharmacokinetics of other medicinal products Based on in vitro studies, ataluren has the potential to inhibit UGT1A9, organic anion transporter 1 (OAT1), organic anion transporter 3 (OAT3) and organic anion transporting polypeptide 1B3 (OATP1B3).
Croatian: Učinak atalurena na farmakokinetiku drugih lijekova Na temelju in vitro ispitivanja, ataluren ima potencijal za inhibiciju UGT1A9, prijenosnika organskih aniona 1 (OAT1), prijenosnika organskih aniona 3 (OAT3) i transportnog polipeptida za organske anione 1B3 (OATP1B3).
English: In a 2-year rat carcinogenicity study, one case of hibernoma was found.
Croatian: U 2-godišnjem ispitivanju karcinogenosti u štakora utvrđen je jedan slučaj hibernoma.
English: Since the mechanism by which ataluren increases nephrotoxicity of intravenous aminoglycosides is not known, concomitant use of other nephrotoxic medicinal products with ataluren is not recommended.
Croatian: Budući da nije poznat mehanizam kojim ataluren povećava nefrotoksičnost intravenskih aminoglikozida, ne preporuča se istovremena primjena drugih nefrotoksičnih lijekova s atalurenom.
English: In particular do not take Translarna with the antibiotics gentamicin, tobramycin, or streptomycin given by injection.
Croatian: Posebice ne uzimajte lijek Translarna s antibioticima gentamicinom, tobramicinom ili streptomicinom koji se primjenjuju injekcijom.
English: Ataluren plasma half-life ranges from 2-6 hours and is unaffected either by dose or repeated administration.
Croatian: Poluvijek atalurena u plazmi iznosi između 2-6 sati i na to ne utječe ni doza ni ponovljena primjena.
English: - If you are allergic to ataluren or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Translarna - Ako ste alergični na ataluren ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Co-administration of rifampicin, a strong inducer of metabolic enzymes including UGT1A9, decreased ataluren exposure by 29%.
Croatian: Istovremena primjena rifampicina, jakog induktora metaboličkih enzima, uključujući UGT1A9, smanjila je izloženost atalurenu za 29%.
English: In rats and rabbits embryo-foetal toxicity (e.g. increased early resorptions, postimplantation loss, decreased viable foetuses) and signs of delayed development (increased skeletal variations) were found in the presence of maternal toxicity.
Croatian: U štakora i kunića utvrđeni su embriofetalna toksičnost (primjerice povišena rana resorpcija, gubitak nakon implantacije, smanjena stopa preživljavanja fetusa) i znakovi usporenog razvoja (povišene skeletalne varijacije) u prisutstvu toksičnosti za majku.
English: Treatment with Translarna should only be initiated by specialist physicians with experience in the management of Duchenne/Becker muscular dystrophy.
Croatian: Liječenje lijekom Translarna treba započeti specijalist iskusan u liječenju Duchenneove/Beckerove mišićne distrofije.
English: Change in renal function tests (increased creatinine, blood urea nitrogen, cystatin C)
Croatian: promjena u testovima bubrežne funkcije (povišeni kreatinin, ureja u krvi, cistatin C)