FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency is aware that ketoconazole is used off-label for treating patients with Cushing's syndrome.
Croatian: Europska agencija za lijekove svjesna je da se ketokonazol koristi za liječenje neodobrene indikacije u bolesnika sa Cushingovim sindromom.
English: The French medicine agency, the National Agency for the Safety of Medicine and Health Products (ANSM), concluded that the benefit-risk balance of oral ketoconazole was negative because of a high level of liver injury associated with the medicine and in view of the currently available alternative treatments, which are deemed to be safer.
Croatian: Francuska agencija za lijekove, Nacionalna agencija za zdravstvenu sigurnost proizvoda za zdravstvo (ANSM), zaključila je da je omjer koristi i rizika oralnog ketokonazola negativan s obzirom na velik broj oštećenja jetre povezan s lijekom, te se trenutno dostupna alternativna liječenja smatraju sigurnijima.
English: Ketoconazole is an antifungal medicine used to treat infections caused by dermatophytes and yeasts.
Croatian: Ketokonazol je sredstvo protiv gljivica koje se koristi za liječenje infekcija uzrokovanih dermatofitima i kvascima.
English: On 25 July 2013, the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) recommended that the marketing authorisations of oral ketoconazole-containing medicines should be suspended throughout the European Union (EU).
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Europskoj agenciji za lijekove preporučilo je suspenziju odobrenja za stavljanje u promet lijekova koji sadrže oralni ketokonazol u cijeloj Europskoj Uniji (EU).
English: Consequently, the French agency asked the EMA to carry out a full assessment of the benefitrisk balance of oral ketoconazole-containing medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Croatian: Nastavno, francuska je agencija zatražila od EMA-e da provede cjelokupnu ocjenu omjera koristi i rizika lijekova koji sadrže oralni ketokonazol, te da dostavi mišljenje o zadržavanju, izmjeni, suspenziji ili povlačenju odobrenja za stavljanje lijeka u promet diljem EU-a.
English: • As oral ketoconazole is no longer recommended, doctors should review patients being treated with this medicine for fungal infections, with a view of stopping treatment or choosing an appropriate alternative treatment.
Croatian: • S obzirom da oralni ketokonazol nije više preporučen, liječnici moraju pregledati terapije bolesnika koji se liječe ovim lijekom protiv gljivičnih infekcija i prekinuti liječenje ili odabrati odgovarajuće alternativno liječenje.
English: Topical formulations of ketoconazole (such as creams, ointments and shampoos) can continue to be used as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Croatian: Topikalne formulacije ketokonazola (poput krema, masti i šampona) mogu se i dalje primjenjivati s obzirom da je količina ketokonazola koja se apsorbira kroz tijelo iz ovih formulacija vrlo mala.
English: Having assessed the available data on the risks with oral ketoconazole, the CHMP concluded that, although liver injury such as hepatitis is a known side effect of antifungal medicines, the incidence and the seriousness of liver injury with oral ketoconazole were higher than with other antifungals.
Croatian: Nakon procjene dostupnih podataka o rizicima povezanima s oralnim ketokonazolom, CHMP je zaključio da, iako je oštećenje jetre poput hepatitisa poznata nuspojava lijekova protiv gljivica, incidencija i ozbiljnost oštećenja jetre kod oralnog ketokonazola bile su većienego s drugim lijekovima protiv gljivica.
English: • If you are taking topical formulations of ketoconazole (such as creams, ointments and shampoos), you can continue your treatment, as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Croatian: • Ako uzimate topikalne formulacije ketokonazola (poput krema, masti i šampona), možete ih i dalje primjenjivati s obzirom da je količina ketokonazola koja se apsorbira kroz tijelo iz ovih formulacija vrlo mala.
English: • Pharmacists should refer patients with a prescription of oral ketoconazole for fungal infections to their treating doctor.
Croatian: • Ljekarnici trebaju uputiti bolesnike s receptom za oralni ketokonazol za liječenje gljivičnih infekcija njihovim ordinirajućim liječnicima.
English: In June 2011, the French medicines agency concluded that the benefit-risk balance of oral ketoconazole was negative and suspended the existing marketing authorisations in France.
Croatian: U srpnju 2011., francuska agencija za lijekove zaključila je da je omjer koristi i rizika negativan i suspendirala je postojeće odobrenja za stavljanje lijeka u promet u Francuskoj.
English: • If you are currently taking oral ketoconazole for fungal infections, you should speak to your doctor at a routine appointment to discuss suitable alternative treatments.
Croatian: • Ako trenutno uzimate oralni ketokonazol protiv gljivičnih infekcija, konzultirajte se sa svojim liječnikom na sljedećem rutinskom pregledu i raspravite pogodna alternativna liječenja.
English: Doctors should no longer prescribe oral ketoconazole and should review patients' treatment options.
Croatian: Liječnici ne smiju više propisivati oralni ketokonazol, te trebaju razmotriti druge mogućnosti za liječenje bolesnika.
English: Patients currently taking oral ketoconazole for fungal infections should make a non-urgent appointment with their doctor to discuss suitable alternative treatments.
Croatian: Bolesnici koji trenutno uzimaju oralni ketokonazol za gljivične infekcije trebaju zakazati konzultacije kod svojeg liječnika kako bi raspravili odgovarajuće alternativne terapije.
English: The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections.
Croatian: CHMP je zaključio da je u liječenju gljivičnih infekcija rizik od oštećenja jetre veći od koristi.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision valid throughout the EU.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji, koja je ga je usvojila kao pravno obvezujuću odluku na razini EU-a.
English: • Although the potential for hepatotoxicity is a class effect with azole antifungals, the data assessed show that the incidence and seriousness of hepatotoxicity is higher with ketoconazole than with other antifungal agents.1 Reported cases of hepatotoxicity included hepatitis, cirrhosis and liver failure with fatal outcomes or requiring liver transplantation.
Croatian: • Iako su izgledi za hepatotoksičnost učinak klase lijekova protiv gljivica koji sadrže azol, ocijenjeni podaci pokazuju da su incidencija i težina hepatotoksičnosti više kod ketokonazola nego u slučaju drugih lijekova protiv gljivica.1
English: * RED60: Rabbit effective dose in 60% of the animals (serology).
Croatian: 5 doza 10 bočica
English: • The prescription should include all of the following details:
Croatian: • Recept treba sadržavati sljedeće podatke:
English: More information on Amglidia can be found on the Agency's website: ema.europa.eu/Find medicine.
Croatian: Više informacija o lijeku Amglidia nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine.
English: • Amglidia is given twice a day.
Croatian: • Amglidia se daje dvaput na dan.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 August 2018 EMA/133231/2018
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22. kolovoza 2018.
English: Information for parents and carers
Croatian: Informacije za roditelje i njegovatelje
English: − how many doses are given each day,
Croatian: − broj doza koje se daju svaki dan,
English: Guide will increase awareness on the different medicine presentations and help avoid medication errors
Croatian: Vodič će povećati osviještenost o različitim prezentacijama lijeka i pomoći u izbjegavanju medikacijskih pogrešaka
English: The dose is prescribed in millilitre (ml) according to body weight.
Croatian: Doza se propisuje u mililitrima (ml) u skladu s tjelesnom težinom.
English: − daily dose of Amglidia in ml,
Croatian: − dnevnu dozu lijeka Amglidia u ml,
English: − size of the oral syringe to be used.
Croatian: − veličinu oralne štrcaljke koju treba upotrijebiti.
English: − volume in ml to be given for each dose,
Croatian: − volumen u ml koji se daje za svaku dozu,
English: Dosing errors may occur due to confusion between milligram (mg) and millilitre (ml), or use of incorrect strength or size of syringe and how the dose is measured, which may result in too high or too low blood sugar levels.
Croatian: Može doći do pogrešaka u doziranju zbog zamjene miligrama (mg) i mililitra (ml) ili uporabe pogrešne jačine ili veličine štrcaljke te načina mjerenja doze, što može dovesti do previsokih ili preniskih razina šećera u krvi.
English: It works on insulin-producing cells in the pancreas and attaches to special channels on their surface called ATP-sensitive potassium channels (KATP channels), through which potassium ions normally enter the cells and trigger the release of insulin.
Croatian: Djeluje na stanice koje proizvode inzulin u gušterači i veže se za posebne kanale na njihovoj površini pod nazivom ATP osjetljivi kalijevi kanali (KATP kanali), putem kojih kalijevi ioni obično ulaze u stanice i aktiviraju oslobađanje inzulina.
English: This is to limit the exposure to the sodium benzoate excipient.
Croatian: Razlog tomu jest ograničavanje izlaganja pomoćnoj tvari natrijeva benzoata.
English: − strength of Amglidia,
Croatian: − jačinu lijeka Amglidia,
English: To avoid medication errors, prescribers will be given a guide specifying which strength and presentation to use and what details to include on each prescription.
Croatian: Radi izbjegavanja medikacijskih pogrešaka liječnici koji propisuju lijek dobit će vodič u kojem se navodi koju jačinu i prezentaciju treba koristiti i koje podatke treba napisati na svaki recept.
English: • The choice of the oral syringe depends on the volume per dose:
Croatian: • Odabir oralne štrcaljke ovisi o volumenu po dozi:
English: Once Amglidia is started, it is usually possible to reduce and even stop the dose of insulin the patient is already receiving.
Croatian: Nakon početka liječenja lijekom Amglidia, obično je moguće smanjiti, a zatim potpuno ukinuti dozu inzulina koju bolesnik već prima.
English: Amglidia is effective in patients with specific genetic mutations (beta-cell ATP-sensitive potassium channel and chromosome 6q24).
Croatian: Lijek Amglidia djelotvoran je u bolesnika s određenim genskim mutacijama (ATP osjetljivi kalijev kanal beta stanica i kromosom 6q24).
English: All healthcare professionals who are expected to prescribe Amglidia (glibenclamide oral suspension) will be provided with a guide to help ensure that the medicine is prescribed and used correctly.
Croatian: Svi zdravstveni radnici za koje se očekuje da će propisivati lijek Amglidia (oralna suspenzija glibenklamida) dobit će vodič kojim će se osigurati ispravno propisivanje i uporaba lijeka.
English: When prescribing the medicine, the doctor will also specify the strength of Amglidia and the correct size of the oral syringe to give this dose accurately.
Croatian: Pri propisivanju lijeka, liječnik će navesti i jačinu lijeka Amglidia, kao i odgovarajuću veličinu oralne štrcaljke za pravilnu primjenu te doze.
English: • If the patient is switched to a different strength or a different oral syringe is appropriate, the prescriber should highlight to the parent or carer the packaging differences and carefully explain how to measure the new dose.
Croatian: • Ako bolesnik počne primati drugu jačinu ili oralnu štrcaljku druge veličine, liječnik koji propisuje lijek roditelju ili njegovatelju treba naglasiti koje su razlike u pakiranju te pažljivo objasniti kako izmjeriti novu dozu.
English: Healthcare professionals should also explain that the dose is to be given with the oral syringe graduated in ml, provided in the pack.
Croatian: Zdravstveni radnici također trebaju objasniti da se doza treba davati pomoću oralne štrcaljke graduirane u mililitrima, koja se isporučuje u pakiranju.
English: • Healthcare professionals should explain to the parent or carer that the dose of Amglidia is prescribed in ml according to the patient's body weight.
Croatian: • Zdravstveni radnici roditelju ili njegovatelju trebaju objasniti da se doza lijeka Amglidia propisuje u ml na temelju tjelesne težine bolesnika.
English: • Parents and carers should always use Amglidia as advised by the doctor.
Croatian: • Roditelji i njegovatelji uvijek trebaju primjenjivati lijek Amglidia prema savjetu liječnika.
English: Parents and carers should speak to a doctor or pharmacist if they have any questions about the treatment.
Croatian: Ako roditelji i njegovatelji imaju pitanja o liječenju, moraju se obratiti liječniku ili ljekarniku.
English: Glibenclamide's effect on the KATP channel restores the cells' ability to release insulin into the blood.
Croatian: Učinak glibenklamida na KATP kanal obnavlja sposobnost stanica za otpuštanje inzulina u tijelo.
English: − If the volume per dose is more than 1 ml, the 5-ml oral syringe should be prescribed.
Croatian: − ako volumen po dozi iznosi više od 1 ml, potrebno je propisati štrcaljku od 5 ml.
English: − If the volume per dose is equal to or less than 1 ml, the 1-ml oral syringe should be prescribed;
Croatian: − ako je volumen po dozi jednak ili manji od 1 ml, potrebno je propisati štrcaljku od 1 ml,
English: • Parents and carers will be advised by their healthcare professional on how to draw up the medicine into the oral syringe and give a dose to the child.
Croatian: • Zdravstveni radnici savjetovat će roditelje i njegovatelje o načinu izvlačenja lijeka pomoću štrcaljke i davanja lijeka djetetu.
English: The active substance in Amglidia, glibenclamide, is a diabetes medicine that belongs to the class of sulfonylureas.
Croatian: Djelatna tvar u lijeku Amglidia, glibenklamid, lijek je protiv dijabetesa koji se ubraja u skupinu sulfonilureja.
English: There are two presentations for each strength: one with an oral syringe of 1 ml and one with an oral syringe of 5 ml (see picture above).
Croatian: Postoje dvije prezentacije za svaku jačinu: jedna s oralnom štrcaljkom od 1 ml i druga s oralnom štrcaljkom od 5 ml (vidjeti prethodnu sliku).
English: • Pharmacists should ensure that the correct strength of Amglidia and the correct size of oral syringe are dispensed.
Croatian: • Farmaceuti trebaju provjeriti jesu li dali ispravnu jačinu lijeka Amglidia i odgovarajuću veličinu oralne štrcaljke.
English: It is a liquid to be given by mouth and is available in two strengths: 0.6 mg/ml and 6 mg/ml.
Croatian: To je tekućina koja se daje na usta te je dostupna u dvije jačine: 0,6 mg/ml i 6 mg/ml.
English: • Amglidia is an oral suspension available in two strengths: 0.6 mg/ml and 6 mg/ml.
Croatian: • Amglidia je oralna suspenzija dostupna u dvije jačine: 0,6 mg/ml i 6 mg/ml.
English: Guide to be given to prescribers to ensure Amglidia is used correctly
Croatian: Vodič koji se daje liječnicima koji propisuju lijek radi ispravne uporabe lijeka Amglidia
English: • Amglidia 0.6 mg/ml strength should only be used for doses up to 0.6 mg/kg daily.
Croatian: • Lijek Amglidia jačine 0,6 mg/ml treba upotrebljavati samo za doze do 0,6 mg/kg dnevno.
English: Each strength is available in two presentations: either with a 1-ml oral syringe or with a 5-ml oral syringe (see picture below).
Croatian: Svaka je jačina dostupna u dvije prezentacije: s oralnom štrcaljkom od 1 ml ili s oralnom štrcaljkom od 5 ml (pogledati sliku u nastavku).
English: Amglidia 6 mg/ml should be used for doses higher than 0.6 mg/kg daily.
Croatian: Lijek Amglidia od 6 mg/ml treba upotrebljavati samo za doze veće od 0,6 mg/kg dnevno.
English: Amglidia is a diabetes medicine used for neonatal diabetes, a form of diabetes that occurs in the first 6 months of life and that requires treatment with insulin.
Croatian: To je oblik dijabetesa koji se javlja u prvih šest mjeseci života i zahtijeva liječenje inzulinom.
English: Amglidia is a medicine used for the treatment of neonatal diabetes, a form of diabetes that occurs in the first 6 months of life.
Croatian: Amglidia je lijek koji se upotrebljava za liječenje neonatalnog dijabetesa.
English: It is important that only the syringe provided with the pack is used to measure Amglidia.
Croatian: Za mjerenje lijeka Amglidia važno je upotrijebiti samo štrcaljku koja je isporučena u pakiranju.
English: • Amglidia is used to treat neonatal diabetes, a form of diabetes that occurs in the first 6 months of life.
Croatian: • Amglidia se upotrebljava za liječenje neonatalnog dijabetesa.
English: • Only the oral syringe provided with the package should be used to measure the dose of Amglidia.
Croatian: • Za mjerenje lijeka Amglidia treba upotrebljavati samo oralnu štrcaljku isporučenu u pakiranju.
English: • Parents and carers should use only the oral syringe provided with the package to measure the dose of Amglidia.
Croatian: • Za mjerenje lijeka Amglidia roditelji i njegovatelji trebaju upotrebljavati samo oralnu štrcaljku isporučenu u pakiranju.
English: In this population, efficacy has not been demonstrated.
Croatian: U ovoj populaciji nije dokazana djelotvornost.
English: Date of first authorisation: 31st August 2018
Croatian: Datum prvog odobrenja: 31. kolovoza 2018.
English: Do not use in children under 18 years of age.
Croatian: Ne smije se primjenjivati u djece mlađe od 18 godina.
English: Observations with missing data were censored at the last date of assessment.
Croatian: Opažanja s podacima koji nedostaju cenzurirana su na posljednji datum procjene.
English: - Take all the tablets with water, at about the same time each day, preferably in the morning.
Croatian: - Uzimajte sve tablete s vodom, otprilike u isto vrijeme svaki dan, po mogućnosti ujutro.
English: Nerlynx with food and drink
Croatian: Nerlynx s hranom i pićem
English: You must also have previously been treated with trastuzumab.
Croatian: Također ste morali prethodno biti liječeni trastuzumabom.
English: Effect of race
Croatian: Učinak rase
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcije
English: There is no data in patients ≥85 years of age.
Croatian: Nema podataka za bolesnike u dobi od ≥85 godina.
English: • For toxicities that result in a treatment delay > 3 weeks, or
Croatian: • za toksičnosti koje su dovele do odgađanja liječenja > 3 tjedna ili
English: The course of treatment is one year.
Croatian: Liječenje traje godinu dana.
English: (see Section 4.4).
Croatian: (vidjeti dio 4.4).
English: No fertility studies in women or men have been conducted.
Croatian: Nisu provedena ispitivanja plodnosti u žena ili muškaraca.
English: The excretion was rapid and complete, with the majority of the radioactivity (61%) recovered within 96 hours and 98% recovered after 10 days.
Croatian: Izlučivanje je bilo brzo i potpuno; većina radioaktivnosti (61 %) izlučena je u roku od 96 sati, a 98 % nakon 10 dana.
English: Carton PC:
Croatian: Kutija: PC:
English: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt France
Croatian: Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt Francuska
English: • Any grade with complicated features†
Croatian: • Bilo koji stupanj sa složenim značajkama†
English: - Do not stop taking Nerlynx without talking to your doctor.
Croatian: Nemojte prestati uzimati Nerlynx bez savjetovanja s liječnikom.
English: Nerlynx dose modification is recommended based on individual safety and tolerability.
Croatian: Prilagodba doze lijeka Nerlynx preporučuje se na temelju pojedinačne sigurnosti i podnošljivosti.
English: - Take the tablets with food.
Croatian: - Uzimajte tablete s hranom.
English: Tablet dimensions are 10.5 mm x 4.3 mm with thickness of 3.1 mm.
Croatian: Dimenzije tableta iznose 10,5 mm x 4,3 mm, a njihova debljina iznosi 3,1 mm.
English: Approximately 75% of patients were re-consented for extended follow-up beyond 24 months.
Croatian: Za približno 75 % bolesnica dobivena je suglasnost za produljeno praćenje nakon 24 mjeseca.
English: Iron oxide red (E172)
Croatian: Željezov oksid, crveni (E172)
English: Grapefruit or grapefruit juice may also increase neratinib plasma concentrations and should be avoided.
Croatian: Grejp ili sok od grejpa također mogu povećati koncentracije neratiniba u plazmi i potrebno ih je izbjegavati.
English: Contents of the pack and other information What Nerlynx contains
Croatian: Sadržaj pakiranja i druge informacije Što Nerlynx sadrži
English: Alanine aminotransferase increased, and aspartate aminotransferase increased
Croatian: Povišena razina alanin aminotransferaze i povišena razina aspartat aminotransferaze
English: Talk to your doctor or pharmacist before taking Nerlynx.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Nerlynx.
English: Nerlynx should be taken with food, preferably in the morning.
Croatian: Nerlynx se mora uzimati uz obrok, po mogućnosti ujutro.
English: Your doctor will stop your treatment with Nerlynx if your liver tests show severe problems.
Croatian: Vaš će liječnik zaustaviti liječenje lijekom Nerlynx ako Vaše jetrene pretrage pokažu teške probleme.
English: It is not known if elimination is as unchanged drug or metabolites.
Croatian: Nije poznato izlučuje li se kao nepromijenjeni lijek ili kao metaboliti.
English: The ‘HER2 receptor' is a protein found on the surface of cells in the body.
Croatian: „Receptor HER2” je protein koji se nalazi na površini stanica u tijelu.
English: ULN=Upper Limit Normal; ALT= Alanine Aminotransferase * Per CTCAE v4.0
Croatian: GGN=gornja granica normalnih vrijednosti; ALT= alanin aminotransferaza * Prema CTCAE v4.0
English: • diltiazem, verapamil (calcium-channel blockers)
Croatian: • diltiazem, verapamil (blokatori kalcijevih kanala)
English: All Patients
Croatian: Sve bolesnice
English: While the treatment benefit of Nerlynx over placebo was maintained at five years, the effect size cannot be reliably estimated.
Croatian: Iako je korist od liječenja lijekom Nerlynx u odnosu na placebo zadržana na pet godina, veličina učinka ne može se pouzdano procijeniti.
English: • For patients that are unable to tolerate 120 mg daily
Croatian: • kod bolesnika koji ne mogu podnijeti dozu od 120 mg dnevno
English: Tests and checks for liver problems
Croatian: Pretrage i pregledi za probleme s jetrom
English: You may or may not have signs or symptoms of liver problems (e.g., yellow skin and/or eyes, dark urine, or light-colour stools).
Croatian: Možete i ne morate imati znakove ili simptome problema s jetrom (npr. žutilo kože i/ili očiju, tamna mokraća ili svijetle stolice).
English: A 6-month carcinogenicity study in Tg.rasH2 transgenic mice and the rat 2-year data showed no signs of carcinogenic potential.
Croatian: Ispitivanje kancerogenosti u trajanju od 6 mjeseci na Tg.rasH2 transgenim miševima i 2-godišnji podaci za štakore nisu pokazali znakove kancerogenog potencijala.
English: Take the medicine pack with you.
Croatian: Sa sobom uzmite ambalažu lijeka.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti (EXP) navedenog na boci i kutiji.
English: Negative
Croatian: Negativno
English: Hazard ratio (95% CI)2
Croatian: Omjer hazarda (95 % CI)2
English: - If you forget a dose, wait until the next day before you take the next dose.
Croatian: Ako zaboravite uzeti dozu lijeka, sljedeću dozu uzmite idući dan.
English: Missed doses should not be replaced and treatment should resume with the next scheduled daily dose (see Section 4.9).
Croatian: Propuštena doza Propuštene doze ne smiju se nadomjestiti, a liječenje treba nastaviti sljedećom predviđenom dnevnom dozom (vidjeti dio 4.9).
English: Your doctor will do blood tests before and during your treatment with Nerlynx.
Croatian: Vaš će liječnik provesti krvne pretrage prije i tijekom liječenja lijekom Nerlynx.