FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recommended that Ledaga be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Ledaga u Europskoj uniji.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ledaga has shown comparable safety and effectiveness to Caryolysine and has shown satisfactory quality.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da su sigurnost i djelotvornost lijeka Ledaga usporedive s onima lijeka Caryolysine te da je kvaliteta lijeka zadovoljavajuća.
English: Ledaga is a medicine used to treat adults with a skin cancer called mycosis fungoides-type cutaneous T-cell lymphoma.
Croatian: Ledaga je lijek koji se primjenjuje za liječenje odraslih osoba s rakom kože naziva kožni T-stanični limfom tipa mycosis fungoides.
English: The company provided data from the published literature showing that chlormethine, the active substance in Ledaga, is effective in treating mycosis fungoides-type cutaneous T-cell lymphoma.
Croatian: Kompanija je dostavila podatke iz objavljene literature kojima se utvrđuje da je klormetin, djelatna tvar lijeka Ledaga, djelotvoran u liječenju kožnog T-staničnog limfoma tipa mycosis fungoides.
English: For practical information about using Ledaga, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Ledaga bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: The ointment's effectiveness was considered comparable to that of the reference medicine, Caryolysine.
Croatian: Djelotvornost masti usporediva je s djelotvornošću lijeka Caryolysine, odnosno referentnog lijeka.
English: Ledaga, which is available as a gel, is applied as a thin film to the affected areas of the skin once a day.
Croatian: Lijek Ledaga, koji je dostupan u obliku gela, nanosi se na zahvaćena područja kože u tankom sloju jedanput na dan.
English: How does Ledaga work?
Croatian: Kako djeluje Ledaga?
English: This summary was last updated in 03-2017
Croatian: Ledaga EMA/880957/2016
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14 August 2015
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA 14. kolovoz 2015
English: • Take your capsule at about the same time each day.
Croatian: • Uzmite svoju kapsulu u otprilike isto vrijeme svakoga dana.
English: • every month during treatment.
Croatian: • svaki mjesec tijekom liječenja.
English: Your doctor will discuss with you the best method of contraception for you.
Croatian: Vaš liječnik će razgovarati s Vama o najboljoj metodi kontracepcije za Vas.
English: 2132JH Hoofddorp
Croatian: 2132JH Hoofddorp Nizozemska
English: *Event refers to disease progression or death due to any reason.
Croatian: * Događaj se odnosi na progresiju bolesti ili smrt od bilo kojeg uzroka.
English: • disturbed sense of taste or strange taste in the mouth
Croatian: • poremećeni osjećaj okusa ili čudan okus u ustima
English: • at least 7 days before starting treatment - to make sure that you are not already pregnant
Croatian: • najmanje 7 dana prije početka liječenja - kako bi provjerio da niste već trudni
English: • vitamin B3, also known as niacin
Croatian: • vitamin B3, poznat i kao niacin
English: Responder (Complete Response/Partial Response) Stable Disease
Croatian: S odgovorom (kompletan odgovor/djelomičan odgovor) Stabilna bolest
English: Talk to your doctor if you plan to have children in the future.
Croatian: Obratite se svom liječniku ako planirate imati djecu u budućnosti.
English: This interaction is not expected to be clinically significant.
Croatian: Ne očekuje se da će ova interakcija biti klinički značajna.
English: Take the medicine and its packaging and leaflet with you.
Croatian: Uzmite lijek i njegovo pakiranje i uputu sa sobom.
English: • has menstruated at any time during the previous 12 consecutive months,
Croatian: • je imala menstruaciju bilo kada tijekom prethodnih 12 uzastopnih mjeseci,
English: It is an anti-cancer medicine.
Croatian: To je lijek protiv raka.
English: These can alert your doctor to possible changes in the function of some parts of your body, for example:
Croatian: To može ukazivati Vašem liječniku na moguće promjene u funkcioniranju nekih dijelova Vašeg tijela, primjerice:
English: It may lead to the death of a baby before it is born or shortly after being born.
Croatian: Može dovesti do smrti djeteta prije rođenja ili ubrzo nakon rođenja.
English: Treatment interruptions of up to 3 weeks were allowed based on individual tolerability.
Croatian: Prekidi liječenja u trajanju do 3 tjedna bili su dopušteni na temelju individualne podnošljivosti.
English: • The need for adequate contraception and definition of adequate contraception
Croatian: • Potrebu za odgovarajućom kontracepcijom i definiciju odgovarajuće kontracepcije
English: Your doctor will test you for pregnancy:
Croatian: Liječnik će Vam napraviti test na trudnoću:
English: You must also use one barrier method, such as:
Croatian: Morate također koristiti jednu metodu barijere, kao što je:
English: • Requirements in the event of pregnancy
Croatian: • Zahtjeve u slučaju trudnoće
English: Sonidegib was evaluated in rats and dogs.
Croatian: Sonidegib se procjenjivao u štakora i pasa.
English: You must use one highly effective method, such as:
Croatian: Morate koristiti jednu visoko učinkovitu metodu, kao što je:
English: The following are recommended forms of highly effective methods
Croatian: U nastavku su navedeni preporučeni oblici visoko učinkovitih metoda
English: Tell your doctor if you notice any changes in your skin.
Croatian: Obratite se liječniku ako primijetite bilo kakve promjene na Vašoj koži.
English: It is important to check with your doctor whether there is a risk that you could become pregnant.
Croatian: Važno je da provjerite sa svojim liječnikom postoji li rizik da zatrudnite.
English: This will help you to remember when to take your medicine.
Croatian: Tako ćete lakše zapamtiti kada trebate uzeti svoj lijek.
English: • low level of white blood cells.
Croatian: • niska razina bijelih krvnih stanica.
English: Most effects occurred close to the intended human exposures.
Croatian: Većina učinaka pojavila se pri izloženostima blizu onih planiranih za ljude.
English: In case of pregnancy or missed menstrual periods
Croatian: U slučaju trudnoće ili izostanka menstruacije
English: CI: confidence interval
Croatian: CI: interval pouzdanosti
English: • National specific requirements as agreed with the National Competent Authority regarding:
Croatian: • Nacionalne specifične zahtjeve usuglašene s nacionalnim nadležnim tijelom koji se odnose na:
English: You must follow the contraception instructions contained in this leaflet.
Croatian: Morate slijediti naputke o kontracepciji navedene u ovoj uputi.
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA PC:
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC:
English: Children and adolescents (under 18 years of age)
Croatian: Djeca i adolescenti (mlađi od 18 godina)
English: - Never give this medicine to anyone else.
Croatian: Nikada nemojte davati ovaj lijekom nekome drugome.
English: • surgical sterilisation.
Croatian: • kirurška sterilizacija.
English: Your doctor will perform blood tests before treatment, and possibly during treatment as well.
Croatian: Liječnik će Vam obaviti krvne pretrage prije liječenja, a moguće također i tijekom liječenja.
English: Read carefully and follow the instructions of the patient brochure and reminder card given to you by your doctor.
Croatian: Pažljivo pročitajte i slijedite upute iz brošure za bolesnike i kartice-podsjetnika koje ste dobili od liječnika.
English: The normal growth of cells is controlled by various chemical signals.
Croatian: Normalan rast stanica kontroliraju razni kemijski signali.
English: The following are recommended barrier methods
Croatian: U nastavku su navedene preporučene metode barijere
English: Usually this type of cancer appears on sun-damaged skin, does not spread and can be cured.
Croatian: Obično se ova vrsta raka pojavljuje na koži oštećenoj suncem, ne širi se i može se izliječiti.
English: If you take more Odomzo than you should
Croatian: Ako uzmete više Odomza nego što ste trebali
English: These could be signs that your muscle fibre is breaking down, which is harmful to your kidneys.
Croatian: To bi mogli biti znakovi da se Vaša mišićna vlakna raspadaju, što je štetno za Vaše bubrege.
English: For a composite Complete Response, all modalities used for assessment had to demonstrate absence of tumour.
Croatian: Za kompozitni kompletan odgovor, sve metode upotrijebljene za procjenu morale su dokazati odsutnost tumora.
English: Objective response rate, n (%) 95% CI Best overall response, n (%) Complete response
Croatian: Stopa objektivnog odgovora, n (%) 95% CI Najbolji ukupni odgovor, n (%) Kompletan odgovor
English: Do not exceed the recommended dose prescribed by your doctor.
Croatian: Nemojte prekoračiti preporučenu dozu koju Vam je propisao liječnik.
English: NE: not estimable
Croatian: NE: ne može se procijeniti
English: Your doctor may need to change your dose, or stop your treatment temporarily or permanently.
Croatian: Liječnik će Vam možda morati promijeniti dozu, ili prekinuti liječenje, privremeno ili trajno.
English: Please refer to these documents for further information.
Croatian: Pogledajte te dokumente za dodatne informacije.
English: In the event of pregnancy, treatment must not be initiated.
Croatian: U slučaju trudnoće, liječenje se ne smije započeti.
English: The majority of patients experienced maintenance and/or improvement in their disease-related symptoms, functioning, and health status.
Croatian: Većina bolesnika imala je održanje i/ili poboljšanje svojih simptoma povezanih s bolešću, funkcioniranja i zdravstvenog stanja.
English: • Emergency contact phone numbers
Croatian: • Telefonske brojeve za kontakt u hitnim slučajevima
English: Among these women, amenorrhoea was observed in 1 patient (20%).
Croatian: Među tim ženama, amenoreja je zabilježena u 1 bolesnice (20%).
English: Talk to your doctor or pharmacist regarding where to return the capsules.
Croatian: Upitajte svoj liječnika ili ljekarnika gdje možete vratiti kapsule.
English: All the metabolites were deemed 4 to 90 times less potent than sonidegib.
Croatian: Za sve se metabolite smatralo da su 4 do 90 puta manje potentni od sonidegiba.
English: • you stop using contraception
Croatian: • prestanete koristiti kontracepciju
English: Odomzo should not be used in children and adolescents below the age of 18.
Croatian: Odomzo se ne smije koristiti u djece i adolescenata mlađih od 18 godina.
English: At exposures well above the clinical exposure, an additional target organ was the kidney.
Croatian: Pri izloženostima dosta iznad kliničke izloženosti dodatni ciljni organ bio je bubreg.
English: • if you are allergic to sonidegib or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na sonidegib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Odomzo may have an impact on fertility in men and women.
Croatian: Odomzo može utjecati na plodnost u muškaraca i žena.
English: Problems with growing teeth and bones were seenwith this medicine.
Croatian: Problemi s rastom zubi i kostiju bili su opaženi u ispitivanjima ovog lijeka.
English: • your periods stop
Croatian: • Vaše menstruacije prestanu
English: • Information on the recommended forms of contraception both for women and men
Croatian: • Informacije o preporučenim oblicima kontracepcije za žene i muškarce
English: Pregnancy testing
Croatian: Testiranje trudnoće
English: Do not change your dose without talking to your doctor.
Croatian: Ne mijenjajte svoju dozu, a da ne razgovarate prije o tome sa svojim liječnikom.
English: The majority of adverse effects of sonidegib can be attributed to its pharmacological mechanism of action on developmental pathways and effects in rats and dogs were similar.
Croatian: Većina štetnih učinaka sonidegiba može se pripisati njegovom farmakološkom mehanizmu djelovanja na razvojne putove, a učinci u štakora i pasa bili su slični.
English: Keep taking Odomzo for as long as your doctor tells you.
Croatian: Nastavite uzimati Odomzo dokle god Vam liječnik kaže.
English: • Check list for healthcare professional ensuring that patients receive the appropriate counselling
Croatian: • Kontrolni popis za zdravstvene djelatnike kako bi se osiguralo da bolesnici dobiju odgovarajuće savjetovanje
English: Pregnancy tests should have a minimum sensitivity of 25 mIU/ml as per local availability.
Croatian: Testovi na trudnoću moraju imati minimalnu osjetljivost od 25 mIU/ml ovisno o lokalnoj dostupnosti.
English: It is available in pack sizes of 10 and 30 capsules.
Croatian: Dostupan je u veličinama pakiranja od 10 i 30 kapsula.
English: Patients should be instructed never to give this medicinal product to another person.
Croatian: Bolesnike je potrebno uputiti da nikada ne daju ovaj lijek drugoj osobi.
English: Each pack contains either 10 or 30 hard capsules.
Croatian: Svako pakiranje sadrži ili 10 ili 30 tvrdih kapsula.
English: It is used when the cancer has spread locally and cannot be treated with surgery or radiation.
Croatian: Koristi se kada se rak proširio lokalno i ne može se liječiti kirurški ili zračenjem.
English: • if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Odomzo Pregnancy Prevention Programme.
Croatian: • ako možete zatrudnjeti, ali ne možete ili ne želite slijediti nužne mjere za sprječavanje trudnoće koje su navedene u Programu sprječavanja trudnoće uz Odomzo.
English: Management of high-grade CK elevation using supportive therapy, including proper hydration, should be considered according to local standards of medical practice and treatment guidelines.
Croatian: Zbrinjavanje povišenja CPK visokog stupnja pomoću potporne terapije, uključujući odgovarajuću hidraciju, potrebno je razmotriti u skladu s lokalnim standardima medicinske prakse i smjernicama za liječenje.
English: Healthcare professionals must educate patients so they understand and acknowledge all the conditions of the Odomzo Pregnancy Prevention Programme.
Croatian: Zdravstveni djelatnici moraju educirati bolesnike kako bi razumjeli i prihvatili sve uvjete Programa za sprječavanje trudnoće uz Odomzo.
English: Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity develops.
Croatian: Liječenje treba nastaviti dokle god se opaža klinička korist ili dok se ne razvije neprihvatljiva toksičnost.
English: This is because Odomzo can affect the way some medicines work.
Croatian: To je zato što Odomzo može utjecati na djelovanje nekih lijekova.
English: If you are able to become pregnant:
Croatian: (vidjeti primjere u nastavku) dok uzimate Odomzo,
English: Women of childbearing potential whose periods are irregular or have stopped must follow all the advice on effective contraception.
Croatian: Žene u reproduktivnoj dobi čije su menstruacije neredovite ili su prestale moraju slijediti sve savjete o učinkovitoj kontracepciji.
English: • She must be able to comply with effective contraceptive measures.
Croatian: • mora biti sposobna pridržavati se učinkovitih mjera kontracepcije.
English: The size of the capsule is “Size #00” (dimensions 23.3 x 8.53 mm).
Croatian: Veličina kapsule je "00" (dimenzije 23,3 x 8,53 mm).
English: There was reduced fertility at low exposure in female rats.
Croatian: Opažena je smanjena plodnost pri niskoj izloženosti u ženki štakora.
English: Odomzo is contraindicated during pregnancy.
Croatian: Odomzo je kontraindiciran tijekom trudnoće.
English: • The format and content of the Healthcare professional and patient material
Croatian: • Format i sadržaj materijala za zdravstvene djelatnike i bolesnike
English: Talk to your doctor if you are unsure.
Croatian: Obratite se liječniku ako niste sigurni.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Risk of severe birth defects.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Rizik od teških urođenih anomalija.
English: Results show a lack of significant efficacy despite the enrichment strategy focussed on Hh-activated medulloblastoma.
Croatian: Rezultati su pokazali da nije bilo značajne djelotvornosti unatoč strategiji poboljšanja koja je bila usmjerena na Hh-aktivirani meduloblastom.
English: • you need to change contraception
Croatian: • trebate promijeniti kontracepciju
English: • has not undergone a hysterectomy or a bilateral oophorectomy, or who does not have medically-confirmed permanent premature ovarian failure,
Croatian: • nije bila podvrgnuta histerektomiji ili bilateralnoj ooforektomiji, ili koja nema medicinski potvrđeno trajno prijevremeno zatajenje jajnika,
English: Stop taking Odomzo and tell your doctor straight away if you notice any of the following as these could be signs of an allergic reaction:
Croatian: Prestanite uzimati Odomzo i odmah se obratite liječniku ako primijetite bilo što od navedenoga jer bi to mogli biti znakovi alergijske reakcije:
English: They must not be chewed or crushed.
Croatian: Ne smiju se žvakati ili drobiti.
English: These tests will check the health of your muscles by measuring the levels of an enzyme in your blood called creatine phosphokinase.
Croatian: Tim će se pretragama provjeriti zdravlje Vaših mišića mjerenjem razina enzima u Vašoj krvi koji se naziva kreatin fosfokinaza.
English: Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Croatian: Korist nastavka liječenja treba redovito procjenjivati, pri čemu će se optimalno trajanje terapije razlikovati za svakog pojedinog bolesnika.
English: • The need to ensure all patients complete and sign the Odomzo Verification of Counselling Form which is to be present in the healthcare professional educational material
Croatian: • Potrebu da se osigura da svi bolesnici popune i potpišu Obrazac potvrde o savjetovanju o Odomzu koji se treba nalaziti u edukacijskim materijalima za zdravstvene djelatnike
English: Odomzo is not likely to affect your ability to drive or use any tools or machines.
Croatian: Odomzo vjerojatno neće utjecati na Vašu sposobnost upravljanja vozilima ili korištenja bilo kakvih alata ili strojeva.
English: The safety and efficacy of Odomzo in children and adolescents aged below 18 years with basal cell carcinoma have not been established.
Croatian: Sigurnost i djelotvornost Odomza u djece i adolescenata u dobi ispod 18 godina s karcinomom bazalnih stanica nisu ustanovljene.
English: b Using only negative histology to define CR among patients who have at least a PR from other modalities (MRI or photography) resulted in a CR rate of 21.2%.
Croatian: b Uporaba samo negativne histologije za definiranje CR-a među bolesnicima koji imaju najmanje PR u drugim metodama (MR ili fotografije) rezultirala je stopom CR-a od 21,2%.
English: The elimination half-life (t1/2) of sonidegib estimated from population pharmacokinetic modeling was approximately 28 days.
Croatian: Poluvijek eliminacije (t1/2) sonidegiba procijenjen iz populacijskog farmakokinetičkog modeliranja bio je otprilike 28 dana.
English: The recommended dose is 200 mg (1 capsule) a day.
Croatian: Preporučena doza je 200 mg (1 kapsula) na dan.
English: Odomzo works by blocking this process, stopping cancer cells from growing and making new cells.
Croatian: Odomzo djeluje tako što blokira taj proces, zaustavlja rast stanica raka i stvaranje novih stanica.
English: Some medicines (e.g. medicines used to treat high cholesterol) might increase the risk for muscle problems.
Croatian: Neki lijekovi (npr. lijekovi koji se koriste za liječenje visokog kolesterola) mogu povećati rizik od mišićnih tegoba.
English: This includes medicines obtained without a prescription and herbal medicines.
Croatian: Ovo uključuje lijekove koji se izdaju bez recepta i biljne lijekove.
English: These could be signs of a problem called rhabdomyolysis, which involves the breakdown of muscle tissue.
Croatian: To bi mogli biti znakovi stanja koje se zove rabdomioliza, koje uključuje raspadanje mišićnog tkiva.
English: • Information for men
Croatian: • Informacije za muškarce
English: Any capsules that remain unused at the end of treatment should immediately be disposed of by the patient in accordance with local requirements (e.g. by returning the capsules to their pharmacist or physician).
Croatian: Sve kapsule koje ostanu neiskorištene na kraju liječenja bolesnik treba odmah zbrinuti sukladno lokalnim propisima (npr. tako da vrati kapsule svom ljekarniku ili liječniku).
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the following with the National Competent Authority:
Croatian: Prije stavljanja u promet u svakoj državi članici, nositelj odobrenja dužan je usaglasiti s nacionalnim nadležnim tijelom:
English: This was also true for grade 3/4 adverse reactions, except fatigue.
Croatian: To je vrijedilo i za nuspojave stupnja 3/4, osim za umor.
English: • The need to tell patients to report immediately to the treating healthcare professional if pregnancy is suspected in a female patient, or in a female partner of a male patient
Croatian: • Potrebu da se kaže bolesnicima da odmah prijave zdravstvenom djelatniku koji ih liječi ako postoji sumnja na trudnoću kod bolesnice, ili kod partnerice muškog bolesnika
English: Sonidegib is a competitive inhibitor of CYP2B6 and CYP2C9 in vitro.
Croatian: Sonidegib je kompetitivni inhibitor CYP2B6 i CYP2C9 in vitro.
English: If a dose is missed, it should be taken as soon as this is realised, unless more than six hours have passed since it was scheduled to be taken; in this case, the patient should wait and take the next scheduled dose.
Croatian: Ako se doza propusti, potrebno ju je uzeti čim se to uvidi, osim ako je prošlo više od šest sati od kada je prema rasporedu trebala biti uzeta; u tom slučaju, bolesnik treba pričekati i uzeti sljedeću dozu prema rasporedu.
English: Efficacy and safety of sonidegib have been studied in two clinical studies involving a total of 62 paediatric patients.
Croatian: Djelotvornost i sigurnost sonidegiba ispitivane su u dvama kliničkim ispitivanjima u kojima su sudjelovala ukupno 62 pedijatrijska bolesnika.
English: In the pivotal study, 29.1% of patients discontinued due to adverse events, which were mostly mild or moderate (see section 4.8).
Croatian: U ključnom ispitivanju 29,1% bolesnika prekinulo je liječenje zbog štetnih događaja, koji su uglavnom bili blagi ili umjereni (vidjeti dio 4.8).
English: They are imprinted with “SONIDEGIB 200MG” and “NVR”.
Croatian: Imaju otisnute oznake „SONIDEGIB 200MG“ i „NVR“.
English: To avoid potential foetal exposure during pregnancy, a male patient must understand that:
Croatian: Da bi se izbjegla potencijalna izloženost fetusa tijekom trudnoće, bolesnik mora razumjeti da:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu
English: • She must have a negative pregnancy test monthly during treatment, even if she has become amenorrhoeic.
Croatian: • mora imati negativan test na trudnoću svaki mjesec tijekom liječenja, čak i ako je postala amenoroična.
English: Pregnancy and breast-feeding (see sections 4.4 and 4.6).
Croatian: Trudnoća i dojenje (vidjeti dijelove 4.4 i 4.6).
English: • Safety advice for men
Croatian: • Sigurnosne savjete za muškarce
English: • absence of menstrual periods
Croatian: • izostanak menstruacija
English: AUCinf of sonidegib was 40%, 22% and 8% lower, respectively.
Croatian: AUCinf sonidegiba bio je 40%, 22% odnosno 8% niži.
English: Prescriptions of Odomzo should be limited to 30 days of treatment, with continuation of treatment requiring a new prescription.
Croatian: Recepti za Odomzo trebaju biti ograničeni na 30 dana liječenja, pri čemu je za nastavak liječenja potreban novi recept.