FrancophonIA/ELRC3.0 huggingface dataset:
English: Make sure you have read all of the package leaflet including the step-by-step guide and keep it in a safe place.
Croatian: Pazite da pročitate cijelu uputu o lijeku, uključujući vodič kroz korake uzimanja, i čuvajte je na sigurnom mjestu.
English: • 2 and 6 months after start of treatment in each treatment year.
Croatian: • 2 i 6 mjeseci nakon početka liječenja u svakoj godini liječenja.
English: If the number of tablets in your pack(s) is different from the number shown for your weight in the table below, speak to your doctor.
Croatian: Ako se broj tableta u pakiranju (pakiranjima) razlikuje od broja prikazanog za Vašu tjelesnu težinu u tablici niže, obratite se liječniku.
English: • Guidance for patient's monitoring during the treatment;
Croatian: • Smjernice za praćenje bolesnika tijekom liječenja;
English: Contact with skin should be limited.
Croatian: Potrebno je ograničiti dodir s kožom.
English: Swallow them without chewing.
Croatian: Progutajte ih bez žvakanja.
English: If this recovery takes more than 6 months, the patient should not receive MAVENCLAD anymore.
Croatian: Ako je za oporavak potrebno više od 6 mjeseci, bolesnik više ne smije primati MAVENCLAD.
English: - If you lose a tablet, contact your doctor for advice.
Croatian: - Ako izgubite tabletu, obratite se liječniku za savjet.
English: Secondary progressive MS with relapses
Croatian: Sekundarno progresivni MS s relapsima
English: Example: if you have to take 8 tablets, you would take 2 tablets on Day 1, Day 2, Day 3, then 1 tablet on Day 4 and Day 5.
Croatian: Primjer: ako morate uzeti 8 tableta, uzet ćete 2 tablete 1. dana, 2. dana, 3. dana, a potom 1 tabletu 4. dana i 5. dana.
English: Live or live attenuated vaccines
Croatian: Živa ili živa atenuirana cjepiva
English: The estimated terminal half-life for a typical patient from the population pharmacokinetic analysis is approximately 1 day.
Croatian: Procijenjeni terminalni poluvijek u tipičnog bolesnika prema populacijskoj farmakokinetičkoj analizi iznosi približno 1 dan.
English: If a daily dose consists of two tablets, both tablets are taken together as a single dose.
Croatian: Ako se dnevna doza sastoji od dvije tablete, obje se tablete uzimaju zajedno kao jedna doza.
English: It is known that the more medicine you take the less lymphocytes may be present in your body, resulting in lymphopenia (see section 4).
Croatian: Poznato je da što više lijeka uzmete, to će manje limfocita biti u Vašem tijelu, što će dovesti do limfopenije (Pogledajte dio 4).
English: Although cladribine may have a potential for genotoxicity, long-term data in mice and monkeys did not provide any evidence of a relevant increased carcinogenicity risk in humans.
Croatian: Iako kladribin možda ima genotoksični potencijal, dugoročni podaci u miševa i majmuna nisu pružili nikakav dokaz za postojanje relevantnog povećanog kancerogenog rizika u ljudi.
English: See also 'Other medicines and MAVENCLAD'.
Croatian: Pogledajte također „Drugi lijekovi i MAVENCLAD”.
English: • A reminder to carefully consider data on blood count monitoring and screening for latent infections before starting the treatment;
Croatian: • Podsjetnik da se pažljivo razmotre podaci iz praćenja krvne slike i probira na latentne infekcije prije početka liječenja;
English: Clinical studies with oral cladribine in MS did not include patients over 65 years of age; therefore, it is not known whether they respond differently from younger patients.
Croatian: Klinička ispitivanja s peroralnim kladribinom kod MS-a nisu uključila bolesnike starije od 65 godina; stoga nije poznato je li njihov odgovor drugačiji od odgovora mlađih bolesnika.
English: (3) Pull the tray out until it stops.
Croatian: (3) Izvlačite pliticu dok se ne zaustavi.
English: Make sure you know how many tablets are contained in the package.
Croatian: Pazite da znate koliko je tableta u pakiranju.
English: Consultation with a haematologist is advised.
Croatian: Predlaže se savjetovanje s hematologom.
English: Have a glass of water ready and make sure your hands are clean and dry before taking the tablet(s).
Croatian: Pripremite čašu vode i pazite da su Vam ruke čiste i suhe prije nego što uzmete tabletu (tablete).
English: Day 1 Day 2 Day 3 Day 4 Day 5
Croatian: 1. dan 2. dan 3. dan 4. dan 5. dan
English: However, net effects in terms of potential cladribine exposure alterations are difficult to predict.
Croatian: Međutim, neto učinke u smislu mogućih promjena izloženosti kladribinu teško je predvidjeti.
English: The most important side effect is a reduction in the number of white blood cells called lymphocytes (lymphopenia), which is very common (may affect more than 1 in 10 people) and may be severe.
Croatian: Najvažnija nuspojava je smanjenje broja bijelih krvnih stanica koje se nazivaju limfociti (limfopenija), koja je vrlo česta (može se javiti u više od 1 na 10 osoba) i može biti teška.
English: Tell your doctor immediately if you have symptoms of shingles such as a 'band' of severe pain and blistering rash, typically on one side of the upper body or the face.
Croatian: Odmah obavijestite liječnika ako imate simptome herpes zostera kao što je „pruga“ jakog bola i osipa s mjehurićima, obično na jednoj strani na gornjoj polovici tijela ili na licu.
English: These may be the symptoms of a rare brain disorder caused by infection and called progressive multifocal leukoencephalopathy (PML).
Croatian: To mogu biti simptomi rijetke moždane bolesti prouzročene infekcijom koja se naziva progresivna multifokalna leukoencefalopatija (PML).
English: Hormonal contraceptives
Croatian: Hormonski kontraceptivi
English: If necessary, the treatment course in year 2 can be delayed for up to 6 months to allow for recovery of lymphocytes.
Croatian: Po potrebi se ciklus liječenja u 2. godini može odgoditi do 6 mjeseci kako bi se omogućio oporavak limfocita.
English: - if you are allergic to cladribine or any of the other ingredients of MAVENCLAD (listed in section 6).
Croatian: - ako ste alergični na kladribin ili neki drugi sastojak lijeka MAVENCLAD (naveden u dijelu 6).
English: In the left column of the table below find the row that fits your body weight (in kg), and then check the number of tablets that should be in the pack(s) for the treatment week you will be starting.
Croatian: U lijevom stupcu tablice niže, pronađite redak s tjelesnom težinom koja odgovara Vašoj težini (u kg) i onda provjerite broj tableta koji bi trebao biti u pakiranju (pakiranjima) za tjedan liječenja koji započinjete.
English: - certain types of vaccines (live and live attenuated vaccines).
Croatian: - određenim vrstama cjepiva (živa i živa atenuirna cjepiva).
English: - Do not leave your tablet(s) exposed on surfaces, for example on a table, or handle the tablet longer than necessary.
Croatian: - Nemojte ostavljati tabletu (tablete) izloženu na površinama, na primjer stolu, ili je dirati rukama dulje nego što je potrebno.
English: MAVENCLAD is a medicine used to treat multiple sclerosis (MS) in adults.
Croatian: MAVENCLAD je lijek koji se primjenjuje za liječenje multiple skleroze (MS) u odraslih.
English: If you get pregnant more than 6 months after the last dose in year 1, no safety risk is expected but this will mean that you cannot receive treatment with MAVENCLAD while you are pregnant.
Croatian: Ako zatrudnite nakon što je prošlo više od 6 mjeseci od zadnje doze u 1. godini, ne očekuje se nikakav sigurnosni rizik, ali to će značiti da se ne možete liječiti lijekom MAVENCLAD dok ste trudni.
English: • patients with 2 or more relapses in the previous year, whether on DMD treatment or not.
Croatian: • bolesnike s 2 ili više relapsa u prethodnoj godini, bez obzira na to jesu li ili nisu bili liječeni
English: Take the tablet(s) at about the same time each day.
Croatian: Uzmite tabletu (tablete) svakog dana u otprilike isto vrijeme.
English: Use of MAVENCLAD is not recommended in patients below the age of 18 years, because it has not been investigated in this age group.
Croatian: Ne preporučuje se primjena lijeka MAVENCLAD u bolesnika mlađih od 18 godina, zato što nije ispitan u toj dobnoj skupini.
English: Keep your tablets in the blister until your next dose.
Croatian: Čuvajte tablete u blisteru do iduće doze.
English: Short-term corticosteroids can be used when advised by your doctor.
Croatian: Kortikosteroidi se smiju uzimati kratkoročno kad to savjetuje liječnik.
English: Testicular degeneration and reversible decrease in spermatozoa with rapid progressive motility were also seen in the monkey.
Croatian: Testikularna degeneracija i reverzibilno smanjenje broja spermija s brzom progresivnom pokretljvošću također su bili opaženi u majmuna.
English: Caution: Do not remove the tray from the carton.
Croatian: Oprez: Nemojte izvaditi pliticu iz kutije.
English: EU/1/17/1212/001 - 1 tablet EU/1/17/1212/002 - 4 tablets EU/1/17/1212/003 - 5 tablets EU/1/17/1212/004 - 6 tablets EU/1/17/1212/005 - 7 tablets EU/1/17/1212/006 - 8 tablets
Croatian: EU/1/17/1212/001 - 1 tableta EU/1/17/1212/002 - 4 tablete EU/1/17/1212/003 - 5 tableta EU/1/17/1212/004 - 6 tableta EU/1/17/1212/005 - 7 tableta EU/1/17/1212/006 - 8 tableta
English: Patients with hereditary problems of fructose intolerance should not take this medicinal product.
Croatian: Bolesnici s nasljednim nepodnošenjem fruktoze ne bi smjeli uzimati/primiti ovaj lijek.
English: If you have been vaccinated within the last 4 to 6 weeks, MAVENCLAD therapy must be delayed.
Croatian: Ako ste bili cijepljeni unutar posljednjih 4 do 6 tjedana, terapija lijekom MAVENCLAD mora se odgoditi.
English: This is important because MAVENCLAD may seriously harm your baby.
Croatian: To je važno zato što MAVENCLAD može ozbiljno naškoditi Vašem djetetu.
English: Histologically, testicular degeneration was only seen in one male monkey in a 1-year subcutaneous toxicity study.
Croatian: Histološki, testikularna degeneracija bila je opažena samo u jednog mužjaka majmuna u 1-godišnjem toksikološkom ispitivanju potkožne primjene.
English: MS is a disease in which inflammation destroys the protective sheath around the nerves.
Croatian: MS je bolest u kojoj upala unišava zaštitnu ovojnicu živaca.
English: • The treatment regimens;
Croatian: • Režime liječenja;
English: What MAVENCLAD is and what it is used for
Croatian: Što je MAVENCLAD i za što se koristi
English: Clinically relevant interactions with inhibitors of P-gp are not expected.
Croatian: Ne očekuju se klinički značajne interakcije s inhibitorima P-gp-a.
English: Lymphopenia may increase the risk of getting an infection.
Croatian: Limfopenija može povećati rizik od dobivanja infekcije.
English: If this is not possible, dose reduction to the minimum mandatory dose of medicinal products containing these compounds, separation in the timing of administration and careful patient monitoring is recommended.
Croatian: Ako to nije moguće, preporučuju se sniženje doze na najnižu nužnu dozu lijekova koji sadrže ove spojeve, primjena s vremenskim razmakom i pažljivo praćenje bolesnika.
English: Do not store the tablets in a different container.
Croatian: Nemojte čuvati tablete u nekom drugom spremniku.
English: Do not take MAVENCLAD:
Croatian: Nemojte uzimati MAVENCLAD:
English: Cladribine and/or its phosphorylated metabolites are substantially accumulated and retained in human lymphocytes.
Croatian: Kladribin i/ili njegovi fosforilirani metaboliti znatno se nakupljaju i zadržavaju u ljudskim limfocitima.
English: There can be overlaps in the effect on your immune system.
Croatian: Može doći do preklapanja učinaka na imunološki sustav.
English: Other common side effects - may affect up to 1 in 10 people - cold sore (oral herpes) - rash - hair loss - reduction in the number of certain white blood cells (neutrophils)
Croatian: Druge česte nuspojave - mogu se javiti u do 1 na 10 osoba - herpes (oralni herpes) - osip - gubitak kose - smanjenje broja određenih bijelih krvnih stanica (neutrofila)
English: - if you have a weakened immune system due to medical conditions or because you are taking other medicines that weaken your immune system or reduce the production of blood cells in your bone marrow.
Croatian: - ako imate oslabljen imunološki sustav zbog zdravstvenih stanja ili zato što uzimate druge lijekove koji Vam slabe imunološki sustav ili smanjuju stvaranje krvnih stanica u koštanoj srži.
English: Do not take MAVENCLAD and talk to your doctor or pharmacist if you are unsure if any of the above applies to you.
Croatian: Nemojte uzimati MAVENCLAD i obratite se liječniku ili ljekarniku ako niste sigurni odnosi li se nešto od gore navedenog na Vas.
English: Talk to your doctor or pharmacist before taking MAVENCLAD.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete MAVENCLAD.
English: • The Patient Guide The Prescriber Guide should include:
Croatian: • Vodič za bolesnike Vodič za propisivače lijeka treba uključivati:
English: Talk to your doctor, if you are or have been treated with: - medicines which may affect your blood cells (for example carbamazepine, used to treat epilepsy).
Croatian: Obratite se liječniku ako se liječite ili ste se liječili: - lijekovima koji mogu utjecati na krvne stanice (na primjer, karbamazepin, koji se primjenjuje za liječenje epilepsije).
English: A population kinetic analysis did not show any effect of age (range 18 to 65 years) or gender on cladribine pharmacokinetics.
Croatian: Analiza populacijske kinetike nije pokazala da dob (u rasponu od 18 do 65 godina) ili spol utječu na farmakokinetiku kladribina.
English: If you require blood transfusions, tell the doctor that you are taking MAVENCLAD.
Croatian: Ako Vam je potrebna transfuzija krvi, obavijestite liječnika da uzimate MAVENCLAD.
English: Each pack contains 1, 4, 5, 6, 7 or 8 tablets in a blister, sealed in a cardboard wallet and fixed in a child-resistant carton.
Croatian: Jedno pakiranje sadrži 1, 4, 5, 6, 7 ili 8 tableta u blisteru, zalijepljenom u kartonskom ovitku i pričvršćenom u kutiji sigurnoj za djecu.
English: However, testicular effects were observed in mice and monkeys (see section 5.3).
Croatian: Međutim, bili su opaženi testikularni učinci u miševa i majmuna (vidjeti dio 5.3).
English: The doctor will also do blood tests during and after treatment to check that you can continue to take MAVENCLAD, and that you are not developing any complications from the treatment.
Croatian: Liječnik će provesti krvne pretrage tijekom i nakon Vašeg liječenja da provjeri možete li nastaviti uzimati MAVENCLAD i da ne razvijate nikakve komplikacije izazvane liječenjem.
English: Your doctor may delay treatment, or interrupt it, until the infection clears up.
Croatian: Liječnik može odgoditi liječenje ili ga prekinuti dok infekcija ne prođe.
English: Your immune system must have recovered before you can be vaccinated, and blood tests will check this.
Croatian: Imunološki sustav se mora oporaviti prije nego što se možete cijepiti, a to će se provjeriti krvnim pretragama.
English: Effects on the kidneys were also seen in mice.
Croatian: Učinci na bubrege bili su opaženi i u miševa.
English: If your doctor believes that MAVENCLAD is essential for you, your doctor will advise you to stop breast-feeding.
Croatian: Ako liječnik smatra da Vam je MAVENCLAD neophodan, savjetovat će Vam da prestanete dojiti.
English: Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „EXP“.
English: While there were no effects on female fertility, reproductive function or general performance of offspring, cladribine was shown to be embryolethal when administered to pregnant mice, and the compound was teratogenic in mice (also following treatment of the males only) and rabbits.
Croatian: Iako nije bilo učinaka na plodnost u ženki, reproduktivnu funkciju ili opću sposobnost potomstva, pokazalo se da je kladribin embrioletalan kad se primjenjuje u gravidnih ženki miša i da je taj spoj bio teratogen u miševa (također i nakon liječenja samo mužjaka) i kunića.
English: Do not take MAVENCLAD at the same time as any other medicine.
Croatian: Nemojte uzeti MAVENCLAD u isto vrijeme kad i neki drugi lijek.
English: Oriented polyamide (OPA)/aluminium (Al)/polyvinyl chloride (PVC) - aluminium (Al) blister sealed in a cardboard wallet and fixed in a child-resistant outer carton.
Croatian: Orijentirani poliamid (OPA)/aluminij (Al)/polivinil klorid (PVC) - aluminijski (Al) blister zalijepljen u kartonskom ovitku i učvršćen u kutiji sigurnoj za djecu.
English: Latent infections may be activated, including tuberculosis or hepatitis.
Croatian: Mogu se aktivirati latentne infekcije, uključujući tuberkulozu i hepatitis.
English: Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight.
Croatian: Svaki tjedan liječenja sastoji se od 4 ili 5 dana u kojima bolesnik prima 10 mg ili 20 mg (jednu ili dvije tablete) u obliku jedne dnevne doze, ovisno o tjelesnoj težini.
English: Careful monitoring of haematological parameters is recommended in such cases.
Croatian: U takvim se slučajevima preporučuje pažljivo praćenje hematoloških parametara.
English: Raise the blister pack by pushing your finger through the hole in the tray.
Croatian: Odignite blister pakiranje tako što ćete provući prst kroz rupu na plitici.
English: Concomitant use of other oral medicinal products
Croatian: Istodobna primjena drugih peroralnih lijekova
English: Do not take the missed dose along with the next scheduled dose.
Croatian: Nemojte uzeti propuštenu dozu zajedno s idućom planiranom dozom.
English: Women who become pregnant under therapy with MAVENCLAD should discontinue treatment.
Croatian: Žene koje zatrudne tijekom terapije lijekom MAVENCLAD moraju prekinuti liječenje.
English: Tablets must be swallowed whole and not chewed or allowed to dissolve in your mouth.
Croatian: Tablete se moraju progutati cijele i ne smiju se žvakati niti ostaviti da se otope u ustima.
English: In the overall study population, the median age was 39 years (range 18 to 65), and the female to male ratio was approximately 2:1.
Croatian: Medijan dobi cijele populacije u ispitivanju bio je 39 godina (raspon od 18 do 65 godina), a omjer žena i muškaraca bio je približno 2:1.
English: The volume of distribution is large, indicating extensive tissue distribution and intracellular uptake.
Croatian: Volumen distribucije je velik, što ukazuje na opsežnu distribuciju u tkiva i ulazak u stanice.
English: Patients with secondary progressive MS were excluded in the CLARITY study.
Croatian: Bolesnici sa sekundarno progresivnim MS-om bili su isključeni iz ispitivanja CLARITY.
English: Cladribine can reduce the body's immune defence and may increase the likelihood of infections.
Croatian: Kladribin može oslabiti imunološku obranu tijela i može povećati vjerojatnost infekcija.
English: Active chronic infection (tuberculosis or hepatitis).
Croatian: Aktivna kronična infekcija (tuberkuloza ili hepatitis).
English: Symptoms of infections can include: fever, aching, painful muscles, headache, generally feeling unwell or loss of appetite.
Croatian: Simptomi infekcija mogu uključivati: vrućicu, bolove, bolne mišiće, glavobolju, opće loše osjećanje ili gubitak apetita.
English: If you take more MAVENCLAD than you should
Croatian: Ako uzmete više lijeka MAVENCLAD nego što ste trebali
English: Particular attention is recommended for patients who have no history of exposure to varicella zoster virus.
Croatian: Preporučuje se osobita pozornost kod bolesnika koji nikad nisu bili izloženi virusu varicella zoster.
English: There is no known specific antidote to an overdose of cladribine.
Croatian: Nema poznatog određenog antidota za predoziranje kladribinom.
English: Teratogenicity/adverse pregnancy outcomes, to ensure that female patients of child bearing potential / partners of male patients receiving Mavenclad: a.
Croatian: Teratogenost/nepovoljni ishodi trudnoće, kako bi se osiguralo da žene reproduktivne dobi / partnerice muških bolesnika koji primaju Mavenclad: a.
English: - if you have active tuberculosis or liver inflammation (hepatitis).
Croatian: ako imate aktivnu tuberkulozu ili upalu jetre (hepatitis).
English: MAVENCLAD tablets are white, round, biconvex tablets engraved with 'C' on one side and '10' on the other side.
Croatian: MAVENCLAD tablete su bijele, okrugle, bikonveksne tablete s utisnutim „C” na jednoj strani i „10” na drugoj strani.
English: The tablets must be taken with water, and swallowed without chewing.
Croatian: Tablete se moraju popiti s vodom i progutati bez žvakanja.
English: Vaccination with live or attenuated live vaccines should be avoided during and after cladribine treatment as long as the patient's white blood cell counts are not within normal limits.
Croatian: Potrebno je izbjegavati cijepljenje živim ili živim atenuiranim cjepivima tijekom i nakon liječenja kladribinom, dokle god broj bijelih krvnih stanica u bolesnika nije unutar granica normale.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije nego uzmete ovaj lijeka.
English: Do not use MAVENCLAD together with other medicines for MS unless specifically advised by your doctor.
Croatian: Nemojte primjenjivati MAVENCLAD zajedno s drugim lijekovima za MS osim kad Vam je to posebno savjetovao liječnik.
English: Leave a gap of at least 3 hours between taking MAVENCLAD and other medicines taken by mouth.
Croatian: Dopustite da protekne najmanje 3 sata između uzimanja lijeka MAVENCLAD i drugih lijekova koji se uzimaju kroz usta.
English: Following oral administration, cladribine is rapidly absorbed.
Croatian: Nakon peroralne primjene, kladribin se brzo apsorbina.
English: Patients who had completed the CLARITY study could be enrolled in CLARITY Extension.
Croatian: Bolesnici koji su završili ispitivanje CLARITY mogli su biti uključeni u ispitivanje CLARITY Extension.
English: - Thoroughly wash your hands after handling the tablets.
Croatian: - Temeljito operite ruke nakon što ste njima dodirivali tabletu.
English: As the tablets are uncoated, they must be swallowed immediately once removed from the blister and not be left exposed on surfaces or handled for any period of time greater than that required for dosing.
Croatian: Budući da su tablete neobložene, moraju se progutati odmah nakon što se izvade iz blistera i ne smiju se ostaviti izložene na površinama niti smiju biti u dodiru s rukama dulje nego što je potrebno za doziranje.
English: MS pathology involves a complex chain of events in which different immune cell types, including autoreactive T and B cells play a key role.
Croatian: Patologija MS-a uključuje kompleksan lanac događaja u kojem različite vrste imunoloških stanica, uključujući autoreaktivne T i B stanice, igraju ključnu ulogu.
English: Tell your doctor immediately if you get symptoms of shingles, a common complication of MAVENCLAD (see section 4), which may need specific treatment.
Croatian: Odmah obavijestite liječnika ako dobijete simptome herpes zostera, koji je česta komplikacija lijeka MAVENCLAD (pogledajte dio 4) i može zahtijevati posebno liječenje.
English: No significant accumulation of cladribine concentration in plasma has been observed after repeated dosing.
Croatian: Nije opaženo značajno nakupljanje koncentracije kladribina u plazmi nakon ponovljenih doza.
English: This is important because MAVENCLAD can seriously harm your baby.
Croatian: To je važno zato što MAVENCLAD može ozbiljno naškoditi djetetu.
English: A delay in initiation of cladribine should also be considered in patients with an acute infection until the infection is fully controlled.
Croatian: Odgađanje početka primjene kladribina potrebno je razmotriti i u bolesnika s akutnom infekcijom sve dok infekcija ne bude potpuno pod kontrolom.