FrancophonIA/ELRC3.0 huggingface dataset:
English: Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face.
Croatian: Trokutasta filmom obložena tableta boje lososa s utisnutom oznakom “7.5” na jednoj strani, a na drugoj.
English: The mean ivabradine doses allowing to achieve a 20% HRR were 0.13 ± 0.04 mg/kg bid, 0.10 ± 0.04 mg/kg bid and 4.1 ± 2.2 mg bid in the age subsets [1-3[ years, [3-18[ years and <40 kg and [3-18[
Croatian: U 69,9% bolesnika koji su primali ivabradin postignuto je 20% sniženje broja otkucaja srca bez bradikardije u usporedbi s 12,2% bolesnika u skupini koja je primala placebo tijekom titracije doza u razdoblju od 2 do 8 tjedana (omjer izgleda E = 17,24, 95% CI [5,91; 50,30]) Srednje doze ivabradina koje su omogućile postizanje sniženje broja otkucaja srca za 20% su 0,13 ± 0,04 mg/kg/dan dva puta na dan, 0,10 ± 0,04 mg/kg/dan dva puta na dan i 4,1 ± 2,2 mg dva puta na dan u starosnim podskupinama [1-3[ godine, [3-18[ godina i s <40 kg te [3-18[ godina i s ≥ 40 kg.
English: In some markets only one of these devices may be available.
Croatian: Na nekim tržištima može biti dostupan samo jedan od ovih uređaja.
English: McDonald (2005) Conversion
Croatian: McDonaldova (2005) konverzija
English: • Certain laboratory tests may change.
Croatian: • Rezultati određenih laboratorijskih testova mogu se promijeniti.
English: • Wait until the green light switches off.
Croatian: • Pričekajte dok se ne isključi zeleno svjetlo.
English: Rebif should be administered three times per week, and if possible:
Croatian: Rebif treba primjenjivati tri puta tjedno, i ako je moguće:
English: Do not put your fingers in the safety guard.
Croatian: Nemojte stavljati prste u sigurnosni štitnik.
English: Depression and suicidal ideation
Croatian: Depresija i suicidalna ideacija
English: Parameter Statistics
Croatian: Parametar Statistika
English: For example, your muscles may feel very tense or very weak, preventing you from moving as you want.
Croatian: Npr. možete osjetiti da su Vam mišići vrlo napeti ili vrlo slabi što Vas sprječava da se pokrećete onako kako biste htjeli.
English: Risk Reduction
Croatian: Redukcija rizika
English: No specific risk factors have been identified.
Croatian: Specifični faktori rizika nisu identificirani.
English: • or if you have experienced depression,
Croatian: • ili ako ste bili depresivni,
English: • if you are severely depressed at present.
Croatian: • ako ste trenutačno u stanju teške depresije.
English: At the present time, it is not known for how long patients should be treated.
Croatian: Do danas još nije poznato koliko dugo se bolesnici moraju liječiti.
English: Push the pen against your skin until you feel resistance.
Croatian: Pogurajte brizgalicu prema koži sve dok ne osjetite otpor.
English: It will also instruct you when you need to change the cartridge.
Croatian: Uputit će vas kada morate promijeniti uložak.
English: Below is a picture showing what RebiDose looks like.
Croatian: U nastavku se nalazi slika koja prikazuje kako RebiDose izgleda.
English: Recommended Titration (% of final dose)
Croatian: Preporučena titracija (% ukupne doze)
English: • at the same time of day (preferably in the evening).
Croatian: • u isto vrijeme (po mogućnosti navečer).
English: • Wash your hands thoroughly with soap and water.
Croatian: • Dobro operite ruke sapunom i vodom.
English: This “Instructions for use” was last revised in
Croatian: Ove „Upute za uporabu“ su zadnji puta revidirane u
English: Not all injection devices may be available.
Croatian: Svi uređaji za injiciranje ne moraju biti dostupni.
English: • Rebif should only be used under the supervision of your doctor.
Croatian: • Rebif se treba koristiti samo pod nadzorom Vašeg liječnika.
English: Cox's Proportional Hazard Ratio [95% CI]
Croatian: Coxov omjer proporcionalnih rizika [95% CI]
English: • Alcohol wipes or similar.
Croatian: • Alkoholne blazinice ili slično
English: • RebiDose is for single use only and should never be reused.
Croatian: • RebiDose je namijenjen samo za jednokratnu primjenu i ne treba ga nikada ponovno koristiti.
English: After first injection use within 28 days.
Croatian: Nakon prve injekcije primijeniti unutar 28 dana.
English: This tells you that the injection is completed.
Croatian: To označava da je Vaša injekcija dovršena.
English: You will hear a click which indicates the start of the injection and the plunger will start moving.
Croatian: Čut ćete klik koji ukazuje na početak injekcije i klip će se početi pomicati.
English: To give yourself an injection you will need:
Croatian: Kako biste dali sami sebi injekciju, potrebno Vam je sljedeće:
English: You should not stop or alter the medication without your doctor's advice.
Croatian: Ne biste trebali prekidati ili mijenjati primjenu lijeka bez savjeta Vašeg liječnika.
English: If you use more Rebif than you should
Croatian: Ako primijenite više Rebifa nego što ste trebali
English: In particular you should tell your doctor if you are using antiepileptics or antidepressants.
Croatian: Svom liječniku naročito recite ako uzimate antiepileptike ili antidepresive.
English: Hepatitis with or without icterus*
Croatian: Hepatitis sa ili bez ikterusa*
English: Other medicines and Rebif
Croatian: Drugi lijekovi i Rebif
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Croatian: Na temelju podataka iz ispitivanja na životinjama (vidjeti dio 5.3), postoji mogućnost povećanog rizika od spontanog pobačaja.
English: It is not necessary to keep the button pressed down with your thumb after the injection has begun.
Croatian: Nije potrebno držati gumb pritisnut nadolje palcem nakon početka injekcije.
English: Remove the needle from the skin.
Croatian: Izvucite iglu iz kože.
English: These are natural substances that transmit messages between cells.
Croatian: To su prirodne tvari koje prenose poruke između stanica.
English: • A new RebiDose and
Croatian: • Novi RebiDose i
English: If a bit of alcohol is left on the skin, you may get a stinging sensation.
Croatian: Ako na koži ostane i malo alkohola, možete osjetiti žarenje.
English: Let the skin dry.
Croatian: Pričekajte da se koža osuši.
English: Liver function tests may be disturbed (very common).
Croatian: Testovi jetrenih funkcija mogu biti poremećeni (vrlo često).
English: Succursale d'Aubonne Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Switzerland
Croatian: Succursale d'Aubonne Zone Industrielle de l'Ouriettaz CH-1170 Aubonne Švicarska
English: • Insomnia (sleeping difficulty)
Croatian: • nesanica (problemi sa spavanjem)
English: Please follow these carefully.
Croatian: Pažljivo ih se pridržavajte.
English: Date of latest renewal: 04 May 2008
Croatian: Datum posljednje obnove odobrenja: 04. svibnja 2008.
English: What Rebif is and what it is used for
Croatian: Što je Rebif i za što se koristi
English: This is to minimise the risk of skin damage (necrosis).
Croatian: To je da bi se smanjio rizik od oštećenja kože (nekroza).
English: Discuss with your doctor which device is the most suitable for you.
Croatian: Raspravite sa svojim liječnikom koji je uređaj najprikladniji za Vas.
English: No harmful effects on the breastfed newborn/infant are anticipated.
Croatian: Ne očekuju se štetni učinci na dojenu novorođenčad/dojenčad.
English: Keep RebiDose pressed against the skin for at least 10 seconds in order to inject all of the medicine.
Croatian: RebiDose držite pritisnut na kožu tijekom najmanje 10 sekundi kako bi se injicirao sav lijek.
English: Depression, insomnia
Croatian: Depresija, nesanica
English: • Visually check that there is no liquid left.
Croatian: • Vizualno provjerite da nema zaostale tekućine.
English: Otherwise go to the section “If you use RebiSlide”.
Croatian: Inače prijeđite na dio „Ako koristite RebiSlide“.
English: The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja opisana je sljedećom terminologijom: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • Serious allergic (hypersensitivity) reactions.
Croatian: • Ozbiljne alergijske reakcije (preosjetljivost).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i genotoksičnosti.
English: The devices are provided separately.
Croatian: Uređaji se isporučuju zasebno.
English: CH-1804 Corsier-sur-Vevey Switzerland or
Croatian: CH-1804 Corsier-sur-Vevey Švicarska ili
English: • Keep enough pressure on the skin and press the button with your thumb.
Croatian: • Zadržite dovoljan pritisak na koži i pritisnite gumb palcem.
English: Other possible side effects include:
Croatian: Ostale nuspojave koje se mogu pojaviti uključuju:
English: Usually symptoms disappear within one or two weeks after treatment is stopped.
Croatian: Uobičajeni simptomi nestaju unutar jednog ili dva tjedna nakon prekida terapije.
English: Log-Rank p-value
Croatian: Log-rang p-vrijednost
English: If you feel depressed or develop thoughts of suicide, report it immediately to your doctor.
Croatian: Ako se osjećate deprimiranim ili razvijate ideje o samoubojstvu, odmah ih prijavite svom liječniku.
English: Rebif 44 mcg tiw* (n=171)
Croatian: Rebif 44 μg tiw* (n=171)
English: What Rebif looks like and contents of the pack
Croatian: Kako Rebif izgleda i sadržaj pakiranja
English: From the fifth week onwards, RebiSmart will automatically switch to the usual dose regimen.
Croatian: Od petog tjedna nadalje RebiSmart automatski se prebacuje na režim uobičajene doze.
English: The number of red blood cells, white blood cells or platelets may decrease either individually (very common) or all at one time (rare).
Croatian: Broj crvenih krvnih stanica, bijelih krvnih stanica ili krvnih pločica može se smanjiti bilo svaki zasebno (vrlo često) bilo svi u isto vrijeme (rijetko).
English: The interaction of Rebif with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Croatian: Interakcija Rebifa s kortikosteroidima ili s adrenokortikotropnim hormonom (ACTH) nije sistematično proučavana.
English: (To prevent accidental freezing, avoid placing near the freezer compartment).
Croatian: (Kako biste izbjegli slučajno zamrzavanje, ne stavljajte lijek blizu odjeljka za zamrzavanje).
English: • Look through the transparent window to make sure that the plunger has moved to the bottom as indicated in the figure.
Croatian: • Pogledajte kroz prozirni prozorčić kako biste se uvjerili da se klip pomaknuo prema dnu kako je to naznačeno na slici.
English: Weeks 5+
Croatian: Tjedni 5+
English: Tell your doctor as they may be signs of a possible kidney problem.
Croatian: Obratite se svom liječniku jer to mogu biti znakovi mogućeg problema s bubrezima.
English: Therefore you should not stop using Rebif but continue to use it regularly to achieve the desired result.
Croatian: Stoga nemojte prekidati primjenu Rebifa već ga nastavite redovno primjenjivati kako bi se postigao očekivani rezultat.
English: Children and teenagers Side effects in children and teenagers are similar to those observed in adults.
Croatian: Djeca i adolescenti Nuspojave kod djece i adolescenata slične su onima opaženima kod odraslih.
English: The occurrence of injection site reactions usually decreases over time.
Croatian: Pojava reakcija na mjestu injiciranja obično se smanjuje tijekom vremena.
English: The physician should discuss with the patient which device is the most appropriate.
Croatian: Liječnik mora s bolesnikom razgovarati o tome koji je uređaj najprikladniji.
English: • To activate the “initiation/titration” menu you need to first select 44 micrograms, then ‘initiation/titration', press ‘change', select ‘on', press ‘ok' and confirm ‘initiation/titration on' by pressing ‘ok'.
Croatian: • Za aktivaciju izbornika „initiation/titration“ prvo trebate odabrati 44 mikrograma, potom „initiation/titration“, pritisnite „change“, odaberite „on“, pritisnite „ok“ i potvrdite „initiation/titration on“ pritiskom na „ok“.
English: Interferons are produced by the body and play an essential role in the immune system.
Croatian: Interferone proizvodi tijelo i imaju bitnu ulogu u imunološkom sustavu.
English: • Read all the following instructions carefully before using RebiDose.
Croatian: • Pročitajte sve sljedeće upute pažljivo prije uporabe brizgalice RebiDose.
English: You should not discontinue the treatment without first contacting your doctor.
Croatian: Ne smijete prekidati liječenje bez da ste prethodno kontaktirali svog liječnika.
English: • Depression is common (may affect up to 1 in 10 people) in treated patients with multiple sclerosis.
Croatian: • Depresija je česta (može se javiti u do 1 na 10 osoba) u liječenih bolesnika s multiplom sklerozom.
English: Effects of the disease itself or of its treatment might influence your ability to drive or to use machines.
Croatian: Bolest sama po sebi ili njeno liječenje mogu utjecati na sposobnost upravljanja vozilima i strojevima.
English: • Hold RebiSlide in place until “0” appears in the dose window, then wait 10 seconds before removing the needle from the skin.
Croatian: •Držite RebiSlide na mjestu sve dok se ne pojavi „0“ u prozorčiću za dozu, a potom pričekajte 10sekundi prije vađenja igle iz kože.
English: If you have been prescribed RebiSmart please go to the section “If you use RebiSmart”.
Croatian: Ako Vam je propisan RebiSmart, idite na dio „Ako koristite RebiSmart“.
English: It is intended for single use and should only be used following adequate training of the patient and/or carer.
Croatian: Namijenjena je za jednokratnu primjenu i treba je koristiti samo nakon odgovarajuće obuke bolesnika i/ili njegovatelja.
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Croatian: Rizik od spontanog pobačaja u trudnica izloženih interferonu beta ne može se odgovarajuće ocijeniti na temelju trenutno dostupnih podataka, ali ti podaci za sada ne ukazuju na povećan rizik.
English: The safety guard automatically surrounds the needle and locks into place to protect you from the needle.
Croatian: Sigurnosni štitnik automatski okružuje iglu i blokira se na mjestu kako bi Vas zaštitio od igle.
English: The injection site can become infected (uncommon); the skin may become swollen tender and hard and the whole area could be very painful.
Croatian: Mjesto injiciranja može postati inficirano (manje često); koža može postati natečena osjetljiva na dodir i tvrda, a cijelo područje može biti vrlo bolno.
English: Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Croatian: Liječenje mora započeti pod nadzorom liječnika iskusnog u liječenju ove bolesti.
English: However, a paediatric retrospective cohort study collected safety data with Rebif from medical records in children (n=52) and adolescents (n=255).
Croatian: Međutim, u pedijatrijskoj retrospektivnoj kohortnoj studiji prikupljeni su podaci o sigurnosti primjene Rebifa iz medicinskih podataka djece (n=52) i adolescenata (n=255).
English: Pharmacotherapeutic group: Immunostimulants, Interferons, ATC code: L03AB07
Croatian: Farmakoterapijska skupina: Imunostimulatori, interferoni, ATK oznaka: L03AB07
English: • Serious skin reactions - some with mucosal lesions
Croatian: • ozbiljne kožne reakcije - neke s oštećenjem sluznice
English: The estimated apparent half-life is 50 to 60 hours, which is in line with the accumulation observed after multiple dosing.
Croatian: Prividni poluvijek procjenjuje se na 50 do 60 sati, što je u skladu s opaženim nakupljanjem nakon višestrukih doza.
English: • Check (just after removing from the refrigerator) that the cartridge is not accidentally frozen in the pack or inside the device.
Croatian: • Provjerite (neposredno po vađenju iz hladnjaka) da se uložak nije slučajno smrznuo u pakiranju unutar uređaja.
English: In case of overdose, patients should be hospitalised for observation and appropriate supportive treatment should be given.
Croatian: U slučaju predoziranja, bolesnike treba hospitalizirati radi promatranja i primjene odgovarajućeg suportivnog liječenja.
English: In any case, treatment should only be considered for patients classified as high risk.
Croatian: U svakom slučaju, liječenje treba razmotriti jedino za bolesnike koji su klasificirani visokorizičnima.
English: The effects of Rebif may not be noticed immediately.
Croatian: Učinak Rebifa ne mora se odmah primijetiti.
English: These changes are generally not noticed by the patient (no symptoms), are usually reversible and mild, and most often do not require particular treatment.
Croatian: Te promjene bolesnici većinom ne osjećaju (nema simptoma), obično su prolazne i blage te za većinu nije potrebno posebno liječenje.
English: What Rebif is and what it is used for What you need to know before you use Rebif How to use Rebif
Croatian: Što je Rebif i za što se koristi Što morate znati prije nego počnete primjenjivati Rebif Kako primjenjivati Rebif
English: • The initiation pack contains two identical cartridges of Rebif and you may initiate treatment with either cartridge.
Croatian: • Početno pakiranje sadrži dva identična uloška lijeka Rebif i možete početi s liječenjem s bilo kojim uloškom.
English: If you use RebiSmart • RebiSmart is programmed to guide you through the entire initiation process and automatically increases the dose during the initiation period.
Croatian: • RebiSmart je programiran da Vas navodi kroz cijeli proces inicijacije i automatski povećava dozu tijekom razdoblja inicijacije.
English: For single dose only.
Croatian: Samo za jednokratnu dozu.
English: What Rebif contains
Croatian: Što Rebif sadrži
English: • Liver inflammation (hepatitis)
Croatian: • upala jetre (hepatitis)
English: If clinically needed, the use of Rebif may be considered during pregnancy
Croatian: Ako je klinički potrebno, može se razmotriti primjena Rebifa tijekom trudnoće.
English: • Do not remove the cap until you are ready to administer the injection.
Croatian: • Nemojte skidati zatvarač sve dok ne budete spremni primijeniti injekciju.
English: It has been shown to reduce the number and the severity of relapses and to slow the progression of disability.
Croatian: Pokazalo se da smanjuje broj i težinu ponovnih pojava bolesti i usporava napredovanje bolesti.
English: The safety and efficacy of Rebif in children below 2 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost Rebifa u djece mlađe od 2 godine nisu još ustanovljene.
English: Hepatic failure* (see section 4.4), autoimmune hepatitis*
Croatian: Zatajenje jetre* (vidjeti dio 4.4), autoimuni hepatitis*
English: However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when the pregnancy was detected and/or confirmed.
Croatian: Međutim, trajanje izloženosti tijekom prvog tromjesečja nije se moglo utvrditi zato što su podaci prikupljani dok je primjena interferona beta tijekom trudnoće bila kontraindicirana pa je liječenje vjerojatno bilo prekinuto kad je otkrivena i/ili potvrđena trudnoća.
English: What you need to know before you use Rebif
Croatian: Što morate znati prije nego počnete primjenjivati Rebif
English: First demyelinating event
Croatian: Prvi događaj demijelinizacije
English: If you miss a dose, continue to inject from the day of the next scheduled dose.
Croatian: Ako propustite dozu, nastavite s primjenom lijeka na dan iduće planirane doze.
English: The precise mechanism of action of Rebif in multiple sclerosis is still under investigation.
Croatian: Točan mehanizam djelovanja Rebifa kod multiple skleroze još se istražuje.
English: It is also approved for use in patients who have experienced a single clinical event likely to be a first sign of multiple sclerosis.
Croatian: Također je odobren za primjenu kod bolesnika koji su iskusili jedan klinički događaj za koji je vjerojatno da predstavlja prvi znak multiple skleroze.
English: Although the clinical significance of the induction of antibodies has not been fully elucidated, the development of neutralising antibodies is associated with reduced efficacy on clinical and MRI variables.
Croatian: Iako kliničko značenje indukcije protutijela nije potpuno razjašnjeno, razvoj neutralizirajućih protutijela povezan je sa smanjenjem djelotvornosti kliničkih i MRI varijabli.
English: A study on embryo/foetal toxicity in monkeys showed no evidence of reproductive disturbances.
Croatian: Ispitivanje embrionalne/fetalne toksičnosti na majmunima nije ukazalo na reproduktivne poremećaje.
English: Interferons are a group of endogenous glycoproteins endowed with immunomodulatory, antiviral and antiproliferative properties.
Croatian: Interferoni su skupina endogenih glikoproteina koji su obogaćeni imunomodulatornim, antivirusnim i antiproliferativnim svojstvima.
English: Do not use RebiDose if the expiry date has passed.
Croatian: Nemojte koristiti RebiDose ako je istekao rok valjanosti.
English: Safety and efficacy with Rebif have not been demonstrated beyond 4 years of treatment.
Croatian: Sigurnost i djelotvornost liječenja Rebifom nije dokazana za razdoblje duže od 4 godine.
English: During the injection, the button will flash with a green light.
Croatian: Tijekom injekcije gumb treperi zeleno.
English: • on the same three days every week (at least 48 hours apart, e.g. Monday, Wednesday, Friday)
Croatian: • na ista tri dana svakog tjedna (s najmanjim razmakom od 48 sati primjerice, ponedjeljkom,
English: Use in children (below 2 years of age) Rebif is not recommended for use in children below 2 years of age.
Croatian: Primjena u djece (mlađa od 2 godine) Primjena Rebifa ne preporučuje se kod djece mlađe od 2 godine.
English: • Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Croatian: • plućna arterijska hipertenzija - bolest jakog suženja krvnih žila u plućima što rezultira visokim krvnim tlakom u krvnim žilama koje prenose krv iz srca u pluća.
English: For storage of the device with the cartridge, see section 6.4.
Croatian: Za čuvanje uređaja s uloškom vidjeti dio 6.4.
English: • Epileptic seizures
Croatian: • epileptični napadaji
English: Equipment
Croatian: Oprema
English: Any disease other than multiple sclerosis that could better explain signs and symptoms of the patient had to be excluded.
Croatian: Treba isključiti bilo koju drugu bolest osim multiple skleroze koja bi mogla bolje objasniti znakove i simptome koje bolesnik osjeća.
English: Patients with single lesions may continue provided that the necrosis is not too extensive.
Croatian: Bolesnici s pojedinačnim lezijama mogu nastaviti s liječenjem, pod uvjetom da nekroza nije preopsežna.
English: Hold the syringe like a pencil or dart.
Croatian: Štrcaljku držite kao olovku ili pikado strelicu.
English: • Irregularities and/or changes in menstrual flow.
Croatian: • nepravilan i/ili promijenjen menstruacijski ciklus.
English: Tell your doctor immediately and stop using Rebif if you experience any of the following serious side effects:
Croatian: Odmah obavijestite svog liječnika i prestanite uzimati Rebif ako osjetite bilo koju od sljedećih ozbiljnih nuspojava:
English: Rebif belongs to a class of medicines known as interferons.
Croatian: Rebif pripada skupini lijekova poznatih pod imenom interferoni.