FrancophonIA/ELRC3.0 huggingface dataset:
English: • Inflammation of the fatty tissue under the skin (panniculitis), which can make the skin feel hard and possibly develop painful red lumps or patches.
Croatian: • upala potkožnog masnog tkiva (panikulitis), zbog koje koža može biti tvrda na dodir i mogu se razviti bolne crvene kvržice ili mrlje.
English: Nephrotic syndrome*, glomerulosclerosis* (see section 4.4) General disorders and administration site conditions Very common:
Croatian: Nefrotski sindrom*, glomeruloskleroza* (vidjeti dio 4.4) Opći poremećaji i reakcije na mjestu primjene Vrlo često:
English: OTHER Merck Europe B.V.
Croatian: DRUGO Merck Europe B.V.
English: It may also be administered with a suitable auto-injector.
Croatian: Također se može primijeniti pomoću odgovarajućeg uređaja za samostalno injiciranje.
English: Rebif must then be returned to the refrigerator and used before the expiry date.
Croatian: Rebif se potom mora vratiti u hladnjak i upotrijebiti do isteka roka valjanosti.
English: If tests are normal at baseline, routine testing is not needed but should be performed if clinical findings of thyroid dysfunction appear (see section 4.8).
Croatian: Kod normalnih početnih vrijednosti, rutinsko testiranje nije potrebno, ali ga treba provesti u slučaju kliničkih nalaza disfunkcije štitnjače (vidjeti dio 4.8).
English: • Kidney problems including scarring that may reduce your kidney function.
Croatian: • Problemi s bubrezima uključujući nastanak ožiljaka koji mogu oslabiti njihovu funkciju.
English: Patients treated with Rebif should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Croatian: Bolesnike liječene Rebifom treba uputiti da svom nadležnom liječniku odmah prijave svaki simptom depresije i/ili suicidne misli.
English: • Flu-like symptoms, such as headache, fever, chills, muscle and joint pains, fatigue and nausea are very common (may affect more than 1 in 10 people).
Croatian: • Simptomi nalik gripi, poput glavobolje, vrućice, zimice, bolova u mišićima i zglobovima, umor i mučnina su vrlo česte (mogu se javiti u više od 1 na10 osoba).
English: Rebif is used for the treatment of multiple sclerosis.
Croatian: Rebif se koristi za liječenje multiple skleroze.
English: From the fifth week onwards, after you have completed your initiation period, you will follow the usual dose regimen prescribed by your doctor.
Croatian: Od petog tjedna nadalje nakon dovršetka početnog razdoblja pridržavat ćete se uobičajenog režima doziranja koji Vam je propisao Vaš liječnik.
English: Rebif, like other interferons beta, has a potential for causing severe liver injury including acute hepatic failure (see section 4.8).
Croatian: Rebif poput svih drugih interferona beta ima potencijal za uzrokovanje teških oštećenja jetre uključujući akutno zatajenje jetre (vidjeti dio 4.8).
English: During week one and two: 0.1 mL, which corresponds to the dose of 8.8 micrograms
Croatian: Tijekom prvog i drugog tjedna: 0,1 ml, što odgovara dozi od 8,8 mikrograma
English: The administration of interferons has been associated with anorexia, dizziness, anxiety, arrhythmias, vasodilation and palpitation, menorrhagia and metrorrhagia.
Croatian: Upotreba interferona povezana je s anoreksijom, omaglicom, anksioznošću, aritmijom, vazodilatacijom, palpitacijom, menoragijom i metroragijom.
English: Talk to your doctor if you experience any of the following side effects:
Croatian: Obavijestite svog liječnika ako osjetite bilo koju od sljedećih nuspojava:
English: If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Rebif is recommended.
Croatian: Ako se dijagnosticira TMA, potrebno je bez odlaganja započeti liječenje (razmotriti plazmaferezu) i preporučuje se odmah prekinuti liječenje Rebifom.
English: Rebif has not been investigated for carcinogenicity.
Croatian: Kancerogenost Rebifa nije istraživana.
English: Intramuscular and subcutaneous administrations produce fully superimposable responses.
Croatian: Intramuskularna i supkutana primjena dovode do potpuno usporedivih odgovora.
English: • Gently pinch the skin together around the site (to lift it up a bit).
Croatian: • Nježno stisnite kožu oko mjesta injiciranja (da se malo podigne).
English: • Once you have finished your injection, immediately discard RebiDose.
Croatian: • Nakon dovršetka injekcije odmah bacite RebiDose.
English: Regardless of the route of dosing, pronounced pharmacodynamic changes are associated with the administration of Rebif.
Croatian: Neovisno o putu primjene, uočene su naglašene farmakodinamičke promjene povezane s primjenom Rebifa.
English: If, immediately following Rebif administration you experience a sudden difficulty breathing, which may appear in association with swelling of face, lips, tongue or throat, nettle rash, itching all over the body, and a feeling of weakness or faintness, contact your doctor immediately or seek urgent medical attention.
Croatian: Ako neposredno nakon primjene Rebifa osjetite iznenadne smetnje disanja koje mogu biti praćene oticanjem lica, usana, jezika ili grla, koprivnjačom, svrbežom cijelog tijela te osjećajem slabosti i nesvjestice, odmah se javite svom liječniku ili potražite hitnu liječničku pomoć.
English: • Your doctor will tell you how to choose the correct dose of 44 micrograms.
Croatian: • Vaš liječnik će Vam reći kako odabrati točnu dozu od 44 mikrograma..
English: Peaks of similar height and time were observed for most of these markers after first and sixth administration.
Croatian: Za većinu ovih biljega opažene su slične vršne vrijednosti u otprilike istim vremenskim intervalima nakon prve i šeste primjene.
English: (LOWER FLAP)
Croatian: (DONJI PREKLOP)
English: Read carefully the package leaflet of Rebif 22 micrograms/0.5 mL or Rebif 44 micrograms/0.5 mL before you start your fifth week treatment.
Croatian: Pažljivo pročitajte Uputu o lijeku Rebif 22 mikrograma/0,5 ml ili lijeku Rebif 44 mikrograma/0,5 ml prije početka petog tjedna terapije.
English: Initiating treatment
Croatian: Početno liječenje
English: • Before the injection, use an alcohol wipe to clean the skin at the injection site.
Croatian: • Prije injiciranja, vatom natopljenom alkoholom očistite kožu na mjestu injiciranja.
English: • Your doctor will tell you how to choose the correct dose of 22 micrograms.
Croatian: • Vaš liječnik će Vam reći kako odabrati točnu dozu od 22 mikrograma.
English: E. Main body F. Button
Croatian: Tijelo brizgalice F. Gumb
English: If the patient population was divided into 2 subgroups (those with and those without relapses in the 2-year period prior to study entry), there was no effect on disability in patients without relapses, but in patients with relapses, the proportion with progression in disability at the end of the study was reduced from 70% (placebo) to 57% (Rebif 22 micrograms and 44 micrograms combined).
Croatian: Ako populaciju bolesnika podijelimo u dvije podgrupe (one sa i one bez relapsa, u dvogodišnjem periodu prije ulaska u ispitivanje), kod bolesnika bez relapsa nema učinka na onesposobljenost, dok je u grupi bolesnika s relapsom udio s napredovanjem onesposobljenosti na kraju ispitivanja smanjen sa 70% (placebo) na 57% (u kombinaciji Rebifa 22 mikrograma i Rebifa 44 mikrograma).
English: • patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1)
Croatian: • bolesnici s pojedinačnim događajem demijelinizacije s aktivnim upalnim procesom ako su isključene druge dijagnoze te ako je utvrđeno da su bolesnici pod velikim rizikom od razvoja klinički jasne multiple skleroze (vidjeti dio 5.1)
English: If a patient responds poorly to therapy with Rebif, and has neutralising antibodies, the treating physician should reassess the benefit/risk ratio of continued Rebif therapy.
Croatian: Ukoliko bolesnik slabo reagira na liječenje Rebifom i ima neutralizirajuća protutijela, nadležni liječnik treba preispitati odnos koristi i rizika nastavka liječenja Rebifom.
English: Neutropenia, lymphopenia, leukopenia, thrombocytopenia, anaemia
Croatian: Neutropenija, limfopenija, leukopenija, trombocitopenija, anemija
English: Ask your pharmacist how to safely dispose of RebiDose.
Croatian: Pitajte svog ljekarnika kako zbrinuti
English: Central nervous system-related adverse events associated with the use of interferon beta (e.g. dizziness) might influence the patient's ability to drive or use machines (see section 4.8).
Croatian: Nuspojave povezane sa središnjim živčanim sustavom vezane uz primjenu interferona beta (npr. omaglica) mogu utjecati na bolesnikovu sposobnost upravljanja vozilima ili rada sa strojevima (vidjeti dio 4.8).
English: Asymptomatic transaminase increase
Croatian: Asimptomatsko povišenje transaminaza
English: Laboratory abnormalities are associated with the use of interferons.
Croatian: Abnormalni laboratorijski nalazi povezani su s primjenom interferona.
English: Symptoms of the flu-like syndrome associated with interferon beta-1a therapy may prove stressful to patients with cardiac conditions.
Croatian: Simptomi sindroma sličnog gripi povezani s primjenom interferona beta-1a mogu biti stresni za srčane bolesnike.
English: If there is liquid left, not all of the medicine has been injected and you should consult your doctor or nurse for assistance.
Croatian: Ako primijetite zaostalu tekućinu, to znači da nije injiciran sav lijek i morate se obratiti svom liječniku ili medicinskoj sestri za pomoć.
English: • Short instructions on how to use Rebif cartridges with each device are given below.
Croatian: • U nastavku su prikazane kratke upute o tome kako koristiti uloške lijeka Rebif sa svakim uređajem.
English: If you get some or all of these symptoms: - foamy urine - fatigue - swelling, particularly in the ankles and eyelids, and weight gain.
Croatian: Ako se kod Vas jave svi ovi simptomi ili neki od njih: - pjenušavi urin - umor - oticanje, posebno gležnjeva ili vjeđa, i dobivanje na težini.
English: Injection site inflammation, injection site reaction, influenza-like symptoms
Croatian: Upala na mjestu injiciranja, reakcija na mjestu injiciranja, simptomi nalik gripi
English: In the absence of clinical symptoms, serum ALT levels should be monitored prior to the start of therapy, at months 1, 3 and 6 on therapy and periodically thereafter.
Croatian: U odsutnosti kliničkih simptoma, vrijednost ALT-a u serumu treba mjeriti prije početka liječenja, u 1., 3. i 6. mjesecu liječenja te nakon toga u ravnomjernim vremenskim razmacima.
English: Caution should be exercised when administering Rebif in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. antiepileptics and some classes of antidepressants.
Croatian: Zbog toga se oprez zahtijeva kod primjene Rebifa u kombinaciji s lijekovima uskog terapijskog indeksa i za klirens ovisnih većinom o jetrenom sustavu citokroma P450, npr. antiepileptici i neke skupine antidepresiva.
English: Rebif is indicated for the treatment of
Croatian: Rebif je indiciran za liječenje
English: Efficacy results of Rebif 44 micrograms given three times per week compared to placebo from this study are as follows:
Croatian: Rezultati djelotvornosti lijeka Rebif 44 mikrograma tri puta tjedno u usporedbi s placebom iz ovog kliničkog ispitivanja su sljedeći:
English: • The first injection(s) must be performed under the supervision of an appropriately qualified healthcare professional.
Croatian: • Davanje prve injekcije mora se provesti pod nadzorom odgovarajuće osposobljenog zdravstvenog djelatnika.
English: After the injection of Rebif with either RebiSmart or RebiSlide
Croatian: Nakon injekcije Rebifa uređajem RebiSlide ili RebiSmart
English: If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with their physician before continuing injections with Rebif.
Croatian: Ako se kod bolesnika pojavi bilo kakvo pucanje kože, a koje može biti praćeno oticanjem ili curenjem tekućine s mjesta injiciranja, bolesnika treba uputiti da se prije nastavka davanja injekcija Rebifa posavjetuje s nadležnim liječnikom.
English: This lower dose is recommended for patients who cannot tolerate the higher dose
Croatian: Ova niža doza preporučuje se za bolesnike koji ne podnose višu dozu
English: Before the injection
Croatian: Prije davanja injekcije
English: • NOTE: From the fifth week onwards, after you have completed your initiation period, 0.5 mL (corresponding to the usual dose) should be selected in the dose window of the device.
Croatian: Od petog tjedna nadalje nakon dovršetka početnog razdoblja, treba odabrati 0,5 ml (odgovara uobičajenoj dozi) u prozorčiću doze uređaja.
English: Approximately 30% of patients will also experience reactions at the injection site, predominantly mild inflammation or erythema.
Croatian: Otprilike 30% bolesnika također će osjetiti reakcije na mjestu injiciranja u vidu blage upale ili eritema.
English: Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome* (class label for interferon beta products, see section 4.4), pancytopenia*
Croatian: Trombotička mikroangiopatija uključujući trombotičku trombocitopeničku purpuru/hemolitički uremički sindrom* (značajka klase lijekova koji sadrže interferon beta; vidjeti dio 4.4), pancitopenija*
English: Rebif is a highly purified soluble protein that is similar to the natural interferon beta that is produced in the human body.
Croatian: Rebif je visoko pročišćeni topivi protein sličan prirodnom interferonu beta kojeg stvara ljudsko tijelo.
English: • Disorders of the retina (back of the eye) such as inflammation or blood clots with consequent vision disorders (vision disturbances, loss of vision)
Croatian: • poremećaj mrežnice (unutarnja ovojnica oka) kao što je upala ili krvni ugrušci koji za posljedicu imaju poremećaje vida (smetnje vida, gubitak vida)
English: After a single dose, intracellular and serum activity of 2'5'OAS synthetase and serum concentrations of beta-2 microglobulin and neopterin increase within 24 hours, and start to decline within 2 days.
Croatian: Nakon primjene jedne doze, intracelularna i serumska aktivnost 2-5A sintetaze te serumske koncentracije beta-2 mikroglobulina i neopterina porastu unutar 24 sata i počinju opadati unutar 2 dana.
English: The precise incidence of antibodies is as yet uncertain.
Croatian: Precizna incidencija protutijela još nije pouzdano utvrđena.
English: The presence of antibodies has been shown to attenuate the pharmacodynamic response to interferon beta-1a (beta-2 microglobulin and neopterin).
Croatian: U prisutnosti protutijela primijećen je atenuirani farmakodinamički odgovor na interferon beta-1a (beta-2 mikroglobulin i neopterin).
English: These results obtained in a subgroup of patients a posteriori should be interpreted cautiously.
Croatian: Prilikom tumačenja a posteriori kasnije dobivenih rezultata u podgrupama bolesnika potreban je oprez.
English: Only clear to opalescent solution without particles and without visible signs of deterioration should be used.
Croatian: Treba koristiti samo bistru do opalescentnu otopinu bez čestica i bez vidljivih znakova kvarenja.
English: The safety and efficacy of Rebif has been evaluated in patients with relapsing-remitting multiple sclerosis at doses ranging from 11 to 44 micrograms (3-12 million IU), administered subcutaneously three times per week.
Croatian: Sigurnost i djelotvornost Rebifa procjenjivana je kod bolesnika s relapsno remitirajućom multiplom sklerozom s dozama u rasponu od 11 do 44 mikrograma (3-12 milijuna IU), primijenjenim supkutano, tri puta tjedno.
English: These symptoms are usually mild, are more common at the start of the treatment and decrease with continued use.
Croatian: Ovi simptomi su obično blagi, češći na početku, a smanjuju se tijekom liječenja.
English: • if you are allergic to natural or recombinant interferon beta or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na prirodni ili rekombinantni interferon beta ili neki drugi sastojak ovog lijeka
English: If you stop using Rebif
Croatian: Ako prestanete primjenjivati Rebif
English: HOW TO USE REBIF PRE-FILLED PEN (RebiDose)
Croatian: KAKO KORISTITI REBIF NAPUNJENU BRIZGALICU (RebiDose)
English: If you experience troubling local reactions, contact your doctor.
Croatian: Ako se pojave neugodne lokalne reakcije, obratite se svom liječniku.
English: In case of severe or persistent undesirable effects, the dose of Rebif may be temporarily lowered or interrupted, at the discretion of the physician.
Croatian: U slučaju težih ili trajnijih nuspojava, prema odluci nadležnog liječnika, doza Rebifa se može privremeno smanjiti ili prekinuti.
English: Patients should be informed of the most frequent adverse reactions associated with interferon beta administration, including symptoms of the flu-like syndrome (see section 4.8).
Croatian: Bolesnike treba upoznati s najčešćim nuspojavama povezanim s primjenom interferona beta, uključujući simptome sindroma sličnog gripi (vidjeti dio 4.8).
English: The patient may store Rebif at or below 25°C for a single period up to 14 days.
Croatian: Bolesnik može čuvati Rebif na ili ispod 25 °C jednokratno u razdoblju od najdulje 14 dana.
English: Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Rebif should be considered.
Croatian: Nefrotski sindrom potrebno je bez odlaganja liječiti i razmotriti prekid liječenja Rebifom.
English: • Itching, rash (skin eruptions)
Croatian: • svrbež, osip (izbijanje kožnih promjena)
English: The adverse reactions presented have been identified from clinical studies as well as from postmarketing reports (an asterisk [*] indicates adverse reactions identified during post-marketing surveillance).
Croatian: Prikazane nuspojave identificirane su u kliničkim ispitivanjima kao i iz izvješća nakon stavljanja lijeka u promet (zvjezdica [*] označava nuspojave identificirane tijekom praćenja lijeka nakon stavljanja lijeka u promet).
English: Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Croatian: Preporučuje se povremeno praćenje zbog pojave ranih znakova i simptoma, npr. edema, proteinurije i oštećenja bubrežne funkcije, posebno u bolesnika s povećanim rizikom od bubrežne bolesti.
English: For the time being there is no well established definition of a high risk patient, although a more conservative approach is to accept at least nine T2 hyperintense lesions on the initial scan and at least one new T2 or one new Gd-enhancing lesion on a follow-up scan taken at least 1 month after the initial scan.
Croatian: Za sada nema dobro utvrđene definicije visokorizičnog bolesnika, iako je konzervativniji pristup prihvaćanje barem devet T2 hiperintenzivnih lezija na početnom snimanju i barem jedne nove T2 lezije ili jedne nove Gd-pozitivne lezije na kontrolnom snimanju barem mjesec dana nakon početnog snimanja.
English: When first starting treatment with Rebif, in order to allow tachyphylaxis to develop thus reducing adverse reactions, it is recommended that patients be started at 8.8 micrograms dose subcutaneously and the dose be increased over a 4 week period to the targeted dose, according to the following schedule:
Croatian: Kada započinju liječenje Rebifom, da bi se razvila tahifilaksija i da bi se umanjile nuspojave, preporučuje se da bolesnici počnu s dozom od 8,8 mikrograma supkutano, a potom se doza treba povećavati tijekom razdoblja od 4 tjedna do ciljane doze prema sljedećem rasporedu:
English: • Hold RebiSlide firmly and slide the release button which is on the side of the device.
Croatian: • Čvrsto držite RebiSlide i gurajte gumb za otpuštanje koji se nalazi na bočnoj strani uređaja.
English: This lower dose is recommended for patients who cannot tolerate the higher dose.
Croatian: Ova niža doza preporučuje se za bolesnike koji ne podnose višu dozu.
English: Subcutaneous and intramuscular administrations of Rebif produce equivalent exposure to interferon beta.
Croatian: Supkutana i intramuskularna primjena Rebifa dovodi do jednakovrijednog izlaganja interferonu beta.
English: • Choose an injection site.
Croatian: • Izaberite mjesto injiciranja.
English: Injection site necrosis, injection site mass, injection site abscess, injection site infections*, increased sweating*
Croatian: Nekroza na mjestu injekcije, masa na mjestu injiciranja, apsces na mjestu injiciranja, infekcije na mjestu injiciranja*, pojačano znojenje*
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Croatian: Utvrđeno je da interferoni kod ljudi i životinja reduciraju aktivnost jetrenih enzima ovisnih o citokromu P450.
English: If you forget to use Rebif
Croatian: Ako ste zaboravili primijeniti Rebif
English: The majority of adverse reactions observed with interferon beta-1a are usually mild and reversible, and respond well to dose reductions.
Croatian: Većina nuspojava uočenih pri primjeni interferona beta-1a obično su blage i reverzibilne i povlače se nakon smanjenja doze.
English: • Remove and discard the needle according to the instruction manual provided with your device.
Croatian: • Uklonite i odbacite iglu u skladu s priručnikom s uputama koji se isporučuje s Vašim uređajem.
English: In a 3-year study in patients with secondary progressive multiple sclerosis (EDSS 3-6.5) with evidence of clinical progression in the preceding two years and who had not experienced relapses in the preceding 8 weeks, Rebif had no significant effect on progression of disability, but relapse rate was reduced by approximately 30%.
Croatian: U trogodišnjem ispitivanju provedenom kod bolesnika sa sekundarnom progresivnom multiplom sklerozom (EDSS 3-6,5) s pokazateljima kliničke progresije u prethodne dvije godine te kod kojih nije bilo relapsa u prethodnih 8 tjedana, Rebif nije pokazao značajan učinak na napredovanje onesposobljenosti, ali je broj relapsa bio smanjen za približno 30%.
English: Rebif can be used during breastfeeding.
Croatian: Rebif se može primjenjivati tijekom dojenja.
English: These changes in the thyroid activity are almost always not felt by the patient as symptoms; however your doctor may recommend testing as appropriate.
Croatian: U većini slučajeva, bolesnik ne osjeća simptome promjene rada štitnjače, međutim, liječnik može preporučiti odgovarajuće pretrage.
English: In healthy volunteers after intravenous administration, interferon beta-1a exhibits a sharp multi-exponential decline, with serum levels proportional to the dose.
Croatian: Nakon intravenske primjene u zdravih dobrovoljaca, interferon beta-1a pokazuje naglo multieksponencijalno opadanje uz razine u serumu proporcionalne dozi.
English: If a second clinical demyelinating event occurred confirming definite multiple sclerosis, patients switched to the recommended posology of Rebif 44 micrograms three times per week in an open label manner, while maintaining blinding as to initial randomisation.
Croatian: Ako se pojavi drugi klinički događaj demijelinizacije koji definitivno potvrđuje jasnu multiplu sklerozu, bolesnici prelaze na preporučeno doziranje lijeka Rebif od 44 mikrograma tri puta tjedno kao u otvorenom kliničkom ispitivanju, dok istovremeno ostaju maskirani za početnu randomizaciju.
English: Patients were randomised in a double-blind manner to either Rebif 44 micrograms given three times per week, Rebif 44 micrograms once weekly, or placebo.
Croatian: Bolesnici su bili randomizirani na dvostruko slijepi način na Rebif 44 mikrograma tri puta tjedno, Rebif 44 mikrograma jednom tjedno ili na placebo.
English: Your doctor has prescribed you a lower dose of 22 micrograms (6 million IU) given three times per week.
Croatian: Vaš liječnik propisao Vam je nižu dozu od 22 mikrograma (6 milijuna IU) koja se daje tri puta tjedno.