FrancophonIA/ELRC3.0 huggingface dataset:
English: The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
Croatian: Povremeno je potrebno provjeriti postupak samostalne primjene lijeka od strane bolesnika, naročito ako se na mjestu injiciranja pojave reakcije.
English: This might happen several weeks to several years after starting Rebif.
Croatian: To bi se moglo dogoditi nekoliko tjedana do nekoliko godina nakon početka primjene Rebifa.
English: After repeated subcutaneous doses in healthy volunteers, the main PK parameters (AUCtau and Cmax) increased proportional to the increased in dose from 22 micrograms to 44 micrograms.
Croatian: Nakon ponovljene supkutane primjene doza u zdravih dobrovoljaca, osnovni farmakokinetički parametri (AUCtau i Cmax) povećali su se proporcionalno povećanju doze s 22 mikrograma na 44 mikrograma.
English: The use of various assays to detect serum antibodies and differing definitions of antibody positivity limits the ability to compare antigenicity among different products.
Croatian: Upotreba različitih testova za otkrivanje serumskih protutijela i različite definicije pozitivnosti tih protutijela ograničavaju mogućnost usporedbe antigenosti različitih preparata.
English: Rebif should not be used in this age group.
Croatian: Rebif se ne smije primjenjivati u ovoj dobnoj skupini.
English: Through mechanisms that are not totally understood, interferons help to limit the damage of the central nervous system associated with multiple sclerosis.
Croatian: Mehanizmima koji još nisu u potpunosti poznati interferoni pomažu smanjiti oštećenje središnjeg živčanog sustava povezana s multiplom sklerozom.
English: The effects of Rebif on fertility have not been investigated.
Croatian: Učinci Rebifa na plodnost nisu ispitani.
English: • Dispose of all used items: once you have finished your injection, immediately discard the syringe in an appropriate disposal unit.
Croatian: • Bacite sve korištene predmete: nakon što ste dovršili svoju injekciju, odmah bacite štrcaljku u odgovarajući spremnik za otpad.
English: In case of overdose, contact your doctor immediately.
Croatian: U slučaju predoziranja, odmah se javite svom liječniku.
English: Weeks 1-2
Croatian: Tjedni 1-2
English: • Current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Croatian: • Bolesnici s postojećom teškom depresijom i/ili suicidnim mislima (vidjeti dijelove 4.4 i 4.8).
English: • You will need to select the dose prescribed by your doctor via the RebiSmart menu to ensure the correct recording of your dose.
Croatian: • Morat ćete odabrati dozu koju Vam je propisao liječnik putem izbornika RebiSmart da bi Vaša doza bila ispravno zabilježena.
English: • Suicide attempt
Croatian: • pokušaj samoubojstva
English: After repeated subcutaneous administration every 48 hours for 4 doses, these biological responses remain elevated, with no signs of tolerance development.
Croatian: Nakon 4 uzastopne supkutane primjene iste doze svakih 48 sati, navedeni biološki odgovori ostaju povišeni, bez znakova razvoja tolerancije.
English: Weeks 3-4
Croatian: Tjedni 3-4
English: If you experience any of these symptoms, contact your doctor for advice.
Croatian: Ako osjetite bilo koji od ovih simptoma, obratite se svom liječniku za savjet.
English: • Your doctor may have prescribed you RebiSmart or RebiSlide device.
Croatian: • Vaš liječnik može Vam propisati RebiSmart ili RebiSlide uređaj.
English: • Press the injection button.
Croatian: • Pritisnite gumb za injiciranje.
English: A large amount of data (more than 1,000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy.
Croatian: Opsežni podaci (više od 1000 trudnoća) iz registara i iz iskustva nakon stavljanja lijeka u promet ukazuju na to da nema povećanog rizika od velikih kongenitalnih anomalija kod izloženosti inteferonu beta prije začeća ili izloženosti tijekom prvog tromjesečja trudnoće.
English: Rebif contains benzyl alcohol
Croatian: Rebif sadrži benzilni alkohol
English: Use in children and teenagers (2 to 17 years old) No formal clinical studies have been conducted in children or teenagers.
Croatian: Primjena u djece i adolescenata (u dobi od 2 do 17 godina) Kod djece i adolescenata nisu provedena formalna klinička ispitivanja.
English: In some cases such symptoms are associated with fever or flu-like symptoms described above.
Croatian: U nekim slučajevima takvi simptomi povezani su s gore opisanom vrućicom i simptomima nalik gripi.
English: • Full instructions for use are provided with your device.
Croatian: • Potpune upute za uporabu isporučuju se s Vašim uređajem.
English: Suicide attempt*
Croatian: Pokušaj samoubojstva*
English: Rebif has not yet been investigated in patients with primary progressive multiple sclerosis and should not be used in these patients.
Croatian: Rebif još nije istražen u bolesnika s primarnom progresivnom multiplom sklerozom te ga ne treba koristiti u tih bolesnika.
English: It is produced in mammalian cells (Chinese hamster ovary) and is therefore glycosylated like the natural protein.
Croatian: Proizvode ga stanice sisavaca (jajnik kineskog hrčka) pa je stoga glikoziliran kao prirodni protein.
English: ** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.
Croatian: ** proizvedeno tehnologijom rekombinantne DNK na stanicama jajnika kineskog hrčka (CHO-K1).
English: • Breathing difficulties
Croatian: • teškoće s disanjem
English: • Check the appearance of Rebif through the transparent window.
Croatian: • Provjerite izgled lijeka Rebif kroz prozirni prozorčić.
English: • Keep track of and rotate your injection sites, so that one area is not injected too often.
Croatian: • Bilježite i mijenjajte mjesta injekcije tako da ne injicirajte prečesto u jedno područje.
English: To help reduce these symptoms your doctor may advise you to take a fever reducing painkiller before a dose of Rebif and then for 24 hours after each injection.
Croatian: Da bi se ovi simptomi ublažili, Vaš liječnik može Vam savjetovati uzimanje lijeka za ublažavanje bolova i snižavanje tjelesne temperature prije uzimanja doze Rebifa i potom 24 sata nakon svake injekcije.
English: If you experience symptoms suggesting a liver disorder, such as loss of appetite accompanied by other symptoms such as nausea, vomiting, jaundice, please contact your doctor immediately (see above “Tell your doctor immediately...”).
Croatian: Ako osjetite simptome koji bi mogli upućivati na poremećaje jetre, kao što su gubitak apetita praćen ostalim simptomima kao što su mučnina, povraćanje, žutica, molimo odmah se obratite svom liječniku (pogledajte gornji tekst „Odmah obavijestite svog liječnika...“).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Rebif.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Rebif.
English: • Use each RebiDose only once.
Croatian: • Svaku brizgalicu RebiDose treba upotrijebiti samo jednom.
English: Patients with poor vision should not use RebiSlide unless someone with good eyesight can provide support.
Croatian: Bolesnici sa slabim vidom ne smiju koristiti RebiSlide osim ako im ne može pomoći netko s dobrim vidom.
English: Clinical studies indicate that multiple sclerosis patients can receive Rebif and corticosteroids or ACTH during relapses.
Croatian: Kliničke studije ukazuju na to da bolesnici s multiplom sklerozom za vrijeme relapsa mogu primati Rebif i kortikosteroide ili ACTH.
English: • Your doctor will tell you how to choose the correct dose.
Croatian: • Vaš liječnik će Vam reći kako odabrati točnu dozu.
English: • Talk to your doctor or pharmacist before taking Rebif if you have an allergy (hypersensitivity) to any other medicines.
Croatian: • Razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja lijeka Rebif ako imate alergiju (preosjetljivost) na bilo koje druge lijekove.
English: • This section tells you how to use RebiDose.
Croatian: • U ovom je dijelu objašnjeno kako se koristi RebiDose.
English: The following side effects were reported for interferon beta (frequency not known)
Croatian: Sljedeće su nuspojave prijavljene za interferon beta (učestalost nije poznata)
English: Following repeated subcutaneous injections of 22 and 44 micrograms doses of Rebif maximum concentrations were typically observed after 8 hours, but this was highly variable.
Croatian: Nakon ponovljenih supkutanih injekcija Rebifa u dozi od 22 i 44 mikrograma, maksimalne koncentracije bile su obično opažene nakon 8 sati, no uz značajne varijacije.
English: Please read also the instructions in the manual provided with your device.
Croatian: Pročitajte i upute u priručniku koji se isporučuje s Vašim uređajem.
English: Tissue destruction (necrosis), abscess and mass at injection site are uncommon (may affect up to 1 in 100 people).
Croatian: Razaranje tkiva (nekroza), apsces i masa na mjestu injiciranja su manje česti (mogu se javiti u do 1 na 100 osoba).
English: The mechanism for the rare symptomatic hepatic dysfunction is not known.
Croatian: Mehanizam rijetkih simptomatskih poremećaja funkcije jetre nije poznat.
English: If you have poor vision you should not use RebiSlide unless someone with good eyesight can provide support.
Croatian: Ako imate slabi vid, ne smijete koristiti RebiSlide osim ako pokraj sebe nemate osobu s dobrim vidom da Vam pomogne.
English: • Blood clots such as deep venous thrombosis
Croatian: • krvni ugrušci kao što je tromboza dubokih vena
English: • use an aseptic injection technique,
Croatian: • da primjenjuju aseptičan postupak injiciranja,
English: • Inject the medicine by using a slow, steady push (push the plunger all the way in until the syringe is empty).
Croatian: • Ubrizgajte lijek laganim, ravnomjernim potiskom (potiskujte potisni klip sve dok se štrcaljka ne isprazni).
English: Treatment with Rebif should be stopped if icterus or other clinical symptoms of liver dysfunction appear.
Croatian: Liječenje lijekom Rebif treba prekinuti u slučaju pojave ikterusa ili drugih kliničkih simptoma poremećaja funkcije jetre.
English: Very common (may affect more than 1 in 10 people): • Headache
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): • glavobolja
English: The majority of the cases of severe liver injury occurred within the first six months of treatment.
Croatian: Do teškog oštećenja jetre u većini slučajeva dolazi u prvih šest mjeseci liječenja.
English: Severe liver problems can be associated with additional signs, e.g. difficulty concentrating, sleepiness and confusion.
Croatian: Teški problemi s jetrom mogu biti povezani s dodatnim znakovima poput poteškoća u koncentraciji, pospanosti i smetenosti.
English: These should be more frequent when initiating Rebif 44 micrograms.
Croatian: Stoga te pretrage trebaju biti češće kad se počne primjenjivati Rebif 44 mikrograma.
English: Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (see section 5.1).
Croatian: Djelotvornost lijeka nije dokazana kod bolesnika sa sekundarnom progresivnom multiplom sklerozom bez prisutnog relapsa (vidjeti dio 5.1).
English: If you use RebiSlide • Make sure before the injection that the dose selected in the dose window of the device is:
Croatian: Ako koristite RebiSlide • Prije injekcije pobrinite se da je doza odabrana na uređaju u prozoru za dozu:
English: Your doctor will advise you on the possible injection sites (good sites include the upper thighs and the lower abdomen).
Croatian: Liječnik će Vam dati savjet o mogućim mjestima injiciranja (dobra mjesta za injiciranje uključuju gornji dio bedara i donji dio trbuha).
English: • Resting your wrist on the skin near the site, stick the needle at a right angle straight into the skin with a quick, firm motion.
Croatian: • Naslonite zapešće na kožu pored mjesta injiciranja, ubodite iglu u kožu pod pravim kutom brzim, čvrstim pokretom.
English: • Insert the needle into the skin as you have been told by your doctor.
Croatian: •Umetnite iglu u kožu kako Vam je rekao Vaš liječnik.
English: In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1).
Croatian: U kliničkim ispitivanjima ovo je karakterizirano s dvije ili više akutne egzarcebacije unutar posljednje dvije godine (vidjeti dio 5.1).
English: Rebif is available in three strengths: 8.8 micrograms, 22 micrograms and 44 micrograms.
Croatian: Rebif je dostupan u tri jačine: 8,8 mikrograma, 22 mikrograma i 44 mikrograma.
English: PARTICULARS TO APPEAR ON THE LAYERS SEPARATORS FOR THE STARTER PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA SEPARATORIMA ZA POČETNO PAKIRANJE
English: • Hold RebiDose at a right angle (90 degrees) to the injection site.
Croatian: • Postavite RebiDose pod pravim kutom (90°) u odnosu na mjesto injekcije.
English: Anaphylactic reactions*
Croatian: Anafilaktičke reakcije*
English: To minimise the risk of injection site necrosis patients should be advised to:
Croatian: Radi smanjenja rizika nastanka nekroze na mjestu injiciranja, bolesnike je potrebno uputiti:
English: These reactions are rare (may affect up to 1 in 1,000 people).
Croatian: Te reakcije su rijetke (mogu se javiti u do 1 na 1000 osoba).
English: Rebif should be initiated with caution in patients with a history of significant liver disease, clinical evidence of active liver disease, alcohol abuse or increased serum ALT (>2.5 times ULN).
Croatian: Primjenu Rebifa treba započeti s oprezom kod bolesnika s povijesti teže bolesti jetre, kliničkih dokaza aktivne bolesti jetre, zlouporabe alkohola ili povišenim vrijednostima ALT-a u serumu (>2,5 puta iznad GGN).
English: Asymptomatic increases in laboratory parameters of hepatic function and decreases in white blood cells are also common.
Croatian: Asimptomatski porasti vrijednosti laboratorijskih parametara jetrene funkcije i pada broja bijelih krvnih stanica također su česti.
English: It must not be given to premature babies or neonates.
Croatian: Ne smije se dati nedonoščadi ili novorođenčadi.
English: One 2-year controlled clinical trial with Rebif was performed in patients with a single clinical event suggestive of demyelination due to multiple sclerosis.
Croatian: Jedno dvogodišnje kontrolirano kliničko ispitivanje Rebifa provedeno je na bolesnicima s jednim kliničkim događajem koji upućuje na demijelinizaciju zbog multiple skleroze.
English: Limited information available on the transfer of interferon beta-1a into breast milk, together with the chemical/physiological characteristics of interferon beta, suggests that levels of interferon beta-1a excreted in human milk are negligible.
Croatian: Ograničene informacije o prelasku interferona beta-1a u majčino mlijeko, zajedno s kemijskim/fiziološkim značajkama interferona beta, ukazuju na to da je razina interferona beta-1a izlučenog u majčino mlijeko zanemariva.
English: When first starting treatment with Rebif, the dose should be gradually escalated in order to allow tachyphylaxis to develop thus reducing adverse reactions.
Croatian: Kod započinjanja liječenja Rebifom doza se mora postupno povećavati kako bi se omogućio razvoj tahifilaksije i da bi se na taj način umanjile nuspojave.
English: • MS pseudo-relapse (frequency not known): There is a possibility that at the beginning of your treatment with Rebif you may experience symptoms that resemble those of a multiple sclerosis relapse.
Croatian: • Simptomi nalik ponovnoj pojavi multiple skleroze (MS pseudo-relaps) (učestalost nije poznata): Postoji mogućnost da na početku liječenja Rebifom osjetite simptome koji nalikuju simptomima ponovne pojave multiple skleroze.
English: • Inform your doctor immediately if you experience any of the following possible symptoms of a liver problem: jaundice (yellowing of the skin or of the whites of the eyes), widespread itching, loss of appetite accompanied by nausea and vomiting and easy bruising of the skin.
Croatian: • Odmah obavijestite svog liječnika ako iskusite išta od sljedećih mogućih simptoma problema s jetrom: žutica (žuta koža ili žute bjeloočnice), široko prošireni svrbež, gubitak apetita popraćen mučninom i povraćanjem te brzo stvaranje modrica na koži.
English: Do not use Rebif
Croatian: Nemojte primjenjivati Rebif
English: • Drug-induced lupus erythematosus: a side-effect of long-term use of Rebif.
Croatian: • lijekovima izazvan lupus eritematozus: nuspojava dugoročne primjene lijeka Rebif.
English: Therefore, in addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, liver enzyme monitoring and complete and differential blood cell counts and platelet counts are recommended at regular intervals (1, 3 and 6 months) following introduction of Rebif therapy and then periodically thereafter in the absence of clinical symptoms.
Croatian: Stoga se, uz te uobičajene laboratorijske pretrage potrebne radi praćenja bolesnika s multiplom sklerozom, preporučuje redovita kontrola jetrenih enzima i kontrola kompletne i diferencijalne krvne slike te trombocita u redovitim vremenskim razmacima (1, 3 i 6 mjeseci) nakon uvođenja liječenja Rebifom i potom periodično, ako nema kliničkih simptoma.
English: Thyroid dysfunction, most often presenting as hypothyroidism or hyperthyroidism
Croatian: Poremećaji rada štitnjače, najčešće u obliku hipotiroidizma ili hipertiroidizma
English: Only sparse safety and efficacy data are available from non-ambulatory patients with multiple sclerosis.
Croatian: Dostupni su samo ograničeni podaci o sigurnosti i djelotvornosti lijeka kod izvanambulantnih bolesnika s multiplom sklerozom.
English: • Blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uremic syndrome).
Croatian: • krvni ugrušci u malim krvnim žilama koji mogu utjecati na Vaše bubrege (trombotička trombocitopenička purpura ili hemolitički uremički sindrom).
English: Patients exhibiting depression should be monitored closely during therapy with Rebif and treated appropriately.
Croatian: Bolesnike sa simptomima depresije treba pomno pratiti tijekom primjene Rebifa i na odgovarajući način liječiti.
English: Cessation of therapy with Rebif should be considered (see sections 4.3 and 4.8).
Croatian: Treba razmotriti i mogućnost prekida liječenja Rebifom (vidjeti dijelove 4.3 i 4.8).
English: Do not use this medicine if you notice any visible signs of deterioration such as if the solution is no longer clear or if it contains particles.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive znakove kvarenja poput zamućenja otopine ili pojave čestica u otopini.
English: Rebif should be administered with caution to patients with previous or current depressive disorders in particular to those with antecedents of suicidal ideation (see section 4.3).
Croatian: Rebif treba oprezno primjenjivati kod bolesnika s prethodnim ili postojećim depresivnim poremećajem, naročito kod onih koji su u prošlosti već imali suicidalne misli (vidjeti dio 4.3).
English: Rebif should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with antiepileptics (see sections 4.5 and 4.8).
Croatian: Rebif treba primjenjivati oprezno kod bolesnika s anamnezom napadaja, onima koji primaju antiepileptike, posebice ako epilepsija nije odgovarajuće liječena antiepilepticima (vidjeti dijelove 4.5 i 4.8).
English: Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with Rebif administration.
Croatian: Prije davanja injekcije i tijekom sljedeća 24 sata nakon svake injekcije, preporučuje se davanje analgoantipiretika, kako bi se smanjili simptomi slični gripi koji su povezani s primjenom Rebifa.
English: Metabolism Interferon beta-1a is mainly metabolised and excreted by the liver and the kidneys.
Croatian: Metabolizam Interferon beta-1a uglavnom metaboliziraju i izlučuju jetra i bubrezi.
English: If the patient has multiple lesions, Rebif should be discontinued until healing has occurred.
Croatian: Ako bolesnik ima multiple lezije, primjenu Rebifa treba prekinuti do zacjeljenja.
English: During week three and four: 0.25 mL, which corresponds to the dose of 22 micrograms
Croatian: Tijekom trećeg i četvrtog tjedna: 0,25 ml, što odgovara dozi od 22 mikrograma
English: No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents.
Croatian: Kod djece ili adolescenata nisu provedena formalna klinička ispitivanja i farmakokinetske studije.
English: • Hypersensitivity to natural or recombinant interferon beta or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na prirodni ili rekombinantni interferon beta ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: • heart,
Croatian: • srca,
English: Inform your doctor if you have a disease of
Croatian: Obavijestite svog liječnika ako imate bolesti:
English: The patients enrolled into the trial had at least two clinically silent lesions on the T2-weighted MRI scan, with a size of at least 3 mm, at least one of which is ovoid or periventricular or infratentorial.
Croatian: Bolesnici koji su sudjelovali u kliničkom ispitivanju imali su barem dvije klinički inaktivne lezije na T2-ponderiranoj MRI snimci veličine najmanje 3 mm, od kojih je jedna jajolika ili periventrikularna ili infratentorijalna.
English: In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
Croatian: U kliničkim ispitivanjima s Rebifom često je zamijećeno asimptomatsko povišenje jetrenih transaminaza (osobito alanin aminotransferaze (ALT)), a kod 1-3% bolesnika povišenje je jetrenih transaminaza više od 5 puta iznad gornje granice normale (GGN).
English: • Hold RebiDose by the main body and use your other hand to remove the cap.
Croatian: • Držite RebiDose za tijelo brizgalice i upotrijebite drugu ruku kako biste uklonili zatvarač.
English: It is recommended that patients should be evaluated at least every second year in the 4-year period after initiation of treatment with Rebif and a decision for longer term treatment should then be made on an individual basis by the treating physician.
Croatian: Preporučuje se procjena bolesnika najmanje svake druge godine od početka liječenja Rebifom tijekom četverogodišnjeg razdoblja, a odluku o dužem liječenju donosi za svakog pojedinog bolesnika nadležni liječnik.
English: • Store your device containing a cartridge of Rebif as instructed in section 5 “How to store
Croatian: • Pohranite svoj uređaj koji sadrži uložak lijeka Rebif kako je objašnjeno u dijelu 5 „Kako čuvati Rebif“.
English: The carton contains a package leaflet with full instructions for use and handling.
Croatian: Kutija sadrži uputu o lijeku s potpunim uputama za primjenu i rukovanje.
English: Laboratory abnormalities
Croatian: Abnormalni laboratorijski nalazi
English: Blood and the lymphatic system disorders Very common:
Croatian: Poremećaji krvi i limfnog sustava Vrlo često:
English: Quincke's oedema (angio-oedema)*, erythema multiforme*, erythema multiforme-like skin reactions*, Stevens Johnson syndrome* Musculoskeletal and connective disorders Common:
Croatian: Quinckeov edem (angioedem)*, multiformni eritem*, kožne reakcije nalik multiformnom edemu*, Stevens Johnsonov sindrom* Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često:
English: Possible symptoms resulting from these changes could include tiredness, reduced ability to fight infection, bruising or unexplained bleeding.
Croatian: Mogući simptomi koji proizlaze iz ovih promjena mogu uključiti umor, smanjenu otpornost prema infekcijama, pojavu modrica ili neočekivanog krvarenja.
English: Rebif solution is clear to opalescent.
Croatian: Otopina Rebifa je bistra do opalescentna.