FrancophonIA/ELRC3.0 huggingface dataset:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 8.8 micrograms (2.4 million IU)/0.2 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 8,8 mikrograma (2,4 milijuna IU)/0,2 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 6 X 8.8 MICROGRAMS SYRINGES + 6 X 22 MICROGRAMS SYRINGES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SA 6 X 8,8 MIKROGRAMA ŠTRCALJKI + 6 X 22 MIKROGRAMA ŠTRCALJKI
English: INFORMATION IN BRAILLE rebif 22/0.5
Croatian: 16. PODACI NA BRAILLEOVOM PISMU rebif 22/0,5
English: G. Safety guard H. Needle
Croatian: Sigurnosni štitnik H.
English: During weeks three and four, Rebif 22 micrograms are injected three times per week.
Croatian: Tijekom trećeg i četvrtog tjedna, Rebif 22 mikrograma injiciraju se tri puta tjedno.
English: A lower dose of 22 micrograms (6 million IU) given three times per week is recommended for patients with multiple sclerosis who cannot tolerate the higher dose.
Croatian: Niža doza od 22 mikrograma (6 milijuna IU) koja se daje tri puta tjedno preporučuje se za bolesnike s multiplom sklerozom koji ne podnose višu dozu.
English: INFORMATION IN BRAILLE rebif 44
Croatian: 16. PODACI NA BRAILLEOVOM PISMU rebif 44
English: Seizures*
Croatian: Dispneja*
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 4 OR 12 CARTRIDGES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SA 4 ILI 12 ULOŽAKA
English: The syringe is sealed in a disposable pen injector called RebiDose.
Croatian: Štrcaljka je zatvorena u jednokratnoj injekcijskoj brizgalici naziva RebiDose.
English: For patients starting treatment with Rebif, Rebif 8.8 micrograms and Rebif 22 micrograms are available in an initiation pack.
Croatian: Za bolesnike koji počinju liječenje Rebifom, Rebif 8,8 mikrograma i Rebif 22 mikrograma dostupni su u pakiranju za početak liječenja.
English: Frequency not known: Pulmonary arterial hypertension* (class label for interferon products, see below Pulmonary arterial hypertension)
Croatian: Plućna arterijska hipertenzija* (značajka skupine lijekova koji sadrže interfereon, vidjeti niže Plućna arterijska hipertenzija) Poremećaji probavnog sustava Često:
English: Relapsing multiple sclerosis
Croatian: Relapsna multipla skleroza
English: Drug-induced lupus erythematosus* Renal and urinary disorders Rare:
Croatian: Lupus eritematozus potaknut lijekom* Poremećaji bubrega i mokraćnog sustava Rijetko:
English: If you use RebiSmart • Please ensure that the dose displayed on the screen of the device corresponds to the prescribed dose of 22 micrograms before the injection.
Croatian: • Prije injiciranja molimo osigurajte da doza prikazana na zaslonu uređaja odgovara propisanoj dozi od 22 mikrograma.
English: • Remove RebiSmart from the injection site.
Croatian: • Uklonite RebiSmart s mjesta injiciranja.
English: The Rebif initiation package corresponds to the patient needs for the first month of treatment.
Croatian: Početno pakiranje lijeka Rebif odgovaraju bolesnikovim potrebama za prvi mjesec liječenja.
English: How to inject Rebif
Croatian: Kako injicirati Rebif
English: If you use RebiSmart • Please ensure that the dose displayed on the screen of the device corresponds to the prescribed dose of 44 micrograms before the injection.
Croatian: • Prije injiciranja molimo osigurajte da doza prikazana na zaslonu uređaja odgovara propisanoj dozi od 44 mikrograma.
English: Thyroid function testing is recommended at baseline and if abnormal, every 6-12 months following initiation of therapy.
Croatian: Zbog toga se preporučuje ispitivanje funkcije štitnjače na početku liječenja, a ako vrijednosti odstupaju od normalnih, ispitivanje treba ponoviti svakih 6-12 mjeseci nakon početka liječenja.
English: Injection site pain, fatigue, rigors, fever
Croatian: Bol na mjestu injiciranja, umor, tresavica, vrućica
English: • Rebif is given by injection under the skin (subcutaneously) using a pre-filled pen called “RebiDose”.
Croatian: • Rebif se daje injekcijom pod kožu (supkutano) primjenom napunjene brizgalice „RebiDose“.
English: • Before treatment with Rebif, read carefully and follow the “RebiDose Instructions for Use” provided in a separate booklet, in order to minimise the risk of injection site necrosis (skin breakdown and tissue destruction) that has been reported in patients treated with Rebif.
Croatian: • Prije liječenja lijekom Rebif pažljivo pročitajte i slijedite „Upute za upotrebu uređaja RebiDose“ koje se nalaze u zasebnoj knjižici kako bi se minimizirao rizik od nekroze mjesta injekcije (propadanje kože i oštećenja tkiva) koje je prijavljeno kod bolesnika liječenih lijekom Rebif.
English: Rebif contains 2.5 mg benzyl alcohol per dose.
Croatian: Rebif sadrži 2,5 mg benzilnog alkohola po dozi.
English: The results of this study suggest that the safety profile in children (2 to 11 years old) and in adolescents (12 to 17 years old) receiving Rebif 22 micrograms or 44 micrograms subcutaneous three times per week is similar to that seen in adults.
Croatian: Rezultati ove studije sugeriraju da je sigurnosni profil lijeka kod djece (u dobi od 2 do 11 godina) i adolescenata (u dobi od 12 do 17 godina) koji su primali Rebif 22 ili 44 mikrograma supkutano tri puta tjedno sličan onom kod odraslih
English: A lower dose of 22 micrograms (6 million IU) given three times per week is recommended for patients who cannot tolerate the higher dose.
Croatian: Niža doza od 22 mikrograma (6 milijuna IU) primijenjena tri puta tjedno preporučuje se za bolesnike koji ne podnose višu dozu.
English: For multidose use.
Croatian: Za višedoznu primjenu.
English: Rebif is intended for subcutaneous (under the skin) injection.
Croatian: Rebif je namijenjen za supkutano (pod kožu) injiciranje.
English: • During weeks one and two, Rebif 8.8 micrograms should be injected three times per week.
Croatian: • tijekom prvog i drugog tjedna Rebif 8,8 mikrograma injicirati tri puta tjedno.
English: Rebif 44 micrograms is available as a package of 1, 3, 12, or 36 syringes.
Croatian: Rebif 44 mikrograma otopina za injekciju dostupan je u pakiranju od 1, 3, 12 ili 36 štrcaljki.
English: • The cartridge is to be used either with the RebiSmart electronic injection device or the RebiSlide manual pen injector device.
Croatian: • Uložak se mora koristiti ili s elektronskim uređajem za injiciranje RebiSmart ili s ručnim uređajem s brizgalicom s injektorom RebiSlide.
English: 3 pre-filled syringes.
Croatian: 3 napunjene brizgalice.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 132 micrograms (36 million IU)/1.5 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 132 mikrograma (36 milijuna IU)/1,5 ml
English: 4 cartridges
Croatian: 4 uloška
English: • Rebif is intended for subcutaneous (under the skin) injection.
Croatian: • Rebif je namijenjen za supkutano (pod kožu) injiciranje.
English: •Before treatment with Rebif, read carefully and follow the advice given under “How to use Rebif” in order to minimise the risk of injection site necrosis (skin breakdown and tissue destruction) that has been reported in patients treated with Rebif.
Croatian: • Prije početka liječenja Rebifom pažljivo pročitajte i slijedite upute navedene u poglavlju „Kako primjenjivati Rebif“ kako bi se umanjio rizik od pojave nekroze na mjestu injiciranja (propadanje kože i oštećenja tkiva), a koja se javljaju kod bolesnika liječenih Rebifom.
English: Excipient with known effect: 7.5 mg benzyl alcohol For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: 7,5 mg benzilnog alkohola Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Each pre-filled pen contains 22 micrograms,
Croatian: Svaka štrcaljka sadrži 22 mikrograma, što odgovara
English: Cartridges (type 1 glass) with a plunger stopper (rubber) and crimp cap (aluminium and halobutyl rubber) containing 1.5 mL solution for injection.
Croatian: Napunjeni uložak (staklo tipa I) s čepom klipa (guma) i sigurnosnim zatvaračem (aluminij i halobutilna guma), sadrži 1,5 ml otopine za injekciju.
English: • rotate the injection sites with each dose.
Croatian: • da za svaku dozu mijenjaju mjesto injiciranja.
English: 12 pre-filled syringes.
Croatian: 12 napunjenih štrcaljki.
English: • During weeks three and four, Rebif 22 micrograms should be injected three times per week.
Croatian: • tijekom trećeg i četvrtog tjedna, Rebif 22 mikrograma injicirati tri puta tjedno.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 May 1998
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: Rebif is available as a solution for injection in a pre-filled pen for self-administration.
Croatian: Rebif je dostupan kao otopina za injekciju u napunjenoj brizgalici za samostalnu primjenu.
English: Each pre-filled cartridge contains 132 micrograms (36 MIU*) of interferon beta-1a** in 1.5 mL solution, corresponding to 88 micrograms/mL.
Croatian: Svaki napunjeni uložak sadrži 132 mikrograma (36 milijuna IU*) interferona beta-1a** u 1,5 ml otopine, što odgovara 88 mikrograma/ml.
English: Excipient with known effect: 2.5 mg benzyl alcohol For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: 2,5 mg benzilnog alkohola Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Limited safety data suggest that the safety profile in children and adolescents (2 to 17 years old) receiving Rebif 22 micrograms or 44 micrograms three times weekly is similar to that seen in adults.
Croatian: Ograničeni podaci o sigurnosti sugeriraju da je sigurnosni profil lijeka kod djece i adolescenata (u dobi od 2 do 17 godina) koji su primali Rebif 22 mikrograma ili 44 mikrograma tri puta tjedno sličan onom kod odraslih.
English: Serum neutralising antibodies against interferon beta-1a may develop.
Croatian: Na interferon beta-1a mogu se razviti serumska neutralizirajuća protutijela.
English: Excipient with known effect: 1.0 mg benzyl alcohol For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: 1,0 mg benzilnog alkohola Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 6 X 8.8 MICROGRAMS PRE-FILLED PENS + 6 X 22 MICROGRAMS PREFILLED PENS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SA 6 X 8,8 MIKROGRAMA NAPUNJENIH BRIZGALICA + 6 X 22 MIKROGRAMA NAPUNJENIH BRIZGALICA
English: • Gently massage the injection site with a dry cotton ball or gauze.
Croatian: • Mjesto uboda nježno masirajte suhim jastučićem vate ili gazom.
English: corresponding to 6 million International Units (IU) of interferon beta-1a.
Croatian: 6 milijuna internacionalnih jedinica (IU) interferona beta-1a.
English: Injection site necrosis
Croatian: Nekroza na mjestu injiciranja
English: Frequency not known: Panniculitis (occurred in the injection site) Paediatric population
Croatian: Panikulitis (na mjestu primjene injekcije)
English: corresponding to 12 million International Units (IU) of interferon beta-1a.
Croatian: 12 milijuna internacionalnih jedinica (IU) interferona beta-1a.
English: RebiDose is a ready to use pre-filled pen for subcutaneous injection.
Croatian: RebiDose je napunjena brizgalica spremna za primjenu za supkutanu injekciju.
English: The usual dose is 44 micrograms (12 million IU) given three times per week.
Croatian: Uobičajena doza je 44 mikrograma (12 milijuna IU) koja se daje tri puta tjedno.
English: The solution for injection in a pre-filled cartridge is ready for use with the RebiSmart electronic injection device or the RebiSlide manual pen-injector device.
Croatian: Otopina za injekciju u napunjenom ulošku spremna je za upotrebu s elektroničkim uređajem za injiciranje RebiSmart ili s ručnim uređajem s brizgalicom s injektorom RebiSlide.
English: Mean CUA Lesions per Subject per Scan During the Double Blind Period Least Square Means (SE) * tiw - three times per week
Croatian: Prosječna CUA (combined unique active) lezija po ispitaniku po snimanju tijekom dvostruko slijepog razdoblja
English: Hepatic dysfunction
Croatian: Poremećaj funkcije jetre
English: • thyroid,
Croatian: • jetre,
English: Secondary progressive multiple sclerosis
Croatian: Sekundarna progresivna multipla skleroza
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 66 micrograms (18 million IU)/1.5 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 66 mikrograma (18 milijuna IU)/1,5 ml
English: How to use Rebif
Croatian: Kako primjenjivati Rebif
English: At licensed posology, Rebif 44 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at least 2 exacerbations in the previous 2 years and with an EDSS of 0-5.0 at entry.
Croatian: Uz odobreno doziranje, za Rebif 44 mikrograma dokazano je smanjenje incidencije (približno 30% nakon 2 godine) i težine kliničkih relapsa kod bolesnika s najmanje 2 egzacebracije u prethodne 2 godine i EDSS vrijednosti od 0-5,0 na početku ispitivanja.
English: 22 micrograms tiw
Croatian: Rebifom 22 mikrograma.
English: This medicinal product contains 2.5 mg benzyl alcohol per dose of 0.5 mL.
Croatian: Ovaj lijek sadrži 2,5 mg benzilnog alkohola po dozi od 0,5 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 3 AND 12 PRE-FILLED PENS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA S 1, 3 I 12 NAPUNJENIH
English: • Rebif is given by injection under the skin (subcutaneously).
Croatian: • Rebif se daje injekcijom pod kožu (supkutano).
English: This is because the needle is now covered by the safety guard.
Croatian: • Nemojte stavljati zatvarač igle natrag na korišteni RebiDose jer je igla sada pokrivena sigurnosnim štitnikom.
English: These symptoms tend to be most prominent at the initiation of therapy and decrease in frequency and severity with continued treatment.
Croatian: Ti su simptomi obično najizraženiji u početku liječenja, a tijekom nastavka liječenja smanjuje se njihova učestalost i težina.
English: Each pre-filled cartridge contains 66 micrograms (18 MIU*) of interferon beta-1a** in 1.5 mL solution, corresponding to 44 micrograms/mL.
Croatian: Svaki napunjeni uložak sadrži 66 mikrograma (18 milijuna IU*) interferona beta-1a** u 1,5 ml otopine, što odgovara 44 mikrograma/ml.
English: Relapsing-remitting multiple sclerosis
Croatian: Relapsno-remitirajuća multipla skleroza
English: Rebif 22 micrograms is a solution for injection in a pre-filled pen for self-administration.
Croatian: Rebif 22 mikrograma je otopina za injekciju u napunjenoj brizgalici za samostalnu primjenu.
English: 2 cartridges
Croatian: 2 uloška
English: INFORMATION IN BRAILLE rebif 22
Croatian: 16. PODACI NA BRAILLEOVOM PISMU rebif 22
English: The syringes are sealed in disposable pen injectors called RebiDose.
Croatian: Štrcaljke su zapečaćene u jednokratnoj injekcijskoj brizgalici imena RebiDose.
English: At licensed posology, Rebif 22 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at least 2 exacerbations in the previous 2 years and with an EDSS of 0-5.0 at entry.
Croatian: Uz odobreno doziranje, za Rebif 22 mikrograma dokazano je smanjenje incidencije (približno 30% nakon 2 godine) i težine kliničkih relapsa kod bolesnika s najmanje 2 egzacebracije u prethodne 2 godine i EDSS vrijednosti od 0-5,0 na početku ispitivanja.
English: NAME OF THE MEDICINAL PRODUCT Rebif 44 micrograms/0.5 mL solution for injection in cartridge
Croatian: NAZIV LIJEKA Rebif 44 mikrograma/0,5 ml otopina za injekciju u ulošku
English: Pack size of 2 cartridges.
Croatian: Veličina pakiranja: 2 uloška.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 44 micrograms (12 million IU)/0.5 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 44 mikrograma (12 milijuna IU)/0,5 ml
English: Where to inject with RebiDose
Croatian: Gdje injicirati s brizgalicom RebiDose
English: Each pre-filled syringe (0.2 mL) contains 8.8 micrograms (2.4 MIU*) of interferon beta-1a**.
Croatian: Svaka napunjena štrcaljka (0,2 ml) sadrži 8,8 mikrograma (2,4 milijuna IU*) interferona beta-1a**.
English: Rebif 8.8 micrograms solution for injection interferon beta-1a
Croatian: Rebif 8,8 mikrograma otopina za injekciju interferon beta-1a
English: How to store Rebif
Croatian: Kako čuvati Rebif
English: 6 pre-filled syringes of Rebif 8.8 micrograms and 6 pre-filled syringes of Rebif 22 micrograms.
Croatian: 6 napunjenih štrcaljki lijeka Rebif 8,8 mikrograma i 6 napunjenih štrcaljki lijeka Rebif 22 mikrograma.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 22 micrograms (6 million IU)/0.5 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 22 mikrograma (6 milijuna IU)/0,5 ml
English: Patients with multiple sclerosis The usual dose is 44 micrograms (12 million IU) given three times per week.
Croatian: Bolesnici s multiplom sklerozom Uobičajena doza je 44 mikrograma (12 milijuna IU) koja se daje tri puta tjedno.
English: Each syringe contains 22 micrograms, corresponding to 6 million International Units (IU) of interferon beta-1a.
Croatian: Svaka napunjena brizgalica sadrži 22 mikrograma što odgovara 6 milijuna internacionalnih jedinica (IU) interferona beta-1a.
English: See the package leaflet for further information.
Croatian: Za više informacija pogledajte uputu o lijeku.
English: Each syringe contains 44 micrograms, corresponding to 12 million International Units (IU) of interferon beta-1a.
Croatian: Svaka napunjena brizgalica sadrži 44 mikrograma što odgovara 12 milijuna internacionalnih jedinica (IU) interferona beta-1a.
English: One-month initiation pack contains six Rebif 8.8 micrograms pre-filled syringes and six Rebif 22 micrograms pre-filled syringes.
Croatian: Jednomjesečno pakiranje za početak liječenja sadrži šest napunjenih štrcaljki lijeka Rebif 8,8 mikrograma i šest napunjenih štrcaljki lijeka Rebif 22 mikrograma.
English: Composition: Each Rebif 8.8 micrograms pre-filled syringe (0.2 mL) contains 8.8 micrograms (2.4 Million IU) of interferon beta-1a.
Croatian: Sastav: Svaka napunjena štrcaljka lijeka Rebif 8,8 mikrograma (0,2 ml) sadrži 8,8 mikrograma (2,4 milijuna IU) interferona beta-1a.
English: NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms/0.5 mL solution for injection in cartridge
Croatian: NAZIV LIJEKA Rebif 22 mikrograma/0,5 ml otopina za injekciju u ulošku
English: See recommendations in section “Warnings and precautions” to minimise the risk of injection site reactions.
Croatian: Kako biste umanjili rizik za reakcije na mjestu injiciranja, pogledajte preporuke u poglavlju „Upozorenja i mjere opreza“.
English: Dose reduction of Rebif should be considered if ALT rises above 5 times the ULN, and gradually re-escalated when enzyme levels have normalized.
Croatian: Dozu se može postupno povećavati kad se razina enzima normalizira.
English: If you have any further questions, please ask your doctor, nurse or pharmacist.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku, medicinskoj sestri ili ljekarniku.
English: Poloxamer 188
Croatian: 6.1 Popis pomoćnih tvari manitol poloksamer 188
English: • Dilatation of the blood vessels and palpitation
Croatian: • proširenje krvnih žila i osjećaj lupanja srca
English: • To place the cartridge in the device and perform the injection follow the instruction manual
Croatian: • Da biste postavili uložak u uređaj i dali injekciju, pridržavajte se uputa iz priručnika (Upute za upotrebu) koji se isporučuje s Vašim uređajem.
English: Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU*) of interferon beta-1a**.
Croatian: Svaka napunjena štrcaljka (0,5 ml) sadrži 44 mikrograma (12 milijuna IU*) interferona beta-1a**.
English: The cartridge is to be used either with the RebiSmart electronic injection device or the RebiSlide manual pen injector device.
Croatian: Uložak je namijenjen za uporabu ili s elektronskim uređajem za injiciranje RebiSmart ili s ručnim uređajem s brizgalicom s injektorom RebiSlide.
English: How to inject with RebiDose
Croatian: Kako injicirati s brizgalicom RebiDose
English: L-methionine
Croatian: Kaplan-Meireova procjena
English: This medicinal product contains 2.5 mg benzyl alcohol per dose.
Croatian: Ovaj lijek sadrži 2,5 mg benzilnog alkohola po dozi.
English: Clinical data suggest that after 24 to 48 months of treatment with Rebif 44 micrograms, approximately 13 to 14% of patients develop persistent serum antibodies to interferon beta-1a.
Croatian: Klinički podaci ukazuju na razvoj perzistirajućih serumskih protutijela na interferon beta-1a kod približno 13 do 14% bolesnika nakon 24-48 mjeseci liječenja Rebifom 44 mikrograma.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 132 micrograms (36 MIU) of interferon beta-1a in 1.5 mL solution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Sastav: Svaki uložak sadrži 132 mikrograma (36 milijuna IU) interferona beta-1a u 1,5 ml otopine.
English: Each 8.8 micrograms syringe contains 8.8 micrograms of interferon beta-1a (2.4 million IU).
Croatian: Svaka štrcaljka s 8,8 mikrograma sadrži 8,8 mikrograma interferona beta-1a (2,4 milijuna IU).
English: • liver,
Croatian: • bubrega,
English: Rebif 8.8 mcg/0.1 mL Rebif 22 mcg/0.25 mL Solution for injection interferon beta-1a SC use
Croatian: Rebif 8,8 μg/0,1 ml Rebif 22 μg/0,25 ml otopina za injekciju interferon beta-1a s.c. primjena
English: Clinical data suggest that after 24 to 48 months of treatment with Rebif 22 micrograms, approximately 24% of patients develop persistent serum antibodies to interferon beta-1a.
Croatian: Klinički podaci ukazuju na razvoj perzistirajućih serumskih protutijela na interferon beta-1a kod približno 24% bolesnika nakon 24-48 mjeseci liječenja Rebifom 22 mikrograma.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU) of interferon beta-1a.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Sastav: Svaka napunjena štrcaljka (0,5 ml) sadrži 44 mikrograma (12 milijuna IU) interferona beta-1a.
English: • Remove the Rebif cartridge from the blister pack by peeling back the plastic covering.
Croatian: • Štrcaljku s lijekom Rebif izvadite iz blister pakiranja odvajanjem plastične poleđine.
English: Each Rebif 22 micrograms pre-filled syringe (0.5 mL) contains 22 micrograms (6 Million IU) of interferon beta-1a.
Croatian: Svaka napunjena štrcaljka lijeka Rebif 22 mikrograma (0,5 ml) sadrži 22 mikrograma (6 milijuna IU) interferona beta-1a.
English: Each 22 micrograms syringe contains 22 micrograms of interferon beta-1a (6 million IU).
Croatian: Svaka štrcaljka od 22 mikrograma sadrži 22 mikrograma interferona beta-1a (6 milijuna IU).
English: • Remove RebiDose from the blister pack by peeling back the plastic covering.
Croatian: • Izvadite RebiDose iz blister pakiranja odvajanjem plastične poleđine.
English: Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU*) of interferon beta-1a**.
Croatian: Svaka napunjena štrcaljka (0,5 ml) sadrži 22 mikrograma (6 milijuna IU*) interferona beta-1a**.
English: Rebif contains 0.5 mg benzyl alcohol per dose of 0.1 mL and 1.25 mg benzyl alcohol per dose of 0.25 mL.
Croatian: Rebif sadrži 0,5 mg benzilnog alkohola po dozi od 0,1 ml i 1,25 mg benzilnog alkohola po dozi od 0,25 ml.
English: NAME OF THE MEDICINAL PRODUCT Rebif 44 micrograms solution for injection in pre-filled syringe
Croatian: NAZIV LIJEKA Rebif 44 mikrograma otopina za injekciju u napunjenoj brizgalici
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 66 micrograms (18 MIU) of interferon beta-1a in 1.5 mL solution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Sastav: Svaki uložak sadrži 66 mikrograma (18 milijuna IU) interferona beta-1a u 1,5 ml otopine.
English: Rebif 22 micrograms solution for injection interferon beta-1a
Croatian: Rebif 22 mikrograma otopina za injekciju interferon beta-1a
English: Each 8.8 micrograms pre-filled pen contains 8.8 micrograms of interferon beta-1a (2.4million IU).
Croatian: Svaka napunjena brizgalica od 8,8 mikrograma sadrži 8,8 mikrograma interferona beta-1a (2,4 milijuna IU).