natgillin/translations-raw huggingface dataset:
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 22 micrograms (6 million IU)/0.5 mL 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 22 mikrograma (6 milijuna IU)/0,5 ml
Patients with multiple sclerosis The usual dose is 44 micrograms (12 million IU) given three times per week. 
Bolesnici s multiplom sklerozom Uobičajena doza je 44 mikrograma (12 milijuna IU) koja se daje tri puta tjedno.
Each syringe contains 22 micrograms, corresponding to 6 million International Units (IU) of interferon beta-1a. 
Svaka napunjena brizgalica sadrži 22 mikrograma što odgovara 6 milijuna internacionalnih jedinica (IU) interferona beta-1a.
See the package leaflet for further information. 
Za više informacija pogledajte uputu o lijeku.
Each syringe contains 44 micrograms, corresponding to 12 million International Units (IU) of interferon beta-1a. 
Svaka napunjena brizgalica sadrži 44 mikrograma što odgovara 12 milijuna internacionalnih jedinica (IU) interferona beta-1a.
One-month initiation pack contains six Rebif 8.8 micrograms pre-filled syringes and six Rebif 22 micrograms pre-filled syringes. 
Jednomjesečno pakiranje za početak liječenja sadrži šest napunjenih štrcaljki lijeka Rebif 8,8 mikrograma i šest napunjenih štrcaljki lijeka Rebif 22 mikrograma.
Composition: Each Rebif 8.8 micrograms pre-filled syringe (0.2 mL) contains 8.8 micrograms (2.4 Million IU) of interferon beta-1a. 
Sastav: Svaka napunjena štrcaljka lijeka Rebif 8,8 mikrograma (0,2 ml) sadrži 8,8 mikrograma (2,4 milijuna IU) interferona beta-1a.
NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms/0.5 mL solution for injection in cartridge 
NAZIV LIJEKA Rebif 22 mikrograma/0,5 ml otopina za injekciju u ulošku
See recommendations in section “Warnings and precautions” to minimise the risk of injection site reactions. 
Kako biste umanjili rizik za reakcije na mjestu injiciranja, pogledajte preporuke u poglavlju „Upozorenja i mjere opreza“.
Dose reduction of Rebif should be considered if ALT rises above 5 times the ULN, and gradually re-escalated when enzyme levels have normalized. 
Dozu se može postupno povećavati kad se razina enzima normalizira.
If you have any further questions, please ask your doctor, nurse or pharmacist. 
Ako imate dodatnih pitanja, obratite se liječniku, medicinskoj sestri ili ljekarniku.
Poloxamer 188 
6.1 Popis pomoćnih tvari manitol poloksamer 188
• Dilatation of the blood vessels and palpitation 
• proširenje krvnih žila i osjećaj lupanja srca
• To place the cartridge in the device and perform the injection follow the instruction manual 
• Da biste postavili uložak u uređaj i dali injekciju, pridržavajte se uputa iz priručnika (Upute za upotrebu) koji se isporučuje s Vašim uređajem.
Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU*) of interferon beta-1a**. 
Svaka napunjena štrcaljka (0,5 ml) sadrži 44 mikrograma (12 milijuna IU*) interferona beta-1a**.
The cartridge is to be used either with the RebiSmart electronic injection device or the RebiSlide manual pen injector device. 
Uložak je namijenjen za uporabu ili s elektronskim uređajem za injiciranje RebiSmart ili s ručnim uređajem s brizgalicom s injektorom RebiSlide.
How to inject with RebiDose 
Kako injicirati s brizgalicom RebiDose
L-methionine 
Kaplan-Meireova procjena
This medicinal product contains 2.5 mg benzyl alcohol per dose. 
Ovaj lijek sadrži 2,5 mg benzilnog alkohola po dozi.
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. 
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.
STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 132 micrograms (36 MIU) of interferon beta-1a in 1.5 mL solution. 
NAVOĐENJE DJELATNE(IH) TVARI Sastav: Svaki uložak sadrži 132 mikrograma (36 milijuna IU) interferona beta-1a u 1,5 ml otopine.
Each 8.8 micrograms syringe contains 8.8 micrograms of interferon beta-1a (2.4 million IU). 
Svaka štrcaljka s 8,8 mikrograma sadrži 8,8 mikrograma interferona beta-1a (2,4 milijuna IU).
• liver, 
• bubrega,
Rebif 8.8 mcg/0.1 mL Rebif 22 mcg/0.25 mL Solution for injection interferon beta-1a SC use 
Rebif 8,8 μg/0,1 ml Rebif 22 μg/0,25 ml otopina za injekciju interferon beta-1a s.c. primjena
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. 
Klinički podaci ukazuju na razvoj perzistirajućih serumskih protutijela na interferon beta-1a kod približno 24% bolesnika nakon 24-48 mjeseci liječenja Rebifom 22 mikrograma.
STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU) of interferon beta-1a. 
NAVOĐENJE DJELATNE(IH) TVARI Sastav: Svaka napunjena štrcaljka (0,5 ml) sadrži 44 mikrograma (12 milijuna IU) interferona beta-1a.
• Remove the Rebif cartridge from the blister pack by peeling back the plastic covering. 
• Štrcaljku s lijekom Rebif izvadite iz blister pakiranja odvajanjem plastične poleđine.
Each Rebif 22 micrograms pre-filled syringe (0.5 mL) contains 22 micrograms (6 Million IU) of interferon beta-1a. 
Svaka napunjena štrcaljka lijeka Rebif 22 mikrograma (0,5 ml) sadrži 22 mikrograma (6 milijuna IU) interferona beta-1a.
Each 22 micrograms syringe contains 22 micrograms of interferon beta-1a (6 million IU). 
Svaka štrcaljka od 22 mikrograma sadrži 22 mikrograma interferona beta-1a (6 milijuna IU).
• Remove RebiDose from the blister pack by peeling back the plastic covering. 
• Izvadite RebiDose iz blister pakiranja odvajanjem plastične poleđine.
Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU*) of interferon beta-1a**. 
Svaka napunjena štrcaljka (0,5 ml) sadrži 22 mikrograma (6 milijuna IU*) interferona beta-1a**.
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. 
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.
NAME OF THE MEDICINAL PRODUCT Rebif 44 micrograms solution for injection in pre-filled syringe 
NAZIV LIJEKA Rebif 44 mikrograma otopina za injekciju u napunjenoj brizgalici
STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 66 micrograms (18 MIU) of interferon beta-1a in 1.5 mL solution. 
NAVOĐENJE DJELATNE(IH) TVARI Sastav: Svaki uložak sadrži 66 mikrograma (18 milijuna IU) interferona beta-1a u 1,5 ml otopine.
Rebif 22 micrograms solution for injection interferon beta-1a 
Rebif 22 mikrograma otopina za injekciju interferon beta-1a
Each 8.8 micrograms pre-filled pen contains 8.8 micrograms of interferon beta-1a (2.4million IU). 
Svaka napunjena brizgalica od 8,8 mikrograma sadrži 8,8 mikrograma interferona beta-1a (2,4 milijuna IU).
Composition: Each pre-filled pen contains 44 micrograms (12 MIU) of interferon beta-1a in 0.5 mL solution. 
Sastav: Svaka napunjena brizgalica sadrži 44 mikrograma (12 milijuna IU) interferona beta-1a u 0,5 ml otopine.
This medicinal product contains 0.5 mg benzyl alcohol per dose of 0.1 mL and 1.25 mg benzyl alcohol per dose of 0.25 mL. 
Ovaj lijek sadrži 0,5 mg benzilnog alkohola po dozi od 0,1 ml i 1,25 mg benzilnog alkohola po dozi od 0,25 ml.
Rebif contains 1.0 mg benzyl alcohol per dose of 0.2 mL and 2.5 mg benzyl alcohol per dose of 0.5 mL. 
Rebif sadrži 1,0 mg benzilnog alkohola po dozi od 0,2 ml i 2,5 mg benzilnog alkohola po dozi od 0,5 ml.
EU/1/98/063/001 1 pre-filled syringe EU/1/98/063/002 3 pre-filled syringes EU/1/98/063/003 12 pre-filled syringes EU/1/98/063/020 36 pre-filled syringes 
EU/1/98/063/001 1 napunjena štrcaljka EU/1/98/063/002 3 napunjene štrcaljke EU/1/98/063/003 12 napunjenih štrcaljki EU/1/98/063/020 36 napunjenih štrcaljki
• Remove RebiDose from the injection site. 
• Uklonite RebiDose s mjesta injiciranja.
EU/1/98/063/004 1 pre-filled syringe EU/1/98/063/005 3 pre-filled syringes EU/1/98/063/006 12 pre-filled syringes EU/1/98/063/021 36 pre-filled syringes 
EU/1/98/063/004 1 napunjena štrcaljka EU/1/98/063/005 3 napunjene štrcaljke EU/1/98/063/006 12 napunjenih štrcaljki EU/1/98/063/021 36 napunjenih štrcaljki
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 8.8 micrograms solution for injection interferon beta-1a 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 8,8 mikrograma otopina za injekciju interferon beta-1a s.c. primjena
This medicinal product contains 1.0 mg benzyl alcohol per dose of 0.2 mL and 2.5 mg benzyl alcohol per dose of 0.5 mL. 
Ovaj lijek sadrži 1,0 mg benzilnog alkohola po dozi od 0,2 ml i 2,5 mg benzilnog alkohola po dozi od 0,5 ml.
STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU) of interferon beta-1a. 
NAVOĐENJE DJELATNE(IH) TVARI Sastav: Svaka napunjena štrcaljka (0,5 ml) sadrži 22 mikrograma (6 milijuna IU) interferona beta-1a.
• Fatigue, fever, chills 
• umor, vrućica, zimica
Composition: Each Rebif 8.8 micrograms pre-filled pen contains 8.8 micrograms (2.4 Million IU) of interferon beta-1a in 0.2 mL solution. 
Sastav: Svaka napunjena brizgalica lijeka Rebif 8,8 mikrograma sadrži 8,8 mikrograma (2,4 milijuna IU) interferona beta-1a u 0,2 ml otopine.
NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms solution for injection in pre-filled syringe 
NAZIV LIJEKA Rebif 22 mikrograma otopina za injekciju u napunjenoj brizgalici
MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/014 1 pre-filled pen EU/1/98/063/015 3 pre-filled pens EU/1/98/063/016 12 pre-filled pens 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/014 1 napunjena brizgalica EU/1/98/063/015 3 napunjene brizgalice EU/1/98/063/016 12 napunjenih brizgalica
Composition: Each pre-filled pen contains 22 micrograms (6 MIU) of interferon beta-1a in 0.5 mL solution. 
Sastav: Svaka napunjena brizgalica sadrži 22 mikrograma (6 milijuna IU) interferona beta-1a u 0,5 ml otopine.
MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/011 1 pre-filled pen EU/1/98/063/012 3 pre-filled pens EU/1/98/063/013 12 pre-filled pens 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/011 1 napunjena brizgalica EU/1/98/063/012 3 napunjene brizgalice EU/1/98/063/013 12 napunjenih brizgalica
Each 22 micrograms pre-filled pen contains 22 micrograms of interferon beta-1a (6 million IU). 
Svaka napunjena brizgalica od 22 mikrograma sadrži 22 mikrograma interferona beta-1a (6 milijuna IU).
After receiving adequate training, you, a family member, friend or carer can use Rebif cartridges with your device to administer the medicine at home. 
Nakon odgovarajuće obuke, Vi, Vaš član obitelji, prijatelj ili njegovatelj možete upotrebljavati uloške lijeka Rebif s Vašim uređajem da bi se lijek primijenio kod kuće.
Biological response markers (e.g., 2',5'-OAS activity, neopterin and beta 2-microglobulin) are induced by interferon beta-1a following subcutaneous doses administered to healthy volunteer subjects. 
Nakon supkutane primjene doza zdravim dobrovoljcima interferon beta-1a inducira biljege biološkog odgovora (npr. aktivnost 2',5'-oligoadenilat-sintetaze (OAS), neopterin i beta-2 mikroglobulin).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 22 micrograms solution for injection interferon beta-1a 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 22 mikrograma otopina za injekciju interferon beta-1a s.c. primjena
The pre-filled syringe is ready for use and contains 0.2 mL of solution. 
Napunjena brizgalica spremna je za primjenu i sadrži 0,2 ml otopine.
Rebif 44 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a 
Rebif 44 mikrograma/0,5 ml otopina za injekciju u ulošku interferon beta-1a
NAME OF THE MEDICINAL PRODUCT Rebif 8.8 micrograms/0.1 mL solution for injection in cartridge Rebif 22 micrograms/0.25 mL solution for injection in cartridge 
Rebif 8,8 mikrograma/0,1 ml otopina za injekciju u ulošku Rebif 22 mikrograma/0,25 ml otopina za injekciju u ulošku
Rebif 8.8 micrograms solution for injection in pre-filled pen interferon beta-1a 
Rebif 8,8 mikrograma otopina za injekciju u napunjenoj brizgalici interferon beta-1a
Patients being treated with Rebif may occasionally develop new or worsening thyroid abnormalities. 
Kod bolesnika liječenih Rebifom može se razviti poremećaj funkcije štitnjače ili pogoršanje već postojećeg poremećaja štitnjače.
MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/008 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/008
Mannitol 
• omaglica
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 44 micrograms solution for injection interferon beta-1a 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 44 mikrograma otopina za injekciju interferon beta-1a s.c. primjena
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 22 mcg/0.5 mL solution for injection interferon beta-1a 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 22 μg/0,5 ml otopina za injekciju interferon beta-1a s.c. primjena
Rebif 22 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a 
Rebif 22 mikrograma/0,5 ml otopina za injekciju u ulošku interferon beta-1a
• Thyroid dysfunction is uncommon. 
• Poremećaj rada štitnjače je manje česta nuspojava.
Caution should be used, and close monitoring considered when administering interferon beta-1a to patients with severe renal and hepatic failure and to patients with severe myelosuppression. 
Primjena interferona beta-1a kod bolesnika s teškim bubrežnim i jetrenim zatajenjem, kao i s teškom mijelosupresijom, zahtijeva poseban oprez i pomno praćenje.
Rebif 44 micrograms solution for injection in pre-filled syringe interferon beta-1a 
Rebif 44 mikrograma otopina za injekciju u napunjenoj brizgalici interferon beta-1a
Each Rebif 22 micrograms pre-filled pen contains 22 micrograms (6 Million IU) of interferon beta-1a in 0.5 mL solution. 
Svaka napunjena brizgalica lijeka Rebif 22 mikrograma sadrži 22 mikrograma (6 milijuna IU) interferona beta-1a u 0,5 ml otopine.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 8.8 mcg solution for injection interferon beta-1a 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 8,8 μg otopina za injekciju interferon beta-1a s.c. primjena
6 pre-filled syringes of Rebif 8.8 micrograms (LOWER FLAP) 
(GORNJI PREKLOP) 6 napunjenih štrcaljki lijeka Rebif 8,8 mikrograma
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 44 mcg/0.5 mL solution for injection interferon beta-1a 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 44 μg/0,5 ml otopina za injekciju interferon beta-1a s.c. primjena
Rebif 8.8 micrograms/0.1 mL solution for injection in cartridge Rebif 22 micrograms/0.25 mL solution for injection in cartridge interferon beta-1a Initiation pack 
Rebif 8,8 mikrograma/0,1 ml otopina za injekciju u ulošku Rebif 22 mikrograma/0,25 ml otopina za injekciju u ulošku interferon beta-1a Pakiranje za početak liječenja
B. Transparent window C. Plunger 
Prozirni prozorčić C.
Store the cartridge in the original package in order to protect from light. 
Štrcaljku čuvati u originalnom pakiranju radi zaštite od svjetlosti.
8.8 micrograms tiw 
4.8 Nuspojave
Store the pre-filled pen in the original package in order to protect from light. 
Napunjenu brizgalicu čuvati u originalnom pakiranju radi zaštite od svjetlosti.
Each pre-filled pen contains 8.8 micrograms (2.4 MIU*) of interferon beta-1a** in 0.2 mL solution. 
Svaka napunjena brizgalica sadrži 8,8 mikrograma (2,4 milijuna IU*) interferona beta-1a** u 0,2 ml otopine.
The pre-filled syringe is ready for use and contains 0.5 mL of solution. 
Napunjena brizgalica spremna je za primjenu i sadrži 0,5 ml otopine.
After receiving adequate training, you, a family member, friend or carer can use RebiDose to administer the medicine at home. 
Nakon odgovarajuće obuke, Vi, Vaš član obitelji, prijatelj ili njegovatelj možete upotrebljavati RebiDose da bi se lijek primijenio kod kuće.
Each pre-filled pen contains 44 micrograms (12 MIU*) of interferon beta-1a** in 0.5 mL solution. 
Svaka napunjena brizgalica sadrži 44 mikrograma (12 milijuna IU*) interferona beta-1a** u 0,5 ml otopine.
What Rebif looks like and contents of the pack Rebif 8.8 micrograms is a solution for injection in a pre-filled syringe with a fixed needle for self-administration. 
Rebif 8,8 mikrograma otopina za injekciju u napunjenoj štrcaljki s pričvršćenom iglom za samostalnu primjenu.
•Remove RebiSlide from the injection site. 
•Uklonite RebiSlide s mjesta injiciranja.
• Remove RebiSlide from the injection site. 
• Uklonite RebiSlide s mjesta injiciranja.
NAME OF THE MEDICINAL PRODUCT Rebif 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe 
Rebif 8,8 mikrograma otopina za injekciju u napunjenoj štrcaljki Rebif 22 mikrograma otopina za injekciju u napunjenoj štrcaljki
Do not use this medicine after the expiry date which is stated on the label after EXP. Store in a refrigerator (2°C - 8°C). 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza „Rok valjanosti“.
NAME OF THE MEDICINAL PRODUCT Rebif 8.8 micrograms/0.1 mL solution for injection in cartridge Rebif 22 micrograms/0.25 mL solution for injection in cartridge interferon beta-1a 
Rebif 8,8 mikrograma/0,1 ml otopina za injekciju u ulošku Rebif 22 mikrograma/0,25 ml otopina za injekciju u ulošku interferon beta-1a
MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/009 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/009
Rebif 22 micrograms solution for injection in pre-filled syringe interferon beta-1a 
Rebif 22 mikrograma otopina za injekciju u napunjenoj brizgalici interferon beta-1a
please ask your doctor, nurse or pharmacist for assistance. 
nemojte koristiti otopinu i obratite se svom liječniku, medicinskoj sestri ili ljekarniku za pomoć.
MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/011 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/011
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGE 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA
MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/007 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/007
MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/017 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/017
MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/014 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/014
NAME OF THE MEDICINAL PRODUCT Rebif 8.8 micrograms solution for injection in pre-filled pen Rebif 22 micrograms solution for injection in pre-filled pen 
Rebif 8,8 mikrograma otopina za injekciju u napunjenoj brizgalici Rebif 22 mikrograma otopina za injekciju u napunjenoj brizgalici
Rebif 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe interferon beta-1a Initiation pack 
Rebif 8,8 mikrograma otopina za injekciju u napunjenoj štrcaljki Rebif 22 mikrograma otopina za injekciju u napunjenoj štrcaljki interferon beta-1a Pakiranje za početak liječenja
6 pre-filled pens of 8.8 micrograms and 6 pre-filled pens of 22 micrograms. 
6 napunjenih brizgalica lijeka Rebif 8,8 mikrograma i 6 napunjenih brizgalica lijeka Rebif 22 mikrograma.
MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/010 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/010
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 44 mcg solution for injection interferon beta-1a 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 44 μg otopina za injekciju interferon beta-1a s.c. primjena
Each pre-filled pen contains 22 micrograms (6 MIU*) of interferon beta-1a** in 0.5 mL solution. 
Svaka napunjena brizgalica sadrži 22 mikrograma (6 milijuna IU*) interferona beta-1a** u 0,5 ml otopine.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 22 mcg solution for injection interferon beta-1a 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 22 μg otopina za injekciju interferon beta-1a s.c. primjena
NAME OF THE MEDICINAL PRODUCT Rebif 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe interferon beta-1a 
Rebif 8,8 mikrograma otopina za injekciju u napunjenoj brizgalici Rebif 22 mikrograma otopina za injekciju u napunjenoj brizgalici interferon beta-1a
After receiving adequate training, you, a family member, friend or carer can use Rebif syringes to administer the medicine at home. 
Nakon odgovarajuće obuke, Vi, Vaš član obitelji, prijatelj ili njegovatelj možete upotrebljavati štrcaljke lijeka Rebif da bi se lijek primijenio kod kuće.
After receiving adequate training, you, a family member, friend or carer can use Rebif pre-filled pen to administer the medicine at home. 
Nakon odgovarajuće obuke, Vi, Vaš član obitelji, prijatelj ili njegovatelj možete upotrebljavati napunjene brizgalice lijeka Rebif da bi se lijek primijenio kod kuće.
Inflammation of the liver has also been reported (uncommon). 
Također je prijavljena i upala jetre (manje često).
Rebif 8.8 micrograms solution for injection in pre-filled pen Rebif 22 micrograms solution for injection in pre-filled pen interferon beta-1a Initiation pack 
Rebif 8,8 mikrograma otopina za injekciju u napunjenoj brizgalici Rebif 22 mikrograma otopina za injekciju u napunjenoj brizgalici interferon beta-1a Pakiranje za početak liječenja
One-month initiation pack contains sixRebif8.8micrograms pre-filled pens and sixRebif22micrograms pre-filled pens. 
Jednomjesečno pakiranje za početak liječenja sadrži šest napunjenih brizgalica lijeka Rebif 8,8 mikrograma i šest napunjenih brizgalica lijeka Rebif 22 mikrograma.
Therefore careful monitoring will be performed. 
Stoga će se provoditi pažljivi nadzor.
9 to < 16 16 to 23 > 23 to 34 
9 do < 16 16 do 23 > 23 do 34
The following information is intended for medical or healthcare professionals only 
Sljedeće informacije namijenjene su samo medicinskim ili zdravstvenim radnicima
Ask your pharmacist how to throw away medicine you no longer use. 
Pitajte svog ljekarnika kako baciti lijek koji više ne koristite.
Incomplete development of teeth. 
Nepotpun razvoj zubi.
The long-term outcomes confirmed that the efficacy was maintained without unexpected effects. 
Dugoročni ishodi potvrdili su da je djelotvornost održana bez neočekivanih učinaka.
By example: 
Primjerice:
These measures will help protect environment. 
Ove će mjere pomoći u očuvanju okoliša.
During the same period there was no death in autologous recipients. 
Tijekom istog razdoblja nije bilo smrti u autolognih primatelja.
Therefore special care is recommended when combining these two compounds. 
Stoga se preporučuje poseban oprez kada se ta dva sastojka kombiniraju.
These risks are assessed in the corresponding national procedures. 
Ovi se rizici ocjenjuju odgovarajućim postupcima na nacionalnoj razini.
In new-born infants, children and adolescents (0 to 17 years): 
U novorođenčadi, djece i adolescenata (0 do 17 godina):
At the recommended dose, this is the desired effect. 
Uz preporučeno doziranje, to je željeni učinak.
There is no primary or secondary graft rejection. 
Nije bilo primarnog niti sekundarnog odbacivanja presatka.
Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. 
Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove dobivene bez recepta.
Paediatric population (0 to 17 years) 
Pedijatrijska populacija (0 do 17 godina)
VOD was reported with a range between 3.9% and 15.4%. 
VOD je prijavljen u rasponu između 3,9% i 15,4%.
Vials: 3 years 
Bočice: 3 godine
Nevertheless the risk of liver toxicity may be increased in this population. 
No rizik od toksičnosti za jetru može biti povećan u toj populaciji.
The patients received the dosing mentioned in section 4.2. 
Bolesnici su primili doziranje navedeno u dijelu 4.2.
This signal was open based on an isolated case from the literature and no additional cases have been reported. 
Signal je pokrenut na temelju izoliranog slučaja iz literature, a dodatni slučajevi nisu prijavljeni.