FrancophonIA/ELRC3.0 huggingface dataset:
English: Composition: Each pre-filled pen contains 44 micrograms (12 MIU) of interferon beta-1a in 0.5 mL solution.
Croatian: Sastav: Svaka napunjena brizgalica sadrži 44 mikrograma (12 milijuna IU) interferona beta-1a u 0,5 ml otopine.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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
Croatian: 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
English: • Remove RebiDose from the injection site.
Croatian: • Uklonite RebiDose s mjesta injiciranja.
English: 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
Croatian: 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
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 8.8 micrograms solution for injection interferon beta-1a
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 8,8 mikrograma otopina za injekciju interferon beta-1a s.c. primjena
English: 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.
Croatian: 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.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU) of interferon beta-1a.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Sastav: Svaka napunjena štrcaljka (0,5 ml) sadrži 22 mikrograma (6 milijuna IU) interferona beta-1a.
English: • Fatigue, fever, chills
Croatian: • umor, vrućica, zimica
English: 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.
Croatian: 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.
English: NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms solution for injection in pre-filled syringe
Croatian: NAZIV LIJEKA Rebif 22 mikrograma otopina za injekciju u napunjenoj brizgalici
English: 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
Croatian: 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
English: Composition: Each pre-filled pen contains 22 micrograms (6 MIU) of interferon beta-1a in 0.5 mL solution.
Croatian: Sastav: Svaka napunjena brizgalica sadrži 22 mikrograma (6 milijuna IU) interferona beta-1a u 0,5 ml otopine.
English: 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
Croatian: 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
English: Each 22 micrograms pre-filled pen contains 22 micrograms of interferon beta-1a (6 million IU).
Croatian: Svaka napunjena brizgalica od 22 mikrograma sadrži 22 mikrograma interferona beta-1a (6 milijuna IU).
English: After receiving adequate training, you, a family member, friend or carer can use Rebif cartridges with your device to administer the medicine at home.
Croatian: 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.
English: 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.
Croatian: 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).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 22 micrograms solution for injection interferon beta-1a
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 22 mikrograma otopina za injekciju interferon beta-1a s.c. primjena
English: The pre-filled syringe is ready for use and contains 0.2 mL of solution.
Croatian: Napunjena brizgalica spremna je za primjenu i sadrži 0,2 ml otopine.
English: Rebif 44 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a
Croatian: Rebif 44 mikrograma/0,5 ml otopina za injekciju u ulošku interferon beta-1a
English: 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
Croatian: Rebif 8,8 mikrograma/0,1 ml otopina za injekciju u ulošku Rebif 22 mikrograma/0,25 ml otopina za injekciju u ulošku
English: Rebif 8.8 micrograms solution for injection in pre-filled pen interferon beta-1a
Croatian: Rebif 8,8 mikrograma otopina za injekciju u napunjenoj brizgalici interferon beta-1a
English: Patients being treated with Rebif may occasionally develop new or worsening thyroid abnormalities.
Croatian: Kod bolesnika liječenih Rebifom može se razviti poremećaj funkcije štitnjače ili pogoršanje već postojećeg poremećaja štitnjače.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/008
English: Mannitol
Croatian: • omaglica
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 44 micrograms solution for injection interferon beta-1a
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 44 mikrograma otopina za injekciju interferon beta-1a s.c. primjena
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 22 mcg/0.5 mL solution for injection interferon beta-1a
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 22 μg/0,5 ml otopina za injekciju interferon beta-1a s.c. primjena
English: Rebif 22 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a
Croatian: Rebif 22 mikrograma/0,5 ml otopina za injekciju u ulošku interferon beta-1a
English: • Thyroid dysfunction is uncommon.
Croatian: • Poremećaj rada štitnjače je manje česta nuspojava.
English: 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.
Croatian: Primjena interferona beta-1a kod bolesnika s teškim bubrežnim i jetrenim zatajenjem, kao i s teškom mijelosupresijom, zahtijeva poseban oprez i pomno praćenje.
English: Rebif 44 micrograms solution for injection in pre-filled syringe interferon beta-1a
Croatian: Rebif 44 mikrograma otopina za injekciju u napunjenoj brizgalici interferon beta-1a
English: Each Rebif 22 micrograms pre-filled pen contains 22 micrograms (6 Million IU) of interferon beta-1a in 0.5 mL solution.
Croatian: Svaka napunjena brizgalica lijeka Rebif 22 mikrograma sadrži 22 mikrograma (6 milijuna IU) interferona beta-1a u 0,5 ml otopine.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 8.8 mcg solution for injection interferon beta-1a
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 8,8 μg otopina za injekciju interferon beta-1a s.c. primjena
English: 6 pre-filled syringes of Rebif 8.8 micrograms (LOWER FLAP)
Croatian: (GORNJI PREKLOP) 6 napunjenih štrcaljki lijeka Rebif 8,8 mikrograma
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 44 mcg/0.5 mL solution for injection interferon beta-1a
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 44 μg/0,5 ml otopina za injekciju interferon beta-1a s.c. primjena
English: 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
Croatian: 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
English: B. Transparent window C. Plunger
Croatian: Prozirni prozorčić C.
English: Store the cartridge in the original package in order to protect from light.
Croatian: Štrcaljku čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: 8.8 micrograms tiw
Croatian: 4.8 Nuspojave
English: Store the pre-filled pen in the original package in order to protect from light.
Croatian: Napunjenu brizgalicu čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Each pre-filled pen contains 8.8 micrograms (2.4 MIU*) of interferon beta-1a** in 0.2 mL solution.
Croatian: Svaka napunjena brizgalica sadrži 8,8 mikrograma (2,4 milijuna IU*) interferona beta-1a** u 0,2 ml otopine.
English: The pre-filled syringe is ready for use and contains 0.5 mL of solution.
Croatian: Napunjena brizgalica spremna je za primjenu i sadrži 0,5 ml otopine.
English: After receiving adequate training, you, a family member, friend or carer can use RebiDose to administer the medicine at home.
Croatian: Nakon odgovarajuće obuke, Vi, Vaš član obitelji, prijatelj ili njegovatelj možete upotrebljavati RebiDose da bi se lijek primijenio kod kuće.
English: Each pre-filled pen contains 44 micrograms (12 MIU*) of interferon beta-1a** in 0.5 mL solution.
Croatian: Svaka napunjena brizgalica sadrži 44 mikrograma (12 milijuna IU*) interferona beta-1a** u 0,5 ml otopine.
English: 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.
Croatian: Rebif 8,8 mikrograma otopina za injekciju u napunjenoj štrcaljki s pričvršćenom iglom za samostalnu primjenu.
English: •Remove RebiSlide from the injection site.
Croatian: •Uklonite RebiSlide s mjesta injiciranja.
English: • Remove RebiSlide from the injection site.
Croatian: • Uklonite RebiSlide s mjesta injiciranja.
English: 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
Croatian: Rebif 8,8 mikrograma otopina za injekciju u napunjenoj štrcaljki Rebif 22 mikrograma otopina za injekciju u napunjenoj štrcaljki
English: 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).
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza „Rok valjanosti“.
English: 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
Croatian: 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
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/009
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/009
English: Rebif 22 micrograms solution for injection in pre-filled syringe interferon beta-1a
Croatian: Rebif 22 mikrograma otopina za injekciju u napunjenoj brizgalici interferon beta-1a
English: please ask your doctor, nurse or pharmacist for assistance.
Croatian: nemojte koristiti otopinu i obratite se svom liječniku, medicinskoj sestri ili ljekarniku za pomoć.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/011
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/011
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/017
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/014
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/014
English: 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
Croatian: Rebif 8,8 mikrograma otopina za injekciju u napunjenoj brizgalici Rebif 22 mikrograma otopina za injekciju u napunjenoj brizgalici
English: 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
Croatian: 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
English: 6 pre-filled pens of 8.8 micrograms and 6 pre-filled pens of 22 micrograms.
Croatian: 6 napunjenih brizgalica lijeka Rebif 8,8 mikrograma i 6 napunjenih brizgalica lijeka Rebif 22 mikrograma.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/010
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/063/010
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 44 mcg solution for injection interferon beta-1a
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 44 μg otopina za injekciju interferon beta-1a s.c. primjena
English: Each pre-filled pen contains 22 micrograms (6 MIU*) of interferon beta-1a** in 0.5 mL solution.
Croatian: Svaka napunjena brizgalica sadrži 22 mikrograma (6 milijuna IU*) interferona beta-1a** u 0,5 ml otopine.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 22 mcg solution for injection interferon beta-1a
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Rebif 22 μg otopina za injekciju interferon beta-1a s.c. primjena
English: 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
Croatian: Rebif 8,8 mikrograma otopina za injekciju u napunjenoj brizgalici Rebif 22 mikrograma otopina za injekciju u napunjenoj brizgalici interferon beta-1a
English: After receiving adequate training, you, a family member, friend or carer can use Rebif syringes to administer the medicine at home.
Croatian: Nakon odgovarajuće obuke, Vi, Vaš član obitelji, prijatelj ili njegovatelj možete upotrebljavati štrcaljke lijeka Rebif da bi se lijek primijenio kod kuće.
English: After receiving adequate training, you, a family member, friend or carer can use Rebif pre-filled pen to administer the medicine at home.
Croatian: Nakon odgovarajuće obuke, Vi, Vaš član obitelji, prijatelj ili njegovatelj možete upotrebljavati napunjene brizgalice lijeka Rebif da bi se lijek primijenio kod kuće.
English: Inflammation of the liver has also been reported (uncommon).
Croatian: Također je prijavljena i upala jetre (manje često).
English: 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
Croatian: 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
English: One-month initiation pack contains sixRebif8.8micrograms pre-filled pens and sixRebif22micrograms pre-filled pens.
Croatian: Jednomjesečno pakiranje za početak liječenja sadrži šest napunjenih brizgalica lijeka Rebif 8,8 mikrograma i šest napunjenih brizgalica lijeka Rebif 22 mikrograma.
English: Therefore careful monitoring will be performed.
Croatian: Stoga će se provoditi pažljivi nadzor.
English: 9 to < 16 16 to 23 > 23 to 34
Croatian: 9 do < 16 16 do 23 > 23 do 34
English: The following information is intended for medical or healthcare professionals only
Croatian: Sljedeće informacije namijenjene su samo medicinskim ili zdravstvenim radnicima
English: Ask your pharmacist how to throw away medicine you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijek koji više ne koristite.
English: Incomplete development of teeth.
Croatian: Nepotpun razvoj zubi.
English: The long-term outcomes confirmed that the efficacy was maintained without unexpected effects.
Croatian: Dugoročni ishodi potvrdili su da je djelotvornost održana bez neočekivanih učinaka.
English: By example:
Croatian: Primjerice:
English: These measures will help protect environment.
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: During the same period there was no death in autologous recipients.
Croatian: Tijekom istog razdoblja nije bilo smrti u autolognih primatelja.
English: Therefore special care is recommended when combining these two compounds.
Croatian: Stoga se preporučuje poseban oprez kada se ta dva sastojka kombiniraju.
English: These risks are assessed in the corresponding national procedures.
Croatian: Ovi se rizici ocjenjuju odgovarajućim postupcima na nacionalnoj razini.
English: In new-born infants, children and adolescents (0 to 17 years):
Croatian: U novorođenčadi, djece i adolescenata (0 do 17 godina):
English: At the recommended dose, this is the desired effect.
Croatian: Uz preporučeno doziranje, to je željeni učinak.
English: There is no primary or secondary graft rejection.
Croatian: Nije bilo primarnog niti sekundarnog odbacivanja presatka.
English: Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove dobivene bez recepta.
English: Paediatric population (0 to 17 years)
Croatian: Pedijatrijska populacija (0 do 17 godina)
English: VOD was reported with a range between 3.9% and 15.4%.
Croatian: VOD je prijavljen u rasponu između 3,9% i 15,4%.
English: Vials: 3 years
Croatian: Bočice: 3 godine
English: Nevertheless the risk of liver toxicity may be increased in this population.
Croatian: No rizik od toksičnosti za jetru može biti povećan u toj populaciji.
English: The patients received the dosing mentioned in section 4.2.
Croatian: Bolesnici su primili doziranje navedeno u dijelu 4.2.
English: This signal was open based on an isolated case from the literature and no additional cases have been reported.
Croatian: Signal je pokrenut na temelju izoliranog slučaja iz literature, a dodatni slučajevi nisu prijavljeni.
English: However, caution is recommended (see sections 4.8 and 5.2).
Croatian: Ipak, preporučuje se oprez (vidjeti dijelove 4.8 i 5.2).
English: • The diluted solution must be mixed thoroughly by inverting several times.
Croatian: • Razrijeđena otopina mora se temeljito promiješati okretanjem nekoliko puta.
English: Each infusion will last 2 hours
Croatian: - Svaka infuzija trajat će 2 sata.
English: Same dose (see section 5.2) for elderly patients as for adults (< 50 years old) should be used.
Croatian: Jednake doze (vidjeti dio 5.2) se trebaju primijeniti za starije bolesnike kao i za odrasle (< 50 godina starosti).
English: Irreversible protein binding may explain the incomplete recovery.
Croatian: Nereverzibilno vezivanje proteina može biti objašnjenje nepotpunog oporavka.
English: Elevated bilirubin (n=3) and elevated AST (n=1) were also observed.
Croatian: Povišeni bilirubin (n=3) i povišeni AST (n=1) također su zabilježeni.
English: The safety and efficacy of FB in pediatric population has not been established.
Croatian: Sigurnost i djelotvornost FB-a u pedijatrijskoj populaciji nisu ustanovljene.
English: No dose adjustment was deemed necessary.
Croatian: Nije se smatralo potrebnim prilagođavati dozu.
English: Small volumes may be administered over 2 hours using electric syringes.
Croatian: Manji volumeni mogu se primijeniti tijekom 2 sata pomoću električnih štrcaljki.
English: Occurrence of VOD was not related to overexposure.
Croatian: Pojavljivanje VOD-a nije bilo povezano s prekomjernom izloženošću.
English: None of the metabolites is thought to contribute significantly to either efficacy or toxicity.
Croatian: Ne smatra se da bilo koji metabolit značajno doprinosi bilo učinkovitosti, bilo toksičnosti.
English: Six of 103 patients (6%) experienced HVOD.
Croatian: Šest od 103 bolesnika (6%) doživjeli su HVOD.
English: Contribution of long-lasting metabolites is not excluded.
Croatian: Nije isključeno djelovanje dugotrajnih metabolita.
English: Infections (documented and non documented febrile neutropenia) were experienced in 89% of patients (49/55).
Croatian: Infekcije (dokumentirane i nedokumentirane febrilne neutropenije) je doživjelo 89% bolesnika (49/55).
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100) or not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100, <1/10), manje često (≥1/1000,<1/100) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene su odgovornost korisnika te ne bi trebali biti duži od gore navedenih uvjeta kada je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: In case of overdose, management would include general supportive care.
Croatian: U slučaju predoziranja liječenje bi uključivalo općenite potporne mjere.
English: Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Croatian: Liječnik će redovito kontrolirati Vašu krvnu sliku i jetrene enzime kako bi otkrio i liječio te događaje.
English: Infections.
Croatian: Infekcije.
English: Not known (frequency cannot be estimated from the available data) Sex glands dysfunction.
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) Smetnje funkcije spolnih žlijezda.
English: PROCEDURE FOR PROPER DISPOSAL
Croatian: POSTUPAK ZA PRAVILNO ODLAGANJE
English: Patients should receive adequate anticonvulsant prophylaxis.
Croatian: Bolesnici trebaju primiti odgovarajuću antikonvulzivnu profilaksu.
English: (range 8-19 days) in autologous patients (OMC-BUS 3).
Croatian: (raspon od 8-19 dana) u autolognih bolesnika (OMC-BUS 3).
English: Headache Nervous system disorders [Not Elsewhere Classified]
Croatian: Glavobolja Poremećaji živčanog sustava [koji nisu drugdje klasificirani]
English: Seven literature reports have been published cumulatively concerning disturbance in dental development.
Croatian: U literaturi je kumulativno objavljeno sedam izvješća o poremećaju dentalnog razvoja.
English: The available data in animals support the carcinogenic potential of busulfan.
Croatian: Dostupni podaci dobiveni na životinjama podržavaju karcinogeni potencijal busulfana.
English: Concentrate 4 vials of 10ml.
Croatian: Koncentrat 4 bočice od 10 ml.
English: Date of first authorisation: 09 July, 2003 Date of latest renewal: 08 July, 2008
Croatian: Datum posljednje obnove odobrenja: 8. srpnja 2008.
English: The administration of FB regimen has not been specifically investigated in elderly patients.
Croatian: Primjena protokola FB-a nije se specifično ispitala u starijih bolesnika.
English: Reversible binding to plasma proteins was around 7% while irreversible binding, primarily to albumin, was about 32%.
Croatian: Reverzibilno vezivanje na plazmatske proteine bilo je otprilike 7%, dok je nereverzibilno vezivanje, primarno na albumin, bilo 32%.