FrancophonIA/ELRC3.0 huggingface dataset:
English: 14 - After drawing up the solution turn the syringe assembly so that the needle is pointing up.
Croatian: 14 - Nakon uvlačenja otopine okrenite sklop štrcaljke tako da je igla usmjerena prema gore.
English: Delayed Betaferon 250 mcg n=176
Croatian: 250 µg n = 176
English: Continue with the green triple pack 3 containing 3 syringes with a 0.75-ml marking, for treatment days 13, 15 and 17.
Croatian: Nastavite sa zelenim trostrukim pakiranjem 3 koje sadrži 3 štrcaljke s oznakom od 0,75 ml, za dane liječenja 13, 15 i 17.
English: Use then the red triple pack 2 containing 3 syringes with a 0.5-ml marking, for treatment days 7, 9 and 11.
Croatian: Potom nastavite s crvenim trostrukim pakiranjem 2 koje sadrži 3 štrcaljke s oznakom od 0,5 ml, za dane liječenja 7, 9 i 11.
English: - After your injection, fill in the used injection site and date on the table in your injection record
Croatian: - Nakon injiciranja unesite mjesto i datum injiciranja u tablicu praćenja injiciranja (pogledajte primjer:
English: Events were reported at various time points including up to several years after starting treatment with interferon beta.
Croatian: Događaji su prijavljeni u različitim vremenskim točkama i do nekoliko godina nakon početka liječenja inteferonom beta.
English: Start with the yellow triple pack 1 containing 3 syringes with a 0.25-ml marking, for treatment days 1, 3 and 5.
Croatian: Počnite sa žutim trostrukim pakiranjem 1 koje sadrži 3 štrcaljke s oznakom od 0,25 ml, za dane liječenja 1, 3
English: (see the example: ‘Keeping track of your injection sites and dates').
Croatian: „Vođenje bilješki o mjestu i datumu injiciranja“).
English: 3 Pre-filled syringes with 1.2 ml solvent: sodium chloride solution, 5.4 mg/ml, 3 Vial adapters with needles + 6 alcohol wipes
Croatian: 3 napunjene štrcaljke s 1,2 ml otapala: otopina natrijevog klorida 5,4 mg/ml, 3 nastavka za bočicu s iglom + 6 tupfera natopljenih alkoholom
English: 0.25 ml for first three injections (at day 1, 3, 5 of therapy), or 0.5 ml for the injections at day 7, 9, 11 of therapy, or 0.75 ml for the injections at day 13, 15, 17 of therapy.
Croatian: 0,5 ml za injekcije na dane liječenja 7, 9 i 11, ili 0,75 ml za injekcije na dane liječenja 13, 15 i 17.
English: Remove the tip cap by twisting it off.
Croatian: Uklonite zatvarač s vrha odvrtanjem.
English: You will find in the Betaferon titration pack 4 differently coloured and numbered triple packs, each containing:
Croatian: U titracijskom pakiranju lijeka Betaferon naći ćete 4 različito obojena i numerirana trostruka pakiranja, od kojih svako sadrži:
English: The treatment with Betaferon should be initiated under the supervision of a physician experienced in the treatment of the disease.
Croatian: 4.2 Doziranje i način primjene Liječenje s lijekom Betaferon treba započeti pod nadzorom liječnika koji ima iskustva u liječenju bolesti.
English: − Be consistent - use Betaferon as described in section 3.
Croatian: − Budite dosljedni - primjenjujte Betaferon kao što je opisano u dijelu 3 „Kako primjenjivati Betaferon“ u prvom dijelu upute o lijeku.
English: PHARMACEUTICAL FORM AND CONTENTS Titration pack comprising 4 triple packs, each containing:
Croatian: Titracijsko pakiranje sastoji se od 4 trostruka pakiranja, svako sadrži:
English: Triple pack 1 is designed to help you prepare the first 3 injections (days 1, 3 and 5).
Croatian: Trostruko pakiranje br. 1 osmišljeno je da Vam pomogne u pripremi prve tri injekcije (dani 1, 3 i 5).
English: Hypertension °
Croatian: (hipertenzija)
English: Malaise * × Laboratory abnormality
Croatian: Laboratorijska abnormalnost
English: Triple pack 2 is designed to help you prepare the next 3 injections (days 7, 9 and 11).
Croatian: Trostruko pakiranje br. 2 osmišljeno je da Vam pomogne u pripremi sljedeće tri injekcije (dani 7, 9 i 11).
English: Urticaria, Pruritus, Alopecia
Croatian: Poremećaji kože i potkožnog tkiva urtikarija, pruritus, alopecija diskoloracija kože
English: Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Betaferon.
Croatian: Bolesnici koji primaju Betaferon dobro podnose liječenje relapsa kortikosteroidima ili s ACTH za razdoblja do 28 dana.
English: Abdominal pain °
Croatian: Bol u abdomenu
English: Tel: +46-(0)8-580 223 00
Croatian: Bayer AB Tel: +46-(0)8-580 223 00
English: These may be reduced by the use of an auto-injector device.
Croatian: Te se reakcije mogu smanjiti primjenom autoinjektora.
English: ► If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Year 3 results Open-label follow-up
Croatian: Rezultati iz treće godine Praćenje u fazi otvorenog liječenja
English: Bayer Austria Ges.
Croatian: Österreich Bayer Austria Ges. m. b. H.
English: EXP After reconst.
Croatian: EXP Preporučuje se odmah upotrijebiti nakon pripreme otopine.
English: Musculoskeletal and connective tissue disorders
Croatian: ° Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL OF PRE-FILLED SYRINGE (SOLVENT)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA NAPUNJENOJ ŠTRCALJKI (OTAPALO)
English: 7- Discard the syringe in the disposal unit.
Croatian: 7 - Odbacite štrcaljku u posudu za otpad.
English: 3 Pre-filled syringes with solvent for reconstitution, each containing 1.2 ml sodium chloride solution, 5.4 mg/ml.
Croatian: 3 napunjene štrcaljke s otapalom za pripremu otopine, svaka sadrži 1,2 ml otopine natrijevog klorida od 5,4 mg/ml.
English: Part of a pack containing 15 single packs in a 3-month pack of 3x15 single packs.
Croatian: Dio pakiranja s 15 pojedinačnih pakiranja u tromjesečnom pakiranju od 3x15 pojedinačnih pakiranja.
English: Dyspnoea *
Croatian: Dispneja *
English: Nephrotic syndrome, glomerulosclerosis (see section 4.4)2, 3
Croatian: Poremećaji bubrega i mokraćnog sustava nefrotski sindrom, glomeruloskleroz a (vidjeti dio
English: Discard the vial with the remaining solution.
Croatian: Odbacite bočicu s preostalom otopinom.
English: This will form the syringe assembly.
Croatian: To stvara sklop štrcaljke.
English: Part of a multipack containing 5 single packs.
Croatian: Dio višestrukog pakiranja koje sadrži 5 pojedinačnih pakiranja.
English: - the number of platelets (which help the blood to clot) may fall (thrombocytopenia) - a certain type of blood fats (triglycerides) may increase (will show up in blood tests), see section 2 ‘Warnings and precautions' - suicide attempt - mood swings - convulsion
Croatian: - može se povećati određeni tip masnoća (triglicerida) u krvi (utvrđuje se krvnim pretragama), pogledajte dio 2 „Upozorenja i mjere opreza“ - pokušaj samoubojstva - promjene raspoloženja - konvulzije - može doći do porasta specifičnog jetrenog enzima (gama glutamiltransferaza) kojeg proizvodi Vaša jetra
English: 2nd dosage step (0.5 ml) for treatment days 7, 9, 11
Croatian: Trostruko pakiranje 2 Drugi korak doziranja (0,5 ml) za dane liječenja 7, 9 i 11
English: Time to McDonald MS Kaplan-Meier
Croatian: Vrijeme do pojave multiple skleroze prema McDonaldovim kriterijima Kaplan-Meierove procjene
English: Part of a pack containing 14 single packs in a 2-month pack of 2x14 single packs.
Croatian: Dio pakiranja s 14 pojedinačnih pakiranja u dvomjesečnom pakiranju od 2x14 pojedinačnih pakiranja.
English: Pack comprising 14 single packs, part of a 2-month pack containing 28 (2 x 14) single packs.
Croatian: Pakiranje se sastoji od 14 pojedinačnih pakiranja te je dio dvomjesečnog pakiranja koje sadrži 28 pojedinačnih pakiranja (2x14).
English: especially between menstrual periods, impotence - injection site reaction (including redness, swelling, discolouration, inflammation, pain, allergic reactions (hypersensitivity), skin breakdown and tissue damage (necrosis) at injection site (see section 2‘Warnings and precautions') - flu-like symptoms, fever, pain, chest pain, accumulation of fluid in arm, leg or face
Croatian: - reakcije na mjestu injiciranja (uključujući crvenilo, oticanje, promjenu boje, upalu, bol, alergijske reakcije (preosjetljivost), puknuća kože i oštećenje tkiva (nekroza) na mjestu injiciranja (pogledajte dio 2 „Upozorenja i mjere opreza“)
English: 1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ml, 1 vial adapter with needle + 2 alcohol wipes
Croatian: 1 napunjena štrcaljka s 1,2 ml otapala: otopina natrijevog klorida 5,4 mg/ml, 1 nastavak za bočicu s iglom + 2 tupfera natopljena alkoholom
English: Part of a multipack containing 12 single packs.
Croatian: Dio višestrukog pakiranja koje sadrži 12 pojedinačnih pakiranja.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for reconstitution of Betaferon
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA
English: Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b
Croatian: Betaferon 250 mikrograma/ml, prašak i otapalo za otopinu za injekciju interferon beta-1b
English: Cough increased
Croatian: Pojačani kašalj
English: METHOD AND ROUTE OF ADMINISTRATION For subcutaneous injection after reconstitution with 1.2 ml of solvent.
Croatian: Za potkožnu injekciju nakon pripreme otopine s 1,2 ml otapala.
English: Vial (with powder for solution for injection): 3 ml clear vial (type I glass) with a butyl rubber stopper (type I) and aluminium overseal and
Croatian: bezbojna bočica od 3 ml (staklo tip I) s čepom od butilne gume (tip I) te aluminijskom kapicom i
English: 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU).
Croatian: 1 bočicu s praškom za otopinu za injekciju koja sadrži 300 mikrograma (9,6 milijuna IU).
English: 3 - Remove the cap from the needle by pulling not twisting it.
Croatian: 3 - Uklonite zatvarač s igle povlačenjem umjesto okretanjem.
English: List 1: Very common side effects which have occurred in clinical trials with Betaferon(at least 10% of the cases) and at a higher percentage than those observed with placebo.
Croatian: Popis 1: Vrlo česte nuspojave koje su se pojavile u kliničkim ispitivanjima s lijekom Betaferon (u najmanje 10
English: 37% versus delayed Betaferon
Croatian: 37 % naspram odgođene primjene lijeka Betaferon
English: Bayer Limited Tel: +353 1 299 93 13
Croatian: Tel: +353 1 299 93 13
English: Betaferon microgram (Placebo) n=360 (n=358)
Croatian: Betaferon mikrograma (placebo) n = 360 (n =
English: 3rd dosage step (0.75 ml) for treatment days 13, 15, 17
Croatian: Trostruko pakiranje 3 Treći korak doziranja (0,75 ml) za dane liječenja 13, 15 i 17
English: − If you experience symptoms like irregular heartbeat, swelling such as of the ankles or legs, or shortness of breath.
Croatian: Ako ste iskusili simptome kao što su nepravilni srčani otkucaji, oticanje gležnjeva ili nogu ili nedostatak zraka.
English: Pack comprising 14 single packs, part of a 3-month pack containing 42 (3 x 14) single packs.
Croatian: Pakiranje se sastoji od 14 pojedinačnih pakiranja te je dio tromjesečnog pakiranja koje sadrži 42 pojedinačna pakiranja (3x14).
English: When reconstituted 250 microgram/ml (8.0 m IU/ml) interferon beta-1b.
Croatian: 250 mikrograma/ml (8,0 milijuna IU/ml) interferona beta-1b.
English: Tel: +385-(0)1-6599 900
Croatian: Bayer d.o.o. Tel: +385-(0)1-6599 900
English: − if you experience symptoms like irregular heartbeat, swelling such as of the ankles or legs, or shortness of breath.
Croatian: − ako osjetite simptome kao što su nepravilan rad srca, oticanje gležnjeva ili nogu ili nedostatak zraka.
English: Triple pack 3 is designed to help you prepare the next 3 injections (days 13, 15 and 17).
Croatian: Trostruko pakiranje br. 3 osmišljeno je da Vam pomogne u pripremi sljedeće tri injekcije (dani 13, 15 i 17).
English: 24% versus delayed Betaferon
Croatian: 24 % naspram odgođene primjene lijeka Betaferon
English: 1 vial adapter with needle + 2 alcohol wipes
Croatian: 1 nastavak za bočicu s iglom + 2 tupfera natopljena alkoholom
English: After finishing with the yellow pack, start using the red triple pack which is clearly marked with a "2" on the top right hand side of the box.
Croatian: Nakon dovršetka žutog pakiranja počnite upotrebljavati crveno trostruko pakiranje koje je jasno označeno brojem „2“ na gornjoj desnoj strani kutije.
English: ROTATION SCHEDULE:
Croatian: RASPORED ROTIRANJA
English: Part of a multipack containing 14 single packs.
Croatian: Dio višestrukog pakiranja koje sadrži 14 pojedinačnih pakiranja.
English: 6 - Inject the medicine using a slow, steady push on the plunger.
Croatian: 6 - Injicirajte lijek polaganim, ravnomjernim guranjem klipa. (Gurnite klip do kraja sve dok se štrcaljka ne isprazni).
English: In order to obtain adequate efficacy, a dose of 250 microgram (1.0 ml) every other day should be reached.
Croatian: mikrograma (1,0 ml) svaki drugi dan.
English: Do not touch the vial adapter.
Croatian: Ne dodirujte nastavak za bočicu.
English: One way to do that is to note the injection site on the enclosed medication record card.
Croatian: Jedan je od načina kako to možete raditi na priloženom predlošku za bilješke o injiciranju.
English: Keep the syringe horizontal.
Croatian: Držite štrcaljku u vodoravnom položaju.
English: Betaferon can also be administered with an auto-injector.
Croatian: Ne zaboravite: Betaferon se također može primjeniti s autoinjektorom.
English: NAME OF THE MEDICINAL PRODUCT Betaferon 250 microgram/ml, powder and solvent for solution for injection
Croatian: Betaferon 250 mikrograma/ml, prašak i otapalo za otopinu za injekciju.
English: 3 Vials with powder: 300 microgram (9.6 m IU) per vial.
Croatian: 3 bočice s praškom: 300 mikrograma (9,6 milijuna IU) po bočici.
English: Solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): Sodium chloride
Croatian: Otapalo (otopina natrijevog klorida 5,4 mg/ml (0,54 % m/V)): natrijev klorid voda za injekcije
English: • 3 vial adapters with a pre-attached needle
Croatian: • 3 napunjene štrcaljke s otapalom za Betaferon prašak
English: 3 Class label for interferon beta products (see section 4.4).
Croatian: Nuspojave temeljene samo na podacima nakon stavljanja lijeka Betaferon u promet Značajka skupine lijekova koji sadrže interferon beta (vidjeti dio 4.4).
English: Hyperthyroidism, Thyroid disorders
Croatian: Endokrini poremećaji hipotiroidizam hipertiroidizam,
English: Aspartate aminotransferase increased (SGOT > 5 times baseline) × Λ * °
Croatian: Povećana aspartat aminotransferaza (SGOT >5 puta više od početne vrijednosti) × Λ * ° Poremećaji kože i potkožnog tkiva Poremećaj kože
English: After reconstitution, immediate use is recommended.
Croatian: Preporučuje se odmah upotrijebiti nakon pripreme otopine.
English: One controlled clinical trial with Betaferon was performed in patients with a single clinical event and MRI features suggestive of multiple sclerosis (at least two clinically silent lesions on the T2-weighted MRI).
Croatian: U bolesnika s jednim kliničkim poremećajem i MR značajkama koje upućuju na razvoj multiple skleroze (najmanje 2 klinički tihe lezije u T2 mjerenoj slici magnetske rezonancije) provedeno je kontrolirano kliničko ispitivanje s lijekom Betaferon.
English: After finishing with the red pack, start using the green triple pack which is clearly marked with a "3" on the top right hand side of the box
Croatian: Nakon dovršetka crvenog pakiranja počnite upotrebljavati zeleno trostruko pakiranje koje je jasno označeno brojem „3“ na gornjoj desnoj strani kutije.
English: 41% versus delayed Betaferon
Croatian: 41 % naspram odgođene primjene lijeka Betaferon
English: 1 vial with powder: 300 microgram (9.6 m IU) per vial.
Croatian: 1 bočica s praškom: 300 mikrograma (9,6 milijuna IU) po bočici.
English: Part of a pack containing 14 single packs in a 3-month pack of 3x14 single packs.
Croatian: Dio pakiranja s 14 pojedinačnih pakiranja u tromjesečnom pakiranju od 3x14 pojedinačnih pakiranja.
English: General disorders and administration site conditions Injection site reaction (various kinds) Λ * ° §
Croatian: Reakcije na mjestu injiciranja (različite vrste)
English: Part of a multipack containing 15 single packs.
Croatian: Dio višestrukog pakiranja koje sadrži 15 pojedinačnih pakiranja.
English: PART II: ROTATING INJECTION SITES
Croatian: ROTIRANJE MJESTA INJICIRANJA
English: • 3 pre-filled syringes with solvent for the Betaferon powder (sodium chloride solution 5.4 mg/ml
Croatian: − 1 napunjenu štrcaljku s otapalom za Betaferon prašak (otopina natrijevog klorida od 5,4 mg/ml
English: Rare ( ≥ 1/10,000 to
Croatian: (≥ 10 000 i < 1/1000)1
English: Doing this allows the solution to flow down into the syringe.
Croatian: Na taj način omogućavate protok tekućine prema dolje u štrcaljku.
English: There have been reports of thrombocytopenia, with profound decreases in platelet count.
Croatian: Zabilježena su izvješća o trombocitopeniji s izraženim smanjenjem broja trombocita.
English: Do not shake the vial.
Croatian: Ne tresite bočicu.
English: Redness, swelling, discolouration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8.0 million IU) Betaferon treatment.
Croatian: Crvenilo, oticanje, promjena boje, upala, bol, preosjetljivost, nekroza i nespecifične reakcije značajno su povezane s liječenjem lijekom
English: Finally, after finishing with the green pack, start using the blue triple pack which is clearly marked with a "4" on the top right hand side of the box.
Croatian: Nakon dovršetka zelenog pakiranja počnite upotrebljavati plavo trostruko pakiranje koje je jasno označeno brojem „4“ na gornjoj desnoj strani kutije.
English: Betaferon microgram (Placebo) n=292 (n=176)
Croatian: Betaferon mikrograma (placebo) n = 292 (n =
English: For the dose titration at the start of treatment, draw the respective volume as given in section 4.2.
Croatian: Za titraciju doze na početku liječenja uvucite odgovarajući volumen kako je to prikazano u dijelu 4.2. Uklonite bočicu s nastavkom za bočicu iz napunjene štrcaljke prije samog injiciranja.
English: Bayer OÜ Tel: +372 655 85 65
Croatian: Tel: +372 655 85 65
English: - reduced number of white blood cells, swollen lymph glands (lymphadenopathy) - decrease of sugar in the blood (hypoglycaemia) - depression, anxiety - headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paraesthesia) - eye inflammation (conjunctivitis), abnormal vision - ear pain - irregular, rapid beating or pulsation of the heart (palpitation) - redness and/or facial flushing due to widening of blood vessels (vasodilation), increased blood pressure (hypertension) - runny nose, cough, hoarseness due to infection of the upper respiratory tract,
Croatian: - sniženi broj bijelih krvnih stanica, otečeni limfni čvorovi (limfadenopatija) - sniženi šećer u krvi (hipoglikemija) - depresija, tjeskoba - glavobolja, omaglica, nesanica, migrena, osjećaj obamrlosti ili trnjenja (parestezija)
English: back pain, pain in extremities such as fingers and toes - difficulty urinating (urine retention), protein in the urine (will show up in urine tests), urinary frequency, inability to hold back urination (urinary incontinence), urinary urgency - painful periods (dysmenorrhoea), menstrual disorder, heavy uterine bleeding (metrorrhagia)
Croatian: učestalo mokrenje, nemogućnost zadržavanja mokraće (urinarna inkontinencija), hitna poteba za mokrenjem - bolne mjesečnice (dismenoreja), menstrualni poremećaji, teško krvarenje iz maternice (metroragija)
English: − Titration pack for dose titration with 4 differently coloured and numbered triple packs: - yellow, with number “1”(treatment days 1, 3 and 5; 0.25-ml syringe marking), - red, with number “2” (treatment days 7, 9 and 11; 0.5-ml syringe marking), - green, with number “3” (treatment days 13, 15 and 17; 0.75-ml syringe marking), - blue, with number “4” (treatment days 19, 21 and 23; 0.25, 0.5, 0.75 and 1-ml syringe marking)
Croatian: − plavo s brojem „4“ (dani liječenja 19, 21 i 23; oznake na štrcaljki 0,25, 0,50, 0,75 ml i 1 ml)
English: Pharmacotherapeutic group: Cytokines, Interferons, ATC Code: L03 AB 08
Croatian: ATK oznaka: L03 AB 08
English: 40% versus delayed Betaferon
Croatian: 40 % naspram odgođene primjene lijeka Betaferon
English: Instructions for keeping track of your injection sites and dates
Croatian: DIO III: BILJEŠKE O INJICIRANJU LIJEKA BETAFERON Upute o praćenju mjesta injiciranja i datuma injiciranja
English: • 3 pre-filled syringes with solvent for the Betaferon powder (sodium chloride solution 5.4 mg/ml (0.54% w/v))
Croatian: 3 bočice lijeka Betaferon (s praškom za otopinu za injekciju): 3 napunjene štrcaljke s otapalom za Betaferon prašak (otopina natrijevog klorida od 5,4 mg/ml (0,54 % m/V)),
English: − in the solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): sodium chloride, water for injection.
Croatian: − u prašku: manitol i ljudski albumin, − u otapalu (otopina natrijevog klorida od 5,4 mg/ml (0,54 % m/V)): natrijev klorid, voda za injekcije.
English: 17 - Dispose of the vial and any unused portion of the solution in the disposal unit
Croatian: 17 - Odložite bočicu i preostali neiskorišteni dio otopine u posudu za otpad 18 - Sad ste spremni za injiciranje.
English: AREA 3
Croatian: PRILOG III.
English: Connect the pre-filled syringe with solvent to the vial adapter and inject the 1.2 ml of the solvent (sodium chloride solution, 5.4 mg/ml (0.54% w/v)) into the Betaferon vial.
Croatian: Spojite napunjenu štrcaljku s otapalom na nastavak bočice i injicirajte 1,2 ml otapala (otopina natrijevog klorida od 5,4 mg/ml (0,54 % m/V)) u bočicu s lijekom Betaferon.
English: Talk to your doctor or nurse about these or any other unusual conditions you may find.
Croatian: Razgovarajte s liječnikom ili medicinskom sestrom o ovim ili drugim
English: NN
Croatian: º
English: − 1 Betaferon vial (with powder for solution for injection),
Croatian: Bočica (s praškom za otopinu za injekciju):
English: • Sodium - this medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free'.
Croatian: • Natrij - ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po ml, tj. zanemarive količine natrija Ako znate da ste alergični (preosjetljivi) na bilo koju pomoćnu tvar lijeka ili ako postanete alergični, ne smijete upotrebljavati Betaferon.
English: Bayer s.r.o.
Croatian: Bayer, spol. s r.o.
English: 1st dosage step (0.25 ml) for treatment days 1, 3, 5
Croatian: Trostruko pakiranje 1 Prvi korak doziranja (0,25 ml) za dane liječenja 1,3 i 5
English: Menorrhagia
Croatian: Doziranje
English: Capillary leak syndrome in pre-existing monoclonal gammopathy2
Croatian: Poremećaji imunološkog sustava anafilaktičke reakcije sindrom povećane propustljivosti kapilara u postojećoj monoklonskoj gamopatiji
English: Blood triglycerides increased
Croatian: smanjenje težine povišeni trigliceridi u krvi anoreksija
English: Retrospective analyses in subgroups showed that a treatment effect on disability progression is most likely in patients with active disease before treatment commences (Hazard Ratio 0.72, 95% confidence interval (0.59, 0.88), p=0.0011, corresponding to a 28 % risk reduction due to Betaferon in patients with relapses or pronounced EDSS progression, 8.0 million IU Betaferon versus all placebo patients).
Croatian: 95 % (0,59; 0,88), p = 0,0011, odgovara 28 %-tnoj redukciji rizika zbog primjene lijeka Betaferon u bolesnika s relapsima ili izraženom progresijom na EDSS ljestvici, 8,0 milijuna IU lijeka Betaferon naspram svih bolesnika koji su primali placebo).
English: Each triple pack contains 3 vials with powder, 3 pre-filled syringes with solvent, 3 vial adapters with pre-attached needle and 6 alcohol wipes for skin and vial cleaning.
Croatian: 3 nastavka za bočicu s prethodno pričvršćenom iglom, 6 tupfera natopljenih alkoholom za čišćenje kože i bočice
English: Nervous system disorders Headache Λ
Croatian: Poremećaji živčanog sustava Glavobolja
English: NAME OF THE MEDICINAL PRODUCT Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b
Croatian: Uputa o lijeku: Informacije za korisnika Betaferon 250 mikrograma/ml, prašak i otapalo za otopinu za injekciju interferon beta-1b