FrancophonIA/ELRC3.0 huggingface dataset:
English: • Once you have finished your injection, immediately discard RebiDose.
Icelandic: Að inndælingu lokinni skaltu farga RebiDose strax.
English: This medicinal product contains 2.5 mg benzyl alcohol per dose of 0.5 mL.
Icelandic: Þetta lyf inniheldur 2,5 mg bensýlalkóhól í hverjum 0,5 ml skammti.
English: Flu-like symptoms tend to be most prominent at the initiation of therapy and decrease in frequency with continued treatment.
Icelandic: Oft eru einkenni sem líkjast inflúensu mest áberandi í upphafi meðferðar og tíðni þeirra lækkar þegar meðferð er haldið áfram.
English: Other medicines and Rebif
Icelandic: Notkun annarra lyfja samhliða Rebif
English: 8.8 micrograms tiw
Icelandic: 8,8 míkrógrömm þ.í.v.
English: Rebif8.8micrograms and Rebif22 micrograms are supplied in an initiation pack that is intended for use during the initial 4 weeks of treatment, during which a gradual increase in Rebif dose is recommended.
Icelandic: Rebif 8,8 míkrógrömm og 22 míkrógrömm fást í aðlögunarpakkningu sem er ætluð til notkunar fyrsta mánuð meðferðarinnar, en á þeim tíma er ráðlagt að stækka skammtana smám saman.
English: How to inject Rebif
Icelandic: Hvernig á að sprauta Rebif
English: 2 cartridges
Icelandic: 2 rörlykjur
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Icelandic: Hvernig geyma á Rebif Geymið lyfið þar sem börn hvorki ná til né sjá.
English: The interaction of Rebif with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Icelandic: Milliverkandi áhrif Rebif við barkstera eða ACTH hafa ekki verið rannsökuð kerfisbundið.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Icelandic: Ef spurningar vakna um hvernig dæla eigi lyfinu inn skaltu biðja lækninn, hjúkrunarfræðing eða lyfjafræðing um aðstoð.
English: A lower dose of 22 micrograms, also given three times per week by subcutaneous injection, is recommended for patients who cannot tolerate the higher dose in view of the treating specialist.
Icelandic: Mælt er með að gefa lægri skammt sem nemur 22 míkrógrömmum, einnig þrisvar í viku með inngjöf undir húð, sjúklingum sem ekki þola hærri skammta að mati sérfræðings.
English: Common:
Icelandic: ● ATHUGIÐ:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 44 micrograms (12 million IU)/0.5 mL
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 44 míkrógrömm (12 milljón a.e.)/0,5 ml
English: Patients treated with Rebif should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Icelandic: Ráðleggja ber sjúklingum, sem meðhöndlaðir eru með Rebif, að tilkynna án tafar einkenni þunglyndis og sjálfvígshugleiðinga, lækninum, er ávísaði lyfinu.
English: • patients with relapsing multiple sclerosis.
Icelandic: sjúklingum með MS með köstum.
English: Cartridges (type 1 glass) with a plunger stopper (rubber) and crimp cap (aluminium and halobutyl rubber) containing 1.5 mL solution for injection.
Icelandic: Rörlykjur (gler af gerð 1) með bullutappa (gúmmí) og þrýstiloki (ál og halóbútýl gúmmí) sem innihalda 1,5 ml stungulyf, lausn.
English: Excipient with known effect: 1.0 mg benzyl alcohol For the full list of excipients, see section 6.1.
Icelandic: 1,0 mg benzýl alkóhól Sjá lista yfir öll hjálparefni í kafla 6.1.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 22 micrograms (6 million IU)/0.5 mL
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 22 míkrógrömm (6 milljón a.e.)/0,5 ml
English: Rebif8.8micrograms and Rebif22micrograms are supplied in an initiation pack that is intended for use during the initial 4 weeks of treatment, during which a gradual increase in Rebif dose is recommended.
Icelandic: Rebif 8,8míkrógrömm og 22míkrógrömm fást í aðlögunarpakkningu sem er ætluð til notkunar fyrsta mánuð meðferðarinnar, en á þeim tíma erráðlagt að stækka skammtana smám saman.
English: Each pre-filled syringe (0.2 mL) contains 8.8 micrograms (2.4 MIU*) of interferon beta-1a**.
Icelandic: Hver áfyllt sprauta (0,2 ml) inniheldur 8,8 míkrógrömm (2,4 milljón a.e.*) af interferoni beta-1a**.
English: After repeated subcutaneous administration every 48 hours for 4 doses, these biological responses remain elevated, with no signs of tolerance development.
Icelandic: Eftir endurtekna gjöf á tveggja sólarhringa fresti, fjórum sinnum, helst áðurnefnd virkni há, án þess að vart verði við þol (tolerance).
English: Excipient with known effect: 2.5 mg benzyl alcohol For the full list of excipients, see section 6.1.
Icelandic: 2,5 mg benzýl alkóhól Sjá lista yfir öll hjálparefni í kafla 6.1.
English: The patients enrolled into the trial had at least two clinically silent lesions on the T2-weighted MRI scan, with a size of at least 3 mm, at least one of which is ovoid or periventricular or infratentorial.
Icelandic: T2 við segulómun, minnst 3 mm að stærð og minnst eina þeirra egglaga, í hvíta hluta heilans eða neðantjalds (infratentorial).
English: Rebif is available as a solution for injection in a pre-filled syringe with a fixed needle for self-administration.
Icelandic: Rebif fæst sem stungulyf, lausn í áfylltri sprautu með áfastri nál, til inndælingar af sjúklingum.
English: Patients with multiple sclerosis The usual dose is 44 micrograms (12 million IU) given three times per week.
Icelandic: Sjúklingar með MS Venjulegur skammtur er 44 míkrógrömm (12 milljón a.e.) þrisvar í viku.
English: Very common (may affect more than 1 in 10 people): • Headache
Icelandic: Mjög algengar (kunna að koma fyrir hjá fleiri en 1 af hverjum 10 einstaklingum):
English: (UPPER FLAP) 6 pre-filled pens RebiDose
Icelandic: 6 áfylltir lyfjapennar RebiDose
English: Seizures*
Icelandic: Segarekstilvik*
English: These symptoms tend to be most prominent at the initiation of therapy and decrease in frequency and severity with continued treatment.
Icelandic: Þessi sjúkdómseinkenni eru alla jafna mest áberandi við upphaf meðferðar, en tíðni þeirra og alvarleiki minnka við áframhaldandi meðferð.
English: Primary progressive multiple sclerosis
Icelandic: Fyrsta klíníska vísbending um MS
English: If you stop using Rebif
Icelandic: Ef hætt er að nota Rebif
English: 6 pre-filled syringes of Rebif 8.8 micrograms and 6 pre-filled syringes of Rebif 22 micrograms.
Icelandic: 6 áfylltar sprautur af Rebif 8,8 míkrógrömm og 6 áfylltar sprautur af Rebif 22 míkrógrömm
English: Where to inject with RebiDose
Icelandic: Hvar á að sprauta RebiDose
English: Each pre-filled cartridge contains 66 micrograms (18 MIU*) of interferon beta-1a** in 1.5 mL solution, corresponding to 44 micrograms/mL.
Icelandic: Hver áfyllt rörlykja inniheldur 66 míkrógrömm (18 milljón a.e.*) af interferoni beta-1a** í 1,5 ml lausn, sem jafngildir 44 míkrógrömm/ml.
English: Diarrhoea, vomiting, nausea Skin and subcutaneous tissue disorders Common:
Icelandic: Öndunarfæri, brjósthol og miðmæti Sjaldgæfar:
English: • Remove RebiDose from the blister pack by peeling back the plastic covering.
Icelandic: RebiDose úr þynnupakkningunni með því að rífa aftur hlífðarplastið.
English: Each cartridge contains 132 micrograms corresponding to 36 million International Units (IU) of interferon beta-1a.
Icelandic: Hver rörlykja inniheldur 132 míkrógrömm sem jafngildir 36 milljón alþjóðlegum einingum (a.e.) af interferoni beta-1a.
English: • Remove the Rebif cartridge from the blister pack by peeling back the plastic covering.
Icelandic: Rebif rörlykjuna úr þynnupakkningunni með því að rífa aftur hlífðarplastið.
English: Rebif has not been investigated for carcinogenicity.
Icelandic: Rebif hafa ekki verið rannsökuð.
English: NAME OF THE MEDICINAL PRODUCT Rebif 44 micrograms/0.5 mL solution for injection in cartridge
Icelandic: HEITI LYFS Rebif 44 míkrógrömm/0,5 ml stungulyf, lausn í rörlykju
English: The highest incidence of adverse reactions associated with Rebif therapy is related to flu-like syndrome.
Icelandic: Inflúensulík einkenni eru algengustu aukaverkanirnar sem tengjast meðferð með Rebif.
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
Icelandic: EU/1/98/063/001 1 áfyllt sprauta EU/1/98/063/002 3 áfylltar sprautur EU/1/98/063/003 12 áfylltar sprautur EU/1/98/063/020 36 áfylltar sprautur
English: This might happen several weeks to several years after starting Rebif.
Icelandic: Slíkur blóðtappi getur haft áhrif á nýrun og gæti komið fram allt frá nokkrum vikum til mörgum árum eftir að meðferð er hafin með Rebif.
English: • Blood clots such as deep venous thrombosis
Icelandic: Blóðkekkir svo sem segarek djúpum bláæðum
English: Each cartridge contains 66 micrograms corresponding to 18 million International Units (IU) of interferon beta-1a.
Icelandic: Hver rörlykja inniheldur 66 míkrógrömm sem jafngildir 18 milljón alþjóðlegum einingum (a.e.) af interferoni beta-1a.
English: If you get some or all of these symptoms: - foamy urine - fatigue - swelling, particularly in the ankles and eyelids, and weight gain.
Icelandic: Nýrnakvillar, þ.m.t. öramyndun í nýrum, sem geta dregið úr nýrnastarfsemi Ef þú færð sum eða öll þessi einkenni: freyðandi þvag þreyta þroti, einkum í ökklum og augnlokum, og þyngdaraukning.
English: Rebif 22 micrograms is a solution for injection in a pre-filled syringe with a fixed needle for self-administration.
Icelandic: Rebif 22 míkrógrömm fæst sem stungulyf, lausn í áfylltri sprautu með áfastri nál, til inndælingar af sjúklingum.
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.
Icelandic: Þetta lyf inniheldur 1,0 mg bensýlalkóhól í hverjum 0,2 ml skammti og 2,5 mg bensýlalkóhól í hverjum 0,5 ml skammti.
English: • Remove RebiSmart from the injection site.
Icelandic: RebiSmart af stungustaðnum.
English: Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU*) of interferon beta-1a**.
Icelandic: Hver áfyllt sprauta (0,5 ml) inniheldur 44 míkrógrömm (12 milljón a.e.*) af interferoni beta-1a**.
English: • Press the injection button.
Icelandic: Þrýstu á inndælingarhnappinn.
English: • Remove and discard the needle according to the instruction manual provided with your device.
Icelandic: Fjarlægðu nálina og fleygðu henni eins og segir í handbókinni sem fylgir með tækinu.
English: Patients exhibiting depression should be monitored closely during therapy with Rebif and treated appropriately.
Icelandic: Fylgjast ber gaumgæfilega með sjúklingum, sem sýna einkenni þunglyndis, meðan á meðferð með Rebif stendur og meðhöndla þá eins og nauðsyn krefur.
English: Each Rebif 22 micrograms pre-filled syringe (0.5 mL) contains 22 micrograms (6 Million IU) of interferon beta-1a.
Icelandic: Hver Rebif 22 míkrógramma áfyllt sprauta (0,5 ml) inniheldur 22 míkrógrömm (6 milljón a.e.) af interferoni beta-1a.
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.
Icelandic: Þetta lyf inniheldur 0,5 mg bensýlalkóhól í hverjum 0,1 ml skammti og 1,25 mg bensýlalkóhól í hverjum 0,25 ml skammti.
English: Each 8.8 micrograms syringe contains 8.8 micrograms of interferon beta-1a (2.4 million IU).
Icelandic: Hver 8,8 míkrógramma sprauta inniheldur 8,8 míkrógrömm af interferoni beta-1a (2,4 milljón a.e.).
English: please ask your doctor, nurse or pharmacist for assistance.
Icelandic: Leitið til læknisins, hjúkrunarfræðings eða lyfjafræðings ef þörf er á frekari upplýsingum.
English: The pre-filled syringe is ready for use and contains 0.2 mL of solution.
Icelandic: Áfyllt sprautan er tilbúin til notkunar og inniheldur 0,2 ml af lausn.
English: Rebif 8.8 micrograms solution for injection interferon beta-1a
Icelandic: Rebif 8,8 μg stungulyf, lausn interferon beta-1a
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.
Icelandic: Lesið vandlega og fylgið leiðbeiningum í kaflanum „Hvernig nota á Rebif“ áður en meðferð með Rebif er hafin, til að lágmarka hættu á drepi á stungustað (fleiður og vefjaskemmdir) sem hefur sést hjá sjúklingum, sem fá Rebif.
English: The solution for injection in a pre-filled syringe is ready for use.
Icelandic: Stungulyf, lausn í áfylltri sprautu tilbúið til notkunar.
English: This package corresponds to the patient needs for the first month of therapy.
Icelandic: Þessi pakkning svarar til þarfa hvers sjúklings sem er að hefja meðferð fyrsta mánuðinn.
English: The usual dose is 44 micrograms (12 million IU) given three times per week.
Icelandic: Venjulegur skammtur er 44 míkrógrömm (12 milljón a.e.) þrisvar í viku.
English: Each 22 micrograms syringe contains 22 micrograms of interferon beta-1a (6 million IU).
Icelandic: Hver 22 míkrógramma sprauta inniheldur 22 míkrógrömm af interferoni beta-1a (6 milljón a.e.).
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products.
Icelandic: Greint hefur verið frá tilvikum lungnaháþrýstings við notkun lyfja sem innihalda interferon beta.
English: 12 pre-filled syringes.
Icelandic: 12 áfylltar sprautur.
English: Rebif contains 2.5 mg benzyl alcohol per dose.
Icelandic: Rebif inniheldur 2,5 mg af bensýlalkóhóli í hverjum skammti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/008 4 cartridges EU/1/98/063/018 12 cartridges
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/008 4 rörlykjur EU/1/98/063/018 12 rörlykjur
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.
Icelandic: Mælt er með að gefa lægri skammt sem nemur 22 míkrógrömmum (6 milljón a.e.), þrisvar í viku sjúklingum sem ekki þola hærri skammta.
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.
Icelandic: Mælt er með að gefa lægri skammt sem nemur 22 míkrógrömmum (6 milljón a.e.) þrisvar í viku sjúklingum með MS sem ekki þola hærri skammta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 6 X 8.8 MICROGRAMS SYRINGES + 6 X 22 MICROGRAMS SYRINGES
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ 6 X 8,8 MÍKRÓG ÁFYLLTUM LYFJAPENNUM + 6 X 22 MÍKRÓG ÁFYLLTUM LYFJAPENNUM
English: Pack sizes of 1, 3 or 12 pre-filled pens.
Icelandic: Pakkningastærðir með 1, 3 og 12 áfylltum lyfjapennum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 6 X 8.8 MICROGRAMS PRE-FILLED PENS + 6 X 22 MICROGRAMS PREFILLED PENS
Icelandic: YTRI UMBÚÐUM ASKJA MEÐ 6 X 8,8 MÍKRÓG SPRAUTUM + 6 X
English: Severe liver problems can be associated with additional signs, e.g. difficulty concentrating, sleepiness and confusion.
Icelandic: Einnig kann að verða vart við önnur merki, svo sem hita, þyngdartap og þreytu.
English: Each pre-filled pen contains 8.8 micrograms (2.4 MIU*) of interferon beta-1a** in 0.2 mL solution.
Icelandic: Hver áfylltur lyfjapenni inniheldur 8,8 míkrógrömm (2,4 milljón a.e.*) af interferoni beta-1a** í 0,2 ml lausn.
English: Rebif solution is clear to opalescent.
Icelandic: Rebif lausn er tær til mjólkurlituð.
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.
Icelandic: Rebif inniheldur 0,5 mg af bensýlalkóhóli í hverjum 0,1 ml skammti og 1,25 mg af bensýlalkóhóli í hverjum 0,25 ml skammti.
English: Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU*) of interferon beta-1a**.
Icelandic: Hver áfyllt sprauta (0,5 ml) inniheldur 22 míkrógrömm (6 milljón a.e.*) af interferoni beta-1a**.
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.
Icelandic: Rebif inniheldur 1,0 mg af bensýlalkóhóli í hverjum 0,2 ml skammti og 2,5 mg af bensýlalkóhóli í hverjum 0,5 ml skammti.
English: This medicinal product contains 2.5 mg benzyl alcohol per dose.
Icelandic: Þetta lyf inniheldur 2,5 mg bensýlalkóhól í hverjum skammti.
English: Each syringe contains 22 micrograms, corresponding to 6 million International Units (IU) of interferon beta-1a.
Icelandic: Hver sprauta inniheldur 22 míkrógrömm sem jafngildir 6 milljón alþjóðlegum einingum (a.e.) af interferoni beta-1a.
English: Myalgia, arthralgia
Icelandic: Kláði, útbrot
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.
Icelandic: Gættu þess að skammturinn sem birtist í glugga tækisins samsvari ávísuðum 22 míkrógramma skammti fyrir inndælinguna.
English: The pre-filled syringe is ready for use and contains 0.5 mL of solution.
Icelandic: Áfyllt sprautan er tilbúin til notkunar og inniheldur 0,5 ml af lausn.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/009 4 cartridges EU/1/98/063/019 12 cartridges
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/009 4 rörlykjur EU/1/98/063/019 12 rörlykjur
English: NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms/0.5 mL solution for injection in cartridge
Icelandic: HEITI LYFS Rebif 22 míkrógrömm/0,5 ml stungulyf, lausn í rörlykju
English: Each syringe contains 44 micrograms, corresponding to 12 million International Units (IU) of interferon beta-1a.
Icelandic: Hver sprauta inniheldur 44 míkrógrömm sem jafngildir 12 milljón alþjóðlegum einingum (a.e.) af interferoni beta-1a.
English: Store the syringe in the original package in order to protect from light.
Icelandic: Geymið sprautuna í upprunalegum umbúðum til varnar gegn ljósi.
English: Each Rebif 22 micrograms pre-filled pen contains 22 micrograms (6 Million IU) of interferon beta-1a in 0.5 mL solution.
Icelandic: Hver Rebif 22 míkrógramma áfylltur lyfjapenni inniheldur 22 míkrógrömm (6 milljón a.e.) af interferoni beta-1a í 0,5 ml lausn.
English: Each 8.8 micrograms pre-filled pen contains 8.8 micrograms of interferon beta-1a (2.4million IU).
Icelandic: Hver 8,8 míkrógramma áfylltur lyfjapenni inniheldur 8,8 míkrógrömm af interferoni beta-1a (2,4 milljón a.e.).
English: Remove the needle from the skin.
Icelandic: Til notkunar undir húð.
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.
Icelandic: Hver Rebif 8,8 míkrógramma áfyllt sprauta (0,2 ml) inniheldur 8,8 míkrógrömm (2,4 milljón a.e.) af interferoni beta-1a.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/008
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/008
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 132 micrograms (36 MIU) of interferon beta-1a in 1.5 mL solution.
Icelandic: Hver rörlykja inniheldur 132 míkrógrömm (36 milljón a.e.) af interferoni beta-1a í 1,5 ml lausn.
English: What Rebif contains
Icelandic: Rebif inniheldur
English: How to store Rebif
Icelandic: Hvernig geyma á Rebif
English: • Gently massage the injection site with a dry cotton ball or gauze.
Icelandic: Nuddaðu stungustaðinn mjúklega með baðmullarhnoðra eða grisju.
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.
Icelandic: Gættu þess að skammturinn sem birtist í glugga tækisins samsvari ávísuðum 44 míkrógramma skammti fyrir inndælinguna.
English: Rebif 44 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a
Icelandic: Rebif 44 μg/0,5 ml stungulyf, lausn interferon beta-1a
English: Severe elevations in transaminases
Icelandic: Alvarleg lifrarvandamál geta tengst
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
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/011 1 áfylltur lyfjapenni EU/1/98/063/012 3 áfylltir lyfjapennar EU/1/98/063/013 12 áfylltir lyfjapennar
English: • To place the cartridge in the device and perform the injection follow the instruction manual
Icelandic: Þegar rörlykjunni er komið fyrir í tækinu og inndælingin framkvæmd skal fara eftir leiðbeiningahandbók (notkunarleiðbeiningunum) sem fylgir tækinu þínu.
English: Each pre-filled pen contains 44 micrograms (12 MIU*) of interferon beta-1a** in 0.5 mL solution.
Icelandic: Hver áfylltur lyfjapenni inniheldur 44 míkrógrömm (12 milljón a.e.*) af interferoni beta-1a** í 0,5 ml lausn.
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.
Icelandic: Rebif 8,8 míkrógrömm fæst sem stungulyf, lausn í áfylltri sprautu með áfastri nál, til inndælingar af sjúklingum.
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
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/014 1 áfylltur lyfjapenni EU/1/98/063/015 3 áfylltir lyfjapennar EU/1/98/063/016 12 áfylltir lyfjapennar
English: The recommended posology of Rebif is 44 micrograms given three times per week by subcutaneous injection.
Icelandic: Mælt er með 44 míkrógrömmum af Rebif þrisvar í viku undir húð.
English: Rebif 22 micrograms/0.5 mL solution for injection in cartridge interferon beta-1a
Icelandic: Rebif 22 μg/0,5 ml stungulyf, lausn interferon beta-1a
English: INSTRUCTIONS ON USE
Icelandic: Geyma skal tækið
English: Rebif 22 micrograms solution for injection interferon beta-1a
Icelandic: Rebif 22 míkrógrömm stungulyf, lausn interferon beta-1a
English: Initiating treatment
Icelandic: Meðferð hafin
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
Icelandic: Rebif 8,8 míkrógrömm/0,1 ml stungulyf, lausn í rörlykju Rebif 22 míkrógrömm/0,25 ml stungulyf, lausn í rörlykju interferon beta-1a
English: Injection site necrosis, injection site mass, injection site abscess, injection site infections*, increased sweating*
Icelandic: Drep á stungustað, þykkildi á stungustað, kýli á stungustað, sýkingar á stungustað*, aukin svitamyndun*
English: Rebif is intended for subcutaneous (under the skin) injection.
Icelandic: Rebif er gefið með inndælingu undir húð.
English: Each pre-filled pen contains 22 micrograms (6 MIU*) of interferon beta-1a** in 0.5 mL solution.
Icelandic: Hver áfylltur lyfjapenni inniheldur 22 míkrógrömm (6 milljón a.e.*) af interferoni beta-1a** í 0,5 ml lausn.
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
Icelandic: Rebif 8,8 míkrógrömm/0,1 ml stungulyf, lausn í rörlykju Rebif 22 míkrógrömm/0,25 ml stungulyf, lausn í rörlykju
English: NAME OF THE MEDICINAL PRODUCT Rebif 44 micrograms solution for injection in pre-filled syringe
Icelandic: HEITI LYFS Rebif 44 míkrógrömm stungulyf, lausn í áfylltum lyfjapenna
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/009
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/009
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 66 micrograms (18 MIU) of interferon beta-1a in 1.5 mL solution.
Icelandic: Hver rörlykja inniheldur 66 míkrógrömm (18 milljón a.e.) af interferoni beta-1a í 1,5 ml lausn.
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.
Icelandic: „Leiðbeiningum um notkun RebiDose“, sem er að finna í bæklingnum sem fylgir með, áður en meðferð með Rebif er hafin, til að lágmarka hættu á drepi á stungustað (fleiður og vefjaskemmdir) sem hefur sést hjá sjúklingum, sem fá Rebif.
English: • MS pseudo-relapse (frequency not known): There is a possibility that at the beginning of your treatment with Rebif you may experience symptoms that resemble those of a multiple sclerosis relapse.
Icelandic: Hugsanlegt er að í upphafi meðferðar með Rebif finnir þú fyrir einkennum sem minna á MS kast.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/063/007
Icelandic: MARKAÐSLEYFISNÚMER EU/1/98/063/007