FrancophonIA/ELRC3.0 huggingface dataset:
English: If you use RebiSlide • Please make sure that the dose selected in the dose window of the device is 0.5 mL (which corresponds to the prescribed dose of 22 micrograms) before the injection.
Estonian: • Veenduge enne süstimist, et seadme annuseaknas valitud annus on 0,5 ml (vastab ettekirjutatud 22-mikrogrammisele annusele).
English: No information is available on the effects of the interferon beta-1a on male fertility.
Estonian: Beeta-1ainterferooni toimest meeste viljakusele andmeid ei ole.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 132 micrograms (36 million IU)/1.5 mL
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 132 mikrogrammi (36 miljonit RÜ)/1,5 ml
English: Events were reported at various time points during treatment and may occur after several years of treatment with interferon-beta.
Estonian: Juhtudest teatati ravi jooksul erinevates ajapunktides ning need võivad tekkida pärast mitu aastat kestnud ravi beetainterferooni preparaatidega.
English: • Remove RebiSmart from the injection site.
Estonian: • Eemaldage RebiSmart süstekohalt.
English: Each pre-filled cartridge contains 66 micrograms (18 MIU*) of interferon beta-1a** in 1.5 mL solution, corresponding to 44 micrograms/mL.
Estonian: Üks eeltäidetud kolbampull sisaldab 66 mikrogrammi (18 MRÜ*) beeta-1a-interferooni** 1,5 ml lahuses, mis vastab 44 mikrogrammi/ml-s.
English: Primary progressive multiple sclerosis
Estonian: Primaarse progresseerumisega sclerosis multiplex
English: Rebif 22 micrograms is a solution for injection in a pre-filled syringe with a fixed needle for self-administration.
Estonian: Rebif 22 mikrogrammi on saadaval süstelahusena iseenesele manustamiseks mõeldud süstlites, millel on fikseeritud nõel.
English: Serum neutralising antibodies against interferon beta-1a may develop.
Estonian: Vereseerumis võivad tekkida beeta-1a-interferooni vastased neutraliseerivad antikehad.
English: If you use RebiSlide • Please make sure that the dose selected in the dose window of the device is 0.5 mL (which corresponds to the prescribed dose of 44 micrograms) before the injection.
Estonian: • Veenduge enne süstimist, et seadme annuseaknas valitud annus on 0,5 ml (vastab ettekirjutatud 44-mikrogrammisele annusele).
English: After a single dose, intracellular and serum activity of 2'5'OAS synthetase and serum concentrations of beta-2 microglobulin and neopterin increase within 24 hours, and start to decline within 2 days.
Estonian: 24 tundi pärast üksikannuse manustamist suurenevad 2',5'OAS-süntetaasi aktiivsused nii rakkude sees kui ka seerumis ning beeta-2-mikroglobuliini ja neopteriini sisaldus seerumis.
English: • During weeks one and two, Rebif 8.8 micrograms should be injected three times per week.
Estonian: • Esimese ja teise nädala jooksul süstitakse Rebif 8,8 mikrogrammi kolm korda nädalas.
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.
Estonian: • Veenduge enne süstimist, et seadme näidikul kuvatav annus vastab ettekirjutatud 22-mikrogrammisele annusele.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 3, 12 AND 36 SYRINGES
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 1, 3, 12 JA 36 SÜSTLIGA KARP
English: 3 pre-filled pens.
Estonian: 3 pen-süstlit.
English: • patients with relapsing multiple sclerosis.
Estonian: • ägenemistega sclerosis multiplex'i raviks.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 66 micrograms (18 million IU)/1.5 mL
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 66 mikrogrammi (18 miljonit RÜ)/1,5 ml
English: 36 pre-filled syringes.
Estonian: 36 süstlit.
English: This package corresponds to the patient needs for the first month of therapy.
Estonian: See pakend vastab patsiendi esimese ravikuu vajadustele.
English: See the package leaflet for further information.
Estonian: Lisainfo saamiseks lugege pakendi infolehte.
English: Laboratory abnormalities
Estonian: Muutused laboratoorsetes analüüsides
English: • During weeks three and four, Rebif 22 micrograms should be injected three times per week.
Estonian: • Kolmanda ja neljanda nädala jooksul süstitakse Rebif 22 mikrogrammi kolm korda nädalas.
English: During weeks three and four, Rebif 22 micrograms are injected three times per week.
Estonian: kolmanda ja neljanda nädala vältel Rebif 22 mikrogrammi süstimise kolm korda nädalas;
English: Excipient with known effect: 1.0 mg benzyl alcohol For the full list of excipients, see section 6.1.
Estonian: Teadaolevat toimet omav abiaine: 1,0 mg bensüülalkoholi Abiainete täielik loetelu vt lõik 6.1.
English: • Rebif is given by injection under the skin (subcutaneously).
Estonian: • Rebif'i manustatakse nahaaluse süstena (subkutaanselt).
English: Excipient with known effect: 7.5 mg benzyl alcohol For the full list of excipients, see section 6.1.
Estonian: Teadaolevat toimet omav abiaine: 7,5 mg bensüülalkoholi Abiainete täielik loetelu vt lõik 6.1.
English: Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products.
Estonian: Beeta-interferooni sisaldavate ravimitega seoses on teatatud trombootilise mikroangiopaatia juhtudest (sh surmaga lõppenud juhud), mis avalduvad trombootilise trombotsütopeenilise purpuri või hemolüütilis-ureemilise sündroomina.
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.
Estonian: • Veenduge enne süstimist, et seadme näidikul kuvatav annus vastab ettekirjutatud 44-mikrogrammisele annusele.
English: •Gently massage the injection site with a dry cotton ball or gauze.
Estonian: • Masseerige õrnalt süstekohta kuiva vati- või marlitupsuga.
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.
Estonian: Väiksemat annust 22 mikrogrammi (6 miljonit RÜ) kolm korda nädalas soovitatakse manustada patsientidele, kes suuremat annust ei talu.
English: Rebif contains 2.5 mg benzyl alcohol per dose.
Estonian: Rebif sisaldab 2,5 mg bensüülalkoholi annuse kohta.
English: Rebif is available as a solution for injection in a pre-filled pen for self-administration.
Estonian: Rebif on saadaval süstelahusena iseenesele manustamiseks mõeldud pen-süstlites.
English: Where to inject Rebif
Estonian: Kuhu RebiDose'i süstida
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 44 micrograms (12 million IU)/0.5 mL
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 44 mikrogrammi (12 miljonit RÜ)/0,5 ml
English: • Rebif is given by injection under the skin (subcutaneously) using a pre-filled pen called “RebiDose”.
Estonian: Manustamisviis Rebif'i manustatakse nahaaluse süstena (subkutaanselt), kasutades pen-süstlit nimetusega RebiDose.
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).
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud sildil pärast „Kõlblik kuni“.
English: How to store Rebif
Estonian: Kuidas Rebif'i säilitada
English: • rotate the injection sites with each dose.
Estonian: • vahetama süstekohti iga süstimise järel.
English: Dose reduction of Rebif should be considered if ALT rises above 5 times the ULN, and gradually re-escalated when enzyme levels have normalized.
Estonian: Kui ALAT aktiivsus on suurem kui 5 korda üle normi ülemise piiri, tuleb kaaluda Rebif'i annuste vähendamist.
English: Excipient with known effect: 2.5 mg benzyl alcohol For the full list of excipients, see section 6.1.
Estonian: Teadaolevat toimet omav abiaine: 2,5 mg bensüülalkoholi Abiainete täielik loetelu vt lõik 6.1.
English: Number of events
Estonian: Episoodide arv
English: 6 pre-filled syringes of Rebif 8.8 micrograms and 6 pre-filled syringes of Rebif 22 micrograms.
Estonian: 6 süstlit Rebif 8,8 mikrogrammiga ja 6 süstlit Rebif 22 mikrogrammiga.
English: Each pre-filled syringe (0.2 mL) contains 8.8 micrograms (2.4 MIU*) of interferon beta-1a**.
Estonian: Üks süstel (0,2 ml) sisaldab 8,8 mikrogrammi (2,4 MRÜ*) beeta-1a-interferooni**.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 22 micrograms (6 million IU)/0.5 mL
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 22 mikrogrammi (6 miljonit RÜ)/0,5 ml
English: PARTICULARS TO APPEAR ON THE LAYERS SEPARATORS FOR THE STARTER PACK
Estonian: STARDIPAKI KIHTIDE ERALDAJAL PEAVAD OLEMA JÄRGMISED ANDMED
English: Clinical data suggest that after 24 to 48 months of treatment with Rebif 22 micrograms, approximately 24% of patients develop persistent serum antibodies to interferon beta-1a.
Estonian: Kliinilised andmed näitavad, et beeta-1ainterferooni vastased antikehad tekivad 24...48-kuulise ravi järel Rebif 22 mikrogrammiga umbes 24% patsientidest.
English: The cartridge is to be used either with the RebiSmart electronic injection device or the RebiSlide manual pen injector device.
Estonian: Kolbampulli tuleb kasutada kas koos elektroonilise süsteseadmega RebiSmart või manuaalse peninjektorseadmega RebiSlide.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 6 X 8.8 MICROGRAMS SYRINGES + 6 X 22 MICROGRAMS SYRINGES
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 6 X 8,8-MIKROGRAMMIST SÜSTLIT + 6 X 22-MIKROGRAMMIST SÜSTLIT KARBIS
English: Cartridges (type 1 glass) with a plunger stopper (rubber) and crimp cap (aluminium and halobutyl rubber) containing 1.5 mL solution for injection.
Estonian: I tüüpi klaasist, (kummist) punnkorgi ning (alumiiniumist ja halobutüülkummist) gofreeritud korgiga kolbampullid, mis sisaldavad 1,5 ml süstelahust.
English: • Press the injection button.
Estonian: • Hoidke tupsu süstekohal.
English: 3 pre-filled syringes.
Estonian: 3 süstlit.
English: Rebif 22 micrograms is a solution for injection in a pre-filled pen for self-administration.
Estonian: Rebif 22 mikrogrammi on saadaval süstelahusena iseenesele manustamiseks mõeldud pen-süstlites.
English: This medicinal product contains 2.5 mg benzyl alcohol per dose of 0.5 mL.
Estonian: Ravim sisaldab 2,5 mg bensüülalkoholi 0,5 ml annuse kohta.
English: Clinical data suggest that after 24 to 48 months of treatment with Rebif 44 micrograms, approximately 13 to 14% of patients develop persistent serum antibodies to interferon beta-1a.
Estonian: Kliinilised andmed näitavad, et beeta-1ainterferoonivastased antikehad tekivad 24...48-kuulise ravi järel Rebif 44 mikrogrammiga umbes 13…14% patsientidest.
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.
Estonian: Koostis: üks Rebif 8,8 mikrogrammi süstel (0,2 ml) sisaldab 8,8 mikrogrammi (2,4 MRÜ) beeta-1ainterferooni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 6 X 8.8 MICROGRAMS PRE-FILLED PENS + 6 X 22 MICROGRAMS PREFILLED PENS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 6 X 8,8-MIKROGRAMMIST PEN-SÜSTLIT + 6 X 22-MIKROGRAMMIST PEN-SÜSTLIT KARBIS
English: NAME OF THE MEDICINAL PRODUCT Rebif 44 micrograms/0.5 mL solution for injection in cartridge
Estonian: RAVIMPREPARAADI NIMETUS Rebif 44 mikrogrammi/0,5 ml süstelahus kolbampullis
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.
Estonian: Väiksemat annust 22 mikrogrammi (6 miljonit RÜ) kolm korda nädalas soovitatakse manustada hulgiskleroosiga patsientidele, kes suuremat annust ei talu.
English: 12 cartridges
Estonian: 12 kolbampulli.
English: 6 pre-filled pens of 8.8 micrograms and 6 pre-filled pens of 22 micrograms.
Estonian: 6 pen-süstlit 8,8 mikrogrammiga ja 6 pen-süstlit 22 mikrogrammiga.
English: An increased formation of auto-antibodies may occur during treatment with interferon beta.
Estonian: Beeta-interferoonravi ajal võib suureneda antikehade moodustumine.
English: INFORMATION IN BRAILLE rebif 22
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) rebif 22
English: • thyroid,
Estonian: • Pearinglus
English: Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU*) of interferon beta-1a**.
Estonian: Üks süstel (0,5 ml) sisaldab 44 mikrogrammi (12 MRÜ*) beeta-1a-interferooni**.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 3 AND 12 PRE-FILLED PENS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 1, 3 JA 12 PEN-SÜSTLIGA KARP
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 66 micrograms (18 MIU) of interferon beta-1a in 1.5 mL solution.
Estonian: TOIMEAINE(TE) SISALDUS Koostis: üks kolbampull sisaldab 66 mikrogrammi (18 MRÜ) beeta-1a-interferooni 1,5 ml lahuses.
English: • Remove the Rebif cartridge from the blister pack by peeling back the plastic covering.
Estonian: • Võtke Rebif'i kolbampull blisterpakendist välja, avades plastkatte.
English: Rare (may affect up to 1 in 1,000 people):
Estonian: Harv (võivad esineda kuni ühel inimesel 1000st):
English: 4 cartridges
Estonian: 4 kolbampulli.
English: Each 8.8 micrograms syringe contains 8.8 micrograms of interferon beta-1a (2.4 million IU).
Estonian: Üks 8,8-mikrogrammine süstel sisaldab 8,8 mikrogrammi beeta-1a-interferooni (2,4miljonitRÜ).
English: One-month initiation pack contains six Rebif 8.8 micrograms pre-filled syringes and six Rebif 22 micrograms pre-filled syringes.
Estonian: Ühe kuu alustuspakend sisaldab kuus süstlit Rebif 8,8 mikrogrammiga ja kuus süstlit Rebif 22 mikrogrammiga.
English: One-month initiation pack contains sixRebif8.8micrograms pre-filled pens and sixRebif22micrograms pre-filled pens.
Estonian: Ühe kuu alustuspakend sisaldab kuus pen-süstlit Rebif 8,8 mikrogrammiga ja kuus pen-süstlit Rebif 22 mikrogrammiga.
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
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/98/063/014 1 pen-süstel EU/1/98/063/015 3 pen-süstlit EU/1/98/063/016 12 pen-süstlit
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each pre-filled syringe (0.5 mL) contains 44 micrograms (12 MIU) of interferon beta-1a.
Estonian: TOIMEAINE(TE) SISALDUS Koostis: üks süstel (0,5 ml) sisaldab 44 mikrogrammi (12 MRÜ) beeta-1a-interferooni.
English: Each Rebif 22 micrograms pre-filled syringe (0.5 mL) contains 22 micrograms (6 Million IU) of interferon beta-1a.
Estonian: Üks Rebif 22 mikrogrammi süstel (0,5 ml) sisaldab 22 mikrogrammi (6 MRÜ) beeta-1a-interferooni.
English: Rebif 8.8 mcg/0.1 mL Rebif 22 mcg/0.25 mL Solution for injection interferon beta-1a SC use
Estonian: Rebif 8,8 μg/0,1 ml Rebif 22 μg/0,25 ml süstelahus beeta-1a-interferoon Subkutaanne
English: Each cartridge contains 132 micrograms corresponding to 36 million International Units (IU) of interferon beta-1a.
Estonian: Üks kolbampull sisaldab 132 mikrogrammi ehk 36 miljonit rahvusvahelist ühikut (RÜ) beeta-1a-interferooni.
English: Rebif is available in packs of 1, 3, 12 and 36 pre-filled syringes.
Estonian: Pakendis on 1, 3, 12 ja 36 Rebif'i süstlit.
English: Thyroid function testing is recommended at baseline and if abnormal, every 6-12 months following initiation of therapy.
Estonian: Seetõttu on soovitatav enne ravi algust hinnata kilpnäärme funktsiooni ning juhul, kui esineb funktsioonihäireid, tuleb vastavaid uuringuid korrata ravi käigus iga 6...12 kuu möödumisel.
English: 6 pre-filled syringes of Rebif 8.8 micrograms (LOWER FLAP)
Estonian: (ÜLEMINE KIHT) 6 süstlit Rebif 8,8 mikrogrammiga
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
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/98/063/011 1 pen-süstel EU/1/98/063/012 3 pen-süstlit EU/1/98/063/013 12 pen-süstlit
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each cartridge contains 132 micrograms (36 MIU) of interferon beta-1a in 1.5 mL solution.
Estonian: TOIMEAINE(TE) SISALDUS Koostis: üks kolbampull sisaldab 132 mikrogrammi (36 MRÜ) beeta-1a-interferooni 1,5 ml lahuses.
English: Suicide attempt*
Estonian: suitsiidikatse*
English: Patients with multiple sclerosis The usual dose is 44 micrograms (12 million IU) given three times per week.
Estonian: Hulgiskleroosiga patsiendid Tavaline annus on 44 mikrogrammi (12 miljonit RÜ), manustatuna kolm korda nädalas.
English: Each 8.8 micrograms pre-filled pen contains 8.8 micrograms of interferon beta-1a (2.4million IU).
Estonian: Üks 8,8 mikrogrammine pen-süstel sisaldab 8,8 mikrogrammi beeta-1a-interferooni (2,4 miljonit RÜ).
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.
Estonian: Subkutaansete annuste manustamise järgselt tervetele vabatahtlikele indutseeris beeta-1a-interferoon bioloogilisi markereid (nt 2',5'-OAS aktiivsus, neopteriin ja beeta-2-mikroglobuliin).
English: The usual dose is 44 micrograms (12 million IU) given three times per week.
Estonian: Tavaline annus on 44 mikrogrammi (12 miljonit RÜ), manustatuna kolm korda nädalas.
English: Rebif should be initiated with caution in patients with a history of significant liver disease, clinical evidence of active liver disease, alcohol abuse or increased serum ALT (>2.5 times ULN).
Estonian: Nendel patsientidel, kellel on anamneesis märkimisväärne maksahaigus, esineb käesoleval hetkel maksahaiguse kliiniline sümptomaatika, kes kuritarvitavad alkoholi või kellel esineb seerumi ALAT aktiivsuse suurenemine (rohkem kui 2,5 korda üle normi ülemise piiri), tuleb Rebif-ravi alustada ettevaatusega.
English: Store the syringe in the original package in order to protect from light.
Estonian: Hoida kolbampull originaalpakendis valguse eest kaitstult.
English: Breast-feeding
Estonian: PEN-SÜSTEL
English: Each syringe contains 22 micrograms, corresponding to 6 million International Units (IU) of interferon beta-1a.
Estonian: Üks süstel sisaldab 22 mikrogrammi ehk 6 miljonit rahvusvahelist ühikut (RÜ) beeta-1a-interferooni.
English: • Rebif is intended for subcutaneous (under the skin) injection.
Estonian: • Rebif on ette nähtud subkutaanseks (nahaaluseks) süstimiseks.
English: • Dilatation of the blood vessels and palpitation
Estonian: • Veresoonte laienemine ja südamepekslemine
English: Class effects
Estonian: Klassi toimed
English: The thyroid gland may function either excessively, or insufficiently.
Estonian: Võib tekkida kilpnäärme ületalitlus või talitluse puudulikkus.
English: RebiDose is a ready to use pre-filled pen for subcutaneous injection.
Estonian: RebiDose on kasutamiseks valmis pen-süstel subkutaanseks süstimiseks.
English: Not all injection devices may be available.
Estonian: Kõik süsteseadmed ei pruugi olla müügil.
English: Injection site cellulitis*
Estonian: tselluliit süstekohal*
English: • Hives
Estonian: • neeruhaigus
English: Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU*) of interferon beta-1a**.
Estonian: Üks süstel (0,5 ml) sisaldab 22 mikrogrammi (6 MRÜ*) beeta-1a-interferooni**.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 44 mcg/0.5 mL solution for injection interferon beta-1a
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Rebif 44 μg/0,5 ml süstelahus beeta-1a-interferoon
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.
Estonian: Koostis: üks Rebif 8,8 mikrogrammi pen-süstel sisaldab 8,8 mikrogrammi (2,4 MRÜ) beeta-1ainterferooni 0,2 ml lahuses.
English: Each cartridge contains 66 micrograms corresponding to 18 million International Units (IU) of interferon beta-1a.
Estonian: Üks kolbampull sisaldab 66 mikrogrammi ehk 18 miljonit rahvusvahelist ühikut (RÜ) beeta-1a-interferooni.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 22 mcg/0.5 mL solution for injection interferon beta-1a
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Rebif 22 μg/0,5 ml süstelahus beeta-1a-interferoon
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rebif 8.8 micrograms solution for injection interferon beta-1a
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Rebif 8,8 mikrogrammi süstelahus beeta-1a-interferoon
English: STATEMENT OF ACTIVE SUBSTANCE(S) Composition: Each pre-filled syringe (0.5 mL) contains 22 micrograms (6 MIU) of interferon beta-1a.
Estonian: TOIMEAINE(TE) SISALDUS Koostis: üks süstel (0,5 ml) sisaldab 22 mikrogrammi (6 MRÜ) beeta-1a-interferooni.
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.
Estonian: Rebif sisaldab 1,0 mg bensüülalkoholi 0,2 ml annuse kohta ja 2,5 mg bensüülalkoholi 0,5 ml annuse kohta.
English: Each syringe contains 44 micrograms, corresponding to 12 million International Units (IU) of interferon beta-1a.
Estonian: Üks süstel sisaldab 44 mikrogrammi ehk 12 miljonit rahvusvahelist ühikut (RÜ) beeta-1a-interferooni.
English: • Remove RebiDose from the blister pack by peeling back the plastic covering.
Estonian: • Võtke RebiDose blisterpakendist välja, avades plastkatte tagakülje.
English: Each 22 micrograms syringe contains 22 micrograms of interferon beta-1a (6 million IU).
Estonian: Üks 22-mikrogrammine süstel sisaldab 22 mikrogrammi beeta-1a-interferooni (6 miljonit RÜ).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, and genotoxicity.
Estonian: Farmakoloogilise ohutuse, korduvtoksilisuse ja genotoksilisuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: • Itching, rash (skin eruptions)
Estonian: • Sügelus, lööve (nahalööbed)
English: Each Rebif 22 micrograms pre-filled pen contains 22 micrograms (6 Million IU) of interferon beta-1a in 0.5 mL solution.
Estonian: Üks Rebif 22 mikrogrammi pen-süstel sisaldab 22 mikrogrammi (6 MRÜ) beeta-1a-interferooni 0,5 ml lahuses.
English: NAME OF THE MEDICINAL PRODUCT Rebif 22 micrograms/0.5 mL solution for injection in cartridge
Estonian: RAVIMPREPARAADI NIMETUS Rebif 22 mikrogrammi/0,5 ml süstelahus kolbampullis
English: The pre-filled syringe is ready for use and contains 0.2 mL of solution.
Estonian: Süstel on kasutamiseks valmis ning sisaldab 0,2 ml süstelahust.
English: How to inject Rebif
Estonian: Kuidas RebiDose'i süstida
English: D. Label
Estonian: D. Silt
English: Each 22 micrograms pre-filled pen contains 22 micrograms of interferon beta-1a (6 million IU).
Estonian: Üks 22 mikrogrammine pen-süstel sisaldab 22 mikrogrammi beeta-1a-interferooni (6 miljonit RÜ).
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
Estonian: RAVIMPREPARAADI NIMETUS Rebif 8,8 mikrogrammi/0,1 ml süstelahus kolbampullis Rebif 22 mikrogrammi/0,25 ml süstelahus kolbampullis
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.
Estonian: Rebif sisaldab 0,5 mg bensüülalkoholi 0,1 ml annuse kohta ja 1,25 mg bensüülalkoholi 0,25 ml annuse kohta.
English: Patients with single lesions may continue provided that the necrosis is not too extensive.
Estonian: Eeldusel, et nekroosikolle ei ole ulatuslik, võib üksiku kahjustuskolde korral süstimist jätkata.
English: Relapsing multiple sclerosis
Estonian: Retsidiveeruva kuluga sclerosis multiplex
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.
Estonian: Ravim sisaldab 0,5 mg bensüülalkoholi 0,1 ml annuse kohta ja 1,25 mg bensüülalkoholi 0,25 ml annuse kohta.
English: Rebif is intended for subcutaneous (under the skin) injection.
Estonian: Rebif on ette nähtud subkutaanseks (nahaaluseks) süstimiseks.
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.
Estonian: Rebif 8,8 mikrogrammi on saadaval süstelahusena iseenesele manustamiseks mõeldud süstlites, millel on fikseeritud nõel.