FrancophonIA/ELRC3.0 huggingface dataset:
English: Quincke's oedema (angio-oedema)*, erythema multiforme*, erythema multiforme-like skin reactions*, Stevens Johnson syndrome* Musculoskeletal and connective disorders Common:
Maltese: Edema ta' Quincke (anġjoedema)*, eritema multiforme*, reazzjonijiet tal-ġilda bħal dawk ta' eritema multiforme*, sindrome ta' Stevens Johnson*
English: Risk Reduction
Maltese: Tnaqqis fir-Riskju
English: However, a paediatric retrospective cohort study collected safety data with Rebif from medical records in children (n=52) and adolescents (n=255).
Maltese: Madankollu, studju retrospettiv dwar koorti ta' pazjenti pedjatriċi ġabar dejta dwar is-sigurtà b'Rebif minn rekords mediċi fit-tfal (n=52) u fl-adoloxxenti (n=255).
English: Clear to opalescent solution, with pH 3.7 to 4.1 and osmolarity 250 to 450 mOsm/L.
Maltese: Soluzzjoni ċara għal opalexxenti b'pH ta' 3.7 sa 4.1 u osmolarità ta' 250 sa 450 mOsm/L.
English: Equipment
Maltese: Apparat
English: Rebif is available in three strengths: 8.8 micrograms, 22 micrograms and 44 micrograms.
Maltese: Rebif jinstab fi tlett tipi : 8.8 mikrogrammi, 22 mikrogrammi u 44 mikrogrammi.
English: The interaction of Rebif with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Maltese: L-effetti ta' Rebif flimkien ma' corticosteroids jew l-ormon adrenokortikotropiku (ACTH) ma ġewx studjati sistematikament.
English: Rebif belongs to a class of medicines known as interferons.
Maltese: Rebif jifforma parti mill-klassi tal-mediċini magħrufa bħala interferons.
English: 12 cartridges
Maltese: 12 skrataċċ
English: 4 cartridges
Maltese: 4 skrataċċ
English: • The other ingredients are mannitol, poloxamer 188, L-methionine, benzyl alcohol, sodium acetate, acetic acid, sodium hydroxide and water for injections.
Maltese: • Is-sustanzi l-oħra huma mannitol, poloxamer 188, L-methionine, benzyl alkohol, sodium acetate, acetic acid, sodium hydroxide u ilma għall-injezzjoni.
English: EU/1/98/063/004 EU/1/98/063/005 EU/1/98/063/006 EU/1/98/063/021
Maltese: EU/1/98/063/005 EU/1/98/063/006 EU/1/98/063/021
English: The presence of antibodies has been shown to attenuate the pharmacodynamic response to interferon beta-1a (beta-2 microglobulin and neopterin).
Maltese: Il-preżenza ta' antikorpi wriet li tnaqqas ir-rispons farmakodinamiku għal interferon beta-1a (beta-2 mikroglobulina u neopterina).
English: Drug-induced lupus erythematosus* Renal and urinary disorders Rare:
Maltese: Lupus erythematosus ikkaġunat mill-mediċina* Disturbi fil-kliewi u fis-sistema urinarja Rari:
English: Store in a refrigerator (2°C - 8°C) away from the cooling element.
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: Nephrotic syndrome*, glomerulosclerosis* (see section 4.4) General disorders and administration site conditions Very common:
Maltese: Sindromu nefrotiku*, glomerulosklerożi* (ara sezzjoni 4.4) Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: • Itching, rash (skin eruptions)
Maltese: • Ħakk, raxx (erruzjonjiet tal-ġilda)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 132 micrograms (36 million IU)/1.5 mL
Maltese: INDIVIDWALI 132 mikrogrammi (36 miljun IU)/1.5 mL
English: Frequency not known: Transient neurological symptoms (i.e. hypoesthesia, muscle spasm, paraesthesia, difficulty in walking, musculoskeletal stiffness) that may mimic multiple sclerosis exacerbations*
Maltese: Sintomi newroloġiċi temporanji (i.e. ipoestesija, spażmu tal-muskoli, parestesija, diffikultà biex timxi, ebusija muskoloskeletrika) li tista' tkun tixbah aggravamenti ta' sklerosi multipla*
English: The effects of Rebif on fertility have not been investigated.
Maltese: L-effetti ta' Rebif fuq il-fertilità ma ġewx investigati.
English: INFORMATION IN BRAILLE rebif 22/0.5
Maltese: rebif 22/0.5
English: In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
Maltese: ALT) kienu komuni u bejn 1 u 3% tal-pazjenti żviluppaw elevazzjoni ta' transminases epatika aktar minn 5 darbiet l-għola limitu normali (ULN-upper limit of normal).
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Maltese: Interferons ġew rappurtati li jnaqqsu l-attività ta' enżimi li jiddependu minn hepatic cytochrome P450-fil-bnedmin u l-annimali.
English: • Place RebiSmart at a right angle (90°) to the skin.
Maltese: • Poġġi RebiSmart f'angolu ta' 90° mal-ġilda.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 66 micrograms (18 million IU)/1.5 mL
Maltese: INDIVIDWALI 66 mikrogrammi (18-il miljun IU)/1.5 mL
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 8.8 micrograms (2.4 million IU)/0.2 mL
Maltese: INDIVIDWALI 8.8 mikrogrammi (2.4 miljuni IU)/0.2 mL
English: It has been shown to reduce the number and the severity of relapses and to slow the progression of disability.
Maltese: Deher li naqqas in-numru u s-severita' ta' l-attakki ripetuti u li jnaqqas il-progressjoni tad-diżabilita'.
English: • To activate the “initiation/titration” menu you need to first select 44 micrograms, then ‘initiation/titration', press ‘change', select ‘on', press ‘ok' and confirm ‘initiation/titration on' by pressing ‘ok'.
Maltese: • Biex tattiva l-menu “initiation/titration” inti l-ewwel għandek tagħżel 44 mikrogramma, imbagħad ‘initiation/titration” tagħfas ‘change', agħżel ‘on', agħfas ‘ok' u kkonferma ‘initiation/titration on' billi tagħfas ‘ok'.
English: Injection site necrosis (ISN) has been reported in patients using Rebif (see section 4.8).
Maltese: Nekrożi fis-sit ta' l-injezzjoni (ISN) kien rappurtat fuq pazjenti li jużaw ir-Rebif (ara sezzjoni 4.8).
English: • Liver inflammation (hepatitis)
Maltese: • Infjammazzjoni tal-fwied (epatite)
English: It is produced in mammalian cells (Chinese hamster ovary) and is therefore glycosylated like the natural protein.
Maltese: Jiġi prodotti fiċ-ċelluli mammaljani (ovarju tal-ħamster Ċiniż) u hu għalhekk glikosilizzat bħal proteina naturali.
English: corresponding to 12 million International Units (IU) of interferon beta-1a.
Maltese: 12 miljun Unità Internazzjonali (IU) ta' interferon beta-1a.
English: (LOWER FLAP)
Maltese: (KARTA TA' TAĦT)
English: Rebif 22 micrograms is available as a package of 1, 3, 12, or 36 syringes.
Maltese: Rebif 22 mikrogramma jinstab f'pakketti ta' 1, 3, 12 jew 36 siringa.
English: Rebif has not been investigated for carcinogenicity.
Maltese: Rebif ma kienx studjat għal karċinoġeniċità.
English: Following repeated subcutaneous injections of 22 and 44 micrograms doses of Rebif maximum concentrations were typically observed after 8 hours, but this was highly variable.
Maltese: Wara injezzjonijiet ripetuti taħt il-ġilda ta' dożi ta' 22 u 44 mikrogramma ta' Rebif, konċentrazzjonijiet massimi ġew tipikament osservati wara 8 sigħat, iżda dan kien varjabbli ħafna.
English: • kidney,
Maltese: • kliewi,
English: Marketing Authorisation Holder Merck Europe B.V.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Merck Europe B.V.
English: • Drug-induced lupus erythematosus: a side-effect of long-term use of Rebif.
Maltese: • Lupus erythematosus ikkaġunati mill-mediċina: effett sekondarju tal-użu fit-tul ta' Rebif.
English: • Dizziness
Maltese: • Anzjetà
English: Excipient with known effect: 7.5 mg benzyl alcohol For the full list of excipients, see section 6.1.
Maltese: Eċċipjent b'effett magħruf: 7.5 mg benzyl alkohol Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: 6 pre-filled syringes of Rebif 22 micrograms
Maltese: (KARTA TA' TAĦT) 6 siringi mimlija għal-lest ta' Rebif 22 mikrogrammi
English: Rebif 44 micrograms is available as a package of 1, 3, 12, or 36 syringes.
Maltese: Rebif 44 mikrogramma jinstab f'pakketti ta' 1, 3, 12 jew 36 siringa.
English: Frequency not known: Pulmonary arterial hypertension* (class label for interferon products, see below Pulmonary arterial hypertension)
Maltese: Ipertensjoni arterjali tal-pulmun* (tikketta tal-klassi għall-prodotti interferon, ara taħt Ipertensjoni arterjali tal-pulmun)
English: In the absence of clinical symptoms, serum ALT levels should be monitored prior to the start of therapy, at months 1, 3 and 6 on therapy and periodically thereafter.
Maltese: Jekk ma hemmx sintomi kliniċi, il-livelli ta' serum ALT għandhom ikunu monitorjati qabel tinbeda l-kura, f'xhur 1, 3 u 6 waqt itterapija u perjodikament wara.
English: • Injection site reactions including redness, swelling, discoloration, inflammation, pain and skin breakdown are very common.
Maltese: • Reazzjonijiet fis-sit ta l-injezzjoni, inklużi ħmura, nefħa, diskolorazzjoni, infjammazzjoni, uġigħ u tifrik tal-ġilda huma komuni ħafna.
English: Dyspnoea*
Maltese: Puplesiji*
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 44 micrograms (12 million IU)/0.5 mL
Maltese: INDIVIDWALI 44 mikrogrammi(12 miljuni IU)/0.5 mL
English: In healthy volunteers after intravenous administration, interferon beta-1a exhibits a sharp multi-exponential decline, with serum levels proportional to the dose.
Maltese: F'persuni f'saħħithom wara għoti mill-vina, interferon beta-1a juri nuqqas serju multi esponenzjali, b'livelli ta' serum proporzjonali għad-doża.
English: Rebif is indicated for the treatment of relapsing multiple sclerosis.
Maltese: Rebif hu indikat għall-kura ta' pazjenti bi sklerożi multipla li terġa tirkadi.
English: • patients with relapsing multiple sclerosis.
Maltese: • pazjenti bi sklerożi multipla li terġa tirkadi.
English: Laboratory abnormalities
Maltese: Abnormalitajiet fir-riżultati tat-testijiet tal-laboratorju
English: Other medicines and Rebif
Maltese: Mediċini oħra u Rebif
English: Symptoms of the flu-like syndrome associated with interferon beta-1a therapy may prove stressful to patients with cardiac conditions.
Maltese: Sintomi ta' sindromu li jixbah lill-influwenza asso`jati mat-terapija bl-interferon beta-1a jistgħu jkunu ta' stress fuq pazjenti li jbatu bil-qalb.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 22 micrograms (6 million IU)/0.5 mL
Maltese: INDIVIDWALI 22 mikrogrammi (6 miljuni IU)/0.5 mL
English: • Depression is common (may affect up to 1 in 10 people) in treated patients with multiple sclerosis.
Maltese: • Id-dipressjoni hi komuni (tista' taffettwa sa persuna 1 minn kull 10) f'pazjenti kkurati bi sklerosi multipla.
English: Time to peak concentrations following a single subcutaneous injection were 24 to 48 hours for neopterin, beta-2-microglobulin and 2'5'OAS, 12 hours for MX1 and 24 hours for OAS1 and OAS2 gene expression.
Maltese: Il-ħin għall-konċentrazzjonijiet massimi wara injezzjoni waħda taħt il-ġilda kien ta' 24 sa 48 siegħa għal neopterin, beta 2-microglobulin u 2'5'OAS, 12-il siegħa għal MX1 u 24 siegħa għall-espressjoni talġeni OAS1 u OAS2.
English: • Kidney problems including scarring that may reduce your kidney function.
Maltese: • Problemi fil-kliewi li jinkludu ċikatriċi li jistgħu jnaqqsu l-funzjoni tal-kliewi tiegħek.
English: Laboratory abnormalities are associated with the use of interferons.
Maltese: Abnormalitajiet tal-laboratorju huma assoċjati ma' l-użu ta' l-interferons.
English: Suicide attempt*
Maltese: Tentattiv ta' suwiċidju*
English: • patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1)
Maltese: • pazjenti b'avveniment demyelinating wieħed bi proċess infjammatorju attiv, jekk dijanjosi alternattivi jkunu ġew esklużi, u jekk huma ddeterminati li huma f'riskju għoli li jiżviluppaw sklerożi multipla definita klinikament (ara sezzjoni 5.1)
English: Read carefully the package leaflet of Rebif 22 micrograms/0.5 mL or Rebif 44 micrograms/0.5 mL before you start your fifth week treatment.
Maltese: Aqra b'attenzjoni ilfuljett tagħrif fil-pakkett ta' Rebif 22 mikrogramma/0.5 mL jew Rebif 44 mikrogramma/0.5 mL qabel ma tibda l-ħames ġimgħa ta' kura tiegħek.
English: These should be more frequent when initiating Rebif 44 micrograms.
Maltese: Dawn għandhom ikunu iżjed frekwenti wara l-introduzzjoni tal-kura ta' Rebif 44 mikrogramma.
English: Rebif is available in packs of 1, 3 and 12 pre-filled pens (RebiDose).
Maltese: Rebif huwa disponibbli f'pakketti ta' 1, 3 u 12-il siringa mimlijin għal-lest (RebiDose).
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.
Maltese: Każijiet ta' mikroanġjopatija trombotika, li tidher bħala tromboċitopenija purpura trombotika (TTP) jew sindrome uremiku emolitiku (HUS) ġew irrappurtati, li jinkludu każijiet fatali bi prodotti li fihom interferon beta.
English: After repeated subcutaneous doses in healthy volunteers, the main PK parameters (AUCtau and Cmax) increased proportional to the increased in dose from 22 micrograms to 44 micrograms.
Maltese: Wara l-għoti ta' dożi ripetuti taħt il-ġilda f'voluntiera b'saħħithom, il-parametri farmakokinetiċi ewlenin (AUCtau and Cmax) żdiedu b'mod proporzjonali maż-żieda fid-doża minn 22 mikrogramma sa 44 mikrogramma.
English: If the patient population was divided into 2 subgroups (those with and those without relapses in the 2-year period prior to study entry), there was no effect on disability in patients without relapses, but in patients with relapses, the proportion with progression in disability at the end of the study was reduced from 70% (placebo) to 57% (Rebif 22 micrograms and 44 micrograms combined).
Maltese: Jekk il-popolazzjoni tal-pazjenti kienet maqsuma f'żewġ gruppi (dawk b'attakki ripetuti matul il-perjodu ta' sentejn qabel ma daħlu għall-istudju u dawk mingħajr), ma kien hemm l-ebda effett fuq pazjenti li ma kellhomx attakki ripetuti, iżda f'pazjenti li kellhom attakki ripetuti, il-proporzjon mal-progress fid-diżabilità fl-aħħar ta' l-istudju naqas minn 70 % (plaċebo) sa' 57% (Rebif 22 mikrogrammi u 44 mikrogrammi flimkien).
English: Not all injection devices may be available.
Maltese: Mhux kull apparat injettatur jista jkun disponibbli.
English: Severe elevations in transaminases
Maltese: Żidiet severi fit-transaminases
English: Early clinical features include thrombocytopenia, new onset hypertension, fever, central nervous system symptoms (e.g. confusion, paresis) and impaired renal function.
Maltese: Karatteristiċi kliniċi jinkludu tromboċitopenija, bidu ġdid ta' pressjoni għolja, deni, sintomi tas-sistema nervuża ċentrali (eż. konfużjoni u paresi) u indeboliment fil-funzjoni tal-kliewi.
English: • thyroid,
Maltese: • mudullun,
English: Each 8.8 micrograms syringe contains 8.8 micrograms of interferon beta-1a (2.4 million IU).
Maltese: - Kull 8.8 mikrogrami siringa fiha 8.8 mikrogrammi ta' interferon-beta-1a (2,4 milljuni IU).
English: Metabolism Interferon beta-1a is mainly metabolised and excreted by the liver and the kidneys.
Maltese: Metaboliżmu Interferon beta-1a hu metabolizzat u mormi mill-fwied u l-kliewi.
English: • Suicide attempt
Maltese: • Tentattiv ta' suwiċidju
English: • Thyroid dysfunction is uncommon.
Maltese: • Disfunzjoni tat-tirojde mhijiex komuni.
English: The pack contains 6 individual doses of 0.2 mL of Rebif 8.8 micrograms solution for injection in a 1 mL type 1 glass syringe with a stainless steel needle and 6 individual doses of 0.5 mL of Rebif 22 micrograms solution for injection in a 1 mL type 1 glass syringe with a stainless steel needle.
Maltese: Il-pakkett fih 6 dożi individwali ta' 0.2 mL ta' Rebif 8.8 mikrogrammi soluzzjoni għall-injezzjoni ġo siringa ta 1 mL tal-ħġieġ tat-tip I b'labra ta' azzar li ma jittebbax u 6 dożi individwali ta' 0.5 mL ta' Rebif 22 mikrogramma soluzzjoni għall-injezzjoni ġo siringa ta 1 mL tal-ħġieġ tat-tip I b'labra ' azzar li ma jittebbax.
English: Patients should be informed of the most frequent adverse reactions associated with interferon beta administration, including symptoms of the flu-like syndrome (see section 4.8).
Maltese: Il-pazjenti għandhom ikunu mgħarrfa bir-reazzjonijiet negattivi l-aktar frekwenti assoċjati mat-teħid ta' l-interferon beta, li jinkludi sintomi ta' sindromu li jixbah lill-influwenza (ara sezzjoni 4.8).
English: • Hypersensitivity to natural or recombinant interferon beta or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għal interferon beta naturali jew rikombinat jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: How to store Rebif
Maltese: Tużax Rebif
English: In a 3-year study in patients with secondary progressive multiple sclerosis (EDSS 3-6.5) with evidence of clinical progression in the preceding two years and who had not experienced relapses in the preceding 8 weeks, Rebif had no significant effect on progression of disability, but relapse rate was reduced by approximately 30%.
Maltese: Fi studju ta' tliet snin f'pazjenti li jbatu minn sklerożi multipla sekondarja progressiva (EDSS 3-6.5) b'evidenza ta' progress kliniku fis-sentejn ta' qabel u li ma kellhomx relaps fit-tmien ġimgħat ta' qabel, Rebif ma kellu l-ebda effett sinjifikattiv fuq il-progress tad-diżabilità, iżda r-rata ta' attakki ripetuti tnaqqset bi 30%.
English: Pack size of 2 cartridges.
Maltese: Daqs tal-pakkett ta' 2 skrataċ.
English: In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1).
Maltese: Fi studji kliniċi, dan ġie karaterizzat bħala ripetizzjoni ta' 2 każi jew aktar fl-aħħar sentejn (ara sezzjoni 5.1).
English: The following side effects were reported for interferon beta (frequency not known)
Maltese: L-effetti mhux mixtieqa li ġejjin ġew irrapurtati għal interferon beta (frekwenza mhux magħrufa)
English: • Rebif is intended for subcutaneous (under the skin) injection.
Maltese: • Rebif hu maħsub għal injezzjoni subkutaneja (taħt il-ġilda).
English: The mechanism for the rare symptomatic hepatic dysfunction is not known.
Maltese: Il-mekkaniżmu għad-disfunzjoni epatika rari sintomatika mhux magħruf.
English: Anaphylactic reactions*
Maltese: Reazzjonijiet anafilattiċi*
English: Rebif should not be used in this age group.
Maltese: Rebif ma għandux jintuża f'dan il-grupp ta' età.
English: Rebif is intended for subcutaneous (under the skin) injection.
Maltese: Rebif hu maħsub għal injezzjoni subkutaneja (taħt il-ġilda).
English: • Irregularities and/or changes in menstrual flow.
Maltese: • Irregolaritajiet u/jew tibdil fil-menstruazzjoni.
English: Rebif 8.8 micrograms solution for injection interferon beta-1a
Maltese: Rebif 8.8 mikrogrammi soluzzjoni għall-injezzjoni Interferon beta-1a
English: Retinal vascular disorders (i.e. retinopathy, cotton wool spots, obstruction of retinal artery or vein)*
Maltese: Mard vaskulari tar-retina (i.e. retinopatija, tikek qishom suf, ostruzzjoni ta' arterja jew vina tar-retina)*
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.
Maltese: Informazzjoni klinika tissuġġerixxi li wara 24 sa 28 xhar ta' kura b'Rebif 44 mikrogramma, madwar 13 sa 14% tal-pazjenti jiżviluppaw antikorpi persistenti fis serum għal interferon beta-1a.
English: It may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Maltese: Jista' jikkawża reazzjonijiet tossiċi u reazzjonijiet allerġiċi fit-trabi u fi tfal sa l-età ta' 3 snin.
English: Rebif is a highly purified soluble protein that is similar to the natural interferon beta that is produced in the human body.
Maltese: Rebif hi proteina pura ħafna u li tinħall sew u hi simili għall-interferon beta naturali li jagħmel ilġisem tal-bniedem.
English: • heart,
Maltese: • qalb,
English: The safety and efficacy of Rebif has been evaluated in patients with relapsing-remitting multiple sclerosis at doses ranging from 11 to 44 micrograms (3-12 million IU), administered subcutaneously three times per week.
Maltese: Is-sigurtà u l-effikaċja ta' Rebif ġiet ippruvata f'pazjenti li jbatu minn attakki ripetuti ta' sklerożi multipla f'dożi li jvarjaw minn 11 sa 44 mikrogramma (3-12-il miljun IU), mogħtija minn taħt il-ġilda tlett darbiet fil-ġimgħa.
English: Mean CUA Lesions per Subject per Scan During the Double Blind Period Least Square Means (SE) * tiw - three times per week
Maltese: Medja ta' leżjonijiet CUA għal kull Individwu f'kull Scan Matul il-Perjodu Double Blind Least Square Means (SE) * tiw - tlett darbiet kull ġimgħa
English: Each 22 micrograms syringe contains 22 micrograms of interferon beta-1a (6 million IU).
Maltese: - Kull 22 mikrogrammi siringa fiha 22 mikrogrammi ta' interferon-beta-1a (6 milljuni IU).
English: • Irregularities and/or changes in menstrual flow
Maltese: • Irregolaritajiet u/jew tibdil fil-menstruazzjoni
English: • Blood clots such as deep venous thrombosis
Maltese: • Emboli tad-demm bħal trombożi tal-vini profondi
English: Thyroid function testing is recommended at baseline and if abnormal, every 6-12 months following initiation of therapy.
Maltese: It-test talfunzjoni tat-tirojde hu rrakkomandat fil-bidu u jekk abnormali, kull 6-12-il xahar wara li tinbeda tterapija.
English: Each pre-filled cartridge contains 132 micrograms (36 MIU*) of interferon beta-1a** in 1.5 mL solution, corresponding to 88 micrograms/mL.
Maltese: Kull skartoċċ mimli għal-lest fih 132 mikrogrammi(36 MIU*) ta' interferon beta-1a** f'soluzzjoni ta' 1.5 mL, li jikkorrispondu għal 88 mikrogrammi/mL.
English: • Check the appearance of Rebif through the transparent window.
Maltese: • Ikkontrolla d-dehra ta' Rebif minn ġot-tieqa trasparenti.
English: RebiDose Instructions for use
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: The adverse reactions presented have been identified from clinical studies as well as from postmarketing reports (an asterisk [*] indicates adverse reactions identified during post-marketing surveillance).
Maltese: Ir-reazzjonijiet avversi ppreżentati ġew identifikati minn studji kliniċi kif ukoll minn rapporti ta' wara t-tqegħid fis-suq (asterisk [*] tindika reazzjonijiet avversi identifikati matul sorveljanza ta' wara ttqegħid fis-suq).
English: (LOWER FLAP) 6 pre-filled pens RebiDose
Maltese: (KARTA TA' FUQ) 6 pinen mimlijin għal-lest RebiDose
English: 36 pre-filled syringes.
Maltese: 36 siringa mimlija għal-lest.
English: Over 4 years, the reduction in the mean exacerbation rate was 22% in patients treated with Rebif 22 micrograms, and 29% in patients treated with Rebif 44 micrograms group compared with a group of patients treated with placebo for 2 years and then either Rebif 22 or Rebif 44 micrograms for 2 years.
Maltese: Fi żmien erba' snin, in-nuqqas tar-rata bejn wieħed u ieħor ta' iggravar kienet 22% f'pazjenti kkurati b'Rebif 22 mikrogramma, u 29% f'pazjenti kkurati b'Rebif 44 mikrogramma kkomparati ma' grupp ta' pazjenti ikkurati bi plaċebo għal sentejn u mbagħad jew b'Rebif 22 jew b'Rebif 44 mikrogramma għal sentejn.
English: At licensed posology, Rebif 44 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at least 2 exacerbations in the previous 2 years and with an EDSS of 0-5.0 at entry.
Maltese: F'posoloġija liċenzjata, Rebif 44 mikrogramma instab li jnaqqas l-inċidenza (bejn wieħed u ieħor bi 30% fi żmien sentejn) u s-severità ta' attakki ripetuti f'pazjenti bi tnejn jew iżjed exaserbazzjonijiet fis-sentejn ta' qabel u bi EDSS ta' 0-5.0 meta beda l-kura.
English: A large amount of data (more than 1,000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy.
Maltese: Ammont kbir ta' reġistri ta' data (aktar minn 1,000 riżultat ta' tqala) u esperjenza ta' wara t-tqegħid fis-suq jindikaw li m'hemm l-ebda żieda fir-riskju ta' anomaliji konġenitali maġġuri wara esponiment għall-interferon beta qabel il-konċepiment jew tali esponiment matul l-ewwel trimestru tat-tqala.