FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon beta products.
Maltese: Waqt kura bi prodotti ta' interferon beta kienu rrappurtati każijiet ta' sindrome nefrotiku b'nefropatiji eżistenti differenti inkluż glomerulosklerosi segmentali fokali b'kollass (FSGS - collapsing focal segmental glomerulosclerosis), marda b'bidla minima (MCD - minimal change disease), glomerulonefrite membranoproliferattiva (MPGN - membranoproliferative glomerulonephritis) u glomerulopatija tal-membrana (MGN - membranous glomerulopathy).
English: Bayer d.o.o.
Maltese: Hrvatska Bayer d.o.o.
English: In the different controlled clinical trials in relapsing-remitting multiple sclerosis and secondary progressive multiple sclerosis, between 23% and 41% of the patients developed serum interferon beta1b neutralising activity confirmed by at least two consecutive positive titres; of these patients, between 43% and 55% converted to a stable antibody negative status (based on two consecutive negative titres) during the subsequent observational period of the respective study.
Maltese: Fil-provi kliniċi kkontrollati differenti fi sklerożi multipla li tirkadi u tbatti u sklerożi multipla progressiva sekondarja, bejn 23% u 41% tal-pazjenti żviluppaw attività newtralizzanti għal interferon beta 1-b fis-serum li kienet ikkonfermata b'minn tal-anqas żewġ titri konsekuttivi pożittivi; minn dawn il-pazjenti, bejn 43% u 55% qalbu għal stat negattiv ta' anti-korpi stabbli (skont żewġ titri negattivi konsekuttivi) matul il-perijodu ta' osservazzjoni sussegwenti tal-istudju rispettiv.
English: Musculoskeletal and connective tissue disorders Hypertonia°
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Ipertonija°
English: 37% versus delayed Betaferon
Maltese: 37% kontra Betaferon ittardjat
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products.
Maltese: Każijiet ta' pressjoni għolja fl-arterja tal-pulmun (PAH - pulmonary arterial hypertension) kienu irrappurtati bi prodotti interferon beta.
English: AREA 3
Maltese: ŻONA 3
English: Pharmacotherapeutic group: Cytokines, Interferons, ATC Code: L03 AB 08
Maltese: Ċitokini, Interferoni, Kodiċi ATC:
English: However, there is some data available in children and adolescents from 12 to 16 years.
Maltese: Madankollu, hemm disponibbli xi dejta fi tfal u adolexxenti b'età minn 12 sa 16-il sena.
English: Bronchospasm2
Maltese: Bronkospażmu2
English: Bayer AB
Maltese: Sverige Bayer AB
English: Part of a titration pack.
Maltese: Parti minn pakkett ta' titrazzjoni.
English: Risk reduction
Maltese: Tnaqqis fir-riskju
English: Single Event suggestive of Multiple Sclerosis (BENEFIT) #
Maltese: Avveniment Wieħed li jissuġġerixxi Sklerożi Multipla (BENEFIT) #
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)
Maltese: − Pakkett ta' titrazzjoni għal titrazzjoni tad-doża b'4 pakketti tripli ta' kuluri u b'numri differenti: - isfar, bin-numru “1” (ġranet ta' kura 1, 3 u 5; siringa b'marka f'0.25- ml), - aħmar, bin-numru “2” (ġranet ta' kura 7, 9 u 11; siringa b'marka f'0.5- ml), - aħdar , bin-numru “3” (ġranet ta' kura 13, 15 u 17; siringa b'marka f'0.75- ml), - blu, bin-numru “4” (ġranet ta' kura 19, 21 u 23; siringa b'marka f'0.25, 0.5, 0.75 u 1-ml) Kull pakkett triplu fih 3 kunjetti bi trab, 3 siringi mimlija għall-lest b'solvent, 3 adatturi għallkunjett b'labra mwaħħla minn qabel u 6 imsielaħ ta' l-alkoħol biex tnaddaf il-ġilda u l-kunjett.
English: Betaferon may cause serious side effects.
Maltese: Betaferon jista' jikkawża effetti sekondarji serji.
English: • Sodium - this medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free'.
Maltese: • sodium - din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull ml, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: From various studies mean clearance rates and half-lives of disposition phases from serum were estimated to be at most 30 ml·min-1·kg-1 and 5 hours, respectively.
Maltese: Minn diversi studji kien stmat li r-rata medja tat-tneħħija u l-half lives tal-fażijiet ta' dispożizzjoni fis-serum, ma kienux aktar minn 30 ml·min-1·kg-1 u 5-sigħat, rispettivament.
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).
Maltese: Analiżi retrospettiva f'sottogruppi wriet li l-effett tal-kura fuq il-progressjoni tad-diżabilità hi l-aktar probabbli f'pazjenti bil-marda attiva qabel il-bidu tal-kura (Proporzjon ta' Periklu 0.72, 95% intervall ta' kunfidenza (0.59, 0.88), p=0.0011, ekwivalenti għal tnaqqis ta' 28% fir-riskju minħabba Betaferon f'pazjenti b'irkadar jew bi progressjoni prominenti fl-EDSS, 8.0 miljun IU Betaferon kontra il-pazjenti kollha tal-plaċebo).
English: No separate investigations were performed regarding the influence of Betaferon on the cardiovascular system, respiratory system and the function of endocrine organs.
Maltese: Ma sarux studji separati dwar l-effett ta' Betaferon fuq is-sistema kardjovaskulari, is-sistema respiratorja u fuq il-funzjoni ta' organi endokrinali.
English: AREA 4
Maltese: ŻONA 4
English: Hepatic injury (including hepatitis), Hepatic failure2
Maltese: Ħsara fil-fwied (inkluż epatite), Insuffiċjenza tal fwied 2
English: − If you have monoclonal gammopathy.
Maltese: Jekk għandek gammopatija monoklonali.
English: Interferons belong to the family of cytokines, which are naturally occurring proteins.
Maltese: L-interferoni huma membri tal-familja taċ-ċitokini, li huma proteini naturali.
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: thrombotic thrombocytopenic purpura) jew sindrome uremiku emolitiku (HUS - haemolytic uraemic syndrome), inkluż każijiet fatali, ġew irrappurtati bi prodotti li fihom interferon beta.
English: Rare ( ≥ 1/10,000 to
Maltese: ( ≥ 1/10,000 sa
English: 24% versus delayed Betaferon
Maltese: 24% kontra Betaferon ittardjat
English: It has been demonstrated in vitro that Betaferon cross-reacts with natural interferon beta.
Maltese: Minn provi li saru in vitro intwera li Betaferon jirreaġixxi ma' interferon beta naturali.
English: From day 19 you are injecting the full dose 1.0 ml.
Maltese: Minn ġurnata 19 inti tkun qed tinjetta d-doża sħiħa ta' 1.0 ml.
English: 41% versus delayed Betaferon
Maltese: 41% kontra Betaferon ittardjat
English: In the placebo-controlled phase, Betaferon delayed the progression from the first clinical event to CDMS in a statistically significant and clinically meaningful manner.
Maltese: Fil-fażi kkontrollata bil-plaċebo, Betaferon ittardja l-progressjoni mill-ewwel avveniment kliniku sa CDMS b'mod statistikament sinifikattiv u ta' tifsira klinika.
English: The syringes in this titration pack are marked accordingly with the appropriate doses (0.25; 0.5; 0.75 or 1.0 ml).
Maltese: Is-siringi f'dan il-pakkett ta' titrazzjoni huma mmarkati skont id-dożi xierqa (0.25; 0.5; 0.75 jew 1.0 ml).
English: − Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
Maltese: − Pazjenti b'mard tal-fwied dekompensat (ara sezzjonijiet 4.4, 4.5 u 4.8)
English: Redness, swelling, discolouration, inflammation, pain, hypersensitivity, necrosis and non-specific reactions were significantly associated with 250 microgram (8.0 million IU) Betaferon treatment.
Maltese: Ħmura, nefħa, bidla fil-kulur, infjammazzjoni, uġigħ, sensittività eċċessiva, nekrosi u reazzjonijiet mhux speċifiċi kienu assoċjati b'mod sinifikattiv ma' kura b'250 mikrogramm (8.0 miljun IU)
English: In-use stability demonstrated for 3 hours at 2-8 °C.
Maltese: Stabbiltà waqt l-użu kienet dimostrata għal 3 sigħat f'temperatura ta' 2-8°C.
English: Two controlled clinical trials with Betaferon involving a total of 1,657 patients with secondary progressive multiple sclerosis (baseline EDSS 3 to 6.5, i.e. patients were able to walk) were performed.
Maltese: Saru żewġ studji kliniċi kkontrollati b'Betaferon li fihom kien hemm total ta' 1,657 pazjent bi sklerożi multipla progressiva sekondarja (linja bażi ta' EDSS 3 sa 6.5, i.e. il-pazjenti setgħu jimxu).
English: Multipack comprising 15 single packs, each containing: Multipack comprising 5 single packs, each containing: Multipack comprising 14 single packs, each containing: Multipack comprising 12 single packs, each containing:
Maltese: Multipakk li jikkonsisti minn 15-il pakkett singolu, li kull wieħed fih: Multipakk li jikkonsisti minn 5 pakketti singoli, li kull wieħed fih: Multipakk li jikkonsisti minn 14-il pakkett singolu, li kull wieħed fih: Multipakk li jikkonsisti minn 12-il pakkett singolu, li kull wieħed fih:
English: 3 Vials with powder: 300 microgram (9.6 m IU) per vial.
Maltese: 3 Kunjetti bi trab: 300 mikrogramma (9.6 m IU) kull kunjett.
English: Year 5 results Open-label follow-up
Maltese: Analiżi open-label ta'
English: Use green triple pack No. 3 for treatment days 13, 15 and 17 Use blue triple pack No. 4 for treatment days 19, 21 and 23
Maltese: Uża l-pakkett triplu No. 3 ta' lewn aħdar għall-ġranet ta' kura 13, 15 u 17 Uża l-pakkett triplu No. 4 ta' lewn blu għall-ġranet ta' kura 19, 21 u 23
English: ‘How to use Betaferon').
Maltese: Betaferon').
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
Maltese: 3 Siringi mimlija għal-lest b'1.2 ml ta' solvent: soluzzjoni ta' sodium chloride, 5.4 mg/ml, 3 Adattaturi tal-kunjett b'labar + 6 imsielaħ ta' l-alkoħol
English: − Betaferon contains human albumin and therefore carries a potential risk for transmission of viral diseases.
Maltese: - Betaferon fih albumina umana u għalhekk għandu riskju potenzjali għal trasmissjoni ta' mard virali.
English: Use the blue triple pack 4 containing 3 syringes with a 0.25; 0.5; 0.75 and 1.0-ml marking, for treatment days 19, 21 and 23.
Maltese: Uża l-pakkett triplu numru 4 ta' lewn blu li fih 3 siringi b'marka f'0.25; 0.5; 0.75 u 1.0-ml, għall ġranet ta' kura 19, 21 u 23.
English: ► Common (may affect up to 1 in 10 users):
Maltese: ► Komuni (jistgħu jaffettwaw sa utent wieħed minn kull 10):
English: AREA 6
Maltese: ŻONA 6
English: Triple pack 3
Maltese: Pakkett triplu no.
English: RR-MS, SP-MS and single clinical event suggestive of MS Betaferon was effective in all multiple sclerosis studies to reduce disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
Maltese: Betaferon kien effettiv biex inaqqas l-attività tal-marda fl-istudji kollha dwar sklerożi multipla (infjammazzjoni akuta fis-sistema nervuża ċentrali u bidla permanenti fit-tessuti) kif imkejjel b'magnetic resonance imaging (MRI).
English: If reactions are severe, Betaferon should be discontinued and appropriate medical intervention instituted.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: • Periodic safety update reports(PSURs)
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs)
English: 40% versus delayed Betaferon
Maltese: 40% kontra Betaferon ittardjat
English: Then draw up solution as far as the 1.0 ml mark on the syringe: 1.0 ml for the injections at day 19, 21 and 23 of therapy.
Maltese: 1.0 ml għall-injezzjonijiet fi ġranet 19, 21 u 23 ta' terapija.
English: Solvent (with sodium chloride solution 5.4 mg/ml (0.54% w/v)): 2.25 ml pre-filled syringe (type I glass) with 1.2 ml solvent.
Maltese: Solvent (b'soluzzjoni ta' sodium chloride ta' 5.4mg/ml (0.54% w/v)): Siringa mimlija għal lest ta' 2.25 ml (ħġieġ tip I) b'1.2ml ta' solvent.
English: This product contains human albumin and hence carries a potential risk for transmission of viral diseases.
Maltese: Dan il-prodott fih albumina umana u għalhekk għandu riskju potenzjali għat-trasmissjoni ta' mard ikkawżat minn virusis.
English: If this occurs and a relationship to Betaferon is suspected, treatment should be discontinued.
Maltese: F'każ li jiġri dan u jkun hemm suspett ta' assoċjazzjoni ma' Betaferon, il-kura għandha titwaqqaf.
English: Gamma-glutamyltransferase increased, Hepatitis
Maltese: Żieda ta' gamma glutamyl transferase,
English: To increase tolerability of Betaferon, a dose titration was applied and non-steroidal anti-inflammatory drugs were administered at start of therapy.
Maltese: Biex tiżdied it-tollerabilità ta' Betaferon, kienet applikata titrazzjoni tad doża u fil-bidu tat-terapija ngħataw mediċini anti-infjammatorji mhux sterojdi.
English: The following side effects listing is based on reports from clinical trials with Betaferon (list 1) and from side effects reported on the marketed product (list 2).
Maltese: L-effetti sekondarji li ġejjin huma bbażati fuq rapporti minn provi kliniċi b'Betaferon (lista 1) u minn effetti sekondarji rrapportati wara t-tqegħid fis-suq (lista 2).
English: Use yellow triple pack No. 1 for treatment days 1, 3 and 5
Maltese: Uża l-pakkett triplu No. 1 ta' lewn isfar għall-ġranet ta' kura 1, 3 u 5
English: New adverse events have not been associated with the development of neutralising activity.
Maltese: Avvenimenti avversi ġodda ma kienux assoċjati mal-iżvilupp ta' attività li tinnewtralizza.
English: 4th dosage step (1.0 ml) for treatment days 19, 21, 23
Maltese: Ir-raba' pass tad-dożaġġ (1.0 ml) għall-ġranet ta' trattament 19, 21, 23
English: When reconstituted 250 microgram/ml (8.0 m IU/ml) interferon beta-1b.
Maltese: Meta rikostitwit fih 250 mikrogramma/ml (8.0 m IU/ml) interferon beta-1b.
English: The effect of alternate-day administration of 250 microgram (8.0 million IU) of Betaferon on drug metabolism in multiple sclerosis patients is unknown.
Maltese: L-effett ta' għoti ta' 250 mikrogramma (8.0 miljun IU) Betaferon ġurnata iva u oħra le fuq ilmetaboliżmu tal-mediċina f'pazjenti bi sklerożi multipla mhux magħruf.
English: After reconstitution, draw 1.0 ml from the vial into the syringe for the administration of 250 microgram Betaferon.
Maltese: Wara r-rikostituzzjoni, iġbed 1.0ml mill-kunjett għal ġos-siringa għall-għoti ta' 250 mikrogramma ta' Betaferon.
English: − During treatment with Betaferon, kidney problems that may reduce your kidney function, including scarring (glomerulosclerosis), may occur.
Maltese: − Waqt kura b'Betaferon, jistgħu jseħħu problemi fil-kliewi li jistgħu jnaqqsu l-funzjoni talkliewi tiegħek, inkluż ċikatriċi (glomerulosklerosi).
English: 3-month pack comprising 45 (3x15) single packs, each containing: 3-month pack comprising 42 (3x14) single packs, each containing: 2-month pack comprising 28 (2x14) single packs, each containing: I.
Maltese: U KONTENUT Pakkett għal 3 xhur li fih 45 (3x15) pakkett singolu, li kull wieħed fih: Pakkett għal 3 xhur li fih 42 (3x14) pakkett singolu, li kull wieħed fih: Pakkett għal xaharejn li fih 28 (2x14) pakkett singolu, li kull wieħed fih:
English: 3rd dosage step (0.75 ml) for treatment days 13, 15, 17
Maltese: It-tielet pass tad-dożaġġ (0.75 ml) għall-ġranet ta' trattament 13, 15, 17 Pakkett triplu no. 4
English: An example of a medication record is also included (see Annex Part III).
Maltese: Hemm inkluż ukoll eżempju ta' rekord tal-mediċina (ara Anness Parti III).
English: Chest pain °
Maltese: Popolazzjoni pedjatrika
English: The recommended dose of Betaferon is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Maltese: Id-doża rrakkomandata ta' Betaferon hija 250 mikrogrammi (8.0 miljun IU), li jinsabu f'1 ml tassoluzzjoni rikostitwita (ara sezzjoni 6.6), li trid tiġi injettata taħt il-ġilda ġurnata iva u oħra le.
English: It contains syringes with 0.25, 0.5, 0.75 and 1.0 ml markings.
Maltese: Huwa fih siringi mmarkati b'mod speċjali b'marki f'0.25, 0.5, 0.75 u 1.0 ml.
English: Dysmenorrhoea
Maltese: L-Awstrija
English: B) Getting ready to inject C) Reconstituting the solution, step by step D) Drawing up the injection E) Making the injection F) Quick review of the process
Maltese: B) Preparazzjoni biex tinjetta C) Rikostituzzjoni tas-soluzzjoni, pass wara pass D) Preparazzjoni tal-injezzjoni E) Kif tagħmel l-injezzjoni F) Reviżjoni malajr tal-proċess
English: Other medicines and Betaferon
Maltese: Mediċini oħra u Betaferon
English: Abscess
Maltese: Ansjetà
English: *Betaferon is formulated to contain a calculated overfill of 20 %.
Maltese: *Betaferon huwa magħmul biex ikun fih ammont ikkalkulat żejjed ta' 20%.
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.
Maltese: Bil-pakkett ta' titrazzjoni, iġbed soluzzjoni sal-marka fuq issiringa biss: 0.25 ml għall-ewwel tliet injezzjonijiet (fi ġranet 1, 3, 5 tatterapija), jew 0.5 ml għall-injezzjonijiet fi ġranet 7, 9, 11 tat-terapija, jew 0.75 ml għall-injezzjonijiet fi ġranet 13, 15, 17 tat-terapija.
English: However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Betaferon 8.0 million IU subcutaneously every other day is similar to that seen in adults.
Maltese: Madankollu, informazzjoni limitata li kienet ippubblikata tissuġġerixxi li l-profil tas-sigurtà f'adoloxxenti minn 12 sa 16-il sena li kienu qed jirċievu Betaferon 8.0 miljun IU minn taħt il-ġilda kull jumejn huwa simili għal dak li kien osservat fl-adulti.
English: Peripheral oedema
Maltese: Uġigħ fis-sider ° Edima periferali
English: 2nd dosage step (0.5 ml) for treatment days 7, 9, 11
Maltese: It-tieni pass tad-dożaġġ (0.5 ml) għall-ġranet ta' trattament 7, 9, 11 Pakkett triplu no. 3
English: The activities of interferon beta-1b are species-restricted and therefore, the most pertinent pharmacological information on interferon beta-1b is derived from studies of human cells in culture or in human in vivo studies.
Maltese: L-attivitajiet ta' interferon beta-1b huma limitati għal lispeċi, u għalhekk, l-aktar informazzjoni farmakoloġika rilevanti dwar interferon beta-1b ġej minn studji ta' ċelluli umani f'koltura jew minn studji in vivo fil-bniedem.
English: Pack comprising 15 single packs, part of a 3-month pack containing 45 (3 x 15) single packs.
Maltese: Pakkett li fih 15-il pakkett singolu, parti minn pakkett għal 3 xhur li fih 45 (3 x 15) pakkett singolu.
English: Thrombotic microangiopathy (TMA)
Maltese: Betaform mikrogramma (Plaċebo)
English: Secondary Progressive Multiple Sclerosis (European Study)
Maltese: Sklerożi multipla progressiva sekondarja:
English: If your depression and/or suicidal thoughts are severe, you will not be prescribed Betaferon (see also ‘Do not use Betaferon').
Maltese: Jekk id-depressjoni u/jew il-ħsibijiet ta' suwiċidju tiegħek huma severi, mhux se tingħata Betaferon (ara wkoll ‘Tużax Betaferon').
English: Fever Λ * °
Maltese: Deni Λ * ° Uġigħ
English: Year 3 results Open-label follow-up
Maltese: Riżultati ta' sena 3 Analiżi open-label ta'
English: 1 vial with powder: 300 microgram (9.6 m IU) per vial.
Maltese: Kunjett wieħed bi trab: 300 mikrogramma (9.6 m IU) f'kull kunjett.
English: Drug-induced lupus erythematosus
Maltese: Lupus erythematosus ikkawżat millmediċina
English: As rodents do not react to human interferon beta, repeated dose studies were carried out with rhesus monkeys.
Maltese: Peress li l-firien ma jkollhomx reazzjoni għal interferon beta uman, saru studji b'dozi ripetuti fuq xadini rhesus.
English: Delayed Betaferon 250 mcg n=176
Maltese: 250 mcg n=292 n=176
English: Do not shake the vial.
Maltese: Ċiklu ta' Rotazzjoni no.
English: Within this period, the development of neutralising activity was associated with a significant increase in newly active lesions and T2 lesion volume on magnetic resonance imaging.
Maltese: Matul dan il-perijodu, l-iżvilupp ta' attività newtralizzanti kien assoċjat ma' żieda sinifikanti ta' leżjonijiet attivi ġodda u ta' volum ta' leżjonijiet T2 fuq magnetic resonance imaging.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull ml, jiġifieri essenzjalment ‘ħieles mis-sodium'.
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).
Maltese: Saret prova klinika waħda kkontrollata b'Betaferon f'pazjenti b'avveniment kliniku wieħed u karatteristiċi tal-MRI li jissuġġerixxu sklerożi multipla (mill-inqas żewġ leżjonijiet mingħajr sintomi kliniċi fuq T2-weighted MRI).
English: The solvent for Betaferon is provided in a 2.25-millilitre pre-filled syringe and contains 1.2 ml sodium chloride solution 5.4 mg/ml (0.54% w/v).
Maltese: Is-solvent għal Betaferon huwa pprovdut f'siringa mimlija għal-lest ta' 1.2 ml u fih 1.2 ml ta' soluzzjoni ta' sodium chloride ta' 5.4 mg/ml (0.54% w/v).
English: What Betaferon is
Maltese: Betaferon jista'
English: 7- Discard the syringe in the disposal unit.
Maltese: - Ipprova ħu l-injezzjoni tiegħek fl-istess ħin kuljum.
English: 0.25 ml for first three injections (at day 1, 3 and 5 of therapy).
Maltese: 0.25 ml għall-ewwel tliet injezzjonijiet (fi ġranet 1, 3 u 5 ta' terapija).
English: Blood bilirubin increased
Maltese: Żieda tal bilirubina fiddemm
English: Year 2 results Placebo-controlled phase
Maltese: Riżultati ta' Sena 2 Fażi kkontrollata bilplaċebo
English: However, the in-use stability has been demonstrated for 3 hours at 2-8 °C.
Maltese: Stabbiltà waqt l-użu kienet dimostrata għal 3 sigħat f'temperatura ta' 2-8 °C.
English: Betaferon contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial.
Maltese: Betaferon fih 300 mikrogramma (9.6 miljun IU) interferon beta-1b rikombinanti f'kull kunjett.
English: Each cycle will be 8 injections (16 days), given in area 1 through to area 8 in turn.
Maltese: Kull ċiklu jinkludi 8 injezzjonijiet (16-il jum), mogħtija f'żona 1 sa żona 8 f'sekwenza.
English: Pack comprising 14 single packs, part of a 2-month pack containing 28 (2 x 14) single packs.
Maltese: Pakkett li fih 14-il pakkett singolu, parti minn pakkett għal xaharejn li fih 28 (2 x 14) pakkett singolu.
English: Maximum serum levels of about 40 IU/ml were found 1-8 hours after subcutaneous injection of 500 microgram (16.0 million IU) interferon beta-1b.
Maltese: IU/ml instabu 1 sa 8 sigħat wara injezzjoni minn taħt il-ġilda ta' 500 mikrogramma (16.0 miljun IU) interferon beta-1b.
English: Symptoms can be redness, swelling, discolouration, inflammation, pain, hypersensitivity, tissue damage (necrosis).
Maltese: Is-sintomi jistgħu jkunu ħmura, nefħa, bidla fil-kulur, infjammazzjoni, uġigħ, sensittività eċċessiva, ħsara fit-tessut (nekrosi).
English: Betaferon should be administered with caution to patients with a history of seizures and to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
Maltese: Betaferon għandu jingħata b'attenzjoni lil pazjenti b'passat ta' aċċessjonijiet u lil dawk li qed jirċievu kura b'anti-epilettiċi, speċjalment jekk l-epilessija tagħhom mhux ikkontrollata b'mod adegwat b'antiepilettiċi (ara sezzjonijiet 4.5 u 4.8).