FrancophonIA/ELRC3.0 huggingface dataset:
English: Xadago 100 mg are orange to copper, round, biconcave film-coated tablets 9 mm diameter with metallic gloss, embossed with “100” on one side of the tablet.
Maltese: Xadago 100 mg, huma pilloli miksijin b'rita, oranġjo għal kulur ir-ram, ġejjin għat-tond miż-żewġ naħat, b'dijametru ta' 9 mm, b'tleqqija metallika, imnaqqxin b'“100” fuq naħa waħda tal-pillola.
English: Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets safinamide
Maltese: Informazzjoni għall-pazjent Xadago 50 mg pilloli miksijin b'rita Xadago 100 mg pilloli miksijin b'rita safinamide
English: In general, safinamide may be used with selective serotonin re-uptake inhibitors (SSRIs) at the lowest effective dose, with caution for serotoninergic symptoms.
Maltese: B'mod ġenerali, safinamide jista' jintuża b'inibituri selettivi ta' teħid mill-ġdid ta' serotonin (selective serotonin re-uptake inhibitors, SSRIs) fid-doża l-inqas effikaċi, b'attenzjoni għal sintomi serotonerġiċi.
English: Safinamide exposure in patients with mild hepatic disease increased marginally (30% in AUC), while in patients with moderate hepatic impairment exposure increased by approximately 80% (see section
Maltese: L-esponiment għal Safinamide f'pazjenti b'mard tal-fwied ħafif żdied marġinalment (30% fl-AUC), filwaqt li f'pazjenti b'indeboliment tal-fwied moderat, l-esponiment żdied b'madwar 80% (ara sezzjoni 4.2).
English: Hyperbilirubinaemia
Maltese: Ċirkustanzi soċjali
English: This interaction has the potential to reduce the clearance of NW1153 and increase its exposure; however the systemic exposure of NW-1153 is low (1/10 of parent safinamide), and as it is metabolised to secondary and tertiary metabolites, it is unlikely to be of any clinical relevance.
Maltese: Din l-interazzjoni għandha l-potenzjal li tnaqqas it-tneħħija tal-NW-1153 u żżid l-espożizzjoni tagħha; madankollu, l-espożizzjoni sistemika tal-NW-1153 hija baxxa (1/10 ta' safinamide prinċipali), u peress li hija mmetabolizzata fil-metaboliti sekondarji u terzjarji, huwa improbabbli li jkollha xi relevanza klinika.
English: The following side effects have been reported in patients at a mid- to late-stage of Parkinson's disease (patients taking safinamide as add-on to levodopa alone or in combination with other medicines for Parkinson's disease):
Maltese: Ġew irrapportati l-effetti sekondarji li ġejjin f'pazjenti fi stadju medju sa tard tal-marda ta' Parkinson (pazjenti li jieħdu safinamide bħala żieda ma' levodopa biss jew flimkien ma' mediċini oħrajn għallmarda ta' Parkinson):
English: Male rat fertility is not affected (see section 5.3).
Maltese: Il-fertilità tal-firien irġiel mhijiex affettwata (ara sezzjoni 5.3).
English: Other medicines and Xadago
Maltese: Kif taħżen Xadago
English: Amblyopia, chromatopsia, diabetic retinopathy, erythropsia, eye haemorrhage, eye pain, eyelid oedema, hypermetropia, keratitis, lacrimation increased, night blindness, papilloedema, presbyopia, strabismus
Maltese: kromatopsja, retinopatija dijabetika, eritropsija, emorraġija tal-għajnejn, uġigħ fl-għajnejn, edema f'tebqet il-għajn, ipermetropja, keratite, żieda fid-dmugħ,
English: What Xadago looks like and contents of the pack Xadago 50 mg are orange to copper, round, biconcave film-coated tablets of 7 mm diameter with metallic gloss, embossed with “50” on one side of the tablet.
Maltese: Pillola miksija b'rita, oranġjo għal kulur ir-ram, ġejja għat-tond miż-żewġ naħat, b'dijametru ta' 7 mm bi tleqqija metallika, imnaqqxa bil-qawwa “50” fuq naħa waħda tal-pillola.
English: Safinamide transiently inhibits BCRP in the small intestine (see section 4.5).
Maltese: Safinamide jinibixxi l-BCRP għal ċertu żmien fl-intestin iż-żgħir (ara sezzjoni 4.5).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of safinamide in milk (for details see 5.3).
Maltese: safinamide/metaboliti fil-ħalib tas-sider (gћad-dettalji ara 5.3).
English: Safinamide is almost exclusively eliminated via metabolism, largely by high capacity amidases that have not yet been characterized.
Maltese: Safinamide jiġi eliminat kważi esklussivament permezz tal-metaboliżmu, l-iktar minn amidażi b'kapaċità għolja li għadhom ma ġewx ikkaratterizzati.
English: In vivo and in vitro pharmacokinetic drug interactions
Maltese: Tagħrif farmakokinetiku
English: The combination of safinamide with levodopa/carbidopa resulted in additive effects in the embryo-foetal development studies with a higher incidence of foetal skeletal abnormalities than seen with either treatment alone.
Maltese: Il-kombinazzjoni ta' safinamide ma' levodopa/carbidopa rriżultat f'effetti addittivi fl-istudji tal-iżvilupp embrijofetali b'inċidenza ogħla ta' anormalitajiet skeletrali milli evidenzjat b'waħda mill-kuri ewlenin.
English: You must wait at least 7 days after stopping Xadago treatment before starting treatment with MAO inhibitors or pethidine.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Internazzjonijiet farmakodinamiċi tal-mediċina in vivo u in vitro Inibituri MAO u pethidine
English: Orange to copper, round, biconcave, film-coated tablet of 9 mm diameter with metallic gloss, embossed with the strength “100” on one side of the tablet.
Maltese: Pillola miksija b'rita, oranġjo għal kulur ir-ram, ġejja għat-tond miż-żewġ naħat, b'dijametru ta' 9 mm bi tleqqija metallika, imnaqqxa bil-qawwa “100” fuq naħa waħda tal-pillola.
English: Rare salivary hypersecretion, gastrooesophageal reflux disease, aphthous stomatitis
Maltese: Rari għama billejl, papilloedema, presbjopija, strabiżmu
English: Retinal degeneration was observed in rodents after repeated safinamide dosing resulting in systemic exposure below the anticipated systemic exposure in patients given the maximal therapeutic dose.
Maltese: Kienet osservata deġenerazzjoni retinali fil-firien wara dożaġġ ripetut b'safinamide li rriżulta f'esponiment sistemiku taħt l-esponiment sistemiku antiċipat fil-pazjenti fid-dawl tad-doża terapewtika massima.
English: - If you have been told that you have severe liver problems - If you have an eye condition which might put you at risk of potential damage to your retina (the light sensitive layers at the back of your eyes), e.g. albinism (lack of pigment in your skin and eyes), retinal degeneration (loss of cells from light sensitive layer at the back of the eye), or uveitis (inflammation inside of the eye), inherited retinopathy (inherited disorders of the vision), or severe progressive diabetic retinopathy (a progressive decrease of the vision due to diabetes).
Maltese: - Jekk qalulek li għandek problemi serji fil-fwied - Jekk għandek kundizzjoni tal-għajnejn li tista' tpoġġik f'riskju ta' ħsara potenzjali fir-retina tiegħek (is-saffi sensittivi għad-dawl fuq wara ta' għajnejk), eż. albiniżmu (nuqqas ta' pigment fil-ġilda tiegħek u f'għajnejk), deġenerazzjoni tar-retina (telf ta' ċelloli mis-saff sensittiv għaddawl fuq wara tal-għajn), jew uveite (infjammazzjoni fuq ġewwa tal-għajn), retinopatija ereditata (disturbi fil-vista li jintirtu), jew retinopatija dijabetika progressiva severa (tnaqqis progressiv tal-vista minħabba d-dijabete).
English: In vitro experiments indicated that inhibition of amidases in human hepatocytes led to complete suppression of the NW-1153 formation.
Maltese: Esperimenti in vitro indikaw li inibizzjoni talamidażi f'epatoċiti tal-bniedem wasslet għal suppressjoni sħiħa tal-formazzjoni tal-NW-1153.
English: 95% CI p-value UPDRS II (c) Baseline (b)
Maltese: UPDRS II (c) Linja Bażi (b) Bidla LSM
English: Impulse control disorders can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Maltese: Disturbi fil-kontroll tal-impulsi jistgħu jseħħu f'pazjenti kkurati b'agonisti tad-dopamina u/jew kuri dopaminerġiċi.
English: Impulse control disorders; pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Maltese: Disturbi fil-kontroll tal-impulsi; logħob tal-azzard patoloġiku, żieda fil-libido, ipersesswalità, infiq jew xiri kompulsiv, iffangar u ikliet kompulsivi jistgħu jseħħu f'pazjenti kkurati b'agonisti tad-dopamine u/jew kuri dopaminerġiċi oħrajn.
English: Back pain, arthralgia, muscle spasms, muscle rigidity, pain in extremity, muscular weakness, sensation of heaviness
Maltese: Uġigħ fid-dahar, artralġija, spażmi tal-muskoli, riġidità tal-muskoli, uġigħ fl-estremitajiet, dgħjufija muskolari, sensazzjoni ta' toqol
English: Hepatobiliary disorders
Maltese: Il-metabolita
English: The symptoms of an excessive MAO-B inhibition (increase in dopamine level) could include hypertension, postural hypotension, hallucinations, agitation, nausea, vomiting, and dyskinesia.
Maltese: Is-sintomi ta' inibizzjoni eċċessiva ta' MAO-B (żieda fil-livell ta' dopamina) jistgħu jinkludu pressjoni għolja, pressjoni baxxa posturali, alluċinazzjonijiet, aġitazzjoni, dardir, rimettar, u diskinesija.
English: Common (may affect up to 1 in 10 people): insomnia, difficulty in performing voluntary movements, feeling sleepy, dizziness, headache, worsening of Parkinson's disease, clouding of the lens of the eye, fall in blood pressure when rising to a standing position, nausea, falling.
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): insomnja, diffikultà fil-movimenti volontarji tal-prestazzjoni (diskinesija, tħossok bi ngħas (sonnolenza), sturdament, uġigħ ta' ras, deterjorament tal-marda ta' Parkinson, tiċpir tal-lenti tal-għajn (katarretti), tnaqqis fil-pressjoni tad-demm meta wieħed iqum bil-wieqfa (ipotensjoni ortostatika), dardir, waqgħat.
English: Safinamide is a highly selective and reversible MAO-B inhibitor causing an increase in extracellular levels of dopamine in the striatum.
Maltese: Safinamide huwa inibitur MAO-B selettiv u riverżibbli ħafna li jikkawża żieda fillivelli extraċellulari ta' dopamina fl-istrajatum.
English: Studies in mid- to late-stage PD patients
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Bronchospasm, dysphonia, oropharyngeal pain, oropharyngeal spasm
Maltese: Urġenza ta' mitturizzjoni, poliurja, materja fl-awrina, eżitazzjoni urinarja
English: If you suffer from moderately reduced liver function, you should not take more than 50 mg a day; your doctor will advise if this applies to you.
Maltese: Jekk issofri minn funzjoni tal-fwied moderatament indebolita, ma għandekx tieħu aktar minn 50 mg kuljum; it-tabib tiegħek sejjer javżak jekk dan japplika għalik.
English: In humans, safinamide is almost exclusively eliminated via metabolism (urinary excretion of unchanged safinamide was <10%) mediated principally through high capacity amidases, that have not yet been characterized.
Maltese: Fil-bnedmin, safinamide jiġi eliminat b'mod kważi esklussiv mill-metaboliżmu (l-eliminazzjoni mal-awrina ta' safinamide mhux mibdul kienet <10%) medjat prinċipalment permezz ta' amidases ta' kapaċità għolja, li għadhom ma ġewx ikkaratterizzati.
English: Safinamide is eliminated mainly in the urine.
Maltese: Safinamide huwa eliminat, prinċipalment flawrina.
English: Weight decreased, weight increased, blood creatine phosphokinase increased, blood triglycerides increased, blood glucose increased, blood urea increased, blood alkaline phosphatase increased, blood bicarbonate increased, blood creatinine increased, electrocardiogram QT prolonged, liver function test
Maltese: Tnaqqis fil-piż, żieda fil-piż, żieda fil-fosfokinażi talkreatinina tad-demm, żieda fit-trigliċeridi taddemm, żieda fil-glukożju fiddemm, żieda fl-urea tad-demm, żieda fil-fosfatażi alkalina tad-demm, żieda fil-bikarbonat taddemm, żieda fil-kreatinina taddemm,
English: D)
Maltese: E)
English: http://www.ema.europa.eu.
Maltese: Mediċini: http://www.ema.europa.eu.
English: Vomiting Λ
Maltese: Rimettar Λ
English: Bayer Portugal, Lda.
Maltese: Portugal Bayer Portugal, Lda.
English: 47% versus placebo
Maltese: 47% kontra plaċebo
English: Müllerstraße 178 13353 Berlin Germany
Maltese: Müllerstraße 178 13353 Berlin
English: Time to McDonald MS Kaplan-Meier
Maltese: Żmien sa McDonald MS Stimi Kaplan-Meier
English: Rash Λ °
Maltese: Raxx Λ °
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 November 1995
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 30 ta' Novembru, 1995
English: Nephrotic syndrome, glomerulosclerosis (see section 4.4)2, 3
Maltese: glomerulosklerosi (ara sezzjoni 4.4)2, 3
English: Laboratory test
Maltese: Test tal-laboratorju
English: Keep the syringe horizontal.
Maltese: Żomm is-siringa f'pożizzjoni orizzontali.
English: Anorexia2
Maltese: Anoressija2
English: Bayer B.V.
Maltese: Nederland Bayer B.V.
English: 62.5 microgram
Maltese: 62.5 mikrogrammi
English: This is called demyelination.
Maltese: Dan huwa msejjaħ demyelination.
English: Interferon alpha, interferon beta, and interferon gamma have overlapping yet distinct biologic activities.
Maltese: Interferon alfa, interferon beta u interferon gamma għandhom karatteristiċi bijoloġiċi komuni iżda distinti.
English: 125 microgram
Maltese: 125 mikrogramma
English: Betaferon may cause side effects in the central nervous system (see section 4.
Maltese: Betaferon jista' jikkawża effetti sekondarji fis-sistema nervuża ċentrali (ara sezzjoni 4.
English: Urticaria, Pruritus, Alopecia
Maltese: Ħakk, Alopeċja
English: Bayer S.p.A.
Maltese: Italia Bayer S.p.A.
English: Common ( ≥ 1/100 to
Maltese: ( ≥ 1/100 sa
English: Nephrotic Syndrome
Maltese: Sindrome nefrotiku
English: A-1121 Vienna
Maltese: Dr.-Boehringer-Gasse 5-11 A-1121 Vienna
English: Boehringer Ingelheim RCV GmbH & Co KG Dr.-Boehringer-Gasse 5-11
Maltese: Boehringer Ingelheim RCV GmbH & Co
English: Please note:
Maltese: NOTA:
English: A) General advice
Maltese: A) Pariri ġenerali
English: Nervous system disorders Headache Λ
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras Λ
English: Bayer Sp. z o.o.
Maltese: Polska Bayer Sp. z o.o.
English: AREA 8
Maltese: ŻONA 8
English: Betaferon 250 microgram (Placebo) n=317 (n=308)
Maltese: Betaferon 250 mikrogramma (Plaċebo) n=317 (n=308)
English: AREA 1
Maltese: ŻONA 1
English: Betaferon microgram (Placebo) n=124 (n=123)
Maltese: Betaferon mikrogramma (Plaċebo) n=124 (n=123)
English: 250 microgram
Maltese: 250 mikrogramma
English: 3 Class label for interferon beta products (see section 4.4).
Maltese: 3 Tikketta tal-klassi għal prodotti li fihom interferon beta (ara sezzjoni 4.4).
English: Betaferon microgram (Placebo) n=360 (n=358)
Maltese: Betaferon mikrogramma (Plaċebo) n=360 (n=358)
English: Three major classes of interferons have been identified: alpha, beta, and gamma.
Maltese: Kienu identifikati tliet klassijiet prinċipali ta' interferoni: alfa, beta, u gamma.
English: 1 frequencies based on pooled clinical trials (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000).
Maltese: 1 frekwenzi ibbażati fuq provi kliniċi miġbura (komuni ħafna ≥1/10, komuni ≥1/100 sa <1/10, mhux komuni ≥ 1/1,000 sa < 1/100, rari ≥1/10,000 sa <1/1,000, rari ħafna < 1/10,000).
English: 10 - 15 cm from groin
Maltese: 10-15 ċm mill-groin
English: LIST OF EXCIPIENTS Excipients: Human albumin, mannitol
Maltese: Albumina umana, mannitol
English: ‘Possible side effects').
Maltese: Effetti sekondarji possibbli).
English: Aspartate aminotransferase increased (SGOT > 5 times baseline) × Λ * °
Maltese: Aspartate aminotransferase miżjud (SGOT > 5 darbiet il-linja bażi) × Λ * °
English: • small amounts of mannitol, a naturally occurring sugar and human albumin, a protein.
Maltese: • ammonti żgħar ta' mannitol, zokkor naturali, u albumina umana, proteina.
English: Bayer d. o. o.
Maltese: Slovenija Bayer d. o. o.
English: Betaferon contains mannitol, human albumin and sodium
Maltese: Betaferon fih mannitol, albumina umana u sodium
English: INFORMATION IN BRAILLE Betaferon
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Abnormal vision Λ
Maltese: Vista mhux normali Λ
English: Very common
Maltese: Awrina frekwenti
English: Interferon beta-1b has been given without serious adverse events compromising vital functions to adult cancer patients at individual doses as high as 5,500 microgram (176 million IU) intravenously three times a week.
Maltese: Interferon beta-1b ingħata mingħajr avvenimenti avversi serji li jikkompromettu funzjonijiet vitali, lillpazjenti adulti bil-kanċer f'dożi individwali għolja sa 5,500 mikrogramma (176 miljun IU) mogħtija fil-vina, tliet darbiet fil-ġimgħa.
English: An in vitro cell transformation test gave no indication of tumorigenic potential.
Maltese: Test in vitro dwar it-trasformazzjoni taċ-ċelluli ma ndikax potenzjal tumoriġeniku.
English: Table 1: Adverse events and laboratory abnormalities with incidence rates ≥ 10% and the respective percentages under placebo; significantly associated side effects < 10% based on reports from clinical trials
Maltese: Tabella 1: Avvenimenti avversi u anormalitajiet tal-laboratorju li seħħew b'rata ta' ≥ 10% u l perċentwali rispettivi għall-plaċebo; effetti sekondarji assoċjati b'mod sinnifikattiv < 10% ibbażat fuq rapporti minn provi kliniċi
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Maltese: Bħal proteini terapewtiċi kollha, hemm potenzjal għal immunoġeniċità.
English: A risk of transmission of Creutzfeld-Jacob disease (CJD) cannot be ruled out.
Maltese: Ir-riskju ta' trasmissjoni tal-marda Creutzfeld-Jacob (CJD) ma jistax jiġi eliminat.
English: AREA 5
Maltese: ŻONA 5
English: − in the powder: mannitol and human albumin,
Maltese: - fit-trab: mannitol u albumina umana,
English: One of the two studies demonstrated a statistically significant delay in the time to disability progression (Hazard Ratio = 0.69, 95% confidence interval (0.55, 0.86), p=0.0010, corresponding to a 31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (Hazard Ratio = 0.61, 95% confidence interval (0.44, 0.85), p=0.0036, corresponding to a 39% risk reduction due to Betaferon) in patients who received Betaferon.
Maltese: Wieħed minn dawn iż-żewġ studji wera ittardjar statistikament sinifikanti fiż-żmien sal-progressjoni tad-diżabilità (Proporzjon ta' Periklu = 0.69, 95% intervall ta' kunfidenza (0.55, 0.86), p=0.0010, ekwivalenti għal tnaqqis ta' 31% fir-riskju minħabba Betaferon) u fiż-żmien li wieħed jieħu biex ikollu bżonn siġġu tar-roti (Proporzjon ta' Periklu = 0.61, 95% intervall ta' kunfidenza (0.44, 0.85), p=0.0036, ekwivalenti għal tnaqqis ta' 39% fir-riskju minħabba Betaferon) f'pazjenti li rċevew Betaferon.
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Maltese: Abbażi ta' data dwar l-annimali (ara sezzjoni 5.3), hemm il-possibbiltà ta' riskju akbar ta' abort spontanju.
English: Betaferon 250 mcg n=292
Maltese: 250 mcg Immedjat n=292
English: Bayer AS
Maltese: Norge Bayer AS
English: Date of last renewal: 31 January 2006
Maltese: Data tal-aħħar tiġdid: 31 ta' Jannar, 2006
English: Thrombocytopenia Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/ haemolytic uraemic syndrome3
Maltese: Tromboċitopenija Mikroanġjopatija trombotika li tinkludi purpura tromboċitopenika trombotika/sindrome uremiku emolitiku3
English: Manufacturer Bayer AG
Maltese: Bayer AG
English: 0.75 ml for the injections at day 13, 15 and 17 of therapy.
Maltese: 0.75 ml għall-injezzjonijiet fi ġranet 13, 15 u 17 ta' terapija.
English: Psychiatric disorders Depression
Maltese: Disturbi psikjatriċi Depressjoni
English: Palpitation *
Maltese: Palpitazzjoni *
English: The active substance is interferon beta-1b, 250 microgram per millilitre when reconstituted.
Maltese: Is-sustanza attiva hi interferon beta-1b, 250 mikrogramma kull millilitru meta rikostitwit.
English: 0.5 ml for the injections at day 7, 9 and 11 of therapy.
Maltese: 0.5 ml għall-injezzjonijiet fi ġranet 7, 9 u 11 ta' terapija.
English: Solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): Sodium chloride
Maltese: Solvent (soluzzjoni ta' sodium chloride 5.4mg/ml (0.54 % w/v)) Sodium chloride
English: Menstrual disorder *
Maltese: - disturbi menstrwali (menoraġja)
English: Cardiomyopathy2
Maltese: Kardjomijopatija2
English: With triple pack “4” you can inject the full dose 1.0 ml.
Maltese: Bil-pakkett triplu “4” tista' tinjetta d-doża kollha ta' 1.0 ml.
English: Fertility No investigations on fertility have been conducted (see section 5.3).
Maltese: Fertilità Ma sarux investigazzjonijiet dwar il-fertilità (ara sezzjoni 5.3).
English: Flu-like symptoms & Λ *°
Maltese: Sintomi jixbħu lill influwenza & Λ *°
English: Absolute neutrophil count decreased (<1,500/mm³) × Λ * °
Maltese: Għadd assolut ta' newtrofili mnaqqas (<1,500/mm³) × Λ * °
English: Betaferon serum levels were followed in patients and volunteers by means of a not completely specific bioassay.
Maltese: Il-livelli ta' Betaferon fis-serum kienu studjati f'pazjenti u voluntiera permezz ta' bioassay li mhux speċifiku kompletament.
English: The triple packs are highlighted in different colours (see section 6.5).
Maltese: Il-pakketti tripli huma mmarkati b'kuluri differenti (ara sezzjoni 6.5).
English: Chills Λ * °
Maltese: Astenja * Kesħa Λ * °
English: Placebo n=176
Maltese: Ittardjat n=176
English: 69% 85% No primary endpoint
Maltese: 69% 85% L-ebda mira primarja L-ebda mira primarja
English: Table 2: Adverse drug reactions (ADRs) identified during post-marketing surveillance (frequencies where known - calculated based on pooled clinical trial data N= 1093)
Maltese: Tabella 2: Reazzjonijiet avversi tal-mediċina (ADRs) identifikati waqt sorveljanza ta' wara t-tqegħid fis-suq (frekwenzi - fejn magħrufa - ikkalkulati abbażi ta' dejta miġbura minn provi kliniċi N= 1093)
English: PHARMACEUTICAL FORM AND CONTENTS Triple pack 1
Maltese: U KONTENUT Pakkett triplu no. 1
English: Interferons have molecular weights ranging from 15,000 to 21,000 Daltons.
Maltese: L-interferoni għandhom piż molekulari li jvarja minn 15,000 sa 21,000
English: AREA 7
Maltese: ŻONA 7
English: AREA 2
Maltese: ŻONA 2
English: Suicide attempt (see also section 4.4), Emotional lability
Maltese: Attentat ta' suwiċidju (ara wkoll sezzjoni 4.4), Instabilità emozjonali
English: 2 ADRs derived only during post-marketing
Maltese: 2 ADRs derivati biss wara t-tqegħid fis-suq
English: Hepatobiliary disorders Alanine aminotransferase increased (SGPT> 5 times baseline) × Λ * °
Maltese: Alanine aminotransferase miżjud (SGPT> 5 darbiet il-linja bażi) × Λ * °
English: RelapsingRemitting Multiple Sclerosis
Maltese: Sklerożi Multipla Progressiva
English: Malaise * × Laboratory abnormality
Maltese: × Anormalità tal-laboratorju
English: In retrospective meta-analyses including the data of both studies, an overall treatment effect was found which was statistically significant (p=0.0076; 8.0 million IU Betaferon versus all placebo patients).
Maltese: F'meta-analiżi retrospettiva li tinkludi tagħrif miż-żewġ studji, instab effett globali tal-kura li kien statistikament sinifikanti (p=0.0076; 8.0 miljun IU Betaferon kontra l-pazjenti kollha tal-plaċebo).
English: A risk for transmission of Creutzfeld-Jacob disease (CJD) cannot be excluded.
Maltese: Ma jistax jiġi eskluż ir-riskju ta' trasmissjoni tal-marda ta' Creutzfeld-Jacob (CJD).
English: Interferon beta-1b also enhances the suppressor activity of peripheral blood mononuclear cells.
Maltese: Interferon beta-1b iżid ukoll l-attività li trażżan iċ-ċelluli mononuklejari periferali tad-demm.
English: Part of a multipack containing 5 single packs.
Maltese: Parti minn multipakk li fih 5 pakketti singoli.