FrancophonIA/ELRC3.0 huggingface dataset:
English: Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b
Maltese: Betaferon 250 mikrogramma/ml, trab u solvent għal soluzzjoni għall-injezzjoni interferon beta-1b
English: - kidney problems including scarring (glomerulosclerosis) that may reduce your kidney function, uncommon severe loss of appetite leading to weight loss (anorexia), rare disease of the heart muscle (cardiomyopathy), rare sudden shortness of breath (bronchospasm), rare the liver does not work properly (hepatic injury (including hepatitis), hepatic failure), rare problems with your small blood vessels may develop when using medicines like Betaferon (systemic capillary leak syndrome), frequency unknown rash, redness of the skin in the face, joint pain, fever, weakness and others caused by the medicine (drug-induced lupus erythematosus), frequency unknown severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs (pulmonary arterial hypertension), frequency unknown.
Maltese: Effetti sekondarji derivati biss wara t-tqegħid fis-suq: - problemi fil-kliewi inkluż ċikatriċi (glomerulosklerosi) li jistgħu jnaqqsu l-funzjoni tal-kliewi tiegħek, mhux komuni telf t'aptit sever li jwassal għal telf ta' piz (anoressija), rari marda tal-muskolu tal-qalb (kardjomijopatija), rari qtugħ ta' nifs f'daqqa waħda (bronkospażmu), rari il-fwied ma jaħdimx sew (ħsara fil-fwied (inkluż epatite), insuffiċjenza tal-fwied), rari problemi bil-kanali ż-żgħar tad-demm tiegħek jistgħu jiżviluppaw meta jintużaw mediċini bħal Betaferon (sindrome sistemika ta' tnixxija mill-kapillari), frekwenza mhux magħrufa raxx, ħmura tal-ġilda fil-wiċċ, uġigħ fil-ġogi, deni, dgħjufija u oħrajn ikkawżati millmediċina (lupus erythematosus ikkawżat mill-mediċina), frekwenza mhux magħrufa tidjiq sever tal-kanali tad-demm fil-pulmun li jwassal għal pressjoni għolja fil-kanali taddemm li jġorru d-demm mill-qalb għall-pulmuni (pressjoni għolja fl-arterja tal-pulmun), frekwenza mhux magħrufa.
English: Interferons have been reported to reduce the activity of hepatic cytochrome P450-dependent enzymes in humans and animals.
Maltese: L-interferoni kienu rrapportati li jnaqqsu l-attività ta' enżimi tal-fwied li jiddependu fuq ic-ċitokromju P-450 fil-bnedmin u l-annimali.
English: Vial (with powder for solution for injection): 3 ml clear vial (type I glass) with a butyl rubber stopper (type I) and aluminium overseal and
Maltese: Kunjett ċar ta' 3 ml (ħġieġ tip I) b'tapp tal-lasktu butyl (tip I) u b'siġill fuq kollox ta' l-aluminiju.
English: - the number of platelets (which help the blood to clot) may fall (thrombocytopenia) - a certain type of blood fats (triglycerides) may increase (will show up in blood tests), see section 2 ‘Warnings and precautions' - suicide attempt - mood swings - convulsion
Maltese: - ċertu tip ta' xaħmijiet fid-demm (trigliċeridi) jista' jiżdied, (osservat fit-testijiet tad-demm), ara sezzjoni 2 ‘Twissijiet u prekawzjonijiet' - attentat ta' suwiċidju
English: List 1: Very common side effects which have occurred in clinical trials with Betaferon(at least 10% of the cases) and at a higher percentage than those observed with placebo.
Maltese: Lista 1: Effetti sekondarji komuni ħafna li seħħew fi provi kliniċi b'Betaferon (f'mill-inqas 10% talkażijiet) u f'persentaġġ ogħla minn dawk osservati bil-plaċebo.
English: Metabolism and nutrition disorders Blood glucose decreased (<55 mg/dl) ×
Maltese: Glukosju fid-demm imnaqqas (< 55 mg/dl) ×
English: Myalgia * °
Maltese: Telqa *
English: Hazard ratio with 95% confidence interval log-rank test
Maltese: Proporzjon ta' periklu b'intervall ta' kunfidenza ta' 95%
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF THE TRIPLE PACK (3 VIALS/3 PFS) AS AN INTERMEDIATE PACK OF THE TITRATION PACK (WITHOUT BLUE BOX)
Maltese: KARTUNA TAL-PAKKETT TRIPLU (3 KUNJETTI/3 SIRINGI MIMLIJA GĦAL-LEST)
English: A large amount of data (more than 1000 pregnancy outcomes) from interferon beta registries, national registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure or exposure during the first trimester of pregnancy.
Maltese: Ammont kbir ta' data (aktar minn 1,000 riżultat ta' tqala) minn reġistri ta' interferon beta, reġistri nazzjonali u esperjenza ta' wara t-tqegħid fis-suq jindika li m'hemm l-ebda riskju miżjud ta' anomaliji konġenitali maġġuri wara esponiment qabel il-konċepiment jew esponiment waqt l-ewwel trimestru tattqala.
English: This is called a Rotation Cycle.
Maltese: Dan jissejjaħ Ċiklu ta' Rotazzjoni.
English: EU/1/95/003/005 EU/1/95/003/006 EU/1/95/003/007 EU/1/95/003/009 EU/1/95/003/010 EU/1/95/003/011 EU/1/95/003/012
Maltese: EU/1/95/003/005 EU/1/95/003/006 EU/1/95/003/007 EU/1/95/003/009 EU/1/95/003/010
English: 1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ml, 1 vial adapter with needle + 2 alcohol wipes
Maltese: Siringa waħda mimlija għal-lest b'1.2 ml ta' solvent: soluzzjoni ta' sodium chloride ta' 5.4 mg/ml, adattatur tal-kunjett wieħed b'labra + 2 imsielaħ ta' l-alkoħol
English: Betaferon is available in pack sizes of:
Maltese: Betaferon hu disponibbli f'daqsijiet tal-pakkett ta':
English: − in the solvent (sodium chloride solution 5.4 mg/ml (0.54% w/v)): sodium chloride, water for injection.
Maltese: (soluzzjoni ta' sodium chloride ta' 5.4mg/ml (0.54% w/v)): sodium chloride, ilma għall-injezzjoni.
English: There have been no formal clinical trials undertaken in children or adolescents.
Maltese: Ma sarux provi kliniċi formali fit-tfal jew fl-adolexxenti.
English: • patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
Maltese: • pazjenti bi sklerożi multipla progressiva sekondarja bil-marda attiva, kif muri mill-irkadar.
English: 1 vial with powder for solution for injection contains 300 microgram (9.6 million IU).
Maltese: Kunjett wieħed bi trab għal soluzzjoni għall-injezzjoni fih 300 mikrogramma (9.6 miljun IU).
English: Part of a multipack containing 12 single packs.
Maltese: Parti minn multipakk li fih 12-il pakkett singolu.
English: In both trials secondary progressive multiple sclerosis patients receiving Betaferon showed a reduction in frequency (30%) of clinical relapses.
Maltese: Fiż-żewġ provi l-pazjenti bi sklerożi multipla progressiva sekondarja li ħadu Betaferon, kellhom tnaqqis fil-frekwenza (30%) ta' episodji ta' rkadar kliniku.
English: • 3 pre-filled syringes with solvent for the Betaferon powder (sodium chloride solution 5.4 mg/ml (0.54% w/v))
Maltese: • 3 siringi mimlija għall-lest b'solvent għat-trad ta' Betaferon (soluzzjoni ta' sodium chloride ta' 5.4 mg/ml (0.54% w/v))
English: Pack comprising 14 single packs, part of a 3-month pack containing 42 (3 x 14) single packs.
Maltese: Pakkett li fih 14-il pakkett singolu, parti minn pakkett għal 3 xhur li fih 42 (3 x 14) pakkett singolu.
English: In MS, inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
Maltese: F'MS, l-infjammazzjoni teqred il-kisja protettiva (imsejħa myelin) madwar in-nervituri tas-CNS u twaqqaf lin-nervaturi milli jibqgħu jaħdmu tajjeb.
English: - if you currently suffer from severe depression and/or suicidal thoughts (see ‘Warnings and precautions' and section 4 ‘Possible side effects').
Maltese: - jekk attwalment tbati minn depressjoni severa u/jew ħsibijiet ta' suwiċidju (ara ‘Twissijiet u prekawzjonijiet' u sezzjoni 4. ‘Effetti sekondarji possibbli').
English: EU/1/95/003/005 EU/1/95/003/006 EU/1/95/003/007 EU/1/95/003/008 EU/1/95/003/009 EU/1/95/003/010 EU/1/95/003/011 EU/1/95/003/012
Maltese: EU/1/95/003/005 EU/1/95/003/006 EU/1/95/003/007 EU/1/95/003/008 EU/1/95/003/009
English: Betaferon is a type of medicine known as interferon used to treat multiple sclerosis.
Maltese: Betaferon huwa tip ta' mediċina magħrufa bħala interferon użata għal-kura ta' sklerożi multipla.
English: − titration pack for the first 12 injections comprising 4 triple packs, each containing 3 vials with powder, 3 pre-filled syringes with solvent, 3 vial adapters with needle, 6 alcohol wipes
Maltese: - pakkett ta' titrazzjoni għall-ewwel 12-il injezzjoni li fih 4 pakketti tripli li kull wieħed fih 3 kunjetti bit-trab, 3 siringi mimlija għall-lest bis-solvent, 3 adatturi għall-kunjett b'labra mwaħħla minn qabel, 6 imsielaħ tal-alkoħol.
English: • patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, 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'każ wieħed ta' demajlinazzjoni bi proċess ta' infjammazzjoni attiva, jekk ikun serju biżżejjed li jeħtieġ kura b'kortikosterojdi fil-vini, jekk dijanjosi alternattiva ġiet eskluża, u jekk jiġi stabbilit li jinsabu f'riskju għoli li jiżviluppaw sklerożi multipla klinikament definittiva (ara sezzjoni 5.1).
English: Use red triple pack No. 2 for treatment days 7, 9 and 11
Maltese: Dan it-tieni pakkett triplu għandu jintuża għal ġranet ta' kura 7, 9 u 11.
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 bikrija jinkludu tromboċitopenija, bidu ġdid ta' pressjoni għolja, deni, sintomi tas-sistema nervuża ċentrali (eż. konfużjoni u paresi) u indeboliment fil-funzjoni tal-kliewi.
English: • 3 Betaferon vials (with powder for solution for injection)
Maltese: • 3 kunjetti ta' Betaferon (bi trab għal soluzzjoni għall-injezzjoni)
English: Experience with other interferons suggests a potential for impairment of male and female fertility.
Maltese: Esperjenza b'interferoni oħrajn tissuġġerixxi potenzjal ta' indeboliment fil-fertilità maskili u femminili.
English: Bayer Vital GmbH Tel: +49-(0)214-30 513 48
Maltese: Tel: +49-(0)214-30 513 48
English: 1st dosage step (0.25 ml) for treatment days 1, 3, 5
Maltese: L-ewwel pass tad-dożaġġ (0.25 ml) għall-ġranet ta' kura 1, 3, 5
English: One controlled clinical trial with Betaferon in patients with relapsing-remitting multiple sclerosis and able to walk unaided (baseline EDSS 0 to 5.5) was performed.
Maltese: Sar studju kliniku ikkontrollat b'Betaferon f'pazjenti bi sklerożi multipla li tirkadi u tbatti, u li setgħu jimxu mingħajr għajnuna (linja bażi ta' EDSS 0 sa 5.5).
English: In multifocal patients, the risk for CDMS was independent from MRI findings at baseline, indicating a high risk for CDMS because of the dissemination of the disease based on clinical findings.
Maltese: F'pazjenti multifokali r-riskju għal CDMS kien indipendenti mir-riżultati tal-MRI fil-linja bażi, li jindika riskju għoli għal CDMS minħabba l-firxa tal-marda skont riżultati kliniċi.
English: PHARMACEUTICAL FORM AND CONTENTS Titration pack comprising 4 triple packs, each containing:
Maltese: U KONTENUT Pakkett ta' titrazzjoni fih 4 pakketti tripli, u kull wieħed fih:
English: − Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Maltese: Għandu jiġi kkunsidrat waqfien tat-terapija b'Betaferon (ara wkoll sezzjonijiet 4.3 u 4.8).
English: In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (89) of the patients treated immediately with Betaferon; of these, 60% (53) returned to negative status based on the last available assessment within the 5 year period.
Maltese: Fl-istudju ta' pazjenti b'avveniment kliniku wieħed li jissuġġerixxi sklerożi multipla, l-attività newtralizzanti li kienet imkejla kull 6 xhur kienet osservata tal-inqas darba f'32% (89) tal-pazjenti kkurati mmedjatament b'Betaferon; minn dawn, 60% (53) marru lura għal stat negattiv ibbażat fuq laħħar valutazzjoni disponibbli fi żmien il-perijodu ta' 5 snin.
English: Reconstitution:
Maltese: Importanti:
English: Events were reported at various time points including up to several years after starting treatment with interferon beta.
Maltese: Avvenimenti kienu rrappurtati f'diversi ħinijiet inkluż sa diversi snin wara l-bidu ta' trattament b'interferon beta.
English: Part of a multipack containing 14 single packs.
Maltese: Parti minn multipakk li fih 14-il pakkett singolu.
English: Menorrhagia
Maltese: Betaferon
English: The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia), which is mainly due to the pharmacological effects of the medicinal product, and injection site reactions.
Maltese: L-aktar reazzjonijiet avversi osservati b'mod komuni huma numru ta' sintomi jixbħu lill influwenza (deni, kesħa, artralġja, telqa ġenerali, għaraq, uġigħ ta' ras, jew uġigħ fil-muskoli), li huma dovuti prinċipalment għall-effetti farmakoloġiċi tal-prodott mediċinali u reazzjonijiet fil-lok talinjezzjoni.
English: Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activities.
Maltese: Interferon beta-1b intwera li għandu kemm azzjonijiet kontra il-virus kif ukoll azzjonijiet immuno regulatorji.
English: 1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ml.
Maltese: Solvent għar-rikostituzzjoni ta' Betaferon 1.2 ml ta' soluzzjoni ta' 5.4 mg/ml sodium chloride
English: Single clinical event indicating a high risk of developing multiple sclerosis: Betaferon has been shown to delay progression to definite multiple sclerosis.
Maltese: Intwera li Betaferon jittardja l-progressjoni għal sklerożi multipla definita.
English: If you have a Betaferon titration pack you will find 4 differently coloured and numbered triple packs, each containing:
Maltese: Fil-pakkett ta' titrazzjoni ta' Betaferon se ssib 4 pakketti tripli ta' kulur u b'numru differenti li kull wieħed fih:
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Maltese: Ir-riskju ta' aborti spontanji f'nisa tqal esposti għal interferon beta ma jistax jiġi evalwat b'mod adegwat abbażi tad-data disponibbli bħalissa, iżda s'issa d-data ma tissuġġerixxix riskju akbar.
English: Using Betaferon with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
Maltese: L-użu ta' Betaferon ma' mediċini oħra li jimmodifikaw ir-rispons tas-sistema immuni mhux irrakkomandat għajr fil-każ ta' mediċini anti-infjammatorji msejħa kortikosterojdi jew l-ormon adrenokortikotropiku (ACTH).
English: These symptoms may be reduced by taking paracetamol or nonsteroidal anti-inflammatory medicines such as ibuprofen.
Maltese: Dawn is-sintomi jistgħu jitnaqqsu billi tieħu paracetamol jew mediċini anti-infjammatorji mhux sterojdi bħal ibuprofen.
English: 3 Vials with powder for solution for injection, each containing 300 microgram (9.6 million IU).
Maltese: 3 kunjetti bi trab għal soluzzjoni għall-injezzjoni, kull wieħed fih 300 mikrogramma (9.6
English: Transitory hyperthermia was observed, as well as a significant rise in lymphocytes and a significant decrease in thrombocytes and segmented neutrophils.
Maltese: Kienet osservata ipertermija transitorja, kif ukoll żieda sostanzjali fil-limfoċiti u tnaqqis sinifikanti fit-tromboċiti u fin-newtrofili segmentati.
English: EXPIRY DATE
Maltese: Avveniment Avvers u
English: However, this did not seem to be associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), time to confirmed EDSS progression and relapse rate).
Maltese: Madankollu, dan ma deherx li huwa assoċjat ma' tnaqqis fl-effikaċja klinika (rigward iż-żmien għall-sklerożi multipla klinikament definita (CDMS), iż żmien sa progressjoni kkonfermata fl-EDSS u r-rata ta' rkadar).
English: Part of a pack containing 15 single packs in a 3-month pack of 3x15 single packs.
Maltese: Parti minn pakkett li fih 15-il pakkett singolu f'pakkett għal 3 xhur ta' 3x15-il pakkett singolu.
English: NAME OF THE MEDICINAL PRODUCT Betaferon 250 microgram/ml, powder and solvent for solution for injection interferon beta-1b
Maltese: Informazzjoni għall-utent Betaferon 250 mikrogramma/ml, trab u solvent għal soluzzjoni għall-injezzjoni interferon beta-1b
English: General disorders and administration site conditions Serious hypersensitivity reactions (rare but severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata Jistgħu jseħħu reazzjonijiet serji ta' sensittività eċċessiva (reazzjonijiet rari iżda severi u akuti bħal bronkospasżmu, anafilassi u urtikarja).
English: White blood cell count decreased (<3,000/mm³) × Λ * °
Maltese: Għadd ta' ċelluli bojod tad-demm imnaqqas (<3,000/mm³) × Λ * °
English: The risk for progression to CDMS within 2 years was higher in monofocal patients with at least 9 T2-lesions or Gd-enhancement on brain MRI at baseline.
Maltese: Ir-riskju ta' progressjoni għal CDMS fi żmien sentejn kien ogħla f'pazjenti monofokali b'tal-inqas 9 leżjonijiet T2 jew titjib b'Gd f'MRI tal-moħħ fillinja bażi.
English: Connect the pre-filled syringe with solvent to the vial adapter and inject the 1.2 ml of the solvent (sodium chloride solution, 5.4 mg/ml (0.54% w/v)) into the Betaferon vial.
Maltese: Qabbad is-siringa mimlija għal-lest bis-solvent ma' l-adattaur tal-kunjett u injetta 1.2 ml tas-solvent (soluzzjoni ta' sodium chloride, 5.4mg/ml (0.54% w/v)) fil-kunjett ta' Betaferon.
English: Therefore Betaferon should not be used in this population.
Maltese: Ma dehrux malformazzjonijiet fl annimali li għexu.
English: Contents of the pack and other information Annex - self injection procedure
Maltese: Kontenut tal-pakkett u informazzjoni oħra Anness - proċedura ta' kif tinjetta lilek innifsek
English: Part of a multipack containing 15 single packs.
Maltese: Parti minn multipakk li fih 15-il pakkett singolu.
English: Part of a pack containing 14 single packs in a 3-month pack of 3x14 single packs.
Maltese: Parti minn pakkett li fih 14-il pakkett singolu f'pakkett għal 3 xhur ta' 3x14-il pakkett singolu.
English: If the patient has multiple lesions Betaferon should be discontinued until healing has occurred.
Maltese: Jekk il-pazjent ikollu feriti multipli, Betaferon għandu jitwaqqaf sakemm ikun hemm fejqan.
English: Separate Annex: INTRODUCTORY LEAFLET FOR TITRATION PACK
Maltese: PAKKETT INTERMEDJU TAL-PAKKETT TA' TITRAZZJONI (MINGĦAJR ILKAXXA BLU)
English: Single clinical event suggestive of MS
Maltese: Avveniment kliniku wieħed li jissuġġerixxi MS
English: In the second trial of Betaferon in secondary progressive multiple sclerosis, no delay in the time to disability progression was observed.
Maltese: Fit-tieni prova tal-użu ta' Betaferon fi sklerożi multipla progressiva sekondarja ma kienx osservat ittardjar fiż-żmien sal-progressjoni tad-diżabilità.
English: Serum samples in controlled clinical trials were collected every 3 months for monitoring of development of antibodies to Betaferon.
Maltese: Kampjuni tas-serum fi provi kliniċi kkontrollati kienu miġbura kull 3 xhur għal sorveljanza ta' żvilupp ta' antikorpi għal Betaferon.
English: - reduced number of white blood cells, swollen lymph glands (lymphadenopathy) - decrease of sugar in the blood (hypoglycaemia) - depression, anxiety - headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paraesthesia) - eye inflammation (conjunctivitis), abnormal vision - ear pain - irregular, rapid beating or pulsation of the heart (palpitation) - redness and/or facial flushing due to widening of blood vessels (vasodilation), increased blood pressure (hypertension) - runny nose, cough, hoarseness due to infection of the upper respiratory tract,
Maltese: depressjoni, ansjetà uġigħ ta' ras, sturdamenti, nuqqas ta' rqad, emigranja, tnemnin jew tingis (parasteżija) infjammazzjoni fl-għajn (konġuntivite), vista mhux normali uġigħ fil-widnejn taħbit irregolari, mgħaġġel jew pulsazzjoni tal-qalb (palpitazzjoni) ħmura u/jew ħmura fil-wiċċ minħabba twessigħ tal-kanali tad-demm (vażodilatazzjoni), żieda fil-pressjoni tad-demm (pressjoni għolja) imnieħer iqattar, sogħla, ħanqa minħabba infezzjoni tal-apparat respiratorju ta' fuq, sinożite, żieda fis-sogħla, qtugħ ta' nifs dijarea, stitikezza, dardir, rimettar, uġigħ addominali żieda fil-livelli fid-demm tal-enzimi tal-fwied (osservati fit-testijiet tad-demm) disturbi fil-ġilda, raxx ebusija tal-muskoli (ipertonija), uġigħ fil-muskoli (majalġja), indeboliment fil-muskoli
English: No interaction studies with anti-epileptics have been carried out.
Maltese: Ma sarux studji dwar l-interazzjoni b'anti-epilettiċi.
English: Subgroup analyses according to baseline factors demonstrated evidence of efficacy on progression to CDMS in all subgroups evaluated.
Maltese: Analiżi ta' sottogruppi skont fatturi tal-linja bażi ta' referenza wrew evidenza ta' effikaċja fuq ilprogressjoni għal CDMS fis-sottogruppi evalwati kollha.
English: ROTATION SCHEDULE:
Maltese: SKEDA TA' ROTAZZJONI:
English: OTHER
Maltese: Sekondarja
English: Hrvatska
Maltese: Sturdament
English: Depression and suicidal ideation are known to occur with increased frequency in the multiple sclerosis population and in association with interferon use.
Maltese: Depressjoni u ħsibijiet ta' suwiċidju huwa magħruf li jseħħu bi frekwenza akbar fil-popolazzjoni bi sklerosi multipla u f'assoċjazzjoni mal-użu ta' interferon.
English: This equals 250 microgram (8.0 million IU) interferon beta-1b.
Maltese: Dan huwa ekwivalenti għal 250 mikrogramma (8.0 miljun IU) interferon beta-1b.
English: EU/1/95/003/012
Maltese: EU/1/95/003/011 EU/1/95/003/012
English: From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS >1 point or >0.5 point for EDSS ≥6 in the previous two years) can help to identify patients with active disease.
Maltese: Minn dawn l-analiżi retrospettivi ta' sottogruppi, kien hemm evidenza li tagħti x'tifhem li rkadar kif ukoll progressjoni prominenti fl-EDSS (EDSS >1 punt jew >0.5 punt għal EDSS ≥6 fis-sentejn ta' qabel) jistgħu jgħinu biex jidentifikaw pazjenti li għandhom marda attiva.
English: Pulmonary arterial hypertension
Maltese: Artralġja
English: ► who suffer from secondary progressive multiple sclerosis with active disease shown by relapses.
Maltese: ► li jbatu minn sklerożi multipla progressiva sekondarja, bil-marda attiva li tintwera permezz tar-rikaduti.
English: How to store Betaferon
Maltese: Betaferon Plaċebo Betaferon Betaferon Betaferon Betaferon
English: Doing this allows the solution to flow down into the syringe.
Maltese: Wara li jiġi rikostitwit huwa rrakkomandat użu immedjat.
English: Capillary leak syndrome in pre-existing monoclonal gammopathy2
Maltese: tnixxija mill kapillari f'gammopatija monoklonali eżistenti minn qabel2
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Dyspnoea *
Maltese: Għaraq *
English: 4 Class label for interferon products, see below Pulmonary arterial hypertension.
Maltese: Tikketta tal-klassi għal prodotti li fihom interferon, ara taħt Pressjoni għolja fl-arterja tal-pulmun.
English: Use all the solvent in the syringe to dissolve the Betaferon powder in the vial.
Maltese: sklerożi multipla li tirkadi u tbatti.
English: Insomnia
Maltese: Infezzjoni
English: Λ °
Maltese: Treddigħ
English: Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Maltese: Il-pazjenti għandhom jinbdew b'doża ta' 62.5 mikrogrammi (0.25 ml) li tingħata minn taħt il-ġilda ġurnata iva u ġurnata le, u li tiżdied bil-mod għal doża ta' 250 mikrogramma (1.0 ml) ġurnata iva u ġurnata le (ara Tabella A).