FrancophonIA/ELRC3.0 huggingface dataset:
English: - serious allergic (anaphylactic) reactions, - the thyroid gland does not work properly(thyroid disorders), too much hormone is produced (hyperthyroidism), - inflammation of the pancreas (pancreatitis), see section 2 “Warnings and precautions”, - blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome).
Maltese: - reazzjonijiet allerġiċi serji (anafilattiċi), - disturbi fil-funzjoni tal-glandola tat-tirojde (disturbi fit-tirojde), produzzjoni ta' wisq ormon prodott (ipertirojdiżmu), - infjammazzjoni tal-frixa (pankreatite), ara sezzjoni 2 “Twissijiet u prekawzjonijiet”, - emboli fid-demm fil-vini ż-żgħar tad-demm li jistgħu jaffettwawlek il-kliewi (purpura tromboċitopenika trombotika jew sindrome emolitika uraemika).
English: Respiratory, thoracic and mediastinal disorders Upper respiratory infection
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Infezzjoni fil-parti respiratorja ta' fuq
English: Secondary Progressive Multiple Sclerosis (European Study)
Maltese: Sklerożi multipla progressiva sekondarja (SP-MS)
English: Table A Schedule for dose titration*
Maltese: Tabella A Skeda għal tittrazzjoni tad-doża*
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 li jiddependu fuq ċitokromi tat-tip P-450 tal-fwied fil-bnedmin u l-annimali.
English: Gastrointestinal disorders Diarrhoea
Maltese: Disturbi gastro-intestinali Dijarrea
English: An example of a medication record is also included (see Annex Part III).
Maltese: Eżempju ta' rekord tal-mediċina hu inkluż ukoll (ara Anness Parti III).
English: Absolute neutrophil count decreased (<1500/mm³)
Maltese: L-għadd ta' limfoċiti mnaqqas (<1500/mm³)
English: - Pack containing 5 vials with powder and 5 pre-filled syringes with solvent - Pack containing 14 vials with powder and 14 pre-filled syringes with solvent - Pack containing 15 vials with powder and 15 pre-filled syringes with solvent - Pack containing 14 vials with powder and 15 pre-filled syringes with solvent
Maltese: - Pakkett li fih 5 kunjetti bit-trab u 5 siringi mimlija għal-lest bis-solvent, jew - Pakkett li fih 14-il kunjett bit-trab u 14-il siringa mimlija għal-lest bis-solvent - Pakkett li fih 15-il kunjett bit-trab u 15-il siringa mimlija għal-lest bis-solvent - Pakkett li fih 14-il kunjett bit-trab u 15-il siringa mimlija għal-lest bis-solvent
English: • 1 Extavia vial (with powder for solution for injection)
Maltese: • 1 kunjett ta' Extavia (bi trab għal soluzzjoni għall-injezzjoni)
English: General disorders and administration site conditions Injection site reaction (various kinds)
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Reazzjonijiet mnejn tingħata l-injezzjoni (diversi tipi)  * ° §
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 human in vivo studies.
Maltese: L-attivitatjiet ta' interferon beta-1b huma limitati għal lispeċi, u għalhekk, l-aktar informazzjoni farmakoloġika rilevanti dwar l-interferon beta-1b ġej minn studji f'kolturi ta' ċelloli tal-bniedem jew studji in vivo fil-bniedem.
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 Extavia in patients with relapses or pronounced EDSS progression, 8.0 million IU Extavia versus all placebo patients).
Maltese: Analiżi retrospettivi fi gruppi żgħar wriet li l-effett tal-kura fuq il-firxa tad-diżabilità hi l-aktar probabbli f'pazjenti bil-marda attiva qabel ma bdiet il-kura (Proporzjon ta' Riskju 0.72, 95% livell ta' kunfidenza (0.59, 0.88), p=0.0011, li jikkorispondu għal tnaqqis ta' 28% tar-riskju minħabba Extavia f'pazjenti rikaduti jew b'firxa ta' EDSS qawwija, 8.0
English: This is a disorder of the immune system where an abnormal protein is found in the blood.
Maltese: Din hija disturb tas-sistema immuni li jkun fiha proteini anormali fid-demm.
English: Adults and adolescents from 12-17 years of age The recommended dose of Extavia 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 rakkomandata ta' Extavia hi ta' 250 mikrogrammi (8.0 miljun IU), li tinsab f'1 ml tassoluzzjoni rikostitwita (ara sezzjoni 6.6), li trid tiġi injettata taħt il-ġilda ġurnata iva u oħra le.
English: CLINICAL PARTICULARS
Maltese: Injezzjoni Personali)
English: 3-month multipack: 45 (3 packs of 15) vials with powder and 45 (3 packs of 15) pre-filled syringes with 1.2 ml solvent.
Maltese: Pakkett b'ħafna għal 3 xhur: 45 (3 pakketti ta' 15) vjal bit-trab u 45 (3 pakketti ta' 15) siringa mimlija għal-lest b'1.2 ml ta' solvent.
English: Injection site necrosis has been reported in patients using Extavia (see section 4.8).
Maltese: Nekrożi fil-lok ta' l-injezzjoni ġiet rapportata f'pazjenti li jużaw Extavia (ara sezzjoni 4.8).
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 tkun serja biżżejjed li tinħtieġ trattament b'kortikostrerojdi intravenużi, 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: 3-month multipack: 42 (3 packs of 14) vials with powder and 42 (3 packs of 14) pre-filled syringes with 1.2 ml solvent.
Maltese: 42 (3 pakketti ta' 14) vjal bit-trab u 42 (3 pakketti ta' 14) siringa mimlija għal-lest b'1.2 ml ta' solvent.
English: Single clinical event suggestive of multiple sclerosis One controlled clinical trial with Extavia was performed in patients with a single clinical event and Magnetic Resonance Imaging (MRI) features suggestive of multiple sclerosis (at least two clinically silent lesions on the T2-weighted MRI).
Maltese: Okkorenza klinika waħdanija indikattiva ta' sklerożi multipla Prova klinika waħda kkontrollata b'Extavia saret fuq pazjenti b'każ kliniku waħdieni u karatteristiċi ta' l-MRI li jimputaw sklerożi multipla (ta' lanqas żewġ feriti klinikament siekta fuq l-Immaġini b'Reżonanza Manjetika (MRI) ppiżat b'T2).
English: 14 vials of interferon beta-1b and 14 pre-filled syringes containing solvent.
Maltese: 14-il kunjett ta' interferon beta-1b u 14-il siringa mimlijin għal-lest li fihom is-solvent.
English: Serious hypersensitivity reactions (severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur.
Maltese: Reazzjonijiet serji ta' sensittività eċċessiva (reazzjonijiet serji u akuti bħal bronkospasżmu, anafilassi u urtikarja) jistgħu jiġru.
English: ► Common (may affect up to 1 in 10 people):
Maltese: ► Komuni (jista' jaffettwa sa persuna 1 minn 10):
English: The following side effects listing is based on reports from clinical trials with Extavia (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'Extavia (Lista 1) u minn effetti sekondarji rrappurtati wara li l-prodott ħareġ fis-suq (Lista 2).
English: RR-MS, SP-MS and single clinical event suggestive of MS In all multiple sclerosis studies Extavia was effective in reducing disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
Maltese: RR-MS, SP-MS u każ kliniku wieħed li jissuġġerixxi MS F'kull studju li sar fuq sklerożi multipla Extavia kien effettiv biex inaqqas l-attività tal-marda (infjammazzjoni akuta tas-sistema nervuża ċentrali u tibdil permanenti fit-tessuti) kif imkejjel blimmaġini ta' reżonanza manjetika (MRI).
English: * produced by genetic engineering from strain of Escherichia coli.
Maltese: * magħmul permezz ta' l-inġenjerija ġenetika minn razza ta' Escherichia coli.
English: Extavia contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial*.
Maltese: U KWANTITATTIVA Extavia fiħ 300 mikrogramma (9.6 miljun IU) ta' interferon beta-1b rikombinanti f'kull fjala*.
English: Interferon beta-1b has been shown to possess both antiviral and immunoregulatory activity.
Maltese: L-interferon beta-1b għandu kemm azzjoni kontra il-virus kif ukoll azzjoni immuno-regulatorji.
English: Patients exhibiting depression should be monitored closely during therapy with Extavia and treated appropriately.
Maltese: Pazjenti li juru mard dipressiv għandhom jiġu monitorati mill-qrib waqt it-terapija b'Extavia u trattati skond dan.
English: Drug-induced lupus erythematosus
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: RelapsingRemitting Multiple Sclerosis
Maltese: Sklerożi Multipla li Tirkadi u Tbatti
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 ta' MRI fil-livelli bażi ta' referenza, li jindika riskju għoli għal CDMS minħabba l-firxa tal-marda skond ir-riżultati kliniċi.
English: 2 - Remove the flip off cap from the Extavia vial.
Maltese: 2 - Neħħi t-tapp tal-kunjett Extavia.
English: - During treatment with Extavia, kidney problems that may reduce your kidney function, including scarring (glomerulosclerosis), may occur.
Maltese: - Matul il-kura b'Extavia, jista' jkun hemm problemi fil-kliewi li jistgħu jnaqqsu l-funzjoni tal-kliewi inkluż ġrieħi (glomerulosklerożi).
English: Using Extavia 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' Extavia ma' mediċini oħra li jimmodifikaw ir-rispons tas-sistema immuni mhuwiex rakkomandat għajr fil-każ ta' mediċini anti-infjammatorji msejħa kortikosterojdi jew l-ormon adrenokortikotropiku (ACTH).
English: Extavia 250 microgram/ml powder for solution for injection interferon beta-1b
Maltese: Extavia 250 mikrogramm/ml, trab li jinħall f'likwidu għall-injezzjoni interferon beta-1b
English: Symptoms can be redness, swelling, discolouration, inflammation, pain, hypersensitivity, tissue damage (necrosis).
Maltese: Is-sintomi jistgħu jkunu ħmura, nefħa, telf fil-kulur, infjammazzjoni, uġigħ sensittività eċċessiva, ħsara fit-tessut (nekrożi).
English: No acute toxicity studies have been performed.
Maltese: Ma sarux studji dwar it-tossiċità akuta.
English: In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Maltese: Barra minn dawk it-testijiet tal-laboratorju li ġeneralment huma meħtieġa biex jimmonitorjaw pazjenti bl-isklerożi multipla, huwa rakkomandat li jsiru testijiet biex jiġi determinat l-għadd sħiħ ta' ċelloli tad-demm u għall-għadd ta' ċelloli bojod differenti, l-għadd ta' plejtlets u l-kimiċi tad-demm li jinkludu t-testijiet għall-funzjoni tal-fwied (eż. aspartate aminotransferase glutamic-oxaloacetic transaminase fis-serum (SGOT), alanine aminotransferase glutamate pyruvate transaminase fis-serum (SGPT) u gamma glutamyltransferase), qabel ma jinbeda u b'mod regolari wara l-introduzzjoni ta' terapija b'Extavia, u mbagħad kull tant żmien wara dan fin-nuqqas ta' sintomi kliniċi.
English: The dose should be increased at every fourth injection in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml).
Maltese: Id-doża għandha tiżdied wara kull raba' injezzjoni f'erba' stadji (0.25 ml, 0.5 ml. 0.75 ml, 1.0 ml).
English: - If you have ever had an allergic reaction to latex.
Maltese: - Jekk qatt kellek reazzjoni allerġika għal-latex.
English: 3-month multipack containing 42 (3x14) vials of interferon beta-1b and 42 (3x14) pre-filled syringes containing solvent.
Maltese: Pakett b'ħafna għal 3 xhur li fih 42 (3x14) kunjett ta' interferon beta-1b u 42 (3x14) siringa mimlijin għal-lest li fihom is-solvent.
English: Single Event suggestive of Multiple Sclerosis (BENEFIT)
Maltese: Okkorenza Waħdanija li hi suġġestiva ta' Sklerożi Multipla (BENEFIT)
English: 3-month multipack containing 45 (3x15) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
Maltese: Pakkett b'ħafna għal 3 xhur li fih 45 (3x15) kunjett ta' interferon beta-1b u 45 (3x15) siringa mimlija għal-lest li fihom is-solvent.
English: ROTATION SCHEDULE:
Maltese: SKEDA TAR-ROTAZZJONI:
English: 3-month multipack: 42 (3 packs of 14) vials with powder and 45 (3 packs of 15) pre-filled syringes with 1.2 ml solvent.
Maltese: 42 (3 pakketti ta' 14) vjal bit-trab u 45 (3 pakketti ta' 15) siringa mimlija għal-lest b'1.2 ml ta' solvent.
English: C) Reconstituting and drawing up the solution for injection, step by step D) Making the injection manually (to make an injection with the ExtaviPro 30G auto injector, refer to the instructions for use provided with the auto-injector)
Maltese: C) Rikostituzzjoni u ġbid tas-soluzzjoni għall-injezzjoni, pass wara pass D) Kif tagħmel l-injezzjoni manwalment (biex taghmel l-injezzjoni bl-ExtaviPro 30G auto injector, irreferi ghall-istruzzjonijiet ghal użu ipprovduti ma' l-auto-injector)
English: The Extavia powder is provided in a 3-millilitre vial.
Maltese: It-trab ta' Extavia hu pprovdut f'kunjett ta' 3 millilitri.
English: Extavia has been shown to cut down the number of attacks and make them less severe.
Maltese: Intwera li Extavia inaqqas innumru ta' attakki u jagħmilhom inqas severi.
English: Transitory hyperthermia was observed, as well as a significant rise in lymphocytes and a significant decrease in thrombocytes and segmented neutrophils.
Maltese: Ġiet osservata żieda transitorja fit-tempertura talġisem, kif ukoll żieda sostanzjali fil-limfoċiti u nuqqas sinifikanti fit-tromboċiti u newtrofili segmentati.
English: 5 vials of interferon beta-1b and 5 pre-filled syringes containing solvent.
Maltese: 5 kunjetti ta' interferon beta-1b u 5 siringi mimlijin għal-lest li fihom is-solvent (soluzzjoni tassodium chloride).
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: L-ogħla livelli fis-serum ta' xi 40 IU/ml instabu minn 1sa 8 sigħat wara injezzjoni taħt il-ġilda ta' 500 mikrogramm (16.
English: - swollen and usually itchy patches of skin or mucous membranes (urticaria), - itching (pruritus), - loss of scalp hair (alopecia), - menstrual disorders (menorrhagia).
Maltese: - irqajja' fil-ġilda jew membrani mukużi minfuħin u normalment li jġegħluk tħokk (urtikarja), - ħakk (pruritus), - telf ta' xagħar mill-qurriegħa (allopeċja), - disturbi fil-menstrwazzjoni (menorraġja).
English: PART I: STEP BY STEP INSTRUCTIONS
Maltese: PARTI I: STRUZZJONIJIET PASS WARA PASS
English: Eye disorders
Maltese: Vista anormali
English: Extavia should be administered with caution to patients with a history of seizures, to patients receiving treatment with anti-epileptics, and in particular to patients with epilepsy who are not adequately controlled with anti-epileptics (see sections 4.5 and 4.8).
Maltese: Extavia għandu jingħata b'kawtela lil pazjenti li għandhom storja ta' puplesija, lil pazjenti li qed jirċievu trattament b'anti-epilettiċi, u b'mod partikulari lil pazjenti b'epilessija li mhumiex adegwatament ikkontrollati b'anti-epilettiċi (ara sezzjonijiet 4.5 u 4.8).
English: Side effects reported on the marketed product (frequencies - where known - based on clinical trials):
Maltese: Effetti sekondarji rrappurtati fuq il-prodott fis-suq (frekwenzi - meta magħrufa - skont provi kliniċi);
English: Early clinical features include thrombocytopenia, new onset hypertension, fever, central nervous system symptoms (e.g. confusion, paresis) and impaired renal function.
Maltese: Fatturi kliniċi bikrija jinkludu tromboċitopenija, bidu ta' pressjoni għolja għall-ewwel darba, deni, sintomi fissistema nervuża ċentrali (eż. konfużjoni, dgħufija fil-muskoli) u diffikultà fil-funzjoni tal-kliewi.
English: Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Maltese: Sejbiet fil-laboratorju li jissuġġerixxu TMA jinkludu tnaqqis fl-ammont tal-plejtlits, żieda fil-lactate dehydrogenase (LDH) fis-serum minħabba emoliżi u skistoċite (frammentazzjoni eritroċite) fuq ilfilm tad-demm.
English: After reconstitution, 1.0 ml of the solution should be drawn from the vial into the syringe for the administration of 250 microgram Extavia.
Maltese: Wara rrikostituzzjoni, iġbed 1.0ml tas-soluzzjoni għandhom jinġibdu mill-kunjett għal ġos-siringa għall-għoti ta' 250 mikrogramma ta' Extavia.
English: Urinary protein positive
Maltese: GĦAMLA KWALITATTIVA
English: Flu-like symptoms may also be reduced by administration of non-steroidal anti-inflammatory medicinal products.
Maltese: Sintomi bħal ta' l-influwenza jistgħu wkoll jitnaqqsu blgħoti ta' prodotti mediċinali mhux sterojdi u anti-infjammatorji.
English: Your doses will then be increased gradually to the full dose of 1.0 ml (250 microgram).
Maltese: Id-dożi tiegħek imbagħad ser jiżdiedu gradwalment saddoża sħiħa ta' 1.0 ml (250 mikrogramma).
English: However, this has not been investigated in vivo and its clinical significance is uncertain.
Maltese: Madankollu dan ma ġiex studjat in vivo u l-importanza klinika ta' dan għadha mhix aċċertata.
English: If clinically needed, the use of Extavia may be considered during pregnancy.
Maltese: Jekk hemm ħtieġa klinika, jista' jitqies li jintuża Extavia waqt it-tqala.
English: New adverse events have not been associated with the development of neutralising activity.
Maltese: Każijiet avversi ġodda ma ġewx assoċjati ma' l-iżvilupp ta' attività li tinnewtralizza.
English: Myalgia * °
Maltese: Telqa*
English: Hypothyroidism
Maltese: Menorraġija
English: Extavia is available in pack sizes of:
Maltese: Extavia hu disponibbli f'daqsijiet tal-pakkett ta':
English: There are follow-up data under controlled clinical conditions for patients with relapsing-remitting multiple sclerosis for up to 5 years and for patients with secondary progressive multiple sclerosis for up to 3 years.
Maltese: Hemm tagħrif talfollow-up taħt kundizzjonijiet kliniċi kontrollati għal pazjenti li għandhom sklerożi multipla li tirkadi u tbatti sa 5 snin u għal pazjenti li għandhom sklerożi multipla progressiva sekondarja sa 3 snin.
English: 14 vials with powder and 14 pre-filled syringes with 1.2 ml solvent.
Maltese: 14-il kunjett bit-trab u 14-il siringa mimlija għal-lest b'1.2 ml ta' solvent.
English: 3-month multipack containing 42 (3x14) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
Maltese: Pakkett b'ħafna għal 3 xhur li fih 42 (3x14) kunjett ta' interferon beta-1b u 45 (3x15) siringa mimlija għal-lest li fihom is-solvent.
English: 15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Maltese: 15-il kunjett bit-trab u 15-il siringa mimlija għal-lest b'1.2 ml ta' solvent.
English: Transfer all the solvent to the vial.
Maltese: Ittrasferixxi s-solvent kollu fil-kunjett.
English: The binding of interferon beta-1b to these receptors induces the expression of a number of gene products that are believed to be the mediators of the biological actions of interferon beta-1b.
Maltese: L-irbit ta' l-interferon beta-1b ma' dawn ir-riċevituri jwassal għall-ħelisen ta' numru ta' prodotti ġenetiċi li huma meqjusa bħala medjaturi ta' l-azzjonijiet bioloġiċi ta' interferon beta-1b.
English: A number of these products have been measured in the serum and cellular fractions of blood collected from patients treated with interferon beta-1b.
Maltese: Numru minn dawn il-prodotti ġew imkejla fis-serum u fi frazzjonijiet ċellulari tad-demm, miġbura minn pazjenti kkurati b'interferon beta-1b.
English: * The titration period may be adjusted if any significant adverse reaction occurs.
Maltese: * Reazzjonijiet avversi (ADRs) li rriżultaw biss wara t-tqegħid tal-prodott fis-suq.
English: • 30-gauge needles for injecting your medicine
Maltese: • Labar b'gauge ta' 30 biex tinjetta l-mediċina tiegħek
English: To reconstitute the powder, the pre-filled syringe with solvent should be used with a needle or a vial adapter to inject the 1.2 ml of the solvent (sodium chloride 5.4 mg/ml (0.54%) solution for injection) into the Extavia vial.
Maltese: Sabiex tirrikostitwixxi t-trab, is-siringa bis-solvent għandha tintuża ma' labra jew adapter tal-kunjett biex tinjetta l-1.2 ml tas-solvent (sodium chloride, 5.4mg/ml (0.54%) soluzzjoni għall-injezzjoni) filkunjett ta' Extavia.
English: Symptoms include redness, swelling, change in skin colour, inflammation, pain, and hypersensitivity.
Maltese: Is-sintomi jinkludu ħmura, nefħa, bidla fil-kulur tal-ġilda, infjammazzjoni, uġigħ u sensittività eċċessiva.
English: Capillary leak syndrome in preexisting monoclonal gammopathy*
Maltese: Reazzjonijiet anafilattiċi Sindrome ta' tnixxija talkapillari f'gammopatija monoklonali eżistenti diġà*
English: Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta.
Maltese: L-episodji kienu rrappurtati f'mumenti differenti matul it-trattament u jistgħu jfeġġu wara bosta snin ta' trattament b'interferon beta.
English: Hypertension °
Maltese: Artralġja
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 mikrogramm (0.25 ml) li tingħata taħt il-ġilda ġurnata iva u ġurnata le, u li tiżdied bil-mod għal doża ta' 250 mikrogramm (1.0 ml) ġurnata iva, ġurnata le (ara Tabella A).
English: 14 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Maltese: 14-il kunjett bit-trab u 15-il siringa mimlija għal-lest b'1.2 ml ta' solvent.
English: Vomiting
Maltese: Volum
English: Blood bilirubin increased
Maltese: Żieda talbilirubin fiddemm
English: Excipients:
Maltese: Trab:
English: How to store Extavia
Maltese: X'inhu Extavia
English: Extavia is a type of medicine known as interferon used to treat multiple sclerosis.
Maltese: Extavia huwa tip ta' mediċina magħrufa bħala interferon użata għat-trattament ta' l-isklerożi multipla.