FrancophonIA/ELRC3.0 huggingface dataset:
English: Saxagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Is-sażagliptina tnaqqas ukoll l-ammont ta' glukożju prodott mill-fwied, billi żżid il-livelli ta' insulina u tnaqqas il livelli tal-ormon glukagon.
English: The full EPAR for Flebogamma DIF can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Flebogamma DIF jinsab fuq il-websajt tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In the second study, up to 14 (73%) of the 19 patients who remained in the study had a platelet count above 50 million platelets per millilitre at least once during the study.
Maltese: Fit-tieni studju, 14 (73%) mid-19-il pazjent li baqgħu jiġu studjati kellhom għadd ta' platelets ogħla minn 50 miljun platelet għal kull millilitru tal-inqas darba waħda waqt l-istudju.
English: human normal immunoglobulin
Maltese: immunoglobulina normali umana
English: It contains the active substance human normal immunoglobulin.
Maltese: Dan fih is-sustanza attiva immunoglobulina normali umana.
English: It contains immunoglobulin G (IgG), which is a type of antibody.
Maltese: Din fiha l-immunoglobulina G (IgG), li hija tip ta' antikorp.
English: • Guillain-Barré syndrome, which causes multiple inflammations of the nerves in the body;
Maltese: • Is-sindromu Guillain-Barré, li jikkawża infjammazzjonijiet multipli fin-nervituri fil-ġisem;
English: • Hypogammaglobulinaemia (low levels of antibodies) in patients: with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) and frequent bacterial infections after preventive treatment with antibiotics has failed; with multiple myeloma (another cancer of a type of white blood cell) and frequent bacterial infections and in whom vaccination against ‘pneumococcal' bacteria has failed; who have had haematopoietic (blood) stem cell transplantation (when the patient receives stem cells from a matched donor to help restore the bone marrow).
Maltese: • Ipogammaglobulinemija (livelli baxxi ta' antikorpi) f'pazjenti li: jkollhom lewkimja limfoċitika kronika (kanċer ta' tip ta' ċellola fid-demm bajda) u infezzjonijiet batterjali frekwenti wara li jkun falla trattament preventiv bl-antibijotiċi; jkollhom mjeloma multipla (kanċer ieħor ta' tip ta' ċellola fid-demm bajda) u infezzjonijiet batterjali frekwenti u li fil-każ tagħhom ma tkunx ħadmet it-tilqima kontra l-batterja talpnewmokokku; kellhom trapjant ta' ċelloli staminati (tad-demm) ematopojetiċi (meta l-pazjent jirċievi ċelloli staminali mingħand donatur jaqbel miegħu biex jgħinu jreġġa' lura l-mudullun).
English: In the first study, involving 46 patients with PID, the medicine was infused every 21 to 28 days.
Maltese: Fl-ewwel studju, li involva 46 pazjent bis-sindromu PID, il-mediċina ġiet infuża kull 21 jum sa 28.
English: Flebogamma DIF is a solution for infusion (drip into a vein).
Maltese: Flebogamma DIF huwa soluzzjoni għall-infużjoni (dripp fil-vina).
English: This is a summary of the European public assessment report (EPAR) for Flebogamma DIF.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Flebogamma DIF.
English: Previously known as Flebogammadif
Maltese: Preċedentement magħruf bħala Flebogammadif
English: The European Commission granted a marketing authorisation valid throughout the European Union for Flebogammadif on 23 August 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea għal Flebogammadif fit-23 ta' Awwissu 2007.
English: • Kawasaki disease, which causes multiple inflammations of several organs in the body.
Maltese: • Il-marda Kawasaki, li tikkawża infjammazzjonijiet multipli f'diversi organi fil-ġisem.
English: The active substance in Flebogamma DIF, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Maltese: Is-sustanza attiva fi Flebogamma DIF, l-immunoglobulina normali tal-bniedem, hija proteina ppurifikata ħafna estratta mill-plażma (parti mid-demm) tal-bniedem.
English: Side effects such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate low back pain may occasionally occur with Flebogamma DIF.
Maltese: Effetti sekondarji bħal tertir, uġigħ ta' ras, sturdament, deni, rimettar, reazzjonijiet allerġiċi, nawżja, artralġja (uġigħ fil-ġogi), pressjoni tad-demm baxxa u uġigħ fil-parti t'isfel tad-dahar jistgħu jseħħu xi kultant bi Flebogamma DIF.
English: Flebogamma DIF is also used to treat certain immune system disorders:
Maltese: Flebogamma DIF jintuża wkoll biex jittratta ċerti disturbi fis-sistema immunitarja:
English: • Primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies).
Maltese: • Sindromi ta' immunodefiċjenza primarja (PID, meta n-nies jitwieldu b'inabilità li jipproduċu biżżejjed antikorpi).
English: • Idiopathic thrombocytopenic purpura (ITP), a condition where people do not have enough platelets in the blood;
Maltese: • Purpura tromboċitopenika idjopatika (ITP), kundizzjoni fejn in-nies ma jkollhomx biżżejjed platelets fid-demm;
English: • Acquired immune deficiency syndrome (AIDS) in children who contracted HIV from birth and have frequent infections.
Maltese: • Sindromu minn immunodefiċjenza akkwiżita (AIDS) fi tfal li jkunu twieldu bl-HIV u jkollhom infezzjonijiet frekwenti.
English: In the first study, the patients had an average of 0.021 serious infections per year.
Maltese: Fl-ewwel studju, il-pazjenti kellhom medja ta' 0.021 infezzjonijiet serji kull sena.
English: The name of the medicine was changed to Flebogamma DIF on 2 September 2010.
Maltese: L-isem tal-mediċina nbidel għal Flebogamma DIF fit-2 ta' Settembru 2010.
English: Flebogamma DIF is made like Flebogamma, another medicine containing human normal immunoglobulin, with some additional steps in the purification of the product from human plasma.
Maltese: Flebogamma DIF huwa magħmul bħal Flebogamma, li hija mediċina oħra li fiha l-immunoglobulina normali tal-bniedem, b'xi passi żejda fil-purifikazzjoni tal-prodott mill-plażma tal-bniedem.
English: Flebogamma DIF works by restoring abnormally low IgG levels to their normal range in the blood.
Maltese: Flebogamma DIF jaħdem billi jreġġa' għannormal il-livelli baxxi u anomali tal-IgG fid-demm.
English: What is the risk associated with Flebogamma DIF?
Maltese: X'inhu r-riskju assoċjat ma' Flebogamma DIF?
English: What is Flebogamma DIF?
Maltese: X'inhu Flebogamma DIF?
English: Flebogamma DIF must not be used in people who are allergic to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulin, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Maltese: Flebogamma DIF m'għandux jintuża f'persuni li huma allerġiċi għall-immunoglobulina normali talbniedem jew għal kwalunkwe mill-ingredjenti l-oħra, jew f'pazjenti allerġiċi għal tipi oħra ta' immunoglobulina tal-bniedem normali, speċjalment jekk ikollhom defiċjenza (livelli baxxi ħafna) ta' immunoglobulina A (IgA) u jkollhom antikorpi kontra l-IgA.
English: They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing haematopoietic stem cell transplantation, without the need for specific studies in these diseases.
Maltese: Jistgħu jiġu approvati wkoll għat-trattament ta' pazjenti bis-sindromu Guillain-Barré, ta' pazjenti bil-marda Kawasaki u ta' pazjenti li jkun qed isirilhom trapjant ta' ċelloli staminati ematopojetiċi, mingħajr il-ħtieġa li jsiru studji speċifiċi għal dan il-mard.
English: Why has Flebogamma DIF been approved?
Maltese: Għaliex ġie approvat Flebogamma DIF?
English: Flebogamma DIF is given by infusion into a vein by a doctor or nurse, but patients (or their carers) may administer it themselves once they have been trained.
Maltese: Flebogamma DIF jingħata permezz ta' infużjoni fil-vina minn tabib jew infermier/a, iżda l-pazjenti (jew min jieħu ħsiebhom) jistgħu jamministrawh huma stess wara li jkunu tħarrġu.
English: (Notes information)
Maltese: (Noti ta' informazzjoni)
English: Johnson & Johnson Romania S.R.L.
Maltese: România Johnson & Johnson Romania S.R.L.
English: UAB "JOHNSON & JOHNSON"
Maltese: UAB "JOHNSON &
English: Biogen Sweden AB
Maltese: Sverige Biogen Sweden AB
English: Date of first authorisation: 13 March 1997 Date of latest renewal: 13 March 2007
Maltese: Data tal-aħħar tiġdid: 13 ta' Marzu 2007
English: Biogen Idec (Ireland) Ltd.
Maltese: Ireland Biogen Idec (Ireland) Ltd.
English: Biogen Denmark A/S
Maltese: Danmark Biogen Denmark A/S
English: Biogen Inc., 5000 Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, USA.
Maltese: Davis Drive, POB 14627, Research Triangle Park, North Carolina, 27709, L-Istati
English: Genesis Pharma Cyprus Ltd
Maltese: Κύπρος Genesis Pharma Cyprus Ltd
English: This is rare.
Maltese: Dan huwa rari.
English: Biogen Idec Limited
Maltese: United Kingdom Biogen Idec Limited
English: Icepharma hf
Maltese: Ísland Icepharma hf
English: Biogen France SAS
Maltese: France Biogen France SAS
English: Biogen Portugal Sociedade Farmacêutica, Unipessoal Lda.
Maltese: Sociedade Farmacêutica, Unipessoal Lda.
English: Biogen Hungary Kft.
Maltese: Magyarország Biogen Hungary Kft.
English: Medis Adria d.o.o.
Maltese: Hrvatska Medis Adria d.o.o.
English: Biogen Austria GmbH
Maltese: Österreich Biogen Austria GmbH
English: These include MHC Class I, Mx protein, 2' / 5'-oligoadenylate synthetase, β2-microglobulin, and neopterin.
Maltese: Klassi I, proteina Mx, 2 '/5' -oligoadenylate synthetase, β2-microglobulin u neopterin.
English: Biogen Poland Sp. z o.o.
Maltese: Polska Biogen Poland Sp. z o.o.
English: *Class label for interferon beta products (see section 4.4).
Maltese: * Tikketta Klassi għal prodotti beta interferon (ara sezzjoni 4.4).
English: Part of a multi-pack.
Maltese: U KONTENUT Parti minn pakkett multiplu.
English: • Check the safety lock is released.
Maltese: • Iċċekkja li s-safety lock tkun miftuħa.
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Maltese: Abbażi ta' dejta dwar l-annimali (ara sezzjoni 5.3), possibbilment hemm riskju miżjud għal abort spontanju.
English: The active substance is: Interferon beta-1a 30 micrograms/0.5 ml
Maltese: Is-sustanza attiva hi: Interferon beta-1a 30 mikrogramma/0.5 ml
English: Biogen Finland Oy
Maltese: Suomi/Finland Biogen Finland Oy
English: UAB "JOHNSON & JOHNSON" Eesti filiaal
Maltese: JOHNSON" Eesti filiaal
English: Biogen GmbH
Maltese: Deutschland Biogen GmbH
English: More about depression.
Maltese: Aktar dwar depressjoni.
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products.
Maltese: Każijiet ta' ipertensjoni arterjali tal-pulmun (PAH) ġew irrapportati bi prodotti interferon beta.
English: Biogen Pharma d.o.o.
Maltese: Slovenija Biogen Pharma d.o.o.
English: Alternative assay techniques are not sufficiently sensitive.
Maltese: Tekniki alternattivi ta' assay mhumiex sensittivi biżżejjed.
English: • Look through the oval display window.
Maltese: • Iċċekkja d-display window tonda.
English: Name and address of the manufacturers responsible for batch release Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Denmark.
Maltese: Biogen (Denmark) Manufacturing ApS, Biogen Allé 1, DK-3400 Hillerød, Id-Danimarka.
English: Three major forms of interferons have been distinguished: alpha, beta, and gamma.
Maltese: Tlett forom prinċipali ta' interferoni ġew identifikati: alfa, beta u gamma.
English: Using the World Health Organisation (WHO) International Standard for Interferon, 30 micrograms of AVONEX contain 6 million IU of antiviral activity.
Maltese: Skond l-istandard Internazzjonali ta' l-Organiżazzjoni Mondjali tas-Saħħa (WHO) għal Interferon, 30 mikrogramma ta' AVONEX fihom 6 miljun IU ta' attività antivirali .
English: The interaction of AVONEX with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Maltese: L-interazzjoni ta' AVONEX ma' kortikosterojdi jew l'ormon adrenokortikotropiku (ACTH )ma ġietx studjata sistematikament.
English: Interferon beta is produced by various cell types including fibroblasts and macrophages.
Maltese: L-interferon beta huwa prodott minn diversi tipi ta' ċelluli, fosthom fibroblasti u makrofaġi.
English: Biogen Netherlands B.V. Prins Mauritslaan 13
Maltese: Prins Mauritslaan 13
English: A double-blind randomised dose comparison study of 802 relapsing MS patients (AVONEX 30 micrograms n=402, AVONEX 60 micrograms n=400) has shown no statistically significant differences or trends between the 30 micrograms and the 60 micrograms doses of AVONEX in clinical and general MRI parameters.
Maltese: Studju randomised u double-blind biex jikkompara d-dożi fuq 802 pazjenti b'MS li tirkadi (AVONEX 30 mikrogramma, n=402, AVONEX 60 mikrogramma, n=400) ma wera l-ebda differenza statistikament sinnifikanti, jew tendenzi bejn dożi ta' 30 mikrogramma u 60 mikrogramma ta' AVONEX, la fil-parametri kliniċi u l-anqas fil-parametri ġenerali tal-MRI.
English: Pulmonary arterial hypertension
Maltese: Ipertensjoni arterjali tal-pulmun
English: The concentration is 30 micrograms per 0.5 ml.
Maltese: Il-konċentrazzjoni hi ta' 30 mikrogramma kull 0.5 ml.
English: The pharmacokinetic profile of AVONEX has been investigated indirectly with an assay that measures interferon antiviral activity.
Maltese: Il-profil farmakokinetiku ta' AVONEX ġie studjat indirettament permezz ta' assay li jkejjel l-attivita' antivirali ta' interferon.
English: It is important to continue using Avonex regularly.
Maltese: Huwa importanti li tkompli tuża Avonex b'mod regolari.
English: The active substance in Avonex is a protein called interferon beta-1a.
Maltese: Is-sustanza attiva f'Avonex hija proteina li tissejjaħ interferon beta-1a.
English: Do not use AVONEX:
Maltese: Tużax AVONEX:
English: Thrombotic microangiopathy (TMA): 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: Mikroanġjopatija trombotika (TMA): Każijiet ta 'mikroanġjopatija trombotika, manifestata bħala purpura tromboċitopenika trombotika (TTP) jew sindromu uremiku emolitiku (HUS), inklużi każijiet fatali, kienu rrappurtati bi prodotti beta interferon.
English: Interferons are cytokines that mediate antiviral, antiproliferative, and immunomodulatory activities.
Maltese: L-interferoni huma ċitokini li jiffaċilitaw attivitajiet antivirali, antiproliferattivi u immunomodulatorji.
English: Cessation of therapy with AVONEX should be considered (see also sections 4.3 and 4.8).
Maltese: Twaqqif tal-kura b'AVONEX għandha tiġi ikkunsidrata (ara sezzjoni 4.3 u 4.8).
English: ┼ Class label for interferon products, see below Pulmonary arterial hypertension.
Maltese: ┼ Tikketta tal-klassi għall-prodotti interferon, ara taħt Ipertensjoni arterjali tal-pulmun.
English: Nephrotic Syndrome: 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: Każijiet ta' sindrome nefrotiku b'nefropatiji sottostanti differenti li jinkludi glomerulosklerożi segmentali fokali li tikkollassa (FSGS), mard b'tibdil minimu (MCD), glomerulonefrite membranoproliferattiva (MPGN) u glomerulopatija membranuża (MGN) ġew irrappurtati matul il-kura bi prodotti li fihom interferon beta.
English: Side effects seen in clinical trials.
Maltese: Effetti sekondarji li deheru fi studji kliniċi.
English: Other medicines and AVONEX
Maltese: Mediċini oħra u AVONEX
English: The estimated risk of a second event was 50% in three years and 39% in two years in the placebo group and 35% (three years) and 21% (two years) in the AVONEX group.
Maltese: Ir-riskju li jkun hemm it-tieni episodju ġie stmat bħala 50 % fi tlett snin u 39 % f'sentejn fil-grupp fuq il-plaċebo u 35 % (fi tlett snin) u 21 % (f'sentejn) fil-grupp fuq AVONEX.
English: Renal and urinary disorders rare nephrotic syndrome, glomerulosclerosis (see section 4.4 ‘special warnings and precautions')
Maltese: Disturbi fil-kliewi u fis-sistema urinarja rari sindrome nefrotiku, glomerulosklerożi (ara sezzjoni 4.4 ‘twissijiet speċjali u prekawzjonijiet għall-użu')
English: Neutralising antibodies are associated with a reduction in the in vivo biological effects of AVONEX and may potentially be associated with a reduction of clinical efficacy.
Maltese: Anti-korpi newtralizzanti huma assoċjati ma' tnaqqis fl-effetti bijoloġiċi ta' AVONEX in vivo u potenzjalment jistgħu jkunu assoċjati ma' tnaqqis ta' l-effikaċja klinika.
English: Common (≥1/100 to <1/10 patient-years);
Maltese: Komuni (≥ 1/100 sa < 1/10 snin tal-pazjent);
English: AVONEX should be administered with caution to patients with a history of seizures, 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: AVONEX għandu jingħata b'attenzjoni lill-pazjenti b'passat ta' attakki epilettiċi, dawk li qed jiġu kkurati b'anti-epilettiċi, partikolarment jekk l-epilessija li għandhom mhux ikkontrollata sew bl-antiepilettiċi (ara sezzjonijiet 4.5 u 4.8)
English: Adults: The recommended dosage for the treatment of relapsing MS is 30 micrograms (0.5 ml solution), administered by intramuscular (IM) injection once a week (see section 6.6).
Maltese: Adulti : Id-doża rakkomandata għall-kura ta' sklerożi multipla rikadenti hi ta' 30 mikrogramma (0,5 ml ta' taħlita likwida) li tingħata b'injezzjoni ġol-muskoli (IM) darba fil-ġimgħa (ara sezzjoni 6.6).
English: Gastrointestinal disorders common vomiting, diarrhoea, nausea2
Maltese: Disturbi gastro-intestinali komuni remettar, dijareja, dardir2
English: Name and address of the manufacturers of the biological active substance Biogen Inc., 250 Binney Street, Cambridge, Massachusetts 02142, USA.
Maltese: Binney Street, Cambridge, Massachusetts 02142, L-Istati Uniti tal-Amerika.
English: Avonex is used to treat Multiple Sclerosis (MS).
Maltese: Avonex jintuża għall-kura ta' Sklerożi Multipla (MS).
English: EU/1/97/033/003 EU/1/97/033/004
Maltese: EU/1/97/033/004
English: muscle spasticity, hypoesthesia neurological symptoms, syncope3, hypertonia, dizziness, paraesthesia, seizures, migraine
Maltese: twebbis tal-muskoli, ipo-estesija sintomi newroloġiċi, sinkope3, ipertonija, sturdament, parasteżija, puplesija, emikranja
English: Psychiatric disorders common not known depression (see section 4.4), insomnia suicide, psychosis, anxiety, confusion, emotional lability
Maltese: Depressjoni (ara sezzjoni 4.4), problemi biex torqod suwiċidju, psikożi, ansjetà, konfużjoni, nuqqas ta' stabilita' emozzjonali
English: Metabolism and nutrition disorders common anorexia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni
English: Uncommon (≥1/1, 000 to <1/100 patient-years); Rare (≥1/10, 000 to <1/1,000 patient-years); Very rare (<1/10,000 patient-years);
Maltese: Rari (≥ 1/10,000 sa < 1/1,000 snin tal-pazjent);
English: Natural interferon beta and AVONEX (interferon beta-1a) are glycosylated and have a single N-linked complex carbohydrate moiety.
Maltese: Interferon beta naturali u AVONEX (interferon beta-1a) huma glikolizzati u għandhom parti waħda minnhom magħmula minn carboidrat kumpless maqgħud permess ta' N.
English: Each single pack contains 1 Avonex pen, injection needle and pen cover.
Maltese: Kull pakkett singlu fih 1 AVONEX PEN, injezzjoni, labra u għatu talpinna.
English: STATEMENT OF ACTIVE SUBSTANCE (S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: AVONEX 30 micrograms/0.5 ml solution for injection Interferon beta-1a
Maltese: AVONEX 30 mikrogramma/0.5 ml taħlita likwida għall-injezzjoni Interferon beta-1a
English: • Patients diagnosed with relapsing multiple sclerosis (MS).
Maltese: • Pazjenti dijanjostikati bi sklerosi multipla (MS) li tirkadi.
English: EU/1/97/033/005 EU/1/97/033/006
Maltese: EU/1/97/033/006
English: Hepatobiliary disorders not known hepatic failure (see section 4.4), hepatitis, autoimmune hepatitis
Maltese: Disturbi fil-fwied u fil-marrara mhux magħrufa falliment tal-fwied (ara sezzjoni 4.4), epatite, epatite awto-immunitarja
English: Recent clinical studies with patients treated up to three years with AVONEX suggest that approximately 5% to 8% develop neutralising antibodies.
Maltese: Informazzjoni dwar pazjenti kkurati b'AVONEX sa sentejn tissuġġerixxi li bejn wieħed u iehor 5%-8 % jiżżviluppaw anti-korpi newtralizzanti.
English: The antibodies of some of those patients reduce the activity of interferon beta-1a in vitro (neutralising antibodies).
Maltese: L-anti-korpi ta' x'uħud minn dawn il-pazjenti jnaqqsu l-attivita' ta' interferon beta-1a in vitro (anti-korpi newtralizzanti).
English: Patients with an EDSS of 1.0 to 3.5 at entry were included in the clinical trial.
Maltese: Pazjenti b'EDSS ta' 1.0 sa 3.5 meta daħlu fl-istudju kienu inklużi fil-prova klinika.
English: Excipient(s) with known effect For the full list of excipients, see section 6.1.
Maltese: Eċċipjent(i) b'effett magħruf Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Store the AVONEX PEN in the inner carton in order to protect from light (see section 6.5).
Maltese: Aħżen l-AVONEX PEN fil-kartuna ta' ġewwa sabiex tilqa' mid-dawl (ara sezzjoni 6.5).
English: Avonex Pen - prepared for injection
Maltese: Avonex Pen - ippreparata għal injezzjoni
English: Avonex Pen contains a pre-filled syringe of Avonex.
Maltese: Avonex Pen tintuża biex tinjetta Avonex.
English: Limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving AVONEX 30 micrograms IM once per week is similar to that seen in adults.
Maltese: Dejta limitata li kienet ippubblikata tissuġġerixxi li l-profil tas-sigurtà f'adolexxenti li għandhom minn 12 sa 16-il sena li jkunu qed jirċievu AVONEX 30 mikrogramma IM darba kull ġimgħa hu simili għal dak li ġie osservat fl-adulti.
English: This means less risk of irritation to your skin and muscle.
Maltese: Dan ifisser inqas riskju ta' irritazzjoni għallġilda u muskoli tiegħek.
English: Call a doctor immediately as they may be signs of a possible liver problem.
Maltese: Għid lit-tabib tiegħek għax dawn jistgħu jkunu sinjali ta' problema possibbli tal-kliewi.
English: Chronic Toxicity: In a 26-week repeated dose toxicity study in rhesus monkeys by intramuscular route once per week, administered in combination with another immunomodulating agent, an anti CD40 ligand monoclonal antibody, no immune response toward interferon beta-1a and no signs of toxicity were demonstrated.
Maltese: Fi studju ta' 26 gimgħa, b'doża ġol-muskolu ripetuta darba fil-gimgħa f'xadini rhesus, mogħtija flimkien ma' aġent immunomodulatorju ieħor; antikorp monoklonali b'ligand anti CD40; ma kienx hemm rispons immunitarju għal interferon beta-1a u ma ntwera l-ebda sinjal ta' tossicita'.
English: Pharmacotherapeutic Group: Interferons, ATC code: L03 AB07.
Maltese: Interferoni, Kodiċi ATC:
English: AVONEX 30 micrograms/0.5 ml solution for injection.
Maltese: AVONEX 30 mikrogramma/0.5 ml taħlita likwida għall-injezzjoni.
English: How to store AVONEX PEN 6.
Maltese: Kif taħżen AVONEX PEN 6.
English: Avonex and allergic reactions.
Maltese: Avonex u reazzjonijiet allerġiċi.
English: Effects of the injection
Maltese: Effetti ta' l-injezzjoni
English: 3A syncope episode may occur after AVONEX injection, it is normally a single episode that usually appears at the beginning of the treatment and does not recur with subsequent injections.
Maltese: 3Jista' jkun hemm episodju ta' sinkope wara injezzjoni ta' AVONEX, dan normalment ikun episodju wieħed li ħafna drabi jidher fil-bidu tal-kura u ma jerġax jidher fl-injezzjonijiet ta' wara.