FrancophonIA/ELRC3.0 huggingface dataset:
English: The pen will deliver a maximum of 12 doses of 2.5 million IU over a period not to exceed 4 weeks.
Maltese: Il-pinna ser tinjetta massimu ta' 12-il doża ta' 2.5 miljun IU fuq perijodu ta' mhux aktar minn 4 ġimgħat.
English: 24 mg of powder (corresponding to 3 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml of water for injections in an ampoule (type I glass) Pack sizes of 6
Maltese: 24 mg ta' trab (li jikkorrispondi għal 3 MIU) f'kunjett (type I glass), b'tapp (lasktu tal-butyl) f'siġill li tiftħu b'saba (aluminium) b'bonit (polypropylene) u ml 1 ilma għall-injezzjonijiet f'ampulla (ħġieġ tat-tip I) Pakketti ta' daqsijiet b'6
English: Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instance after treatment with alpha interferons.
Maltese: Każijiet avversi okulari (ara sezzjoni 4.8) li jinkludu emorraġiji tar-retina, tikkek bojod fl-għajn, u mblukkar fl-arterji jew fil-vini tar-retina, kienu irrappurtati f'każijiet rari wara t-trattament blinterferon alpha.
English: Manufacturer:
Maltese: Manifattur
English: 30 million IU solution for injection multidose pen 1 pen, 12 injection needles and 12 cleansing swabs 2 pens, 24 injection needles and 24 cleansing swabs 8 pens, 96 injection needles and 96 cleansing swabs
Maltese: FARMAĊEWTIKA U KONTENUT 30 miljun IU ta' soluzzjoni għall-injezzjoni għall-pinna b'ħafna dożi pinna 1, 12-il labra għall-injezzjoni u 12-il tajjara 2 pinen, 24 labra għall-injezzjoni u 24 tajjara għat-tindif 8 pinen, 96 labra għall-injezzjoni u 96 tajjara għat-tindif
English: Viraferon, 30 million IU solution for injection, multidose pen Interferon alfa-2b
Maltese: Viraferon 30 miljun IU soluzzjoni għall-injezzjoni, pinna b'ħafna dożi Interferon alfa-2b
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/128/029 1 pen
Maltese: FIS-SUQ EU/1/99/128/029 pinna 1
English: The active substance is recombinant interferon alfa-2b, 18 million IU/pen The other ingredients are disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections.
Maltese: - Is-sustanza attiva hi interferon alfa-2b rikombinanti, 18-il miljun IU/pinna - Is-sustanzi l-oħra huma disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 u ilma għallinjezzjonijiet.
English: Once opened, the product may be stored for a maximum of 28 days at 2ºC - 8ºC.
Maltese: Ladarba jinfetaħ, il-prodott jista' jinħażen għal mhux aktar minn 28 jum bejn 2ºC - 8ºC.
English: The pen will deliver a maximum of 12 doses of 1.5 million IU over a period not to exceed 4 weeks.
Maltese: Il-pinna ser tinjetta massimu ta' 12-il doża ta' 1.5 miljun IU fuq perijodu ta' mhux aktar minn 4 ġimgħat.
English: (Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C).
Maltese: (Ara wkoll l-SPC ta' ribavirin jekk Viraferon se jingħata flimkien ma' ribavirin lill-pazjenti bl-epatite Ċ kronika).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 million IU/ml
Maltese: INDIVIDWALI 1 miljun IU/ml
English: Viraferon, 18 million IU solution for injection, multidose pen Interferon alfa-2b
Maltese: Viraferon 18-il miljun IU soluzzjoni għall-injezzjoni, pinna b'ħafna dożi interferon alfa-2b
English: One ml contains 25 million IU of interferon alfa-2b.
Maltese: Millilitru wieħed fih 25-il miljun IU interferon alfa-2b.
English: One ml of solution contains 10 million IU of interferon alfa-2b.
Maltese: Millilitru wieħed fih 10 miljun IU interferon alfa-2b.
English: Viraferon, 1 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Maltese: Viraferon 1 miljun IU/ml trab u solvent għal soluzzjoni għall-injezzjoni interferon alfa-2b
English: PHARMACEUTICAL FORM AND CONTENTS 3 million IU/ml powder and solvent for solution for injection 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 6 vials of powder and 6 ampoules of solvent
Maltese: FARMAĊEWTIKA U KONTENUT 1 miljun IU/ml trab u solvent għal soluzzjoni għall-injezzjoni kunjett 1 ta' trab, ampulla 1 ta' solvent, siringa 1 għall-injezzjoni, 2 labar għall-injezzjoni u tajjara 1 għat-tindif
English: This is called performing the Air-Shot.
Maltese: ħsibijiet dwar suwiċidju jew attentati ta' suwiċidju.
English: Viraferon, 5 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Maltese: Viraferon 5 miljun IU/ml trab u solvent għal soluzzjoni għall-injezzjoni interferon alfa-2b
English: INFORMATION IN BRAILLE Viraferon 25 MIU solution
Maltese: INFORMAZZJONI BIL-BRAILLE Viraferon 25
English: During ALT flare, liver function tests: ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin must be monitored at two-week intervals.
Maltese: Waqt ilqabża kbira fl-ALT, testijiet ta' kif qed jaħdem il-fwied, ALT, ħin tal-protrombina, alkaline phosphatase, albumina u bilirubin iridu jkunu mkejjla f'intervalli ta' ġimagħtejn.
English: 3 ml of solution (corresponding to 18 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flipoff seal (aluminium) with a bonnet (polypropylene).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih soluzzjoni ta' 3 ml (li jikkorrispondi għal 18-il MIU) f'kunjett (ħġieġ tat-tip I), b'tapp (lasktu halobutyl) f'siġill li tiftħu b'saba (aluminium) b'bonit (polypropylene).
English: Any thyroid abnormality detected at that time must be treated with conventional therapy.
Maltese: Xi anormalità tat-tirojde li tinstab f'dak l-istadju trid tkun ittrattata bit-terapija konvenzjonali.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/128/035 1 pen
Maltese: FIS-SUQ EU/1/99/128/035 pinna 1
English: Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96 %).
Maltese: Pazjenti li ma jiksbux rispons viroloġiku mat12-il ġimgħa x'aktarx li ma jiksbux rispons viroloġiku sostnut (valur ta' tbassir negattiv 96 %).
English: Viraferon (interferon alfa-2b) modifies the response of the body's immune system to help fight infections and severe diseases.
Maltese: Viraferon (interferon alfa-2b) ibiddel ir-rispons tas-sistema immunitarja tal-ġisem biex jgħin fil-ġlieda kontra l-infezzjonijiet u l-mard serju.
English: The pen is designed to deliver its contents of 60 million IU in doses ranging from 5 to 20 million IU.
Maltese: Il-pinna hi magħmula biex tinjetta l-kontenuti tagħha ta' 60 miljun IU f'dożi f'medda ta' minn 5 sa 20 miljun IU.
English: EU/1/99/128/018 1 single dose vial, 1 injection syringe, 1 injection needle and 1 cleansing swab EU/1/99/128/019 6 single dose vials
Maltese: EU/1/99/128/018 kunjett 1 b'doża waħda, siringa 1 għall-injezzjoni, labra 1 għall-injezzjoni u tajjara 1 għall-injezzjoni
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 million IU/ml
Maltese: INDIVIDWALI 5 miljun IU/ml
English: Hypothyroidism
Maltese: TAL-PRODOTT
English: 18 million IU solution for injection multidose pen 1 pen, 12 injection needles and 12 cleansing swabs 2 pens, 24 injection needles and 24 cleansing swabs 8 pens, 96 injection needles and 96 cleansing swabs
Maltese: FARMAĊEWTIKA U KONTENUT 18-il miljun IU ta' soluzzjoni għall-injezzjoni għall-pinna b'ħafna dożi pinna 1, 12-il labra għall-injezzjoni u 12-il tajjara 2 pinen, 24 labra għall-injezzjoni u 24 tajjara għat-tindif 8 pinen, 96 labra għall-injezzjoni u 96 tajjara għat-tindif
English: Chronic Hepatitis B: The recommended dosage is in the range 5 to 10 million IU administered subcutaneously three times a week (every other day) for a period of 4 to 6 months.
Maltese: Id-dożaġġ rakkomandat huwa bejn 5 u 10 miljun IU mogħtija taħt il-ġilda tliet darbiet fil-ġimgħa (darba kull jumejn) għal perijodu ta' 4 sa 6 xhur.
English: Viraferon, 3 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Maltese: Viraferon 3 miljun IU/ml trab u solvent għal soluzzjoni għall-injezzjoni interferon alfa-2b
English: PHARMACEUTICAL FORM AND CONTENTS 5 million IU/ml powder and solvent for solution for injection 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 6 vials of powder and 6 ampoules of solvent
Maltese: 5 miljun IU/ml trab u solvent għal soluzzjoni għall-injezzjoni kunjett 1 ta' trab, ampulla 1 ta' solvent, siringa 1 għall-injezzjoni, 2 labar għall-injezzjoni u tajjara 1 għat-tindif
English: Treatment should be continued in patients who exhibit negative HCV-RNA.
Maltese: It-trattament għandu jitkompla fejn il-pazjenti juru HCV-RNA negattiv.
English: Injection site pain Injection site necrosis, face oedema
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Komuni:
English: After reconstitution, 1 ml contains 10 million IU of interferon alfa-2b.
Maltese: Meta jkun rikostitwit, 1 ml jkun fih 10 miljun IU ta' interferon alfa-2b.
English: No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa2b on growth, development, sexual maturation, and behaviour (see section 4.4 and Rebetol SPC if Viraferon is to be administered in combination with ribavirin).
Maltese: Ma sarux studji f'annimali ta' età żgħira sabiex jiġu eżaminati l-effetti tal-kura b'interferon alfa-2b fuq it-tkabbir, żvilupp, maturazzjoni sesswali, u imġieba (ara sezzjoni 4.4 u l-SPC ta' Rebetol jekk Viraferon ikun ser jingħata ma' ribavirin).
English: EU/1/99/128/009 EU/1/99/128/010 EU/1/99/128/011 EU/1/99/128/012
Maltese: EU/1/99/128/009 EU/1/99/128/010
English: §, malaise, irritability Chest pain, asthenia, oedema, injection site pain
Maltese: §, astenja, irritabilità, uġigħ fis sider, tħossok ma tiflaħx
English: Children and adolescents:
Maltese: Pazjenti adulti:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/128/032 1 pen
Maltese: FIS-SUQ EU/1/99/128/032 pinna 1
English: 24 mg of powder (corresponding to 10 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Maltese: 24 mg ta' trab (li jikkorrispondi għal 10 MIU) f'kunjett (type I glass), b'tapp (lasktu tal-butyl) f'siġill li tiftħu b'saba (aluminium) b'bonit (polypropylene) u ml 1 ilma għall-injezzjonijiet f'ampulla (ħġieġ tat-tip I) b'siringa 1 għall-injezzjoni, 2 labar ta' l-injezzjoni u tajjara għat-tindif.
English: Diagram L
Maltese: Disinn L
English: §, virilism Hyperthyroidism
Maltese: §, viriliżmu
English: Diagram N
Maltese: Disinn N
English: EU/1/99/128/014 1 single dose vial, 1 injection syringe, 1 injection needle and 1 cleansing swab EU/1/99/128/015 6 single dose vials
Maltese: EU/1/99/128/014 kunjett 1 b'doża waħda, siringa 1 għall-injezzjoni, labra 1 għall-injezzjoni u tajjara 1 għall-injezzjoni
English: MARKETING AUTHORISATION NUMBERS EU/1/99/128/035
Maltese: FIS-SUQ EU/1/99/128/035
English: 24 mg of powder (corresponding to 3 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml of water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Maltese: 24 mg ta' trab (li jikkorrispondi għal 3 MIU) f'kunjett (type I glass), b'tapp (lasktu tal-butyl) f'siġill li tiftħu b'saba (aluminium) b'bonit (polypropylene) u ml 1 ilma għall-injezzjonijiet f'ampulla (ħġieġ tat-tip I) b'siringa 1 għall-injezzjoni, 2 labar ta' l-injezzjoni u tajjara għat-tindif.
English: INFORMATION IN BRAILLE Viraferon 60 MIU pen
Maltese: INFORMAZZJONI BIL-BRAILLE Viraferon 60
English: Ribavirin therapy is contraindicated in women who are pregnant.
Maltese: It-terapija b'ribavirin hija kontra-indikata f'nisa waqt it-tqala.
English: Treatment should be continued for another 6-month period (i.e., a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load.
Maltese: It-trattament għandu jitkompla għal perijodu ieħor ta' 6 xhur (i.e., għal total ta' 12-il xahar) f'pazjenti li juru HCV-RNA negattiv f'xahar 6, u b'ġenotip virali 1 (kif stabbilit f'kampjun ta' qabel ittrattament) u b'viral load għoli qabel it-trattament.
English: EU/1/99/128/013 EU/1/99/128/014 EU/1/99/128/015 EU/1/99/128/016
Maltese: EU/1/99/128/013 EU/1/99/128/014
English: 24 mg of powder (corresponding to 5 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) Pack sizes of 6
Maltese: 24 mg ta' trab (li jikkorrispondi għal 10 MIU) f'kunjett (type I glass), b'tapp (lasktu tal-butyl) f'siġill li tiftħu b'saba (aluminium) b'bonit (polypropylene) u ml 1 ilma għall-injezzjonijiet f'ampulla (ħġieġ tat-tip I) Pakketti ta' daqsijiet b'6
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 million IU/pen
Maltese: INDIVIDWALI 60 miljun IU/pinna
English: EU/1/99/128/010 1 single dose vial, 1 injection syringe, 1 injection needle and 1 cleansing swab EU/1/99/128/011 6 single dose vials
Maltese: EU/1/99/128/010 kunjett 1 b'doża waħda, siringa 1 għall-injezzjoni, labra 1 għall-injezzjoni u tajjara 1 għall-injezzjoni
English: Viraferon is available in three different pack sizes:
Maltese: Viraferon jiġi fi tlett daqsijiet ta' pakketti differenti:
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. Sustained virological response rates in children and adolescents were similar to those in adults.
Maltese: Rati ta' rispons viroloġiku sostnut fi tfal u adolexxenti kienu simili għal dawk fl-adulti.
English: These very serious side effects are very rare.
Maltese: Dawn l-effetti sekondarji serji ħafna huma rari ħafna.
English: 0.5 ml of solution (corresponding to 5 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) with 1 injection syringe, 1 injection needle and 1 cleansing swab.
Maltese: u soluzzjoni ta' 0.5 ml (li jikkorrispondi għal 3 MIU) f'kunjett (ħġieġ tat-tip I), b'tapp (lasktu halobutyl) f'siġill li tiftħu b'saba (aluminium) b'bonit (polypropylene). b'siringa 1 għall-injezzjoni, labra 1 ta' l-injezzjoni u tajjara għat-tindif.
English: Water for injections q.s.
Maltese: Ilma għall-injezzjonijiet.
English: 1 ml of solution (corresponding to 10 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flipoff seal (aluminium) with a bonnet (polypropylene)
Maltese: MIU) f'kunjett (ħġieġ tat-tip I), b'tapp (lasktu halobutyl) f'siġill li tiftħu b'saba (aluminium) b'bonit (polypropylene).
English: Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
Maltese: Kardjomajopatija li tista' tkun riversibbli bit-twaqqif ta' interferon alpha, kienet irrappurtata f'każijiet rari f'pazjenti li ma kellhomx evidenza minn qabel ta' mard tal-qalb (ara sezzjoni 4.4).
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Maltese: Miżuri standard biex jiġu evitati infezzjonijiet li jiġu mill-użu ta' prodotti mediċinali li jkunu preparati mid-demm jew plażma tal-bniedem inkluż l-għażla tad-donaturi, screening tad-donazzjonijiet individwali u ġabra tal-plażma għal markaturi speċifiċi ta' l-infezzjoni u l-inklużjoni ta' passi effettivi fil-manifattura għall-inattivazzjoni/tneħħija ta' viruses.
English: EU/1/99/128/028 12 multiple dose vials
Maltese: EU/1/99/128/028 12-il kunjett b'ħafna dożi
English: Two trials have been conducted in patients co-infected with HIV and HCV.
Maltese: Saru żewġ provi f'pazjenti ko-infettati b'HIV u HCV.
English: Depression, insomnia, anxiety, emotional lability*, agitation, nervousness
Maltese: Dipressjoni, nuqqas ta' rqad, ansjetà, burdati emozzjonali*, aġitazzjoni, nervi
English: 24 mg of powder (corresponding to 1 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Maltese: 24 mg ta' trab (li jikkorrispondi għal 1 MIU) f'kunjett (type I glass), b'tapp (lasktu tal-butyl) f'siġill li tiftħu b'saba (aluminium) b'bonit (polypropylene) u ml 1 ilma għall-injezzjonijiet f'ampulla (ħġieġ tat-tip I) b'siringa 1 għall-injezzjoni, 2 labar ta' l-injezzjoni u tajjara għat-tindif.
English: Viraferon, 10 million IU/ml powder and solvent for solution for injection Interferon alfa-2b
Maltese: Viraferon 10 miljun IU/ml trab u solvent għal soluzzjoni għall-injezzjoni interferon alfa-2b
English: Stomatitis ulcerative, right upper quadrant pain, glossitis, gingivitis, constipation, loose stools Pancreatitis, ischaemic colitis, ulcerative colitis, gingival bleeding
Maltese: Id-deċiżjoni jekk għandhiex tingħata l-kura għandha tittieħed skond il-każ, billi jkun meqjus jekk hemmx avvanz tal-marda bħal infjammazzjoni epatika u fibrożi, kif ukoll fatturi ta' tbassir għar-rispons, ġenotip tal-HCV u viral load.
English: Corresponding dose (million IU) using Viraferon 18 million IU/3 ml solution for injection
Maltese: Volum (ml) Doża li tikkorrispondi (miljun IU) b'Viraferon 18-il miljun IU/3 ml soluzzjoni għallinjezzjoni jew infużjoni
English: 2.5 ml of solution (corresponding to 25 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih soluzzjoni ta' 2.5 ml (li jikkorrispondi għal 25-il MIU) f'kunjett (ħġieġ tat-tip I), b'tapp (lasktu halobutyl) f'siġill li tiftħu b'saba (aluminium) b'bonit (polypropylene).
English: Pack of 1 vial of powder for solution for injection, 1 ampoule of water for injections, 1 injection syringe, 2 injection needles and 1 cleansing swab Pack of 6 vials of powder for solution for injection and 6 ampoules of water for injections Not all pack sizes may be marketed.
Maltese: Pakkett b'kunjett 1 ta' trab għal soluzzjoni għall-injezzjoni jew infużjoni, ampulla 1 bl-ilma għall-injezzjonijiet, siringa 1 għall-injezzjoni, 2 labar għall-injezzjoni u tajjara 1 biex tnaddaf.
English: One ml contains 15 million IU of interferon alfa-2b.
Maltese: Millilitru wieħed fih 15-il miljun IU interferon alfa-2b.
English: p value a pegylated interferon alfa-2b (100 or 150c µg/week)
Maltese: Valur pa interferon alfa-2b pegilat(100 jew c µg/ġimgħa) + ribavirin
English: Genotype 2/3: The recommended duration of treatment is 24 weeks.
Maltese: Ġenotip 2/3: It-tul ta' trattament rakkomandat huwa 24 ġimgħa.
English: Eye disorders Very common: Common:
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna: Komuni:
English: In a large study, 1,071 patients were enrolled after treatment in a prior non pegylated interferon alfa-2b or non pegylated interferon alfa-2b/ribavirin study to evaluate the durability of sustained virologic response and assess the impact of continued viral negativity on clinical outcomes.
Maltese: Fi studju kbir, 1,071 pazjent ħadu sehem wara kura fi studju b'interferon alfa-2b mhux pegilat jew b'interferon alfa-2b mhux pegilat/ribavirin sabiex jiġi evalwat kemm idum ir-rispons viroloġiku sistnut u jiġi stmat l-impatt ta' negattività virali kontinwa fuq il-konsegwenzi kliniċi.
English: The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see “Do not use Viraferon”) if you have ever had depression or develop symptoms associated with depression (e.g. feelings of sadness, dejection, etc.) while on treatment with Viraferon (see section 4).
Maltese: Pazjenti b'passat mediku ta' insuffiċjenza tal-qalb konġestiva, infarti mijokardjali u/jew problemi arritmiċi passati jew attwali, li jeħtieġu t-terapija b'Viraferon, għandhom ikunu segwiti mill-qrib.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 million IU/pen
Maltese: INDIVIDWALI 30 miljun IU/pinna
English: It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus-infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Maltese: Huwa maħsub li dan il-proċess huwa responsabbli, għall-inqas parzjalment, għad-diversi risponsi ċellulari għall-interferon, fosthom l-inibizzjoni tar-replikazzjoni tal-vajrus f' ċelluli infettati minn vajrus, it-trażżin tal-proliferazzjoni taċ-ċelluli u attivitajiet immunomodulattivi bħal ma huma żżieda ta' l-attività fagoċitika tal-makrofaġi u ż-żieda taċ-ċitotossiċità speċifika tal-limfoċiti għaċċelluli li huma targits.
English: MARKETING AUTHORISATION NUMBERS EU/1/99/128/032
Maltese: FIS-SUQ EU/1/99/128/032
English: INFORMATION IN BRAILLE Viraferon 5 MIU solution
Maltese: INFORMAZZJONI BIL-BRAILLE Viraferon 5
English: EU/1/99/128/024 12 multiple dose vials
Maltese: EU/1/99/128/024 12-il kunjett b'ħafna dożi
English: Myalgia, arthralgia, musculoskeletal pain Rhabdomyolysis, myositis, leg cramps, back pain
Maltese: Tregħid, parasteżija, ipoesteżija, emigranja, fwawar, ngħas, perverżjoni tat-togħma
English: While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
Maltese: Filwaqt li dan kien irrappurtat aktar ta' spiss fil-pazjenti bl-epatite Ċ kronika ttrattati bl-interferon alpha, kien ukoll irrappurtat fil-pazjenti b'mard onkoloġiku ttrattati bl-interferon alpha.
English: High doses of other forms of interferons alpha and beta are known to produce dose-related anovulatory and abortifacient effects in rhesus monkeys.
Maltese: Dożi għoljin ta' forom oħra ta' interferoni alpha u beta huma magħrufa li jipproduċu effetti konnessi mad-doża li jwaqqfu l-ovulazzjoni u li jwasslu għall-abort fix-xadini tar-razza rhesus.
English: Discontinuation of
Maltese: Disturbi perjodontali
English: Regardless of genotype, patients who received Viraferon in combination with ribavirin and received ≥ 80 % of their treatment had a higher sustained response 6 months after 1 year of treatment than those who took < 80 % of their treatment (56 % vs. 32 % in trial C/I98-580).
Maltese: Irrispettiv millġenotip, il-pazjenti li rċivew Viraferon flimkien ma' ribavirin u rċivew ≥ 80 % tat-trattament tagħhom kellhom rispons sostnut ogħla 6 xhur wara sena ta' trattament minn dawk li ħadu < 80 % tat-trattament tagħhom (56 % vs.
English: NAME OF THE MEDICINAL PRODUCT Viraferon 60 million IU solution for injection multidose pen interferon alfa-2b
Maltese: Viraferon 60 miljun IU soluzzjoni għall-injezzjoni, pinna b'ħafna dożi Interferon alfa-2b
English: §, optic neuritis, papilloedema, loss of visual acuity or visual field, cotton
Maltese: Sturdament, uġigħ ta' ras, telf tal-konċentrazzjoni, ħalq xott
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Maltese: Tista' tkun meħtieġa ssostituzzjoni tal-fluwidi.
English: Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)§, rash maculopapular, rash erythematous, eczema, erythema, skin disorder Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Maltese: Reazzjoni ta' fotosensittività, raxx makulopapulari, ekżema, akne, disturbi fil-ġilda, disturbi fid-dwiefer, telf tal-lewn talġilda, ħakk, ġilda xotta, ħmura, dbenġil, żieda fl-għaraq
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/128/004 1 vial of powder EU/1/99/128/005 6 vials of powder
Maltese: FIS-SUQ EU/1/99/128/004 kunjett 1 ta' trab