FrancophonIA/ELRC3.0 huggingface dataset:
English: One vial of powder contains 5 million IU of interferon alfa-2b and provides 5 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed ta' trab fih 5 miljun IU ta' interferon alfa-2b u jipprovdi 5 miljun IU kull ml ta' interferon alfa-2b meta jkun rikostitwit kif rakkomandat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Viraferon solution for injection, multiple dose vial, contains 25 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 2.5 ml of solution.
Maltese: Kunjett wieħed ta' Viraferon soluzzjoni għall-injezzjoni, kunjett b'doża waħda, fih 25 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 2.5 ml ta' soluzzjoni.
English: • chest pain or persistent and severe cough; irregular or rapid heartbeat; shortness of breath, confusion, difficulty remaining alert, numbness or tingling sensation or pain in hands or feet; seizure (convulsions); trouble sleeping, thinking or concentrating; altered mental state; suicidal thoughts, suicide attempt, changed behaviour or aggressive behaviour (sometimes directed against others), hallucinations; severe stomach pain; black or tar like stools; blood in stool or urine, severe nosebleed; waxy pallor, high sugar level in blood, fever or chills beginning after a few weeks of treatment, lower back or side pain, difficult urination, problems with your eyes or your eyesight or hearing, loss of hearing, severe or painful reddening or sores on your skin or mucous membrane.
Maltese: • uġigħ fis-sider jew sogħla qawwija u persistenti; taħbit tal-qalb irregolari jew mgħaġġel; qtugħ ta' nifs, konfużjoni, tbatija biex toqod attent, tnemnim jew tingiż fl-idejn jew fis-saqajn; aċċessjoni (konvulżjoni); tbati biex torqod, taħseb jew tikkonċentra; stat mentali mibdul; ħsibijiet dwar suwiċidju, attentati ta' suwiċidju, imġieba aggressiva jew mibdula (kultant indirizzata lejn l-oħrajn); alluċinazzjonijiet; uġigħ qawwi fl-istonku; ippurgar iswed jew jixbah lill-qatran; demm fl-ippurgar jew fl-awrina, tinfaraġ bil-qawwa; issir abjad karti, livell għoli ta' zokkor fid-demm, deni jew tkexkix ta' bard jibdew wara ftit ġimgħat ta' trattament, uġigħ fin-naħa t'isfel tad-dahar jew fil-ġenb, diffikultà biex tagħmel l-awrina, problemi flgħajnejn jew fil-vista jew fis-smigħ, telf tas-smigħ, ħmura qawwija jew li tweġġa' jew feriti fuq il-ġilda jew fuq il-membrana mukuża.
English: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Maltese: Iperkinesja, tregħid, disfonja, parasteżija, ipoesteżija, iperesteżija, telf tal-konċentrazzjoni, ngħas
English: NAME OF THE MEDICINAL PRODUCT Viraferon 18 million IU/3 ml solution for injection
Maltese: Viraferon 18-il miljun IU/3 ml soluzzjoni għall-injezzjoni
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains 60 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1.2 ml.
Maltese: Kull skartoċċ fih 60 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 1.2 ml.
English: Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with Viraferon.
Maltese: Testijiet standard ematoloġiċi u tal-komponenti kimiċi tad-demm (l-għadd totali u d-differenzjal taddemm, l-għadd tal-plejlets, l-elettroliti, l-enżimi tal-fwied, il-proteina fis-serum, il-bilirubin fis-serum u l-kreatinina fis-serum) għandhom isiru lill-pazjenti kollha qabel u b'mod perijodiku matul ittrattament sistemiku b'Viraferon.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 25 million IU of interferon alfa-2b in 2.5 ml of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed fih 25 miljun IU ta' interferon alfa-2b f'soluzzjoni ta' 2.5 ml.
English: Maarssenbroeksedijk 4
Maltese: Il-Ġenotipi kollha
English: One ml of solution contains 6 million IU of interferon alfa-2b.
Maltese: Millilitru wieħed fih 6 miljun IU interferon alfa-2b.
English: After first opening the container: Chemical and physical in-use stability has been demonstrated for 28 days at 2ºC - 8ºC.
Maltese: L-istabilità kimika u fiżika waqt l-użu intweriet għal 28 jum f'2ºC - 8ºC.
English: Diagram P
Maltese: Disinn P
English: EXPIRY DATE
Maltese: DATA META JISKADI JIS
English: NAME OF THE MEDICINAL PRODUCT Viraferon 25 million IU/2.5 ml solution for injection
Maltese: Viraferon 25 miljun IU/2.5 ml soluzzjoni għall-injezzjoni
English: Efficacy was defined as sustained virologic response, 6 months after the end of treatment.
Maltese: Effettività kienet iddefinita bħala rispons viroloġiku sostnut, 6 xhur wara t-tmiem tat-trattament.
English: Diagram T
Maltese: Disinn T
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 100 copies/ml), a liver biopsy consistent with a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Maltese: Il-pazjenti eliġibbli għal dawn il-provi kellhom epatite Ċ kronika kkonfermata minn analiżi pożittiva (>100 kopji/ml) tar-reazzjoni katina talpolimerat (PCR) HCV-RNA, bijopsija tal-fwied konsistenti ma' dijanjosi istoloġika ta' epatite kronika bla ebda kawża oħra għall-epatite kronika, u ALT fis-serum anormali.
English: The pen will deliver a maximum of 12 doses of 2.5 million IUover a period not to exceed 4 weeks.
Maltese: Il-pinna tinjetta massimu ta' 12-il doża ta' 2.5 miljun IU fuq perijodu ta' mhux aktar minn 4 ġimgħat.
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) with 6 injection syringes, 6 injection needles and 12 cleansing swabs.
Maltese: u 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). b'6 siringi għall-injezzjoni, 6 labar għall-injezzjoni u 12-il tajjara għat-tindif.
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8).
Maltese: Pazjenti b'sinjali jew b'sintomi kompatibbli ma' problemi ta' awtoimmunità għandhom ikunu evalwati b'attenzjoni, u l-benefiċċju-riskju tat-tkomplija tat-terapija b'interferon għandu jitqies mill-ġdid (ara wkoll sezzjoni 4.4 Epatite Ċ kronika, Monoterpaija (anormalitajiet tattirojde) u sezzjoni 4.8).
English: One ml contains 50 million IU of interferon alfa-2b.
Maltese: Millilitru wieħed fih 50 miljun IU interferon alfa-2b.
English: There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.
Maltese: M'hemmx rapporti dwar infezjonijiet b'albumina manifatturata skond l-ispeċifikazzjonijiet talEuropean Pharmacopoeia bi proċessi stabiliti.
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) with 6 injection syringes, 6 injection needles and 12 cleansing swabs.
Maltese: u 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). b'6 siringi għall-injezzjoni, 6 labar għall-injezzjoni u 12-il tajjara għat-tindif.
English: Measuring the dose of Viraferon
Maltese: 2. QABEL MA TUŻA VIRAFERON
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 3 million IU of interferon alfa-2b in 0.5 ml of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed fih 3 miljun IU ta' interferon alfa-2b f'soluzzjoni ta' 0.5 ml.
English: In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year.
Maltese: F'Tabella 1 il-frekwenza ta' pazjenti li rrappurtaw effetti mhux mixtieqa (konnessi mat-trattament) huma elenkati minn provi kliniċi f'pazjenti naive ittrattati għal sena.
English: Viraferon, 10 million IU/ml solution for injection Interferon alfa-2b
Maltese: Viraferon 10 miljun IU/ml soluzzjoni għall-injezzjoni Interferon alfa-2b
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Viraferon solution for injection, multiple dose vial, contains 18 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 3 ml of solution.
Maltese: Kunjett wieħed ta' Viraferon soluzzjoni għall-injezzjoni, kunjett b'doża waħda, fih 18-il miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 3 ml ta' soluzzjoni.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 10 million IU of interferon alfa-2b in 1 ml of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed fih 10 miljun IU ta' interferon alfa-2b f'soluzzjoni ta' 1 ml.
English: Patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia.
Maltese: Pazjenti kkurati b'Viraferon u ribavirin f'terapija kombinata u zidovudine jista' jkollhom riskju akbar li jiżviluppaw anemija.
English: Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4).
Maltese: Viraferon huwa ndikat għat-trattament ta' pazjenti adulti li għandhom l-epatite Ċ kronika u għandhom transaminases elevati mingħajr dikompensazzjoni tal-fwied u li huma pożittivi għall-HCV-RNA jew għall-anti-HCV fis-serum (ara sezzjoni 4.4).
English: EU/1/99/128/036 2 pens
Maltese: EU/1/99/128/036 2 pinen
English: It is obtained from a clone of E. coli, which harbours a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Maltese: Huwa jinkiseb minn klonu ta' E. coli, li għandu ġo fih ibridu plażmidu mfassal ġenetikament imdawwar ma' ġene ta' interferon alfa-2b minn lewkoċiti umani.
English: Diarrhoea, vomiting, nausea, abdominal pain Mouth ulceration, stomatitis ulcerative, stomatitis, right upper quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder
Maltese: Dijarea, rimettar, tqalligħ, uġigħ fl-addome Ulċeri fil-ħalq, stomatite b'ulċera, stomatite, uġigħ fil-kwadrant lemini ta' fuq, dispepsja, glossite, ittella' mill-istonku, disturbi fir-rektum, disturbi gastro-intestinali, stitikezza, ippurgar maħlul, uġigħ fis-snien, disturbi fis-snien
English: EU/1/99/128/022 1 multiple dose vial, 6 injection syringes, 6 injection needles and 12 cleansing swabs EU/1/99/128/023 2 multiple dose vials
Maltese: EU/1/99/128/022 kunjett 1 b'ħafna dożi, 6 siringi għall-injezzjoni, 6 labar għall-injezzjoni u 12-il tajjara għall-injezzjoni
English: Volume (ml) Corresponding dose (million IU) using Viraferon 25 million IU/2.5 ml solution for injection
Maltese: Volum (ml) Doża li tikkorrispondi (miljun IU) b'Viraferon 25-il miljun IU/3 ml soluzzjoni għallinjezzjoni jew infużjoni
English: §, influenza-like symptoms
Maltese: §, sintomi bħal
English: This must be considered during concomitant therapy with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
Maltese: Dan għandu jkun ikkunsidrat waqt terapija konkomitanti ma' prodotti mediċinali li jkunu metabolati permezz ta' din ir-rotta, bħal ma huma d-derivattivi ta' xanthine, theophylline jew aminophylline.
English: NAME OF THE MEDICINAL PRODUCT Viraferon 3 million IU/0.5 ml solution for injection
Maltese: Viraferon 3 miljun IU/0.5 ml soluzzjoni għall-injezzjoni
English: EU/1/99/128/033 2 pens
Maltese: EU/1/99/128/033 2 pinen
English: The active substance is recombinant interferon alfa-2b, 3 million IU/ml.
Maltese: - Is-sustanza attiva hi interferon alfa-2b rikombinanti, 3 miljun IU f'kunjett b'doża waħda.
English: The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
Maltese: Il-pinna hi magħmula b'mod li tinjetta l-kontenuti tagħha ta' 18-il miljun IU f'dożi fuq medda ta bejn 1.5 sa 6 miljun IU.
English: Viraferon, 25 million IU/2.5 ml solution for injection Interferon alfa-2b
Maltese: Viraferon 25 miljun IU/2.5 ml soluzzjoni għall-injezzjoni interferon alfa-2b
English: Interferon neutralising factor assays were performed on serum samples of patients who received Viraferon in Schering-Plough monitored clinical trials.
Maltese: Interazzjonijiet bejn Viraferon u prodotti mediċinali oħra għadhom ma kinux evalwati għal kollox.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 5 million IU of interferon alfa-2b in 0.5 ml of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed fih 5 miljun IU ta' interferon alfa-2b f'soluzzjoni ta' 0.5 ml.
English: The active substance is recombinant interferon alfa-2b, 5 million IU/ml.
Maltese: - Is-sustanza attiva hi interferon alfa-2b rikombinanti, 5 miljun IU f'kunjett b'doża waħda.
English: After reconstitution, 1 ml contains 5 million IU of interferon alfa-2b.
Maltese: Meta jkun rikostitwit, 1 ml jkun fih 5 miljun IU ta' interferon alfa-2b.
English: One vial of powder contains 10 million IU of interferon alfa-2b and provides 10 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed ta' trab fih 10 miljun IU ta' interferon alfa-2b u jipprovdi 10 miljun IU kull ml ta' interferon alfa-2b meta jkun rikostitwit kif rakkomandat.
English: Diagrams A and B show you all the different parts of the pen and the injection needle.
Maltese: Id-Dijagrammi A u B juruk il-partijiet differenti kollha tal-pinna u tal-labra għall-injezzjoni.
English: Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with Viraferon.
Maltese: Infiltrazzjonijiet pulmonarji, pulmonite, u pnewmonja, li kultant wasslu għall-mewt, kienu innutati f'każijiet rari fil-pazjenti ttrattati bl-interferon alpha, inklużi dawk ittrattati b'Viraferon.
English: Conjunctivitis, vision abnormal, lacrimal gland disorder, eye pain
Maltese: Konġuntivite, vista anormali, disturbi fil-glandola taddmugħ, uġigħ fl-għajnejn
English: One vial of powder contains 3 million IU of interferon alfa-2b and provides 3 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed ta' trab fih 3 miljun IU ta' interferon alfa-2b u jipprovdi 3 miljun IU kull ml ta' interferon alfa-2b meta jkun rikostitwit kif rakkomandat.
English: NAME OF THE MEDICINAL PRODUCT Viraferon 10 million IU/ml solution for injection
Maltese: Viraferon 10 miljun IU/ml soluzzjoni għall-injezzjoni
English: After reconstitution, 1 ml contains 3 million IU of interferon alfa-2b.
Maltese: Meta jkun rikostitwit, 1 ml jkun fih 3 miljun IU ta' interferon alfa-2b.
English: One cartridge contains 30 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1.2 ml.
Maltese: Kull skartoċċ fih 30 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 1.2 ml.
English: The increased response rate to the combination of Viraferon + ribavirin, compared with Viraferon alone, is maintained across all subgroups.
Maltese: Ir-rata ogħla ta' rispons għall-kumbinazzjoni ta' Viraferon + ribavirin, imqabbla ma' Viraferon waħdu, tibqa' ogħla fis-sottogruppi kollha.
English: As in adult patients, children and adolescents also experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Maltese: Bħal f'pazjenti adulti, tfal u adolexxenti kellhom każijiet psikjatriċi avversi oħrajn (eż. dipressjoni, burdati emozzjonali, u ngħas) (ara sezzjoni 4.4).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 million IU/ml
Maltese: INDIVIDWALI 10 miljun IU/ml
English: The active substance is recombinant interferon alfa-2b, 60 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, 60 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: The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
Maltese: Il-pinna hi magħmula b'mod li tinjetta l-kontenuti tagħha ta' 30 miljun IU f'dożi fuq medda ta bejn 2.5 sa 10 miljun IU.
English: NAME OF THE MEDICINAL PRODUCT Viraferon 5 million IU/0.5 ml solution for injection
Maltese: Viraferon 5 miljun IU/0.5 ml soluzzjoni għall-injezzjoni
English: MARKETING AUTHORISATION NUMBERS EU/1/99/128/029
Maltese: FIS-SUQ EU/1/99/128/029
English: 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: EU/1/99/128/026 1 multiple dose vial, 6 injection syringes, 6 injection needles and 12 cleansing swabs EU/1/99/128/027 2 multiple dose vials
Maltese: EU/1/99/128/026 kunjett 1 b'ħafna dożi, 6 siringi għall-injezzjoni, 6 labar għall-injezzjoni u 12-il tajjara għall-injezzjoni
English: Clinical trials in paediatric patients with chronic hepatitis C:
Maltese: Provi kliniċi f'pazjenti pedjatriċi b'epatite Ċ kronika:
English: One vial of powder contains 1 million IU of interferon alfa-2b and provides 1 million IU per ml of interferon alfa-2b when reconstituted as recommended.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed ta' trab fih 1 miljun IU ta' interferon alfa-2b u jipprovdi 1 miljun IU kull ml ta' interferon alfa-2b meta jkun rikostitwit kif rakkomandat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Viraferon solution for injection, single dose vial, contains 10 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1 ml of solution.
Maltese: Kunjett wieħed ta' Viraferon soluzzjoni għall-injezzjoni, kunjett b'doża waħda, fih 10 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 1 ml ta' soluzzjoni.
English: The active substance is recombinant interferon alfa-2b, 10 million IU/ml.
Maltese: - Is-sustanza attiva hi interferon alfa-2b rikombinanti, 10 miljun IU f'kunjett b'doża waħda.
English: 10 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: 10 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: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Viraferon solution for injection, single dose vial, contains 3 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 0.5 ml of solution.
Maltese: Kunjett wieħed ta' Viraferon soluzzjoni għall-injezzjoni, kunjett b'doża waħda, fih 3 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 0.5 ml ta' soluzzjoni.
English: The active substance is recombinant interferon alfa-2b, 30 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, 30 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: EU/1/99/128/030 2 pens
Maltese: EU/1/99/128/030 2 pinen
English: After reconstitution, 1 ml contains 1 million IU of interferon alfa-2b.
Maltese: Meta jkun rikostitwit, 1 ml jkun fih 1 miljun IU ta' interferon alfa-2b.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3 million IU/ml
Maltese: INDIVIDWALI 3 miljun IU/ml
English: §, retinopathies (including macular Retinal haemorrhages oedema), retinal artery or vein obstruction
Maltese: Emoraġġiji fir-retina§, retinopatiji (inkluża edema makulari),
English: Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin.
Maltese: Viraferon għandu jingħata waħdu l-aktar f'każijiet ta' intolleranza jew ta' kontra-indikazzjoni għal ribavirin.
English: Enuresis, micturition disorder, urinary incontinence
Maltese: Enureżi, disturbi ta' l-awrina, inkontinenza ta' l-awrina
English: 60 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 60 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: Prior to initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
Maltese: Qabel tibda t-terapija b'Viraferon għattrattament ta' l-epatite Ċ kronika, qies l-livelli ta' l-ormoni li jistimulaw it-tirojde (TSH) fis-serum.
English: Viraferon, 3 million IU/0.5 ml solution for injection Interferon alfa-2b
Maltese: Viraferon 3 miljun IU/0.5 ml soluzzjoni għall-injezzjoni interferon alfa-2b
English: Viraferon, 5 million IU/0.5 ml solution for injection Interferon alfa-2b
Maltese: Viraferon 5 miljun IU/0.5 ml soluzzjoni għall-injezzjoni Interferon alfa-2b
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of Viraferon solution for injection, single dose vial, contains 5 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 0.5 ml of solution.
Maltese: Kunjett wieħed ta' Viraferon soluzzjoni għall-injezzjoni, kunjett b'doża waħda, fih 5 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 0.5 ml ta' soluzzjoni.
English: 0.5 ml of solution (corresponding to 3 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in an flip-off seal (aluminium) with a bonnet (polypropylene).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 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).
English: Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)
Maltese: Alopeċja, ħakk*, ġilda xotta*, raxx*, żieda fl-għaraq Psorajiżi (tibda jew taggrava)
English: Psychiatric disorders
Maltese: Disturbi psikjatriċi§
English: The relative benefit of combination therapy with Viraferon + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Maltese: Il-benefiċċju relattiv tat-terapija kombinata b'Viraferon + ribavirin hi b'mod partikulari sinifikattiva fis-sotto-grupp ta' pazjenti li huma l-aktar diffiċli biex ikunu ttrattati (ġenotip 1 u piż għoli ta' vajrus) (Tabella 3).