FrancophonIA/ELRC3.0 huggingface dataset:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: Renal and urinary disorders Common:
Maltese: Disturbi fil-kliewi u fissistema urinarja Komuni:
English: The administered dose should be reduced by 50 % in case of occurrence of haematological disorders (white 3, granulocytes < 1,000/mm 3, thrombocytes < 100,000/mm 3).
Maltese: Id-doża mogħtija għanda titnaqqas b'50 % f'każ li jseħħu problemi ematoloġiċi (ċelluli bojod tad3, granuloċiti < 1,000/mm 3, tromboċiti < 100,000/mm 3).
English: HCV/HIV Coinfection: Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Maltese: Pazjenti ko-infettati bl-HIV u li qed jirċievu Terapija Anti-Retrovirali Attiva Ħafna (HAART) jista' jkollhom riskju akbar li jiżviluppaw l-aċidożi lattika.
English: All Genotype 1,
Maltese: Kollox Ġenotip 1,
English: Outer carton
Maltese: Kodici talkulur
English: Needle
Maltese: Gibjun
English: Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Maltese: Minħabba nuqqas ta' dejta fi tfal b'avvanz sever talmarda, u l-potenzjal ta' effetti sekondarji, il-benefiċċju/riskju tat-taħlita ta' ribavirin ma' interferon alfa-2b għandha titqies bl-attenzjoni f'din il-popolazzjoni (ara sezzjonijiet 4.1, 4.4 u 4.8).
English: Children and adolescents: Multiple-dose pharmacokinetic properties for Viraferon injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized in Table 6.
Maltese: Il-karatteristiċi tal-farmakokinetika ta' ħafna dożi għall-injezzjoni Viraferon u kapsuli ribavirin fi tfal u adolexxenti b'epatite Ċ kronika, bejn 5 u 16-il sena, qegħdin imqassra f'Tabella 6.
English: However, based on interim data from a long-term follow-up study, 12 (14 %) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6 %) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Maltese: Madankollu, minn dejta interim minn studju ta' follow-up fuq perijodu twil, 12 (14 %) ta' l-84 tfal kellhom > 15 perċentwali fir-rata ta' tkabbir linejari, li minnhom 5 (6 %) tat-tfal kellhom tnaqqis ta' > 30 perċentwali minkejja li kienu waqqfu l-kura għal aktar minn sena.
English: For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue Viraferon therapy.
Maltese: Għall-pazjenti kollha, jekk ma jidhirx titjib ta' l-HBV-DNA fis-serum wara 3 sa 4 xhur ta' trattament (bid-doża massima ttollerata), waqqaf it-terapija b'Viraferon.
English: The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Maltese: Itterapija damet 48 ġimgħa b'perijodu ta' follow-up ta' 6 xhur ħlief għall-pazjenti li kienu infettati b'ġenotipi 2 jew 3 u viral load < 800,000 IU/ml (Amplicor) li kienu kkurati għal 24 ġimgħa b'perijodu ta 6 xhur follow-up.
English: Belgium
Maltese: Belgique/Belgien
English: Pack of 12 vials
Maltese: Pakketti b'12-il kunjett
English: Diagram B
Maltese: Disinn B
English: Store in a refrigerator.
Maltese: Aħżen fil-friża.
English: In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
Maltese: F'terapija kombinata ma' ribavirin, agħti każ tat-tagħrif rispettiv talprodotti mediċinali li fihom ribavirin.
English: INFORMATION IN BRAILLE Viraferon 18 MIU pen
Maltese: INFORMAZZJONI BIL-BRAILLE Viraferon 18 MIU pinna
English: Diagram H
Maltese: Disinn H
English: Rarely reported side effects (at least 1 in every 10,000 patients, but less than 1 in every 1,000 patients): pneumonia
Maltese: Effetti sekondarji rrappurtati b'mod rari (mill-anqas 1 f'kull 10,000 pazjent, iżda anqas minn 1 f'kull 1,000 pazjent): pulmonite
English: d p value b
Maltese: 1,200 mg)d valur p
English: Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
Maltese: Anormalitajiet tal-laboratorju klinikament sinifikanti, li l-aktar li jseħħu f'dożi ta' aktar minn 10 miljun IU kuljum, jinkludu t-tnaqqis fl-għadd tal-granuloċiti u taċ-ċelluli bojod tad-demm; tnaqqis fil-livell ta' l-emoglobina u ta' l-għadd tal-plejtlets; żidiet fil-livelli ta' alkaline phosphatase, LDH, kreatinina fis-serum u tan-nitroġenu ta' l-urea fis-serum.
English: Daily dosing of cynomolgus monkeys with 20 x 10
Maltese: It-tossiċità dehret fix-xadini li ngħataw 100 x 10
English: Combination therapy with ribavirin: Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Maltese: Terapija flimkien ma' ribavirin: Ara wkoll l-SPC ta' ribavirin jekk l-interferon alfa-2b se jingħata flimkien ma' ribavirin fil-pazjenti bl-epatite Ċ kronika.
English: Children 3 years of age and older and adolescents3 million IU/m
Maltese: Tfal 3 snin jew akbar u adolexxenti - 3 miljun IU/m
English: Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Maltese: L-informazzjoni preliminari tindika li t-terapija bl-interferon alpha hija assoċjata ma' rata ikbar ta' riġett ta' trapjanti tal-kliewi.
English: However, the chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC.
Maltese: Madankollu, l-istabilità kimika u fiżika waqt l-użu intweriet għal 24 siegħa f'25ºC.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Komuni:
English: Break the top of the ampoule of solvent.
Maltese: 6 kunjetti ta' trab u 6 ampulli ta' solvent
English: Very rarely reported side effects (less than 1 in every 10,000 patients): low blood pressure, puffy face, diabetes, leg cramps, back pain, kidney problems, nerve damage, bleeding gums, aplastic anaemia.
Maltese: Effetti sekondarji rrappurtati rari ħafna (anqas minn 1 f'kull 10,000 pazjent): pressjoni baxxa, wiċċ impaħpaħ, dijabete, bugħawwieġ fir-riġlejn, uġigħ fid-dahar, problemi talkliewi, ħsara fin-nervituri, fsada tal-ħanek, anemija aplastika.
English: §, hyperuricemia, increased appetite Hypertriglyceridemia
Maltese: §, iperuriċemija, żieda fl-aptit Ipertrigliċeridemika
English: Pack sizes of 1 and 10
Maltese: Pakketti ta' daqsijiet b'1 jew 10
English: p value a alfa-2b (100 or c µg/week) + ribavirin
Maltese: Valur pa alfa-2b pegilat(100 jew 150c µg/ġimgħa) + ribavirin
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3 million IU/0.5 ml
Maltese: INDIVIDWALI 3 miljun IU/0.5 ml
English: Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/kg/week) plus ribavirin (800 mg/day) or Viraferon (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Maltese: Il-pazjenti kienu randomized biex jirċievu interferon alfa-2b pegilat (1.5 µg/kg/ġimgħa) flimkien ma' ribavirin (800 mg/jum) jew inkella Viraferon (3 MIU TIW) flimkien ma' ribavirin (800 mg/jum) għal 48 ġimgħa b'perijodu ta' follow-up ta' 6 xhur.
English: Pack sizes of 1
Maltese: Pakketti ta' daqsijiet b'1
English: Hyperglycaemia, hypertriglyceridaemia
Maltese: Ipergliċemija, ipertrigliċeridemija
English: Chemical and physical in-use stability has been demonstrated for 27 days at 2ºC - 8ºC.
Maltese: L-istabilità kimika u fiżika waqt l-użu intweriet għal 27 jum f'2ºC - 8ºC.
English: After intravenous administration, serum interferon levels peaked (135 to 273 IU/ml) by the end of the infusion, then declined at a slightly more rapid rate than after subcutaneous or intramuscular administration of medicinal product, becoming undetectable four hours after the infusion.
Maltese: Wara l-għoti ġol-vina, il-livelli ta' l-interferon fis-serum laħqu l-ogħla livell (135 sa 273 IU/ml) mattmiem ta' l-infużjoni, imbagħad naqsu b'rata ftit aktar mgħaġġla milli wara l-għoti tal-prodott mediċinali taħt il-ġilda jew ġol-muskolu, u ma setgħux jitkejjlu aktar erba' sigħat wara l-infużjoni.
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCVRNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received Viraferon 3 MIU/m
Maltese: Tfal u adolexxenti minn 3 sa 16-il sena b'epatite Ċ kronika kumpensata u HCV-RNA li jista' jitkejjel (stmat b'laboratorju ċentrali b'assay RT-PCR bażat fuq riċerka) ħadu sehem f'żewġ provi multiċentriċi u rċevew Viraferon 3 MIU/m
English: * 4 full turns correspond to the maximum dose to be administered in one injection.
Maltese: *4 dawriet sħaħ jikkorrispondu għad-doża massima li tista' tingħata b'injezzjoni waħda.
English: Reservoir
Maltese: Viraferon
English: Pack of 6 vials of powder for solution for injection and 6 ampoules of water for injections Pack of 10 vials of powder for solution for injection, 10 ampoules of water for injections, 10 injection syringes, 20 injection needles and 10 cleansing swabs Not all pack sizes may be marketed.
Maltese: Pakkett b'10 kunjetti ta' trab għal soluzzjoni għall-injezzjoni jew infużjoni, 10 ampulli bl-ilma għall-injezzjonijiet, 10 siringi għall-injezzjoni, 20 labra għall-injezzjoni u 10 tajjar biex tnaddaf.
English: Relapse patients: A total of 345 interferon alpha relapse patients were treated in two clinical trials with Viraferon monotherapy or in combination with ribavirin.
Maltese: Total ta' 345 pazjent ta' l-interferon alpha li rkadew kienu ittrattati f'żewġ provi kliniċi bil-monoterapija b'Viraferon jew flimkien ma' ribavirin.
English: For the next step hold the pen in the middle of the barrel.
Maltese: B'id waħda oqros biċċa ġilda 'l barra.
English: The abnormalities were controlled by conventional therapy for thyroid dysfunction.
Maltese: L-anormalitajiet kienu kkontrollati bit-terapija konvenzjonali għall-funzjoni ħażina tat-tirojde.
English: Excipients: disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 and water for injections
Maltese: - Is-sustanzi l-oħra huma disodium phosphate anhydrous, sodium dihydrogen phosphate monohydrate, edetate disodium, sodium chloride, m-cresol, polysorbate 80 u ilma għall injezzjonijiet.
English: Viraferon is usually intended for subcutaneous use.
Maltese: Viraferon huwa normalment maħsub għall-użu taħt il-ġilda.
English: In adult patients receiving interferon in combination with ribavirin, the achieved sustained response rate is 47 %.
Maltese: F'pazjenti adulti li jkunu qed jirċievu interferon ma' ribavirin, ir-rata ta' rispons sostnut li nkisbet hija 47 %.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pen contains 60 million IU of interferon alfa-2b in 1.2 ml of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pinna waħda fiha 60 miljun IU ta' interferon alfa-2b f'1.2 ml ta' soluzzjoni.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, <1/10).
Maltese: Bil-klassijiet tas-sistemi ta' l-organi, ir-reazzjonijiet avversi huma elenkati taħt it-titli tal-frekwenza bil-kategoriji li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100, <1/10).
English: Patients who also have HIV infection: Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti-Retroviral Therapy (HAART), an HIV treatment.
Maltese: L-aċidożi lattika u l-funzjoni tal-fwied li teħżien huma effetti sekondarji assoċjati mat-Terapija Anti-Retrovirali Attiva Ħafna (HAART), li hija trattament għall-HIV.
English: Viraferon, 18 million IU/3 ml solution for injection Interferon alfa-2b
Maltese: Viraferon 18 miljun IU/3 ml soluzzjoni għall-injezzjoni Interferon alfa-2b
English: The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials.
Maltese: Ir-reazzjonijiet avversi elenkati f'Tabella 2 huma bbażati fuq esperjenza minn provi kliniċi pedjatriċi.
English: Pack of 1 vial
Maltese: Pakkett b'kunjett 1
English: In adult patients with loss of HBeAg and HBV-DNA, a significant reduction in morbidity and mortality has been observed.
Maltese: F'pazjenti adulti bi tnaqqis ta' HBeAg u ta' HBV-DNA, kien innutat tnaqqis sinifikattiv filmorbidità u fil-mortalità.
English: 1 single dose vial, 1 injection syringe, 1 injection needle and 1 cleansing swab 6 single dose vials, 6 injection syringes, 6 injection needles and 6 cleansing swabs 12 single dose vials, 12 injection syringes, 12 injection needles and 12 cleansing swabs
Maltese: 10 miljun IU/ml soluzzjoni għall-injezzjoni kunjett 1 b'doża waħda kunjett 1 b'doża waħda, siringa 1 għall-injezzjoni, labra 1 għall-injezjoni u tajjara 1 għat-tindif 6 kunjetti b'doża waħda, 6 siringi għall-injezzjoni, 6 labar għall-injezzjoni u 6 tajjara għat-tindif 12-il kunjett b'doża waħda, 12-il siringa għall-injezzjonijiet, 12-il labra għall-injezzjonijiet u 12-il tajjara għat-tindif
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pen contains 18 million IU of interferon alfa-2b in 1.2 ml of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pinna waħda fiha 18-il miljun IU ta' interferon alfa-2b f'1.2 ml ta' soluzzjoni.
English: Very commonly reported side effects (at least 1 in every 10 patients): pain, swelling and redness or skin damage at site of injection, hair loss, dizziness, changes in appetite, stomach or abdominal pains, diarrhoea, nausea (feeling sick), viral infection, depression, emotional lability, insomnia, anxiety, sore throat and painful swallowing, fatigue, chills/rigors, fever, flu-like reaction, feeling of general discomfort, headaches, weight loss, vomiting, irritability, weakness, mood swings, coughing (sometimes severe), shortness of breath, itching, dry skin, rash, sudden and severe muscle pain, joint pain, musculoskeletal pain, changes in laboratory blood values including decreased white blood cell count.
Maltese: Effetti sekondarji rrappurtati komuni ħafna (mill-anqas 1 f'kull 10 pazjenti): uġigħ, nefħa u ħmura jew ħsara fil-ġilda fis-sit mnejn tingħata l-injezzjoni, telf tax-xagħar, sturdament, tibdil fl-aptit, weġgħat fl-istonku jew fl-addome, dijarea, tqalligħ (tħossok marid), infezzjoni virali, depressjoni, burdati emozzjonali, nuqqas ta' rqad, ansjetà, grieżem misluħa u uġigħ biex tibla, għeja, dehxiet/tregħid, deni, reazzjoni bħal ta' l-influwenza, tħossok skomdu b'mod ġenerali, attakki ta' uġigħ ta' ras, telf tal-piż, rimettar, irritabilità, dgħjufija, tibdil fil-burdati, sogħla (kultant qawwija), qtugħ ta' nifs, ħakk, ġilda xotta, raxx, uġigħ muskolari sever f'salt, uġigħ fil-ġogi, uġigħ muskoluskeletali, bidliet fil-valuri tal-laboratorju inkluż tnaqqis fl-għadd taċ-ċelluli bojod.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 million IU/0.5 ml
Maltese: INDIVIDWALI 5 miljun IU/0.5 ml
English: You can save the swab to clean the skin area where you will inject the dose.
Maltese: Każijiet ta' puplesija (każ ċerebrovaskulari) kien irrappurtat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/128/006 1 vial of powder EU/1/99/128/007 6 vials of powder EU/1/99/128/008 10 vials of powder
Maltese: EU/1/99/128/007 6 kunjetti ta' trab EU/1/99/128/008 10 kunjetti ta' trab
English: Study results are summarized in Table 5.
Maltese: Riżultati ta' l-istudju qegħdin imqassra f'Tabella 5
English: Virological response is defined as absence of detectable HCV-RNA at Week 12.
Maltese: Rispons viroloġiku huwa definit bħala nuqqas ta' HCV-RNA li jista' jitkejjel f'ġimgħa 12.
English: Preparation Collect necessary items before you begin: a vial of Viraferon solution for injection; a 1 ml syringe; a needle for the subcutaneous injection (for example 0.4 × 13 mm [27 gauge 0.5 inch]); a cleansing swab.
Maltese: Preparazzjoni Iġbor l-affarjiet kollha li għandek bżonn qabel tibda: kunjett ta' Viraferon soluzzjoni għall-injezzjoni; siringa ta' 1 ml; labra biex tinjetta taħt il-ġilda (per eżempju 0.4 x 13 mm [ 27 gauge 0.5 pulzieri]; tajjara għat-tindif Aħsel idejk sew.
English: EU/1/99/128/034 8 pens
Maltese: EU/1/99/128/034 8 pinen
English: INFORMATION IN BRAILLE Viraferon 3 MIU powder
Maltese: INFORMAZZJONI BIL-BRAILLE Viraferon 3 MIU soluzzjoni
English: SK-811 01 Bratislava Tel: + 421 (2) 5920 2712
Maltese: Tel: + 421 (2) 5920 2712
English: Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhea, sneezing
Maltese: Dispneja, takipneja, epistassi, sogħla, konġestjoni fl-imnieħer, irritazzjoni fl-imnieħer, flissjoni, għatis
English: Diagram S
Maltese: Disinn S
English: Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive
Maltese: Epistassi, disturbi respiratorji, konġestjoni fl-imnieħer, rinoreja, sogħla fil-vojt
English: 1.2 ml of solution (corresponding to 18 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs
Maltese: Soluzzjoni ta' 1.2 ml (jikkorrispondi għal 18 MIU) f'pinna mgħamula minn skartoċċ (ħġieġ tat-tip I) siġillata minn naħa waħda b'għatu (aluminium) li għandu kisja (lasktu tal-bromobutyl ) u fuq in-naħa l-oħra bi planġer (lasktu tal-bromobutyl) bi 12-il labra għall-injezzjonijiet u 12 il-tajjara għat-tindif.
English: Pack of 1 vial, 6 injection syringes, 6 injection needles and 12 cleansing swabs Pack of 2 vials
Maltese: Pakkett b'kunjett 1, 6 siringi għall-injezzjoni, 6 labar għall-injezzjoni u 12-il tajjara għat-tindif Pakkett b'2 kunjetti
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCVRNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received Viraferon 3 MIU/m2 3 times a week plus ribavirin 15 mg/kg per day for 1 year followed by 6 months follow-up after-treatment.
Maltese: Tfal u adolexxenti minn 3 sa 16-il sena b'epatite Ċ kronika kumpensata u HCV-RNA li jista' jitkejjel (stmat b'laboratorju ċentrali b'assay RT-PCR bażat fuq riċerka) ħadu sehem f'żewġ provi multiċentriċi u rċevew Viraferon 3 MIU/m2 3 darbiet fil-ġimgħa ma' ribavirin 15 mg/kg għal kul jum għal sena segwit b'6 xhur follow-up wara l-kura.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pen contains 30 million IU of interferon alfa-2b in 1.2 ml of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pinna waħda fiha 30 miljun IU ta' interferon alfa-2b f'1.2 ml ta' soluzzjoni.
English: Diagram O
Maltese: Disinn O
English: Current clinical experience in patients who remain on interferon alfa-2b for 4 to 6 months indicates that therapy can produce clearance of serum HBV-DNA.
Maltese: L-esperjenza klinika attwali f'pazjenti li jibqgħu fuq l-interferon alfa-2b minn 4 sa 6 xhur tindika li tterapija tista' tipproduċi l-eliminazzjoni ta' l-HBV-DNA mis-serum.
English: Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons.
Maltese: Effetti oħra fuq is-CNS inkluż imġieba aggressiva (kultant indirizzata lejn loħrajn), konfużjoni u tibdil fl-istat mentali dehru b'alpha interferons.
English: Diagram K
Maltese: Disinn K
English: INFORMATION IN BRAILLE Viraferon 18 MIU solution
Maltese: INFORMAZZJONI BIL-BRAILLE Viraferon 18 MIU soluzzjoni
English: During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCVRNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
Maltese: Waqt provi kliniċi, il-pazjenti li ma wrewx rispons viroloġiku wara 6 xhur ta' trattament (HCV-RNA inqas mil-limitu li jista' jkun imkejjel) ma sostnewx ir-rispons viroloġiku tagħhom (HCV-RNA inqas mil-limitu li jista' jkun imkejjel sitt xhur wara l-waqfien tat-trattament).
English: Among children and adolescents treated with Viraferon in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % vs 1 %) during treatment and during the 6-month follow-up after treatment.
Maltese: Fost it-tfal u adolexxenti kkurati b'Viraferon ma' ribavirin, ħsibijiet dwar suwiċidju u attentati ta' suwiċidju kienu rrappurtati aktar ta' spiss meta mqabbla ma' pazjenti adulti (2.4 % vs 1 %) waqt il-kura u fil-perijodu ta' 6 xhur follow-up ta' wara lkura.
English: HCV Genotype
Maltese: KIF TINJETTA
English: However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is indicated.
Maltese: Madankollu, bħal f'kull sustanza farmakoloġikament attiva, huwa indikat li jsir trattament sintomatiku b'monitoraġġi spissi tas-sinjali vitali u osservazzjoni mill-qrib tal-pazjent.
English: §, increased appetite
Maltese: §, ipertajrojdiżmu§
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 18 million IU of interferon alfa-2b in 3 ml of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed fih 18-il miljun IU ta' interferon alfa-2b f'soluzzjoni ta' 3 ml.
English: Packs sizes of 1, 6 or 12.
Maltese: Pakketti ta' daqsijiet b'1, 6 jew 12.
English: Preparation Collect necessary items before you begin: a vial of Viraferon solution for injection; a 2 ml syringe; a needle for the subcutaneous injection (for example 0.4 × 13 mm [27 gauge 0.5 inch]); a cleansing swab.
Maltese: Preparazzjoni Iġbor l-affarjiet kollha li għandek bżonn qabel tibda: kunjett ta' Viraferon soluzzjoni għall-injezzjoni; siringa ta' 2 ml; labra biex tinjetta taħt il-ġilda (per eżempju 0.4 x 13 mm [ 27 gauge 0.5 pulzieri]; tajjara għat-tindif Aħsel idejk sew.
English: INFORMATION IN BRAILLE Viraferon 1 MIU powder
Maltese: INFORMAZZJONI BIL-BRAILLE Viraferon 1 MIU trab
English: In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).
Maltese: Fi studji ta' l-użu ta' l-interferon fi primati mhux umani, anormalitajiet taċ-ċiklu mestruwali kienu innutati (ara sezzjoni 4.4).
English: Interferon neutralising factors are antibodies which neutralise the antiviral activity of interferon.
Maltese: Il-fatturi li jinnewtralizzaw l-interferon huma antikorpi li jinnewtralizzaw l-attività antivirali ta' l-interferon.
English: The potential risk for humans is unknown.
Maltese: Mhux magħruf ir-riskju potenzjali fuq innies.
English: ANNEX II
Maltese: IS-210
English: EU/1/99/128/031 8 pens
Maltese: EU/1/99/128/031 8 pinen
English: HOW TO STORE VIRAFERON
Maltese: VIRAFERON LILEK
English: Hypertension Peripheral ischaemia, hypotension
Maltese: Pressjoni għolja Iskemija periferali, pressjoni baxxa
English: These three main classes are themselves not homogeneous and may contain several different molecular species of interferon.
Maltese: Dawn it-tliet klassijiet ewlenin fihom infushom mhumiex omoġeni u jista' jkun fihom diversi speċi molekulari differenti ta' interferon.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One cartridge contains 18 million IU of recombinant interferon alfa-2b produced in E.coli by recombinant DNA technology, in 1.2 ml.
Maltese: Kull skartoċċ fih 18-il miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 1.2 ml.
English: EU/1/99/128/037 8 pens
Maltese: EU/1/99/128/037 8 pinen
English: EU/1/99/128/025 EU/1/99/128/026 EU/1/99/128/027 EU/1/99/128/028
Maltese: EU/1/99/128/026 EU/1/99/128/027 EU/1/99/128/028