FrancophonIA/ELRC3.0 huggingface dataset:
English: The powder is contained in a 2 ml vial (Type I flint glass) with a butyl rubber stopper in an aluminium flip-off seal with a polypropylene bonnet.
Maltese: It-trab jinżamm f'kunjett ta' 2 ml, (ħġieġ taż-żnied ta' Tip I), b'tapp tal-lasktu tal-butyl b'siġill talaluminium tat-tip flip-off b'għatu tal-polypropylene.
English: 205 N/A
Maltese: 48 ġimgħa
English: Micturition frequency, polyuria, urine abnormality
Maltese: Frekwenza tal-awrina, żieda fl-awrina, anormalità fl-awrina
English: Neuropathy, neuropathy peripheral
Maltese: Newropatija, newropatija periferali
English: - Patients with detectable but ≥ 2 log decrease in HCV-RNA level from baseline at treatment week 12 should be reassessed at treatment week 24 and, if HCV-RNA is undetectable, they should continue with full course of therapy (i.e. a total of 48 weeks).
Maltese: - Pazjenti b'livell ta' HCV-RNA li jista' jitkejjel iżda bi tnaqqis ta' ≥2 log mil-linja bażi filġimgħa ta' kura 12 għandhom jiġu evalwati mill-ġdid f'ġimgħa 24 u, jekk l-HCV-RNA ma jkunx jista' jitkejjel, għandhom ikomplu bil-kors kollu ta' terapija (i.e. total ta' 48 ġimgħa).
English: Aplasia pure red cell Immune system disorders Uncommon:
Maltese: Disturbi fis-sistema immuni Mhux komuni:
English: These reactions are listed in table 6 by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Maltese: Dawn ir-reazzjonijiet huma elenkati f'Tabella 6 skont ilklassi tas-sistemi u tal-organi u l-frekwenza (komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) jew mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: HCV/HBV Coinfection
Maltese: Infezzjoni fl-istess ħin b'HCV/HBV
English: Renal clearance appears to account for 30 % of total clearance of ViraferonPeg.
Maltese: Tneħħija mill-kliewi tidher li hija responsabbli għal 30 % tat-tneħħija totali ta' ViraferonPeg.
English: 100 micrograms/0.5 ml
Maltese: 100 mikrogramma/0,5 ml
English: Patients were randomized to receive either ViraferonPeg (100 or 150 µg/week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).
Maltese: Il-pazjenti ntgħażlu b'mod każwali biex jirċievu ViraferonPeg (100 jew 150 µg/ġimgħa skont il-piż) flimkien ma' ribavirin (800-1.200 mg/jum skont il-piż) jew interferon alfa-2b (3 MIU TIW) flimkien ma' ribavirin (800-1,200 mg/jum skont il-piż).
English: 80 micrograms/0.5 ml
Maltese: 80 mikrogramma/0,5 ml
English: Geometric Mean Ratio (Ratio with/without peginterferon alfa-2b)
Maltese: Proporzjon tal-Medja Ġeometrika (Proporzjoni bi/mingħajr peginterferon alfa-2b)
English: Forty-one percent of subjects (97/235) had nondetectable plasma HCV-RNA levels at week 4 and week 24 of therapy.
Maltese: Wieħed u erbgħin fil-mija tal-individwi (97/235) kellhom livelli ta' HCV-RNA fil-plażma li ma jitkejlux f'ġimgħa 4 u ġimgħa 24 tat-terapija.
English: 50 micrograms/0.5 ml
Maltese: 50 mikrogramma/0.5 ml
English: These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with ViraferonPeg monotherapy.
Maltese: Dawn ir-reazzjonijiet avversi kienu komuni (≥1/100 sa < 1/10) fi provi kliniċi f'pazjenti kkurati b'monoterapija b'ViraferonPeg.
English: • Genotypes 2 or 3:
Maltese: • Ġenotip 2 jew 3:
English: 150 micrograms/0.5 ml
Maltese: 150 mikrogramma/0,5 ml
English: Photosensitivity reaction, rash maculo-papular, skin exfoliation, pigmentation disorder, dermatitis atopic, skin discolouration Musculoskeletal and connective tissue disorders Very common:
Maltese: Reazzjoni ta' fotosensittività, raxx makulopapulari, tqaxxir tal-ġilda, disturb tal-pigmentazzjoni, dermatite atopika, il-ġilda titlef il-kulur Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna:
English: Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 14).
Maltese: Rispons Viroloġiku Sostnut (SVR - sustained virologic response) huwa definit bħala HCV-RNA li ma jistax jitkejjel fl-24 ġimgħa wara l-kura (Tabella 14).
English: "Push-On Needle"
Maltese: "Labra PushOn"
English: Mean (SD) ViraferonPeg elimination half-life is approximately 40 hours (13.3 hours), with apparent clearance of 22.0 ml/hr/kg.
Maltese: Il-half-life tal-eliminazzjoni medja ta' ViraferonPeg hija ta' madwar 40 siegħa (13,3 siegħa) b'rata ta' tneħħija apparenti ta' 22,0 ml/siegħa/kg.
English: Conjunctival haemorrhage, eye pruritus, keratitis, vision blurred, photophobia Ear and labyrinth disorders Common:
Maltese: Emorraġija fil-konġuntiva, ħakk fl-għajnejn, keratite, vista mċajpra, fotofobija Distrubi fil-widnejn u fis-sistema labirintika Komuni:
English: How to self-inject ViraferonPeg?
Maltese: Kif tinjetta ViraferonPeg lilek innifsek?
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa products, notably in patients with risk factors for PAH (such as portal hypertension, HIV-infection, cirrhosis).
Maltese: Ġew irrapportati każijiet ta' pressjoni arterjali pulmonari għolja (PAH) bi prodotti li fihom interferon alfa, b'mod partikolari f'pazjenti b'fatturi ta' riskju għall-PAH (bħal pressjoni portali għolja, infezzjoni tal-HIV, ċirrożi).
English: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µl.
Maltese: F'pazjenti li jkollhom fl-istess ħin HCV/HIV, dejta limitata dwar l-effikaċja u s-sigurtà (N=25) hija disponibbli f'individwi b'għadd ta' CD4 anqas minn 200 ċellula/µl.
English: Anaemia, leucopenia, neutropenia
Maltese: Ipokalċemija, iperuriċemija, deidratazzjoni, żieda fl-aptit
English: One ampoule of solvent contains 0.7 ml of water for injections.
Maltese: Ampulla waħda ta' solvent fiha 0,7 ml ilma għall-injezzjonijiet.
English: ViraferonPeg 1.5 micrograms/kg
Maltese: ViraferonPeg 1,5 mikrogrammi/kg
English: Leukocytes
Maltese: Lewkoċiti
English: Clinical efficacy and safety - Adults Tritherapy with ViraferonPeg, ribavirin and boceprevir Refer to the SmPC for boceprevir.
Maltese: Terapija bi tliet mediċini b'ViraferonPeg, ribavirin u boceprevir Irreferi għall-SmPC ta' boceprevir.
English: HCV-RNA negative or ≥ 2 log decrease in viral load
Maltese: HCV-RNA negattiv jew tnaqqis ta' ≥ 2 log fl-ammont virali
English: The reconstituted solution has a concentration of 80 micrograms/0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 80 mikrogramma/0,5 ml.
English: Excipients with known effect: Each vial contains 40 mg of sucrose per 0.5 ml.
Maltese: Kull kunjett fih 40 mg ta' sucrose f'kull 0,5 ml.
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated ribavirin for co-HCV infection (see section 4.4).
Maltese: Tossiċità mitokondrijali u aċidożi lattika kienu rrappurtati f'pazjenti pożittivi għall-HIV li kienu qed jirċievu kors ta' NRTI u ribavirin assoċjat għall-infezzjoni fl-istess ħin b'HCV (ara sezzjoni 4.4).
English: Aggression, agitation, anger, mood altered, abnormal behaviour, nervousness, sleep disorder, libido decreased, apathy, abnormal dreams, crying
Maltese: Imġiba aggressiva, aġitazzjoni, rabja, burdata tinbidel, imġiba mhux normali, nervi, disturbi fl-irqad, nuqqas fil-libido, apatija, ħolm mhux normali, biki
English: ViraferonPeg monotherapy was not studied in HCV/HIV co-infected patients.
Maltese: Monoterapija b'ViraferonPeg ma kinitx studjata f'pazjenti koinfettati b'HCV/HIV.
English: For patients with prior failure on therapy with nonpegylated interferon or pegylated interferon and negative at week 12, the sustained response rates were 59 % and 50 %, respectively.
Maltese: Għall-pazjenti li ma kinux irnexxew b'terapija li ngħatat qabel b'interferon mhux pegilat jew interferon pegilat u negattivi f'ġimgħa 12, ir-rati ta' rispons sostnut kienu ta' 59 % u 50 %, rispettivament.
English: Class label for interferon products, see below Pulmonary arterial hypertension.
Maltese: Tikketta tal-klassi għall-prodotti ta' interferon, ara hawn taħt “Pressjoni arterjali pulmonari għolja”.
English: Second dose reduction to ViraferonPeg 0.5 µg/kg
Maltese: It-tieni tnaqqis tad-doża għal ViraferonPeg 0,5 µg/kg
English: After injection of the dose, discard the pen in an appropriate container.
Maltese: Wara li tinjetta d-doża, armi l-pinna f'kontenitur adattat.
English: The following other side effects (not listed above) have occurred with the combination of this medicine and ribavirin capsules (adults) in HCV/HIV co-infected patients receiving HAART: - oral candidiasis (oral thrush), - defective metabolism of fat, - CD4 lymphocytes decreased, - appetite decreased, - back pain, - hepatitis, - limb pain, - and various laboratory blood values abnormalities.
Maltese: L-effetti sekondarji l-oħra li ġejjin (mhux elenkati fuq) seħħew bil-kombinazzjoni ta' din il-mediċina u lkapsuli ta' ribavirin (adulti) f'pazjenti infettati wkoll b'HCV/HIV li kienu qed jirċievu HAART: - kandidijasi fil-ħalq (tbajja' bojod fil-ħalq), - metaboliżmu diffettuż tax-xaħam, - tnaqqis tal-limfoċiti CD4, - tnaqqis fl-aptit, - uġigħ fid-dahar, - epatite, - uġigħ fid-dirgħajn u fir-riġlejn, - u diversi anormalitajiet ta' valuri tal-laboratorju ta' testijiet tad-demm.
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Maltese: L-użu ta' ribavirin flimkien ma' zidovudine mhux irrakkomandat minħabba żieda fir-riskju ta' anemija (ara sezzjoni 4.4).
English: However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Maltese: Madankollu dan ma jeskludix li jkun hemm avvenimenti epatiċi f'pazjenti b'ċirrożi (inkluża epatokarċinoma).
English: Amnesia, memory impairment, syncope, migraine, ataxia, confusion, neuralgia, paraesthesia, hypoaesthesia, hyperaesthesia, hypertonia, somnolence, disturbance in attention, tremor, dysgeusia
Maltese: Amnesija, indeboliment tal-memorja, sinkope, emigranja, atassja, konfużjoni, nevralġija, parestesija, ipoestesija, iperestesija, ipertonija, ngħas, disturbi fl-attenzjoni, rogħda, tibdil fis-sens tattogħma
English: Eleven percent of subjects (5/46) treated for 24 weeks and 13 % of subjects (6/48) treated for 48 weeks were observed to have a decrease from pre-treatment baseline of > 30 height-for-age percentiles to the end of the 5 year long-term follow-up.
Maltese: Ħdax fil-mija tal-individwi (5/46) ikkurati għal 24 ġimgħa u 13% tal-individwi (6/48) ikkurati għal 48 ġimgħa kien osservat li kellhom tnaqqis ta' > 30 percentile tat-tul għall-età mil-linja bażi ta' qabel il-kura sal-aħħar tas-segwitu fit-tul ta' 5 snin.
English: ViraferonPeg Cmax and AUC measurements increase in a dose-related manner.
Maltese: Cmax u l-AUC ta' ViraferonPeg jiżdiedu b'mod relatat mad-doża.
English: 25 % of subjects included nausea, chills, insomnia, anaemia, pyrexia, myalgia, asthenia, pain, alopecia, anorexia, weight decreased, depression, rash and irritability.
Maltese: Reazzjonijiet avversi oħrajn irrappurtati f'aktar minn 25% tal-individwi kienu jinkludu nawsja, tertir ta' bard, insomnja, anemija, deni, mijalġja, astenja, uġigħ, alopeċja, anoressija, telf ta' piż, depressjoni, raxx u irritabilità.
English: 1 vial of powder, 1 ampoule of solvent
Maltese: 4 kunjetti ta' trab, 4 ampulli ta' solvent
English: Patients with creatinine clearance < 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (bitherapy or tritherapy) (see section 4.3).
Maltese: Pazjenti bi tneħħija tal-krejatinina ta' < 50 ml/minuta m'għandhomx ikunu kkurati b'ViraferonPeg flimkien ma' ribavirin (terapija b'żewġ mediċini jew bi tlieta) (ara sezzjoni 4.3).
English: For BMI, pre-treatment to end of long-term follow-up, BMI-for-age percentiles decreased 1.8 and 7.5 percentiles among subjects treated for 24 weeks or 48 weeks, respectively.
Maltese: Għall-BMI, minn qabel il-kura sal-aħħar tas-segwitu fit-tul ta' 5 snin, il-percentiles tal-BMI għall-età naqsu b'1,8 u 7,5 percentiles fost individwi kkurati għal 24 ġimgħa jew 48 ġimgħa, rispettivament.
English: Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
Maltese: Ġew osservati ipertrigliċeridemija u żjieda fl-ipertrigliċeridemija, kultant severa.
English: Dose to be administered
Maltese: Twissijiet u prekawzjonijiet
English: Visual disturbance, vision blurred, photophobia, conjunctivitis, eye irritation, lacrimal disorder, eye pain, dry eye
Maltese: Disturbi fil-vista, vista mċajpra, fotofobija, konġuntivite, irritazzjoni fl-għajn, disturbi fil-glandola tad-dmugħ, uġigħ flgħajnejn, għajn xotta
English: Table 4 Effect of Peginterferon alfa-2b on Co-administered Medicines
Maltese: Tabella 4 Effett ta' Peginterferon alfa-2b fuq Mediċini Li Jingħataw Fl-Istess Ħin
English: However, renal elimination may account for a minority (approximately 30 %) of ViraferonPeg apparent clearance.
Maltese: Madankollu, eliminazzjoni mill-kliewi tista' tkun responsabbli ta' ammont ċkejken (madwar 30 %) tat-tneħħija apparenti ta' ViraferonPeg.
English: Following subcutaneous administration, maximal serum concentrations occur between 15-44 hours post-dose, and are sustained for up to 48-72 hours post-dose.
Maltese: Wara li jingħata taħt il-ġilda, l-ogħla konċentrazzjonijiet fis-serum jintlaħqu bejn 15 u 44 siegħa wara ddoża, u huma sostnuti sa 48-72 siegħa wara d-doża.
English: One vial of powder contains 120 micrograms of peginterferon alfa-2b and provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Maltese: Kunjett wieħed bit-trab fih 120 mikrogramma ta' peginterferon alfa-2b u jipprovdi 120 mikrogramma/0,5 ml ta' peginterferon alfa-2b meta jiġi rikostitwit kif irrakkomandat.
English: Collect the necessary items before you begin: - a vial of ViraferonPeg powder for injection; - an ampoule of water for injections solvent to prepare ViraferonPeg injection; - a 1 ml syringe; - a long needle (for example 0.8  40 mm [21 gauge 1.5 inch]) to be used to add water for injections to the ViraferonPeg powder vial; - a short needle (for example 0.3  13 mm [30 gauge 0.5 inch]) for the subcutaneous injection; - a cleansing swab.
Maltese: Iġbor l-affarijiet li jkollok bżonn qabel tibda: - kunjett ta' trab ta' ViraferonPeg għall-injezzjoni; - ampulla ta' ilma għall-injezzjonijiet, solvent biex tipprepara injezzjoni ta' ViraferonPeg; - siringa ta' 1 ml; - labra twila (per eżempju 0,8 x 40 mm [kalibru 21 ta' 1,5 pulzieri] li tintuża biex iżżid l-ilma għall injezzjonijiet mal-kunjett ta' trab ta' ViraferonPeg; - labra qasira (pereżempju 0,3 x 13 mm [kalibru 30 ta' 0,5 pulzieri] li tintuża biex tingħata l injezzjoni taħt il-ġilda; - imselħa biex tnaddaf.
English: In the ViraferonPeg monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with ViraferonPeg (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
Maltese: Fil-prova ta' monoterapija b'ViraferonPeg, total ta' 916-il pazjenti b'epatite Ċ kronika li qatt ma ħadu kura qabel kienu kkurati b'ViraferonPeg (0,5, 1,0 jew 1,5 mikrogrammi/kg/ġimgħa) għal sena b'perjodu follow-up ta' sitt xhur.
English: ViraferonPeg 100 micrograms - vial of powder
Maltese: ViraferonPeg 100 mikrogramma - kunjett ta' trab
English: ViraferonPeg/ribavirin retreatment of prior treatment failures In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with ViraferonPeg, 1.5 micrograms/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Maltese: Kura mill-ġdid b'ViraferonPeg/ribavirin ta' każijiet li ma rnexxewx b'kura li ngħatat qabel Fi prova mhux komparattiva, 2.293 pazjent b'fibrożi moderata sa severa li ma kinux irnexxew b'kura li ngħataw fil-passat b'kombinazzjoni ta' alfa interferon/ribavirin kienu kkurati mill-ġdid b'ViraferonPeg, 1,5 mikrogrammi/kg minn taħt il-ġilda, darba fil-ġimgħa, flimkien ma' ribavirin aġġustat skont il-piż tal-ġisem.
English: Using a sterilised injection syringe and injection needle, 0.7 ml of water for injections is injected into the vial of ViraferonPeg.
Maltese: Billi tintuża siringa sterilizzata għall-injezzjoni u labra tal-injezzjoni, 0,7 ml ta' ilma għall-injezzjonijiet jiġu injettati ġol-kunjett ta' ViraferonPeg.
English: Table 3c Reduced ViraferonPeg dose (0.5 g/kg) for the 1.0 g/kg monotherapy regimen in adults Body weight (kg)
Maltese: Tabella 3ċ Doża mnaqqsa ta' ViraferonPeg (0,5 g/kg) għall-iskeda ta' monoterapija ta' 1,0 g/kg fl-adulti Piż tal-ġisem (kg)
English: Baseline Viral Load
Maltese: Valur imbassar pożittiv
English: Paediatric population (bitherapy only) - Duration of treatment
Maltese: Popolazzjoni pedjatrika (terapija b'żewġ mediċini biss) - Tul tal-kura
English: First dose reduction to ViraferonPeg 1 µg/kg
Maltese: L-ewwel tnaqqis tad-doża għal ViraferonPeg 1 µg/kg
English: HCV-RNA negative or ≥ 1 log decrease in viral load
Maltese: HCV-RNA negattiv jew tnaqqis ta' ≥ 1 log flammont virali
English: If week 12 HCV-RNA is positive and decreased ≥ 2log10 from baseline, then retest HCV-RNA at week 24 and if positive, patients to stop therapy.
Maltese: Jekk l-HCV-RNA ta' ġimgħa 12 ikun pożittiv u jkun hemm tnaqqis ta' < 2log10 millinja bażi, il-pazjenti għandhom iwaqqfu t-terapija.
English: In those patients that received > 10.6 mg/kg ribavirin (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received  10.6 mg/kg ribavirin (Table 9), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
Maltese: F'dawk ilpazjenti li ngħataw > 10,6 mg/kg ta' ribavirin (doża ta' 800 mg f'pazjent tipiku li jiżen 75 kg), minkejja l-ġenotip jew l-ammont virali, ir-rati ta' rispons kienu, b'mod sinifikattiv, ogħla minn dawk ta' pazjenti li ngħataw  10,6 mg/kg ta' ribavirin (Tabella 9), filwaqt illi r-rati ta' rispons f'pazjenti li ngħataw > 13,2 mg/kg ta' ribavirin kienu saħansitra ogħla.
English: Preliminary data indicate that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Maltese: Dejta preliminari tindika li terapija b'interferon alpha tista' tkun assoċjata ma' żieda fir-rata ta' rifjut ta' trapjant tal-kliewi.
English: By extrapolation from clinical data on combination therapy with standard interferon in paediatric patients (negative predictive value 96 % for interferon alfa-2b/ribavirin), patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders.
Maltese: Bl-estrapolazzjoni minn dejta klinika fuq terapija kombinata b'interferon standard f'pazjenti pedjatriċi (valur negattiv imbassar ta' 96% għal interferon alfa-2b/ribavirin), pazjenti li ma jirnexxilhomx jiksbu rispons viroloġiku wara 12-il ġimgħa għandhom probabbiltà kbira li ma jiksbux rispons viroloġiku sostnut.
English: Pruritus, rash, rash erythematous, eczema, acne, erythema
Maltese: Ħakk, raxx, raxx eritematuż, ekżema, akne, eritema
English: Patients were randomized to receive either ViraferonPeg (1.5 µg/kg/week) plus ribavirin (800 mg/day) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Maltese: Il-pazjenti ntgħażlu b'mod każwali sabiex jirċievu ViraferonPeg (1,5 µg/kg/ġimgħa) flimkien ma' ribavirin (800 mg/jum) jew interferon alfa-2b (3 MIU TIW) flimkien ma' ribavirin (800 mg/jum) għal 48 ġimgħa b'perjodu ta' follow-up ta' 6 xhur.
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with ViraferonPeg (1.5 µg/kg)/ribavirin combination therapy resulted in a higher sustained virologic response rate compared to ViraferonPeg 1 µg/kg dose.
Maltese: F'pazjenti ta' nisel Afrikan-Amerikan (li huwa fattur ta' pronjosi batut magħruf għat-tneħħija tal-HCV), kura b'terapija kombinata ta' ViraferonPeg (1,5 µg/kg)/ribavirin irriżultat f'rispons viroloġiku sostnut ogħla meta mqabbel ma' doża ta' ViraferonPeg 1µg/kg.
English: One vial of powder contains 80 micrograms of peginterferon alfa-2b and provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Maltese: Kunjett wieħed bit-trab fih 80 mikrogramma ta' peginterferon alfa-2b u jipprovdi 80 mikrogramma/0.5 ml ta' peginterferon alfa-2b meta jiġi rikostitwit kif irrakkomandat.
English: c: Patients with genotype 3 low viral load (< 600,000 IU/ml) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/ml) were to receive 48 weeks of treatment.
Maltese: IU/ml) kellhom jirċievu 24 ġimgħa ta' kura filwaqt li dawk b'ġenotip 3 u ammont virali għoli (≥ 600.000 IU/ml) kellhom jirċievu 48 ġimgħa ta' kura.
English: Hypotension, pallor
Maltese: Sinjali, Sintomi, u Kura
English: In the ViraferonPeg monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of ViraferonPeg than by either 1.0 microgram/kg of ViraferonPeg once weekly or 3 MIU of interferon alfa-2b three times a week.
Maltese: Fl-istudju fejn ingħatat monoterapija b'ViraferonPeg, il-Kwalità tal-Ħajja ġeneralment kienet inqas affettwata b'0,5 mikrogramma/kg ta' ViraferonPeg milli b'1,0 mikrogramma/kg ta' ViraferonPeg darba fil-ġimgħa jew b'3 MIU ta' interferon alfa-2b tliet darbiet fil-ġimgħa.
English: In all three treatment groups, sustained virologic response rates were similar.
Maltese: Fit-tliet gruppi kollha ta' kura, ir-rati ta' rispons viroloġiku sostnut kienu simili.
English: Rare side effects (may affect up to 1 in 1,000 people): - convulsion (“fit”), - blood or clots in stool (or black, tarry stool),
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1.000): - konvulżjoni (“aċċessjoni”), - demm jew demm magħqud fl-ippurgar (jew ippurgar iswed qisu qatran),
English: This medicinal product should only be reconstituted with the solvent provided (see section 6.6).
Maltese: Dan il-prodott mediċinali għandu jkun rikostitwit biss bis-solvent ipprovdut (ara sezzjoni 6.6).
English: Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Maltese: Pazjenti li għandhom ukoll l-infezzjoni tal-HIV u li qed jingħataw Terapija AntiRetrovirali Attiva Ħafna (HAART - Highly Active Anti-Retroviral Therapy) jista' jkollhom riskju akbar illi jiżviluppaw aċidożi lattika.
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: It-tul tat-terapija kien ta' 48 ġimgħa b'perjodu ta' follow-up ta' 6 xhur ħlief għal pazjenti infettati b'ġenotip 2 jew 3 u ammont virali ta' < 800,000 IU/ml (Ampiclor) li kienu kkurati għal 24 ġimgħa b'perjodu ta' follow-up ta' 6 xhur.
English: One vial of powder contains 150 micrograms of peginterferon alfa-2b and provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Maltese: Kunjett wieħed bit-trab fih 150 mikrogramma ta' peginterferon alfa-2b u jipprovdi 150 mikrogramma/0,5 ml ta' peginterferon alfa-2b meta jiġi rikostitwit kif irrakkomandat.