FrancophonIA/ELRC3.0 huggingface dataset:
English: a: 2 morning, 2 evening b: 2 morning, 3 evening c: 3 morning, 3 evening d: 3 morning, 4 evening * Refer to the SmPC of boceprevir for details about the dose of boceprevir to be administered in tritherapy.
Maltese: 2 filgħodu, 2 filgħaxija b: 2 filgħodu, 3 filgħaxija ċ: 3 filgħodu, 3 filgħaxija d: 3 filgħodu, 4 filgħaxija * Irreferi għall-SmPC ta' boceprevir għad-dettalji dwar id-doża ta' boceprevir li għandha tingħata f'terapija bi tliet mediċini.
English: Adults (bitherapy and monotherapy)
Maltese: Adulti (terapija b'żewġ mediċini u monoterapija)
English: ViraferonPeg pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2'5'-oligoadenylate synthetase (2'5'-OAS), as well as white cell and neutrophil counts.
Maltese: Il-farmakodinamika ta' ViraferonPeg kienet evalwata fi prova ta' doża waħda li tiżdied f'individwi b'saħħithom billi ġew eżaminati bidliet fit-temperatura orali, konċentrazzjonijiet ta' proteini effector bħalma huma neopterin tas-serum u 2'5'-oligoadenylate synthetase (2'5'-OAS), kif ukoll l-għadd ta' ċelluli bojod u tan-newtrofili.
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis, urinary tract infection, gastroenteritis Blood and lymphatic system disorders Very common:
Maltese: Pnewmonja, askarjasi, enterobijasi, herpes zoster, ċellulite, infezzjoni talpassaġġ tal-awrina, gastroenterite Disturbi tad-demm u tas-sistema limfatika Komuni ħafna:
English: Guidelines were developed in clinical trials for dose modification.
Maltese: Linji gwida ġew żviluppati fi provi kliniċi għall-modifikazzjoni tad-doża.
English: Approximately 21 % of children treated with ViraferonPeg/ribavirin combination therapy developed increase in thyroid stimulating hormone (TSH).
Maltese: Madwar 21% tat-tfal ikkurati b'terapija kombinata b'ViraferonPeg/ribavirin żviluppaw żieda fl-ormon li jistimula t-tirojde (TSH - thyroid stimulating hormone).
English: During combination therapy for up to 48 weeks with ViraferonPeg and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Maltese: Waqt terapija kombinata għal sa 48 ġimgħa b'ViraferonPeg u ribavirin, ġiet osservata inibizzjoni tat-tkabbir li f'xi pazjenti wasslet għal tnaqqis fittul (ara sezzjoni 4.4).
English: Homicidal ideation, mania Nervous system disorders Very common:
Maltese: Infezzjonijiet u infestazzjonijiet Disturbi fis-sistema nervuża Komuni ħafna:
English: ViraferonPeg is indicated for the treatment of adult patients (18 years of age and older) with CHC who are positive for hepatitis C virus RNA (HCV-RNA), including patients with compensated cirrhosis and/or co-infected with clinically stable HIV (see section 4.4).
Maltese: ViraferonPeg jintuża għall-kura ta' pazjenti adulti (età ta' 18-il sena u akbar) b'CHC li huma pożittivi għall-RNA tal-virus tal-epatite Ċ (HCV-RNA - hepatitis C virus RNA), inkluż pazjenti b'ċirrożi kkumpensata u/jew b'koinfezzjoni ta' HIV klinikament stabbli (ara sezzjoni 4.4).
English: Metabolism of thioridazine is suppressed by inhibitory action of the product (ViraferonPeg) on CYP2D6.
Maltese: Il-metaboliżmu ta' thioridazine jitrażżan permezz tal-azzjoni inibitorja tal-prodott (ViraferonPeg) fuq CYP2D6.
English: ViraferonPeg plus ribavirin
Maltese: ViraferonPeg flimkien ma' ribavirin
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Maltese: Studju 1 (RIBAVIC; P01017) kien studju multiċentriku li fih ilparteċipanti ntgħażlu b'mod każwali li fih ħadu sehem 412 pazjent adult li ma kinux ikkurati fil-passat, li kellhom epatite Ċ kronika u li kellhom ukoll infezzjoni b'HIV.
English: Healthy Subjects (N=13)
Maltese: Individwi b'Saħħithom (N=13)
English: Suicide, suicide attempt, suicidal ideation, psychosis, hallucination, panic attack
Maltese: Suwiċidju, attentat ta' suwiċidju, ħsibijiet dwar suwiċidju, psikożi, alluċinazzjoni, attakk ta' paniku
English: Arthritis, back pain, muscle spasms, pain in extremity
Maltese: Artrite, uġigħ fid-dahar, spażmi muskolari, uġigħ fl-estremità
English: Retreated patients who fail to achieve virological response (i.e. HCV-RNA below the limits of detection) at week 12 are unlikely to become sustained virological responders after 48 weeks of therapy (see also section 5.1).
Maltese: Pazjenti kkurati mill-ġdid li ma jirnexxilhomx jiksbu rispons viroloġiku (i.e. livelli ta' HCV-RNA taħt il-limitu li jista' jitkejjel) fit-12-il ġimgħa x'aktarx li ma jiksbux rispons viroloġiku sostnut wara 48 ġimgħa ta' terapija (ara wkoll sezzjoni 5.1).
English: This study showed that ViraferonPeg was superior to interferon alfa-2b (Table 8).
Maltese: Dan l-istudju wera li ViraferonPeg kien superjuri għal interferon alfa-2b (Tabella 8).
English: 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs
Maltese: 12-il kunjett ta' trab, 12-il ampulla ta' solvent, 12-il siringa għall-injezzjoni, 24 labra tal-injezzjoni u 12-il imselħa biex tnaddaf
English: Aplastic anaemia
Maltese: Anemija alpastika
English: At the ViraferonPeg 1.5 µg/kg plus ribavirin dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/ml, and in patients > 40 years old.
Maltese: Bid-doża ta' ViraferonPeg 1,5 µg/kg flimkien ma' ribavirin, ir-rati ta' rispons viroloġiku sostnut kienu aktar baxxi f'pazjenti b'ċirrożi, f'pazjenti b'livelli normali ta' ALT, f'pazjenti b'ammont virali ta' > 600,000 IU/ml fil-linja bażi, u f'pazjenti b'età > 40 sena.
English: *produced by rDNA technology in E. coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes.
Maltese: *magħmul bit-teknoloġija ta' rDNA f'ċelluli ta' E. coli li fihom iżommu plasmid ibrida imfassla ġenetikament imdawra ma' ġene ta' interferon alfa-2b minn ċelluli ta' lewkoċiti umani.
English: Table 13 Sustained virological response based on genotype after ViraferonPeg in combination with Ribavirin in HCV/HIV Co-infected patients Study 1
Maltese: Tabella 13 Rispons viroloġiku sostnut ibbażat fuq il-ġenotip wara ViraferonPeg f'kombinazzjoni ma' Ribavirin f'pazjenti infettati fl-istess ħin b'HCV/HIV Studju 1
English: Pericardial effusion
Maltese: Effużjoni perikardijaka
English: Healthy Subjects (N=24)
Maltese: Individwi b'Saħħithom (N=24)
English: For disposal instructions, see section 5 “How to store ViraferonPeg”.
Maltese: Għall-istruzzjonijiet dwar ir-rimi, ara sezzjoni 5 “Kif taħżen ViraferonPeg”.
English: Psoriasis, photosensitivity reaction, rash maculo-papular, dermatitis, erythematous rash, eczema, night sweats, hyperhidrosis, acne, furuncle, erythema, urticaria, abnormal hair texture, nail disorder
Maltese: Psorjasi, reazzjoni ta' fotosensittività, raxx makulopapulari, dermatite, raxx eritematuż, ekżema, issir għarqan bil-lejl, iperidrożi, akne, furunkolite, eritema, urtikarja, għamla tax-xagħar mhux normali, disturbi fid-dwiefer
English: Among 480 patients with > 2 log viral reduction but detectable virus at week 12, altogether 188 patients continued therapy.
Maltese: Fost 480 pazjent bi tnaqqis virali ta' >2 log iżda b'ammont ta' virus li jista' jiġi mkejjel f'ġimgħa 12, b'kollox 188 pazjent komplew it-terapija.
English: ANNEX II
Maltese: Tabella 14
English: Relapse
Maltese: Idratazzjoni
English: In vitro and in vivo studies suggest that the biological activity of ViraferonPeg is derived from its interferon alfa-2b moiety.
Maltese: Studji in vitro u in vivo jissuġġerixxu li l-attività bijoloġika ta' ViraferonPeg tinkiseb mill-parti interferon alfa-2b tiegħu.
English: The following treatment-related adverse reactions were reported in adults in clinical trials or through post-marketing surveillance in patients treated with peginterferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg/ribavirin.
Maltese: Ir-reazzjonijiet avversi li ġejjin relatati mal-kura kienu rrappurtati fl-adulti fi provi kliniċi jew waqt issorveljanza ta' wara t-tqegħid fis-suq f'pazjenti kkurati b'peginterferon alfa-2b, inkluża monoterapija b'ViraferonPeg jew ViraferonPeg/ribavirin.
English: Adults (tritherapy)
Maltese: Adulti (terapija bi tliet mediċini)
English: Haemoglobin
Maltese: Emoglobina
English: ViraferonPeg strength (g/0.5 ml)
Maltese: Qawwa ta' ViraferonPeg (g/0.5ml)
English: Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “Laboratory tests” and section 4.8).
Maltese: Għalkemm il-parti lkbira tagħhom jistgħu jkunu mmaniġġjati bi tnaqqis fid-doża, monitoraġġ mill-qrib ta' parametri ematoloġiċi għandu jsir f'din il-popolazzjoni ta' pazjenti (ara sezzjoni 4.2 u hawn taħt “Testijiet talLaboratorju” u sezzjoni 4.8).
English: No pharmacokinetic interactions were noted between ViraferonPeg and ribavirin in a multiple-dose pharmacokinetic study.
Maltese: Ma ġewx osservati interazzjonijiet farmakokinetiċi bejn ViraferonPeg u ribavirin fi studju farmakokinetiku fejn ingħataw ħafna dożi.
English: Bacterial infection (including sepsis), fungal infection, influenza, upper respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis
Maltese: Infezzjoni kkawżata minn batterja (inkluża sepsi), infezzjoni kkawżata minn fungu, influwenza, infezzjoni fin-naħa ta' fuq talpassaġġ tan-nifs, bronkite, herpes simplex, sinożite, otitis media, rinite
English: The biologic activity of the pegylated isomers is qualitatively similar, but weaker than free interferon alfa-2b.
Maltese: L-attività bijoloġika tal-isomeri pegilati hija b'mod kwalitattiv simili, iżda aktar dgħajfa minn ta' interferon alfa-2b liberu.
English: Blood thyroid stimulating hormone increased, thyroglobulin increased
Maltese: Ormon li jistimula t-tirojde fid-demm jiżdied, jiżdied it-thyroglobulin
English: 1 mcg/kg/week (4 weeks)
Maltese: 1 mcg/kg/ġimgħa (4 ġimgħat)
English: Multiple-dose pharmacokinetic properties for ViraferonPeg and ribavirin (capsules and oral solution) in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
Maltese: Il-karatteristiċi tal-farmakokinetika ta' dożi multipli ta' ViraferonPeg u ribavirin (kapsuli u soluzzjoni orali) f'pazjenti tfal u adolexxenti b'epatite Ċ kronika kienu evalwati waqt studju kliniku.
English: §, depression, aggression, affect lability, anger, agitation, anxiety, mood altered, restlessness, nervousness, insomnia
Maltese: §, depressjoni, aggressjoni, burdati emozzjonali , rabja, aġitazzjoni, ansjetà, tibdil fil-burdata, aġitazzjoni, nervi, insomnja
English: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two ViraferonPeg/ribavirin regimens [ViraferonPeg 1.5 µg/kg and 1 µg/kg subcutaneously once weekly both in combination with ribavirin 800 to 1,400 mg p.o. daily (in two divided doses)] and peginterferon alfa-2a 180 µg subcutaneously once weekly with ribavirin 1,000 to 1,200 mg p.o. daily (in two divided doses) in 3,070 treatment-naïve adults with chronic hepatitis C genotype 1.
Maltese: Prova klinika kbira li fiha l-parteċipanti ntgħażlu b'mod każwali qabblet is-sigurtà u l-effikaċja talkura għal 48 ġimgħa ma' żewġ korsijiet ta' ViraferonPeg/ribavirin [ViraferonPeg 1,5 µg/kg u 1 µg/kg minn taħt il-ġilda darba fil-ġimgħa t-tnejn flimkien ma' ribavirin 800 sa 1.400 mg p.o. kuljum (maqsum f'żewġ dożi)] u peginterferon alfa-2a 180 µg minn taħt il-ġilda darba fil-ġimgħa ma' ribavirin 1.000 sa 1.200 mg p.o. kuljum (maqsum f'żewġ dożi) fi 3.070 adult li qatt ma ħadu kura qabel b'epatite Ċ kronika ta' ġenotip 1.
English: Twenty-four % had bridging fibrosis or cirrhosis (Knodell 3/4).
Maltese: Erbgħa u għoxrin % kellhom fibrożi li tgħaqqad jew ċirrożi (Knodell 3/4).
English: Pulmonary fibrosis, pulmonary arterial hypertension Gastrointestinal disorders Very common:
Maltese: Fibrożi pulmonari, pressjoni arterjali pulmonari għolja
English: Haematological abnormalities in HCV/HIV co-infected patients HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and HAART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
Maltese: Anormalitajiet ematoloġiċi f'pazjenti infettati b'HCV/HIV fl-istess ħin F'pazjenti li jkollhom fl-istess ħin HCV/HIV li jkunu qed jirċievu kura b'peginterferon alfa-2b/ribavirin u HAART jista' jkollhom riskju akbar li jiżviluppaw anormalitajiet ematoloġiċi (bħal newtropenija, tromboċitopenija u anemija) meta mqabbla ma' pazjenti infettati b'HCV waħdu.
English: Ophthalmological disorders that have been reported rarely with alpha interferons include retinopathies (including macular oedema), retinal haemorrhages, retinal artery or vein occlusion, retinal exudates, loss of visual acuity or visual field, optic neuritis, and papilloedema (see section 4.4).
Maltese: Disturbi fl-għajnejn li ġew irrappurtati b'mod rari b'alfa interferons jinkludu retinopatija (inkluż edima makulari), emorraġiji fir-retina, okklużjoni ta' arterja jew vina tar-retina, tnixxijiet fir-retina, tnaqqis fiċ-ċarezza tal-vista jew fil-kamp viżiv, nevrite ottika, u papilloedima (ara sezzjoni 4.4).
English: Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alpha interferons.
Maltese: Effetti oħrajn fis-CNS inklużi mġiba aggressiva (kultant indirizzata lejn persuni oħrajn bħal ħsibijiet biex jitwettaq omiċidju), disturbi bipolari, manija, konfużjoni u alterazzjonijiet fl-istat mentali ġew osservati b'alpha interferons.
English: Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Maltese: Pazjenti li jkollhom id-doża ta' ribavirin imnaqqsa għal 600 mg kuljum jirċievu kapsula waħda ta' 200 mg filgħodu u żewġ kapsuli ta' 200 mg filgħaxija.
English: Fatigue, alopecia, pruritus, nausea, anorexia, weight decreased, irritability and insomnia occur at a notably lower rate in patients treated with ViraferonPeg monotherapy compared to those treated with combination therapy (see Table 6).
Maltese: Għeja, alopeċja, ħakk, nawsja, anoressija, telf ta' piż, irritabilità u insomnja jseħħu b'rata ferm aktar baxxa f'pazjenti kkurati b'ViraferonPeg bħala monoterapija meta mqabbel ma' dawk ikkurati b'terapija kkombinata (ara Tabella 6).
English: How to store ViraferonPeg
Maltese: Tużax ViraferonPeg
English: Hypothyroidism, hyperthyroidism Metabolism and nutrition disorders Very common:
Maltese: Ipotirojdiżmu, ipertirojdiżmu Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna:
English: Standard haematologic tests, blood chemistry and a test of thyroid function must be conducted in all patients prior to initiating therapy.
Maltese: Testijiet ematoloġiċi standard, kimika tad-demm u test tal-funzjoni tat-tirojde għandhom isiru fil-pazjenti kollha qabel ma tinbdilhom it-terapija.
English: ViraferonPeg combination therapy (bitherapy or tritherapy) Bitherapy (ViraferonPeg with ribavirin): applies to all adult and paediatric patients 3 years of age and older.
Maltese: Terapija kkombinata b'ViraferonPeg (terapija b'żewġ mediċini jew bi tlieta) Terapija b'żewġ mediċini (ViraferonPeg ma' ribavirin): tapplika għall-adulti u l-pazjenti pedjatriċi kollha li għandhom età ta' 3 snin u akbar.
English: The reconstituted solution has a concentration of 150 micrograms/0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 150 mikrogramma/0,5 ml.
English: More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses for oncology indications.
Maltese: Ottudazzjoni aktar sinifikanti u koma, inklużi każijiet ta' enċefalopatija, ġew osservati f'xi pazjenti, normalment anzjani, ikkurati b'dożi ogħla għall-indikazzjonijiet onkoloġiċi.
English: ViraferonPeg 150 micrograms - vial of powder
Maltese: ViraferonPeg 150 mikrogramma - kunjett ta' trab
English: Rare side effects (may affect up to 1 in 1,000 people): - diabetic ketoacidosis (medical emergency due to build-up of ketone bodies in the blood as a result of out-of-control diabetes), - seizures (convulsions) and bipolar disorders (mood disorders characterized by alternating episodes of sadness and excitement), - eye problems including changes in vision, damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye, - congestive heart failure, abnormal heart rhythm, pericarditis (inflammation of the lining of the heart), inflammation and degeneration of muscle tissue and peripheral nerves, kidney problems, - sarcoidosis (a disease characterized by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands).
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1.000): - ketoaċidożi dijabetika (emerġenza medika minħabba akkumulazzjoni ta' ketone bodies fid-demm ikkawżata minn dijabete li ma tkunx ikkontrollata), - aċċessjonijiet (konvulżjonijiet) u disturbi bipolari (disturbi fil-burdata kkaratterizzati minn episodji ta' dwejjaq u eċċitament li jalternaw bejniethom), - problemi fl-għajnejn inkluż bidla fil-vista, ħsara fir-retina, ostruzzjoni tal-arterja tar-retina, infjammazzjoni tan-nerv ottiku, nefħa fl-għajnejn, - insuffiċjenza konġestiva tal-qalb, ritmu anormali tal-qalb, perikardite (infjammazzjoni tal-kisja talqalb), infjammazzjoni u deġenerazzjoni tat-tessut tal-muskoli u nervaturi periferali, problemi talkliewi, - sarkojdożi (marda kkaratterizzata minn deni persistenti, telf tal-piż, nefħa u wġigħ fil-ġogi, feriti filġilda u glandoli minfuħin).
English: - If you are also being treated for HIV (see section “Other medicines and ViraferonPeg”).
Maltese: - jekk qed tingħataw ukoll kura għall-HIV (ara sezzjoni “Mediċini oħra u ViraferonPeg”).
English: ViraferonPeg 50 micrograms - vial of powder
Maltese: ViraferonPeg 50 mikrogramma - kunjett ta' trab
English: Use in adults - ViraferonPeg alone
Maltese: Użu fl-adulti - ViraferonPeg waħdu
English: The reconstituted solution has a concentration of 120 micrograms/0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 120 mikrogramma/0,5 ml.
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Maltese: Dejta limitata storika tindika li l-kura għal 48 ġimgħa tista' tkun assoċjata ma' rata ogħla ta' rispons sostnut (11/11) u ma' riskju iktar baxx ta' rikaduta (0/11 meta mqabbel ma' 7/96 wara 24 ġimgħa ta' kura).
English: Hearing impaired/loss, tinnitus, vertigo
Maltese: Nuqqas/telf tas-smigħ, tisfir fil-widnejn, vertigo
English: In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 micrograms/kg subcutaneously, once weekly, in combination with ribavirin 800 mg -1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 10).
Maltese: Fi prova separata, 224 pazjent b'ġenotip 2 jew 3 irċivew ViraferonPeg, 1,5 mikrogrammi/kg minn taħt il-ġilda, darba fil-ġimgħa, flimkien ma' ribavirin 800 mg -1.400 mg p.o. għal 6 xhur (ibbażat fuq il-piż tal-ġisem, tliet pazjenti biss li kienu jiżnu > 105 kg, irċivew doża ta' 1.400 mg) (Tabella 10).
English: Table 10 Virologic response at end of treatment, Sustained Virologic Response and relapse by HCV Genotype and viral load* ViraferonPeg 1.5 g/kg once weekly plus Ribavirin 800-1,400 mg/day End of treatment response
Maltese: Tabella 10 Rispons viroloġiku fi tmiem il-kura, Rispons Viroloġiku Sostnut u rikaduta skont ilĠenotip ta' HCV u l-ammont virali* ViraferonPeg 1,5 g/kg darba fil-ġimgħa flimkien ma' Ribavirin 8001.400 mg/jum
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of ViraferonPeg therapy.
Maltese: Arritmiji kardijaċi (l-aktar dawk supraventrikulari) ġeneralment jirrispondu għal terapija konvenzjonali iżda jistgħu jkunu jeħtieġu li t-terapija b'ViraferonPeg ma titkompliex.
English: 120 micrograms/0.5 ml
Maltese: 120 mikrogramma/0,5 ml
English: Following multiple dosing of ViraferonPeg (1.0 microgram/kg subcutaneously administered every week for four weeks) the clearance of ViraferonPeg is reduced by a mean of 17 % in patients with moderate renal impairment (creatinine clearance 30-49 ml/minute) and by a mean of 44 % in patients with severe renal impairment (creatinine clearance 15-29 ml/minute) compared to subjects with normal renal function.
Maltese: Wara li jingħataw ħafna dożi ta' ViraferonPeg (1,0 mikrogramma/kg minn taħt il-ġilda kull ġimgħa għal erba' ġimgħat) it-tneħħija ta' ViraferonPeg titnaqqas b'medja ta' 17% f'pazjenti b'indeboliment renali moderat (tneħħija tal-krejatinina ta' 30-49 ml/minuta) u b'medja ta' 44% f'pazjenti b'indeboliment renali sever (tneħħija tal-krejatinina ta' 15-29 ml/minuta) mqabbla ma' individwi b'funzjoni renali normali.
English: In this trial, the combination of ViraferonPeg (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 8), particularly in patients infected with Genotype 1 (Table 9).
Maltese: F'din il-prova, il-kombinazzjoni ta' ViraferonPeg (1,5 mikrogrammi/kg/ġimgħa) u ribavirin kienet, b'mod sinifikattiv, aktar effettiva mill-kombinazjoni ta' interferon alfa-2b u ribavirin (Tabella 8), laktar f'pazjenti infettati b'Ġenotip 1 (Tabella 9).
English: Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease.
Maltese: Kardjomijopatija, li tista' tkun riversibbli wara t-twaqqif ta' interferon alpha, kienet irrappurtata b'mod rari f'pazjenti mingħajr evidenza preċedenti ta' mard kardijaku.
English: ViraferonPeg 80 micrograms - vial of powder
Maltese: ViraferonPeg 80 mikrogramma - kunjett ta' trab
English: Use in adults - ViraferonPeg in combination treatment This medicine, when given with ribavirin capsules, is usually given at a dose of 1.5 microgram per kilogram of body weight once a week.
Maltese: Din il-mediċina, meta tingħata mal-kapsuli ta' ribavirin, normalment tingħata f'doża ta' 1,5 mikrogrammi għal kull kilogramma ta' piż tal-ġisem darba fil-ġimgħa.
English: ViraferonPeg 120 micrograms - vial of powder
Maltese: ViraferonPeg 120 mikrogramma - kunjett ta' trab
English: - In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).
Maltese: IU/ml) li jsiru negattivi għal HCV-RNA fir-4 ġimgħa ta' kura u jibqgħu negattivi għal HCV-RNA fl24 ġimgħa ta' kura, il-kura tista' jew titwaqqaf wara dan il-kors ta' 24 ġimgħa jew titkompla għal 24 ġimgħa oħra (i.e. b'kollox 48 ġimgħa ta' kura).
English: These reactions are listed in Table 7 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 7 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).