FrancophonIA/ELRC3.0 huggingface dataset:
English: Adults (tritherapy) PegIntron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy (see section 5.1).
Maltese: PegIntron flimkien ma' ribavirin u boceprevir (terapija bi tliet mediċini) huwa indikat għall-kura ta' infezzjoni kronika tal-epatite Ċ (CHC - chronic hepatitis C) ta' ġenotip 1 f'pazjenti adulti (età ta' 18-il sena u akbar) b'mard kumpensat tal-fwied li qatt ma ġew ikkurati qabel jew li l-kura li ħadu qabel ma ħadmitx fuqhom (ara sezzjoni 5.1).
English: This study showed that PegIntron was superior to interferon alfa-2b (Table 8).
Maltese: Dan listudju wera li PegIntron kien superjuri għal interferon alfa-2b (Tabella 8).
English: Fatigue, alopecia, pruritus, nausea, anorexia, weight decreased, irritability and insomnia occur at a notably lower rate in patients treated with PegIntron 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'PegIntron bħala monoterapija meta mqabbel ma' dawk ikkurati b'terapija kkombinata (ara Tabella 6).
English: Patients were randomized to receive either PegIntron (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 PegIntron (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: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of PegIntron therapy.
Maltese: Arritmiji kardijaċi (l-aktar dawk supraventrikulari) ġeneralment jirrispondu għal terapija konvenzjonali iżda jistgħu jkunu jeħtieġu li t-terapija b'PegIntron ma titkompliex.
English: PegIntron 150 micrograms - vial of powder
Maltese: PegIntron 150 mikrogramma - kunjett ta' trab
English: Table 10 Virologic response at end of treatment, Sustained Virologic Response and relapse by HCV Genotype and viral load* PegIntron 1.5 µg/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* PegIntron 1,5 g/kg darba fil-ġimgħa flimkien ma' Ribavirin 8001.400 mg/jum
English: In vitro and in vivo studies suggest that the biological activity of PegIntron is derived from its interferon alfa-2b moiety.
Maltese: Studji in vitro u in vivo jissuġġerixxu li l-attività bijoloġika ta' PegIntron tinkiseb mill-parti interferon alfa2b tiegħu.
English: Clinical efficacy and safety - Adults Tritherapy with PegIntron, ribavirin and boceprevir Refer to the SmPC for boceprevir.
Maltese: Terapija bi tliet mediċini b'PegIntron, ribavirin u boceprevir Irreferi għall-SmPC ta' boceprevir.
English: Therefore, the combination of PegIntron with telbivudine is contraindicated (see section 4.3).
Maltese: Għalhekk, il-kombinazzjoni ta' PegIntron ma' telbivudine hija kontraindikata (ara sezzjoni 4.3).
English: PegIntron 80 micrograms - vial of powder
Maltese: PegIntron 80 mikrogramma - kunjett ta' trab
English: However, renal elimination may account for a minority (approximately 30 %) of PegIntron apparent clearance.
Maltese: Madankollu, eliminazzjoni mill-kliewi tista' tkun responsabbli ta' ammont ċkejken (madwar 30 %) tat-tneħħija apparenti ta' PegIntron.
English: In a separate trial, 224 patients with genotype 2 or 3 received PegIntron, 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 PegIntron, 1,5 mikrogrammi/kg minn taħt ilġilda, 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: Hepatitis B reactivation in HCV/HBV co-infected patients
Maltese: Infezzjoni fl-istess ħin b'HCV/HBV
English: Additional adverse reactions reported in more than 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: In the PegIntron monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with PegIntron (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'PegIntron, total ta' 916-il pazjenti b'epatite Ċ kronika li qatt ma ħadu kura qabel kienu kkurati b'PegIntron (0,5, 1,0 jew 1,5 mikrogrammi/kg/ġimgħa) għal sena b'perjodu follow-up ta' sitt xhur.
English: PegIntron 120 micrograms - vial of powder
Maltese: PegIntron 120 mikrogramma - kunjett ta' trab
English: PegIntron combination therapy (bitherapy or tritherapy) Bitherapy (PegIntron with ribavirin): applies to all adult and paediatric patients 3 years of age and older.
Maltese: Terapija kkombinata b'PegIntron (terapija b'żewġ mediċini jew bi tlieta) Terapija b'żewġ mediċini (PegIntron ma' ribavirin): tapplika għall-adulti u l-pazjenti pedjatriċi kollha li għandhom età ta' 3 snin u akbar.
English: PegIntron has a potential to depegylate to free interferon alfa-2b.
Maltese: PegIntron jista' jitlef ilpegylate biex isir interferon alfa-2b liberu.
English: PegIntron 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: Adulti (terapija b'żewġ mediċini u monoterapija) PegIntron 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: How to self-inject PegIntron?
Maltese: Kif tinjetta PegIntron lilek innifsek?
English: PegIntron 120 micrograms powder and solvent for solution for injection EU/1/00/131/016
Maltese: PegIntron 120 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni EU/1/00/131/016
English: Use in adults - PegIntron 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: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two PegIntron/ribavirin regimens [PegIntron 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' PegIntron/ribavirin [PegIntron 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: Renal clearance appears to account for 30 % of total clearance of PegIntron.
Maltese: Tneħħija mill-kliewi tidher li hija responsabbli għal 30 % tat-tneħħija totali ta' PegIntron.
English: Homicidal ideation, mania Nervous system disorders Very common:
Maltese: Disturbi fis-sistema nervuża Komuni ħafna:
English: Mean (SD) PegIntron 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' Pegintron 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
Maltese: Emorraġija fil-konġuntiva, ħakk fl-għajnejn, keratite, vista mċajpra, fotofobija Distrubi fil-widnejn u fis-sistema labirintika Komuni:
English: 50 micrograms/0.5 ml
Maltese: 50 mikrogramma/0,5 ml
English: The reconstituted solution has a concentration of 150 micrograms in 0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 150 mikrogramma f'0.5 ml.
English: The clinical incidence of neutralising factors in patients who received PegIntron 0.5 micrograms/kg is 1.1 %.
Maltese: L-inċidenza klinika tal-fatturi li jinnewtralizzaw f'pazjenti li rċivew PegIntron 0,5 mikrogramma/kg hija ta' 1,1 %.
English: The reconstituted solution has a concentration of 120 micrograms in 0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 120 mikrogramma f'0.5 ml.
English: Table 4Effect of Peginterferon alfa-2b on Co-administered Medicines
Maltese: Tabella 4 Effett ta' Peginterferon alfa-2b fuq Mediċini Li Jingħataw Fl-Istess Ħin
English: 327 patients completed at least 5 years of long-term follow-up and only 3 out of 366 sustained responders relapsed during the study.
Maltese: 327 pazjent lestew mill-anqas 5 snin ta' follow-up fuq medda twila ta' żmien u 3 biss minn 366 pazjent li kellhom rispons viroloġiku sostnut irkadew waqt l-istudju.
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,
English: As monotherapy the PegIntron regimen is 0.5 or 1.0 µg/kg/week.
Maltese: Bħala monoterapija l-kors ta' PegIntron huwa ta' 0,5 jew 1,0 µg/kg/ġimgħa.
English: The reconstituted solution has a concentration of 120 micrograms/0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 120 mikrogramma/0.5 ml.
English: Using a sterilised injection syringe and injection needle, 0.7 ml of water for injections is injected into the vial of PegIntron.
Maltese: Billi tintuża siringa sterilizzata għall-injezzjoni u labra tal-injezzjoni, 0.7 ml ta' ilma għall-injezzjonijiet jiġu injettati ġol-kunjett ta' PegIntron.
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with PegIntron (1.5 µg/kg)/ribavirin combination therapy resulted in a higher sustained virologic response rate compared to PegIntron 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' PegIntron (1,5 µg/kg)/ribavirin irriżultat f'rispons viroloġiku sostnut ogħla meta mqabbel ma' doża ta' PegIntron 1µg/kg.
English: The reconstituted solution has a concentration of 150 micrograms/0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 150 mikrogramma/0.5 ml.
English: Patients were randomized to receive either PegIntron (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 PegIntron (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: PegIntron 50 micrograms - vial of powder
Maltese: PegIntron 50 mikrogramma - kunjett ta' trab
English: The reconstituted solution has a concentration of 80 micrograms in 0.5 ml.
Maltese: Is-soluzzjoni rikostitwita għandha konċentrazzjoni ta' 80 mikrogramma f'0.5 ml.
English: PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 80 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 120 micrograms powder and solvent for solution for injection in pre-filled pen PegIntron 150 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Maltese: PegIntron 50 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni PegIntron 80 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni PegIntron 100 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni PegIntron 120 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni PegIntron 150 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni peginterferon alfa-2b
English: Collect the necessary items before you begin: - a vial of PegIntron powder for injection; - an ampoule of water for injections solvent to prepare PegIntron 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 PegIntron 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' PegIntron għall-injezzjoni; - ampulla ta' ilma għall-injezzjonijiet, solvent biex tipprepara injezzjoni ta' PegIntron; - 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' PegIntron; - 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: The reconstituted solution has a concentration of 80 micrograms/0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 80 mikrogramma/0.5 ml.
English: PegIntron monotherapy was not studied in HCV/HIV co-infected patients.
Maltese: Monoterapija b'PegIntron ma kinitx studjata f'pazjenti koinfettati b'HCV/HIV.
English: PegIntron 100 micrograms - vial of powder
Maltese: PegIntron 100 mikrogramma - kunjett ta' trab
English: PegIntron 150 micrograms powder and solvent for solution for injection EU/1/00/131/021
Maltese: PegIntron 150 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni EU/1/00/131/021
English: Table 3c Reduced PegIntron dose (0.5 g/kg) for the 1.0 g/kg monotherapy regimen in adults Body weight (kg)
Maltese: Tabella 3ċ Doża mnaqqsa ta' PegIntron (0,5 g/kg) għall-iskeda ta' monoterapija ta' 1,0 g/kg fl-adulti Piż tal-ġisem (kg)
English: PegIntron 1.5 micrograms/kg
Maltese: PegIntron 1,5 mikrogrammi/kg
English: In this trial, the combination of PegIntron (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' PegIntron (1.5 mikrogrammi/kg/ġimgħa) u ribavirin kienet, b'mod sinifikattiv, aktar effettiva mill-kombinazjoni ta' interferon alfa-2b u ribavirin (Tabella 8), l-aktar f'pazjenti infettati b'Ġenotip 1 (Tabella 9).
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: PegIntron 100 micrograms powder and solvent for solution for injection EU/1/00/131/011
Maltese: PegIntron 100 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni EU/1/00/131/011
English: In the PegIntron monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of PegIntron than by either 1.0 microgram/kg of PegIntron once weekly or 3 MIU of interferon alfa-2b three times a week.
Maltese: Fl-istudju fejn ingħatat monoterapija b'PegIntron, il-Kwalità tal-Ħajja ġeneralment kienet inqas affettwata b'0,5 mikrogramma/kg ta' PegIntron milli b'1,0 mikrogramma/kg ta' PegIntron darba filġimgħa jew b'3 MIU ta' interferon alfa-2b tliet darbiet fil-ġimgħa.
English: PegIntron 50 micrograms powder and solvent for solution for injection EU/1/00/131/001
Maltese: PegIntron 50 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni EU/1/00/131/001
English: For disposal instructions, see section 5 “How to store PegIntron”.
Maltese: Għall-istruzzjonijiet dwar ir-rimi, ara sezzjoni 5 “Kif taħżen Pegintron”.
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during PegIntron therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Maltese: Sistema Psikjatrika u Sistema Nervuża Ċentrali (CNS - Central Nervous System) Effetti severi fis-CNS, l-aktar depressjoni, ħsibijiet ta' suwiċidju u attentat ta' suwiċidju ġew osservati f'xi pazjenti waqt terapija b'PegIntron, u anki wara t-twaqqif tal-kura l-aktar fil-perijodu tas-sitt xhur ta' wara li fih ġew segwiti.
English: Patients with creatinine clearance < 50 ml/minute must not be treated with PegIntron 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'PegIntron flimkien ma' ribavirin (terapija b'żewġ mediċini jew bi tlieta) (ara sezzjoni 4.3).
English: The reconstituted solution has a concentration of 50 micrograms/0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 50 mikrogramma/0.5 ml.
English: Data are not available for the use of PegIntron in patients with creatinine clearance < 15 ml/minute (see section 5.2).
Maltese: M'hemmx dejta dwar lużu ta' PegIntron f'pazjenti bi tneħħija tal-krejatinina < 15 ml/min (ara sezzjoni 5.2).
English: PegIntron 80 micrograms powder for injection peginterferon alfa-2b
Maltese: PegIntron 80 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: Patients with severe renal dysfunction (creatinine clearance 15-29 ml/minute) should have the starting dose of PegIntron reduced by 50 %.
Maltese: Pazjenti li jkollhom disfunzjoni renali severa (tneħħija tal-krejatinina 15-29 ml/min) għandu jkollhom id-doża tal-bidu ta' PegIntron imnaqqsa b'50%.
English: The reconstituted solution has a concentration of 100 micrograms/0.5 ml.
Maltese: Issoluzzjoni rikostitwita għandha konċentrazzjoni ta' 100 mikrogramma/0.5 ml.
English: Body weight(kg)
Maltese: Piż talġisem (kg)
English: PegIntron in combination with ribavirin (bitherapy) is indicated for the treatment of CHC infection in adult patients who are previously untreated including patients with clinically stable HIV co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
Maltese: PegIntron flimkien ma' ribavirin (terapija b'żewġ mediċini) huwa indikat għall-kura ta' infezzjoni b'CHC f'pazjenti adulti li ma kinux ikkurati qabel inkluż pazjenti b'koinfezzjoni ta' HIV klinikament stabbli u f'pazjenti adulti li ma ħadmitx fuqhom kura li tkun ingħatat qabel ta' interferon alpha (pegilat jew mhux pegilat) u terapija kombinata b'ribavirin jew monoterapija b'interferon alpha (ara sezzjoni
English: Table 7 Adverse reactions very commonly, commonly and uncommonly reported in the clinical trial in children and adolescent patients treated with PegIntron in combination with ribavirin
Maltese: Tabella 7 Reazzjonijiet avversi rrappurtati b'mod komuni ħafna, komuni u mhux komuni fil prova klinika f'pazjenti tfal u adolexxenti kkurati b'PegIntron flimkien ma' ribavirin Infezzjonijiet u infestazzjonijiet
English: PegIntron 150 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Maltese: PegIntron 150 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett għandu jiġi rikostitwit b'0,7 ml ta' ilma għall-injezzjonijiet biex tingħata sa 0,5 ml ta' soluzzjoni.
English: Table 5 Precautions for co-administration (PegIntron should be administered with care when co-administered with the following medicines)
Maltese: Tabella 5 Prekawzjonijiet għall-għoti flimkien (PegIntron għandu jingħata b'kawtela meta jingħata flimkien mal-mediċini li ġejjin)
English: PegIntron 80 micrograms powder and solvent for solution for injection Each vial is to be reconstituted with 0.7 ml of water for injections for administration of up to 0.5 ml of solution.
Maltese: PegIntron 80 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni Kull kunjett għandu jiġi rikostitwit b'0,7 ml ta' ilma għall-injezzjonijiet biex tingħata sa 0,5 ml ta' soluzzjoni.
English: PegIntron 80 micrograms powder and solvent for solution for injection EU/1/00/131/006
Maltese: PegIntron 90 mikrogramma ta' trab u solvent għal soluzzjoni għall-injezzjoni EU/1/00/131/006
English: PegIntron/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 PegIntron, 1.5 micrograms/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Maltese: Kura mill-ġdid b'PegIntron/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'PegIntron, 1,5 mikrogrammi/kg minn taħt il-ġilda, darba fil-ġimgħa, flimkien ma' ribavirin aġġustat skont il-piż tal-ġisem.
English: PegIntron 50 micrograms powder for injection peginterferon alfa-2b
Maltese: PegIntron 50 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: Solvent for PegIntron Water for injections
Maltese: Solvent għal PegIntron Ilma għall-injezzjonijiet
English: Treatment with PegIntron in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Maltese: Kura b'PegIntron flimkien ma' ribavirin kienet assoċjata ma' tnaqqis fl-għadd assolut ta' ċelluli CD4+ fl-ewwel 4 ġimgħat mingħajr tnaqqis fil-perċentwali taċ-ċelluli CD4+.
English: PegIntron 120 micrograms powder for injection peginterferon alfa-2b
Maltese: PegIntron 120 mikrogramma trab għall-injezzjoni. peginterferon alfa-2b
English: Because of marked inter-subject variability in interferon pharmacokinetics, it is recommended that patients with severe renal impairment be closely monitored during treatment with PegIntron (see section 4.2)
Maltese: Minħabba differenzi kbar bejn individwu u ieħor fil-farmakokinetika ta' interferon, huwa rrakkomandat li pazjenti b'indeboliment renali sever ikunu mmonitorjati mill-qrib waqt kura b'PegIntron (ara sezzjoni 4.2).