qanastek/EMEA-V3 huggingface dataset:
Because of marked inter-subject variability in interferon pharmacokinetics, it is recommended that patients with severe renal impairment be closely monitored during treatment with ViraferonPeg (see section 4.2)
Peress li jidhru differenzi kbar bejn individwu u ieħor fil- farmakokinetika ta ’ interferon, huwa irrikkmandat li pazjenti li jkollhom indeboliment renali sever ikunu monitorjati mill- qrib waqt kura bi ViraferonPeg (ara sezzjoni 4. 2).
The pharmacokinetics of ViraferonPeg have not been evaluated in patients with severe hepatic dysfunction.
Il- farmakokinetika ta ’ ViraferonPeg ma ġietx studjata f’ pazjenti li għandom funzjoni ħażina severa tal- fwied.
The pharmacokinetics of ViraferonPeg following a single subcutaneous dose of 1.0 microgram/kg were not affected by age.
Il- farmakokinetiċi ta ’ ViraferonPeg wara doża waħda ta ’ 1. 0 mikrogramma/ kg mogħtija taħt il- ġilda ma kenitx affetwata bl- età.
The data suggest that no alteration in ViraferonPeg dosage is necessary based on advancing age.
L- informazzjoni tissuġġerixxi li ma hemm bżonn ta ’ ebda tibdil fid- doża ta ’ ViraferonPeg f’ età avvanzata.
ViraferonPeg is indicated for the treatment of chronic hepatitis C only in patients 18 years of age or older.
ViraferonPeg huwa intiż biss għat- trattament ta ’ epatite Ċ kronika f’ pazjenti li għandhom 18- il sena jew aktar.
Interferon neutralising factor assays were performed on serum samples of patients who received ViraferonPeg in the clinical trial.
Assays tal- fatturi li jinnewtralizzaw l- interferon saru fuq kampjuni ta ’ serum ta ’ pazjenti li ngħataw ViraferonPeg fil- prova klinika.
The clinical incidence of neutralising factors in patients who received ViraferonPeg 0.5 micrograms/kg is 1.1%.
L- inċidenza klinika tal- fatturi newtralizzanti f’ pazjenti li ngħataw ViraferonPeg 0. 5 mikrogramma/ kg hija ta ’ 1. 1%.
Reproduction studies of ViraferonPeg have not been performed.
Studji ta ’ l- effett ta ’ ViraferonPeg fuq ir- riproduzzjoni għadhom ma twettqux.
ViraferonPeg is likely to also cause this effect.
Intwera illi interferon alfa- 2b jikkawża l- abort fix- xadini u x’ aktarx illi ViraferonPeg ukoll għandu dan l- effett.
It is not known whether the components of this medicinal product are excreted into experimental animal or human milk (see section 4.6 for relevant human data on pregnancy and lactation).
M’ huwiex magħruf jekk il- komponenti ta ’ dan il- prodott mediċinali jiġux eliminati ġol- ħalib tal- bniedem jew ta ’ l- annimali li jintużaw fl- esperimenti (ara sezzjoni 4. 6 għal dejta rilevanti fuq il- bniedem waqt it- tqala u treddigħ).
ViraferonPeg showed no genotoxic potential.
ViraferonPeg ma deherx li seta ’ jagħmel ħsara ġenotossika.
The relative non-toxicity of monomethoxy-polyethylene glycol (mPEG), which is liberated from ViraferonPeg by metabolism in vivo has been demonstrated in preclinical acute and subchronic toxicity studies in rodents and monkeys, standard embryo-foetal development studies and in in vitro mutagenicity assays.
Meta mqabbel mal- monomethoxy- polyethylene glycol tal- monomethoxy- polyethylene glycol (mPEG), illi jinħeles minn ma 'ViraferonPeg waqt il- metaboliżmu in vivo in- nuqqas ta ’ tossiċità relattiva ġiet stabbilita fi studji li saru qabel l- użu kliniku fuq tossiċità akuta u sotto- kronika illi saru fuq firien u xadini, studji standard fuq l- iżvilupp embrijo- fetali u assays in vitro fuq mutaġeniċità.
ViraferonPeg plus ribavirin:
ViraferonPeg flimkien ma 'ribavirin:
When used in combination with ribavirin, ViraferonPeg did not cause any effects not previously seen with either active substance alone.
Meta ġie wżat flimkien ma ’ ribavirin, ViraferonPeg ma kkawża l - ebda effett li ma kienx digà deher b’ wieħed mis- sustanzi attivi waħidhom.
The major treatment-related change was a reversible, mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
L- akbar bidla relatata mat - trattament kienet anemija ħafifa għal moderata riversibbli, u li s- serjetà tagħha kienet akbar minn dik ikkaġunata minn xi waħda mis- sustanzi attivi waħidhom.
ViraferonPeg 50 micrograms is supplied as:
ViraferonPeg 50 mikrogrammi jiġi bħala:
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 50 micrograms for single use.
ViraferonPeg jiġi bħala trab ta ’ peginterferon alfa- 2b b’ qawwa ta ’ 50 mikrogrammi li jista ’ jintuża darba biss.
A small volume is lost during preparation of ViraferonPeg for injection when the dose is measured and injected.
Volum żgħir jintilef waqt il- preparazzjoni ta ’ ViraferonPeg għall- injezzjoni meta d- doża tiġi mkejla u injettata.
Therefore, each vial contains an excess amount of solvent and ViraferonPeg powder to ensure delivery of the labelled dose in 0.5 ml of ViraferonPeg, solution for injection.
Għaldaqstant, kull kunjett fiha ammont żejjed ta ’ solvent u trab ta ’ ViraferonPeg sabiex jiġi żgurat l- għoti tad- doża msemmija fuq it- tikketta ġo 0. 5 ml ta ’ ViraferonPeg, soluzzjoni għall- injezzjoni.
The reconstituted solution has a concentration of 50 micrograms/0.5 ml.
Is - soluzzjoni rikostitwita għandha konċentrazzjoni ta ’ 50 mikrogrammi/ 0. 5 ml.
Using a sterilised injection syringe and injection needle, inject 0.7 ml of water for injections into the vial of ViraferonPeg.
Permezz ta ’ siringa sterilizzata għall- injezzjoni u labra ta ’ l- injezzjoni, injetta 0. 7 ml ta ’ ilma għall - injezzjonijiet ġol- kunjett ta ’ ViraferonPeg.
29 May 2000 Date of last renewal:
29 ta ’ Mejju 2000 Data ta ’ l- aħħar tiġdid:
ViraferonPeg 80 micrograms powder and solvent for solution for injection
ViraferonPeg 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni.
Each vial of ViraferonPeg, powder for solution for injection contains 80 micrograms of peginterferon alfa- 2b as measured on a protein basis.
Kull kunjett ta ’ ViraferonPeg, trab għal soluzzjoni għall- injezzjoni fih 80 mikrogrammi ta ’ peginterferon alfa- 2b hekk kif imkejjel fuq bażi ta ’ proteina.
25 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta ViraferonPeg 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
The intended dose of 1.5 μg/kg of ViraferonPeg to be used in combination with ribavirin may be delivered in weight categories with the pen/vial strengths according to Table 1.
Id- doża maħsuba ta ’ 1. 5 μg/ kg ta ’ ViraferonPeg li għandha tintuża flimkien ma 'ribavirin tista ’ tingħata f’ kategoriji ta ’ piż bil- qawwiet tal- pinna/ kunjett skond Tabella 1.
The negative predictive value for sustained response in HCV/HIV co-infected patients treated with ViraferonPeg in combination with ribavirin was 99% (67/68; Study 1) (see section 5.1).
Il- valur ta ’ tbassir negattiv għal rispons sostnut f’ pazjenti infettati fl- istess ħin b’ HCV/ HIV ikkurati b’ ViraferonPeg f’ kombinazzjoni ma ’ ribavirin kien 99% (67/ 68; Studju 1) (ara sezzjoni 5. 1).
ViraferonPeg monotherapy As monotherapy the ViraferonPeg regimen is 0.5 or 1.0 microgram/kg/week.
Monoterapija b’ ViraferonPeg Bħala monoterapija l- kors ta ’ ViraferonPeg huwa ta ’ 0. 5 jew 1. 0 mikrogramma/ kg/ ġimgħa.
ViraferonPeg monotherapy was not studied in HCV/HIV co-infected patients.
Monoterapija b’ ViraferonPeg ma kienitx studjata f’ pazjenti ko - infettati b’ HCV/ HIV.
(ml) (μg/0.5ml)
30- 35 36- 45 46- 56 57- 72 73- 88
600 mg/day* if: < 10 g/dl
għal nofs- doża biss jekk:
therapy if: < 8.5 g/dl
8. 5 g/ dl
g/dl decrease in haemoglobin during any four week period during treatment (permanent dose reduction) - < 1.5 x 109/l - < 0.75 x 109/l 9
erba ’ ġimgħat waqt it- trattament (tnaqqis permanenti fid- doża) 9
Creatinine ALT/AST
> 2. 0 mg/ dl
- - - -
ALT/ AST
> 2.0 mg/dl 2 x baseline and > 10 x ULN**
x linja bażi u
28 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ ViraferonPeg 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
For patients who use 1.0 μg/kg ViraferonPeg monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 3b.
Għal pazjenti illi jużaw il- monoterapija ta ’ ViraferonPeg 1. 0 μg/ kg, tnaqqis fid- doża jista ’ jinkiseb billi jitnaqqas il- volum li ġie miktub mit- tabib bin- nofs jew billi tintuża doża anqas qawwija kif muri f 'Tabella 3b.
Table 3b – Reduced ViraferonPeg Dose for the 1.0 μg/kg Monotherapy Regimen
Tabella 3b – Tnaqqis fid- Doża ta ’ ViraferonPeg għall- Kors ta ’ Monoterapija 1. 0 μg/ kg
In patients with moderate renal dysfunction (creatinine clearance 30-50 ml/minute), the starting dose of ViraferonPeg should be reduced by 25%.
F’ pazjenti li jkollhom il- funzjoni renali ħażina b’ mod moderat (tneħħija tal- krejatinina 30- 50 ml/ minuta), id- doża tal- bidu ta ’ ViraferonPeg għandha titnaqqas b’ 25%.
Patients with severe renal dysfunction (creatinine clearance 15-29 ml/minute) should have the starting dose of ViraferonPeg reduced by 50%.
Pazjenti li jkollhom funzjoni renali ħażina b’ mod sever (tneħħija tal- krejatinina 15- 29 ml/ min) għandhom jieħdu d- doża tal- bidu ta ’ ViraferonPeg imnaqqsa b’ 50%.
Data are not available for the use of ViraferonPeg in patients with creatinine clearance < 15 ml/minute (see section 5.2).
M’ hemmx tagħrif dwar l- użu ta ’ ViraferonPeg f’ pazjenti bi tneħħija tal- krejatinina < 15 ml/ min (ara sezzjoni 5. 2).
Patients with creatinine clearance < 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (see ribavirin SPC).
Terapija kombinata: Pazjenti bit- tneħħija tal- krejatinina < 50 ml/ minuta m’ għandhom jiġu kkurati b’ ViraferonPeg f’ taħlita ma ’ ribavirin (ara SPC ta ’ ribavirin).
- Initiation of ViraferonPeg is contraindicated in HCV/HIV patients with cirrhosis and a Child-Pugh
- Huwa kontra- indikat li tinbeda kura bi ViraferonPeg f’ pazjenti HCV/ HIV b’ ċirrożi u punteġġ Child -
As with interferon alfa-2b, patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, receiving ViraferonPeg therapy require close monitoring.
Bħalma jiġri b 'interferon alfa- 2b, pazjenti li għandhom passat ta ’ insuffiċjenza tal - qalb konġestiva, attakk tal- qalb kif ukoll/ jew li kellhom jew għandhom problemi arritmiċi u li qed jingħataw terapija b’ ViraferonPeg jeħtieġu sorveljanza mill- qrib.
32 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu ViraferonPeg darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
ViraferonPeg is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus
ViraferonPeg għandu jintuża waqt it- tqala biss jekk il - benefiċċju li jista ’ jkun hemm jiġġustifika r- riskju li jista ’ jkun hemm għall- fetu.
33 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
36 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Fi prova klinika, madwar 1. 2% tal- pazjenti li kienu trattati b’ ViraferonPeg jew interferon alfa- 2b flimkien ma 'ribavirin rrapurtaw każijiet psikjatriċi waqt it- trattament.
37 Doses up to 10.5 times the intended dose have been reported.
Dożi sa 10. 5- il darba d- doża intiża kienu rrappurtati.
In general, the adverse events seen in overdose cases involving ViraferonPeg are consistent with the known safety profile for ViraferonPeg; however, the severity of the events may be increased.
B’ mod ġenerali, il- każijiet avversi li dehru f’ każijiet ta ’ doża eċċessiva li kienu jinvolvu ViraferonPeg huma konsistenti mal- profil ta ’ sigurtà maghruf għal ViraferonPeg; madankollu, is- severità tal- każijiet tista ’ tiżdied.
38 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.
Fl- istudju fejn intużat monoterapija b’ ViraferonPeg, b’ kollox 916 pazjenti naïve b’ epatite Ċ kronika ġew ittrattati b 'ViraferonPeg (0. 5, 1. 0 jew 1. 5 mikrogrammi/ kg/ ġimgħa) għal sena u mbagħad ġew osservati għal sitt xhur.
Sustained virological response (% patients HCV negative) Viraferon Peg monotherapy ViraferonPeg + ribavirin
Reazzjoni viroloġika sostenuta (% ta ’ pazjenti negattivi għal HCV) Monoterapija b 'ViraferonPeg ViraferonPeg + ribavirin
ViraferonPeg (1.5 micrograms/kg) + ribavirin (800 mg) ViraferonPeg (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) Interferon alfa-2b (3 MIU) + ribavirin (1,000/1,200 mg) p < 0.001 P 1.5 vs.
ViraferonPeg (1. 5 mikrogrammi/ kg) + ribavirin (800 mg) ViraferonPeg (1. 5 sa 0. 5 mikrogramma/ kg) + ribavirin (1, 000/ 1, 200 mg) Interferon alfa- 2b (3 MIU) + ribavirin (1, 000/ 1, 200 mg) p < 0. 001 P 1. 5 vs.
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.
Fl- istudju fejn ingħatat monoterapija b 'ViraferonPeg, il- Kwalità tal- Ħajja kienet ġeneralment inqas affettwata b’ 0. 5 mikrogramma/ kg ta ’ ViraferonPeg milli jew b’ 1. 0 mikrogramma/ kg ta ’ ViraferonPeg darba fil- ġimgħa jew b’ 3 MIU ta ’ interferon alfa- 2b tliet darbiet fil- ġimgħa.
40 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Fi prova mhux kumparattiva, 235 pazjent b’ ġenotip 1 u viral load baxx (< 600, 000 IU/ ml) irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il- ġilda, darba fil- ġimgħa, flimkien ma ’ ribavirin aġġustat skond il- piż.
Table 8
Kura
Predictability of sustained response by viral response at week 12 and genotype*
Ġinotip Rispons viroloġiku Rispons sostnut Valur negattiv ma ’ ġimgħa 12 imbassar
Treatment ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment ViraferonPeg 1.5 + ribavirin 800-1,400 mg
ViraferonPeg 1. 5 ribavirin (> 10. 6 mg/ kg)
Genotype Viral response Sustained response Negative predictive value at week 12 1 Yes 75% (82/110) 71% (58/82) ---- No 25% (28/ 110) 0% (0/28) 100% 2 and 3 Yes 99% (213/215) 83% (177/213) ----
+ 1 Iva 75% (82/ 110) 71% (58/ 82) ---- Le 25% (28/ 110) 0% (0/ 28) 100%
44 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ ViraferonPeg għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
ViraferonPeg 80 micrograms is supplied as:
ViraferonPeg 80 mikrogrammi jiġi bħala:
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 80 micrograms for single use.
ViraferonPeg jiġi bħala trab ta ’ peginterferon alfa- 2b b’ qawwa ta ’ 80 mikrogrammi li jista ’ jintuża darba biss.
The reconstituted solution has a concentration of 80 micrograms/0.5 ml.
Is - soluzzjoni rikostitwita għandha konċentrazzjoni ta ’ 80 mikrogrammi/ 0. 5 ml.
ViraferonPeg 100 micrograms powder and solvent for solution for injection
ViraferonPeg 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni.
Each vial of ViraferonPeg, powder for solution for injection contains 100 micrograms of peginterferon alfa-2b as measured on a protein basis.
Kull kunjett ta ’ ViraferonPeg, trab għal soluzzjoni għall- injezzjoni fih 100 mikrogrammi ta ’ peginterferon alfa- 2b hekk kif imkejjel fuq bażi ta ’ proteina.
ViraferonPeg is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV, including naïve patients with clinically stable HIV co-infection (see section 4.4).
ViraferonPeg jintuża għat- trattament ta ’ pazjenti adulti b’ epatite Ċ kronika li għandhom transaminases għoljin mingħajr nuqqas ta ’ kumpensament tal- fwied u li huma pożittivi għal HCV- RNA fis- serum jew anti- HCV inklużi pazjenti naïve b’ ko- infezzjoni ta ’ HIV klinikament stabbli (ara sezzjoni 4. 4).
48 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta ViraferonPeg 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
51 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ ViraferonPeg 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
55 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu ViraferonPeg darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
56 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
59 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Fi prova klinika, madwar 1. 2% tal- pazjenti li kienu trattati b’ ViraferonPeg jew interferon alfa- 2b flimkien ma 'ribavirin rrapurtaw każijiet psikjatriċi waqt it- trattament.
60 Doses up to 10.5 times the intended dose have been reported.
Dożi sa 10. 5- il darba d- doża intiża kienu rrappurtati.
61 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.
Fl- istudju fejn intużat monoterapija b’ ViraferonPeg, b’ kollox 916 pazjenti naïve b’ epatite Ċ kronika ġew ittrattati b 'ViraferonPeg (0. 5, 1. 0 jew 1. 5 mikrogrammi/ kg/ ġimgħa) għal sena u mbagħad ġew osservati għal sitt xhur.
P 1.5 ViraferonPeg 1.5 micrograms/kg P 1.0 ViraferonPeg 1.0 microgram/kg P 0.5 ViraferonPeg 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/R I/ R * **
P 1. 5 ViraferonPeg 1. 5 mikrogrammi/ kg P 1. 0 ViraferonPeg 1. 0 mikrogramma/ kg P 0. 5 ViraferonPeg 0. 5 mikrogramma/ kg I Interferon alfa- 2b 3 MIU P 1. 5/ R P 0. 5/ R I/ R * ** Tabella 6
Sustained response rates with Viraferon Peg + ribavirin (by ribavirin dose, genotype and viral load)
I/ R Rati ta ’ risponsi sostnuti b 'ViraferonPeg + ribavirin (bid- doża ta ’ ribavirin, ġenotip u viral load)
63 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Fi prova mhux kumparattiva, 235 pazjent b’ ġenotip 1 u viral load baxx (< 600, 000 IU/ ml) irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il- ġilda, darba fil- ġimgħa, flimkien ma ’ ribavirin aġġustat skond il- piż.
Genotype Viral response Sustained response Negative predictive value at week 12 1 Yes 75% (82/110) 71% (58/82) ---- No 25% (28/110) 0% (0/28) 100% 2 and 3 Yes 99% (213/215) 83% (177/213) ----
+ 1 Iva 75% (82/ 110) 71% (58/ 82) ---- Le 25% (28/ 110) 0% (0/ 28) 100%
67 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ ViraferonPeg għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
ViraferonPeg 100 micrograms is supplied as:
ViraferonPeg 100 mikrogrammi jiġi bħala:
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 100 micrograms for single use.
ViraferonPeg jiġi bħala trab ta ’ peginterferon alfa- 2b b’ qawwa ta ’ 100 mikrogrammi li jista ’ jintuża darba biss.
The reconstituted solution has a concentration of 100 micrograms/0.5 ml.
Is - soluzzjoni rikostitwita għandha konċentrazzjoni ta ’ 100 mikrogrammi/ 0. 5 ml.
ViraferonPeg 120 micrograms powder and solvent for solution for injection
ViraferonPeg 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni.
Each vial of ViraferonPeg, powder for solution for injection contains 120 micrograms of peginterferon alfa-2b as measured on a protein basis.
Kull kunjett ta ’ ViraferonPeg, trab għal soluzzjoni għall- injezzjoni fih 120 mikrogrammi ta ’ peginterferon alfa- 2b hekk kif imkejjel fuq bażi ta ’ proteina.
71 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta ViraferonPeg 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
74 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ ViraferonPeg 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
78 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu ViraferonPeg darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
79 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
82 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Fi prova klinika, madwar 1. 2% tal- pazjenti li kienu trattati b’ ViraferonPeg jew interferon alfa- 2b flimkien ma 'ribavirin rrapurtaw każijiet psikjatriċi waqt it- trattament.
83 Doses up to 10.5 times the intended dose have been reported.
Dożi sa 10. 5- il darba d- doża intiża kienu rrappurtati.
84 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.
Fl- istudju fejn intużat monoterapija b’ ViraferonPeg, b’ kollox 916 pazjenti naïve b’ epatite Ċ kronika ġew ittrattati b 'ViraferonPeg (0. 5, 1. 0 jew 1. 5 mikrogrammi/ kg/ ġimgħa) għal sena u mbagħad ġew osservati għal sitt xhur.
Sustained virological response (% patients HCV negative Viraferon Peg monotherapy
Reazzjoni viroloġika sostenuta (% ta ’ pazjenti negattivi għal HCV) Monoterapija b 'ViraferonPeg ViraferonPeg + ribavirin
Viraferon Peg + ribavirin
Kors ta ’ trattament Numru ta ’ pazjenti
Sustained response rates with Viraferon Peg + ribavirin (by ribavirin dose, genotype and viral load)
Rati ta ’ risponsi sostnuti b 'ViraferonPeg + ribavirin (bid- doża ta ’ ribavirin, ġenotip u viral load)
86 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Fi prova mhux kumparattiva, 235 pazjent b’ ġenotip 1 u viral load baxx (< 600, 000 IU/ ml) irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il- ġilda, darba fil- ġimgħa, flimkien ma ’ ribavirin aġġustat skond il- piż.
MIU = million international units; TIW = three times a week. a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week ViraferonPeg and subjects ≥ 75 kg received 150 µg/week ViraferonPeg. d: ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1, 200 mg for patients > 75 kg.
MIU =miljun unitajiet internazzjonali; TIW = tlett darbiet fil- ġimgħa. a: valur- p ibbażat fuq it- test Cochran- Mantel Haenszel Chi square. b: valur- p ibbażat fuq it- test chi- square. c: individwi < 75 kg irċevew 100 µg/ ġimgħa ViraferonPeg u individwi ≥ 75 kg irċevew 150 µg/ ġimgħa ViraferonPeg. d: għall- pazjenti < 60 kg ingħataw dożi ta ’ 800 mg ribavirin, 1, 000 mg għall- pazjenti 60- 75 kg, u 1, 200 mg għall- pazjenti > 75 kg.
90 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ ViraferonPeg għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
ViraferonPeg 120 micrograms is supplied as:
ViraferonPeg 120 mikrogrammi jiġi bħala:
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 120 micrograms for single use.
ViraferonPeg jiġi bħala trab ta ’ peginterferon alfa- 2b b’ qawwa ta ’ 120 mikrogrammi li jista ’ jintuża darba biss.
The reconstituted solution has a concentration of 120 micrograms/0.5 ml.
Is - soluzzjoni rikostitwita għandha konċentrazzjoni ta ’ 120 mikrogrammi/ 0. 5 ml.
ViraferonPeg 150 micrograms powder and solvent for solution for injection
ViraferonPeg 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni.
Each vial of ViraferonPeg, powder for solution for injection contains 150 micrograms of peginterferon alfa-2b as measured on a protein basis.
Kull kunjett ta ’ ViraferonPeg, trab għal soluzzjoni għall- injezzjoni fih 150 mikrogrammi ta ’ peginterferon alfa- 2b hekk kif imkejjel fuq bażi ta ’ proteina.
94 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta ViraferonPeg 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
g/dl decrease in haemoglobin during any four week period during treatment (permanent dose reduction) -< 1.5 x 109/l -< 0.7 5 x 109/l 9
erba ’ ġimgħat waqt it- trattament (tnaqqis permanenti fid- doża) 9
97 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ ViraferonPeg 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
101 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu ViraferonPeg darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
102 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
Hepatobiliary disorders
Infezzjoni fil- frixa
Common:
Rari ħafna:
Skin and subcutaneous tissue disorders
Disturbi fil- fwied u fil- marrara
Hepatomegaly, hyperbilirubinemia
Kolite iskemika, kolite b’ ulċera
105 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Fi prova klinika, madwar 1. 2% tal- pazjenti li kienu trattati b’ ViraferonPeg jew interferon alfa- 2b flimkien ma 'ribavirin rrapurtaw każijiet psikjatriċi waqt it- trattament.
106 Doses up to 10.5 times the intended dose have been reported.
Dożi sa 10. 5- il darba d- doża intiża kienu rrappurtati.
107 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.
Fl- istudju fejn intużat monoterapija b’ ViraferonPeg, b’ kollox 916 pazjenti naïve b’ epatite Ċ kronika ġew ittrattati b 'ViraferonPeg (0. 5, 1. 0 jew 1. 5 mikrogrammi/ kg/ ġimgħa) għal sena u mbagħad ġew osservati għal sitt xhur.
However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with Viraferon Peg or interferon alfa-2b.
Madankollu intwera li r- rati ta ’ reazzjoni f’ dan l- istudju kienu jiddependu wkoll fuq id - doża ta ’ ribavirin li ngħatat flimkien ma 'ViraferonPeg jew interferon alfa- 2b.
109 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Fi prova mhux kumparattiva, 235 pazjent b’ ġenotip 1 u viral load baxx (< 600, 000 IU/ ml) irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il- ġilda, darba fil- ġimgħa, flimkien ma ’ ribavirin aġġustat skond il- piż.
Predictability of sustained response by viral response at week 12 and genotype *
Ġinotip Rispons viroloġiku Rispons sostnut Valur negattiv ma ’ ġimgħa 12 imbassar
27% (56/205) 20% (4 1/205) 0.047 44% (23/52) 21% (9/43) 0.017 17% (21/125) 6% (8/129) 0.006 38% (12/32) 7% (2/27) 0.007
27% (56/ 205) 20% (41/ 205) 0. 047 44% (23/ 52) 21% (9/ 43) 0. 017 17% (21/ 125) 6% (8/ 129) 0. 006 38% (12/ 32) 7% (2/ 27) 0. 007
113 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ ViraferonPeg għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
ViraferonPeg 150 micrograms is supplied as:
ViraferonPeg 150 mikrogrammi jiġi bħala:
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 150 micrograms for single use.
ViraferonPeg jiġi bħala trab ta ’ peginterferon alfa- 2b b’ qawwa ta ’ 150 mikrogrammi li jista ’ jintuża darba biss.
The reconstituted solution has a concentration of 150 micrograms/0.5 ml.
Is - soluzzjoni rikostitwita għandha konċentrazzjoni ta ’ 150 mikrogrammi/ 0. 5 ml.
ViraferonPeg 50 micrograms, powder and solvent for solution for injection in pre-filled pen
ViraferonPeg 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Each pre-filled pen of ViraferonPeg 50 micrograms contains a sufficient amount of peginterferon alfa-2b as measured on a protein basis in a powder for solution for injection, and the corresponding amount of solvent, to provide 50 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kull pinna mimlija għal lest ta ’ ViraferonPeg 50 mikrogramma fihom biżżejjed peginterferon alfa- 2b hekk kif imkejjel fuq bażi ta ’ proteina f’ trab għal soluzzjoni għall- injezzjoni, u l- ammont korrispondenti ta ’ solvent, sabiex jipprovdi 50 mikrogramma f’ 0. 5 ml ta ’ peginterferon alfa- 2b meta rikostitwit kif rakkomandat.
117 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta ViraferonPeg 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
ViraferonPeg monotherapy As monotherapy the ViraferonPeg regimen is 0.5 or 1.0 microgram/k g/week.
Monoterapija b’ ViraferonPeg Bħala monoterapija l- kors ta ’ ViraferonPeg huwa ta ’ 0. 5 jew 1. 0 mikrogramma/ kg/ ġimgħa.
120 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ ViraferonPeg 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
There are no apparent age -related effects on the pharmacokinetics of ViraferonPeg.
Jidher li ma hemm l- ebda effetti relatati ma ’ l- età fuq il- farmakokinetiċi ta ’ ViraferonPeg.
124 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu ViraferonPeg darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
125 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
128 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Fi prova klinika, madwar 1. 2% tal- pazjenti li kienu trattati b’ ViraferonPeg jew interferon alfa- 2b flimkien ma 'ribavirin rrapurtaw każijiet psikjatriċi waqt it- trattament.
129 Doses up to 10.5 times the intended dose have been reported.
Dożi sa 10. 5- il darba d- doża intiża kienu rrappurtati.
130 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.
Fl- istudju fejn intużat monoterapija b’ ViraferonPeg, b’ kollox 916 pazjenti naïve b’ epatite Ċ kronika ġew ittrattati b 'ViraferonPeg (0. 5, 1. 0 jew 1. 5 mikrogrammi/ kg/ ġimgħa) għal sena u mbagħad ġew osservati għal sitt xhur.
131
Ġenotip 1
> 10.6
Kollha ≤ 10. 6
Genotype 1 > 600,000 IU/ml
> 600, 000 IU/ ml
All ≤ 10.6 > 10.6
> 10. 6
In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Fi prova mhux kumparattiva, 235 pazjent b’ ġenotip 1 u viral load baxx (< 600, 000 IU/ ml) irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il- ġilda, darba fil- ġimgħa, flimkien ma ’ ribavirin aġġustat skond il- piż.
132 Predictability of sustained virological response – Naïve patients Virological reponse by week 12, defined as a 2-log viral load decrease or undetectable levels of HCV- RNA has been shown to be predictive for sustained response (Table 8).
Tbassir ta ’ rispons viroloġiku sostnut - Pazjenti li qatt ma kienu ħadu din il- kura qabel Rispons viroloġiku sat- tnax- il ġimgħa, mfissra bħala tnaqqis ta ’ 2- log fil- viral load jew livelli ta ’ HCV RNA li ma jitkejlux intweriet li tista ’ tintuża biex jitbassar ir- rispons sostnut (Tabella 8) Table 8
Viral response Sustained response Negative predictive value at week 12 1 Yes 75% (82/110) 71% (58/82) ---- No 25% (28/ 110) 0% (0/28) 100%
+ 1 Iva 75% (82/ 110) 71% (58/ 82) ---- Le 25% (28/ 110) 0% (0/ 28) 100%
136 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ ViraferonPeg għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
Not all pack sizes may be marketed.
għat- tindif Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
ViraferonPeg pre-filled pen contains a powder of peginterferon alfa-2b and a solvent for solution at a strength of 50 micrograms for single use.
Il- pinna ViraferonPeg mimlija għal- lest tiġi bħala trab ta ’ peginterferon alfa- 2b u solvent għal soluzzjoni b’ qawwa ta ’ 50 mikrogrammi li jista ’ jintuża darba biss.
Each pen is reconstituted with the solvent provided in the two- chamber cartridge (water for injections) for administration of up to 0.5 ml of solution.
Kull pinna tiġi rikostitwita bis- solvent li jkun hemm magħha l- iskartoċċ b’ żewġ kavitajiet (ilma għall- injezzjonijiet) biex tingħata sa 0. 5 ml ta ’ soluzzjoni.
Therefore, each pen contains an excess amount of solvent and ViraferonPeg powder to ensure delivery of the labelled dose in 0.5 ml of ViraferonPeg, solution for injection.
Għaldaqstant, kull pinna fiha ammont żejjed ta ’ solvent u trab ta ’ ViraferonPeg sabiex jiġi żgurat l- għoti tad - doża msemmija fuq it- tikketta ġo 0. 5 ml ta ’ ViraferonPeg, soluzzjoni għall- injezzjoni.
ViraferonPeg is injected subcutaneously after reconstituting the powder as instructed, attaching an injection needle and setting the prescribed dose.
ViraferonPeg jiġi injettat taħt il- ġilda wara li jkun rikostitwit it- trab kif hemm fl- istruzzjonijiet, billi twaħħal labra ta ’ l- injezzjoni u tirregola d- doża ordnata.
Remove ViraferonPeg pre-filled pen from the refrigerator before administration to allow the solvent to
Neħħi l- pinna mimlija għal- lest ta ’ ViraferonPeg mill- friġġ qabel l- għotja sabiex tħalli s- solvent jilħaq it - temperatura tal- kamra (mhux aktar minn 25ºC).
After administering the dose, discard the ViraferonPeg pre- filled pen and any unused solution contained in it.
Wara li tingħata d- doża, armi l- pinna mimlija għal- lest ta ’ ViraferonPeg u kwalunkwe materjal li jkun fiha.
ViraferonPeg 80 micrograms, powder and solvent for solution for injection in pre-filled pen
ViraferonPeg 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Each pre-filled pen of ViraferonPeg 80 micrograms contains a sufficient amount of peginterferon alfa-2b as measured on a protein basis in a powder for solution for injection, and the corresponding amount of solvent, to provide 80 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kull pinna mimlija għal lest ta ’ ViraferonPeg 80 mikrogramma fihom biżżejjed peginterferon alfa- 2b hekk kif imkejjel fuq bażi ta ’ proteina f’ trab għal soluzzjoni għall- injezzjoni, u l- ammont korrispondenti ta ’ solvent, sabiex jipprovdi 80 mikrogramma f’ 0. 5 ml ta ’ peginterferon alfa- 2b meta rikostitwit kif rakkomandat.
140 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta ViraferonPeg 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
600 m g/day* if: < 10 g/ dl
għal nofs- doża biss jekk:
143 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ ViraferonPeg 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
Data from elderly patients treated with a s ingle dose of ViraferonPeg suggest no alteration in ViraferonPeg dose is necessary based on age (see section 5.2).
Informazzjoni minn pazjenti anzjani li ngħataw doża waħda ta ’ ViraferonPeg tissuġġerixxi li m’ hemmx bżonn ta ’ tibdil fid- doża minħabba l- età (ara sezzjoni 5. 2).
147 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu ViraferonPeg darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
148 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
151 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Fi prova klinika, madwar 1. 2% tal- pazjenti li kienu trattati b’ ViraferonPeg jew interferon alfa- 2b flimkien ma 'ribavirin rrapurtaw każijiet psikjatriċi waqt it- trattament.
152 consistent with the known safety profile for ViraferonPeg; however, the severity of the events may be increased.
B’ mod ġenerali, il- każijiet avversi li dehru f’ każijiet ta ’ doża eċċessiva li kienu jinvolvu ViraferonPeg huma konsistenti mal- profil ta ’ sigurtà maghruf għal ViraferonPeg; madankollu, is- severità tal- każijiet tista ’ tiżdied.
153 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.
Fl- istudju fejn intużat monoterapija b’ ViraferonPeg, b’ kollox 916 pazjenti naïve b’ epatite Ċ kronika ġew ittrattati b 'ViraferonPeg (0. 5, 1. 0 jew 1. 5 mikrogrammi/ kg/ ġimgħa) għal sena u mbagħad ġew osservati għal sitt xhur.
Viraferon Peg (1.5 micrograms/kg) + ribavirin (800 mg) ViraferonPeg (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) Interferon alfa-2b (3 MIU) + ribavirin (1,000/1,200 mg) p < 0.001 P 1.5 vs.
ViraferonPeg (1. 5 mikrogrammi/ kg) + ribavirin (800 mg) ViraferonPeg (1. 5 sa 0. 5 mikrogramma/ kg) + ribavirin (1, 000/ 1, 200 mg) Interferon alfa- 2b (3 MIU) + ribavirin (1, 000/ 1, 200 mg) p < 0. 001 P 1. 5 vs.
All
Kollha ≤ 10. 6
≤ 10.6 > 10.6
> 10. 6
In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 microgram/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, which has not yet been validated) (Table 7).
Fi prova separata, 224 pazjent b’ ġenotip 2 jew 3 irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il - ġilda, darba fil- ġimgħa, f’ kombinazzjoni ma ’ ribavirin 800 mg- 1, 400 mg p. o. għal 6 xhur (ibbażat fuq il - piż tal- ġisem, tlett pazjenti biss kienu jiżnu > 105 kg, irċevew doża ta ’ 1, 400 mg) (Tabella 7).
155 Predictability of sustained virological response – Naïve patients Virological reponse by week 12, defined as a 2-log viral load decrease or undetectable levels of HCV- RNA has been shown to be predictive for sustained response (Table 8).
Tbassir ta ’ rispons viroloġiku sostnut - Pazjenti li qatt ma kienu ħadu din il- kura qabel Rispons viroloġiku sat- tnax- il ġimgħa, mfissra bħala tnaqqis ta ’ 2- log fil- viral load jew livelli ta ’ HCV RNA li ma jitkejlux intweriet li tista ’ tintuża biex jitbassar ir- rispons sostnut (Tabella 8) Table 8
159 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ ViraferonPeg għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
ViraferonPeg pre-filled pen contains a powder of peginterferon alfa-2b and a solvent for solution at a strength of 80 micrograms for single use.
Il- pinna ViraferonPeg mimlija għal- lest tiġi bħala trab ta ’ peginterferon alfa- 2b u solvent għal soluzzjoni b’ qawwa ta ’ 80 mikrogrammi li jista ’ jintuża darba biss.
The refore, each pen contains an excess amount of solvent and ViraferonPeg powder to ensure delivery of the labelled dose in 0.5 ml of ViraferonPeg, solution for injection.
Għaldaqstant, kull pinna fiha ammont żejjed ta ’ solvent u trab ta ’ ViraferonPeg sabiex jiġi żgurat l- għoti tad - doża msemmija fuq it- tikketta ġo 0. 5 ml ta ’ ViraferonPeg, soluzzjoni għall- injezzjoni.
ViraferonPeg 100 micrograms, powder and solvent for solution for injection in pre-filled pen
ViraferonPeg 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Each pre-filled pen of ViraferonPeg 100 micrograms contains a sufficient amount of peginterferon alfa-2b as measured on a protein basis in a powder for solution for injection, and the corresponding amount of solvent, to provide 100 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kull pinna mimlija għal lest ta ’ ViraferonPeg 100 mikrogramma fihom biżżejjed peginterferon alfa- 2b hekk kif imkejjel fuq bażi ta ’ proteina f’ trab għal soluzzjoni għall- injezzjoni, u l- ammont korrispondenti ta ’ solvent, sabiex jipprovdi 100 mikrogramma f’ 0. 5 ml ta ’ peginterferon alfa- 2b meta rikostitwit kif rakkomandat.
163 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta ViraferonPeg 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
166 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ ViraferonPeg 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
There are no apparent age-related effects on the pharmacok inetics of ViraferonPeg.
Jidher li ma hemm l- ebda effetti relatati ma ’ l- età fuq il- farmakokinetiċi ta ’ ViraferonPeg.
170 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu ViraferonPeg darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
171 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
174 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Fi prova klinika, madwar 1. 2% tal- pazjenti li kienu trattati b’ ViraferonPeg jew interferon alfa- 2b flimkien ma 'ribavirin rrapurtaw każijiet psikjatriċi waqt it- trattament.
175 Doses up to 10.5 times the intended dose have been reported.
Dożi sa 10. 5- il darba d- doża intiża kienu rrappurtati.
176 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.
Fl- istudju fejn intużat monoterapija b’ ViraferonPeg, b’ kollox 916 pazjenti naïve b’ epatite Ċ kronika ġew ittrattati b 'ViraferonPeg (0. 5, 1. 0 jew 1. 5 mikrogrammi/ kg/ ġimgħa) għal sena u mbagħad ġew osservati għal sitt xhur.
In this trial, the combination of Viraferon Peg (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 5), particularly in patients infected with Genotype 1 (Table 6).
F’ din il- prova, il- kombinazzjoni ta ’ ViraferonPeg (1. 5 mikrogrammi/ kg/ ġimgħa) u ribavirin kien, b’ mod sinifikattiv, aktar effettiv mill- kombinazjoni ta ’ interferon alfa- 2b u ribavirin (Tabella 5), l- aktar f’ pazjenti infettati b’ Ġenotip 1 (Tabella 6).
P 1.5 ViraferonPeg 1.5 micrograms/kg P 1.0 ViraferonPeg 1.0 microgram/kg P 0.5 ViraferonPeg 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/ R P 0.5/R I/R * **
P 1. 5 ViraferonPeg 1. 5 mikrogrammi/ kg P 1. 0 ViraferonPeg 1. 0 mikrogramma/ kg P 0. 5 ViraferonPeg 0. 5 mikrogramma/ kg I Interferon alfa- 2b 3 MIU P 1. 5/ R P 0. 5/ R I/ R * **
177
Ġenotip 1
178 Predictability of sustained virological response – Naïve patients Virological reponse by week 12, defined as a 2-log viral load decrease or undetectable levels of HCV- RNA has been shown to be predictive for sustained response (Table 8).
Tbassir ta ’ rispons viroloġiku sostnut - Pazjenti li qatt ma kienu ħadu din il- kura qabel Rispons viroloġiku sat- tnax- il ġimgħa, mfissra bħala tnaqqis ta ’ 2- log fil- viral load jew livelli ta ’ HCV RNA li ma jitkejlux intweriet li tista ’ tintuża biex jitbassar ir- rispons sostnut (Tabella 8) Table 8
24-week treatment * reflects patients
ġimgħa ta ’ kura 48 ViraferonPeg 1. 5 + ribavirin 800- 1, 400 mg
182 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ ViraferonPeg għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
ViraferonPeg pre-filled pen contains a powder of peginterferon alfa-2b and a solvent for solution at a strength of 100 micrograms for single use.
6. 6 Prekawzjonijiet speċjali li għ andhom jittieħ du meta jintrema u għ al immaniġġar ieħ or Il- pinna ViraferonPeg mimlija għal- lest tiġi bħala trab ta ’ peginterferon alfa- 2b u solvent għal soluzzjoni b’ qawwa ta ’ 100 mikrogrammi li jista ’ jintuża darba biss.
ViraferonPeg 120 micrograms, powder and solvent for solution for injection in pre-filled pen
ViraferonPeg 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.