qanastek/EMEA-V3 huggingface dataset:
Each pre-filled pen of ViraferonPeg 120 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 120 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kull pinna mimlija għal lest ta ’ ViraferonPeg 120 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 120 mikrogramma f’ 0. 5 ml ta ’ peginterferon alfa- 2b meta rikostitwit kif rakkomandat.
186 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.
to one -half dose if: -
Emoglobina Emoglobina fi:
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
189 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.
193 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.
194 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
197 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.
198 Doses up to 10.5 times the intended dose have been reported.
Dożi sa 10. 5- il darba d- doża intiża kienu rrappurtati.
199 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 the Viraferon Peg combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: • ViraferonPeg (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • ViraferonPeg (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) + ribavirin (1,000/1,200 mg/day), (n = 514). • Interferon alfa-2b (3 MIU three times a week) + ribavirin (1,000/1,200 mg/day) (n = 505).
Fi prova fejn ViraferonPeg intuża f’ kombinazzjoni, 1, 530 pazjent naïve ingħataw trattament għal sena b’ wieħed mill- korsijiet ikkumbinati li ġejjin: • ViraferonPeg (1. 5 mikrogrammi/ kg/ ġimgħa) + ribavirin (800 mg kuljum), (n = 511). • ViraferonPeg (1. 5 mikrogrammi/ kg/ ġimgħa għal xahar segwit 0. 5 mikrogrammi/ kg/ ġimgħa għal ħdax- il xahar) + ribavirin (1, 000/ 1, 200 mg kuljum), (n = 514). • Interferon alfa- 2b (3 MIU tlett darbiet fil- ġimgħa) + ribavirin (1, 000/ 1, 200 mg kuljum) (n = 505).
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 * **
200
Ġenotip 1
201 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
205 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 120 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 ’ 120 mikrogrammi li jista ’ jintuża darba biss.
ViraferonPeg 150 micrograms, powder and solvent for solution for injection in pre-filled pen
ViraferonPeg 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Each pre-filled pen of ViraferonPeg 150 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 150 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kull pinna mimlija għal lest ta ’ ViraferonPeg 150 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 150 mikrogramma f’ 0. 5 ml ta ’ peginterferon alfa- 2b meta rikostitwit kif rakkomandat.
209 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.
Labora tory values
Valuri tal -
212 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.
216 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.
217 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
220 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.
CD4 lymphocytes decrease:Treatment with ViraferonPeg 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.
Kura b’ ViraferonPeg f’ kombinazzjoni ma ’ ribavirin kienet assoċjata ma ’ tnaqqis fl- għadd assolut ta ’ ċelluli CD4+ fl- ewwel 4 ġimgħat mingħajr tnaqqis fil- perċentwali taċ- ċelluli CD4+.
221 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.
222 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.
This study showed that Viraferon Peg was superior to interferon alfa-2b (Table 5).
Dan l- istudju wera li ViraferonPeg kien superjuri għal interferon alfa- 2b (Tabella 5).
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 * **
224 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
Ġinotip Rispons viroloġiku Rispons sostnut Valur negattiv ma ’ ġimgħa 12 imbassar
ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg)
ViraferonPeg 1. 5 ribavirin (> 10. 6 mg/ kg)
0% (0/28)
+ 1 Iva 75% (82/ 110) 71% (58/ 82) ---- Le 25% (28/ 110) 0% (0/ 28) 100%
+ ribavirin 800-1,400 mg
ġimgħa ta ’ kura 48 ViraferonPeg 1. 5 + ribavirin 800- 1, 400 mg
228 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 150 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 ’ 150 mikrogrammi li jista ’ jintuża darba biss.
ViraferonPeg 50 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
EU/1/00/132/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 001 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 132/ 002 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l - injezzjoni u biċċa 1 biex tnaddaf) EU/ 1/ 00/ 132/ 003 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 004 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l - injezzjoni u 4 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 005 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 026 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
ViraferonPeg 50 mcg
ViraferonPeg 50 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ViraferonPeg 50 micrograms – vial of powder
ViraferonPeg 50 mikrogrammi – kunjett ta ’ trab
ViraferonPeg 50 micrograms powder for injection SC
S. C.
ViraferonPeg 80 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
EU/1/00/132/006 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/007 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/008 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/009 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 006 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 132/ 007 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l - injezzjoni u biċċa 1 biex tnaddaf) EU/ 1/ 00/ 132/ 008 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 009 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l - injezzjoni u 4 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 010 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 027 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
ViraferonPeg 80 mcg
ViraferonPeg 80 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ViraferonPeg 80 micrograms - vial of powder
ViraferonPeg 80 mikrogrammi – kunjett ta ’ trab
ViraferonPeg 80 micrograms powder for injection SC
S. C.
ViraferonPeg 100 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
EU/1/00/132/011 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/012 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/013 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 011 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 132/ 012 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l - injezzjoni u biċċa 1 biex tnaddaf) EU/ 1/ 00/ 132/ 013 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 014 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l - injezzjoni u 4 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 015 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 028 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
ViraferonPeg 100 mg
ViraferonPeg 100 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ViraferonPeg 100 micrograms - vial of powder
ViraferonPeg 100 mikrogrammi – kunjett ta ’ trab
ViraferonPeg 100 micrograms powder for injection SC
S. C.
ViraferonPeg 120 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
EU/1/00/132/016 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/017 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/018 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 016 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 132/ 017 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l - injezzjoni u biċċa 1 biex tnaddaf) EU/ 1/ 00/ 132/ 018 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 019 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l - injezzjoni u 4 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 020 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 029 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
ViraferonPeg 120 mcg
ViraferonPeg 120 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ViraferonPeg 120 micrograms - vial of powder
ViraferonPeg 120 mikrogrammi – kunjett ta ’ trab
ViraferonPeg 120 micrograms powder for injection SC
S. C.
ViraferonPeg 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
ViraferonPeg 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
EU/1/00/132/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/132/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/132/023 (4 vials of powder, 4 ampoules of solvent) EU/1/00/132/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/132/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/132/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 132/ 021 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 132/ 022 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l - injezzjoni u biċċa 1 biex tnaddaf) EU/ 1/ 00/ 132/ 023 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 024 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l - injezzjoni u 4 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 055 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 132/ 030 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
ViraferonPeg 150 mcg
ViraferonPeg 150 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ViraferonPeg 150 micrograms - vial of powder
ViraferonPeg 150 mikrogrammi – kunjett ta ’ trab
ViraferonPeg 150 micrograms powder for injection SC
S. C.
ViraferonPeg - ampoule of solvent
ViraferonPeg – ampulla tas- solvent
Solvent for ViraferonPeg Water for injections
Solvent għal ViraferonPeg Ilma għall- injezzjonijiet
ViraferonPeg 50 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
ViraferonPeg 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b
One ViraferonPeg pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 50 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pinna mimlija għal- lest ta ’ ViraferonPeg fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 50 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
EU/1/00/132/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/033 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/132/034 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 132/ 031 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 032 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 033 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 034 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
ViraferonPeg 50 micrograms powder and solvent for solution for injection
ViraferonPeg 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
ViraferonPeg 50 micrograms powder and solvent for injection SC
S. C.
ViraferonPeg 80 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
ViraferonPeg 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b
One ViraferonPeg pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 80 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pinna mimlija għal- lest ta ’ ViraferonPeg fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 80 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
EU/1/00/132/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/037 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/132/038 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 132/ 035 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 036 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 037 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 038 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
ViraferonPeg 80 micrograms powder and solvent for solution for injection
ViraferonPeg 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
ViraferonPeg 80 micrograms powder and solvent for injection SC
S. C.
ViraferonPeg 100 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
ViraferonPeg 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b
One ViraferonPeg pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 100 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pinna mimlija għal- lest ta ’ ViraferonPeg fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 100 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
EU/1/00/132/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/041 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/132/042 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 132/ 039 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 040 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 041 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 042 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
ViraferonPeg 100 mcg
ViraferonPeg 100 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ViraferonPeg 100 micrograms powder and solvent for solution for injection
ViraferonPeg 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
ViraferonPeg 100 micrograms powder and solvent for injection SC
S. C.
ViraferonPeg 120 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
ViraferonPeg 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b
One ViraferonPeg pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 120 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pinna mimlija għal- lest ta ’ ViraferonPeg fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 120 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
EU/1/00/132/043 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/044 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/045 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/132/046 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 132/ 043 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 044 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 045 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 046 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
ViraferonPeg 120 micrograms powder and solvent for solution for injection
ViraferonPeg 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
ViraferonPeg 120 micrograms powder and solvent for injection SC
S. C.
ViraferonPeg 150 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
ViraferonPeg 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b
One ViraferonPeg pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 150 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pinna mimlija għal- lest ta ’ ViraferonPeg fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 150 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
EU/1/00/132/047 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/132/048 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/132/049 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/132/050 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 132/ 047 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 048 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 049 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 132/ 050 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
ViraferonPeg 150 micrograms powder and solvent for solution for injection
ViraferonPeg 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
ViraferonPeg 150 micrograms powder and solvent for injection SC
S. C.
ViraferonPeg 50 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
ViraferonPeg 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b (konjugazzjoni ta ’ interferon alfa- 2b rikombinat b’ monomethoxy polyethylene glycol)
What ViraferonPeg is and what it is used for 2.
X’ inhu ViraferonPeg u għalxiex jintuża 2.
Before you use ViraferonPeg 3.
Qabel ma tuża ViraferonPeg 3.
How to use ViraferonPeg 4.
Kif għandek tuża ViraferonPeg 4.
How to store ViraferonPeg 6.
Kif taħżen ViraferonPeg 6.
WHAT VIRAFERONPEG IS AND WHAT IT IS USED FOR
X’ INHU VIRAFERONPEG U GĦALXIEX JINTUŻA
ViraferonPeg, which contains an interferon, is used for the treatment of chronic hepatitis C, a viral infection of the liver, including in first time users co-infected with clinically stable HIV.
ViraferonPeg, li fih hemm interferon, jintuża fit- trattament ta ’ l- epatite Ċ kronika, infezzjoni virali tal- fwied, inkluż għal min se jużah l- ewwel darba li jkollu fl- istess ħin marda klinikament stabbli ta ’ l- HIV.
ViraferonPeg is best used for this treatment in combination with ribavirin.
ViraferonPeg l- aħjar li jintuża flimkien ma 'ribavirin għal dan it- trattament.
ViraferonPeg is used alone in case of intolerance or contraindication to ribavirin.
ViraferonPeg jintuża waħdu f’ każ ta ’ intolleranza jew meta ribavirin ikun kontra- indikat.
BEFORE YOU USE VIRAFERONPEG
QABEL MA TUŻA VIRAFERONPEG
ViraferonPeg is not recommended for use in patients under the age of 18 years.
ViraferonPeg mhux rakkomandat għall- użu f’ pazjenti li għ andhom taħt it- 18- il sena.
Do not use ViraferonPeg
Tużax ViraferonPeg
ViraferonPeg.
ta ’ ViraferonPeg.
268 Take special care with ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
If you have a kidney disease and you are using ViraferonPeg in combination with medicinal products containing ribavirin, your doctor should monitor you more carefully for a decrease in red blood cell count.
Jekk għandek marda tal- kliewi u qed tuża ViraferonPeg flimkien ma ’ prodotti mediċinali li fihom ribavirin, it- tabib tiegħek għandu jeżaminak aktar bir- reqqa biex jara jekk l- għadd taċ- ċelluli fid- demm ikunx qed jonqos.
- If you have psoriasis, it may become worse while you are using ViraferonPeg.
- Jekk għandek psorajiżi, tista ’ tmurlek għall- agħar waqt li qed tuża ViraferonPeg.
- If you are planning to become pregnant, discuss this with your doctor before starting to use
- Jekk qed tippjana li toħroġ tqila, iddiskuti dan mat- tabib tiegħek qabel ma tibda tuża ViraferonPeg.
sadness, dejection, etc) while on treatment with ViraferonPeg (see section 4).
jew qalbek sewda, eċċ) waqt li tkun fuq kura bi ViraferonPeg (ara sezzjoni 4).
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving ViraferonPeg and ribavirin combination therapy.
Mard tas- snien jew tal- ħanek, li jistgħu jwasslu li jaqawlek xi snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu ViraferonPeg u ribavirin f’ terapija kombinata.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long -term treatment with the combination of ViraferonPeg with ribavirin.
Minbarra hekk, ħalq xott jista ’ jgħamel il- ħsara fis - snien u l- membrani mukużi tal- ħalq f’ kura fit- tul b’ kombinazzjoni ta ’ ViraferonPeg ma ’ ribavirin.
While being treated with ViraferonPeg Your doctor may want you to drink extra fluids to help prevent low blood pressure.
Waqt li tkun qed tiġi kkurat b’ ViraferonPeg It- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi biex jevita li taqalek il- pressjoni.
Therefore, do not breast-feed an infant if you are taking ViraferonPeg.
Għalhekk, m’ għandekx tredda ’ tarbija jekk qed tieħu ViraferonPeg.
Driving and using machines Do not drive or operate any tools or machines if you feel tired, sleepy or confused while taking ViraferonPeg.
Sewqan u tħaddim ta ’ magni M' għandekx issuq jew tħaddem għodda jew magni jekk tħossok għajjien, bin- ngħas jew imħawwad waqt li qed tieħu ViraferonPeg.
Important information about some of the ingredients of ViraferonPeg This medicinal product contains less than 1 mmol sodium (23 mg) per 0.7 ml, i.e., essentially "sodium-free".
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ViraferonPeg Dan il- prodott mediċinali fih anqas minn 1 mmol (23 mg) sodium għal kull 0. 7 ml, ie tista ’ titqies “ ħielsa mis- sodium ”.
If you are receiving HAART, the addition of ViraferonPeg and ribavirin may increase your risk of lactic acidosis and of liver failure.
Jekk qed tingħata l- HAART, iż - żjieda ta ’ ViraferonPeg u ribavirin jistgħu jżidulek ir- riskju ta ’ l- aċidożi lattika u tal- mard fil- fwied.
Your doctor will monitor you for signs and symptoms of these conditions (Please be sure to read the ribavirin Patient Leaflet also).
(Jekk jogħġbok aċċerta ruħ ek li taqra l- Fuljett ta ’ Tagħrif ta ’ ribavirin ukoll).
Additionally, patients treated with ViraferonPeg and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Minbarra hekk, pazjenti ikkurati b’ terapija kombinata ta ’ ViraferonPeg u ribavirin u zidovudine jista ’ jkollhom riskju akbar li jiżviluppaw anemija (numru baxx ta ’ ċelluli ħomor tad- demm).
If you are also being treated for Human Immunodeficiency Virus (HIV) infection (AIDS) with zidovudine or stavudine, it is not certain if ribavirin will change the way these medicines work.
Jekk qed tingħata wkoll kura għall- infezzjoni (AIDS) bil- Vajrus Tal- Bniedem ta ’ L- Immuno- deffiċjenza (HIV) b’ zidovudine jew stavudine, mhux ċar jekk ribavirin jibdilx il- mod kif jaħdmu dawn il- mediċini.
HOW TO USE VIRAFERONPEG
KIF GĦANDEK TUŻA VIRAFERONPEG
Your doctor has prescribed ViraferonPeg specifically for you and your current condition; do not share this medicine with anyone else.
It- tabib tiegħek kiteb ViraferonPeg speċifikament għalik u għall- kundizzjoni attwali tiegħek; m' għandekx taqsam din il- mediċina ma ’ ħaddieħor.
Your doctor has determined your dose of ViraferonPeg based on your weight.
It- tabib tiegħek stabilixxa d- doża ta ’ ViraferonPeg li int għandek tieħu skond il- piż tiegħek.
If necessary, the dose may be changed during treatment.
Jekk meħtieġ, id- doża tista ’ tinbidel matul it- trattament.
Combination treatment ViraferonPeg, when given with ribavirin capsules, is usually given at a dose of 1.5 microgram/kg once a week.
Trattament Ikkombinat ViraferonPeg, meta mogħti mal- kapsuli ta ’ ribavirin, huwa normalment mogħti f’ doża ta ’ 1. 5 mikrogrammi/ kg darba fil- ġimgħa.
ViraferonPeg alone:
ViraferonPeg waħdu:
ViraferonPeg, when given alone, is usually given at a dose of 0.5 or 1.0 microgram/kg once a week, for at least 6 months, and possibly for 1 year.
ViraferonPeg, meta mogħti waħdu, huwa normalment mogħti f’ doża ta ’ 0. 5 jew 1. 0 mikrogramma/ kg darba fil- ġimgħa, għal ta ’ l- anqas 6 xhur, u possibilment għal sena 1.
ViraferonPeg alone was not studied in HCV/HIV co-infected patients.
ViraferonPeg waħdu ma kienx studjat f’ pazjenti li jkollhom infezzjoni fl- istess ħin ta ’ HCV/ HIV.
If you are injecting ViraferonPeg yourself, please be sure that the dose that has been prescribed for you is clearly provided on the package of medicine you receive.
Jekk qed tinjetta ViraferonPeg inti stess, jekk jogħġbok kun ċert illi d- doża li ġiet miktuba lilek hija indikata fuq il- pakkett tal- mediċina li tingħata.
If you have the impression that the effect of ViraferonPeg is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett ta ’ ViraferonPeg huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
ViraferonPeg is intended for subcutaneous use.
ViraferonPeg jintuża għal taħt il- ġilda.
Detailed instructions for subcutaneous administration are provided with this leaflet (see How to self-inject ViraferonPeg at the end of the package leaflet).
Istruzzjonijiet dettaljati għall - għotja minn taħt il- ġilda huma provduti ma ’ dan il- fuljett (ara Kif tinjetta ViraferonPeg fuqek innifsek fl - aħħar tal- fuljett ta ’ tagħrif).
Discard any solution that is left in the vial after you give yourself the injection.
Armi kull soluzzjoni li tibqa fil- kunjett wara li tagħti l- injezzjoni lilek innifsek. / ViraferonPeg għandu jintuża darba biss.
Inject ViraferonPeg once each week on the same day.
Injetta ViraferonPeg darba fil- ġimgħa fl- istess jum.
Always use ViraferonPeg exactly as your doctor has told you.
Dejjem għandek tuża ViraferonPeg skond il- parir tat- tabib.
Do not exceed the recommended dosage, and take it for as long as prescribed.
Taqbizx id- doża rakkomanda, u ħudu għaż - żmien kif kitiblek it- tabib.
If you use more ViraferonPeg than you should Tell your doctor or healthcare professional as soon as possible.
Jekk tuża ViraferonPeg aktar milli suppost Informa lit- tabib jew professjonista tal- kura tas- saħħa malajr kemm jista ’ jkun.
If you forget to take ViraferonPeg Take the dose as soon as you remember, then continue your treatment as usual.
Jekk tinsa tuża ViraferonPeg Ħu d- doża malli tiftakar, imbagħad kompli it- trattament tiegħek bħas- soltu.
Like all medicines, ViraferonPeg can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ViraferonPeg jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some people get depressed when taking ViraferonPeg alone or in combination treatment with ribavirin, and in some cases people had suicidal thoughts or aggressive behaviour (sometimes directed against others).
Xi nies taqbadhom dipressjoni meta jkunu qed jieħdu ViraferonPeg waħdu jew f’ kombinazzjoni ma ’ ribavirin, u f’ xi każijiet xi nies kellhom ħsibijiet ta ’ suwiċidju jew imġieba aggressive (kulltant indirizzata lejn l- oħrajn).
Other side effects that may occur with the combination of ViraferonPeg and ribavirin capsules include:
Effetti sekondarji oħrajn li jistgħu jseħħu bil- kombinazzjoni ta ’ ViraferonPeg u l- kapsuli ta ’ ribavirin jinkludu:
The following rare and very rare events have been reported with ViraferonPeg:
Każijiet rari u rari ħafna li ġejjin kienu rrappurtati bi ViraferonPeg:
Very rarely, ViraferonPeg alone or in combination with ribavirin may cause aplastic anaemia.
Rari ħafna, ViraferonPeg mogħti waħdu jew f’ kombinazzjoni ma ’ ribavirin jista ’ jikkawża anemija aplastika.
Pure red cell aplasia, a condition where the body stopped or reduced the production of red blood cells, has been reported.
Aplażja pura taċ- ċelluli ħomor, kundizzjoni fejn il- ġisem waqaf jew naqqas il- produzzjoni taċ - ċelluli ħomor tad- demm, kienet irrappurtata.
272 necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degree of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin), mania (excessive or unreasonable enthusiasm), bipolar disorders (mood disorders characterized by alternating episodes of sadness and excitement), pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), pericarditis (inflammation of the lining of the heart).
Minbarra hekk, il- każijiet li ġejjin kienu rrappurtati b’ ViraferonPeg: palsi tal- wiċċ (dgħjufija u naħa waħda tal- wiċċ jitgħawweġ) u reazzjonijiet allerġiċi severi bħal anġjoedema (marda allerġika tal- ġilda li l - karatteristika tagħha hija dbabar ta ’ nefħa ċirkomċiża li tinvolvi l- ġilda u s- saffi ta ’ taħtha, il- membrani mukużi, u kultant l- organi interni), nekroliżi tossika ta ’ l- epidermide/ Sindrome ta ’ Stevens Johnson/ erythema multiforme (medda ta ’ raxxijiet b’ gradi varji ta ’ severità inkluża l- mewt li tista ’ tkun assoċjata ma ’ bżieżaq fil- ħalq, imnieħer, għajnejn u membrani mukużi oħrajn u tinqala l- ġilda tal- parti affettwata), manija (entużjażnu eċċessiv jew bla- raġuni), disturbi bipolari (disturbi fil- burdati li l - karatteristika tagħhom hija episodji li jalternaw bejn dwejjaq u eċitament), effużjoni perikardijaka (jinġabar fluwidu bejn il perikardju (rita mad- dawra tal- qalb) u l- qalb innifisha), perikardite (infjammazzjoni tar- rita tal- qalb).
Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported with ViraferonPeg use.
Minbarra hekk, bl- użu ta ’ ViraferonPeg kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s- sinsla).
When ViraferonPeg is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Meta ViraferonPeg jintuża waħdu, uħud minn dawn l- effetti huma anqas probabbli li jseħħu, u wħud minnhom ma seħħew qatt.
If you are receiving HAART, the addition of ViraferonPeg and ribavirin may increase your risk of lactic acidosis, liver failure, and development of blood abnormalities (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).
Jekk qed tirċievu HAART, meta tieħu wkoll ViraferonPeg u ribavirin jista ’ jżidlek ir- riskju li taqbdek aċidożi lattika, insuffiċjenza tal- fwied, u li tiżviluppa anormalitajiet fid- demm (tnaqqis fin- numru ta ’ ċelluli ħomor fid- demm li jġorru l- ossiġnu, ċerti ċelluli bojod li jiġġieldu l- infezzjoni, u ċelluli li huma marbuta mat- tgħaqid tad- demm imsejjħin plejtlits).
The following other side effects (not listed above) have occurred with the combination of ViraferonPeg 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.
L- effetti sekondarji li ġejjin (mhux elenkati hawn fuq) seħħew bil- kombinazzjoni ta ’ ViraferonPeg u kapsuli ribavirin (adulti) f’ pazjenti ko- infettati b’ HCV/ HIV li kienu qed jirċievu HAART: kandidijasi orali (traxx orali), metaboliżmu tax- xaħam difettuż, tnaqqis fil- limfoċiti CD4, tnaqqis fl- aptit, uġigħ fid- dahar, epatite, uġigħ fir- riġlejn jew driegħ, u anormalitajiet tal- valuri tad- demm varji tal - laboratorju.
HOW TO STORE VIRAFERONPEG
KIF TAĦŻEN X
Do not use ViraferonPeg after the expiry date which is stated on the carton.
Tużax ViraferonPeg wara d- data ta ’ skadenza li tidher fuq il- kartuna.
Do not use ViraferonPeg if you notice discolouration of the powder.
Tużax ViraferonPeg jekk tinnota xi telf tal- kulur tat- trab.
What ViraferonPeg contains
X’ fih ViraferonPeg
What ViraferonPeg looks like and contents of the pack
Id- Dehra ta ’ ViraferonPeg u l- kontenuti tal- pakkett
273 The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
It- trab abjad qiegħed f’ kunjett tal- ħġieġ ta ’ 2 ml u s- solvent ċar u mingħajr kulur qiegħed f’ ampulla tal - ħġieġ ta ’ 2 ml.
ViraferonPeg 50 micrograms is available in different pack sizes:
ViraferonPeg 50 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
SP Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgium
SP Europe, 73, rue de Stalle, B- 1180 Bruxelles, Il - Belġju Manifattur:
Detailed information on this product is available on the web -site of the Europe an Medicines Agency (EMEA) http://www.emea.europa.eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
275 HOW TO SELF-INJECT VIRAFERONPEG?
KIF TINJETTA VIRAFERONPEG FUQEK INNIFSEK?
The following instructions explain how to inject ViraferonPeg yourself.
L- istruzzjonijiet li ġejjin jispegaw kif tinjetta ViraferonPeg int stess.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra sew l - istruzzjonijiet u segwihom pass wara pass.
Your doctor or his/her assistant will instruct you how to self- inject ViraferonPeg.
It- tabib tiegħek jew l- assistant tiegħu/ tagħha ser jurik kif injetta ViraferonPeg fuqek innifsek.
- a vial of ViraferonPeg powder for injection;
- kunjett ta ’ tarb ta ’ ViraferonPeg għall- injezzjoni;
- an ampoule of solvent for ViraferonPeg (water for injections);
- ampulla ta ’ solvent għal ViraferonPeg (ilma għall- injezzjonijiet);
injections to the ViraferonPeg powder vial;
injezzjonijiet lill- kunjett ta ’ ViraferonPeg;
Reconstituting ViraferonPeg powder for injection Before reconstitution, ViraferonPeg may appear either as a white, tablet-shaped solid that is whole or in pieces, or as a white powder.
Rikostituzzjoni ta ’ ViraferonPeg trab għal soluzzjoni Qabel ir- rikostituzzjoni, ViraferonPeg jista ’ jidher bħala solidu abjad f’ għamla ta ’ pillola li hija sħiħa jew imfarrka, jew bħala trab abjad.
Remove the protective cap from the ViraferonPeg vial.
Neħħi l- għatu protettiv mill- kunjett ta ’ ViraferonPeg.
You can save the swab to clean the skin area where you will inject the dose.
Tista ’ żżomm il - biċċa biex tnaddaf il- parti tal- ġilda fejn tkun ser tinjetta d- doża.
When the total amount of solvent is combined with the full amount of ViraferonPeg powder, the solution will be at the correct concentration to measure your dose (i.e., the labelled amount is contained in 0.5 ml).
Meta l- ammont ta ’ solvent kollu jkun tħallat mat- trab ta ’ ViraferonPeg, is- soluzzjoni jkollha l - konċentrazzjoni tajba biex tkejjel id- doża tiegħek (ie, l- ammont li hemm fuq it- tikketta f’ 0. 5 ml).
A small volume is lost during preparation of ViraferonPeg for injection and when the dose is measured and injected.
Volum żgħir jintilef waqt li tkun qed tħallat ViraferonPeg għall- injezzjoni u meta d- doża titkejjel u tiġi 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.
Għalhekk, kull kunjett fih aktar solvent u trab ViraferonPeg biex jiżgura li tkun tista ’ tieħu d - doża li hemm fuq it- tikketta f’ 0. 5 ml tas- soluzzjoni ViraferonPeg, soluzzjoni għall- injezzjoni.
To prepare the ViraferonPeg solution, insert the needle through the rubber top of the ViraferonPeg vial and gently place the needle tip against the glass wall of the vial without touching the cleaned top of the vial with your hands.
Biex tipprepara s- soluzzjoni ViraferonPeg, daħħal il- labra mill- lasktu li hemm fuq il- kunjett ta ’ ViraferonPeg u bil- galbu immira t- tarf tal- labra lejn il- ġenb tal- kunjett mingħajr ma tmiss b’ idejk il- lasktu li tkun għadek kif imsaħt bil- biċċa.
To dissolve the entire contents, swirl the ViraferonPeg vial with a gentle rotary motion leaving the needle and attached syringe in the vial.
Biex tħoll il- kontenuti kollha, dawwar il- kunjett ta ’ ViraferonPeg b’ moviment f’ ċirku fil- waqt li tħalli l - labra u s- siringa imwaħħlin fil- kunjett.
Measuring the dose of ViraferonPeg from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Kif tkejjel id- doża ta ’ ViraferonPeg mit- trab rikostitwit għall- injezzjoni Dawwar il- kunjett u s- siringa bil- maqlub f’ id waħda.
Be sure the tip of needle is in the ViraferonPeg reconstituted solution.
Aċċerta ruħek li l- ponta tal- labra tkun fis- soluzzjoni rikostitwita ta ’ ViraferonPeg.
ViraferonPeg 80 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
ViraferonPeg 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b (konjugazzjoni ta ’ interferon alfa- 2b rikombinat b’ monomethoxy polyethylene glycol)
Storing ViraferonPeg 6.
Kif taħżen ViraferonPeg 6.
278 Take special care with ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
282 necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degree of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin), mania (excessive or unreasonable enthusiasm), bipolar disorders (mood disorders characterized by alternating episodes of sadness and excitement), pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), pericarditis (inflammation of the lining of the heart).
Minbarra hekk, il- każijiet li ġejjin kienu rrappurtati b’ ViraferonPeg: palsi tal- wiċċ (dgħjufija u naħa waħda tal- wiċċ jitgħawweġ) u reazzjonijiet allerġiċi severi bħal anġjoedema (marda allerġika tal- ġilda li l - karatteristika tagħha hija dbabar ta ’ nefħa ċirkomċiża li tinvolvi l- ġilda u s- saffi ta ’ taħtha, il- membrani mukużi, u kultant l- organi interni), nekroliżi tossika ta ’ l- epidermide/ Sindrome ta ’ Stevens Johnson/ erythema multiforme (medda ta ’ raxxijiet b’ gradi varji ta ’ severità inkluża l- mewt li tista ’ tkun assoċjata ma ’ bżieżaq fil- ħalq, imnieħer, għajnejn u membrani mukużi oħrajn u tinqala l- ġilda tal- parti affettwata), manija (entużjażnu eċċessiv jew bla- raġuni), disturbi bipolari (disturbi fil- burdati li l - karatteristika tagħhom hija episodji li jalternaw bejn dwejjaq u eċitament), effużjoni perikardijaka (jinġabar fluwidu bejn il perikardju (rita mad- dawra tal- qalb) u l- qalb innifisha), perikardite (infjammazzjoni tar- rita tal- qalb).
283 The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
It- trab abjad qiegħed f’ kunjett tal- ħġieġ ta ’ 2 ml u s- solvent ċar u mingħajr kulur qiegħed f’ ampulla tal - ħġieġ ta ’ 2 ml.
ViraferonPeg 80 micrograms is available in different pack sizes:
ViraferonPeg 80 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
285 HOW TO SELF-INJECT VIRAFERONPEG?
KIF TINJETTA VIRAFERONPEG FUQEK INNIFSEK?