qanastek/EMEA-V3 huggingface dataset:
Each pre-filled pen of PegIntron 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 ’ PegIntron 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 PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta PegIntron 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
164 Duration of treatment - Retreatment Predictability of sustained virological response:
Kemm għandha ddum il- kura – Trattament mill- ġdid Kemm jista ’ jiġi mbassar r- rispons viroloġiku sostnut:
165 Combination Therapy Dose Reduction Guidelines
Linji Gwida Dwar it- Tnaqqis fid- Doża tat- Terapija Kombinata
166 Dose reduction for patients who use 0.5 μg/kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ PegIntron 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 PegIntron.
Jidher li ma hemm l- ebda effetti relatati ma ’ l- età fuq il- farmakokinetiċi ta ’ PegIntron.
in the previous six months (see section 4.4); 167
sitt xhur ta ’ qabel (ara sezzjoni 4. 4);
168 Hydration:
Idratazzjoni:
169 Haematological abnormalities in HCV/HIV co-infected patients:
Anormalitajiet ematoloġiċi f’ pazjenti li jkollhom fl- istess ħin HCV/ HIV:
Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly Peg Intron (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu PegIntron darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
171 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Nisa li jista ’ jkollhom it- tfal u s- sieħba tagħhom għandhom jużaw kontraċezzjoni effettiva kull wieħed waqt il- kura u għal 4 xhur wara li tkun intemmet il- kura.
172 Metabolism and nutrition disorders Very common:
Dijabete Disturbi fil- metaboliżmu u n - nutrizzjoni Komuni ħafna:
Interstitial lung disease 173
Disturbi gastro- intestinali Komuni ħafna:
Injection site infl ammation, injection site reaction*, dizziness, fatigue, rigors, fever, flu-like symptoms, asthenia
Infjammazzjoni fis- sit mnejn tingħata l- injezzjoni, reazzjoni fis - sit mnejn tingħata l- injezzjoni *, sturdament, għeja, tregħid, deni, sintomi bħal ta ’ l- influwenza, astenja
174 Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Każijiet avversi kardjovaskulari (CVS), l- aktar arritmija, dehru li kellhom x’ jaqsmu l- aktar ma ’ mard pri - eżistenti CVS u ma ’ l- għotja ta ’ aġenti kardjotossiċi xi darba qabel (ara sezzjoni 4. 4).
Although haematological toxicities of neutropenia, thrombocytopenia and aaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Valuri tal- laboratorju għall- pazjenti infettati fl- istess ħim b’ HCV/ HIV Għalkemm tossiċitajiet ħematoloġiċi ta ’ newtropenija, tromboċitopenja u anemija seħħew b’ mod aktar frekwenti f’ pazjenti li kellhom fl- istess ħin infezzjoni b’ HCV/ HIV, il- parti l- kbira setgħu ikunu maniġġjati b’ tibdil fid- doża u rari kellhom bżonn iwaqqfu l- kura aktar kmieni (ara sezzjoni 4. 4).
Treatment with Peg Intron 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’ PegIntron 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+.
175 treatment and close observation of the patient are recommended in cases of overdose.
M’ hemm l- ebda antidotu speċifiku għal PegIntron; għalhekk, kura sintomatika o osservaz+zjoni mill- qrib tal- pazjent hija rakkomandata f’ każijiet ta ’ doża eċċessiva.
176 In the PegIntron combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: • PegIntron (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • PegIntron (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 PegIntron intuża f’ kombinazzjoni, 1, 530 pazjent naïve ingħataw trattament għal sena b’ wieħed mill- korsijiet ikkumbinati li ġejjin: • PegIntron (1. 5 mikrogrammi/ kg/ ġimgħa) + ribavirin (800 mg kuljum), (n = 511). • PegIntron (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 PegIntron 1.5 micrograms/kg P 1.0 PegIntron 1.0 microgram/kg P 0.5 PegIntron 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/ R P 0.5/R I/R * **
P 1. 5 PegIntron 1. 5 mikrogrammi/ kg P 1. 0 PegIntron 1. 0 mikrogramma/ kg P 0. 5 PegIntron 0. 5 mikrogramma/ kg I Interferon alfa- 2b 3 MIU P 1. 5/ R P 0. 5/ R I/ R * **
24-week treatment * reflects patients
ġimgħa ta ’ kura 48 PegIntron 1. 5 + ribavirin 800- 1, 400 mg
No 1% (2/215) 50% (1/2) 50% with 12 week data available
Le 1% (2/ 215)
Stu dy 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co- infected with HIV.
Studju 2 (P02080) kien randomized, f’ ċentru wieħed li fih ħadu sehem 95 pazjent adult li ma kienux ikkurati qabel b’ epatite C kronika li kellhom l- HIV fl- istess ħin.
179 Table 9
Tabella 9
180 Table 10 Rates of Response to retreatment in prior treatment failures
Tabella 10 Rati ta ’ Rispons għall- kura mill- ġdid f’ Każijiet fejn il- Kura Qabel kienet falliet
4 2.6 (69/162) 32.6, 52.6
42. 6 (69/ 162) 32. 6, 52. 6
181 Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
B’ mod globali, madwar 36% (821/ 2, 286) tal- pazjenti kellhom livelli ta ’ HCV- RNA fil- plażma li ma setgħux jitkejlu mat- 12- il Ġimgħa ta ’ terapija imkejjla permezz ta ’ test ibbażat fuq riċerka (limitu li seta ’ jitkejjel 125 IU/ ml).
182 for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ PegIntron għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
183 Water for injections.
Ilma għall- injezzjoni
immediately, in -use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
kemm idum merfugħ waqt l- użu u l- kundizzjonijiet qabel ma jintuża huma r- responsabbiltà ta ’ min qed juża l- mediċina u s- soltu m’ għandux ikun itwal minn 24 siegħa f’ temperatura ta ’ bejn 2°C - 8°C.
PegIntron pre-filled pen contains a powder of peginterferon alfa-2b and a solvent for solution at a strength of 100 micrograms for single use.
Il- pinna PegIntron mimlija għal- lest tiġi bħala trab ta ’ peginterferon alfa- 2b u solvent għal soluzzjoni b’ qawwa ta ’ 100 mikrogrammi li jista ’ jintuża darba biss.
The reconstituted solution has a concentration of 100 micrograms in 0.5 ml.
Is- soluzzjoni rikostitwita għandha konċentrazzjoni ta ’ 100 mikrogrammi/ 0. 5 ml.
PegIntron 120 micrograms, powder and solvent for solution for injection in pre-filled pen
PegIntron 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Each pre-filled pen of PegIntron 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 ’ PegIntron 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 PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta PegIntron 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ml) who become HCV-RN A negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i.e. overall 48 weeks treatment duration).
Fis- sottogrupp ta ’ pazjenti b’ infezzjoni tal- ġenotip 1 u viral load baxx (< 6000, 000 IU/ ml) li jsiru negattivi għal HCV- RNA mar- 4 ġimgħa ta ’ kura u jibqgħu negattivi għal HCV- RNA ma ’ l - 24 ġimgħa ta ’ kura, il- kura tista ’ titwaqqaf wara dan il- kors ta ’ 24 ġimgħa jew jitkompla għal 24 ġimgħa oħra (i. e. b’ kollox 48 ġimgħa ta ’ kura).
187 Duration of treatment - Retreatment Predictability of sustained virological response:
Kemm għandha ddum il- kura – Trattament mill- ġdid Kemm jista ’ jiġi mbassar r- rispons viroloġiku sostnut:
188 Combination Therapy Dose Reduction Guidelines
Linji Gwida Dwar it- Tnaqqis fid- Doża tat- Terapija Kombinata
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)
189 Dose reduction for patients who use 0.5 μg/kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ PegIntron 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
in the previous six months (see section 4.4); 190
sitt xhur ta ’ qabel (ara sezzjoni 4. 4);
191 Hydration:
Idratazzjoni:
192 Haematological abnormalities in HCV/HIV co-infected patients:
Anormalitajiet ematoloġiċi f’ pazjenti li jkollhom fl- istess ħin HCV/ HIV:
194 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Nisa li jista ’ jkollhom it- tfal u s- sieħba tagħhom għandhom jużaw kontraċezzjoni effettiva kull wieħed waqt il- kura u għal 4 xhur wara li tkun intemmet il- kura.
195 Metabolism and nutrition disorders Very common:
Dijabete Disturbi fil- metaboliżmu u n - nutrizzjoni Komuni ħafna:
Interstitial lung disease 196
Disturbi gastro- intestinali Komuni ħafna:
197 Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Każijiet avversi kardjovaskulari (CVS), l- aktar arritmija, dehru li kellhom x’ jaqsmu l- aktar ma ’ mard pri - eżistenti CVS u ma ’ l- għotja ta ’ aġenti kardjotossiċi xi darba qabel (ara sezzjoni 4. 4).
198 treatment and close observation of the patient are recommended in cases of overdose.
M’ hemm l- ebda antidotu speċifiku għal PegIntron; għalhekk, kura sintomatika o osservaz+zjoni mill- qrib tal- pazjent hija rakkomandata f’ każijiet ta ’ doża eċċessiva.
199 In the PegIntron combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: • PegIntron (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • PegIntron (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 PegIntron intuża f’ kombinazzjoni, 1, 530 pazjent naïve ingħataw trattament għal sena b’ wieħed mill- korsijiet ikkumbinati li ġejjin: • PegIntron (1. 5 mikrogrammi/ kg/ ġimgħa) + ribavirin (800 mg kuljum), (n = 511). • PegIntron (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 PegIntron 1.5 micrograms/kg P 1.0 PegIntron 1.0 microgram/kg P 0.5 PegIntron 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/ R I/R * **
P 1. 5 PegIntron 1. 5 mikrogrammi/ kg P 1. 0 PegIntron 1. 0 mikrogramma/ kg P 0. 5 PegIntron 0. 5 mikrogramma/ kg I Interferon alfa- 2b 3 MIU P 1. 5/ R P 0. 5/ R I/ R * **
200
PegIntron (1. 5 mikrogrammi/ kg) + ribavirin (800 mg) PegIntron (1. 5 to 0. 5 mikrogramma/ kg) + ribavirin (1, 000/ 1, 200 mg) Interferon alfa- 2b (3 MIU) + ribavirin (1, 000/ 1, 200 mg)
> 600,000 IU/ ml
> 600, 000 IU/ ml
The res ponse to treatment in both of these trials is presented in Table 9.
Ir- rispons għall- kura f’ dawn iż- żewġ provi jidher f’ Tabella 9.
Patients were ran domized to receive either PegIntron (1.5 µg/kg/week) plus ribavirin (800 mg/day) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Il- pazjenti kienu randomized sabiex jirċievu PegIntron (1. 5 µg/ kg/ ġimgħa) ma ’ ribavirin (800 mg/ jum) jew interferon alfa- 2b (3 MIU TIW) ma ’ ribavirin (800 mg/ jum) għal 48 ġimgħa b’ perijodu ta ’ follow- up ta ’ 6 xhur.
202 Table 9
Tabella 9
203 Table 10 Rates of Response to retreatment in prior treatment failures
Tabella 10 Rati ta ’ Rispons għall- kura mill- ġdid f’ Każijiet fejn il- Kura Qabel kienet falliet
23.0 (162/70 4)
23. 0 (162/ 704)
204 Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
B’ mod globali, madwar 36% (821/ 2, 286) tal- pazjenti kellhom livelli ta ’ HCV- RNA fil- plażma li ma setgħux jitkejlu mat- 12- il Ġimgħa ta ’ terapija imkejjla permezz ta ’ test ibbażat fuq riċerka (limitu li seta ’ jitkejjel 125 IU/ ml).
Peg Intron Cm ax and AUC measurements increase in a dose-related manner.
Is- Cmax u l- AUC ta ’ PegIntron jogħlew b’ mod relatat mad- doża.
The re is, however, only a modest increase in biologic activity as measured by a bioassay.
Madankollu, hemm biss żjieda żgħira fl- attività bijoloġika meta mkejla b’ assay bijoloġiku.
205 for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ PegIntron għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
206 Water for injections.
Ilma għall- injezzjoni
PegIntron pre-filled pen contains a powder of peginterferon alfa-2b and a solvent for solution at a strength of 120 micrograms for single use.
Il- pinna PegIntron mimlija għal- lest tiġi bħala trab ta ’ peginterferon alfa- 2b u solvent għal soluzzjoni b’ qawwa ta ’ 120 mikrogrammi li jista ’ jintuża darba biss.
The reconstituted solution has a concentration of 120 micrograms in 0.5 ml.
Is- soluzzjoni rikostitwita għandha konċentrazzjoni ta ’ 120 mikrogrammi/ 0. 5 ml.
PegIntron 150 micrograms, powder and solvent for solution for injection in pre-filled pen
PegIntron 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni f’ pinna mimlija għal- lest.
Each pre-filled pen of PegIntron 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 ’ PegIntron 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 PegIntron 1.5 micrograms/kg/week in combination with ribavirin capsules.
Terapija konġunta PegIntron 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
210 Duration of treatment - Retreatment Predictability of sustained virological response:
Kemm għandha ddum il- kura – Trattament mill- ġdid Kemm jista ’ jiġi mbassar r- rispons viroloġiku sostnut:
211 Combination Therapy Dose Reduction Guidelines
Linji Gwida Dwar it- Tnaqqis fid- Doża tat- Terapija Kombinata
ribavirin dose to 600 m g/day* if:
600 mg/ kuljum * biss jekk:
212 Dose reduction for patients who use 0.5 μg/kg PegIntron monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ PegIntron 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
in the previous six months (see section 4.4); 213
sitt xhur ta ’ qabel (ara sezzjoni 4. 4);
214 Hydration:
Idratazzjoni:
215 Haematological abnormalities in HCV/HIV co-infected patients:
Anormalitajiet ematoloġiċi f’ pazjenti li jkollhom fl- istess ħin HCV/ HIV:
217 breast-feeding should be discontinued prior to initiation of treatment.
Peress li jista ’ jkun hemm reazzjonijiet avversi fi tfal li jkunu qed jieħdu l- ħalib tas- sider, it - treddigħ għandu jitwaqqaf qabel tibda l- kura.
217 childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Nisa li jista ’ jkollhom it- tfal u s- sieħba tagħhom għandhom jużaw kontraċezzjoni effettiva kull wieħed waqt il- kura u għal 4 xhur wara li tkun intemmet il- kura.
218 Metabolism and nutrition disorders Very common:
Dijabete Disturbi fil- metaboliżmu u n - nutrizzjoni Komuni ħafna:
Interstitial lung disease 219
Disturbi gastro- intestinali Komuni ħafna:
220 Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Każijiet avversi kardjovaskulari (CVS), l- aktar arritmija, dehru li kellhom x’ jaqsmu l- aktar ma ’ mard pri - eżistenti CVS u ma ’ l- għotja ta ’ aġenti kardjotossiċi xi darba qabel (ara sezzjoni 4. 4).
CD4 lymphocytes decrease:Treatment with PegIntron in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Kura b’ PegIntron 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+.
Limited safety data (N= 25) are available in co- infected patients with CD4+ cell counts < 200/µl (see section 4.4).
Hemm tgħarif limitat dwar is- sigurtà (N=25) f’ pazjenti li jkollhom infezzjoni fl- istess ħin b’ għadd ta ’ ċelluli CD4+ < 200µl (ara sezzjoni 4. 4).
221 treatment and close observation of the patient are recommended in cases of overdose.
M’ hemm l- ebda antidotu speċifiku għal PegIntron; għalhekk, kura sintomatika o osservaz+zjoni mill- qrib tal- pazjent hija rakkomandata f’ każijiet ta ’ doża eċċessiva.
222 In the PegIntron combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: • PegIntron (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • PegIntron (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 PegIntron intuża f’ kombinazzjoni, 1, 530 pazjent naïve ingħataw trattament għal sena b’ wieħed mill- korsijiet ikkumbinati li ġejjin: • PegIntron (1. 5 mikrogrammi/ kg/ ġimgħa) + ribavirin (800 mg kuljum), (n = 511). • PegIntron (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 PegIntron 1.5 micrograms/kg P 1.0 PegIntron 1.0 microgram/kg P 0.5 PegIntron 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/R I/ R * **
P 1. 5 PegIntron 1. 5 mikrogrammi/ kg P 1. 0 PegIntron 1. 0 mikrogramma/ kg P 0. 5 PegIntron 0. 5 mikrogramma/ kg I Interferon alfa- 2b 3 MIU P 1. 5/ R P 0. 5/ R I/ R * **
All ≤ 10.6> 10.6
Kollha ≤ 10. 6 > 10. 6
Genotype Viral response Sustained response Negative predictive value at week 12
Tbassir ta ’ rispons sostnut permezz ta ’ reazzjoni virali sat- tnax- il ġimgħa u ġenotip *
PegIntron 1.5 ribavirin
Kura PegIntron 1. 5 + ribavirin (> 10. 6 mg/ kg)
+ 1 Yes 75% (82/110) 71% (58/82) ----
Ġinotip Rispons viroloġiku Rispons sostnut Valur negattiv ma ’ ġimgħa 12 imbassar 1 Iva 75% (82/ 110) 71% (58/ 82) ---- Le 25% (28/ 110) 0% (0/ 28) 100%
(> 10.6 mg/kg) 48-week treatment PegIntron 1.5 +
ġimgħa ta ’ kura 48 PegIntron 1. 5 + ribavirin 800- 1, 400 mg
No 25% (28/110)
2 and 3
0% (0/28)
Iva 99% (213/ 215)
100%
83% (177/ 213)
Stu dy 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Studju 1 (RIBAVIC; P01017) kien studju multiċentriku randomized li fih ħadu sehem 412 pazjent adult li ma kienux ikkurati qabel b’ epatite C kronika li kellhom ukoll infezzjoni b’ HIV.
225 Table 9
Tabella 9
226 Table 10 Rates of Response to retreatment in prior treatment failures
Tabella 10 Rati ta ’ Rispons għall- kura mill- ġdid f’ Każijiet fejn il- Kura Qabel kienet falliet
5 1.6 (94/182) 42.1, 61.2
51. 6 (94/ 182) 42. 1, 61. 2
70.3 (5 2/74) 56.6, 84.0
70. 3 (52/ 74) 56. 6, 84. 0
51.3 (176/3 43) 44.4, 58.3
51. 3 (176/ 343) 44. 4, 58. 3
227 Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
B’ mod globali, madwar 36% (821/ 2, 286) tal- pazjenti kellhom livelli ta ’ HCV- RNA fil- plażma li ma setgħux jitkejlu mat- 12- il Ġimgħa ta ’ terapija imkejjla permezz ta ’ test ibbażat fuq riċerka (limitu li seta ’ jitkejjel 125 IU/ ml).
228 for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ PegIntron għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
The se studies were limited to four weeks due to the appearance of anti-interferon antibodies in most monkeys.
Dawn l- istudji kienu limitati għal tul ta ’ erba ’ ġimgħat minħabba li tfaċċaw antikorpi kontra l - interferon fil- biċċa l- kbira tax- xadini.
229 Water for injections.
Ilma għall- injezzjoni
immediately, in -use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 2 4 hours at 2°C - 8°C.
kemm idum merfugħ waqt l- użu u l- kundizzjonijiet qabel ma jintuża huma r- responsabbiltà ta ’ min qed juża l- mediċina u s- soltu m’ għandux ikun itwal minn 24 siegħa f’ temperatura ta ’ bejn 2°C - 8°C.
PegIntron pre-filled pen contains a powder of peginterferon alfa-2b and a solvent for solution at a strength of 150 micrograms for single use.
Il- pinna PegIntron mimlija għal- lest tiġi bħala trab ta ’ peginterferon alfa- 2b u solvent għal soluzzjoni b’ qawwa ta ’ 150 mikrogrammi li jista ’ jintuża darba biss.
The reconstituted solution has a concentration of 150 micrograms in 0.5 ml.
Is- soluzzjoni rikostitwita għandha konċentrazzjoni ta ’ 150 mikrogrammi/ 0. 5 ml.
231 ANNEX II
ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
CONDITIONS OF THE MARKETING AUTH ORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ A.
SP (Brinny) Company Innishannon - County Cork Ireland
Isem u indirizz tal- manifattur tas- sustanza bijoloġika attiva SP (Brinny) Company Innishannon - County Cork L- Irlanda
Industriepark 30 B-2220 Heist-op-den-Berg Belgium
Industriepark, 30 B- 2220 Heist- op- den- Berg Il- Belġju
233 ANNEX III
ANNESS III
235 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 50 micrograms
Kartuna 50 mikrogrammi
PegIntron 50 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
One vial of powder contains 50 micrograms of peginterferon alfa-2b and provides 50 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kunjett trab fiha 50 mikrogrammi ta ’ peginterferon alfa- 2b u tipprovdi 50 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
Excipients: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80.
Sustanzi mhux attivi: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sukrożju u polysorbate 80.
One ampoule of solvent contains 0.7 ml of water for injections.
Ampulla ta ’ solvent fiha 0. 7 ml ilma għall- injezzjonijiet.
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 50 micrograms/0.5 ml
kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l- injezzjoni u biċċa 1 biex tnaddaf 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l- injezzjoni u 4 biċċiet biex tnaddaf 6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent 12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 50 mikrogrammi/ 0. 5 ml
Subcutaneous use Read the package leaflet before use.
Użu għal taħt il- ġilda Aqra l- fuljett ta ’ tagħrif qabel l- użu.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA 8.
EXP After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Wara r- rikostituzzjoni, uża s- soluzzjoni rikostitwita mill- ewwel jew fi żmien 24 siegħa meta maħżuna fi friġġ (2ºC – 8ºC).
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦ AŻEN
After withdrawal of the dose, any remaining solution must be discarded.
Wara li tkun inġibdet id- doża, kull soluzzjoni li jkun għad baqa 'għandha tintrema.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦ ID FIS- SUQ
Marketing authorisation holder:
Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- suq:
SP Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgium
SP Europe, 73, rue de Stalle, B- 1180 Bruxelles, Il - Belġju
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦ AT- TQEGĦID FIS- SUQ
EU/1/00/131/001 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/002 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/003 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/004 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/005 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/026 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 001 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 003 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 005 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 026 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
16.
ISTRUZZJONIJIET DWAR L- UŻU 16.
PegIntron 50 mcg
PegIntron 50 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PegIntron 50 micrograms – vial of powder
PegIntron 50 mikrogrammi – kunjett ta ’ trab
PegIntron 50 micrograms powder for injection SC
S. C.
50 micrograms/0.5 ml
50 mikrogrammi/ 0. 5 ml
238 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 80 micrograms
Kartuna 80 mikrogrammi
PegIntron 80 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
One vial of powder contains 80 micrograms of peginterferon alfa-2b and provides 80 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kunjett trab fiha 80 mikrogrammi ta ’ peginterferon alfa- 2b u tipprovdi 80 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 80 micrograms/0.5 ml
kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l- injezzjoni u biċċa 1 biex tnaddaf 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l- injezzjoni u 4 biċċiet biex tnaddaf 6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent 12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 80 mikrogrammi/ 0. 5 ml
239 After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Wara r- rikostituzzjoni, uża s- soluzzjoni rikostitwita mill- ewwel jew fi żmien 24 siegħa meta maħżuna fi friġġ (2ºC – 8ºC).
EU/1/00/131/006 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/007 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/008 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/009 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/010 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/027 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 006 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 008 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 010 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 027 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
PegIntron 80 mcg
PegIntron 80 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PegIntron 80 micrograms - vial of powder
PegIntron 80 mikrogrammi – kunjett ta ’ trab
PegIntron 80 micrograms powder for injection SC
S. C.
80 micrograms/0.5 ml
80 mikrogrammi/ 0. 5 ml
241 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 100 micrograms
Kartuna 100 mikrogrammi
PegIntron 100 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
One vial of powder contains 100 micrograms of peginterferon alfa-2b and provides 100 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kunjett trab fiha 100 mikrogrammi ta ’ peginterferon alfa- 2b u tipprovdi 100 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 100 micrograms/0.5 ml
kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l- injezzjoni u biċċa 1 biex tnaddaf 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l- injezzjoni u 4 biċċiet biex tnaddaf 6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent 12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 100 mikrogrammi/ 0. 5 ml
EU/1/00/131/011 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/012 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/013 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/014 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/015 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/028 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 011 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 013 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 015 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 028 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
PegIntron 100 mg
PegIntron 100 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PegIntron 100 micrograms - vial of powder
PegIntron 100 mikrogrammi – kunjett ta ’ trab
PegIntron 100 micrograms powder for injection SC
S. C.
100 micrograms/0.5 ml
100 mikrogrammi/ 0. 5 ml
244 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 120 micrograms
Kartuna 120 mikrogrammi
PegIntron 120 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
One vial of powder contains 120 micrograms of peginterferon alfa-2b and provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kunjett trab fiha 120 mikrogrammi ta ’ peginterferon alfa- 2b u tipprovdi 120 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 120 micrograms/0.5 ml
kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l- injezzjoni u biċċa 1 biex tnaddaf 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l- injezzjoni u 4 biċċiet biex tnaddaf 6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent 12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 120 mikrogrammi/ 0. 5 ml
245 After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Wara r- rikostituzzjoni, uża s- soluzzjoni rikostitwita mill- ewwel jew fi żmien 24 siegħa meta maħżuna fi friġġ (2ºC – 8ºC).
EU/1/00/131/016 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/017 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/018 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/019 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/020 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/029 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 016 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 018 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 020 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 029 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
PegIntron 120 mcg
PegIntron 120 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PegIntron 120 micrograms - vial of powder
PegIntron 120 mikrogrammi – kunjett ta ’ trab
PegIntron 120 micrograms powder for injection SC
S. C.
120 micrograms/0.5 ml
120 mikrogrammi/ 0. 5 ml
247 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 150 micrograms
Kartuna 150 mikrogrammi
PegIntron 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b
PegIntron 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b
One vial of powder contains 150 micrograms of peginterferon alfa-2b and provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kunjett trab fiha 150 mikrogrammi ta ’ peginterferon alfa- 2b u tipprovdi 150 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
1 vial of powder, 1 ampoule of solvent 1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab 4 vials of powder, 4 ampoules of solvent 4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs 6 vials of powder, 6 ampoules of solvent 12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs 150 micrograms/0.5 ml
kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent, siringa 1 għall- injezzjoni, 2 labar ta ’ l- injezzjoni u biċċa 1 biex tnaddaf 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent 4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent, 4 siringi għall- injezzjoni, 8 labar ta ’ l- injezzjoni u 4 biċċiet biex tnaddaf 6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent 12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 150 mikrogrammi/ 0. 5 ml
248 After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Wara r- rikostituzzjoni, uża s- soluzzjoni rikostitwita mill- ewwel jew fi żmien 24 siegħa meta maħżuna fi friġġ (2ºC – 8ºC).
EU/1/00/131/021 (1 vial of powder, 1 ampoule of solvent) EU/1/00/131/022 (1 vial of powder, 1 ampoule of solvent, 1 injection syringe, 2 injection needles and 1 cleansing swab) EU/1/00/131/023 (4 vials of powder, 4 ampoules of solvent) EU/1/00/131/024 (4 vials of powder, 4 ampoules of solvent, 4 injection syringes, 8 injection needles and 4 cleansing swabs) EU/1/00/131/025 (6 vials of powder, 6 ampoules of solvent) EU/1/00/131/030 (12 vials of powder, 12 ampoules of solvent, 12 injection syringes, 24 injection needles and 12 cleansing swabs)
EU/ 1/ 00/ 131/ 021 (kunjett 1 ta ’ trab, ampulla 1 ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 023 (4 kunjetti ta ’ trab, 4 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 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/ 131/ 055 (6 kunjetti ta ’ trab, 6 ampulli ta ’ solvent) EU/ 1/ 00/ 131/ 030 (12 kunjetti ta ’ trab, 12 ampulli ta ’ solvent, 12 siringi għall- injezzjoni, 24 labar ta ’ l - injezzjoni u 12 biċċiet biex tnaddaf)
PegIntron 150 mcg
PegIntron 150 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PegIntron 150 micrograms - vial of powder
PegIntron 150 mikrogrammi – kunjett ta ’ trab
PegIntron 150 micrograms powder for injection SC
S. C.
150 micrograms/0.5 ml
150 mikrogrammi/ 0. 5 ml
250 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
OĦRAJN TA’ GĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PegIntron - ampoule of solvent
PegIntron – ampulla tas- solvent
Solvent for PegIntron Water for injections
Solvent għal PegIntron Ilma għall- injezzjonijiet
251 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 50 micrograms powder and solvent for solution for injection
Kartuna 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 50 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
PegIntron 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b
One PegIntron 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 ’ PegIntron fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 50 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
1 pen, 1 injection needle and 2 cleansing swabs 4 pens, 4 injection needles and 8 cleansing swabs 6 pens, 6 injection needles and 12 cleansing swabs 12 pens, 12 injection needles and 24 cleansing swabs 50 micrograms/0.5 ml
pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf 4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf 6 pinnen, 6 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 12 pinnen, 12 labar ta ’ l- injezzjoni u 24 biċċiet biex tnaddaf 50 mikrogrammi/ 0. 5 ml
After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
JIS Wara r- rikostituzzjoni, uża s- soluzzjoni rikostitwita mill- ewwel jew fi żmien 24 siegħa meta maħżuna fi friġġ (2ºC – 8ºC).
After injection of the dose, discard the pen in an appropriate container.
Wara li tinjetta d- doża, armi l- pinna f’ kontenitur xieraq.
EU/1/00/131/031 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/032 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/033 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/131/034 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 131/ 031 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 032 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 033 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 034 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
PegIntron 50 micrograms powder and solvent for solution for injection
PegIntron 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 50 micrograms powder and solvent for injection SC
S. C.
254 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 80 micrograms powder and solvent for solution for injection
Kartuna 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 80 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
PegIntron 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b
One PegIntron 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 ’ PegIntron fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 80 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
1 pen, 1 injection needle and 2 cleansing swabs 4 pens, 4 injection needles and 8 cleansing swabs 6 pens, 6 injection needles and 12 cleansing swabs 12 pens, 12 injection needles and 24 cleansing swabs 80 micrograms/0.5 ml
pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf 4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf 6 pinnen, 6 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 12 pinnen, 12 labar ta ’ l- injezzjoni u 24 biċċiet biex tnaddaf 80 mikrogrammi/ 0. 5 ml
EU/1/00/131/035 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/036 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/037 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/131/038 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 131/ 035 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 036 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 037 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 038 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
PegIntron 80 micrograms powder and solvent for solution for injection
PegIntron 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 80 micrograms powder and solvent for injection SC
S. C.
257 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 100 micrograms powder and solvent for solution for injection
Kartuna 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 100 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
PegIntron 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b