qanastek/EMEA-V3 huggingface dataset:
Study 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 studju randomised, f’ ċentru wieħed li ingaġġa 95 pazjent adult li ma kienux ingħataw kura minn qabel
or 150 µg / week based on weight) plus ribavirin (800-1,200 mg/ day based on weight) or Viraferon (3 MIU TIW) plus ribavirin (800-1,200 mg/ day based on weight).
Il- pazjenti kienu randomised sabiex jirċievu interferon alfa- 2b pegilat (100 or 150 µg / ġimgħa skond il- piż) flimkien ma ’ ribavirin (800- 1, 200 mg/ jum skond il- piż) jew Viraferon (3 MIU TIW) flimkien ma ’ ribavirin (800 mg- 1, 200 mg/ jum skond il- piż).
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load na
It -
< 800,000 IU/ ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period. i
aw terapija damet 48 ġimgħa b’ perijodu ta ’ follow- up ta ’ 6 xhur ħlief għall- pazjenti li kienu infettati b’ ġenotipi 2 jew 3 u viral load < 800, 000 IU/ ml (Amplicor) li kienu kkurati għal 24 ġimgħa b’ perijodu ta 6 xhur follow- up.
Table 4
ux Tabella 4
Sustained virological response based on genotype after Viraferon in combination with
Rispons viroloġiku sostnut ibbażat fuq il- ġenotip wara Viraferon flimkien ma ’ ribavirin kontra interferon alfa- 2b pegilat flimkien ma ’ ribavirin f’ pazjenti ko- infettati b’ HCV/ HIV
dic
ad
Me
Studju 11
Study 11
interferon alfa- 2b
interferon
’ għ
alfa-2b (100
pegilat( 100 jew 150c
or
im
week) +
ġimgħa) + ribavirin
+ ribavirin + ribavirin
ribavirin (800 -
(800- (800-
Valur
1,200 mg)
(800 mg) li l
95 All Genotype 1, 4
Kollox Ġenotip 1,
0.047 0.006
0. 047 0. 006
44% (35/ 80)
44% (35/ 80) diċ
ed a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/ week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/ week pegylated interferon alfa-2b.
MIU = miljun unit internazzjonali; TIW = tlett darbiet fil- ġmgħa. a: valur p bażat fuq test Cochran- Mantel Haenszel Chi square. b: valur p bażat fuq it- test chi- square. c: individwi < 75 kg irċievew 100 µg/ ġimgħa interferon alfa- 2b pegilat u individwi ≥ 75 kg irċevew 150 µg/ week interferon me
s d: ribavirin dosing was 800 mg for patients< 60 kg, 1,000 mg for patients 60- 75 kg, and 1,200 mg for patients > 75 kg.
alfa- 2b pegilat. d: dożi ta ’ ribavirin kien 800 mg għal pazjenti < 60 kg, 1, 000 mg għal pazjenti 60- 75 kg, u 1, 200 mg għal pazjenti > 75 kg.
F27-F36.
F27- F36. ott
uth Relapse patients:
Pazjenti li rkadew:
A total of 345 interferon alpha relapse patients were treated in two clinical trials with Viraferon monotherapy or in combination with ribavirin.
Total ta ’ 345 pazjent ta ’ l- interferon alpha li rkadew kienu ittrattati f’ żewġ provi od
ra Viraferon increased by as much as 10-fold the efficacy of Viraferon used alone in the treatment of chronic hepatitis C (48.6% vs.
F’ dawn il- pazjenti, meta ribavirin ingħata ma ’ Viraferon żied b ’ 10 darbiet l- effettività ta ’ Viraferon użat waħdu fit- trattament ta ’ l - epatite Ċ kronika (48. 6% vs.
This enhancement in efficacy included loss of serum HCV (< 100 copies/ ml by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when
Dan it- titjib fl- effettività kien jinkludi t- tnaqqis ta ’ l- HCV fis - Pr
ge measured 6 months after the end of treatment.
serum (< 100 kopja/ ml bil- PCR), it- titjib fl- infjammazzjoni epatika, u n- normalizzazzjoni ta ’ l- ALT, u kien sostnut meta mkejjel 6 xhur wara t- tmiem tat- trattament.
Long-Term efficacy data lon In a large study, 1,071 patients were enrolled after treatment in a prior non pegylated interferon alfa-2b or non pegylated interferon alfa-2b/ ribavirin study to evaluate the durability of sustained virologic response and assess the impact of continued viral negativity on clinical outcomes.
Dejta dwar l- effikaċja fuq Tul ta ’ Żmien Fi studju kbir, 1, 071 pazjent ħadu sehem wara kura fi studju b’ interferon alfa- 2b mhux pegilat jew b’ interferon alfa- 2b mhux pegilat/ ribavirin sabiex jiġi evalwat kemm idum ir- rispons viroloġiku sistnut u jiġi stmat l- impatt ta ’ negattività virali kontinwa fuq il- konsegwenzi kliniċi.
462 patients completed at least 5 years of long-term follow-up and only 12 sustained responders' out of 492 relapsed during this study. no
462 pazjent lestew mill- anqas 5 snin tal- follow- up fuq żmien fit- tul u 12 biss minn dawk li wrew rispons minn
The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 97% with a 95% Confidence Interval of [95%, 99%].
izz Kunfidenza ta ’ 95% ta ’ [95%, 99%].
SVR after treatment of chronic HCV with non pegylated interferon alfa-2b (with or without ribavirin) results t
SVR wara l- kura ta ’ HCV kronika b’ interferon alfa- 2b mhux pegilat (b’ ribavirin jew mingħajru) irriżulta fi tneħħija fuq żmien fit- tul tal- virus li wasslet għall riżoluzzjoni ta ’ l- infezzjoni epatika u
chronic HCV.
tor ‘ fejqan ’ kliniku minn HCV kronika.
However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma). rod
Madankollu, dan ma jeskludix li jkun hemm każijiet epatiċi f’ pazjenti li jkollhom ċirrożi (inkluż tumur epatiku).
Clinical trials in paediatric patients with chronic hepatitis C:
aw Provi kliniċi f’ pazjenti pedjatriċi b’ epatite Ċ kronika:
Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV- RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two lp
Tfal u adolexxenti minn 3 sa 16- il sena b’ epatite Ċ kronika kumpensata u HCV- RNA li jista ’ jitkejjel (stmat b’ laboratorju ċentrali b’ assay RT- PCR bażat fuq riċerka) ħadu sehem f’ żewġ provi multiċentriċi u rċevew Viraferon 3 MIU/ m2 3 darbiet fil- ġimgħa ma ’ ribavirin 15 mg/ kg għal kul jum
multicentre trials and received Viraferon 3 MIU/ m2 3 times a week plus ribavirin 15 mg/ kg per day for 1 year followed by 6 months follow-up after-treatment.
ux għal sena segwit b’ 6 xhur follow- up wara l- kura.
children with mild to moderate hepatitis C.
Il- popolazzjoni li ħadet sehem kienet fil- parti l- kbira mgħamula minn tfal b’ epatite Ċ ħafifa għal moderata.
Sustained virological response rates in children and adolescents were similar to those in adults.
Rati ta ’ rispons viroloġiku sostnut fi tfal u
the potential for undesirable effects, the benefit/ risk of the combination of ribavirin and interferon alfa-2b dic
Minħabba nuqqas ta ’ dejta fi tfal b’ avvanz sever tal - marda, u l- potenzjal ta ’ effetti sekondarji, il- benefiċċju/ riskju tat- taħlita ta ’ ribavirin ma ’ interferon alfa- 2b għandha titqies bl- attenzjoni f’ din il- popolazzjoni (ara sezzjonijiet 4. 1, 4. 4 u 4. 8). ’ għ Riżultati ta ’ l- istudju qegħdin imqassra f’ Tabella 5
needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Rispons viroloġiku f’ pazjenti
Me
pedjatriċi li ma kienux ikkurati qabel. im
Table 5.
li l
Virological response in previously untreated paediatric patients Viraferon 3 MIU/ m2 3 times a week + ribavirin 15 mg/ kg/ day
Viraferon 3 MIU/ m2 3 darbiet fil- ġimgħa ribavirin 15 mg/ kg/ jum
96 Genotype 1 (n=92)
Ġenotip 1 (n=92)
Genotype 2/ 3/ 4 (n=26) *Number (%) of patients
Ġenotip 2/ 3/ 4 (n=26)
1.
* Numru (%) ta ’ pazjenti 1.
Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period
Defimit bħala HCV- RNA taħt il- limitu li jista ’ jitkejjel b’ assay RT- PCR bażat fuq riċerka fl- aħħar tal- kura u waqt il - perijodu ta ’ follow- up me
ed 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
s 10 million IU doses administered subcutaneously, at 5 million IU/ m2 administered intramuscularly and as a
Il- farmakokinetiċi ta ’ Viraferon kienu studjati fuq voluntiera b’ saħħithom wara dożi ta ’ 5 miljun IU/ m² mogħtija taħt il- ġilda, 10 miljun IU mogħtija taħt il- ġilda, 5 miljun IU/ m² mogħtija ġol- muskolu ott
ori 30-minute intravenous infusion.
u bħala infużjoni ta ’ 30 minuta ġol- vina.
Cmax occurred three to 12 hours after the lower dose and six to eight hours after the higher dose.
Is- Cmax intlaħqet minn tlieta sa 12- il siegħa wara d- doża l- baxxa u minn sitta sa tmien sigħat wara d- doża l- għolja.
The elimination half-lives of interferon injections were approximately two
L- eliminazzjoni tal- half od
uth to three hours, and six to seven hours, respectively.
lives ta ’ l- injezzjonijiet ta ’ l- interferon kienu ta ’ madwar tnejn sa tliet sigħat, u sitta sa seba ’ sigħat, rispettivament.
Both subcutaneous and intramuscular administration resulted in bioavailabilities greater than 100%.
f’ bijodisponibilità ta ’ aktar minn 100%.
ra After intravenous administration, serum interferon levels peaked (135 to 273 IU/ ml) by the end of the infusion, then declined at a slightly more rapid rate than after subcutaneous or intramuscular administration
Wara l- għoti ġol- vina, il- livelli ta ’ l- interferon fis- serum laħqu l- ogħla livell (135 sa 273 IU/ ml) mat - tmiem ta ’ l- infużjoni, imbagħad naqsu b’ rata ftit aktar mgħaġġla milli wara l- għoti tal- prodott mediċinali taħt il- ġilda jew ġol- muskolu, u ma setgħux jitkejjlu aktar erba ’ sigħat wara l- infużjoni.
Children and adolescents:
at Tfal u adolexxenti:
Multiple-dose pharmacokinetic properties for Viraferon injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized no
Il- karatteristiċi tal- farmakokinetika ta ’ ħafna dożi għall- injezzjoni Viraferon u
in Table 6.
izz kapsuli ribavirin fi tfal u adolexxenti b’ epatite Ċ kronika, bejn 5 u 16- il sena, qegħdin imqassra f’ Tabella 6.
The pharmacokinetics of Viraferon and ribavirin (dose-normalized) are similar in adults and children or adolescents. t
Il- farmakokinetika ta ’ Viraferon u ribavirin (normalizzata mad- doża) jixxiebhu fl- adulti u tfal jew adolexxenti.
Table 6.
tor Tabella 6.
Mean (% CV) multiple-dose pharmacokinetic parameters for Viraferon and ribavirin uc
Medja (% CV) tal- parametri farmakokinetiċi b’ ħafna dożi għal Viraferon u kapsuli ribavirin meta jingħataw lil tfal jew adolexxenti b’ epatite Ċ kronika
capsules when administered to children or adolescents with chronic hepatitis C
aw Viraferon
15 mg/ kg/ day as 2 divided
3 MIU/ m2 3 darbiet fil- ġimgħa
(n = 54)
15 mg/ kg/ jum bħala 2 dożi (n = 54) maqsuma (n = 17)
(n = 17)
ux
Apparent
ad
clearance l/ hr/ kg na
Tneħħija apparenti l/ hr/ kg
*AUC12 (ng. hr/ ml) for ribavirin; AUC0-24 (IU. hr/ ml) for Viraferon i
* AUC12 (ng. hr/ ml) għal ribavirin; AUC0- 24 (IU. hr/ ml) għal Viraferon ’ għ Fi provi kliniċi taħt is- sorveljanza ta ’ Schering- Plough, assays ta ’ fatturi li jinnewtralizzaw l- interferon saru fuq kampjuni tas- serum ta ’ pazjenti li rċivew Viraferon.
The detectable titres are low in almost Me
L- inċidenza klinika ta ’ fatturi newtralizzanti li jiżviluppaw fil- pazjenti bil- kankru ttrattati sistemikament hi ta ’ 2. 9% u ta ’ 6. 2% fil - im
all cases and have not been regularly associated with loss of response or any other autoimmune phenomenon.
It- titri li jistgħu jitkejjlu huma baxxi kważi fil- każijiet kollha, u ma kinux assoċjati regolarment ma ’ tnaqqis ta ’ rispons jew ma ’ xi fenomenu awtoimmunitarju ieħor.
In patients with hepatitis, no loss of response was observed apparently due to the low titres.
Fil - pazjenti bl- epatite, l- ebda tnaqqis ta ’ rispons ma ’ kien innutat, milli jidher minħabba t- titri baxxi. li l
5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina ina
Daily dosing of cynomolgus monkeys with 20 x 106 IU/ kg/ day
Doża ta ’ 20 x 106 IU/ kg/ jum għal 3 diċ
97 for 3 months caused no remarkable toxicity.
xhur mogħtija lil xadini tar- razza cynomolgus ma kkawżat ebda tossiċità ta ’ importanza.
Toxicity was demonstrated in monkeys given 100 x 106 IU/ kg/ day for 3 months.
It- tossiċità dehret fix- xadini li ngħataw 100 x 106 IU/ kg/ kuljum għal 3 xhur.
In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).
Fi studji ta ’ l- użu ta ’ l- interferon fi primati mhux umani, anormalitajiet taċ- ċiklu mestruwali kienu me
Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not teratogenic in rats
Ir- riżultati ta ’ studji tar- riproduzzjoni ta ’ l- annimali jindikaw li l- interferon alfa- 2b rikombinanti ma ’ kienx teratoġeniku fil- firien jew fil- fniek, u l- anqas ma kellu xi effett ħażin fuq it- tqala, fuq l- iżvilupp ott
ed or rabbits, nor did it adversely affect pregnancy, foetal development or reproductive capacity in offspring of treated rats.
tal- fetu jew fuq il- kapaċità riproduttiva tal- frieħ ta ’ firien li rċivew it- trattament.
Interferon alfa-2b has been shown to have abortifacient effects in Macaca mulatta (rhesus monkeys) at 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/ m2.
L- abort od
s Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/ kg), and was statistically
kien innutat fil- kategoriji tad- dożi kollha (7. 5 miljuni, 15- il miljun u 30 miljun IU/ kg) u kien statistikament sinifikattiv meta mqabbel mal- kontroll fil- kategoriji tad- doża l- medja u ta ’ dik għolja (li tikkkorrispondi għal 90 u 180 darba iktar mid- doża rakkomandata ta ’ 2 miljun IU/ m² ġol- muskolu jew Pr
ori significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/ m2).
taħt il- ġilda).
High doses of other forms of interferons alpha and beta are known to produce dose-related anovulatory and abortifacient effects in rhesus
Dożi għoljin ta ’ forom oħra ta ’ interferoni alpha u beta huma magħrufa li jipproduċu effetti konnessi mad- doża li jwaqqfu l- ovulazzjoni u li jwasslu għall- abort fix- xadini tar- razza rhesus.
ra No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa- 2b on growth, development, sexual maturation, and behaviour (see section 4.4 and Rebetol SPC if Viraferon
Ma sarux studji f’ annimali ta ’ età żgħira sabiex jiġu eżaminati l- effetti tal- kura b’ interferon alfa- 2b fuq it- tkabbir, żvilupp, maturazzjoni sesswali, u imġieba (ara sezzjoni 4. 4 u l- SPC ta ’ Rebetol jekk Viraferon ikun ser jingħata ma ’ ribavirin).
ge is to be administered in combination with ribavirin). lon 6.
at 6.
6.1 List of excipients no
Disodium phosphate anhydrous,
Disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Edetate disodium, Sodium chloride, t uc
tor Sodium dihydrogen phosphate monohydrate, Edetate disodium, Sodium chloride,
M-cresol, Polysorbate 80, Water for injections. rod
aw M- cresol, Polysorbate 80, Ilma għall- injezzjonijiet.
6.2 Incompatibilities lp
6. 2 Inkompatibilitajiet
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. na
ux Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f ’ sezzjoni 6. 6.
6.3 Shelf life
ad 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali ’ għ 18- il xahar
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna im
Me
Aħżen fi friġġ (2°C – 8°C).
Within its shelf-life, for the purpose of transport, the solution can be kept at or below 25ºC for a period up to seven days before use.
Fil- perijodu ta ’ meta jkun għadu tajjeb, għal skopijiet ta ’ trasport, is- soluzzjoni tista ’ tinżamm li l
Viraferon can be put back in the refrigerator at any time during this seven-day period.
Viraferon jista ’ jitpoġġa lura fil- friġġ fi kwalunkwe ħin f’ dawn is- sebat ijiem.
If the product is not used during the seven-day period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
ijiem, ma jistax jitpoġġa lura fil- friġġ għal perijodu ġdid ta ’ ħażna u għandu jintrema.
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih diċ
98 0.5 ml of solution (corresponding to 3 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in an flip-off seal (aluminium) with a bonnet (polypropylene).
soluzzjoni ta ’ 0. 5 ml (li jikkorrispondi għal 3 MIU) f’ kunjett (ħġieġ tat- tip I), b’ tapp (lasktu halobutyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene).
Pack sizes of 1
Pakketti ta ’ daqsijiet b’ 1. me
0.5 ml of solution (corresponding to 3 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in an
soluzzjoni ta ’ 0. 5 ml (li jikkorrispondi għal 3 MIU) f’ kunjett (ħġieġ tat- tip I), b’ tapp (lasktu halobutyl) ott
ed flip-off seal (aluminium) with a bonnet (polypropylene). with 1 injection syringe, 1 injection needle and 1 cleansing swab.
f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene). b’ siringa 1 għall- injezzjoni, labra 1 ta ’ l- injezzjoni u tajjara għat- tindif.
s Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali. od
ori 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor Pr
uth Not all dosage forms and strengths are appropriate for some indications.
Mhux il- forom kollha tad- dożaġġi u qawwiet ikunu xierqa għal xi indikazzjonijiet.
ra Viraferon solution for injection, may be injected directly after withdrawal of the appropriate doses from the vial with a sterile injection syringe.
Viraferon, soluzzjoni għall- injezzjoni jew infużjoni, jista ’ jkun injettat immedjatament wara li jinġibdu d- dożi xierqa mill- kunjett b’ siringa ta ’ l- injezzjoni sterili.
ge As with all parenteral medicinal products, prior to administration inspect Viraferon, solution for injection, visually for particulate matter and discolouration.
Bħal f’ kull prodott mediċinali parenterali, Viraferon, soluzzjoni għall- injezzjoni jew infużjoni, għandha tkun miflija għal xi frak u għal telf ta ’ kulur qabel tingħata.
The solution should be clear and colourless. lon Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”).
at Istruzzjonijiet dettaljati dwar l- użu għal taħt il- ġilda tal- prodott qed jingħataw fil- fuljett ta ’ tagħrif (irreferi għal “ Kif tinjetta lilek innifsek b’ Viraferon ”).
Any unused product must be discarded after withdrawal of the dose. no
izz Kwalunkwe prodott li ma jintużax għandu jintrema wara li titwaqqaf id- doża.
MARKETING AUTHORISATION HOLDER t uc
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Belgium lp
aw 73, rue de Stalle B- 1180 Bruxelles Il- Belġju
8.
ux 8.
EU/ 1/ 99/ 128/ 009 na
ad EU/ 1/ 99/ 128/ 009 EU/ 1/ 99/ 128/ 010 EU/ 1/ 99/ 128/ 011 EU/ 1/ 99/ 128/ 012
EU/ 1/ 99/ 128/ 010 EU/ 1/ 99/ 128/ 011 EU/ 1/ 99/ 128/ 012 i dic
’ għ
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Me
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI im
23 May 2005
23 Mejju 2005 li l
DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA L- KITBA ina
100 1.
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. diċ me ott od Pr 1.
Viraferon 5 million IU/ 0.5 ml solution for injection
Viraferon 5 miljun IU/ 0. 5 ml soluzzjoni għall- injezzjoni
ed One vial of Viraferon solution for injection, single dose vial, contains 5 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 0.5 ml of solution.
izz Kunjett wieħed ta ’ Viraferon soluzzjoni għall- injezzjoni, kunjett b’ doża waħda, fih 5 miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 0. 5 ml ta ’ soluzzjoni.
101 At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens administered subcutaneously.
Skond id- diskrezzjoni tat- tabib, il- pazjent jista ’ jagħti d - doża lilu nnifsu għall- korsijiet ta ’ dożaġġi ta ’ manteniment mogħtija taħt il- ġilda.
102 It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon waħdu għal mill- inqas 3 sa 4 xhur, f’ liema punt l- istat ta ’ l- HCV- RNA għandu jkun stabbilit.
myocardial infarction, severe arrhythmic disorders. lon Severe renal or hepatic dysfunction; including that caused by metastases.
- Funzjoni ħażina severa renali jew epatika; inklużi dawk ikkaġunati minn metastażi
103 Patients with existence of or history of severe psychiatric conditions:
Pazjenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi:
104 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
B’ mod aktar sinifikanti jistgħu jseħħu obtundation u koma, inklużi każijiet ta ’ enċefelopatija f’ xi pazjenti, ġeneralment anzjani, ittrattati b’ dożi aktar għoljin.
105 Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
Aktar monitoraġġ speċifiku għal tfal u adolexxenti Monitoraġġ tat- Tirojde:
106 Interactions between Viraferon and other medicinal products have not been fully evaluated.
at Interazzjonijiet bejn Viraferon u prodotti mediċinali oħra għadhom ma kinux evalwati għal kollox.
uth (Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C).
ad (Ara wkoll l- SPC ta ’ ribavirin jekk Viraferon se jingħata flimkien ma ’ ribavirin lill- pazjenti bl- epatite Ċ kronika). ’ għ 4. 6 Tqala u Treddigħ
107 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
at Fi provi kliniċi li saru bil- popolazzjoni bl- epatite Ċ fejn il- pazjenti kienu ttrattati b’ Viraferon waħdu jew flimkien ma ’ ribavirin għal sena.
109 rigors, fever§, flu-like symptoms§, asthenia, irritability, chest pain, malaise Common:
aw sider, tħossok ma tiflaħx Komuni:
110 vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
ux Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
111 Common:
ad Komuni:
112 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Huwa maħsub li dan il- proċess huwa responsabbli, għall- inqas parzjalment, għad- diversi im
113 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
tagħhom (56% vs.
114 All Genotype 1, 4
Kollox Ġenotip 1,
115 Genotype 1 (n=92)
Ġenotip 1 (n=92)
Defined as HCV-RNA below limit of detection using a research based period
Defimit bħala HCV- RNA taħt il- limitu li jista ’ jitkejjel b’ assay RT- PCR bażat fuq riċerka fl- aħħar tal- kura u waqt il - perijodu ta ’ follow- up me
116 for 3 months caused no remarkable toxicity.
xhur mogħtija lil xadini tar- razza cynomolgus ma kkawżat ebda tossiċità ta ’ importanza.
Disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Edetate disodium, Eodium chloride, t uc
tor Sodium dihydrogen phosphate monohydrate, Edetate disodium, Sodium chloride,
117 0.5 ml of solution (corresponding to 5 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) Pack sizes of 1
Pakketti ta ’ daqsijiet b’ 1 me
0.5 ml of solution (corresponding to 5 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a
soluzzjoni ta ’ 0. 5 ml (li jikkorrispondi għal 5 MIU) f’ kunjett (ħġieġ tat- tip I), b’ tapp (lasktu halobutyl) ott
ed flip-off seal (aluminium) with a bonnet (polypropylene) with 1 injection syringe, 1 injection needle and 1 cleansing swab.
f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene). b’ siringa 1 għall- injezzjoni, labra 1 ta ’ l- injezzjoni u tajjara għat- tindif.
EU/ 1/ 99/ 128/ 013 na
ad EU/ 1/ 99/ 128/ 013 EU/ 1/ 99/ 128/ 014 EU/ 1/ 99/ 128/ 015 EU/ 1/ 99/ 128/ 016
EU/ 1/ 99/ 128/ 014 EU/ 1/ 99/ 128/ 015 EU/ 1/ 99/ 128/ 016 i dic
’ għ
118 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. diċ me ott od Pr 1.
Viraferon 10 million IU/ ml solution for injection
Viraferon 10 miljun IU/ ml soluzzjoni għall- injezzjoni
ed One vial of Viraferon solution for injection, single dose vial, contains 10 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1 ml of solution.
izz Kunjett wieħed ta ’ Viraferon soluzzjoni għall- injezzjoni, kunjett b’ doża waħda, fih 10 miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 1 ml ta ’ soluzzjoni.
120 At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens administered subcutaneously.
Skond id- diskrezzjoni tat- tabib, il- pazjent jista ’ jagħti d - doża lilu nnifsu għall- korsijiet ta ’ dożaġġi ta ’ manteniment mogħtija taħt il- ġilda.
121 It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon waħdu għal mill- inqas 3 sa 4 xhur, f’ liema punt l- istat ta ’ l- HCV- RNA għandu jkun stabbilit.
122 Patients with existence of or history of severe psychiatric conditions:
Pazjenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi:
123 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
B’ mod aktar sinifikanti jistgħu jseħħu obtundation u koma, inklużi każijiet ta ’ enċefelopatija f’ xi pazjenti, ġeneralment anzjani, ittrattati b’ dożi aktar għoljin.
124 Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
Aktar monitoraġġ speċifiku għal tfal u adolexxenti Monitoraġġ tat- Tirojde:
125 Interactions between Viraferon and other medicinal products have not been fully evaluated.
at Interazzjonijiet bejn Viraferon u prodotti mediċinali oħra għadhom ma kinux evalwati għal kollox.
126 In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
at Fi provi kliniċi li saru bil- popolazzjoni bl- epatite Ċ fejn il- pazjenti kienu ttrattati b’ Viraferon waħdu jew flimkien ma ’ ribavirin għal sena.
s Table 1.
Tabella 1:
ori alone or in combination with ribavirin System Organ Class Infections and infestations
ux Viraferon waħdu jew ma ’ ribavirin Klassi tas- Sistema ta ’ l- Organi Infezzjonijiet u infestazzjonijiet
uth Very common:
ad Komuni ħafna:
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Pneumonia§
Farinġite *, infezzjoni virali * Bronkite, sinusite, herpes simplex (reżistenza), flissjoni Pnewmonja§ ’ għ
Not known:
Lewkopenja
Aplastic anaemia Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura lon
im
Sarcoidosis, exacerbation of sarcoidosis Systemic lupus erythematosus, vasculitis, rheumatoid arthritis (new or aggravated), Vogt-Koyanagi-Harada no
Tromboċitopenja, limfadenopatija, limfopenija Anemija aplastika Aplasja taċ- ċelluli ħomor puri, purpura tromboċitopenika idjopatika, purpura trombotika tromboċitopenika
syndrome, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis§
Sarkojdożi, tiħrax s- sarkojdożi
uc
diċ
Metabolism and nutrition disorders rod
me
Very common:
Disturbi fil- metaboliżmu u n - nutrizzjoni Komuni ħafna:
Suicide ideation Suicide, suicide attempts, aggressive behaviour (sometimes
Konfużjoni, disturbi ta ’ l- irqad, tnaqqis fil- libido Ħsibijiet dwar suwiċidju Suwiċidju, attentati ta’ suwiċidju, imġieba aggressiva
Nervous system disorders
(kulltant indirizzata lejn l- oħrajn), psikożi inklużi alluċinazzjonijiet Tibdil fl- istat mentali§ Mhux magħruf Disturbi fis- sistema nervuża§ Komuni ħafna:
Tremor, paresthesia, hypoesthesia, migraine, flushing, somnolence, taste perversion
Sturdament, uġigħ ta ’ ras, telf tal- konċentrazzjoni, ħalq xott Tregħid, parasteżija, ipoesteżija, emigranja, fwawar, ngħas, perverżjoni tat- togħma
127 Common:
Komuni:
Conjunctivitis, vision abnormal, lacrimal gland disorder, eye pain
Vista mċajpra Konġuntivite, vista anormali, disturbi fil- glandola tad - dmugħ, uġigħ fl- għajnejn
ed Common:
aw tikek qieshom tajjar§ Disturbi fil- widnejn u fis- sistema labirintika Komuni:
Very rarely:
ux Rari ħafna:
Vertigo, tinnitus Hearing loss, hearing disorder
Telf tas- smigħ, disturbi tas- smigħ
ori Rarely:
ad Rari:
Very rarely:
Kardjomijopatija Rari ħafna:
Cardiomyopathy Myocardial infarction, cardiac ischaemia Arrhythmia
Infart majokardijaku, iskemija kardijaka Arritmija ’ għ
uth Vascular disorders Common:
Komuni:
Hypertension Peripheral ischaemia, hypotension§
Disturbi respiratorji, toraċiċi u
ra Respiratory, thoracic and mediastinal disorders Very common:
Pressjoni għolja Iskemija periferali, pressjoni baxxa§
Dyspnoea*, coughing*
medjastinali
Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive
Dispneja *, sogħla * Epistassi, disturbi respiratorji, konġestjoni fl- imnieħer,
Very rarely:
rinoreja, sogħla fil- vojt Infiltrati fil- pulmun§, pnumonite§ Rari ħafna:
Stomatitis ulcerative, right upper quadrant pain, glossitis, no
diċ
gingivitis, constipation, loose stools
Stomatite b’ ulċera, uġigħ fil- kwadrant lemini ta ’ fuq,
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ott
Hepatotoxicity, (including fatality)
Epatomegalija Epatotossiċità, (inkluż fatalità)
Very common:
ġilda Komuni ħafna:
Common: lp
Komuni: od
Alopecia, pruritus*, skin dry*, rash*, sweating increased Psoriasis (new or aggravated)§, rash maculopapular, rash
Alopeċja, ħakk *, ġilda xotta *, raxx *, żieda fl- għaraq Psorajiżi (tibda jew taggrava) §, raxx makulopapulari, raxx
erythematous, eczema, erythema, skin disorder Very rarely:
bi ħmura, ekżema, ħmura, disturbi tal- ġilda Rari ħafna:
Musculoskeletal and connective tissue disorders i
Disturbi muskolu- skeletrali u tal - connective tissue Komuni ħafna:
Arthritis Rhabdomyolysis, myositis, leg cramps, back pain
Mijalġja, artralġja, uġigħ muskoluskeletrali Artrite Rabdomajelożi, majożite, bugħawwieġ fir- riġlejn, uġigħ fid -
Common:
dahar Disturbi fil- kliewi u fis- sistema urinarja Komuni:
128 Very common:
tor Komuni ħafna:
Injection site inflammation, injection site reaction*, fatigue, rigors, fever§, flu-like symptoms§, asthenia, irritability, chest pain, malaise
Infjammazzjoni tas- sit mnejn tingħata l- injezzjoni, reazzjoni tas- sit mnejn tingħata l- injezzjoni *, għeja, tertir, deni§, sintomi bħal ta ’ l- influwenza§, astenja, irritabilità, uġigħ fis -
Common:
aw sider, tħossok ma tiflaħx Komuni:
ed *These events were only common with Viraferon alone § See section 4.4
* Dawn il- każijiet kienu komuni biss b’ Viraferon waħdu § Ara sezzjoni 4. 4
s These undesirable effects have also been reported with Viraferon alone.
ad Dawn l- effetti mhux mixtieqa kienu ukoll irrappurtati ma ’ Viraferon waħdu. ’ għ Każijiet avversi kardjovaskulari (CVS), b' mod partikolari arritmija, dehru li kienu korrelati l- aktar mal- mard CVS li kien jeżisti minn qabel u mat- terapija b’ sustanzi kardjotossiċi li saret qabel (ara sezzjoni 4. 4).
Cardiomyopathy, that may
Kardjomajopatija li tista ’ tkun riversibbli bit- twaqqif ta ’ interferon alpha, kienet irrappurtata f’ każijiet rari f’ pazjenti li ma kellhomx evidenza minn qabel ta ’ mard tal- qalb (ara im
uth be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
sezzjoni 4. 4).
ra A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies
Varjetà kbira ta ’ problemi awtoimmunitarji u ta ’ problemi konnessi ma ’ l- immunità kienu irrappurtati bl- interferoni alpha, u jinkludu disturbi tat- tirojde, lupus erythematosus sistemika, artrite rewmatika li l
ge (see also section 4.4).
(tibda jew taggrava), purpura idjopatika u tromboċitopenika trombotika, vaskulite, u newropatiji li jinkludu mononewropatiji (ara wkoll sezzjoni 4. 4). ina
Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU lon daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
Anormalitajiet tal- laboratorju klinikament sinifikanti, li l- aktar li jseħħu f’ dożi ta ’ aktar minn 10 miljun IU kuljum, jinkludu t- tnaqqis fl- għadd tal- granuloċiti u taċ- ċelluli bojod tad- demm; tnaqqis fil- livell ta ’ l- emoglobina u ta ’ l- għadd tal- plejtlets; żidiet fil- livelli ta ’ alkaline phosphatase, LDH, diċ
Paediatric population t
Popolazzjoni pedjatrika
Children and adolescents – Chronic Hepatitis C uc
Tfal u adolexxenti – Epatite Ċ Kronika Fi provi kliniċi b’ 118 tfal jew adolexxenti ta ’ 3 sa 16- il sena, 6% waqfu t- terapija minħabba każijiet ott
In general, the adverse event profile in the limited paediatric population studied was similar to that observed in adults, although there is a paediatric specific concern regarding growth inhibition as decrease in rod
B’ mod ġenerali, il- profil ta ’ każijiet avversi fil- popolazzjoni pedjatrika limitata kien jixbah lill- dak ta ’ l- adulti, għalkemm hemm tħassib speċifiku għat- tfal dwar l- inibizzjoni tat- tkabbir bħal tnaqqis fit- tul (perċentwali medja ta ’ tnaqqis fir- rata ta ’ tkabbir b’ 9%) u fil- piż (perċentwali medja ta ’ od
height (mean percentile decrease of growth velocity of 9%) and weight (mean percentile decrease of 13%) percentile were observed during treatment (see section 4.4).
tnaqqis ta ’ 13%) perċentwali dehret waqt il- kura (ara sezzjoni 4. 4).
Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month lp
Bħal f’ pazjenti adulti, tfal u Pr
As in adult patients, children and adolescents also experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence) (see section 4.4).
adolexxenti kellhom każijiet psikjatriċi avversi oħrajn (eż. dipressjoni, burdati emozzjonali, u ngħas) (ara sezzjoni 4. 4).
In addition, injection site disorders, fever, anorexia, vomiting, and emotional lability occurred more frequently in children and na
Minbarra hekk, disturbi fis- sit mnejn tingħata l- injezzjoni, deni, anoressija, rimettar u burdati emozzjonali seħħew aktar ta ’ spiss fi tfal u adolexxenti meta mqabbla ma ’ pazjenti adulti.
Dose modifications were required in 30% of patients, most commonly for anaemia and neutropaenia. i dic
Tibdil fid- dożi kienu meħtieġa fi 30% tal- pazjenti, l- aktar għal anemija u newtropenija.
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis
Infezzjoni virali, farinġite Infezzjonijiet tal- fungu, infezzjoni tal- batteri, infezzjoni fil - pulmun, otite medja, ħofra fis- snien, herpes simplex, infezzjoni fil- passaġġ ta ’ l- awrina, gastro- enterite
129 media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
ux Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
Blood and lymphatic system
Disturbi tad- demm u tas -
ed disorders Very common:
sistema limfatika Komuni ħafna:
ori Very common:
Komuni ħafna:
Hypothyroidism§, Hyperthyroidism§, virilism
Ipotajrojdiżmu§ Ipertajrojdiżmu§, viriliżmu li l
uth Metabolism and nutrition disorders Very common:
n- nutrizzjoni Komuni ħafna:
ra Psychiatric disorders§ Very common:
§ Disturbi psikjatriċi Komuni ħafna:
Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour
Depressjoni, burdati emozzjonali, nuqqas ta ’ rqad Ħsiebijiet dwar suwiċidju, reazzjoni aggressiva, konfużjoni, disturbi fl- imġieba, aġitazzjoni, ħmar il- lejl, ansjetà, nervi,
ge disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy Nervous system disorders§ lon Very common:
disturbi fl- irqad, ħolm anormali, apatija Disturbi fis- sistema nervuża§ me
Headache, dizziness Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence no
Uġigħ ta ’ ras, sturdament Iperkinesja, tregħid, disfonja, parasteżija, ipoesteżija, iperesteżija, telf tal- konċentrazzjoni, ngħas
Raynaud’ s disease, flushing, pallor t
Disturbi respiratorji, toraċiċi u medjastinali Pr
Respiratory, thoracic and uc
Marda ta ’ Raynaud, fwawar, pallidità
mediastinal disorders Common:
Disturbi gastro- intestinali
Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal
Dispneja, takipneja, epistassi, sogħla, konġestjoni fl- imnieħer, irritazzjoni fl- imnieħer, flissjoni, għatis
irritation, rhinorrhea, sneezing Gastrointestinal disorders Very common:
Komuni ħafna:
quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, na
Dijarea, rimettar, tqalligħ, uġigħ fl- addome Ulċeri fil- ħalq, stomatite b’ ulċera, stomatite, uġigħ fil- kwadrant lemini ta ’ fuq, dispepsja, glossite, ittella ’ mill- istonku, disturbi fir- rektum, disturbi gastro- intestinali, stitikezza, ippurgar maħlul, uġigħ fis- snien, disturbi fis- snien
toothache, tooth disorder Hepatobiliary disorders Common:
Disturbi fil- ġilda u fit- tessuti
disorders Very common:
izz ta ’ taħt il- ġilda Komuni ħafna:
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin
Alopeċja, raxx Reazzjoni ta ’ fotosensittività, raxx makulopapulari, ekżema,
disorder, nail disorder, skin discolouration, pruritus, dry skin, erythema, bruise, sweating increased Musculoskeletal and connective tissue disorders Very common:
tor akne, disturbi fil- ġilda, disturbi fid- dwiefer, telf tal- lewn tal - ġilda, ħakk, ġilda xotta, ħmura, dbenġil, żieda fl- għaraq Disturbi muskolu- skeletali u
Reproductive system and
Disturbi fis- sistema riproduttiva u fis- sider
130 breast disorders Common:
ad Komuni:
ed Very common:
Komuni ħafna:
Injection site inflammation, injection site reaction, fatigue, rigors, fever§, influenza-like symptoms§, malaise, irritability
sit mnejn tingħata l- injezzjoni, għeja, tregħid, deni§, sintomi bħal ta ’ l- influwenza§, tħossok ma tiflaħx, irritabilità
Injury and poisoning
injezzjoni Investigazzjonijiet Titnaqqas ir- rata ta ’ tkabbir (tul u/ jew piż aktar baxx għall- età) § Komuni ħafna: ina
Common:
Komuni: § Ara sezzjoni 4. 4
uth § See section 4.4
4. 9 Doża eċċessiva me
However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close
Madankollu, bħal f’ kull sustanza farmakoloġikament attiva, huwa indikat li jsir trattament sintomatiku b’ monitoraġġi spissi tas- sinjali vitali u osservazzjoni mill- qrib tal- pazjent. ott
PHARMACOLOGICAL PROPERTIES
TAGĦRIF FARMAKOLOĠIKU od
5.1 Pharmacodynamic properties no
5. 1 Tagħrif farmakodinamiku
Immunostimulants, cytokines and immunomodulators, interferons, interferon alfa-2b, ATC code:
interferon alfa- 2b, Kodiċi ATC:
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA uc
Viraferon huwa formulazzjoni sterili u stabbli ta ’ interferon alfa- 2b ippurifikat sa grad għoli ħafna magħmul bit- teknika tad- DNA rikombinanti.
International Units are determined by comparison of the activity of the lp
L- Unitajiet Internazzjonali huma stabbiliti bil- paragun
recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation. na
at bejn l- attività ta ’ l- interferon alfa- 2b rikombinanti u l- attività ta ’ preparazzjoni għar- referenza internazzjonali ta ’ l- interferon tal- lewkoċita tal- bniedem stabbilita mill- Organizzazzjoni Dinjija tas -
The interferons are a family of small protein molecules with molecular weights of approximately 15,000 to 21,000 daltons.
L- interferoni huma familja ta ’ molekuli żgħar ta ’ proteina bil- piżijiet molekulari ta ’ madwar 15, 000 sa
Three major classes of interferons have been identified: alpha, beta and gamma. i dic
Kienu identifikati tliet klassijiet ewlenin ta ’ interferoni: alpha, beta u gamma.
More than 14 genetically distinct human alpha interferons have been identified.
Kienu identifikati aktar minn 14- il interferon
131 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Huwa maħsub li dan il- proċess huwa responsabbli, għall- inqas parzjalment, għad- diversi im
132 response 6 months after 1 year of treatment than those who took < 80% of their treatment (56% vs.
tagħhom (56% vs.
133 All Genotype 1, 4
Kollox Ġenotip 1,
134 Genotype 1 (n=92)
Ġenotip 1 (n=92)
135 for 3 months caused no remarkable toxicity.
xhur mogħtija lil xadini tar- razza cynomolgus ma kkawżat ebda tossiċità ta ’ importanza.
136 1 ml of solution (corresponding to 10 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip- off seal (aluminium) with a bonnet (polypropylene) Pack sizes of 1
Pakketti ta ’ daqsijiet b’ 1 me
1 ml of solution (corresponding to 10 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-
soluzzjoni ta ’ 1 ml (li jikkorrispondi għal 10 MIU) f’ kunjett (ħġieġ tat- tip I), b’ tapp (lasktu halobutyl) ott
ed off seal (aluminium) with a bonnet (polypropylene) with 1 injection syringe, 1 injection needle and 1 cleansing swab.
f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene). b’ siringa 1 għall- injezzjoni, labra 1 ta ’ l- injezzjoni u tajjara għat- tindif.
Packs sizes of 1, 6 or 12
Pakketti ta ’ daqsijiet b’ 1, 6 jew 12.
EU/ 1/ 99/ 128/ 017 na
ad EU/ 1/ 99/ 128/ 017 EU/ 1/ 99/ 128/ 018 EU/ 1/ 99/ 128/ 019 EU/ 1/ 99/ 128/ 020
EU/ 1/ 99/ 128/ 018 EU/ 1/ 99/ 128/ 019 EU/ 1/ 99/ 128/ 020 i dic
’ għ
137 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. diċ me ott od Pr 1.
Viraferon 18 million IU/ 3 ml solution for injection
Viraferon 18- il miljun IU/ 3 ml soluzzjoni għall- injezzjoni
ed One vial of Viraferon solution for injection, multiple dose vial, contains 18 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 3 ml of solution.
izz Kunjett wieħed ta ’ Viraferon soluzzjoni għall- injezzjoni, kunjett b’ doża waħda, fih 18- il miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 3 ml ta ’ soluzzjoni.
s One ml of solution contains 6 million IU of interferon alfa-2b.
tor Millilitru wieħed fih 6 miljun IU interferon alfa- 2b.
ori For a full list of excipients, see section 6.1.
aw Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
ra Solution for injection Solution is clear and colourless.
ux Soluzzjoni għall- injezzjoni Is- soluzzjoni hi ċara u bla kulur.
CLINICAL PARTICULARS Therapeutic indications
TAGĦRIF KLINIKU Indikazzjonijiet terapewtiċi
lon
’ għ
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and no
It- trattament ta ’ pazjenti adulti li għandhom l- epatite B kronika assoċjata ma ’ im
histologically proven active liver inflammation and/ or fibrosis.
evidenza ta ’ replikazzjoni virali ta ’ l- epatite B (preżenza ta ’ HBV- DNA u HBeAg), alanine aminotransferase (ALT) elevat u infjammazzjoni u/ jew fibrożi attiva fil- fwied li tkun konfermata b' mod istoloġiku. li l
Chronic Hepatitis C: t
Epatite Ċ Kronika:
Adult patients: uc
Pazjenti adulti:
Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4). rod
transaminases elevati mingħajr dikompensazzjoni tal- fwied u li huma pożittivi għall- HCV- RNA jew għall- anti- HCV fis- serum (ara sezzjoni 4. 4). diċ
Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver na
Viraferon huwa intenzjonat biex jintuża, f’ kors ta ’ kombinazzjoni ma ’ ribavirin, għall- kura ta ’ tfal u me
decompensation, and who are positive for serum HCV-RNA.
adolexxenti minn 3 snin ‘ l fuq, li għandhom epatite Ċ kronika, li ma ġietx ikkurata qabel, mingħajr dikumpensazzjoni tal- fwied, u li huma pożittivi għall- HCV- RNA.
The expected benefit of i dic
Id- deċiżjoni jekk għandhiex tingħata l- kura għandha tittieħed skond il- każ, billi jkun meqjus jekk hemmx avvanz tal- marda bħal infjammazzjoni epatika u fibrożi, kif ukoll fatturi ta ’ tbassir għar- rispons, ġenotip tal- HCV u viral ott
treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).
Il- benefiċċju mistenni mill- kura għandu jintiżen mas- sejbiet tas- sigurtà li jkunu dehru għal individwi pedjatriċi fil- provi kliniċi (ara sezzjonijiet 4. 4, 4. 8 u 5. 1). od
4.2 Posology and method of administration Me
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
If persistent or recurrent intolerance
Jekk iseħħu każijiet avversi matul il- kors tat- trattament b’ Viraferon għal kwalunkwe indikazzjoni, ibdel id- dożaġġ jew waqqaf it- terapija temporanjament sakemm il- każijiet avversi jonqsu.
139 develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
Jekk tiżviluppa intolleranza persistenti jew rikorrenti wara aġġustament xieraq fid- dożaġġ, jew il- marda tavvanza, waqqaf it- trattament b’ Viraferon.
The recommended dosage is in the range 5 to 10 million IU administered subcutaneously three times a week (every other day) for a period of 4 to 6 months.
izz darbiet fil- ġimgħa (darba kull jumejn) għal perijodu ta ’ 4 sa 6 xhur.
ed The administered dose should be reduced by 50% in case of occurrence of haematological disorders (white blood cells < 1,500/ mm3, granulocytes < 1,000/ mm3, thrombocytes < 100,000/ mm3).
Id- doża mogħtija għanda titnaqqas b’ 50% f' każ li jseħħu problemi ematoloġiċi (ċelluli bojod tad -
s thrombocytopaenia (< 70,000/ mm3).
tor demm < 1, 500/ mm3, granuloċiti < 1, 000/ mm3, tromboċiti < 100, 000/ mm3).
ori For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue Viraferon therapy.
aw Għall- pazjenti kollha, jekk ma jidhirx titjib ta ’ l- HBV- DNA fis- serum wara 3 sa 4 xhur ta ’ trattament (bid- doża massima ttollerata), waqqaf it- terapija b’ Viraferon.
uth Chronic Hepatitis C:
Epatite Ċ Kronika:
Viraferon is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin.
Viraferon jingħata taħt il- ġilda f’ doża ta ’ 3 miljun IU tliet darbiet fil- ġimgħa