qanastek/EMEA-V3 huggingface dataset:
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.
462 pazjent lestew mill- anqas 5 snin tal- follow- up fuq żmien fit- tul u 12 biss minn dawk li wrew rispons minn 492 pazjent irkadew waqt dan l- istudju.
462 patients completed at least 5 years na
L- istima Kaplan- Meier għal rispons sostnut fuq 5 snin għall- pazjenti kollha huwa 97% b’ Intervall ta ’ ott
The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 97% with a 95% Confidence Interval of [95%, 99%]. i dic
Kunfidenza ta ’ 95% ta ’ [95%, 99%].
SVR after treatment of chronic HCV with non pegylated interferon alfa-2b (with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical'cure 'from chronic HCV.
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 od
(including hepatocarcinoma).
Pr
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 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.
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 għal sena segwit b’ 6 xhur follow- up wara l- kura.
57% male, 80% Caucasian, and 78% genotype 1,64% ≤ 12 years of age.
57% irġiel, 80% Kawkażi, u 78% ġenotip 1, 64% ≤ 12- il sena.
Sustained virological response rates in children and adolescents
Rati ta ’ rispons viroloġiku sostnut fi tfal u adolexxenti kienu simili għal dawk fl- adulti.
Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/ risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
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).
Study results are summarized in Table 5.
at Riżultati ta ’ l- istudju qegħdin imqassra f’ Tabella 5
Table 5.
izz Tabella 5.
Virological response in previously untreated paediatric patients
Rispons viroloġiku f’ pazjenti pedjatriċi li ma kienux ikkurati qabel.
ed Viraferon 3 MIU/ m2 3 times a week +
Viraferon 3 MIU/ m2 3 darbiet fil- ġimgħa
s ribavirin 15 mg/ kg/ day
tor ribavirin 15 mg/ kg/ jum
ori Overall Response1 (n=118)
aw Rispons Globali1 (n=118)
uth Genotype 1 (n=92)
Ġenotip 1 (n=92)
Genotype 2/ 3/ 4 (n=26)
ux Ġenotip 2/ 3/ 4 (n=26) * Numru (%) ta ’ pazjenti
ra *Number (%) of patients 1.
ad 1.
ge 5.2 Pharmacokinetic properties lon The pharmacokinetics of Viraferon were studied in healthy volunteers following single 5 million IU/ m2 and 10 million IU doses administered subcutaneously, at 5 million IU/ m2 administered intramuscularly and as a 30-minute intravenous infusion.
Il- konċentrazzjonijiet medji ta ’ interferon fis- serum wara l - im
The mean serum interferon concentrations following subcutaneous and intramuscular injections were comparable.
injezzjonijiet taħt il- ġilda u ġol- muskolu kienu komparabbli.
Cmax occurred three to 12 hours after the lower dose and six to no
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.
eight hours after the higher dose.
rispettivament.
Both subcutaneous and intramuscular administration resulted in bioavailabilities greater than 100%. t uc
Kemm l- għoti taħt il- ġilda kif ukoll dak ġol- muskolu rriżultaw f’ bijodisponibilità ta ’ aktar minn 100%. ina
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 rod
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 diċ
of medicinal product, becoming undetectable four hours after the infusion.
mediċinali taħt il- ġilda jew ġol- muskolu, u ma setgħux jitkejjlu aktar erba ’ sigħat wara l- infużjoni.
Urine levels of interferon were below the detection limit following each of the three routes of administration. lp
Il- livelli ta ’ l- interferon fl- awrina kienu anqas mil- limitu li jista ’ jitkejjel wara kull waħda mit- tliet me
Multiple-dose pharmacokinetic properties for Viraferon injection and ribavirin na
Il- karatteristiċi tal- farmakokinetika ta ’ ħafna dożi għall- injezzjoni Viraferon u kapsuli ribavirin fi tfal u adolexxenti b’ epatite Ċ kronika, bejn 5 u 16- il sena, qegħdin imqassra ott
capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized in Table 6.
f’ Tabella 6.
18 Table 6.
Il- farmakokinetika ta ’ Viraferon u ribavirin (normalizzata mad- doża) jixxiebhu fl- adulti u tfal jew adolexxenti. od Pr Tabella 6.
Mean (% CV) multiple-dose pharmacokinetic parameters for Viraferon and ribavirin capsules when administered to children or adolescents with chronic hepatitis C
Medja (% CV) tal- parametri farmakokinetiċi b’ ħafna dożi għal Viraferon u kapsuli ribavirin meta jingħataw lil tfal jew adolexxenti b’ epatite Ċ kronika Viraferon
15 mg/ kg/ day as 2 divided doses (n = 17)
3 MIU/ m2 3 darbiet fil- ġimgħa
3 MIU/ m2 3 times a week (n = 54)
at 15 mg/ kg/ jum bħala 2 dożi (n = 54) maqsuma (n = 17)
Apparent clearance l/ hr/ kg
Tneħħija apparenti l/ hr/ kg
ori *AUC12 (ng. hr/ ml) for ribavirin; AUC0-24 (IU. hr/ ml) for Viraferon
* AUC12 (ng. hr/ ml) għal ribavirin; AUC0- 24 (IU. hr/ ml) għal Viraferon
Interferon neutralising factor assays were performed on serum samples of patients who received Viraferon in
aw 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 clinical incidence of neutralising factors developing in cancer patients treated systemically is 2.9% and in chronic hepatitis patients is 6.2%.
L- inċidenza klinika ta ’ fatturi newtralizzanti li jiżviluppaw fil- pazjenti bil- kankru ttrattati sistemikament hi ta ’ 2. 9% u ta ’ 6. 2% fil -
ra 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.
ge 5.3 Preclinical safety data
ad 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina ’ għ Għalkemm l- interferon hu ġeneralment magħruf li huwa speċifiku għall- ispeċi, saru studji dwar it - tossiċità fuq l- annimali.
Daily dosing of cynomolgus monkeys with 20 x 106 IU/ kg/ day for 3 months caused no remarkable toxicity.
It- tossiċità im
Toxicity was demonstrated in monkeys given 100 x 106 IU/ kg/ day for 3 months. no
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). t uc
Fi studji ta ’ l- użu ta ’ l- interferon fi primati mhux umani, anormalitajiet taċ- ċiklu mestruwali kienu li l
Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not teratogenic in rats or rabbits, nor did it adversely affect pregnancy, foetal development or reproductive capacity in offspring of treated rats.
kienx teratoġeniku fil- firien jew fil- fniek, u l- anqas ma kellu xi effett ħażin fuq it- tqala, fuq l- iżvilupp 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 rod
L- interferon alfa- 2b intwera li għandu effetti li jwasslu għall- abort fil- Macaca mulatta (xadini tar- razza rhesus) b’ dożi ta ’ diċ
monkeys) at 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/ m2.
90 u 180 darba iktar minn dik rakkomandata ta ’ 2 miljun IU/ m² ġol- muskolu jew taħt il- ġilda.
Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/ kg), and was statistically significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the lp
L- abort 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 me
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 monkeys. na
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.
Mutagenicity studies with interferon alfa-2b revealed no adverse events. i dic
Studji dwar il- mutaġeniċità b’ interferon alfa- 2b ma wrew ebda każijiet avversi. ott
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 is to be administered in combination with ribavirin).
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 od
Glycine, Disodium phosphate anhydrous,
Glycine, disodium phosphate anhydrous, sodium phosphate monobasic, soluzzjoni ta ’ l- albumina tal- bniedem.
6.2 Incompatibilities
at 6. 2 Inkompatibilitajiet
ed This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
izz Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f ’ sezzjoni 6. 6.
s 6.3 Shelf life
tor 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
ori 3 years
3 snin
uth After reconstitution:
aw Wara r- rikostituzzjoni:
ra 6.4 Special precautions for storage
ux 6. 4 Prekawzjonijiet speċjali għall- ħażna
ge Do not freeze.
ad Aħżen fil- friża.
Within its shelf-life, for the purpose of transport and/ or to facilitate ambulatory use the non-reconstituted product can be kept at or below 25°C for a period up to four weeks before use.
Fil- perijodu ta ’ meta jkun għadu tajjeb, għal skopijiet ta ’ trasport u/ jew biex jitħaffef l- użu ambulatorju, il- prodott mhux rikostitwit jista ’ jinżamm f’ temperatura ta ’ 25°C jew anqas għal perijodu ’ għ ta ’ mhux aktar minn erba ’ ġimgħat qabel l- użu.
If the product is not lon reconstituted during the four-week period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
Jekk il- prodott ma jkunx rikostitwit matul il- perijodu ta ’ erba ’ ġimgħat, ma jistax jitpoġġa lura fil- friġġ għal perijodu ġdid ta ’ ħażna u għandu jintrema.
6.5 Nature and contents of container no
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih im
24 mg of powder (corresponding to 1 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) t
24 mg ta ’ trab (li jikkorrispondi għal 1 MIU) f’ kunjett (type I glass), b’ tapp (lasktu tal- butyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene) li l
with 1 injection syringe, 2 injection needles and 1 cleansing swab.
u ml 1 ilma għall- injezzjonijiet f’ ampulla (ħġieġ tat- tip I) b’ siringa 1 għall- injezzjoni, 2 labar ta ’ l- injezzjoni u tajjara għat- tindif.
Pack sizes of 1. rod
Pakketti ta ’ daqsijiet b’ 1. ina
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali. diċ
6.6 Special precautions for disposal lp
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Please make sure to select an appropriate dosage form and strength. na
Jekk jogħġbok kun żgur li tgħażel il- forma tad- dożaġġ u qawwa xierqa. me
Reconstitution of Viraferon, powder for solution for injection, for parenteral administration:
Rikostituzzjoni ta ’ Viraferon, trab li jinħall f’ likwidu għall- injezzjoni jew infużjoni, biex jingħata b’ injezzjoni:
Vials must be reconstituted with i dic
Viraferon hu pprovdut bħala trab b’ qawwa ta ’ 1 miljun IU/ ml għall- użu f’ doża waħda.
1 ml of water for injections.
Il - kunjetti jridu jkunu rrikostitwiti b’ 1 ml ta ’ ilma għall- injezzjonijiet.
The reconstituted solutions are isotonic for parenteral administration.
Is- soluzzjonijiet rrikostitwiti huma iżotoniċi biex jingħataw b’ injezzjoni. ott
Me
Prekawzjonijiet xierqa għandhom jittieħdu waqt ir- rikostituzzjoni sabiex jiġi evitat li jkun hemm kontaminazzjoni b’ mikrobi (irreferi għall- fuljett ta ’ tagħrif). od
Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon.
Permezz ta ’ siringa u labra għall- injezzjoni sterilizzati, injetta 1 ml ta ’ ilma għall- injezzjonijiet ġol - kunjett ta ’ Viraferon.
The appropriate dose can then be withdrawn with a sterile injection syringe and injected.
tista ’ mbagħad tinġibed b’ siringa ta ’ l- injezzjoni sterili u tkun injettata.
As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discoloration prior to administration.
Bħal f’ kull prodott mediċinali li jingħata b’ injezzjoni, is- soluzzjoni rikostitwita għandha tkun miflija għal xi frak u għal telf ta ’ kulur qabel tingħata.
20 Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”).
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 ”).
7.
at 7.
ed SP Europe 73, rue de Stalle
izz SP Europe 73, rue de Stalle
s B-1180 Bruxelles
tor B- 1180 Bruxelles Il- Belġju
uth 8.
aw 8.
ra 9.
ux 9.
23 May 2005 lon 10.
ad 9 ta ’ Marzu 2000 ’ għ 10.
DATE OF REVISION OF THE TEXT no
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/ t uc rod lp i na dic Me
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /. im li l ina diċ me ott od Pr 1.
Viraferon 3 million IU/ ml powder and solvent for solution for injection
Viraferon 3 miljun IU trab u solvent għal soluzzjoni għall- injezzjoni
ed One vial of powder contains 3 million IU of interferon alfa-2b produced in E. coli by recombinant DNA technology.
izz Kull kunjett ta ’ trab fih 3 miljun IU ta ’ interferon alfa- 2b mgħamul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti.
22 If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
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.
23 The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
L- aħjar tul ta ’ żmien tat- terapija b’ Viraferon waħdu għadu ma kienx stabbilit għall- kollox, iżda terapija ta ’ bejn 12 u 18- il xahar hija rakkomandata.
t
im
agents excluding short term corticosteroid withdrawal. uc
immunosoppressivi, bl- esklużjoni tat- twaqqif għal żmien qasir tal- kortikosterojdi
24 symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġi mitbuħ li hemm ħsibijiet dwar suwiċidju, huwa rakkomandat li l- kura b’ Viraferon titwaqqaf, u l- pazjent jiġi segwit, b’ intervent psikjatriku kif ikun xieraq.
25 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.
26 All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Il- pazjenti kollha fl- istudji dwar l- epatite Ċ kronika saritilhom bijopsija tal- fwied qabel ma kienu inklużi, iżda f’ ċerti każijiet (jiġifieri l- pazjenti bil- ġenotipi 2 u 3), it- trattament jista ’ jkun possibbli mingħajr konferma istoloġika.
27 Laboratory Tests:
Testijiet tal- Laboratorju:
28 each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Pazjenti rġiel u s- sieħba nisa tagħhom għandhom it- tnejn li huma jużaw kontraċezzjoni effettiva waqt il- kura u għal 7 xhur wara t- twaqqif tal- kura (ara l- SPC ta ’ ribavirin).
29 Very common:
at Rari ħafna:
30 erythematous, eczema, erythema, skin disorder Very rarely:
izz Psorajiżi (tibda jew taggrava) §, raxx makulopapulari, raxx Komuni: bi ħmura, ekżema, ħmura, disturbi tal- ġilda Rari ħafna:
31 percentile were observed during treatment (see section 4.4).
tor tnaqqis ta ’ 13%) perċentwali dehret waqt il- kura (ara sezzjoni 4. 4).
32 Very common:
aw irritazzjoni fl- imnieħer, flissjoni, għatis Disturbi gastro- intestinali Komuni ħafna:
33 The activity of Viraferon is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l08 IU.
ad L- attività ta ’ Viraferon hija mfissra f’ termini ta ’ IU, u 1 mg ta ’ proteina ta ’ interferon alfa- 2b rikombinanti li tikkorrispondi għal 2. 6 x l08 IU.
34 a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
polimerat (PCR) HCV- RNA, bijopsija tal- fwied konsistenti ma ’ dijanjosi istoloġika ta ’ epatite kronika bla ebda kawża oħra għall- epatite kronika, u ALT fis- serum anormali. li l
36 Table 4
Studju 11
The pharmacokinetics of Viraferon and ribavirin (dose-normalized) are similar in adults and children or adolescents. i dic Me
Il- farmakokinetika ta ’ Viraferon u ribavirin (normalizzata mad- doża) jixxiebhu fl- adulti u tfal jew adolexxenti. od Pr Tabella 6.
24 mg of powder (corresponding to 3 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) t
24 mg ta ’ trab (li jikkorrispondi għal 3 MIU) f’ kunjett (type I glass), b’ tapp (lasktu tal- butyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene) li l
Pack sizes of 1 rod
Pakketti ta ’ daqsijiet b’ 1 ina
Or
u diċ
seal (aluminium) with a bonnet (polypropylene) and 1 ml of water for injections in an ampoule (type I glass) Pack sizes of 6 na
24 mg ta ’ trab (li jikkorrispondi għal 3 MIU) f’ kunjett (type I glass), b’ tapp (lasktu tal- butyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene) u ml 1 ilma għall- injezzjonijiet f’ ampulla (ħġieġ tat- tip I) Pakketti ta ’ daqsijiet b’ 6 me
6.6 Special precautions for disposal i dic
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Me
żgur li tgħażel il- forma tad- dożaġġ u qawwa xierqa.
Reconstitution of Viraferon, powder for solution for injection, for parenteral administration:
Rikostituzzjoni ta ’ Viraferon, trab li jinħall f’ likwidu għall- injezzjoni jew infużjoni, biex jingħata od
Viraferon is supplied as a powder at strengths of 3 million IU/ ml for single-dose use.
Viraferon hu pprovdut bħala trab b’ qawwa ta ’ 3 miljun IU/ ml għall- użu f’ doża waħda.
The reconstituted solutions are isotonic for parenteral administration.
Pr
40 Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon.
Permezz ta ’ siringa u labra għall- injezzjoni sterilizzati, injetta 1 ml ta ’ ilma għall- injezzjonijiet ġol - kunjett ta ’ Viraferon.
As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discoloration prior to administration.
Bħal f’ kull prodott mediċinali li jingħata b’ injezzjoni, is- soluzzjoni rikostitwita għandha tkun miflija
ed Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”).
izz 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 ”).
s Any unused product must be discarded after withdrawal of the dose.
tor Kwalunkwe prodott li ma jintużax għandu jintrema wara li titwaqqaf id- doża.
uth SP Europe 73, rue de Stalle
aw SP Europe 73, rue de Stalle B- 1180 Bruxelles
ra B-1180 Bruxelles Belgium
ux Il- Belġju
ge 8.
ad 8.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI im
23 May 2005 t uc
23 Mejju 2005 li l
DATE OF REVISION OF THE TEXT rod
DATA TA ’ META ĠIET RIVEDUTA L- KITBA ina
Agency (EMEA) http: / /www. emea. europa. eu/ i na dic Me
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/ ml powder and solvent for solution for injection
Viraferon 5 miljun IU trab u solvent għal soluzzjoni għall- injezzjoni
ed One vial of powder contains 5 million IU of interferon alfa-2b produced in E. coli by recombinant DNA technology.
izz Kull kunjett ta ’ trab fih 5 miljun IU ta ’ interferon alfa- 2b mgħamul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti.
42 If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
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.
43 The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
L- aħjar tul ta ’ żmien tat- terapija b’ Viraferon waħdu għadu ma kienx stabbilit għall- kollox, iżda terapija ta ’ bejn 12 u 18- il xahar hija rakkomandata.
44 symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġi mitbuħ li hemm ħsibijiet dwar suwiċidju, huwa rakkomandat li l- kura b’ Viraferon titwaqqaf, u l- pazjent jiġi segwit, b’ intervent psikjatriku kif ikun xieraq.
45 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.
46 All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Il- pazjenti kollha fl- istudji dwar l- epatite Ċ kronika saritilhom bijopsija tal- fwied qabel ma kienu inklużi, iżda f’ ċerti każijiet (jiġifieri l- pazjenti bil- ġenotipi 2 u 3), it- trattament jista ’ jkun possibbli mingħajr konferma istoloġika.
47 Laboratory Tests:
Testijiet tal- Laboratorju:
48 each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Pazjenti rġiel u s- sieħba nisa tagħhom għandhom it- tnejn li huma jużaw kontraċezzjoni effettiva waqt il- kura u għal 7 xhur wara t- twaqqif tal- kura (ara l- SPC ta ’ ribavirin).
49 Very common:
at Rari ħafna:
50 erythematous, eczema, erythema, skin disorder Very rarely:
izz Psorajiżi (tibda jew taggrava) §, raxx makulopapulari, raxx Komuni: bi ħmura, ekżema, ħmura, disturbi tal- ġilda Rari ħafna:
51 percentile were observed during treatment (see section 4.4).
tor tnaqqis ta ’ 13%) perċentwali dehret waqt il- kura (ara sezzjoni 4. 4).
52 Very common:
aw irritazzjoni fl- imnieħer, flissjoni, għatis Disturbi gastro- intestinali Komuni ħafna:
53 The activity of Viraferon is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l08 IU.
ad L- attività ta ’ Viraferon hija mfissra f’ termini ta ’ IU, u 1 mg ta ’ proteina ta ’ interferon alfa- 2b rikombinanti li tikkorrispondi għal 2. 6 x l08 IU.
54 a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
polimerat (PCR) HCV- RNA, bijopsija tal- fwied konsistenti ma ’ dijanjosi istoloġika ta ’ epatite kronika bla ebda kawża oħra għall- epatite kronika, u ALT fis- serum anormali. li l
56 Table 4
Studju 11
24 mg of powder (corresponding to 5 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) t
24 mg ta ’ trab (li jikkorrispondi għal 5 MIU) f’ kunjett (type I glass), b’ tapp (lasktu tal- butyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene) li l
seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) Pack sizes of 6 na
24 mg ta ’ trab (li jikkorrispondi għal 5 MIU) f’ kunjett (type I glass), b’ tapp (lasktu tal- butyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene) u ml 1 ilma għall- injezzjonijiet f’ ampulla (ħġieġ tat- tip I) Pakketti ta ’ daqsijiet b’ 6 me
Viraferon is supplied as a powder at strengths of 5 million IU/ ml for single-dose use.
Viraferon hu pprovdut bħala trab b’ qawwa ta ’ 5 miljun IU/ ml għall- użu f’ doża waħda.
60 Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon.
Permezz ta ’ siringa u labra għall- injezzjoni sterilizzati, injetta 1 ml ta ’ ilma għall- injezzjonijiet ġol - kunjett ta ’ Viraferon.
Viraferon 10 million IU/ ml powder and solvent for solution for injection
Viraferon 10 miljun IU trab u solvent għal soluzzjoni għall- injezzjoni
ed One vial of powder contains 10 million IU of interferon alfa-2b produced in E. coli by recombinant DNA technology.
izz Kull kunjett ta ’ trab fih 10 miljun IU ta ’ interferon alfa- 2b mgħamul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti.
62 If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
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.
63 The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
L- aħjar tul ta ’ żmien tat- terapija b’ Viraferon waħdu għadu ma kienx stabbilit għall- kollox, iżda terapija ta ’ bejn 12 u 18- il xahar hija rakkomandata.
64 symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġi mitbuħ li hemm ħsibijiet dwar suwiċidju, huwa rakkomandat li l- kura b’ Viraferon titwaqqaf, u l- pazjent jiġi segwit, b’ intervent psikjatriku kif ikun xieraq.
65 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.
66 All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Il- pazjenti kollha fl- istudji dwar l- epatite Ċ kronika saritilhom bijopsija tal- fwied qabel ma kienu inklużi, iżda f’ ċerti każijiet (jiġifieri l- pazjenti bil- ġenotipi 2 u 3), it- trattament jista ’ jkun possibbli mingħajr konferma istoloġika.
67 Laboratory Tests:
Testijiet tal- Laboratorju:
68 each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Pazjenti rġiel u s- sieħba nisa tagħhom għandhom it- tnejn li huma jużaw kontraċezzjoni effettiva waqt il- kura u għal 7 xhur wara t- twaqqif tal- kura (ara l- SPC ta ’ ribavirin).
69 Very common:
at Rari ħafna:
70 erythematous, eczema, erythema, skin disorder Very rarely:
izz Psorajiżi (tibda jew taggrava) §, raxx makulopapulari, raxx Komuni: bi ħmura, ekżema, ħmura, disturbi tal- ġilda Rari ħafna:
71 percentile were observed during treatment (see section 4.4).
tor tnaqqis ta ’ 13%) perċentwali dehret waqt il- kura (ara sezzjoni 4. 4).
72 Very common:
aw irritazzjoni fl- imnieħer, flissjoni, għatis Disturbi gastro- intestinali Komuni ħafna:
73 The activity of Viraferon is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l08 IU.
ad L- attività ta ’ Viraferon hija mfissra f’ termini ta ’ IU, u 1 mg ta ’ proteina ta ’ interferon alfa- 2b rikombinanti li tikkorrispondi għal 2. 6 x l08 IU.
74 a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
polimerat (PCR) HCV- RNA, bijopsija tal- fwied konsistenti ma ’ dijanjosi istoloġika ta ’ epatite kronika bla ebda kawża oħra għall- epatite kronika, u ALT fis- serum anormali. li l
76 Table 4
Studju 11
24 mg of powder (corresponding to 10 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) t
24 mg ta ’ trab (li jikkorrispondi għal 10 MIU) f’ kunjett (type I glass), b’ tapp (lasktu tal- butyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene) li l
Pack sizes of 1 and 10 rod
Pakketti ta ’ daqsijiet b’ 1 jew 10 ina
Pack sizes of 6 na
24 mg ta ’ trab (li jikkorrispondi għal 10 MIU) f’ kunjett (type I glass), b’ tapp (lasktu tal- butyl) f’ siġill li tiftħu b’ saba (aluminium) b’ bonit (polypropylene) u ml 1 ilma għall- injezzjonijiet f’ ampulla (ħġieġ tat- tip I) Pakketti ta ’ daqsijiet b’ 6 me
Viraferon is supplied as a powder at strengths of 10 million IU/ ml for single-dose use.
Viraferon hu pprovdut bħala trab b’ qawwa ta ’ 10 miljun IU/ ml għall- użu f’ doża waħda.
80 Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon.
Permezz ta ’ siringa u labra għall- injezzjoni sterilizzati, injetta 1 ml ta ’ ilma għall- injezzjonijiet ġol - kunjett ta ’ Viraferon.
MARKETING AUTHORISATION NUMBERS lon EU/ 1/ 99/ 128/ 006 EU/ 1/ 99/ 128/ 007 EU/ 1/ 99/ 128/ 008 no
EU/ 1/ 99/ 128/ 006 EU/ 1/ 99/ 128/ 007 EU/ 1/ 99/ 128/ 008
9 March 2000 t uc
9 ta ’ Marzu 2000 li l
23 May 2005 rod
23 Mejju 2005 ina
DATE OF REVISION OF THE TEXT lp
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/ i na dic Me
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 3 million IU/ 0.5 ml solution for injection
Viraferon 3 miljun IU/ 0. 5 ml soluzzjoni għall- injezzjoni
ed One vial of Viraferon solution for injection, single dose vial, contains 3 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 3 miljun IU ta ’ interferon alfa- 2b rikombinanti magħmul fl- E. coli bit- teknoloġija ta ’ DNA rikombinanti, ġo 0. 5 ml ta ’ soluzzjoni.
s For a full list of excipients, see section 6.1.
tor Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
ori 3.
aw 3.
uth Solution for injection Solution is clear and colourless.
Soluzzjoni għall- injezzjoni Is- soluzzjoni hi ċara u bla kulur.
ra 4.
ux 4.
Chronic Hepatitis B:
ad 4. 1 Indikazzjonijiet terapewtiċi ’ għ Epatite B Kronika:
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 histologically proven active liver inflammation and/ or fibrosis. no
It- trattament ta ’ pazjenti adulti li għandhom l- epatite B kronika assoċjata ma ’ 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 im
Adult patients:
Pazjenti adulti: li l
transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see uc
Viraferon huwa ndikat għat- trattament ta ’ pazjenti adulti li għandhom l- epatite Ċ kronika u għandhom transaminases elevati mingħajr dikompensazzjoni tal- fwied u li huma pożittivi għall- HCV- RNA jew għall- anti- HCV fis- serum (ara sezzjoni 4. 4). ina
The best way to use Viraferon in this indication is in combination with ribavirin. rod
L- aħjar mod kif tuża Viraferon f’ din l- indikazzjoni huwa flimkien ma ’ ribavirin. diċ
adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Viraferon huwa intenzjonat biex jintuża, f’ kors ta ’ kombinazzjoni ma ’ ribavirin, għall- kura ta ’ tfal u 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 decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and na
Id- deċiżjoni jekk għandhiex me
fibrosis, as well as prognostic factors for response, HCV genotype and viral load.
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 load.
The expected benefit of 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). i dic
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). ott
Me
It- trattament għandu jkun mibdi minn tabib li għandu l- esperjenza fl- imaniġġjar tal- marda.
Please make sure to select an appropriate dosage form and strength.
żgur li tagħżel il- forma tad- dożaġġ u qawwa li tkun xierqa.
If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
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.
82 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.
The administered dose should be reduced by 50% in case of occurrence of haematological disorders (white
at Id- doża mogħtija għanda titnaqqas b’ 50% f' każ li jseħħu problemi ematoloġiċi (ċelluli bojod tad -
ed blood cells < 1,500/ mm3, granulocytes < 1,000/ mm3, thrombocytes < 100,000/ mm3).
izz demm < 1, 500/ mm3, granuloċiti < 1, 000/ mm3, tromboċiti < 100, 000/ mm3).
s 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.
tor 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:
aw 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 (darba kull jumejn) lill- pazjenti adulti, kemm jekk jingħata bħala monoterapija kif ukoll flimkien ma ’ ribavirin.
ra Children 3 years of age or older and adolescents:
ux Tfal ta ’ 3 snin jew akbar u adolexxenti:
ge (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
ad (Ara l- SPC tal- kapsuli ribavirin u l- linji gwida għal tibdil fid- dożaġġ għal terapija kombinata.
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC). lon Relapse patients (adults):
Għal pazjenti pedjatriċi li jiżnu < 47 kg jew li ma jistgħux jibilaw kapsuli, ara l- SPC tas- soluzzjoni orali ’ għ ribavirin).
Viraferon is given in combination with ribavirin. no
Viraferon jingħata flimkien ma ’ ribavirin. im
Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for 6 months. t uc
Skond ir- riżultati ta ’ provi kliniċi, li għandhom informazzjoni għal 6 xhur ta ’ trattament, huwa rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon flimkien ma ’ ribavirin għal 6 xhur. li l
Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin. rod
jingħata waħdu l- aktar f’ każijiet ta ’ intolleranza jew ta ’ kontra- indikazzjoni għal ribavirin.
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months. lp
rakkomandat li l- pazjenti jkunu ttrattati b’ Viraferon flimkien ma ’ ribavirin għal mill- inqas 6 xhur.
Treatment should be continued for another 6-month period (i. e., a total of 12 months) in patients who exhibit na
It- trattament għandu jitkompla għal perijodu ieħor ta ’ 6 xhur (i. e., għal total ta ’ 12- il xahar) f’ pazjenti me
negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load. i
li juru HCV- RNA negattiv f’ xahar 6, u b’ ġenotip virali 1 (kif stabbilit f’ kampjun ta ’ qabel it - trattament) u b’ viral load għoli qabel it- trattament.
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into dic
Fatturi oħra ta ’ tbassir negattiv (età > 40 sena, sess maskili, fibrożi li tgħaqqad) għandhom ikunu ikkunsidrati sabiex it- terapija tkun estiża għal 12- il xahar. ott
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- Me
Waqt provi kliniċi, il- pazjenti li ma wrewx rispons viroloġiku wara 6 xhur ta ’ trattament (HCV- RNA inqas mil- limitu li jista ’ jkun imkejjel) ma sostnewx ir- rispons viroloġiku tagħhom (HCV- RNA inqas od
RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
mil- limitu li jista ’ jkun imkejjel sitt xhur wara l- waqfien tat- trattament).
The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
L- aħjar tul ta ’ żmien tat- terapija b’ Viraferon waħdu għadu ma kienx stabbilit għall- kollox, iżda terapija ta ’ bejn 12 u 18- il xahar hija rakkomandata.
83 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.
The efficacy and safety of Viraferon in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.
L- effikaċja u s- sigurtà ta ’ Viraferon flimkien ma ’ ribavirin kienu studjati fi tfal u
ed Genotype 1:
izz Ġenotip 1:
Treatment
Il- kura
s should be discontinued in these patients.
tor għandha titwaqqaf f’ dawn il- pazjenti.
ori Genotype 2/ 3:
Ġenotip 2/ 3:
Virological responses after 1 year of treatment and 6 months of follow-up were 36% for genotype 1 and
Rispons viroloġiku wara sena 1 ta ’ trattament u 6 xhur follow- up kienu ta ’ 36% għall- ġenotip 1 u
uth 81% for genotype 2/ 3/ 4.
aw 81% għall- ġenotip 2/ 3/ 4.
ra 4.3 Contraindications
ux 4. 3 Kontra- indikazzjonijiet
ge
ad
- Hypersensitivity to the active substance or to any of the excipients.
- Passat ta ’ mard tal- qalb sever li kien jeżisti minn qabel, eż., insuffiċjenza tal- qalb konġestiva
- A history of severe pre-existing cardiac disease, e. g., uncontrolled congestive heart failure, recent
mhux taħt kontroll, infart mijokardjali reċenti, disturbi arritmiċi severi
myocardial infarction, severe arrhythmic disorders. lon
- Funzjoni ħażina severa renali jew epatika; inklużi dawk ikkaġunati minn metastażi
- Severe renal or hepatic dysfunction; including that caused by metastases.
’ għ
agents excluding short term corticosteroid withdrawal.
immunosoppressivi, bl- esklużjoni tat- twaqqif għal żmien qasir tal- kortikosterojdi im
t uc
li l
Children and adolescents:
Tfal u adolexxenti: ina
ideation or suicide attempt. rod
ħsibijiet dwar suwiċidju jew attentati ta ’ suwiċidju.
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C. lp
Ara wkoll l- SPC ta ’ ribavirin jekk l- interferon alfa- 2b se jingħata diċ
4.4 Special warnings and precautions for use na
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu me
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after i dic
Fost it- tfal u adolexxenti kkurati b’ Viraferon ott
treatment discontinuation mainly during the 6-month follow-up periodand in the follow-up period.
ma ’ ribavirin, ħsibijiet dwar suwiċidju u attentati ta ’ suwiċidju kienu rrappurtati aktar ta ’ spiss meta mqabbla ma ’ pazjenti adulti (2. 4% vs 1%) waqt il- kura u fil- perijodu ta ’ 6 xhur follow- up ta ’ wara l - kura.
Among children and adolescents treated with Viraferon in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6-month Me
Bħal f’ pazjenti adulti, tfal u adolexxenti kellhom każijiet avversi oħra (eż dipressjoni, burdati od
follow-up after treatment.
emozzjonali, u ngħas).
Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons.
Effetti oħra fuq is- CNS inkluż imġieba aggressiva (kultant indirizzata lejn l - oħrajn), konfużjoni u tibdil fl- istat mentali dehru b’ alpha interferons.
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Jekk jidhru dawn is - Pr
If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
sintomi, is- serjetà li jista ’ jkollhom dawn l- effetti għandha titqies mit- tabib li jkun qed jordnhom u l - ħtieġa ta ’ maniġġar terapewtiku xieraq għandha tkun ikkunsidrata.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk sintomi psikjatriċi jippersistu jew imorru għall- agħar, jew jiġi mitbuħ li hemm ħsibijiet dwar suwiċidju, huwa rakkomandat li l- kura b’ Viraferon titwaqqaf, u l- pazjent jiġi segwit, b’ intervent psikjatriku kif ikun xieraq.
84 Patients with existence of or history of severe psychiatric conditions:
Pazjenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi:
The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
L- użu ta ’ interferon alfa- 2b fi tfal u adolexxenti li jkollhom jew fil- passat kellhom kundizzjonijiet psikjatriċi severi huwa kontra- indikat
If such a reaction develops, discontinue the
F’ każijiet ta ’
Transient rashes do not necessitate interruption of treatment.
tor raxx li jgħaddi malajr, m’ għandux jitwaqqaf it- trattament.
s Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon
Esperjenzi avversi minn moderati sa serji jistgħu jeħtieġu bidla fir- reġimen tad- dożaġġ tal- pazjent, jew
ori alfa-2b have been observed rarely during Viraferon therapy.
aw f’ xi każijiet, il- waqfien tat- terapija b’ Viraferon.
Transient rashes do not necessitate interruption of treatment.
Kull pazjent li jiżviluppa anormalitajiet fil- funzjoni tal- fwied waqt it- trattament b’ Viraferon għandu jkun osservat mill- qrib u t- trattament jitwaqqaf jekk is- sinjali u s- sintomi javvanzaw.
uth Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of Viraferon therapy.
Pressjoni baxxa ħafna tista ’ sseħħ waqt t- terapija b’ Viraferon jew sa jumejn wara, u tista ’ teħtieġ
ra with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
ux trattament ta ’ appoġġ.
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive
Idratazzjoni xierqa għandha tkun sostnuta fil- pazjenti li qed jagħmlu terapija b’ Viraferon billi kienet
ge treatment.
ad innutata f’ xi pazjenti pressjoni baxxa ħafna relatata ma’ nuqqas ta ’ fluwidu.
Fluid replacement may be necessary.
’ għ
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. no
Filwaqt li d- deni jista ’ jkun assoċjat mas- sindrome li jixbah l- influwenza li spiss tkun rrapportata waqt it- terapija bl- interferon, kawżi oħrajn ta ’ deni persistenti għandhom ikunu esklużi. im