qanastek/EMEA-V3 huggingface dataset:
The full EPAR for ViraferonPeg is available here.
L- EPAR sħiħ għal ViraferonPeg huwa disponibbli minn hawn.
ViraferonPeg 50 micrograms powder and solvent for solution for injection
ViraferonPeg 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni.
Each vial of ViraferonPeg, powder for solution for injection contains 50 micrograms of peginterferon alfa- 2b as measured on a protein basis.
Kull kunjett ta ’ ViraferonPeg, trab għal soluzzjoni għall- injezzjoni fih 50 mikrogrammi ta ’ peginterferon alfa- 2b hekk kif imkejjel fuq bażi ta ’ proteina.
ViraferonPeg contains 40 mg of sucrose per 0.5 ml.
ViraferonPeg fih 40 mg sucrose għal kull 0. 5 ml.
ViraferonPeg is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV, including naïve patients with clinically stable HIV co-infection (see section 4.4).
ViraferonPeg jintuża għat- trattament ta ’ pazjenti adulti b’ epatite Ċ kronika li għandhom transaminases għoljin mingħajr nuqqas ta ’ kumpensament tal- fwied u li huma pożittivi għal HCV- RNA fis- serum jew anti- HCV inklużi pazjenti naïve pazjenti b’ ko- infezzjoni ta ’ HIV klinikament stabbli (ara sezzjoni 4. 4).
The best way to use ViraferonPeg in this indication is in combination with ribavirin.
L- aħjar mod biex tuża ViraferonPeg f’ din l- indikazzjoni huwa f’ kombinazzjoni ma 'ribavirin.
Interferon monotherapy, including ViraferonPeg, is indicated mainly in case of intolerance or contraindication to ribavirin.
Il- monoterapija b’ interferon, li tinkludi ViraferonPeg, tintuża l- aktar f’ każ ta ’ intolleranza jew f’ każ li ribavirin ikun kontra- indikat.
Please refer also to the ribavirin Summary of Product Characteristics (SPC) when ViraferonPeg is to be used in combination with ribavirin.
Jekk jogħġbok irreferi wkoll għas- Sommarju tal- Karatteristiċi tal- Prodott (SPC) ta ’ ribavirin meta ViraferonPeg ikun ser jintuża flimkien ma 'ribavirin.
Dose to be administered ViraferonPeg should be administered as a once weekly subcutaneous injection.
Id- doża li għandha tingħata ViraferonPeg għandu jkun amministrat bħala injezzjoni taħt il- ġilda darba f’ ġimgħa.
2 Combination therapy ViraferonPeg 1.5 micrograms/ kg/ week in combination with ribavirin capsules.
Terapija konġunta ViraferonPeg 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
The intended dose of 1.5 μ g/ kg of ViraferonPeg to be used in combination with ribavirin may be delivered in weight categories with the pen/ vial strengths according to Table 1.
Id- doża maħsuba ta ’ 1. 5 μg/ kg ta ’ ViraferonPeg li għandha tintuża flimkien ma 'ribavirin tista ’ tingħata f’ kategoriji ta ’ piż bil- qawwiet tal- pinna/ kunjett skond Tabella 1.
The negative predictive value for sustained response in HCV/ HIV co-infected patients treated with ViraferonPeg in combination with ribavirin was 99% (67/ 68; Study 1) (see section 5.1).
Il- valur ta ’ tbassir negattiv għal rispons sostnut f’ pazjenti infettati fl- istess ħin b’ HCV/ HIV ikkurati b’ ViraferonPeg f’ kombinazzjoni ma ’ ribavirin kien 99% (67/ 68; Studju 1) (ara sezzjoni 5. 1).
ViraferonPeg monotherapy As monotherapy the ViraferonPeg regimen is 0.5 or 1.0 microgram/ kg/ week.
Monoterapija b’ ViraferonPeg Bħala monoterapija l- kors ta ’ ViraferonPeg huwa ta ’ 0. 5 jew 1. 0 mikrogramma/ kg/ ġimgħa.
ViraferonPeg monotherapy was not studied in HCV/ HIV co-infected patients.
Monoterapija b’ ViraferonPeg ma kienitx studjata f’ pazjenti ko - infettati b’ HCV/ HIV.
Dose modification for all patients If severe adverse reactions or laboratory abnormalities develop during treatment with ViraferonPeg monotherapy or ViraferonPeg in combination with ribavirin, modify the dosages of each product as appropriate, until the adverse reactions abate.
Tibdil fid- doża għal pazjenti kollha Jekk reazzjonijiet akuti mhux mixtieqa jew anormalitajiet tal- laboratorju jiżviluppaw waqt it- trattament bil - monoterapija ta ’ ViraferonPeg jew ViraferonPeg flimkien ma 'ribavirin, id- dożi għandhom jiġu regolati għal kull prodott kif jixraq, sakemm ir- reazzjonijiet mhux mixtieqa jbattu.
As adherence might be of importance for outcome of therapy, the dose should be kept as close as possible to the recommended standard dose.
Peress li kemm jiġu segwiti l - istruzzjonijiet jista ’ jkun importanti għar- riżultati tat- terapija, id- doża għandha tinżamm kemm jista ’ jkun viċin id- doża standard irrikkmandata.
Guidelines were developed in clinical trials for dose modification.
Linji gwida ġew żviluppati fi provi kliniċi għall- modifikazzjoni tad - doża.
Laboratory values
Valuri tal -
Reduce only Reduce only
Naqqas id- doża ta ’ Naqqas id- doża ta ’
Discontinue
Laboratorju
ribavirin dose to
ribavirin għal
combination
terapija konġunta
Haemoglobin Haemoglobin in:
600 mg/ kuljum * biss jekk:
600 mg/ day* if: < 10 g/ dl
għal nofs- doża biss jekk:
dose
jekk:
to one-half dose if: -
Emoglobina Emoglobina fi:
therapy if: < 8.5 g/ dl
8. 5 g/ dl
g/ dl decrease in haemoglobin during any four week period during treatment (permanent dose reduction) - < 1.5 x 109/ l - < 0.75 x 109/ l 9
erba ’ ġimgħat waqt it- trattament (tnaqqis permanenti fid- doża) 9
> 2.0 mg/ dl 2 x baseline and > 10 x ULN**
x linja bażi u
Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening. ** Upper limit of normal
> 10 x ULN ** * Pazjenti li d- doża tagħhom ta ’ ribavirin hija mnaqqsa għal 600 mg kuljum jieħdu kapsula waħda ta ’ 200 mg filgħodu u żewġ kapsuli ta ’ 200 mg filgħaxija. ** Limitu ta ’ fuq tan- normal
Dose reduction of ViraferonPeg may be accomplished by either reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 2b.
Tnaqqis fid- doża ta ’ ViraferonPeg jista ’ jinkiseb jew billi jitnaqqas il- volum preskritt bin- nofs jew billi tintuża doża anqas qawwija kif muri f 'Tabella 2b.
Table 2b – Reduced ViraferonPeg Dosing for Combination Therapy
Tabella 2b – Tnaqqis fid- Doża ta ’ ViraferonPeg għal Terapija Kombinata
ViraferonPeg Monotherapy Dose Reduction Guidelines
Linji Gwida għat- Tnaqqis fid- Doża ta ’ Monoterapija b 'ViraferonPeg
Dose modification guidelines for patients who use ViraferonPeg monotherapy are shown in Table 3a.
Il- linji gwida għat- tibdil fid- doża għal pazjenti li jużaw il- monoterapija b 'ViraferonPeg huma indikati f' Tabella 3a.
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
Tabella 3a Linji gwida għat- tibdil fid- doża tal- monoterapija b 'ViraferonPeg Valuti tal - laboratorju
Reduce ViraferonPeg to one-half dose if:
Naqqas ViraferonPeg għal nofs doża jekk:
Discontinue ViraferonPeg if:
Waqqaf ViraferonPeg jekk:
5 Dose reduction for patients who use 0.5 μ g/ kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Tnaqqis fid- doża għal pazjenti li jużaw il- monoterapija ta ’ ViraferonPeg 0. 5 μg/ kg għandu jinkiseb billi jitnaqqas il- volum preskritt bin- nofs.
For patients who use 1.0 μ g/ kg ViraferonPeg monotherapy, dose reduction may be accomplished by reducing the prescribed volume by one-half or by utilizing a lower dose strength as shown in Table 3b.
Għal pazjenti illi jużaw il- monoterapija ta ’ ViraferonPeg 1. 0 μg/ kg, tnaqqis fid- doża jista ’ jinkiseb billi jitnaqqas il- volum li ġie miktub mit- tabib bin- nofs jew billi tintuża doża anqas qawwija kif muri f 'Tabella 3b.
Table 3b – Reduced ViraferonPeg Dose for the 1.0 μ g/ kg Monotherapy Regimen
Tabella 3b – Tnaqqis fid- Doża ta ’ ViraferonPeg għall- Kors ta ’ Monoterapija 1. 0 μg/ kg
ViraferonPeg should be used with caution in patients with moderate to severe renal impairment.
Monoterapija: ViraferonPeg għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment renali moderat għal sever.
In patients with moderate renal dysfunction (creatinine clearance 30-50 ml/ minute), the starting dose of ViraferonPeg should be reduced by 25%.
F’ pazjenti li jkollhom il- funzjoni renali ħażina b’ mod moderat (tneħħija tal- krejatinina 30- 50 ml/ minuta), id- doża tal- bidu ta ’ ViraferonPeg għandha titnaqqas b’ 25%.
Patients with severe renal dysfunction (creatinine clearance 15-29 ml/ minute) should have the starting dose of ViraferonPeg reduced by 50%.
Pazjenti li jkollhom funzjoni renali ħażina b’ mod sever (tneħħija tal- krejatinina 15- 29 ml/ min) għandhom jieħdu d- doża tal- bidu ta ’ ViraferonPeg imnaqqsa b’ 50%.
Data are not available for the use of ViraferonPeg in patients with creatinine clearance < 15 ml/ minute (see section 5.2).
M’ hemmx tagħrif dwar l- użu ta ’ ViraferonPeg f’ pazjenti bi tneħħija tal- krejatinina < 15 ml/ min (ara sezzjoni 5. 2).
Patients with severe renal impairment, including those on hemodialysis, should be closely monitored.
Pazjenti b’ indeboliment renali sever, inklużi dawk fuq il- ħemodijaliżi, għandhom ikunu monitorati mill- qrib.
If renal function decreases during treatment, ViraferonPeg therapy should be discontinued.
Jekk il- funzjoni renali tonqos waqt il - kura, it- terapija b’ ViraferonPeg għandha titwaqqaf.
Patients with creatinine clearance < 50 ml/ minute must not be treated with ViraferonPeg in combination with ribavirin (see ribavirin SPC).
Terapija kombinata: Pazjenti bit- tneħħija tal- krejatinina < 50 ml/ minuta m’ għandhom jiġu kkurati b’ ViraferonPeg f’ taħlita ma ’ ribavirin (ara SPC ta ’ ribavirin).
When administered in combination with ribavirin, subjects with impaired renal function should be more carefully monitored with respect to the development of anaemia.
Meta jingħata f’ kombinazzjoni ma ’ ribavirin, individwi li jkollhom indeboliment fil- funzjoni renali għandhom ikunu monitorati aktar b’ kawtela għall - iżvilupp ta ’ anemija.
The safety and efficacy of ViraferonPeg therapy has not been evaluated in patients with severe hepatic dysfunction, therefore ViraferonPeg must not be used for these patients.
Is- sigurtà u l- effikaċja ta ’ ViraferonPeg ma ġewx evalwati f’ pazjenti b’ funzjoni ħ aż ina serja fil- fwied, għalhekk ViraferonPeg m’ għandux jintuża f’ dawn il- pazjenti.
There are no apparent age-related effects on the pharmacokinetics of ViraferonPeg.
Jidher li ma hemm l- ebda effetti relatati ma ’ l- età fuq il- farmakokinetiċi ta ’ ViraferonPeg.
Data from elderly patients treated with a single dose of ViraferonPeg suggest no alteration in ViraferonPeg dose is necessary based on age (see section 5.2).
Informazzjoni minn pazjenti anzjani li ngħataw doża waħda ta ’ ViraferonPeg tissuġġerixxi li m’ hemmx bżonn ta ’ tibdil fid- doża minħabba l- età (ara sezzjoni 5. 2).
- Initiation of ViraferonPeg is contraindicated in HCV/ HIV patients with cirrhosis and a Child-Pugh
- Huwa kontra- indikat li tinbeda kura bi ViraferonPeg f’ pazjenti HCV/ HIV b’ ċirrożi u punteġġ Child -
score ≥ 6.
Pugh ≥ 6.
Also see ribavirin Summary of the Product Characteristics (SPC) if ViraferonPeg is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Ara wkoll is- Sommarju tal- Karatteristiċi tal- Prodott (SPC) ta ’ ribavirin jekk ViraferonPeg ikun ser jingħata flimkien ma ’ ribavirin f’ pazjenti b’ epatite C kronika.
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during ViraferonPeg therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Effetti CNS sekondarji severi, l- aktar dipressjoni, ħsibijiet ta ’ suwiċidju u attentati ta ’ suwiċidju dehru f’ xi pazjenti waqt terapija b’ ViraferonPeg, u anki wara twaqqfet il- kura l- aktar fil- perijodu follow- up tas- sitt xhur ta ’ wara.
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with ViraferonPeg be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Jekk is- sintomi psikjatriċi jibqgħu jew imorru għall- agħar, jew jidher le jkun hemm ħsibijiet ta ’ suwiċidju, huwa irrikkmandat li l- kura b’ ViraferonPeg titwaqqaf, u l- pazjent jiġi segwit, b’ interventi psikjatriċi kif ikun jixraq.
If such a reaction develops during treatment with ViraferonPeg, discontinue treatment and institute appropriate medical therapy immediately.
Jekk reazzjoni bhal din tiżviluppa waqt it- trattament b 'ViraferonPeg, tkomplix it- trattament u għandek tibda terapija medika xierqa minnufih.
As with interferon alfa-2b, patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, receiving ViraferonPeg therapy require close monitoring.
Bħalma jiġri b 'interferon alfa- 2b, pazjenti li għandhom passat ta ’ insuffiċjenza tal - qalb konġestiva, attakk tal- qalb kif ukoll/ jew li kellhom jew għandhom problemi arritmiċi u li qed jingħataw terapija b’ ViraferonPeg jeħtieġu sorveljanza mill- qrib.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of ViraferonPeg therapy.
Arritmiji kardijaċi (l- aktar dawk supraventrikulari) ġeneralment jirrispondu ghal terapija konvenzjonali iżda jistgħu jkunu jeħtieġu li t- terapija b’ ViraferonPeg ma titkompliex.
As with all interferons, discontinue treatment with ViraferonPeg in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Bħal ma huwa l- każ b 'interferoni kollha, waqqaf it- trattament b' ViraferonPeg f’ pazjenti li jiżviluppaw żjieda fl- indikaturi tal- koagulazzjoni tad- demm, peress li dan jista ’ jkun qed jindika mard mhux kumpensat tal- fwied.
Adequate hydration must be maintained in patients undergoing ViraferonPeg therapy since hypotension related to fluid depletion has been seen in some patients treated with alpha interferons.
Idratazzjoni xierqa għandha tinżamm f’ pazjenti li qed jingħataw it- terapija b 'ViraferonPeg billi l- pressjoni baxxa konnessa ma ’ nuqqas ta ’ likwidi ġiet osservata f’ xi pazjenti ttrattati b' alfa interferoni.
Periodic visual examinations are recommended during ViraferonPeg therapy, particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Huwa rakkomandat illi jsiru eżamijiet ta ’ l- għajnejn kull tant żmien waqt li qed jingħata ViraferonPeg, l- aktar f’ dawk il- pazjenti b’ mard illi jista ’ jkun konness mar- retinopatija, bħal zokkor għoli fid- demm jew pressjoni għolja.
Discontinuation of ViraferonPeg should be considered in patients who develop new or worsening ophthalmological disorders.
F’ pazjenti illi jiżviluppaw mard f’ għajnejhom, jew li l- mard f’ għajnejhom imur għall- agħar, wieħed għandu jikkunsidra li ViraferonPeg jitwaqqaf.
In the presence of thyroid dysfunction, ViraferonPeg treatment may be continued if TSH levels can be maintained in the normal range by medication.
Jekk it- tirojde ma tkunx qed taħdem tajjeb, xorta jista ’ jitkompla t- trattament b 'ViraferonPeg jekk il- livelli tat- TSH jinżammu fil- livell normali permezz ta ’ mediċini.
Caution should be used when adding ViraferonPeg and ribavirin to HAART therapy (see ribavirin SPC).
Wieħed għandu joqgħod attent meta jżid ViraferonPeg u ribavirin ma 'terapija HAART (ara l- SPC ta ’ ribavirin).
Patients treated with ViraferonPeg and ribavirin combination therapy and zidovudine are at increased risk of developing anaemia and therefore the concomitant use of this combination with zidovudine is not recommended (see section 4.5).
Pazjenti kkurati b’ terapija bit- taħlita ta ’ ViraferonPeg u ribavrin ma ’ zidovudine għandhom riskju akbar li jiżviluppaw anemija u għalhekk l- użu ta ’ din it- taħlita ma ’ zidovudine mhux rakkomandata (ara sezzjoni 4. 5).
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with ViraferonPeg and ribavirin.
Jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott tal- prodotti mediċinali antiretrovirali li jkollhom jittieħdu fl- istes ħin ma’ terapija HCV għall- għarfien u maniġġjar tat- tossiċitajiet speċifiċi għal kull prodott u l- potenzjal li jista ’ jkun hemm tossiċitajiet f ’ daqqa b’ ViraferonPeg u ribavirin.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving ViraferonPeg and ribavirin combination therapy.
Disturbi tas- snien u tal- ħanek: Disturbi tas- snien u tal- ħanek, li jistgħu jwasslu għal telf ta ’ snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu ViraferonPeg u ribavirin f’ terapija kombinata.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long- term treatment with the combination of ViraferonPeg and ribavirin.
Minbarra hekk, ħalq xott jista ’ jgħamel il- ħsara fis- snien u l- membrani mukużi tal- ħalq waqt kura għal tul ta ’ żmien bil - kombinazzjoni ta ’ ViraferonPeg u ribavirin.
The safety and efficacy of ViraferonPeg alone or in combination with ribavirin for the treatment of hepatitis C in liver or other organ transplant recipients have not been studied.
Is- sigurtà u l- effikaċja ta ’ ViraferonPeg waħdu jew f’ kombinazzjoni ma’ ribavirin għall- kura ta ’ epatite C f’ pazjenti li jkunu rċevew trapjant tal- fwied jew ta ’ xi organu ieħor ma ġewx studjati.
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of ViraferonPeg in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Minħabba rapporti illi interferon alpha jista ’ jħarrax il- mard tal- psorajiżi u tas- sarkojdożi, l- użu ta ’ ViraferonPeg f’ pazjenti bi psorajiżi jew sarkojdożi huwa rakkomandat biss jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali.
Acceptable baseline values that may be considered as a guideline prior to initiation of ViraferonPeg therapy are:
Riżultati ta ’ referenza bażi aċċettati li jistgħu jkunu kkunsidrati bħala linja gwida qabel ma tinbeda t- terapija ta ’ ViraferonPeg huma:
Important information about some of the ingredients of ViraferonPeg:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ViraferonPeg:
9 Results from a multiple-dose probe study assessing P450 substrates in chronic hepatitis C patients receiving once weekly ViraferonPeg (1.5 µg/kg) for 4 weeks demonstrated an increase in activity of CYP2D6 and CYP2C8/9.
Riżultati minn studju bi probe b’ ħafna dożi li evalwa is- sottostrati P450 f’ pazjenti b’ epatite C kronika likienu qed jirċievu ViraferonPeg darba fil- ġimgħa (1. 5 µg/ kg) għal 4 ġimgħat wrew żieda fl- attività ta ’ CYP2D6 u CYP2C8/ 9.
These findings may partly relate to improved metabolic capacity due to reduced hepatic inflammation in patients undergoing treatment with ViraferonPeg.
Dawn is- sejbiet jistgħu jgħinu xi ftit sabiex titjieb il- ħila metabolika minħabba tnaqqid fl- infjammazzjoni epatika f’ pazjenti li jkunu taħt kura b’ ViraferonPeg.
Caution is therefore advised when ViraferonPeg treatment is initiated for chronic hepatitis in patients treated with medication with a narrow therapeutic window and sensitive to mild metabolic impairment of the liver.
Il- kawtela għalhekk hija konsiljata meta tinbeda l - kura b’ ViraferonPeg f’ pazjenti b’ epatite C kronika kkurati b’ mediċini li għandhom firxa terapewtika dejqa u li jkunu sensittivi għal indeboliment ħafif tal- fwied.
No pharmacokinetic interactions were noted between ViraferonPeg and ribavirin in a multiple-dose pharmacokinetic study.
Ma kienx hemm interazzjonijiet farmakokinetiċi sinifikanti bejn ViraferonPeg u ribavirin fi studju farmakokinetiku fejn ingħataw ħafnadożi.
In patients with chronic hepatitis C that were on stable methadone maintenance therapy and naïve to peginterferon alfa-2b, addition of 1.5 microgram/kg/week of ViraferonPeg subcutaneously for 4 weeks increased R-methadone AUC by approximately 15% (95% Cl for AUC ratio estimate 103 – 128%).
F’ pazjenti b’ epatite C kronika li kienu ġew stabbiliti fuq terapija ta ’ manteniment b’ methadone u naïve għal peginterferon alfa- 2b, iż- żieda ta ’ 1. 5 mikrogramma/ kg/ ġimgħa ta ’ ViraferonPeg minn taħt il- ġilda għal 4 ġimgħat żied l- AUC ta ’ R- methadone b’ madwar 15% (95% Cl għall- istima tal- proporzjon AUC 103 – 128%).
ViraferonPeg is recommended for use in fertile women only when they are using effective contraception during the treatment.
L- użu ta ’ ViraferonPeg f’ nisa fertili huwa irrikkmandat biss meta jkunu qed jużaw metodi ta ’ kontraċezzjoni effettiva waqt il- kura.
ViraferonPeg is likely to also cause this effect.
X’ aktarx li ViraferonPeg jikkawża dan l- effett.
ViraferonPeg is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
ViraferonPeg għandu jintuża waqt it- tqala biss jekk il - benefiċċju li jista ’ jkun hemm jiġġustifika r- riskju li jista ’ jkun hemm għall- fetu.
Ribavirin therapy is
Ribavirin jista ’ jikkawża difetti tat- twelid serji meta jingħata waqt it- tqala.
10 contraindicated in women who are pregnant.
It- terapija b’ ribavirin hija kontra- indikata f’ nisa waqt it- tqala.
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking ViraferonPeg in combination with ribavirin.
Għandha tittieħed kawtela estrema sabiex tiġi evtata t- tqala f’ pazjenti nisa jew fis- sieħba ta ’ pazjenti rġiel li jkunu qed jieħdu ViraferonPeg flimkien ma ’ ribavirin.
Females of childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Nisa li jista ’ jkollhom it- tfal u s- sieħba tagħhom għandhom jużaw kontraċezzjoni effettiva kull wieħed waqt il- kura u għal 4 xhur wara li tkun intemmet il- kura.
Patients who develop fatigue, somnolence or confusion during treatment with ViraferonPeg are cautioned to avoid driving or operating machinery.
Pazjenti li jiżviluppaw għejja, ħedla jew konfużjoni matul it- trattament b 'ViraferonPeg huma mwissija sabiex jevitaw li jsuqu jew iħaddmu magni.
The most common treatment-related adverse reactions reported during clinical trials with ViraferonPeg in combination with ribavirin, seen in more than half of the study subjects, were headache, fatigue, and injection site reaction.
L- aktar reazzjonijiet avversi komuni relatati mal- kura irrappurtata waqt provi kliniċi b’ ViraferonPeg flimkien ma ’ ribavirin, li dehret f’ aktar minn- nofs l- individwi li kienu qed jieħdu sehem fl- istudju, kienu uġigħ ta ’ ras, għeja, u reazzjoni fis- sit mnejn tingħata l- injezzjoni.
Fatigue, alopecia, pruritus, nausea, anorexia, weight decrease, irritability and insomnia occur at a notably lower rate in patients treated with ViraferonPeg monotherapy compared to those treated with combination therapy (see Table 4).
Għeja, alopeċja, ħakk, nawsja, anoressija, telf tal- piż, irritabilità u nuqqas ta ’ rqad iseħħu b’ rata ferm aktar baxxa f’ pazjenti kkurati b’ ViraferonPeg bħala monoterapija meta mqabbel ma ’ dawk ikkurati b’ terapija kkombinata (ara Tabella 4).
The following treatment-related adverse reactions were reported during therapy with ViraferonPeg.
Ir- reazzjonijiet avversi li ġejjin relatati mal- kura kienu rrappurtati waqt terapija b’ ViraferonPeg.
Adverse reactions reported in clinical trials or through post-marketing surveillance in patients treated with interferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin.
Reazzjonijiet avversi irrappurtati fil- provi kliniċi jew minn sorveljenza f’ pazjenti kkurati b’ interferon alfa- 2b, inkluża monoteraija b’ ViraferonPeg jew ViraferonPeg ma ’ ribavirin.
Diabetes Metabolism and nutrition disorders Very common:
Dijabete Disturbi fil- metaboliżmu u n - nutrizzjoni Komuni ħafna:
Nervous system disorders
Psikożi, alluċinazzjoni
Mania, bipolar disorders
Frekwenza mhux magħrufa:
Very common:
Disturbi fis- sistema nervuża Komuni ħafna:
Headache, mouth dry*
Manija, disturbi bipolari Uġigħ ta ’ ras, ħalq xott *
Gastrointestinal disorders
Disturbi gastro- intestinali Komuni ħafna:
These adverse reactions were common (≥1/100 to < 1/10) in clinical trials in patients treated with ViraferonPeg monotherapy.
Dawn ir- reazzjonijiet avversi kienu komuni (≥1/ 100 sa < 1/ 10) fi provi kliniċi f’ pazjenti kkurati b’ monoterapija b’ ViraferonPeg.
There were some cases of more severe neutropenia in patients treated with the recommended doses of ViraferonPeg in combination with ribavirin (WHO grade 3:
Kien hemm xi każijiet ta ’ newtropenja iktar qawwija f’ pazjenti li ġew trattati bid- dożi rakkomandati ta ’ ViraferonPeg flimkien ma 'ribavirin (Gradi ta ’ WHO 3:
13 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
Fi prova klinika, madwar 1. 2% tal- pazjenti li kienu trattati b’ ViraferonPeg jew interferon alfa- 2b flimkien ma 'ribavirin rrapurtaw każijiet psikjatriċi waqt it- trattament.
Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to be correlated mostly with pre-existing CVS disease and prior therapy with cardiotoxic agents (see section 4.4).
Każijiet avversi kardjovaskulari (CVS), l- aktar arritmija, dehru li kellhom x’ jaqsmu l- aktar ma ’ mard pri - eżistenti CVS u ma ’ l- għotja ta ’ aġenti kardjotossiċi xi darba qabel (ara sezzjoni 4. 4).
HCV/HIV co-infected patients For HCV/HIV co-infected patients receiving ViraferonPeg in combination with ribavirin, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the larger studies with a frequency > 5% were: oral candidiasis (14%), lipodystrophy acquired (13%), CD4 lymphocytes decreased (8%), appetite decreased (8%), gamma-glutamyltransferase increased (9%), back pain (5%), blood amylase increased (6%), blood lactic acid increased (5%), cytolytic hepatitis (6%), lipase increased (6%) and pain in limb (6%).
Pazjenti infettati fl- istess ħin b’ HCV/ HIV Għall- pazjenti infettati fl- istess ħin b’ HCV/ HIV li qed jirċievu ViraferonPeg f’ kombinazzjoni ma ’ ribavirin, effetti oħra mhux mixtieqa (li ma kienux irrappurtati f’ pazjenti b’ infezzjoni waħda) li kienu irrappurtati fl - istudji b’ frekwenza ta ’ > 5% kienu: kandidijażi orali (14%), lipodistrofija akkwiżita (13%), tnaqqis fil - limfoċiti CD4 (8%), tnaqqis fl- aptit (8%), żieda tal- gamma- glutamyltransferase (9%), uġigħ fid- dahar (5%), żieda ta ’ l- amylase fid- demm (6%), żieda tal- lactic acid fid- demm (5%), epatite ċitolitika (6%), żieda tal - lipase (6%) u uġigħ fir- riġel (6%).
Haematological abnormalities were more frequently reported in patients receiving ViraferonPeg in combination with ribavirin when compared to patients receiving interferon alfa-2b in combination with ribavirin.
Anormalitajiet ħematoloġiċi kienu rrappurtati b’ mod aktar frekwenti f’ pazjenti li kienu qed jirċievu ViraferonPeg f’ kombinazzjoni ma ’ ribavirin meta mqabbel ma ’ pazjenti li kienu qed jirċievu interferon alfa- 2b flimkien ma ’ ribavirin.
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4% (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4% (8/194) of patients receiving ViraferonPeg in combination with ribavirin.
Fi Studju wieħed (ara sezzjoni 5. 1), tnaqqis fl- għadd assolut tan- newtrofili taħt il- 500 ċellula/ mm3 dehru f’ 4% (8/ 194) tal- pazjenti u tnaqqis fl- għadd tal- plejtlits għal taħt 50, 000/ mm3 deher f’ 4% (8/ 194) tal- pazjenti li kienu qed jirċievu ViraferonPeg f’ kombinazzjoni ma ’ ma ’ ribavirin.
Anaemia (hemoglobin < 9.4g/dl) was reported in 12% (23/194) of patients treated with ViraferonPeg in combination with ribavirin.
Anemija (ħemoglobina < 9. 4g/ dl) kienet irrappurtata f’ 12% (23/ 194) tal- pazjenti ikkurati b’ ViraferonPeg f’ kombinazzjoni ma ’ ribavirin.
Treatment with ViraferonPeg in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Kura b’ ViraferonPeg f’ kombinazzjoni ma ’ ribavirin kienet assoċjata ma ’ tnaqqis fl- għadd assolut ta ’ ċelluli CD4+ fl- ewwel 4 ġimgħat mingħajr tnaqqis fil- perċentwali taċ- ċelluli CD4+.
The use of ViraferonPeg in combination with ribavirin had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
L- użu ta ’ ViraferonPeg f’ kombinazzjoni ma ’ ribavirin ma deherx li kellu impatt negattiv fuq il- kontroll ta ’ virimja bl- HIV waqt it - terapija jew fiż- żmien ta ’ follow- up.
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with ViraferonPeg in combination with ribavirin.
Jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott tal- prodotti mediċinali antiretrovirali li jkollhom jittieħdu fl- istes ħin ma ’ terapija HCV għall- għarfien u maniġġjar tat- tossiċitajiet speċifiċi għal kull prodott u l- potenzjal li jista ’ jkun hemm tossiċitajiet f’ daqqa b’ ViraferonPeg f’ kombinazzjoni ma ’ ribavirin.
14 consistent with the known safety profile for ViraferonPeg; however, the severity of the events may be increased.
B’ mod ġenerali, il- każijiet avversi li dehru f’ każijiet ta ’ doża eċċessiva li kienu jinvolvu ViraferonPeg huma konsistenti mal- profil ta ’ sigurtà maghruf għal ViraferonPeg; madankollu, is- severità tal- każijiet tista ’ tiżdied.
No specific antidote for ViraferonPeg is available; therefore, symptomatic treatment and close observation of the patient are recommended in cases of overdose.
M’ hemm l- ebda antidotu speċifiku għal ViraferonPeg; għalhekk, kura sintomatika o osservaz+zjoni mill- qrib tal- pazjent hija rakkomandata f’ każijiet ta ’ doża eċċessiva.
If available, prescribers are advised to consult with a poison control centre (PCC).
Jekk ikun hemm, it- tobba li jordnawh huma konsiljati li jirreferu għal ċentru tal- kontroll tal- veleni (PCC).
Interferon alfa-2b In vitro and in vivo studies suggest that the biological activity of ViraferonPeg is derived from its interferon alfa-2b moiety.
Interferon alfa- 2b Studji in vitro u in vivo jissuġġerixxu li l- attività bijoloġika ta ’ ViraferonPeg titnissel minn kull wieħed minn żewġ partijiet ta ’ interferon alfa- 2b.
ViraferonPeg ViraferonPeg pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2’5’-oligoadenylate synthetase (2’5’-OAS), as well as white cell and neutrophil counts.
ViraferonPeg Il- farmakodinamiċi ta ’ ViraferonPeg kienu mistħarrġa fi prova ta ’ doża waħda li tiżdied f’ suġġetti b’ saħħithom billi ġew mkejla bidliet fit- temperatura orali, konċentrazzjonijiet ta ’ proteini effetturi bħalma huma neopterin tas- serum u 2’ 5 ’ - oligoadenylate synthetase (2’ 5 ’ - OAS), kif ukoll in- numru ta ’ ċelluli bojod u tan- newtrofili.
Subjects treated with ViraferonPeg showed mild dose-related elevations in body temperature.
Dawk illi kienu trattati b’ ViraferonPeg urew zjieda żgħ ira fit- temperatura tal - ġisem li kienet konnessa mad- doża.
Following single doses of ViraferonPeg between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Wara dożi singoli ta ’ ViraferonPeg ta ’ bejn 0. 25 u 2. 0 mikrogrammi/ kg/ ġimgħa, il- konċentrazzjoni ta ’ neopterin fis- serum żdiedet b’ mod li kien relatat mad- doża.
Neutrophil and white cell count reductions at the end of week 4 correlated with the dose of ViraferonPeg.
Tnaqqis fl- għadd ta ’ newtrofili u ċelloli bojod fl- aħħar tar- raba ġimgħa kien korrelatat mad- doża ta ’ ViraferonPeg.
ViraferonPeg clinical trials – Naïve patients Two pivotal trials have been conducted, one (C/I97-010) with ViraferonPeg monotherapy; the other (C/I98-580) with ViraferonPeg in combination with ribavirin.
Studji Kliniċi fuq ViraferonPeg - Pazjenti li qatt ma kienu ħadu din il- kura qabel Saru żewġ studji pivitali, wieħed (C/ I97- 010) b’ monoterapija b’ ViraferonPeg u l- ieħor (C/ I98- 580) b’ ViraferonPeg flimkien ma 'ribavirin.
15 In the ViraferonPeg monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with ViraferonPeg (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
Fl- istudju fejn intużat monoterapija b’ ViraferonPeg, b’ kollox 916 pazjenti naïve b’ epatite Ċ kronika ġew ittrattati b 'ViraferonPeg (0. 5, 1. 0 jew 1. 5 mikrogrammi/ kg/ ġimgħa) għal sena u mbagħad ġew osservati għal sitt xhur.
This study showed that ViraferonPeg was superior to interferon alfa-2b (Table 5).
Dan l- istudju wera li ViraferonPeg kien superjuri għal interferon alfa- 2b (Tabella 5).
In the ViraferonPeg combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: • ViraferonPeg (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • ViraferonPeg (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) + ribavirin (1,000/1,200 mg/day), (n = 514). • Interferon alfa-2b (3 MIU three times a week) + ribavirin (1,000/1,200 mg/day) (n = 505).
Fi prova fejn ViraferonPeg intuża f’ kombinazzjoni, 1, 530 pazjent naïve ingħataw trattament għal sena b’ wieħed mill- korsijiet ikkumbinati li ġejjin: • ViraferonPeg (1. 5 mikrogrammi/ kg/ ġimgħa) + ribavirin (800 mg kuljum), (n = 511). • ViraferonPeg (1. 5 mikrogrammi/ kg/ ġimgħa għal xahar segwit 0. 5 mikrogrammi/ kg/ ġimgħa għal ħdax- il xahar) + ribavirin (1, 000/ 1, 200 mg kuljum), (n = 514). • Interferon alfa- 2b (3 MIU tlett darbiet fil- ġimgħa) + ribavirin (1, 000/ 1, 200 mg kuljum) (n = 505).
In this trial, the combination of ViraferonPeg (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 5), particularly in patients infected with Genotype 1 (Table 6).
F’ din il- prova, il- kombinazzjoni ta ’ ViraferonPeg (1. 5 mikrogrammi/ kg/ ġimgħa) u ribavirin kien, b’ mod sinifikattiv, aktar effettiv mill- kombinazjoni ta ’ interferon alfa- 2b u ribavirin (Tabella 5), l- aktar f’ pazjenti infettati b’ Ġenotip 1 (Tabella 6).
However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with ViraferonPeg or interferon alfa-2b.
Madankollu intwera li r- rati ta ’ reazzjoni f’ dan l- istudju kienu jiddependu wkoll fuq id - doża ta ’ ribavirin li ngħatat flimkien ma 'ViraferonPeg jew interferon alfa- 2b.
In those patients that received > 10.6 mg/kg ribavirin (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received ≤ 10.6 mg/kg ribavirin (Table 6), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
F’ dawk il- pazjenti li ngħataw iktar minn 10. 6 mg/ kg ribavirin (doża ta ’ 800 mg f’ pazjent tipiku li jiżen 75 kg), minkejja l - ġenotip jew il- viral load, ir- rati ta ’ reazzjoni kienu, b’ mod sinifikattiv, ogħla minn dawk tal- pazjenti li ngħataw inqas minn 10. 6 mg/ kg ribavirin (Tabella 6), filwaqt illi r- rati tar- reazzjoni f’ pazjenti li ngħataw > 13. 2 mg/ kg ribavirin kienu saħansitra ogħla.
Sustained virological response (% patients HCV negative) ViraferonPeg monotherapy ViraferonPeg + ribavirin
Reazzjoni viroloġika sostenuta (% ta ’ pazjenti negattivi għal HCV) Monoterapija b 'ViraferonPeg ViraferonPeg + ribavirin
303
I 303
P 1.5 ViraferonPeg 1.5 micrograms/kg P 1.0 ViraferonPeg 1.0 microgram/kg P 0.5 ViraferonPeg 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/R I/R * **
P 1. 5 ViraferonPeg 1. 5 mikrogrammi/ kg P 1. 0 ViraferonPeg 1. 0 mikrogramma/ kg P 0. 5 ViraferonPeg 0. 5 mikrogramma/ kg I Interferon alfa- 2b 3 MIU P 1. 5/ R P 0. 5/ R I/ R * **
ViraferonPeg (1.5 micrograms/kg) + ribavirin (800 mg) ViraferonPeg (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) Interferon alfa-2b (3 MIU) + ribavirin (1,000/1,200 mg) p< 0.001 P 1.5 vs.
ViraferonPeg (1. 5 mikrogrammi/ kg) + ribavirin (800 mg) ViraferonPeg (1. 5 sa 0. 5 mikrogramma/ kg) + ribavirin (1, 000/ 1, 200 mg) Interferon alfa- 2b (3 MIU) + ribavirin (1, 000/ 1, 200 mg) p < 0. 001 P 1. 5 vs.
Sustained response rates with ViraferonPeg + ribavirin (by ribavirin dose, genotype and viral load)
Rati ta ’ risponsi sostnuti b 'ViraferonPeg + ribavirin (bid- doża ta ’ ribavirin, ġenotip u viral load)
Genotype 1
Ġenotip 1 ≤ 600, 000 IU/ ml
ViraferonPeg (1.5 micrograms/kg) + ribavirin (800 mg) ViraferonPeg (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) Interferon alfa-2b (3 MIU) + ribavirin (1,000/1,200 mg)
ViraferonPeg (1. 5 mikrogrammi/ kg) + ribavirin (800 mg) ViraferonPeg (1. 5 to 0. 5 mikrogramma/ kg) + ribavirin (1, 000/ 1, 200 mg) Interferon alfa- 2b (3 MIU) + ribavirin (1, 000/ 1, 200 mg)
In the Vir aferonPeg monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of ViraferonPeg than by either 1.0 microgram/kg of ViraferonPeg once weekly or 3 MIU of interferon alfa-2b three times a week.
Fl- istudju fejn ingħatat monoterapija b 'ViraferonPeg, il- Kwalità tal- Ħajja kienet ġeneralment inqas affettwata b’ 0. 5 mikrogramma/ kg ta ’ ViraferonPeg milli jew b’ 1. 0 mikrogramma/ kg ta ’ ViraferonPeg darba fil- ġimgħa jew b’ 3 MIU ta ’ interferon alfa- 2b tliet darbiet fil- ġimgħa.
In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 7).
Fi prova separata, 224 pazjent b’ ġenotip 2 jew 3 irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il - ġilda, darba fil- ġimgħa, f’ kombinazzjoni ma ’ ribavirin 800 mg- 1, 400 mg p. o. għal 6 xhur (ibbażat fuq il - piż tal- ġisem, tlett pazjenti biss kienu jiżnu > 105 kg, irċevew doża ta ’ 1, 400 mg) (Tabella 7).
Virologic Response at End of Treatment, Sustained Virologic Response and Relapse by HCV Genotype and Viral Load* ViraferonPeg 1.5 μg/kg once weekly plus Ribavirin 800-1,400 mg/day
Tabella 7 Rispons viroloġiku fi Tmiem il- kura, Rispons Viroloġiku Sostnut u Irkadar b’ Ġenotip HCV u Viral Load. * ViraferonPeg 1. 5 μg/ kg darba fil- ġimgħa ma ’ Ribavirin 800 - 1, 400 mg/ jum
17 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Fi prova mhux kumparattiva, 235 pazjent b’ ġenotip 1 u viral load baxx (< 600, 000 IU/ ml) irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il- ġilda, darba fil- ġimgħa, flimkien ma ’ ribavirin aġġustat skond il- piż.
Forty-one percent of subjects (97/235) had nondetectable plasma HCV-RNA levels at Week 4 and Week 24 of therapy.
Wieħed u erbgħin ta ’ l- individwi (97/ 235) kellhom livelli ta ’ HCV- RNA fil- plażma li ma jitkejlux f’ Ġimgħa 4 u Ġimgħa 24 tat - terapija.
Table 8
Tbassir ta ’ rispons sostnut permezz ta ’ reazzjoni virali sat- tnax- il ġimgħa u ġenotip *
Predictability of
Kura
sustained response by viral response at week 12 and genotype*
Ġinotip Rispons viroloġiku Rispons sostnut Valur negattiv ma ’ ġimgħa 12 imbassar
Treatment ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment ViraferonPeg 1.5 +
ViraferonPeg 1. 5 ribavirin (> 10. 6 mg/ kg)
Viral response Sustained response Negative predictive value at week 12 1 Yes 75% (82/110) 71% (58/82) ---- No 25% (28/110) 0% (0/28) 100%
+ 1 Iva 75% (82/ 110) 71% (58/ 82) ---- Le 25% (28/ 110) 0% (0/ 28) 100%
ribavirin 800-1,400 mg
ġimgħa ta ’ kura 48 ViraferonPeg 1. 5 + ribavirin 800- 1, 400 mg
The negative predictive value for sustained response in patients treated with ViraferonPeg in monotherapy was 98%.
Il- valur negattiv li jbassar għal rispons sostnut f’ pazjenti li ġew trattati b 'ViraferonPeg f’ monoterapija kien ta ’ 98%.
Patients were randomized to receive either ViraferonPeg (1.5 µg/kg/week) plus ribavirin (800 mg/day) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Il- pazjenti kienu randomized sabiex jirċievu ViraferonPeg (1. 5 µg/ kg/ ġimgħa) ma ’ ribavirin (800 mg/ jum) jew interferon alfa- 2b (3 MIU TIW) ma ’ ribavirin (800 mg/ jum) għal 48 ġimgħa b’ perijodu ta ’ follow- up ta ’ 6 xhur.
Patients were randomized to receive either ViraferonPeg (100 or 150 µg /week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).
Il- pazjenti kienu randomized biex jirċievu ViraferonPeg (100 jew 150 µg/ ġimgħa skond il- piż) ma ’ ribavirin (800- 1, 200 mg/ jum skond il- piż) jew interferon alfa- 2b (3 MIU TIW) ma ’ ribavirin (800- 1, 200 mg/ jum skond il- piż).
Sustained virological response based on genotype after ViraferonPeg in combination with Ribavirin in HCV/HIV Co-infected patients Study 11 Study 22 ViraferonPeg Interferon ViraferonPeg Interferon (100 or alfa-2b (1.5 µg/kg/ alfa-2b 150c µg/week) (3 MIU TIW) week) + (3 MIU TIW) + + ribavirin + ribavirin ribavirin ribavirin p (800- (800- p (800 mg) (800 mg) valuea 1,200 mg) d 1,200 mg) d valueb
Rispons viroloġiku sostnut ibbażat fuq il- ġenotip wara ViraferonPeg f’ kombinazzjoni ma ’ Ribavirin f’ pazjenti infettati fl- istess ħin b’ HCV/ HIV Studju 11 Studju 22 ViraferonPeg (100 jew Interferon 150c ViraferonPeg Interferon alfa- 2b µg/ ġimgħa) + (3 MIU TIW) (1. 5 µg/ kg / alfa- 2b ribavirin + ribavirin ġimgħa) + (3 MIU TIW) + valur - ribavirin ribavirin valur - (800 - (800 - pb d a d 1, 200 mg) (800 mg) (800 mg) p 1, 200 mg)
27% (56/205) 20% (41/205) 0.047 44% (23/52) 21% (9/43) 0.017 17% (21/125) 6% (8/129) 0.006 38% (12/32) 7% (2/27) 0.007
27% (56/ 205) 20% (41/ 205) 0. 047 44% (23/ 52) 21% (9/ 43) 0. 017 17% (21/ 125) 6% (8/ 129) 0. 006 38% (12/ 32) 7% (2/ 27) 0. 007
44% (35/80) 43% (33/76) 0.88 53% (10/19) 47% (7/15)
44% (35/ 80) 43% (33/ 76) 0. 88 53% (10/ 19) 47% (7/ 15)
MIU = million international units; TIW = three times a week. a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week ViraferonPeg and subjects ≥ 75 kg received 150 µg/week ViraferonPeg. d: ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
MIU =miljun unitajiet internazzjonali; TIW = tlett darbiet fil- ġimgħa. a: valur- p ibbażat fuq it- test Cochran- Mantel Haenszel Chi square. b: valur- p ibbażat fuq it- test chi- square. c: individwi < 75 kg irċevew 100 µg/ ġimgħa ViraferonPeg u individwi ≥ 75 kg irċevew 150 µg/ ġimgħa ViraferonPeg. d: għall- pazjenti < 60 kg ingħataw dożi ta ’ 800 mg ribavirin, 1, 000 mg għall- pazjenti 60- 75 kg, u 1, 200 mg għall- pazjenti > 75 kg.
Both the Metavir score and Ishak grade decreased among subjects treated with ViraferonPeg in combination with ribavirin.
Kemm il- punteġġ Metavir u l- grad Ishak naqsu fost l- individwi ikkurati b’ ViraferonPeg f’ kombinazzjoni ma ’ ribavirin.
ViraferonPeg/ribavirin retreatment of prior treatment failures In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Kura mill- ġdid b’ ViraferonPeg/ ribavirin ta ’ każijiet fejn kuri li kienu ngħataw qabel fallew Fi prova mhux kumparattiva, 2, 293 pazjent b’ fibrożi moderata għal severa li kienu fallew għall- kura li ngħataw qabel b’ taħlita ta ’ interferon alfa/ ribavirin kienu kkurati mill- ġdid b’ ViraferonPeg, 1. 5 mikrogramma/ kg minn taħt il- ġilda, darba fil- ġimgħa, flimkien ma ’ ribavirin mogħti skond il- piż tal - ġisem.
Long-Term efficacy data A large long-term follow-up study enrolled 567 patients after treatment in a prior study with ViraferonPeg (with or without ribavirin).
Dejta dwar l- effikaċja fuq medda twila ta ’ żmien Studju kbir ta ’ follow- up fuq medda twila ta ’ żmien ingaġġa 567 pazjent wara kura fi studju li sar qabel b’ ViraferonPeg (b’ ribavirin jew mingħajru).
The purpose of the study was to evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes.
L- għan ta ’ l- istudju kienu li jiġi evalwat kemm idum ir - rispons viroloġiku sostnut (SVR) u jiġi stmat l- impatt ta ’ negattività virali kontinwa fuq ir- riżultati kliniċi.
SVR after treatment of chronic HCV with ViraferonPeg (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 kura ta ’ HCV kronika b’ ViraferonPeg (b’ ribavirin jew mingħajru) twassal għal tneħħija fit- tul tal- virus u b’ hekk tfejjaq l- infezzjoni epatika u “ fejqan ” kliniku minn HCV kroniku.
ViraferonPeg is a well characterized polyethylene glycol-modified (“pegylated”) derivative of interferon alfa-2b and is predominantly composed of monopegylated species.
ViraferonPeg huwa derivattiv modifikat ta ’ polyethylene glycol (“ pegylated ”) b' karatteristiċi mfissra tajjeb ta ’ interferon alfa- 2b u huwa magħmul prinċipalment minn speċi monopegylated.
The plasma half-life of ViraferonPeg is prolonged compared with non-pegylated interferon alfa-2b.
Il- half- life ta ’ ViraferonPeg fil- plażma hija mtawwla meta ’ mqabbla ma ’ interferon alfa- 2b mhux pegylated.
ViraferonPeg has a potential to depegylate to free interferon alfa-2b.
ViraferonPeg jista ’ jitlef il- pegylate biex isir interferon alfa- 2b liberu.
ViraferonPeg Cmax and AUC measurements increase in a dose-related manner.
Is- Cmax u l- AUC ta ’ ViraferonPeg jogħlew b’ mod relatat mad- doża.
Mean (SD) ViraferonPeg elimination half-life is approximately 40 hours (13.3 hours), with apparent clearance of 22.0 ml/hr·kg.
Il- half- life ta ’ ViraferonPeg hija ta ’ madwar 40 siegħa (13. 3 siegħa) b’ rata ta ’ eliminazzjoni apparenti ta ’ 22. 0 ml/ hr· kg.
However, renal elimination may account for a minority (approximately 30%) of ViraferonPeg apparent clearance.
Madanakollu, l- eliminazzjoni mill- kliewi tista ’ tirrifletti ammont ċkejken (madwar 30%) tal- clearance apparenti ta ’ ViraferonPeg.
Renal clearance appears to account for 30% of total clearance of ViraferonPeg.
Jidher illi l- clearance mill- kliewi hija responsabbli għal 30% tar- rata kollha ta ’ eliminazzjoni ta ’ ViraferonPeg.
Following multiple dosing of ViraferonPeg (1.0 microgram/kg subcutaneously administered every week for four weeks) the clearance of ViraferonPeg is reduced by a mean of 17% in patients with moderate renal impairment (creatinine clearance 30-49 ml/minute) and by a mean of 44% in patients with severe renal impairment (creatinine clearance 15-29 ml/minute) compared to subjects with normal renal function.
Wara li ngħataw ħafna dożi ta ’ ViraferonPeg (1. 0 mikrogramma/ kg minn taħt il- ġilda kull ġimgħa għal erba ’ ġimgħat) it- tneħħija ta ’ ViraferonPeg tnaqqset b’ medja ta ’ 17% f’ pazjenti b’ indeboliment renali moderat (tneħħija tal- krejatinina 30- 49 ml/ min) u b’ medja ta ’ 44% f’ pazjenti b’ indeboliment renali sever (tneħħija tal- krejatinina 15- 29 ml/ minuta) mqabbel ma ’ individwi b’ funzjoni renali normali.
The dose of
Ibbażat minn dejta b’ doża waħda, it- tneħħija kienet simili f’ pazjenti b’ indeboliment renali sever li ma kienux fuq dijaliżi u f’ pazjenti li kienu qed jirċievu emodijaliżi.
21 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Id- doża ta ’ ViraferonPeg għal monoterapija għandha titnaqqas f’ pazjenti b’ indeboliment renali ħafif għal moderat (ara sezzjonijiet 4. 2 u 4. 4).
Patients with creatinine clearance < 50 ml/minute must not be treated with ViraferonPeg in combination with ribavirin (see section 4.3).
Pazjenti bi tneħħija tal- krejatinina < 50 ml/ minuta m’ għandhom ikunu ikkurati bi ViraferonPeg ikkombinat ma’ ribavirin (ara sezzjoni 4. 3).