natgillin/translations-raw huggingface dataset:
uth (genotype 1 and high virus load) (Table 3).
no
Regardless of genotype, patients who received
Ne glede na genotip so imeli bolniki, ki so prejemali Viraferon skupaj z ribavirinom in so prejeli ≥ 80% terapije, večji ohranjen odziv 6 mesecev po enoletnem zdravljenju kot tisti, ki so prejeli < 80% terapije (56% v lat
32% in trial C/ I98-580).
primerjavi z 32% v raziskavi C/ I98- 580). up
Sustained virologic response rates with Viraferon + ribavirin (one year of treatment) by genotype and viral load
Pogostnosti ohranjenega virološkega odziva pri uporabi zdravila Viraferon in ribavirina (enoletno zdravljenje) glede na genotip in virusno obremenitev
C95-132/ I95-143 C95-132/ I95-143
C95- 132/ I95- 143 C95- 132/ I95- 143 če
ed All Genotypes
Vsi genotipi
s ori Genotype 1
Genotip 1
uth Genotype 1 ≤ 2 million copies/ ml Genotype 1
Genotip 1 ≤ 2 milijona kopij/ ml Genotip 1 ks
ra > 2 million copies/ ml
> 2 milijona kopij/ ml Lie
ge Genotype 2/ 3
79% Genotip 2/ 3
I Viraferon (3 MIU 3 times a week) lon I/ R Viraferon (3 MIU 3 times a week) + ribavirin (1,000/ 1,200 mg/ day)
I Viraferon (3 mio i. e. trikrat na teden) I/ R Viraferon (3 mio i. e. trikrat na teden) + ribavirin (1. 000/ 1. 200 mg/ dan)
Overall, in both studies, patients no
Bolniki, sočasno okuženi z virusoma HCV in HIV 16 Opravljeni sta bili dve preskušanji pri bolnikih, ki so bili sočasno okuženi z virusoma HCV in HIV.
who received Viraferon plus ribavirin, were less likely to respond than patients who received pegylated interferon alfa-2b with ribavirin.
Na splošno so v obeh študijah opazili, da je bila pri bolnikih, ki so prejemali zdravilo Viraferon z ribavirinom, manjša verjetnost za odziv kot pri tistih, ki so prejemali pegiliran interferon alfa- 2b z ribavirinom.
Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated t
Študija 1 (RIBAVIC; P01017) je bila randomizirana, multicentrična študija, v katero je bilo vključenih 412 predhodno nezdravljenih
adult patients with chronic hepatitis C who were co-infected with HIV.
ie odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi z virusom HIV.
Patients were randomized to receive uc
Bolnike so naključno razporedili bodisi v skupino, ki je prejemala pegiliran interferon alfa- 2b (v odmerku
either pegylated interferon alfa-2b (1.5 µg/ kg/ week) plus ribavirin (800 mg/ day) or Viraferon (3 MIU TIW) plus ribavirin (800 mg/ day) for 48 weeks with a follow-up period of 6 months.
ác 1, 5 µg/ kg/ teden) z ribavirinom (v odmerku 800 mg/ dan) ali pa v skupino, ki je prejemala zdravilo Viraferon (3 mio i. e. trikrat na teden) z ribavirinom (v odmerku 800 mg/ dan), v času 48 tednov, z
Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C rod
ist enocentrična študija, v katero je bilo vključenih 95 predhodno nezdravljenih odraslih bolnikov s kroničnim hepatitisom C, ki so bili sočasno okuženi z virusom HIV.
Patients were randomized to receive either pegylated interferon alfa-2b (100 or 150 µg / week based on weight) plus ribavirin (800-1,200 mg/ day based on weight) or Viraferon (3 MIU TIW) plus ribavirin (800-1,200 mg/ day based on weight).
eg telesne mase) z ribavirinom (v odmerku 800- 1. 200 mg/ dan, odvisno od telesne mase) ali pa v skupino, ki je prejemala zdravilo Viraferon (3 m. i. e. trikrat na teden) z ribavirinom (v odmerku 800- 1. 200 mg/ dan odvisno od telesne mase).
The duration of therapy was 48 weeks with a lp
Zdravljenje je trajalo 48 tednov, z nadaljnjim 6- mesečnim obdobjem
follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
ur spremljanja bolnikov, razen pri tistih, ki so bili okuženi z genotipoma 2 ali 3 in so imeli virusno breme < 800. 000 i. e. / ml (Amplicor) - njih so zdravili 24 tednov z nadaljnjim 6- mesečnim obdobjem spremljanja.
16 Table 4
sťo Preglednica 4 Trajni virološki odziv glede na genotip po uporabi zdravila Viraferon v kombinaciji z ribavirinom, v primerjavi z uporabo pegiliranega interferona alfa- 2b v kombinaciji z ribavirinom pri bolnikih, ki so bili sočasno okuženi z virusoma HCV in HIV no
Study 22 pegylated
pegiliran
ed
Študija 22
pegylated
interferon lat
interferon
alfa- 2b (100 ali
alfa-2b (100
interferon
s
teden) +
(1.5 µg/ kg/
trikrat na
150c µg/ week) (3 MIU TIW)
(3 m. i. e. trikrat na teden) +
ori
ribavirin (800 -
week) +
teden) +
+ ribavirin
no
ribavirin
Vrednost
p
1. 200
(800-
ribavirin
p
1. 200 mg)
(800 mg) (800 mg)
27% (56/ 205) 20%
valuea
0, 047
uth All Genotype 1, 4
4
21% (9/ 43) 7% (2/ 27)
(12/ 32)
ra Genotype 2, 3
Genotipa 2,
53% (10/ 19)
53%
MIU = million international units; TIW = three times a week.
m. i. e. = milijonov mednarodnih enot; TIW = trikrat na teden a: vrednost p na podlagi Cochran- Mantel Haenszelovega testa hi- kvadrat b: vrednost p na podlagi testa hi- kvadrat c: preiskovanci s telesno maso < 75 kg so prejemali odmerek 100 µg/ teden pegiliranega interferona alfa- 2b in preiskovanci s ks
ge a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/ week pegylated interferon alfa-2b and subjects ≥ 75 kg received 150 µg/ week pegylated interferon alfa-2b. lon 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.
Lie
A total of 345 interferon alpha relapse patients were treated in two clinical trials with t
Skupaj 345 bolnikov z interferon alfa relapsom je bilo zdravljenih v dveh kliničnih raziskavah z zdravilom Viraferon, v monoterapiji ali v kombinaciji z
Viraferon monotherapy or in combination with ribavirin.
17 ribavirinom.
4.7%).
Pri teh bolnikih je dodatek ribavirina zdravilu Viraferon povečal učinkovitost samega zdravila Viraferon v monoterapiji kroničnega hepatitisa C za kar 10- krat (48, 6% v primerjavi s 4, 7%).
This enhancement in efficacy included loss of serum HCV (< 100 copies/ ml by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when rod
Ta okrepitev učinkovitosti je vključevala odsotnost HCV v serumu (< 100 kopij/ ml pri PCR), izboljšanje vnetja jeter in normalizacijo ALT in je bila še ohranjena ob merjenju 6 mesecev po koncu terapije.
measured 6 months after the end of treatment.
ie Dolgoročni podatki o učinkovitosti V veliko študijo so vključili skupaj 1. 071 bolnikov, ki so bili predhodno vključeni v študijo z
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.
ác nepegiliranim interferonom alfa- 2b ali z nepegiliranim interferonom alfa- 2b in ribavirinom, da bi ovrednotili trajanje stalnega virološkega odziva in ocenili vpliv nadaljnjih negativnih izvidov določanja
462 patients completed at least 5 years na
Pri 462 bolnikih se je zaključilo najmanj 5 letno dolgoročno spremljanje in le pri
of long-term follow-up and only 12 sustained responders' out of 492 relapsed during this study.
ist 12 bolnikih s stalnim virološkim odzivom od skupaj 492 je prišlo do ponovitve bolezni v času te študije.
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
Kaplan- Meierjeva ocena ohranjanja stalnega virološkega odziva v obdobju 5 let za vse bolnike znaša 97%, s 95% intervalom zaupanja [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.
eg Stalni virološki odziv po zdravljenju kronične okužbe z virusom hepatitisa C z nepegiliranim interferonom alfa- 2b (z ali brez ribavirina) vodi dodolgotrajnega očistkavirusa ter tako odpravi jetrno okužbo in omogoči klinično » ozdravitev « kronične okužbe z virusom hepatitisa C.
However, this does not preclude the occurrence of hepatic events in patients with cirrhosis Me
To pa ne pomeni, da ne bo prišlo
(including hepatocarcinoma).
ur do jetrnih dogodkov pri bolnikih s cirozo (vključno s hepatokarcinomom).
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.
sťo Otroci in mladostniki, stari od 3 do 16 let in s kompenziranim kroničnim hepatitisom C in merljivimi količinami HCV RNA (kar je ocenil osrednji laboratorij z uporabo raziskovalnega testa RT- PCR), so bili vključeni v dve multicentrični preskušanji in so zdravilo Viraferon prejemali v odmerku 3 mio i. e. / m2 trikrat na teden skupaj z ribavirinom v odmerku 15 mg/ kg na dan v času enega leta, čemur je sledilo 6 - no mesečno spremljanje po zdravljenju.
57% male, 80% Caucasian, and 78% genotype 1,64% ≤ 12 years of age.
V študijo je bilo vključenih 118 bolnikov; od tega je bilo 57% moških, 80% bolnikov bele rase, 78% bolnikov z genotipom 1 in 64% otrok, starih ≤ 12 let.
Sustained virological response rates in children and adolescents
Delež trajenega virološkega odziva lat
17 were similar to those in adults.
pri otrocih in mladostnikih je bil podoben tistemu pri odraslih.
Study results are summarized in Table 5.
Povzetek izsledkov študije je podan v Preglednici 5. no
Virological response in previously untreated paediatric patients
Virološki odziv pri predhodno nezdravljenih pediatričnih bolnikih če
ed Viraferon 3 MIU/ m2 3 times a week +
Viraferon 3 mio i. e. / m2 3 – krat na teden + ribavirin 15 mg/ kg/ dan on
ori Overall Response1 (n=118)
Skupni odziv1 (n=118) uk
Genotype 2/ 3/ 4 (n=26)
Genotip 2/ 3/ 4 (n=26) ks
ra *Number (%) of patients 1.
* Število (%) bolnikov 1.
Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period
Lie
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.
Farmakokinetiko zdravila Viraferon so raziskovali pri zdravih prostovoljcih po enkratnih subkutanih odmerkih po 5 milijonov i. e. / m2 in 10 milijonov i. e., po intramuskularnem dajanju 5 milijonov i. e. / m2 in po 30- minutni intravenski infuziji.
Cmax occurred three to 12 hours after the lower dose and six to no
18 je bila podobna tisti po intravenskem injiciranju.
eight hours after the higher dose.
Cmax je bila dosežena 3 do 12 ur po manjšem odmerku in 6 do 8 ur po večjem odmerku.
The elimination half-lives of interferon injections were approximately two to three hours, and six to seven hours, respectively.
6 do 7 ur.
Both subcutaneous and intramuscular administration resulted in bioavailabilities greater than 100%. t uc
Tako pri subkutani uporabi kot pri intramuskularni uporabi je bila biološka uporabnost zdravila večja od 100%.
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
ie Po intravenski uporabi so bile največje serumske koncentracije interferona (od 135 do 273 i. e. / ml) dosežene ob koncu infuzije, potem pa so upadale nekoliko hitreje kot po subkutani ali intramuskularni
of medicinal product, becoming undetectable four hours after the infusion.
ác uporabi zdravila in 4 ure po infuziji več niso bile merljive.
Urine levels of interferon were below the detection limit following each of the three routes of administration. lp
r ist Koncentracija interferona v seču je bila pod mejo detekcije pri vseh treh omenjenih načinih uporabe zdravila.
Children and adolescents:
eg Otroci in mladostniki:
Multiple-dose pharmacokinetic properties for Viraferon injection and ribavirin na
Farmakokinetične lastnosti pri večkratnem odmerjanju zdravila Viraferon injekcije in kapsul ribavirina pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v Preglednici 6.
capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized in Table 6.
Preglednica 6.
The pharmacokinetics of Viraferon and ribavirin (dose-normalized) are similar in adults and children or adolescents. i dic Me
Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju
Mean (% CV) multiple-dose pharmacokinetic parameters for Viraferon and ribavirin capsules when administered to children or adolescents with chronic hepatitis C
sťo zdravila Viraferon in kapsul ribavirina otrokom ali mladostnikom s kroničnim hepatitisom C
15 mg/ kg/ day as 2 divided doses (n = 17)
3 mio i. e. / m2 3- krat na teden 15 mg/ kg na dan v obliki
3 MIU/ m2 3 times a week (n = 54)
2 deljenih odmerkov (n = 17)
ed
no
1.9 (83)
1, 9 (83) lat
Apparent clearance l/ hr/ kg
Navidezni očistek l/ h/ kg
0.27 (27)
0, 27 (27) up
ori *AUC12 (ng. hr/ ml) for ribavirin; AUC0-24 (IU. hr/ ml) for Viraferon
* AUC12 (ng x h/ ml) za ribavirin; AUC0- 24 (i. e. x h/ ml) za Viraferon
Interferon neutralising factor assays were performed on serum samples of patients who received Viraferon in
Testi za določanje nevtralizacijskega faktorja za interferon so bili opravljeni na vzorcih seruma pri bolnikih, ki so prejeli zdravilo Viraferon v kliničnih raziskavah, ki so potekale pod nadzorom družbe no
uth Schering-Plough monitored clinical trials.
Schering- Plough.
The detectable titres are low in almost
Klinična incidenca nevtralizacijskih faktorjev, ki se pojavijo pri sistemsko zdravljenih bolnikih z rakavimi boleznimi, je 2, 9%, pri bolnikih s kroničnim hepatitisom pa 6, 2%. če
ra all cases and have not been regularly associated with loss of response or any other autoimmune phenomenon.
Merljivi titri so majhni skoraj v vseh primerih in jih niso redno povezovali s prenehanjem odziva ali s kakršnimkoli drugim avtoimunskim pojavom.
In patients with hepatitis, no loss of response was observed apparently due to the low titres.
odzivnosti, kar naj bi bilo posledica majhnih titrov.
ge 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti uk
Although interferon is generally recognised as being species specific, toxicity studies in animals were lon conducted.
Četudi interferon na splošno šteje za vrstno specifičnega, so bile opravljene predklinične raziskave toksičnosti na živalih.
Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits.
Vsakodnevno odmerjanje ks
Daily dosing of cynomolgus monkeys with 20 x 106 IU/ kg/ day for 3 months caused no remarkable toxicity.
zdravila pri opicah vrste cynomolgus v odmerku 20 x 106 i. e. / kg na dan 3 mesece ni povzročilo izrazitejše toksičnosti.
Toxicity was demonstrated in monkeys given 100 x 106 IU/ kg/ day for 3 months. no
Lie
In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4). t uc
V predkliničnih raziskavah uporabe interferona pri nečloveških primatih so opažali motnje menstrualnega ciklusa (glejte točko poglavje 4. 4).
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.
Izsledki reprodukcijskih raziskav na živalih kažejo, da rekombinantni interferon alfa- 2b ni teratogen za podgane in kunce in da ne vpliva negativno na nosečnost, razvoj ploda ali reprodukcijsko sposobnost 19 potomcev zdravljenih podgan.
Interferon alfa-2b has been shown to have abortifacient effects in Macaca mulatta (rhesus rod
Za interferon alfa- 2b so raziskave pokazale, da povzroča splav pri opicah rhesus (Macaca mulatta), če ga prejemajo v odmerku, ki je 90 oz.
monkeys) at 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/ m2.
180- krat večji od priporočenega intramuskularnega ali subkutanega odmerka 2 milijona i. e. / m2.
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
Splav so opažali v vseh skupinah po velikosti odmerka (7, 5 milijonov, 15 milijonov in 30 milijonov i. e. / kg), in je bil v primerjavi s kontrolno skupino statistično značilno pogostejši pri skupinah s srednjimi in velikimi odmerki (ki so ustrezali 90 oz.
recommended intramuscular or subcutaneous dose of 2 million IU/ m2).
ie 180- kratnemu priporočenemu intramuskularnemu ali subkutanemu odmerku 2 milijona i. e. / m2).
High doses of other forms of interferons alpha and beta are known to produce dose-related anovulatory and abortifacient effects in rhesus monkeys. na
Tudi za velike odmerke drugih oblik interferonov alfa in beta je znano, da povzročijo od odmerka odvisne učinke
Mutagenicity studies with interferon alfa-2b revealed no adverse events. i dic
r Raziskave mutagenosti interferona alfa- 2b niso pokazale nobenih neželenih dogodkov.
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).
ist Študije za proučevanje učinkov zdravljenja z interferonom alfa- 2b na rast, razvoj, spolno zorenje in vedenje živali niso bile opravljene pri mladih živalih (če boste zdravilo Viraferon uporabljali v
Me
eg kombinaciji z ribavirinom, glejte poglavje 4. 4 in SPC za zdravilo Rebetol).
19 Sodium dihydrogen phosphate monohydrate, Human albumin solution.
sťo Glicin Brezvodni natrijev hidrogenfosfat Natrijev dihidrogen fosfat monohidrat no Raztopina humanega albumina
Solvent: water for injections
Vehikel: voda za injekcije lat
6.2 Incompatibilities
6. 2 Inkompatibilnosti up
ed This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavje 6. 6.
s 6.3 Shelf life
6. 3 Rok uporabnosti no
ori 3 years
3 leta če
However, the chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC.
Vseeno je zdravilo med uporabo kemično in fizikalno stabilno 24 ur pri temperaturi 25 ºC. on
ra 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
Store in a refrigerator (2°C – 8°C).
Shranjujte v hladilniku (2 °C - 8 °C). uk
ge Do not freeze.
Ne zamrzujte.
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.
Če zdravilo v času 4 ks
6.5 Nature and contents of container no
6. 5 Vrsta ovojnine in vsebina
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 praška (kar ustreza 1 milijonu i. e.) v viali (iz stekla tipa I), z zamaškom (iz butilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) in 1 ml vode za injekcije v ampuli (iz stekla tipa I), z 1 injekcijsko brizgo, 2 injekcijskima iglama in 1 čistilnim tamponom.
and 1 ml water for injections in an ampoule (type I glass) uc
Velikost pakiranja:
Pack sizes of 1. rod
1 komplet.
Not all pack sizes may be marketed.
20 Na trgu ni vseh navedenih pakiranj.
6.6 Special precautions for disposal lp
6. 6 Posebni varnostni ukrepi za odstranjevanje
Please make sure to select an appropriate dosage form and strength. na
ie primerno obliko in koncentracijo.
Reconstitution of Viraferon, powder for solution for injection, for parenteral administration:
ác Rekonstitucija zdravila Viraferon, prašek za raztopino za injiciranje za parenteralno uporabo:
Viraferon is supplied as a powder at strengths of 1 million IU/ ml for single-dose use.
Viale
Vials must be reconstituted with i dic
r morate rekonstituirati z 1 ml vode za injekcije.
1 ml of water for injections.
ist uporabo.
The reconstituted solutions are isotonic for parenteral administration.
Med rekonstitucijo je potrebno upoštevati določene ukrepe za preprečevanje okužb (nanaša se na navodilo
Me
Z uporabo sterilizirane injekcijske brizge in injekcijske igle injicirajte 1 ml vode za injekcije v vialo
Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon.
ur zdravila Viraferon.
As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discoloration prior to administration.
sťo Kot velja za vsa parenteralna zdravila, morate pred uporabo vizualno pregledati rekonstituirano raztopino in preveriti, da ne vsebuje delcev in da ni obarvana.
20 Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”).
no opisana v navodilu za uporabo (nanaša se na "Kako
Any unused product must be discarded after withdrawal of the dose.
Neporabljeno zdravilo je potrebno zavreči potem, ko vzamete dmerek. up
ed SP Europe 73, rue de Stalle
SP Europe no
s B-1180 Bruxelles
73, rue de Stalle B- 1180 Bruxelles Belgija če
MARKETING AUTHORISATION NUMBER
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET on
EU/ 1/ 99/ 128/ 001
EU/ 1/ 99/ 128/ 001 uk
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET ks
ge Date of first authorisation:
Datum pridobitve dovoljenja za promet:
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
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
21 1.
ác
Viraferon 3 million IU/ ml powder and solvent for solution for injection
Viraferon 3 milijoni i. e. / ml prašek in vehikel za raztopino za injiciranje
ed One vial of powder contains 3 million IU of interferon alfa-2b produced in E. coli by recombinant DNA technology.
ác Ena viala s praškom vsebuje 3 milijone i. e. interferona alfa- 2b pridobljenega iz E. coli s tehnikami rekombinantne DNA tehnologije.
After reconstitution, 1 ml contains 3 million IU of interferon alfa-2b.
r Po rekonstituciji 1 ml vsebuje 3 milijone i. e. interferona alfa- 2b.
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.
23 Če se v teku zdravljenja z zdravilom Viraferon za katerokoli od indikacij pojavijo neželeni dogodki, prilagodite odmerjanje zdravila ali začasno ukinite zdravljenje, dokler se neželeni dogodki ne ublažijo.
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- 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).
24 V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCV - RNA pod spodnjo mejo detekcije), tudi kasneje niso postali virološko odzivni (HCV- RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
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.
ie Optimalna dolžina monoterapije z zdravilom Viraferon še ni bila dokončno ugotovljena, vendar svetujemo, naj zdravljenje traja od 12 do 18 mesecev.
agents excluding short term corticosteroid withdrawal. uc
kratkotrajne ukinitve kortikosteroidov,