natgillin/translations-raw huggingface dataset:
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 follow-up after treatment.
67 pogosteje poročali o samomorilnih mislih ali poskusu samomora kot pri odraslih (2, 4% v primerjavi z 1%) med zdravljenjem in v času 6- mesečnega spremljanja bolnikov po zdravljenju.
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.
Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z
hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
68 malignimi boleznimi, zdravljenimi z interferonom alfa.
65 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
r povezane z retinopatijo, npr. sladkorna bolezen ali hipertenzija.
markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
69 inaktivacijo oz. odstranjevanje virusov.
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.
eg Pri vseh bolnikih, vključenih v raziskave kroničnega hepatitisa C, so pred vključitvijo v raziskavo opravili jetrno biopsijo, vendar je v določenih primerih (npr. pri bolnikih z genotipoma 2 in 3), zdravljenje možno
In addition, preclicinal juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
Pri novorojenih podganjih mladičih, ki so jim dajali odmerke ribavirina, so ugotovili manjše, od odmerka odvisno splošno zmanjšanje rasti, ki se je kasneje pokazalo kot rahlo zmanjšanje telesne mase, razdalje od temena do trtice 70 in dolžine kosti (glejte poglavje 5. 3).
67 Laboratory Tests:
Laboratorijske preiskave:
(Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C). rod
71 (Če boste zdravilo Viraferon uporabljali v kombinaciji z ribavirinom pri bolnikih s kroničnim hepatitisom C, glejte tudi SPC za ribavirin).
68 each use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Tudi bolniki in njihove partnerke morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 7 mesecev po zaključku zdravljenja (glejte SPC za ribavirin). no 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji lat
Infections and infestations uc
72 samostojno ali v kombinaciji z ribavirinom Razporeditev po organskih sistemih Infekcijske in parazitske bolezni Zelo pogosti:
ge oedema), retinal artery or vein obstruction§, optic neuritis, papilloedema, loss of visual acuity or visual field, cotton- wool spots§ lon Ear and labyrinth Common:
mrežnične krvavitve§, retinopatija (vključno z edemom Redki: makule), zamašitev mrežnične arterije ali vene§, nevritis vidnega živca, papiloedem, zmanjšanje ostrine vida ali vidnega polja, belkaste lise na očesnem ozadju§ Ušesne bolezni, vključno z motnjami labirinta 73 Pogosti:
uth menstrual disorder, vaginal disorder General disorders and administration site conditions
amenoreja, bolečine v dojkah, dismenoreja, menoragija, 74 motnje menstruacije, bolezni nožnice vnetje na mestu injiciranja, reakcija na mestu injiciranja *, utrujenost, mrzlica, zvišana telesna temperatura§, gripi
s categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10).
75 V okviru razvrstitve po organskih sistemih so neželeni učinki dodatno razvrščeni po pogostnosti v naslednji dve kategoriji: zelo pogosti (≥1/ 10), pogosti (≥1/ 100, < 1/ 10).
ed Skin and subcutaneous tissue disorders Very common:
76 gastroezofagealni refluks, bolezni rektuma, bolezen prebavil, zaprtje, vodeno blato, zobobol, zobne bolezni Bolezni jeter, žolčnika in žolčevodov motnje delovanja jeter Pogosti:
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.
77 Aktivnost zdravila Viraferon izražamo v i. e., pri čemer 1 mg rekombinantne beljakovine interferona alfa - 2b ustreza 2, 6 x 108 i. e.
This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell. rod
Tako zavira replikacijo virusov, če pa do replikacije kljub temu pride, novi virioni ne morejo zapustiti celice. če
Adult patients:
78 Odrasli bolniki:
74 a histologic diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
ác drugega vzroka za kronični hepatitis, ter nenormalno serumsko vrednostjo ALT.
Overall, in both studies, patients no
Bolniki, sočasno okuženi z virusoma HCV in HIV 79 Opravljeni sta bili dve preskušanji pri bolnikih, ki so bili sočasno okuženi z virusoma HCV in HIV.
Viraferon monotherapy or in combination with ribavirin.
80 ribavirinom.
77 were similar to those in adults.
pri otrocih in mladostnikih je bil podoben tistemu pri odraslih.
Cmax occurred three to 12 hours after the lower dose and six to no
81 je bila podobna tisti po intravenskem injiciranju.
Multiple-dose pharmacokinetic properties for Viraferon injection and ribavirin na
Farmakokinetične lastnosti pri dajanju večih odmerkov zdravila Viraferon injekcije in ribavirin kapsule pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v Preglednici 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 za večkratno odmerjanje za
Mean (% CV) multiple-dose pharmacokinetic parameters for Viraferon and ribavirin capsules when administered to children or adolescents with chronic hepatitis C
sťo Viraferon in zdravilo ribavirin kapsule pri dajanju zdravila otrokom ali mladostnikom s kroničnim hepatitisom C Viraferon
Viraferon
15 mg/ kg
15 mg/ kg/ day as 2 divided doses (n = 17)
2 deljenih odmerkov (n = 17) lat
Cmax (ng/ ml)
Cmax (ng/ ml) AUC *
3,275 (25)
3. 275 (25) 29. 774 (26) up
AUC*
Navidezni očistek l/ h/ kg
29,774 (26)
0, 27 (27)
622 (48)
ni bil določen
Apparent clearance l/ hr/ kg
* 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 no
uth Schering-Plough monitored clinical trials.
bolnikih, ki so prejeli zdravilo Viraferon v kliničnih raziskavah, ki so potekale pod nadzorom družbe Schering- Plough.
The clinical incidence of neutralising factors developing in cancer patients treated systemically is 2.9% and in chronic hepatitis patients is 6.2%.
zdravljenih bolnikih z rakavimi boleznimi, je 2, 9%, pri bolnikih s kroničnim hepatitisom pa 6, 2%.
The detectable titres are low in almost
Merljivi titri so majhni skoraj v vseh primerih in jih niso redno povezovali s prenehanjem odziva ali s on
ra all cases and have not been regularly associated with loss of response or any other autoimmune phenomenon.
kakršnimkoli drugim avtoimunskim pojavom.
In patients with hepatitis, no loss of response was observed apparently due to the low titres.
Pri bolnikih s hepatitisom niso opažali prenehanja odzivnosti, kar naj bi bilo posledica majhnih titrov. uk
ge 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits.
opažali nobenih znakov toksičnosti zdravila pri miših, podganah in kuncih.
Daily dosing of cynomolgus monkeys with 20 x 106 IU/ kg/ day for 3 months caused no remarkable toxicity.
Vsakodnevno odmerjanje 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
Raziskave pa so pokazale toksičnost interferona pri opicah, ki so prejemale 100 x 106 i. e. / kg Lie
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.
82 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 potomcev zdravljenih podgan.
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
ie 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).
ác 180- kratnemu priporočenemu intramuskularnemu ali subkutanemu odmerku 2 milijona i. e. / m2).
Mutagenicity studies with interferon alfa-2b revealed no adverse events. i dic
ist Raziskave mutagenosti interferona alfa- 2b niso pokazale nobenih neželenih dogodkov
Me
eg 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 kombinaciji z ribavirinom, glejte poglavje 4. 4 in SPC za zdravilo Rebetol).
6.1 List of excipients
sťo 6. 1 Seznam pomožnih snovi
79 Sodium dihydrogen phosphate monohydrate, Human albumin solution.
Glicin no Brezvodni natrijev hidrogenfosfat Natrijev dihidrogen fosfat monohidrat Raztopina humanega albumina lat
Solvent: water for injections
Vehikel: voda za injekcije 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. no
s 6.3 Shelf life
6. 3 Rok uporabnosti če
ori 3 years
3 leta
uth After reconstitution:
Po rekonstituciji: priporočena je takojšnja uporaba.
An immediate use is recommended.
Vseeno je zdravilo med uporabo kemično in fizikalno on
However, the chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC.
stabilno 24 ur pri temperaturi 25 ºC.
ra 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje uk
ge Do not freeze.
Ne zamrzujte. ks
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.
V času roka uporabnosti pri prevozu in/ ali za lažjo ambulantno uporabo lahko nerekonstituirano zdravilo pred uporabo shranjujete pri temperaturi do vključno 25°C za čas do 4 tednov.
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.
Če zdravilo v času 4 tednov ni rekonstituirano, ga ne smete dati nazaj v hladilnik za naslednje 4 tedne, ampak ga morate Lie
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
83 24 mg praška (kar ustreza 10 milijonom 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
Velikosti pakiranj:
with 1 injection syringe, 2 injection needles and 1 cleansing swab.
1 komplet in 10 kompletov.
Or
ie ali
24 mg of powder (corresponding to 10 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off lp
ác 24 mg praška (kar ustreza 10 milijonom 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
Pack sizes of 6 na
r stekla tipa I).
6.6 Special precautions for disposal i dic
eg 6. 6 Posebni varnostni ukrepi za odstranjevanje
Me
ur primerno obliko in koncentracijo.
Reconstitution of Viraferon, powder for solution for injection, for parenteral administration:
Zdravilo
Viraferon is supplied as a powder at strengths of 10 million IU/ ml for single-dose use.
sťo Viraferon je na voljo v obliki praška z jakostjo 10 milijonov i. e. / ml., za dajanje v enkratnem odmerku.
Proper precautions should be taken during reconstitution to prevent microbial contamination (refer to package leaflet).
Med rekonstitucijo je potrebno upoštevati določene ukrepe za preprečevanje okužb (nanaša se na navodilo za uporabo). lat
80 Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon.
Z uporabo sterilizirane injekcijske brizge in injekcijske igle injicirajte 1 ml vode za injekcije v vialo zdravila Viraferon.
The appropriate dose can then be withdrawn with a sterile injection syringe and injected.
odmerek v sterilno injekcijsko brizgo in ga injicirate.
ed Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”).
si sami injicirate zdravilo Viraferon ").
s Any unused product must be discarded after withdrawal of the dose.
Neporabljeno zdravilo je potrebno zavreči potem, ko vzamete dmerek. on uk
ra B-1180 Bruxelles Belgium
SP Europe 73, rue de Stalle ks
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 84 9.
9 March 2000 t uc
9. marec 2000
Date of last renewal:
ie Datum podaljšanja dovoljenja za promet:
23 May 2005 rod
23. maja 2005
10.
ác 10.
DATE OF REVISION OF THE TEXT lp
DATUM ZADNJE REVIZIJE BESEDILA
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
r ist Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Viraferon 3 million IU/ 0.5 ml solution for injection
Viraferon 3 milijoni i. e. / 0, 5 ml raztopina za injiciranje
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.
ác Ena viala zdravila Viraferon, raztopina za injiciranje v viali z enkratnim odmerkom vsebuje 3 milijone i. e. rekombinantnega interferona alfa- 2b pridobljenega iz E. coli s tehnikami rekombinantne DNA tehnologije
s For a full list of excipients, see section 6.1.
ist Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
uth Solution for injection Solution is clear and colourless.
Raztopina je bistra in brezbarvna.
ra 4.
sťo 4.
Therapeutic indications
4. 1 Terapevtske indikacije no Kronični hepatitis B:
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
in histološko dokazano aktivno vnetje in/ ali fibrozo jeter. up
Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated t
Viraferon je indiciran za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki imajo povečane vrednosti transaminaz brez dekompenzacije jeter in pozitivne izvide za serumsko HCV- RNA ali anti- HCV no
transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see uc
(glejte poglavje 4. 4).
The best way to use Viraferon in this indication is in combination with ribavirin. rod
Pri tej indikaciji je zdravilo Viraferon najbolje uporabljati v kombinaciji z ribavirinom. če
Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and lp
Zdravilo Viraferon je namenjeno uporabi v kombinirani terapiji z ribavirinom za zdravljenje otrok, starih on
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.
3 leta ali več, ki imajo predhodno nezdravljen kronični hepatitis C brez jetrne dekompenzacije in pozitiven izvid na serumsko 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
Odločitev za zdravljenje mora biti sprejeta za vsak primer posebej, ob upoštevanju morebitnih znakov napredovanja bolezni, npr. vnetja jeter in fibroze, pa tudi prognostičnih uk
fibrosis, as well as prognostic factors for response, HCV genotype and viral load.
dejavnikov odziva, genotipa HCV in virusne obremenitve.
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
Pri tem morate pretehtati pričakovano korist zdravljenja v primerjavi z izsledki o varnosti zdravila pri pediatričnih bolnikih v kliničnih preskušanjih (glejte poglavja 4. 4, 4. 8 in 5. 1). ks
4.2 Posology and method of administration
4. 2 Odmerjanje in način uporabe Lie
Me
Zdravljenje mora uvesti zdravnik z izkušnjami iz zdravljenja bolnikove bolezni.
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.
86 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.
82 At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens administered subcutaneously.
Zdravnika lahko po lastni presoji bolniku dovili, da si sam subkutano injicira vzdrževalni odmerek zdravila.
Chronic Hepatitis B:
ie Kronični hepatitis B:
The recommended dosage is in the range 5 to 10 million IU administered subcutaneously three times a week (every other day) for a period of 4 to 6 months.
ác trikrat na teden (vsak drugi dan) v času 4 do 6 mesecev.
The administered dose should be reduced by 50% in case of occurrence of haematological disorders (white
Če se pojavijo hematološke motnje (število levkocitov < 1. 500/ mm3, število granulocitov < 1. 000/ mm3,
ed blood cells < 1,500/ mm3, granulocytes < 1,000/ mm3, thrombocytes < 100,000/ mm3).
r ist število trombocitov < 100. 000/ mm3), odmerek zmanjšajte za 50%.
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.
eg Pri vseh bolnikih velja, da če po 3 do 4 mesecih zdravljenja ne ugotavljate nobenega izboljšanja serumske vrednosti HBV- DNA (ob največjem odmerku, ki ga bolnik še prenaša), morate terapijo z zdravilom Viraferon ukiniti.
uth Chronic Hepatitis C:
ur Kronični hepatitis C:
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.
Zdravilo Viraferon dajemo subkutano v odmerku 3 milijoni i. e. trikrat na teden (vsak drugi dan) za odrasle bolnike, ne glede na to, ali zdravilo uporabljate v monoterapiji ali v
ra Children 3 years of age or older and adolescents:
Otroci, stari 3 leta ali starejši in mladostniki:
Interferon alfa-2b 3 MIU/ m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening).
Za bolnike, ki tehtajo < 47 kg ali ne morejo lat
ge (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
pogoltniti kapsul, glejte SPC za peroralno raztopino. up
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC). lon Relapse patients (adults):
Bolniki z relapsom bolezni (odrasli):
Viraferon is given in combination with ribavirin. no
Viraferon se uporablja v kombinaciji z ribavirinom.
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
priporočamo, da te bolnike zdravite 6 mesecev z zdravilom Viraferon v kombinaciji z ribavirinom.
Naïve patients:
Bolniki, ki še niso bili zdravljeni s tem zdravilom: če
Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin. rod
Zdravilo Viraferon uporabljajte samostojno predvsem v primeru intolerance ali kontraindikacij za ribavirin. on
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
Na podlagi poročil iz kliničnih raziskav, v katerih so navedeni podatki za 12- mesečno zdravljenje, priporočamo, da te bolnike zdravite najmanj 6 mesecev z zdravilom Viraferon v kombinaciji z uk
Treatment should be continued for another 6-month period (i. e., a total of 12 months) in patients who exhibit na
ribavirinom.
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
Pri bolnikih z negativnim izvidom HCV- RNA po 6 mesecih, virusnim genotipom 1 (kar se določi na ks
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into dic
Lie
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- Me
Pri odločitvi o podaljšanju terapije na 12 mesecev upoštevajte tudi druge negativne prognostične dejavnike (starost > 40 let, moški spol, premostitvena fibroza).
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).
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).
Viraferon alone:
87 Viraferon v monoterapiji:
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.
ie Priporočamo, da bolnike zdravite z zdravilom Viraferon v monoterapiji najmanj 3 do 4 mesece, potem pa opravite preiskave na HCV- RNA.
Children and adolescents:
r Otroci in mladostniki:
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.
ist so ocenjevali pri otrocih in mladostnikih, ki jih predhodno še niso zdravili za hepatitis C.
Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
eg 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
Treatment
Virološki odziv je opredeljen kot odsotnost merljive vrednosti HCV- RNA v 12. tednu zdravljenja.
s should be discontinued in these patients.
Pri teh bolnikih je treba zdravljenje prekiniti.
ori Genotype 2/ 3:
ur Genotip 2 or 3: