FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of peginterferon alfa-2a and ribavirin concomitantly with azathioprin should be avoided.
Slovenian: Uporabi peginterferona alfa-2a in ribavirina sočasno z azatioprinom se je treba izogibati.
English: Superior efficacy of Pegasys compared to interferon alfa-2a was demonstrated also in terms of histological response, including patients with cirrhosis and/or HIV-HCV co-infection.
Slovenian: Večja učinkovitost zdravila Pegasys v primerjavi z interferonom alfa-2a se je pokazala tudi v smislu histološkega odziva, vključno pri bolnikih s cirozo in/ali sočasno okužbo s HIV in HCV.
English: In patients with compensated cirrhosis (e.g., Child-Pugh A), Pegasys has been shown to be effective and safe.
Slovenian: Jetrna okvara Pri bolnikih s kompenzirano cirozo (npr. stopnja Child-Pugh A) se je zdravilo Pegasys pokazalo kot učinkovito in varno zdravilo.
English: HCV genotype 2 and 3
Slovenian: HCV genotipa 2 in 3
English: If this occurs, therapy must be discontinued and appropriate medical therapy instituted immediately.
Slovenian: Če se pojavi, moramo zdravljenje prekiniti in takoj vpeljati ustrezno zdravljenje.
English: Negative
Slovenian: Negativen
English: If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Pegasys be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Slovenian: Če simptomi trajajo dalj časa, se poslabšajo ali če se ugotovi razmišljanje o samomoru, je priporočljivo, da zdravljenje z zdravilom Pegasys prekinemo, bolnika pa spremljamo in mu nudimo ustrezno psihiatrično pomoč, če je potrebno.
English: If the abnormality is reversed, ribavirin may be restarted at 600 milligrams daily, and further increased to 800 milligrams daily at the discretion of the treating physician.
Slovenian: Če se stanje popravi, lahko ponovno vpeljemo ribavirin v odmerku 600 miligramov na dan, nato pa odmerek povečujemo do 800 miligramov na dan po navodilu lečečega zdravnika.
English: Where dose adjustment is required for moderate to severe adverse reactions (clinical and/or laboratory) initial dose reduction to 135 micrograms is generally adequate for adult patients.
Slovenian: Kadar moramo prilagajati odmerke zaradi zmernih do hudih neželenih učinkov (klinični in/ali laboratorijski), običajno pri odraslih bolnikih zadošča začetno zmanjšanje odmerka na 135 mikrogramov.
English: Patients who have detectable virus at week 12 should stop therapy.
Slovenian: Bolniki, pri katerih lahko določimo virus v 12. tednu, naj zdravljenje prekinejo.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Slovenian: < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000).
English: The use of Pegasys had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Slovenian: Uporaba zdravila Pegasys ni imela opaznega negativnega vpliva na kontrolo HIV viremije med zdravljenjem ali v obdobju sledenja bolnikov.
English: 180 micrograms
Slovenian: 180 mikrogramov
English: Overall treatment for 16 weeks resulted in lower sustained viral response (65%) than treatment for 24 weeks (76%) (p < 0.0001).
Slovenian: Celokupno je bil trajni virološki odziv pri 16-tedenskem zdravljenju manjši (65 %) kot pri 24-tedenskem zdravljenju (76 %) (p < 0,0001).
English: For information on predictive values for ontreatment response, see section 5.1.
Slovenian: Za informacije glede napovednih vrednosti za odziv med zdravljenjem glejte poglavje 5.1.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: The response rate of HBeAg seroconversion was lower in patients with HBV genotype D, also in patients with no to minimal increase in ALT level at baseline (see Table 23).
Slovenian: Delež odgovora HBeAg serokonverzije je bil nižji pri bolnikih s HBV genotipa D, pa tudi pri bolnikih brez zvišane vrednosti ali minimalno zvišano vrednostjo ALT v izhodišču (glejte preglednico 23).
English: Pegasys is used alone only if you cannot take ribavirin for any reason.
Slovenian: Zdravilo Pegasys boste jemali samostojno le v primeru, da ribavirina iz katerega koli razloga ne smete jemati.
English: NOTE: The cap contains a loose-fitting metal tube.
Slovenian: OPOMBA: V pokrovčku je ohlapno pritrjena kovinska cevka.
English: For patients with ANC < 500 cells/mm3 treatment should be suspended until ANC values return to > 1000 cells/mm3.
Slovenian: Pri bolnikih z ANC < 500 celic/mm3 moramo zdravljenje prekiniti, dokler se vrednosti ANC ne vrnejo na > 1000 celic/mm3.
English: The safety profiles in both ribavirin groups were consistent with the known safety profile of Pegasys plus ribavirin combination treatment and not indicative of any relevant differences, with the exception of a slight increase in anaemia in the high dose ribavirin arm.
Slovenian: Varnostna profila sta se v obeh skupinah z ribavirinom ujemala z znanim varnostnim profilom kombiniranega zdravljenja z zdravilom Pegasys in ribavirinom in nista nakazovala relevantnih razlik, z izjemo rahlega povečanja pojava anemije v skupini z večjim odmerkom ribavirina.
English: If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued.
Slovenian: Če se srčnožilni status bolniku poslabša, zdravljenje prekinemo ali ukinemo.
English: Decreases in haemoglobin, neutrophils, platelets or increased ALT may require dose reduction or permanent discontinuation from treatment (see section 4.2).
Slovenian: Znižanja hemoglobina, nevtrofilcev, trombocitov ali zvišane vrednosti ALT lahko zahtevajo zmanjšanje odmerka ali trajno ukinitev zdravljenja (glejte poglavje 4.2).
English: ● attempt to open or dismantle the pre-filled pen.
Slovenian: • poskušajte odpreti ali razstaviti napolnjenega injekcijskega peresnika;
English: Undesirable effects reported in clinical studies are grouped according to frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Slovenian: Neželeni učinki, o katerih so poročali v kliničnih preskušanjih, so navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000).
English: The ultimate clinical impact of a shortened initial treatment of 16 weeks instead of 24 weeks is unknown, taking into account the need for re-treating non-responding and relapsing patients.
Slovenian: Končni klinični učinek skrajšanja začetnega zdravljenja s 24 na 16 tednov, ki upošteva potrebo po ponovnem zdravljenju bolnikov, ki se na zdravljenje niso odzvali ali se je pri njih bolezen ponovila, ni znan.
English: The usual dose of Pegasys is based on your child's height and weight.
Slovenian: Običajni odmerek zdravila Pegasys je osnovan na podlagi telesne mase in višine vašega otroka.
English: Pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1).
Slovenian: Zdravilo Pegasys je v kombinaciji z drugimi zdravili indicirano za zdravljenje kroničnega hepatitisa C (CHC) pri bolnikih s kompenzirano jetrno boleznijo (glejte poglavja 4.2, 4.4 in 5.1).
English: 250 to < 500 cells/mm3: interrupt dosing until ≥ 1000 cells/mm3, then resume dose with 2 level adjustments and monitor.
Slovenian: 250 do < 500 celic/mm3: prekinitev odmerjanja, dokler ni doseženo ≥ 1000 celic/mm3, nato nadaljevanje z zmanjšanim odmerkom 2. stopnje in spremljanje.
English: For children and adolescents aged 3 to 17 years with CHB and having a BSA greater than 0.54 m2 and for children and adolescents aged 5 to 17 years with CHC and having a BSA greater than 0.71 m2, the recommended doses for Pegasys are provided in Table 4.
Slovenian: Za otroke in mladostnike s CHB, stare od 3 do 17 let in telesno površino, večjo od 0,54 m2, ter za otroke in mladostnike s CHC, stare od 5 do 17 let in telesno površino, večjo od 0,71 m2, so priporočeni odmerki za zdravilo Pegasys navedeni v preglednici 4.
English: Patients infected with viral genotypes 2 or 3 should receive 24 weeks of treatment, while patients infected with any other genotype should receive 48 weeks of therapy.
Slovenian: Bolniki, okuženi z virusnim genotipom 2 ali 3, naj bi prejeli 24 tedenov zdravljenja, bolniki, okuženi z drugimi genotipi, pa 48 tednov zdravljenja.
English: Reduce ribavirin to 600 mg
Slovenian: Zmanjšamo odmerek ribavirina na 600 mg
English: When Pegasys is used alone in hepatitis B or C patients, some of these effects are less likely to occur.
Slovenian: Pri samostojni uporabi zdravila Pegasys pri bolnikih s hepatitisom B ali C je verjetnost, da se pojavijo nekateri od teh učinkov, manjša.
English: *Results indicate undetectable HCV-RNA defined as HCV RNA less than 50 IU/ml at 24 weeks post-treatment using the AMPLICOR HCV test v2.
Slovenian: *Rezultati glede na nemerljive koncentracije HCV-RNA, opredeljene kot koncentracije HCV RNA manjše od 50 i.e./ml, 24 tednov po zdravljenju, z uporabo testa AMPLICOR HCV v2.
English: The Pegasys pre-filled pen is intended to be used in a home-setting by patients who have been properly instructed.
Slovenian: Pegasys napolnjeni injekcijski peresnik je namenjen domači uporabi s strani bolnikov, ki so jih o tem primerno podučili.
English: ALT <1xULN >=1xULN<1.5xULN >=1.5xULN<2xULN >=2xULN<5xULN >=5xULN<10xULN >=10xULN
Slovenian: <1,5 x ULN >=1,5 x ULN<2 x ULN >=2 x ULN<5 x ULN
English: Psychiatric and Central Nervous System (CNS): Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Pegasys therapy, and even after treatment discontinuation mainly during the 6-month follow-up period.
Slovenian: Psihiatrične motnje in bolezni centralnega živčnega sistema (CŽS): Hudi neželeni učinki centralnega živčnega sistema, posebno depresija, razmišljanje o samomoru in poskus samomora, so bili pri nekaterih bolnikih, ki so se zdravili z zdravilom Pegasys, opaženi med zdravljenjem in celo po končanem zdravljenju, večinoma v obdobju 6-mesečnega sledenja.
English: Once you have started Pegasys treatment, talk to your doctor, nurse or pharmacist:
Slovenian: Po začetku zdravljenja z zdravilom Pegasys se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro:
English: Patients with existence of, or history of severe psychiatric conditions: If treatment with Pegasys is judged necessary in patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Slovenian: Bolniki s predhodnim ali obstoječim hudim duševnim stanjem: Če je zdravljenje z zdravilom Pegasys pri bolnikih s predhodnim ali obstoječim hudim duševnim stanjem potrebno, ga lahko pričnemo šele potem, ko zagotovimo ustrezno, posamezniku prilagojeno, diagnostično in terapevtsko obravnavo psihičnega stanja.
English: 1) Visually check the pre-filled pen
Slovenian: 1) Vizualno preglejte napolnjeni injekcijski peresnik
English: ≥2 log10 decline
Slovenian: ≥2 log10
English: For paediatric patients, based on toxicities, up to three levels of dose modification can be made before dose interruption or discontinuation is considered (see Table 5).
Slovenian: Pri pediatričnih bolnikih lahko glede na toksičnosti odmerek prilagodimo v do treh stopnjah, preden z odmerjanjem prekinemo ali ga ukinemo (glejte preglednico 5).
English: The absolute bioavailability of Pegasys is 84% and is similar to that seen with interferon alfa-2a.
Slovenian: Absolutna biološka uporabnost zdravila Pegasys je 84 % in je podobna kot pri interferonu alfa-2a.
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Slovenian: Število celic CD4+ se je vrnilo na prvotno raven po zmanjšanju odmerka ali prekinitvi terapije.
English: Patients predisposed to the development of autoimmune disorders may be at increased risk.
Slovenian: Možno je, da so bolniki, podvrženi razvoju avtoimunske bolezni, izpostavljeni večjemu tveganju.
English: During treatment, co-infected patients should be closely monitored for signs and symptoms of hepatic decompensation (including ascites, encephalopathy, variceal bleeding, impaired hepatic synthetic function; e.g., Child-Pugh score of 7 or greater).
Slovenian: Med zdravljenjem je treba bolnike, ki so okuženi z obema virusoma, skrbno spremljati glede znakov in simptomov jetrne dekompenzacije (vključno z ascitesom, encefalopatijo, krvavitvijo iz varic, okvarjeno jetrno sintezno funkcijo; npr. število točk po Child-Pughovi lestvici 7 ali več).
English: Press the pre-filled pen firmly against the skin until the needle-shield is completely pushed into the pen.
Slovenian: Trdno pritisnite napolnjeni injekcijski peresnik na kožo, dokler ni ščitnik za iglo popolnoma porinjen v peresnik.
English: Modified Assessment
Slovenian: Ocena sprememb
English: In paediatric patients, ribavirin treatment-associated toxicities, such as treatment-emergent anaemia, will be managed by reduction of the full dose.
Slovenian: Pri pediatričnih bolnikih so toksičnosti, povezane z zdravljenjem z ribavirinom, kot je anemija, ki se pojavi med zdravljenjem, obvladane z zmanjšanjem celotnega odmerka.
English: If patients infected with virus genotype 1, not responding to prior treatment with peginterferon and ribavirin are considered for treatment, the recommended total duration of therapy is 72 weeks (see section 5.1).
Slovenian: Če nameravamo zdraviti bolnike z genotipom 1, ki se na prejšnje zdravljenje s peginterferonom in ribavirinom niso odzvali, je priporočeno skupno trajanje zdravljenja 72 tednov (glejte poglavje 5.1).
English: Duration of therapy when Pegasys is used in combination with other medicinal products
Slovenian: Trajanje zdravljenja, če zdravilo Pegasys uporabljamo v kombinaciji z drugimi zdravili
English: In clinical trials, Pegasys treatment was associated with decreases in both total white blood cell (WBC) count and ANC, usually starting within the first 2 weeks of treatment (see section 4.8).
Slovenian: Med kliničnimi preskušanji je bilo zdravljenje z zdravilom Pegasys povezano z zmanjšanjem celokupnega števila belih krvnih celic in zmanjšanjem ANC, ki se je običajno pojavilo v prvih 2 tednih zdravljenja (glejte poglavje 4.8).
English: Visually examine the pre-filled pen, as well as the medicine through the viewing window.
Slovenian: Vizualno preglejte peresnik in zdravilo skozi okence.
English: Laboratory values for HIV-HCV co-infected patients Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HIV-HCV patients, the majority could be managed by dose modification and the use of growth factors and infrequently required premature discontinuation of treatment.
Slovenian: Laboratorijske vrednosti za bolnike, sočasno okužene s HIV in HCV Čeprav so se hematološke toksičnosti nevtropenija, trombocitopenija in anemija pri bolnikih, okuženih s HIV in HCV, pojavile pogosteje, so večino lahko uravnali s spremembo odmerka in uporabo rastnih dejavnikov; predčasna prekinitev zdravljenja je bila potrebna zelo redko.
English: In clinical trials with Pegasys in HBV, marked transaminase flares have been accompanied by mild changes in other measures of hepatic function and without evidence of hepatic decompensation.
Slovenian: V kliničnih preskušanjih zdravila Pegasys pri bolnikih s HBV so znatna nihanja transaminaze spremljale blage spremembe drugih meritev jetrne funkcije brez dokazov jetrne dekompenzacije.
English: You may see a small drop(s) or loss of some liquid coming out of the pen.
Slovenian: Opazite lahko eno ali več majhnih kapljic ali iztek manjše količine tekočine iz peresnika.
English: The decrease in ANC was reversible upon dose reduction or cessation of therapy (see section 4.2), reached normal values by 8 weeks in the majority of patients and returned to baseline in all patients after about 16 weeks.
Slovenian: Zmanjšanje absolutnega števila nevtrofilcev je bilo po zmanjšanju odmerka ali prekinitvi zdravljenja reverzibilno (glejte poglavje 4.2), v 8 tednih po prekinitvi zdravljenja je pri večini bolnikov doseglo normalne vrednosti, po približno 16 tednih pa se je na izhodiščno vrednost vrnilo pri vseh bolnikih.
English: Please refer to the ribavirin SmPC.
Slovenian: Prosimo, glejte SmPC za ribavirin.
English: For HBV genotype A and D, subgroup size was insufficient to be analyzed.
Slovenian: Za virus hepatitisa B genotipov A in D je bila velikost podskupine za analizo nezadostna.
English: The peak to trough ratio after 48 weeks of treatment is about 1.5 to 2.
Slovenian: Po 48 tednih zdravljenja je razmerje med C∞max in C∞min približno 1,5 do 2.
English: After intravenous administration, the terminal half-life of peginterferon alfa2a in healthy subjects is approximately 60 to 80 hours compared to values of 3-4 hours for standard interferon.
Slovenian: Po intravenskem dajanju je končna razpolovna doba peginterferona alfa-2a pri zdravih ljudeh približno 60 do 80 ur v primerjavi s 3 do 4 urami pri standardnem interferonu.
English: Efficacy response in group C to Pegasys treatment was in line with that seen in group A. For paediatric patients, efficacy has not been established in HBV genotypes other than genotypes A-D.
Slovenian: Učinkovitost odziva na zdravljenje zdravilom Pegasys v skupini C je bila skladna s tistim v skupini A. Pri pediatričnih bolnikih ni dokazane učinkovitosti za genotipe HBV,
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Slovenian: Če se to zgodi tudi vam, si takoj zatem temeljito izperite usta.
English: A clinical trial investigating the combination of telbivudine 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration for the treatment of HBV, indicates that the combination is associated with an increased risk for developing peripheral neuropathy.
Slovenian: Klinično preskušanje, s katerim so preiskovali kombinacijo telbivudina 600 mg na dan ter pegiliranega interferona alfa-2a 180 mikrogramov enkrat na teden subkutano pri zdravljenju HBV, je pokazalo, da je kombinacija povezana s povečanim tveganjem za razvoj periferne nevropatije.
English: Patients in group B had the choice to switch to treatment with Pegasys after Week 48 of the principal observation period.
Slovenian: Bolniki iz skupine B so imeli na izbiro, da po 48. tednu glavnega obdobja opazovanja preidejo na zdravljenje z zdravilom Pegasys.
English: Appropriate training is recommended for non-healthcare professionals administering this medicinal product.
Slovenian: Če to zdravilo dajejo ljudje, ki niso zdravstveni strokovnjaki, je zanje priporočljivo ustrezno izobraževanje.
English: During treatment your doctor will take blood samples regularly to check for changes in your white blood cells (cells that fight infection), red blood cells (cells that carry oxygen), platelets (blood clotting cells), liver function, glucose (blood sugar levels) or changes in other laboratory values.
Slovenian: Med zdravljenjem vam bo zdravnik redno pregledoval kri, da bo lahko spremljal spremembe belih krvnih celic (celice, ki se borijo proti infekcijam), rdečih krvnih celic (celice, ki prenašajo kisik), krvnih ploščic (celice za strjevanje krvi), delovanje jeter, spremembe ravni glukoze (sladkorja v krvi)
English: Once the cap is removed, the pre-filled pen should be used immediately.
Slovenian: Potem ko pokrovček odstranite, je treba napolnjeni injekcijski peresnik uporabiti nemudoma.
English: For children and adolescents 23 kg or greater, a dosing schedule using 200 mg ribavirin tablets is provided in Table 7.
Slovenian: Za otroke in mladostnike, ki imajo 23 kg ali več, je v preglednici 7 podana shema odmerjanja za uporabo 200-mg tablet ribavirina.
English: In humans, the systemic clearance of peginterferon alfa-2a is about 100-fold lower than that of the native interferon alfa-2a.
Slovenian: Pri ljudeh je sistemski očistek peginterferona alfa-2a približno 100-krat nižji od očistka naravnega interferona alfa-2a.
English: Pegasys contains benzyl alcohol
Slovenian: Zdravilo Pegasys vsebuje benzilalkohol
English: Co-administration of ribavirin and didanosine is not recommended.
Slovenian: Sočasno jemanje ribavirina in didanozina ni priporočljivo.
English: Driving and using machines Do not drive or use machines if you feel drowsy, tired, or confused while taking Pegasys.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne upravljajte vozil in strojev, če se med jemanjem zdravila Pegasys počutite omotični, utrujeni ali zmedeni.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Subcutaneous use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo za subkutano uporabo
English: Treatment with interferon alfa-2a resulted in a statistically significant increase in abortifacient activity in rhesus monkeys.
Slovenian: Zdravljenje z interferonom alfa-2a je pri opicah rhesus povzročilo statistično značilno povečanje splavov.
English: 1 Cochran-Mantel-Haenszel test, stratified by genotype (A vs. non-A) and baseline ALT (< 5 × ULN and >= 5 × ULN) 2 Fisher's Exact Test
Slovenian: Cochran-Mantel-Haenszelov test, stratificiran glede na genotip (A proti ne-A) in izhodiščno ALT (< 5 × ULN in >= 5 × ULN) 2 Fisherjev natančni test
English: Body Surface Area (BSA) range (m2)
Slovenian: Razpon telesne površine (TP) (m2)
English: Österreich Roche Austria GmbH Tel: +43 (0) 1 27739
Slovenian: Roche Austria GmbH Tel: +43 (0) 1 27739
English: When Pegasys is used in combination with ribavirin, both male and female patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur, as ribavirin can be very damaging to an unborn baby:
Slovenian: Pri uporabi zdravila Pegasys v kombinaciji z ribavirinom morata biti oba, moški in ženska, izredno previdna zaradi možnosti zanositve pri spolnih odnosih, ker je lahko ribavirin zelo škodljiv za nerojenega otroka.
English: However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1).
Slovenian: Vendar pa je skupna dolžina zdravljenja 24 tednov lahko povezana z večjim tveganjem ponovitve bolezni kot pri skupni dolžini zdravljenja 48 tednov (glejte poglavje 5.1).
English: Patients missing HCV RNA results at week 12 have been excluded from the analysis.
Slovenian: Bolniki, za katere ni bilo podatka o koncentraciji HCV RNA v 12. tednu, so bili izključeni iz analize.
English: ● manipulate the needle-shield before, during or after use, as this is a safety device.
Slovenian: • poskušajte ponovno uporabiti napolnjenega injekcijskega peresnika; • dotikajte se ščitnika za iglo pred, med ali po uporabi peresnika, ker je to varnostni pripomoček.
English: Early virological response by week 12, defined as a 2 log viral load decrease or undetectable levels of HCV RNA has been shown to be predictive for sustained response (see Tables 2 and 13).
Slovenian: Zgodnji virološki odziv do 12. tedna, opredeljen kot zmanjšanje virusnega bremena za dve logaritemski enoti ali kot nemerljiva koncentracija HCV RNA, se je pokazal kot napovedovalen za trajni odziv (glejte preglednici 2 in 13).
English: Exposure to Pegasys was decreased in studies following administration of Pegasys in the arm (see section 5.2).
Slovenian: Izpostavljenost zdravilu Pegasys je bila v študijah zmanjšana, če so ga dali v roko (glejte poglavje 5.2).
English: It is also used to treat chronic hepatitis B in children and adolescents aged 3 years and older and chronic hepatitis C in children and adolescents aged 5 years and older, who have not been treated before.
Slovenian: Prav tako se uporablja za zdravljenje kroničnega hepatitisa B pri otrocih in mladostnikih, starih 3 leta in več, ali kroničnega hepatitisa C pri otrocih in mladostnikih, starih 5 let in več, ki predhodno še niso bili zdravljeni.