FrancophonIA/ELRC3.0 huggingface dataset:
English: Common Uncommon Rare
Slovenian: Pogostnost neznana
English: There are no or limited amount of data from the use of peginterferon alfa-2a in pregnant women.
Slovenian: Podatkov o uporabi peginterferona alfa-2a pri nosečnicah ni oziroma so omejeni.
English: Genotype 2 or 3 without RVR**
Slovenian: Genotip 2 ali 3, brez hitrega virološkega odziva**
English: Withhold ribavirin
Slovenian: Odmerek ribavirina
English: High viral load = > 800,000 IU/ml, low viral load = ≤ 800,000 IU/ml.
Slovenian: Visoko virusno breme = > 800.000 i.e./ml, nizko virusno breme = ≤ 800.000 i.e./ml.
English: Pegasys given alone or in combination with ribavirin is usually given at a dose of 180 micrograms once a week.
Slovenian: Zdravilo Pegasys kot samostojno zdravilo ali v kombinaciji z ribavirinom običajno dajemo v odmerku 180 mikrogramov enkrat na teden.
English: Heart and blood vessel disorders: High blood pressure Breathing disorders: Wheezing
Slovenian: Srčne in žilne bolezni: visok krvni tlak.
English: • Pegasys 180 mcg/week for 72 weeks
Slovenian: • zdravilo Pegasys 180 mikrogramov/teden 72 tednov,
English: What you need to know before you use Pegasys
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Pegasys Ne uporabljajte zdravila Pegasys, če:
English: ● Place the needle firmly on the tip of the syringe (4).
Slovenian: ● Iglo trdno namestite na vrh brizge (4).
English: As with other alfa interferons, prolongation of the menstrual cycle was observed following administration of peginterferon alfa-2a to female monkeys.
Slovenian: Kot pri drugih interferonih alfa so pri samicah opic pri jemanju peginterferona alfa-2a opazili podaljšanje menstrualnega cikla.
English: • Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 60 weeks
Slovenian: • zdravilo Pegasys 360 mikrogramov/teden 12 tednov, čemur je sledilo 180 mikrogramov/teden naslednjih 60 tednov,
English: Psychiatric and nervous system disorders: Mood /emotion changes, aggression, nervousness, decreased sexual desire, poor memory, fainting, decreased muscle strength, migraine, numbness, tingling, burning sensation, tremor, changes in the sense of taste, nightmares, sleepiness Eye disorders: Blurry vision, eye pain, eye inflammation and dry eyes Ear disorders: ear pain
Slovenian: Psihiatrične motnje in bolezni živčevja: spremembe razpoloženja/občutkov, agresivnost, živčnost, zmanjšano spolno poželenje, slab spomin, omedlevica, zmanjšana mišična moč, migrena, otopelost, mravljinci, pekoč občutek, tremor, spremembe občutka okusa, nočne more, zaspanost.
English: For patients <75 kg and ≥75 kg, 1000 mg daily and 1200 mg daily of ribavirin, respectively, and regardless of genotype, should be administered.
Slovenian: Bolnikom, lažjim od 75 kg, dajemo 1000 mg dnevni odmerek, bolnikom s 75 kg ali več pa 1200 mg dnevni odmerek ribavirina, ne glede na genotip.
English: Group A (Pegasys treatment) (N=101)
Slovenian: Skupina A (zdravljenje z zdravilom Pegasys)
English: The following may be considered as baseline values for initiation of treatment: - Platelet count ≥ 90,000 cells/mm3 - ANC ≥ 1500 cells/mm3
Slovenian: - število trombocitov ≥ 90.000 celic/mm3, - ANC ≥ 1500 celic/mm3,
English: 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 Pegasys and ribavirin.
Slovenian: Razen tega lahko imajo suha usta pri dolgotrajnem kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom škodljiv vpliv na zobe in mukozne membrane v ustih.
English: Pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis have been reported during therapy with Pegasys.
Slovenian: Med zdravljenjem z zdravilom Pegasys so poročali o pulmonalnih simptomih, kot so dispneja, pljučni infiltrati, pljučnica in pnevmonitis.
English: Overall, the safety profile for Pegasys in combination with ribavirin in prior non-responder patients was similar to that in naïve patients.
Slovenian: Celokupno je varnostni profil zdravljenja s kombinacijo zdravila Pegasys in ribavirina pri bolnikih, ki se na prejšnje zdravljenje niso odzvali, podoben kot pri bolnikih, ki se še niso zdravili.
English: Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 135 micrograms/0.5 ml
Slovenian: Skupno pakiranje: 12 (2 pakiranji po 6) napolnjenih injekcijskih brizg + 12 injekcijskih igel 135 mikrogramov/0,5 ml
English: Plasma exposure of ribavirin did not appear to be affected by concomitant administration of nucleoside reverse transcriptase inhibitors (NRTIs).
Slovenian: Sočasno jemanje nukleozidnih zaviralcev reverzne transkriptaze (NRTIs) na plazemsko izpostavljenost ribavirinu ni vplivalo.
English: Pegasys 180 mcg Ribavirin 1000/1200 mg 48 weeks
Slovenian: Pegasys 180 µg in ribavirin 1000/1200 mg 48 tednov
English: Administration of Pegasys 180 micrograms once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that Pegasys has no effect on in vivo metabolic activity of cytochrome P450 3A4, 2C9, 2C19 and 2D6 isozymes.
Slovenian: Dajanje 180 mikrogramov zdravila Pegasys enkrat na teden 4 tedne pri zdravih moških prostovoljcih ni vplivalo na farmakokinetični profil mefenitoina, dapsona, debrisokina in tolbutamida.
English: Ribavirin had no significant effect on the initial viral kinetics over the first 4 to 6 weeks in patients treated with the combination of ribavirin and pegylated interferon alfa-2a or interferon alfa.
Slovenian: Ribavirin pri bolnikih, ki prejemajo kombinacijo ribavirina in pegiliranega interferona alfa-2a ali interferona alfa, na začetno kinetiko virusa med prvimi 4 do 6 tedni značilno ne vpliva.
English: Patients infected with HCV genotype 1 who have detectable HCV RNA at week 4 regardless of pre-treatment viral load should receive 48 weeks of therapy.
Slovenian: Bolnike, okužene s HCV genotipom 1, ki imajo merljivo koncentracijo HCV RNA v 4. tednu, zdravimo ne glede na virusno breme pred začetkom zdravljenja 48 tednov.
English: Myocardial infarction, congestive heart failure, cardiomyopat hy, angina, arrhythmia, atrial fibrillation, pericarditis, supraventricu lar tachycardia
Slovenian: kardiomiopatija, angina pektoris, aritmija, fibrilacija atrijev, perikarditis, supraventrikularna tahikardija
English: When used in combination with ribavirin, Pegasys did not cause any effects in monkeys not previously seen with either active substance alone.
Slovenian: Zdravilo Pegasys in ribavirin Ko so zdravilo Pegasys uporabili v kombinaciji z ribavirinom, zdravilo Pegasys pri opicah ni povzročilo nobenih dodatnih neželenih učinkov, ki jih prej ne bi videli pri posameznih učinkovinah.
English: Co-infected patients with advanced cirrhosis receiving HAART may also be at increased risk of hepatic decompensation and possibly death if treated with ribavirin in combination with interferons, including Pegasys.
Slovenian: Pri sočasno okuženih bolnikih z napredovalo cirozo, ki prejemajo HAART in se zdravijo z ribavirinom v kombinaciji z interferoni, vključno z zdravilom Pegasys, je tveganje za jetrno dekompenzacijo in možno smrt večje.
English: The response rate was lower in patients with no to minimal increase in ALT level at baseline (see Section 5.1).
Slovenian: Pri bolnikih, ki niso imeli zvišanih ravni ALT v izhodišču ali pa so bile te ravni zvišane minimalno, je bila stopnja odziva nižja (glejte poglavje 5.1).
English: 3 MIU
Slovenian: 3 mio i.e.
English: In a pharmacokinetic study of 24 HCV patients concomitantly receiving methadone maintenance therapy (median dose 95 mg; range 30 mg to 150 mg), treatment with Pegasys 180 micrograms sc once weekly for 4 weeks was associated with mean methadone levels that were 10% to 15% higher than at baseline.
Slovenian: V farmakokinetični študiji, v kateri je 24 bolnikov s HCV sočasno prejemalo vzdrževalno zdravljenje z metadonom (mediana odmerka 95 mg, razpon od 30 mg do 150 mg), je bilo zdravljenje z zdravilom Pegasys v odmerku 180 mikrogramov, danim subkutano enkrat na teden 4 tedne, povezano z 10 do 15
English: In the HALT-C study, patients with CHC and advanced fibrosis or cirrhosis who were non-responders to previous treatment with interferon alfa or pegylated interferon alfa monotherapy or in combination therapy with ribavirin were treated with Pegasys 180 mcg/week and ribavirin 1000/1200 mg daily.
Slovenian: V študiji HALT-C so bolnike s CHC in napredovalo fibrozo ali cirozo, ki se niso odzvali na prejšnje samostojno zdravljenje z interferonom alfa ali pegiliranim interferonom alfa oziroma zdravljenje v kombinaciji z ribavirinom, zdravili z zdravilom Pegasys 180 mikrogramov/teden in ribavirinom 1000/1200 mg na dan. Bolniki, pri katerih je bila po 20 tednih zdravljenja koncentracija HCV RNA nemerljiva, so nadaljevali z zdravljenjem s kombinacijo zdravila Pegasys in ribavirina.
English: In case of intolerance to ribavirin, Pegasys monotherapy should be continued.
Slovenian: Če bolnik ribavirina ne prenaša, moramo nadaljevati s samostojnim zdravljenjem z zdravilom Pegasys.
English: Predictability of response and non-response with Pegasys and ribavirin dual therapy - treatmentnaïve patients
Slovenian: Napoved odzivnosti in neodzivnosti pri dvojnem zdravljenju z zdravilom Pegasys in ribavirinom - že zdravljeni bolniki
English: ● The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic acid and water for injections.
Slovenian: • Pomožne snovi so: natrijev klorid, polisorbat 80, benzilalkohol, natrijev acetat, ocetna kislina in voda za injekcije.
English: HBV DNA response *
Slovenian: HBV DNA
English: Ischaemic colitis, tongue pigmentation
Slovenian: pankreatitis ishemični kolitis, pigmentacija jezika
English: Treatment with Pegasys should be discontinued immediately in patients with hepatic decompensation.
Slovenian: Pri bolnikih z jetrno dekompenzacijo je treba zdravljenje z zdravilom Pegasys takoj prekiniti.
English: Treatment should normally not be initiated if ALT is >10x ULN .
Slovenian: Zdravljenja normalno ne smemo začeti, če so vrednosti ALT
English: P=0.04 P=0.0002
Slovenian: p = 0,0002
English: Pegasys is presented as a solution for injection in a vial (1 ml).
Slovenian: Zdravilo Pegasys je na voljo v obliki raztopine za injiciranje v viali (1,0 ml).
English: Paediatric patients treated with Pegasys plus ribavirin combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline.
Slovenian: Pri pediatričnih bolnikih, ki so prejemali kombinirano zdravljenje z zdravilom Pegasys in ribavirinom, so po 48 tednih zdravljenja opazili zastoj v pridobivanju telesne mase in višine v primerjavi z izhodiščno vrednostjo.
English: For HCV monoinfected patients and HIV-HCV co-infected patients, for treatment regimens, duration of therapy and study outcome see Tables 13, 14, 15 and Table 21, respectively.
Slovenian: Sheme zdravljenja, trajanje zdravljenja in ugotovitve študij za bolnike, ki so okuženi le s HCV, in za bolnike, ki so sočasno okuženi s HIV in HCV, najdete v preglednicah 13, 14, 15 in 21.
English: Interferon alfa-2b 3 MIU
Slovenian: Interferon alfa-2b
English: ● use if pre-filled pen appears to be damaged.
Slovenian: • uporabljajte napolnjenega injekcijskega peresnika, če se vam zdi poškodovan;
English: Based on the population pharmacokinetic model, the mean exposure (AUC) during the dosing interval for each BSA category was comparable with that observed in adults receiving 180 mcg fixed dosing.
Slovenian: (AUC) med intervali odmerjanja za vsako skupino telesne površine primerljiva s tisto pri odraslih, ki so prejemali 180-µg odmerek zdravila.
English: Thrombocytopenia Platelet 25,000 to <50,000 cells/mm3: 2 level adjustment.
Slovenian: Trombocitopenija Trombociti 25.000 do< 50.000 celic/mm3: zmanjšanje odmerka 2. stopnje.
English: Depression*, anxiety, insomnia*
Slovenian: Psihiatrične motnje depresija*, anksioznost,
English: ● Remove the rubber cap from the syringe (3).
Slovenian: ● Z injekcijske brizge odstranite gumijasti pokrovček (3).
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Slovenian: Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Nemčija
English: Peginterferon alfa-2a
Slovenian: Interferon alfa-2a
English: Use of peginterferon as long term maintenance monotherapy (unapproved use) In a randomised, controlled US study (HALT-C) of HCV non-responder patients with varied degrees of fibrosis where 3.5 years of treatment with 90 micrograms/week of Pegasys monotherapy was studied, no significant reductions were observed in the rate of fibrosis progression or related clinical events.
Slovenian: Samostojna uporaba peginterferona za dolgotrajno vzdrževalno zdravljenje (neodobrena uporaba) V randomizirani, kontrolirani študiji (HALT-C), ki je potekala v ZDA, so bolniki s HCV in različnimi stopnjami fibroze, ki se na zdravljenje niso odzivali, 3,5 let prejemali 90 mikrogramov zdravila Pegasys na teden kot monoterapijo.
English: Overall Low viral load High viral load Genotype 1/4 Low viral load High viral load Genotype 2/3 Low viral load High viral load Cirrhosis Status Cirrhosis Noncirrhosis Best Response during Previous Treatment ≥2log10 decline in HCV RNA <2log10 decline in HCV RNA Missing best previous response
Slovenian: Brez ciroze Najboljši odziv med prejšnjim zdravljenjem ≥ 2 log10 znižanje HCV RNA < 2 log10 znižanje HCV RNA Brez podatka o prejšnjem najboljšem odzivu
English: Table 10: Adverse reactions reported among paediatric patients infected with HCV and assigned to Pegasys plus ribavirin in study NV17424
Slovenian: Preglednica 10: Neželeni učinki, poročani pri pediatričnih bolnikih, ki so bili okuženi z virusom HCV in so jim dodelili kombinaciji zdravila Pegasys in ribavirina v študiji
English: In CHC clinical trials with adult patients, isolated increases in ALT (≥ 10x upper limit of normal [ULN], or ≥ 2x BL for patients with a BL ALT ≥ 10x ULN) which resolved without dose-modification were observed in 8 of 451 patients treated with combination therapy.
Slovenian: Med kliničnimi preskušanji CHC pri odraslih bolnikih, so pri 8 od 451 bolnikov, ki so prejemali kombinirano zdravljenje, opazili posamezne primere zvišanja ALT (≥ 10-kratna zgornja referenčna vrednost (ULN - Upper Limit of Normal) ali ≥ 2-kratna BL pri bolnikih z BL ALT ≥ 10-kratna ULN),
English: The reversibility of growth inhibition is uncertain.
Slovenian: Ne moremo zagotovo reči, da je zastoj rasti reverzibilen.
English: The virological responses of HCV monoinfected patients treated with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 14 and Table 15, respectively.
Slovenian: Virološki odzivi bolnikov, okuženih le s HCV, ki so se zdravili z zdravilom Pegasys v kombinaciji z ribavirinom, so v odvisnosti od genotipa in virusnega bremena pred začetkom zdravljenja ter v odvisnosti od genotipa, virusnega bremena pred začetkom zdravljenja in hitrega virološkega odziva v 4. tednu, prikazani v preglednicah 14 in 15.
English: It is recommended that Pegasys pre-filled syringes be used for paediatric patients.
Slovenian: Za pediatrične bolnike je priporočljiva uporaba zdravila Pegasys v obliki napolnjenih injekcijskih brizg.
English: LVL = ≤ 800,000 IU/ml; HVL = > 800,000 IU/ml (a) It is presently not clear whether a higher dose of ribavirin (e.g.1000/1200 mg/day based on body weight) results in higher SVR rates than does the 800 mg/day, when treatment is shortened to 16 weeks.
Slovenian: Hiter virološki odziv = nemerljiva koncentracija HCV RNA v 4. tednu Za zdaj še ni jasno, če večji odmerek ribavirina (npr. 1000/1200 mg na dan glede na telesno maso) povzroči višji delež trajnega virološkega odziva kot odmerek 800 mg na dan, kadar je zdravljenje skrajšano na 16 tednov.
English: Contact your doctor or pharmacist if you need any help determining how to manage a missed dose of Pegasys.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če potrebujete pomoč pri določanju dneva naslednjega odmerka.
English: Neoplasms benign and malignant disorders: Liver tumour Immune system disorders: Sarcoidosis (areas of inflamed tissue occurring throughout the body), inflammation of the thyroid
Slovenian: Bolezni imunskega sistema: sarkoidoza (področja vnetega kožnega tkiva po celem telesu), vnetje ščitnice.
English: Fluctuations in abnormalities of liver function tests are common in patients with CHC.
Slovenian: Delovanje jeter Pri bolnikih s CHC so fluktuacije patoloških rezultatov testov jetrnih funkcij pogoste.
English: Do not use this medicine if you notice the syringe or needle packaging is damaged, if the solution is cloudy or if it has floating particles or if the medicine is any colour besides colourless to light yellow.
Slovenian: Ne uporabljate tega zdravila, če ste opazili, da je ovojnina injekcijske brizge ali igle poškodovana, če je raztopina motna ali če vsebuje lebdeče delce in če je barva zdravila drugačna od brezbarvne do rahlo rumene barve.
English: Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alfa interferons.
Slovenian: (včasih proti drugim osebam, npr. razmišljanje o umoru), bipolarnimi motnjami razpoloženja, manijo, zmedenostjo in spremembami duševnega stanja.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/016
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/02/221/016
English: Ribavirin 800 mg 24 weeks
Slovenian: 800 mg 24 tednov
English: Ribavirin 800 mg 48 weeks
Slovenian: 800 mg 48 tednov
English: The virological responses of patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load for HIV-HCV coinfected patients are summarised below in Table 21.
Slovenian: Virološki odzivi bolnikov, zdravljenih le z zdravilom Pegasys, in bolnikov, ki so se zdravili z zdravilom Pegasys v kombinaciji z ribavirinom, so v povezavi z genotipom in virusnim bremenom pred začetkom zdravljenja za bolnike, okužene s HCV in HIV, prikazani v preglednici 21.
English: ● the medicine is cloudy
Slovenian: • je zdravilo motno;
English: You or your partner must use an effective contraceptive during the time you are taking the treatment and for 7 months after stopping treatment.
Slovenian: Med zdravljenjem in 7 mesecev po končanem zdravljenju morate vi ali vaša partnerka uporabljati učinkovito kontracepcijo.
English: (copies/mL) / 5.26) ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
Slovenian: ** Bolnike, ki so prešli na zdravljenje z zdravilom Pegasys v obdobju po opazovanju and pred 24-tedenskim obdobjem spremljanja, štejemo kot neodzivne.
English: Similarly for patients with cirrhosis or transition to cirrhosis, the frequencies of withdrawal from Pegasys treatment and ribavirin treatment were higher in the 72-week treatment arms (13% and 15%) than in the 48-week arms (6% and 6%).
Slovenian: Podobno je bila pri bolnikih s cirozo ali prehodu v cirozo prekinitev zdravljenja z zdravilom Pegasys in ribavirinom pogostejša v skupini, ki se je zdravila 72 tednov (13 % zaradi neželenih učinkov in 15 % zaradi laboratorijskih nenormalnosti) kot v skupini, ki se je zdravila 48 tednov (6 % zaradi neželenih učinkov in 6 % zaradi laboratorijskih nenormalnosti).
English: Dizziness, disturbance in attention, migraine
Slovenian: Bolezni živčevja glavobol omotica, motnje pozornosti, migrena
English: ALT Normalisation
Slovenian: odziv * normalizacija ALT
English: Positive predictive values of 45% (50/110) and 70% (59/84) were observed for genotype 1 and genotype 2/3 HIV-HCV co-infected patients receiving combination therapy.
Slovenian: Pozitivne napovedne vrednosti so pri bolnikih, sočasno okuženih s HIV in HCV, ki so prejemali kombinirano zdravljenje, opazili v 45 % (50/110) za genotip 1 in v 70 % (59/84) za genotip 2/3.
English: The Child-Pugh classification divides patients into groups A, B, and C, or "Mild", "Moderate" and "Severe" corresponding to scores of 5-6, 7-9 and 10-15, respectively.
Slovenian: srednje ali hude oziroma glede na število točk na stopnjo A (5 do 6 točk), B (7 do 9 točk) ali C (10 do 15 točk).
English: Pegasys 180 mcg Ribavirin 800 mg 16 weeks
Slovenian: Pegasys 180 μg in ribavirin 800 mg 16 tednov
English: 1000 mg/day
Slovenian: 1000 mg/dan
English: Table 23: HBeAg seroconversion rates (%) by HBV genotype and baseline ALT levels Group A (Pegasys treatment) (N=101)
Slovenian: Preglednica 23: Deleži HBeAg serokonverzije (%) glede na HBV genotip in izhodiščne vrednosti
English: Ear disorders: ear pain
Slovenian: Ušesne bolezni: bolečina v ušesu.
English: • Pegasys 180 mcg/week for 48 weeks
Slovenian: • zdravilo Pegasys 180 mikrogramov/teden 48 tednov.
English: Clinical efficacy and safety
Slovenian: Klinična učinkovitost in varnost Kronični hepatitis B
English: Skin disorder
Slovenian: Bolezni kože
English: Low viral load = ≤ 800,000 IU/ml; High viral load= > 800,000 IU/ml RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24
Slovenian: Nizko virusno breme = ≤ 800.000 i.e./ml; visoko virusno breme = > 800.000 i.e./ml Hiter virološki odziv = nemerljiva koncentracija HCV RNA v tednu 4 in nemerljiva koncentracija HCV RNA v tednu 24
English: Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/lactic acidosis have been reported with use of ribavirin.
Slovenian: Pri jemanju ribavirina so poročali o smrti zaradi jetrne odpovedi, periferni nevropatiji, pankreatitisu in simptomatski hiperlaktatemiji/laktacidozi.
English: For children and adolescents aged 5 to 17 years with CHC, the recommended dose of ribavirin is based on the patient's body weight, with a target dose of 15 mg/kg/day, divided in two daily doses.
Slovenian: Za otroke in mladostnike s CHC, stare od 5 do 17 let, je priporočen odmerek ribavirina osnovan glede na bolnikovo telesno maso.
English: Table 14: Sustained virological response based on genotype and pre-treatment viral load after Pegasys combination therapy with ribavirin in CHC patients
Slovenian: Preglednica 14: Trajni virološki odziv v povezavi z genotipom in virusnim bremenom pred začetkom zdravljenja po kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom pri bolnikih s CHC
English: Acute and chronic toxicity studies have been carried out in cynomolgus monkeys, and the findings observed in peginterferon dosed animals were similar in nature to those produced by interferon alfa-2a.
Slovenian: Rezultati, ki so jih opazili pri živalih, ki so prejemale peginterferon, so bili po naravi podobni rezultatom, ki so jih opazili pri interferonu alfa-2a.
English: Ribavirin 1000/1200 mg 24 weeks
Slovenian: 1000/1200 mg 24 tednov
English: Do not use this medicine if you notice the vial or packaging is damaged, if the solution is cloudy or if it has floating particles or if the medicine is any colour besides colourless to light yellow.
Slovenian: Ne uporabljate tega zdravila, če ste opazili, da je viala ali ovojnina poškodovana, če je raztopina motna ali če vsebuje lebdeče delce in če je barva zdravila drugačna od brezbarvne do rahlo rumene barve.
English: (N=88) 48 weeks
Slovenian: (n = 88) 48 tednov
English: Treatment for only 16 weeks may be considered in selected patients infected with genotype 2 or 3 with LVL (≤ 800,000 IU/ml) at baseline who become HCV negative by week 4 of treatment and remains HCV negative by week 16.
Slovenian: Krajše 16-tedensko zdravljenje lahko vpeljemo pri izbranih bolnikih, ki so okuženi z genotipom 2 ali 3 in imajo nizko virusno breme pred začetkom zdravljenja (≤ 800.000 i.e./ml), ter pri bolnikih, katerih izvidi na HCV RNA postanejo negativni v 4. tednu zdravljenja in so še vedno negativni v 16. tednu zdravljenja.