natgillin/translations-raw huggingface dataset:
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%).
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).
Dizziness, disturbance in attention, migraine
Bolezni živčevja glavobol omotica, motnje pozornosti, migrena
ALT Normalisation
odziv * normalizacija ALT
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.
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.
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.
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).
Pegasys 180 mcg Ribavirin 800 mg 16 weeks
Pegasys 180 μg in ribavirin 800 mg 16 tednov
Table 23: HBeAg seroconversion rates (%) by HBV genotype and baseline ALT levels Group A (Pegasys treatment) (N=101)
Preglednica 23: Deleži HBeAg serokonverzije (%) glede na HBV genotip in izhodiščne vrednosti
Ear disorders: ear pain
Ušesne bolezni: bolečina v ušesu.
• Pegasys 180 mcg/week for 48 weeks
• zdravilo Pegasys 180 mikrogramov/teden 48 tednov.
Clinical efficacy and safety
Klinična učinkovitost in varnost Kronični hepatitis B
Skin disorder
Bolezni kože
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
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
Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/lactic acidosis have been reported with use of ribavirin.
Pri jemanju ribavirina so poročali o smrti zaradi jetrne odpovedi, periferni nevropatiji, pankreatitisu in simptomatski hiperlaktatemiji/laktacidozi.
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.
Za otroke in mladostnike s CHC, stare od 5 do 17 let, je priporočen odmerek ribavirina osnovan glede na bolnikovo telesno maso.
Table 14: Sustained virological response based on genotype and pre-treatment viral load after Pegasys combination therapy with ribavirin in CHC patients
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
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.
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.
Ribavirin 1000/1200 mg 24 weeks
1000/1200 mg 24 tednov
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.
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.
(N=88) 48 weeks
(n = 88) 48 tednov
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.
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.
Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, dry mouth
bruhanje, dispepsija, disfagija, razjeda v ustih, krvavitev dlesni, glositis, stomatitis, flatulenca suha usta krvavitev v prebavilih želodčni čir,
Your doctor has determined the exact dose of Pegasys for your child and will tell you how often to use it.
Vaš zdravnik je za vašega otroka določil natančen odmerek zdravila Pegasys.
It should be inspected visually for particulate matter and discoloration before administration.
Pred dajanjem je treba vizualno preveriti prisotnost delcev in morebitno spremembo barve.
The possibility to consider shortening treatment duration to 24 weeks in genotype 1 and 4 patients was examined based on a sustained rapid virological response observed in patients with rapid virological response at week 4 in studies NV15942 and ML17131 (see Table 15).
Možnost zmanjšanja trajanja zdravljenja na 24 tednov pri bolnikih z genotipoma 1 in 4 so proučevali na osnovi trajnega virološkega odziva, ki so ga opazili pri bolnikih s hitrim virološkim odzivom v 4.
Genotype 2 or 3
Genotip 2 in 3
● Remove the protective cap that covers the back of the needle (1-2).
Priprava injekcijske brizge in igle za injiciranje ● Z injekcijske igle odstranite zaščitni pokrovček (1-2).
Ribavirin 1000/1200 mg 48 weeks
1000/1200 mg 48 tednov
INFORMATION IN BRAILLE pegasys 135 mcg
pegasys 135 mcg
In HIV-HCV co-infected patients, the clinical adverse reaction profiles reported for Pegasys, alone or in combination with ribavirin, were similar to those observed in HCV mono-infected patients.
Klinični profili neželenih učinkov za zdravilo Pegasys ali kombinacijo zdravila Pegasys z ribavirinom, ki so jih opazili pri bolnikih, sočasno okuženih s HIV in HCV, so bili podobni kot pri bolnikih, okuženih le s HCV.
The recommended dose of Pegasys in combination with ribavirin is 180 mcg once weekly by subcutaneous administration.
Priporočeni odmerek zdravila Pegasys v kombinaciji z ribavirinom je 180 mikrogramov enkrat na teden s subkutano aplikacijo.
Each pre-filled syringe of 0.5 ml solution contains 90, 135 or 180 micrograms peginterferon alfa-2a.
Ena napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 90, 135 ali 180 mikrogramov peginterferona alfa-2a.
Also contains sodium chloride, polysorbate 80, benzyl alcohol (see leaflet for further information), sodium acetate, acetic acid and water for injections.
Pomožne snovi so natrijev klorid, polisorbat 80, benzilalkohol (glejte navodilo za uporabo za dodatne informacije), natrijev acetat, ocetna kislina in voda za injekcije.
Hypoglycaemia, hyperglycaemia and diabetes mellitus have been observed with Pegasys (see section 4.8).
Med zdravljenjem z zdravilom Pegasys so poročali o hipoglikemiji, hiperglikemiji in sladkorni bolezni (glejte poglavje 4.8).
Do not use this medicine if you notice the pre-filled pen 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.
Ne uporabljate tega zdravila, če ste opazili, da je ovojnina ali napolnjeni injekcijski peresnik poškodovan, če je raztopina motna ali če vsebuje lebdeče delce in če je barva zdravila drugačna od brezbarvne do rahlo rumene barve.
Pegasys is designed for administration by the patient or carer.
Zdravilo Pegasys je zasnovano tako, da si ga lahko bolnik da sam ali pa mu ga da njegov skrbnik.
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Pegasys in combination with ribavirin.
Pri bolnicah ali pri partnerkah bolnikov moškega spola, ki jemljejo zdravilo Pegasys v kombinaciji z ribavirinom, je treba nameniti posebno skrb preprečitvi nosečnosti.
Adverse events were experienced by 88% of Pegasys-treated patients as compared with 53% of patients in the lamivudine comparator group, while 6% of the Pegasys-treated and 4% of the lamivudine-treated patients experienced serious adverse events during the studies.
Neželeni dogodki so se pojavili pri 88 % bolnikov, zdravljenih z zdravilom Pegasys, v primerjalni skupini, zdravljeni z lamivudinom, pa pri 53 %
Cut-off (IU/mL)
Genotip Mejna vrednost (i.e./mL)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 135 mcg/0.5 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 135 μg/0,5 ml
Retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction which may result in loss of vision have been reported in rare instances with Pegasys.
Med zdravljenjem z zdravilom Pegasys so se v redkih primerih pojavile retinopatije, vključno z retinalnimi krvavitvami, pege, papiloedem, očesna nevropatija in obstrukcija retinalne arterije ali vene, kar lahko povzroči izgubo vida.
Neoplasms benign and malignant
Benigne in maligne neoplazme maligne jetrne novotvorbe
Pegasys 180 micrograms solution for injection 4 years.
Pegasys 180 mikrogramov raztopina za injiciranje 4 leta
No apparent evidence of drug interaction was observed in 47 HIV-HCV co-infected patients who completed a 12-week pharmacokinetic substudy to examine the effect of ribavirin on the intracellular phosphorylation of some nucleoside reverse transcriptase inhibitors (lamivudine and zidovudine or stavudine).
Bolniki, sočasno okuženi s HIV in HCV V 12-tedenski farmakokinetični podštudiji, kjer so raziskovali učinek ribavirina na intracelularno fosforilacijo nekaterih nukleozidnih zaviralcev reverzne transkriptaze (lamivudin in zidovudin ali stavudin) pri 47 bolnikih, sočasno okuženih s HIV in HCV, ki so zaključili podštudijo, jasnih dokazov o interakcijah med zdravili niso opazili.
The development of auto-antibodies and autoimmune disorders has been reported during treatment with alfa interferons.
Avtoimunska bolezen Med zdravljenjem z interferoni alfa so poročali o nastanku avtoprotiteles in avtoimunskih boleznih.
In study NV17317 in patients infected with viral genotype 2 or 3, all patients received Pegasys 180 mcg sc qw and a ribavirin dose of 800 mg and were randomised to treatment for either 16 or 24 weeks.
V študiji NV17317 so bolniki, okuženi z virusnim genotipom 2 ali 3, prejemali zdravilo Pegasys v odmerku 180 μg subkutano enkrat tedensko in ribavirin 800 mg. Randomizirani so bili v 24- ali 16tedensko zdravljenje.
Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Med zdravljenjem in še 7 mesecev po končanem zdravljenju morajo bolniki moškega spola ali njihove partnerke uporabljati učinkovito kontracepcijsko zaščito.
Heart and blood vessel disorders: Rapid heart rate, pulsation of the heart beats, swelling in the extremities, flushing
Srčne in žilne bolezni: hitro bitje srca, močno utripanje srca, otekanje udov, rdečica.
< 8.5 g/dl
< 8,5 g/dl hemoglobin
(N=87) 48 weeks
(n = 87) 48 tednov
Serious infections (bacterial, viral, fungal) and sepsis have been reported during treatment with alfa interferons including Pegasys.
Med zdravljenjem z interferoni alfa, vključno z zdravilom Pegasys, so poročali o resnih okužbah (bakterijskih, virusnih in glivičnih) ter sepsi.
● Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
● Z igle snemite zaščito, ne da bi se je dotaknili.
Metabolic disorders: Loss of appetite
Ušesne bolezni: izguba sluha.
● if you are allergic to peginterferon-alfa-2a, to any interferon or any of the other ingredients of this medicine (listed in section 6).
• ste alergični na peginterferon alfa-2a, kateri koli drugi interferon ali katero koli sestavino tega zdravila (navedeno v poglavju 6), • ste kdaj imeli srčni infarkt ali ste bili hospitalizirani zaradi hude bolečine v prsnem košu v zadnjih šestih mesecih,
Genotype 4 with RVR*
Genotip 4 in hiter virološki odziv*
Pegasys 180 mcg Ribavirin 800 mg
Pegasys 180 μg in ribavirin 800 mg
The recommended dosage and duration of Pegasys for both HBeAg-positive and HBeAg-negative CHB is 180 micrograms once weekly for 48 weeks.
HBeAg negativni CHB je 180 mikrogramov enkrat na teden 48 tednov.
● Inject the solution by gently pushing the plunger all the way down.
● S počasnim pritiskom bata navzdol injicirajte raztopino.
Pegasys 135 micrograms solution for injection in pre-filled syringe 4 years
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi 4 leta
● Keep this leaflet.
• Navodilo shranite.
In a direct comparison with 90 micrograms, the 180 micrograms-dose was associated with superior sustained virological response in patients with cirrhosis, but in a study in non-cirrhotic patients very similar results were obtained with doses of 135 micrograms and 180 micrograms.
Odziv glede na odmerek pri samostojnem zdravljenju V neposredni primerjavi odmerkov 90 mikrogramov in 180 mikrogramov so pri bolnikih s cirozo pri odmerku 180 mikrogramov opazili močnejši trajni virološki odziv.
HCV RNA levels decline in a biphasic manner in responding patients with hepatitis C who have received treatment with 180 micrograms Pegasys.
Pri odzivnih bolnikih s hepatitisom C, ki so prejeli zdravljenje s 180 mikrogrami zdravila Pegasys, se koncentracije HCV RNA zmanjšajo v dveh fazah.
Predictability of response and non-response with Pegasys and ribavirin dual therapy - treatmentexperienced patients
Napoved odzivnosti in neodzivnosti pri dvojnem zdravljenju z zdravilom Pegasys in ribavirinom bolniki, ki se še niso zdravili
Pegasys 135 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 135 mcg, 90 mcg and 45 mcg.
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Na injekcijski brizgi so oznake za odmerke 135 mcg, 90 mcg in 45 mcg.
HCV monoinfected patients and HBV monoinfected patients
Bolniki, okuženi le s HCV ali HBV
(N=478) 48 weeks
(n = 478) 48 tednov
In a clinical trial of non-responder patients to prior pegylated interferon alfa-2b/ribavirin, which exposed patients to either 48 or 72 weeks of treatment, the frequency of withdrawal for adverse events or laboratory abnormalities from Pegasys treatment and ribavirin treatment was 6% and 7%, respectively, in the 48 week arms and 12% and 13% ,respectively, in the 72 week arms.
V kliničnem preskušanju pri bolnikih, ki se na prejšnje zdravljenje s pegiliranim interferonom alfa-2b/ribavirinom niso odzvali in ki so se v preskušanju zdravili 48 tednov, je bilo prekinitev zdravljenja zaradi neželenih učinkov 6 % in laboratorijskih nenormalnosti 7 %.
Pegasys 180 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 180 mcg, 135 mcg and 90 mcg.
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Na injekcijski brizgi so oznake za odmerke 180 mcg, 135 mcg in 90 mcg.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Kombinirano zdravljenje z zdravilom
● a long needle to withdraw Pegasys from the vial
• 1 ml injekcijska brizga, • dolga igla za odvzem zdravila Pegasys iz viale,
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mcg/0.5 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 180 μg/0,5 ml
Interferon alfa-2b 3 MIU Ribavirin mg (N=444) 48 weeks
3 mio i.e. in ribavirin mg (n = 444) 48 tednov
For patients infected with HCV genotype 1 <75 kg and ≥75 kg, 1000 mg daily and 1200 mg daily of ribavirin, respectively, should be administered.
Bolnikom, okuženim s HCV genotipom 1, dajemo 1000 mg ribavirina (lažjim od 75 kg) oziroma 1200 mg ribavirina (tistim s 75 kg ali več) na dan.
Ribavirin dose
Dnevni odmerek ribavirina
Ribavirin 800 mg
3 mio i.e. in ribavirin 800 mg
● small bandage or sterile gauze
• dezinfekcijska krpica, • manjši ovoj ali sterilna gaza,
● If you get any side effects, talk to your doctor, pharmacist or nurse.
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Regardless of the starting dose or degree of renal impairment, patients should be monitored and appropriate dose reductions of Pegasys during the course of therapy should be made in the event of adverse reactions.
Če se pojavijo neželeni učinki, moramo bolnike nadzorovati in ustrezno prilagajati odmerek zdravila Pegasys med samim zdravljenjem, ne glede na začetni odmerek ali stopnjo ledvične okvare.
Pegasys pre-filled pen
Pegasys napolnjeni injekcijski peresnik
TSH levels should be determined during the course of therapy if a patient develops clinical symptoms consistent with possible thyroid dysfunction (see section 4.8).
Če se pri bolniku med zdravljenjem pojavijo klinični simptomi, povezani z možno motnjo delovanja ščitnice, moramo določiti koncentracije TSH (glejte poglavje 4.8).
* Subgroup of patients with genotype D had a higher proportion with baseline ALT < 1.5x ULN (13/31) compared to other genotype groups ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
* V podskupini bolnikov z genotipom D je bil delež z izhodiščno ALT < 1.5x ULN (13/31) večji kot pri drugih skupinah genotipov (16/70).
Psoriasis, urticaria, eczema, rash, sweating increased, skin disorder, photosensitivi ty reaction, night sweats
Bolezni kože: kožni izpuščaj, povečano znojenje, psoriaza, koprivnica, ekcem, občutljivost na sončno svetlobo, nočno znojenje.
Discontinue combination
Prekinemo kombinirano terapijo
● Remove the needle guard from the syringe needle (5).
● Z injekcijske igle snemite zaščito (5).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 90 mcg/0.5 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 90 μg/0,5 ml
1 - <2 log10 decline
<2 log10
Each syringe should be used by one person only and is for single use.
Vsako napolnjeno injekcijsko brizgo lahko uporablja le ena oseba in le za enkratno uporabo.
Table 17: Sustained virological response overall and based on rapid viral response by week 4 for genotype 2 or 3 after Pegasys combination therapy with ribavirin in CHC patients
Preglednica 17: Celokupen trajni virološki odziv in trajni virološki odziv v povezavi s hitrim virološkim odzivom v 4. tednu za genotipa 2 ali 3 po kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom pri bolnikih s CHC Študija NV17317
Duration of therapy when Pegasys is used in combination with other medicinal products Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with Pegasys.
Če zdravilo Pegasys uporabljate v kombinaciji z drugimi zdravili, si preberite tudi povzetek glavnih značilnosti (SmPC) za ta zdravila.
Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml *Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 800 mg, 48 w: Odds Ratio (95% CI) = 1.52 (1.07 to 2.17), P-value (stratified Cochran-Mantel-Haenszel test) = 0.020 *Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 1000/1200 mg, 24 w: Odds Ratio (95% CI) = 2.12 (1.30 to 3.46), P-value (stratified Cochran-Mantel-Haenszel test) = 0.002.
*Zdravilo Pegasys 180 µg & ribavirin 1000/1200 mg, 48 tednov v primerjavi z zdravilo Pegasys 180 µg & ribavirin 800 mg, 48 tednov: razmerje (95 % CI) = 1,52 (1,07 do 2,17) p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = 0,020 *Zdravilo Pegasys 180 µg & ribavirin 1000/1200 mg, 48 tednov v primerjavi z zdravilo Pegasys 180 µg & ribavirin 1000/1200 mg, 24 tednov: razmerje (95 % CI) = 2,12 (1,30 do 3,46) p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = 0,002.
Blindness transient, retinal exudates, visual impairment eye irritation, eye pain, eye pruritis
Očesne bolezni prehodna slepota, nabiranje tekočine pod mrežnico, moten vid, draženje oči, bolečina v očesu, očesni pruritis
● Remove the syringe from the wrapping.
● Injekcijsko brizgo vzemite iz ovojnine.
Available in packs containing 1, 4 or 12 pre-filled pens.
Pakiranje vsebuje 1, 4 ali 12 napolnjenih injekcijskih peresnikov.
Reproductive system and breast disorders
Motnje reprodukcije in dojk impotenca
The terminal half-life may not only reflect the elimination phase of the compound, but may also reflect the sustained absorption of Pegasys.
Končna razpolovna doba lahko kaže na fazo izločanja učinkovine in zapoznelo absorpcijo zdravila
Table 5: Pegasys dose modification recommendations in paediatric patients with chronic hepatitis B or chronic hepatitis C Starting dose (mcg)
Preglednica 5: Priporočila za prilagajanje odmerka zdravila Pegasys pri pediatričnih bolnikih s kroničnim hepatitisom C ali kroničnim hepatitisom B Začetni odmerek (mikrogrami)
Roche Pharma AG Emil-Barell-Str.1
Emil-Barell-Str.1
Table 6: Pegasys dose modification recommendations for toxicities in paediatric patients with chronic hepatitis B or chronic hepatitis C
Preglednica 6: Priporočila za prilagajanje odmerka zdravila Pegasys zaradi toksičnosti pri pediatričnih bolnikih s kroničnim hepatitisom B ali kroničnim hepatitisom C Toksičnost
Table 4: Pegasys dosing recommendations for paediatric patients with chronic hepatitis B and chronic hepatitis C
Preglednica 4: Priporočila za odmerjanje zdravila Pegasys pri pediatričnih bolnikih s kroničnim hepatitisom C in kroničnim hepatitisom B
Pyrexia, rigors*, pain*, asthenia, fatigue, injection site reaction*, irritability*
astenija, utrujenost, reakcija na mestu injiciranja*,
Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml RVR = rapid viral response (HCV RNA undetectable) at week 4
Nizko virusno breme = ≤ 800.000 i.e./ml; visoko virusno breme = > 800.000 i.e./ml Hiter virološki odziv = nemerljiva koncentracija HCV RNA v 4. tednu
Wheezing Interstitial pneumonitis including fatal outcome, pulmonary embolism
vključno s smrtnim izidom, pljučna embolija pljučna arterijska hipertenzija
- genotype 4 who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24.
- z genotipom 4, pri katerih izvidi na HCV RNA postanejo negativni v 4. tednu zdravljenja in so še vedno negativni v
In approximately half the cases of flares exceeding 10x ULN, Pegasys dosing was reduced or withheld until the transaminase elevations subsided, while in the rest therapy was continued unchanged.
Odmerek zdravila Pegasys so zmanjšali ali pa prekinili dajanje, dokler se nihanja transaminaze niso umirila.
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/009
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/02/221/009
With the exception of pyrexia, the frequency of the majority of the reported adverse reactions was notably less in CHB patients treated with Pegasys monotherapy compared with CHC patients treated with Pegasys monotherapy (see Table 9).
CHB, zdravljenem samo z zdravilom Pegasys, v primerjavi z bolniki s CHC, zdravljenimi le z zdravilom Pegasys (glejte preglednico 9).
6) Place the pre-filled pen on the injection site
6) Napolnjeni injekcijski peresnik približajte mestu injiciranja
*RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24; **RVR = rapid viral response (HCV RNA negative) by week 4
*Hiter virološki odziv = nemerljiva koncentracija HCV RNA v tednu 4 in nemerljiva koncentracija HCV RNA v tednu 24.
Pegasys 90 micrograms solution for injection in pre-filled syringe 3 years.
Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi 3 leta
Eye disorders: Bleeding in the retina (back of the eye) Ear disorders: Hearing loss
Očesne bolezni: krvavitev v mrežnici (zadnji del očesa).
1 x 200 mg tablets A.M. 2 x 200 mg tablets P.M.
1 x 200-mg tableta zjutraj 2 x 200-mg tableti zvečer