natgillin/translations-raw huggingface dataset:
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
Each vial of 1.0 ml solution contains 180 micrograms peginterferon alfa-2a. 
Ena viala z 1,0 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a.
The recommended duration of therapy is 48 weeks in patients with CHB. Before initiating therapy for CHB, persistently elevated serum ALT levels should have been documented. 
Pred začetkom zdravljenja CHB je treba dokumentirati dolgotrajno zvišane ravni ALT v serumu.
Injury, poisoning and procedural complications 
Poškodbe in zastrupitve in zapleti pri posegih preveliko odmerjanje učinkovine
Activation button 
Sprožilni gumb 4.
D-79639 Grenzach- Wyhlen Germany 
D-79639 Grenzach- Wyhlen Nemčija
HIV-HCV co-infected patients 
Bolniki, sočasno okuženi s HIV in HCV
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 135 µg PRE-FILLED SYRINGES (WITH BLUE BOX) - Multipack 
ZUNANJA OVOJNINA - 12 x 135 µg NAPOLNJENE INJEKCIJSKE BRIZGE (Z MODRIM OKENCEM) - skupno pakiranje
Never re-attach protective cap after removal. 
Po odstranitvi pokrovčka ne poskušajte namestiti znova.
Hold the pre-filled pen comfortably in your hand. 
V roki sproščeno držite napolnjeni injekcijski peresnik.
Pegasys 135 micrograms solution for injection in pre-filled pen Pegasys 180 micrograms solution for injection in pre-filled pen 
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Pegasys 180 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku
Pegasys is administered subcutaneously in the abdomen or thigh. 
Zdravilo Pegasys dajemo subkutano v trebuh ali stegno.
Pegasys 180 micrograms solution for injection in pre-filled syringe 4 years 
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi 4 leta
Weight decreased 
Znižanje do
Caution should be exercised when administering Pegasys in combination with other potentially myelosuppressive agents. 
Pri dajanju zdravila Pegasys v kombinaciji z drugimi zdravili z možnim mielosupresivnim delovanjem je potrebna previdnost.
Bronchitis, upper respiratory infection, oral candidiasis, herpes simplex, fungal, viral and bacterial infections 
Infekcijske in parazitske bolezni bronhitis, okužba zgornjih dihal, kandidaza v ustih, herpes simpleks,
No HBV-HIV co-infected patients were included in these clinical trials. 
ta klinična preskušanja bolniki, sočasno okuženi s HBV in HIV, niso bili vključeni.
Pegasys is presented as a solution for injection in a pre-filled syringe (0.5 ml) with a separate injection needle. 
Zdravilo Pegasys je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi (0,5 ml).
Specific recommendations for management of treatment-emergent anaemia in adults are as follows: ribavirin should be reduced to 600 milligrams/day (200 milligrams in the morning and 400 milligrams in the evening) if either of the following apply: (1) a patient without significant cardiovascular disease experiences a fall in haemoglobin to < 10 g/dl and ≥ 8.5 g/dl, or (2) a patient with stable cardiovascular disease experiences a fall in haemoglobin by ≥ 2 g/dl during any 4 weeks of treatment. 
(1) se pri bolniku brez pomembnega srčnožilnega obolenja pojavi zmanjšanje hemoglobina na < 10 g/dl in ≥ 8,5 g/dl ali (2) če se pri bolniku s stabilnim srčnožilnim obolenjem pojavi padec hemoglobina za ≥ 2 g/dl kadar koli med štiritedenskim zdravljenjem.
Hyperglycaemia, type 1 diabetes mellitus 
Bolezni endokrinega sistema hipotiroidizem, hipertiroidizem diabetes diabetična ketoacidoza
Benzyl alcohol Sodium acetate Acetic acid Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid polisorbat 80 benzilalkohol natrijev acetat ocetna kislina voda za injekcije
Ribavirin 1000/1200 mg 72 or 48 Weeks (N = 942) Pts with VR at Wk 12 a 
1000/1200 mg 72 tednov (n = 473)
In the investigator sponsored CHIPS study (Chronic Hepatitis C International Paediatric Study), 65 children and adolescents (6-18 years) with chronic HCV infection were treated with Pegasys 100 mcg/m2 sc once weekly and ribavirin 15 mg/kg/day for 24 weeks (genotypes 2 and 3) or 48 weeks 
V raziskovalčevi študiji CHIPS (Chronic Hepatitis C International Pediatric Study) so 65 otrok in mladostnikov (starih 6 do 18 let) s kronično okužbo s HCV zdravili z zdravilom Pegasys
Pegasys 180 micrograms solution for injection Peginterferon alfa-2a 
Pegasys 180 mikrogramov raztopina za injiciranje peginterferon alfa-2a
Pegasys 90 micrograms solution for injection in pre-filled syringe Pegasys 135 micrograms solution for injection in pre-filled syringe Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a 
Navodilo za uporabo Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
Liver and renal graft rejections have been reported with Pegasys, alone or in combination with ribavirin. 
Pri zdravilu Pegasys, uporabljenem samostojno ali v kombinaciji z ribavirinom, so poročali o zavrnitvah jetrnih in ledvičnih presadkov.
Pegasys 180 micrograms solution for injection Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a*. 
Pegasys 180 mikrogramov raztopina za injiciranje Ena viala z 1 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a*.
Pegasys 90 micrograms solution for injection in pre-filled syringe EU/1/02/221/017 
Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/02/221/017
Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml * Pegasys 180 mcg & ribavirin 800 mg vs. Interferon alfa-2a 3 MIU & ribavirin 800 mg: Odds Ratio (95% CI) = 5.40 (3.42 to 8.54), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0001 * Pegasys 180 mcg & ribavirin 800 mg vs. Pegasys 180 mcg: 
*Zdravilo Pegasys 180 μg & ribavirin 800 mg v primerjavi z interferonom alfa-2a 3 mio i.e. & ribavirinom 800 mg: razmerje (95 % CI) = 5,40 (3,42 do 8,54), p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = < 0,0001 *Zdravilo Pegasys 180 μg & ribavirin 800 mg v primerjavi z zdravilom Pegasys 180 µg: razmerje (95 % CI) = 2,89 (1,93 do 4,32), p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = < 0,0001 *Interferon alfa-2a 3 mio i.e. & ribavirin 800 mg v primerjavi z zdravilom Pegasys 180 µg: razmerje (95 % CI) = 0,53 (0,33 do 0,85), p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = < 0,0084
Retinal haemorrhage 
zamaščenost jeter
Table 9: Undesirable effects reported with Pegasys monotherapy for CHB or CHC or in combination with ribavirin for CHC patients in clinical trials and post marketing Body system Very common 
Preglednica 9: Neželeni učinki, ki so se pojavili v kliničnih preskušanjih in po prihodu zdravila na trg pri samostojnem zdravljenju z zdravilom Pegasys pri bolnikih s CHB ali CHC ali v kombiniranem zdravljenju z ribavirinom pri bolnikih s CHC
Degree of abnormality Score Encephalopathy None Grade 1-2 
Encefalopatija odsotna stopnja 1-2 stopnja 3-4*
Overall Sustained Response 
Celokup en trajni odziv
Pegylated interferon Interferon plus ribavirin Pegylated interferon plus ribavirin 
Pegasys 180 μg in ribavirin 1000/1200 mg 48 tednov interferon pegiliran interferon interferon in ribavirin pegiliran interferon in ribavirin
A total of 151 patients without advanced fibrosis were 2:1 randomized to Pegasys (group A, n=101) or untreated control (group B, n=50), respectively. 
151 bolnikov brez napredovale fibroze v razmerju 2:1 na skupino, ki je prejemala zdravilo Pegasys
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED SYRINGES (WITH BLUE BOX) - Multipack 
ZUNANJA OVOJNINA- 12 x 180 µg NAPOLNJENE INJEKCIJSKE BRIZGE (Z MODRIM OKENCEM) - skupno pakiranje
● Remove the needle guard from the syringe needle. 
● Z injekcijske igle snemite zaščito.
Tachycardia, oedema peripheral, palpitations, 
Srčne bolezni tahikardija, periferni edem, palpitacije miokardni infarkt, kongestivno srčno popuščanje,