natgillin/translations-raw huggingface dataset:
Thyroid function abnormalities or worsening of pre-existing thyroid disorders have been reported with the use of alfa interferons, including Pegasys. 
obstaja povečano tveganje za nastanek novih ali poslabšanje že obstoječih psihiatričnih motenj, če jih zdravimo z interferonom alfa.
NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection 
Pegasys 180 mikrogramov raztopina za injiciranje
The mean changes from baseline in height and weight for age Z-scores at Week 48 of treatment in study YV25718 were -0.07 and -0.21 (n=108 and n= 106 respectively) for Pegasys-treated patients as compared to -0.01 and -0.08 (n=47 each) in untreated patients. 
-0,07 in -0,21 (n = 108 in n = 106) v primerjavi z -0,01 in -0,08 (n = 47 za vsako) pri nezdravljenih bolnikih.
Pegasys 135 micrograms solution for injection in pre-filled syringe EU/1/02/221/005 
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/02/221/005
Genotype 2 or 3 RVR Low viral load High viral load 
Genotip 2 ali 3, nizko virusno breme in hiter virološki odziv**
1 pre-filled syringe + 1 injection needle 90 micrograms/0.5 ml 
1 napolnjena injekcijska brizga + 1 injekcijska igla 90 mikrogramov/0,5 ml
● if you think you are getting an infection (such as pneumonia) as when receiving Pegasys you may temporarily have a greater risk of getting an infection. 
• če mislite, da ste dobili okužbo (kot je pljučnica).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg VIALS 
ZUNANJA OVOJNINA - 4 x 180 µg VIALE
● Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle while keeping the needle in the vial and without touching the tip of the syringe. 
Snemite brizgo z dolge igle, igla pa naj ostane v viali.
Tooth extraction, cholecystectomy 
Kirurški in drugi medicinski posegi ekstrakcija zoba, holecistektomija
Alopecia, dermatitis, pruritis, dry skin 
Bolezni kože in podkožja alopecija, dermatitis, pruritus, suha koža psoriaza, urtikarija, ekcem,
4 pre-filled syringes + 4 injection needles 135 micrograms/0.5 ml 
4 napolnjene injekcijske brizge + 4 injekcijske igle 135 mikrogramov/0,5 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 135 µg PRE-FILLED PENS 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 12 x 135 µg NAPOLNJENI INJEKCIJSKI PERESNIKI
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy. 
Pri bolnikih, ki prejemajo zdravilo Pegasys v kombinaciji z ribavirinom, so poročali o zobnih in periodontalnih boleznih, ki lahko vodijo do izgube zob.
Roche Pharma AG Emil-Barell-Str. 1 
Emil-Barell-Str. 1
NAME OF THE MEDICINAL PRODUCT 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 
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
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED PENS 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 12 x 180 µg NAPOLNJENI INJEKCIJSKI PERESNIKI
Pegasys dose 
Odmerek zdravila Pegasys
1 pre-filled syringe + 1 injection needle 180 micrograms/0.5 ml 
1 napolnjena injekcijska brizga + 1 injekcijska igla 180 mikrogramov/0,5 ml
1 x 200 mg tablets A.M. 
1 x 200-mg tableta zvečer
Fertility 
lamivudin
* Similar to end point of HBV DNA < 10 
* za HBeAg-pozitivne bolnike: HBV DNA < 10
4 pre-filled syringes + 4 injection needles 180 micrograms/0.5 ml 
4 napolnjene injekcijske brizge + 4 injekcijske igle 180 mikrogramov/0,5 ml
8) Dispose of pre-filled pen 
8) Odvrzite napolnjeni injekcijski peresnik
Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it. 
Vaš zdravnik je določil natančen odmerek zdravila Pegasys.
Back pain, arthritis, muscle weakness, bone pain, neck pain, musculoskelet al pain, muscle cramps 
bolečina v kosteh, bolečina v vratu, mišičnoskeletna bolečina, mišični krči miozitis rabdomioliza
1 pre-filled syringe + 1 injection needle 135 micrograms/0.5 ml 
1 napolnjena injekcijska brizga + 1 injekcijska igla 135 mikrogramov/0,5 ml
1 ml of solution for injection in vial (Type I glass) with stopper (rubber butyl). 
Viala (steklo tipa I) z zamaškom (butil guma) z 1 ml raztopine za injiciranje.
Pegasys 135 micrograms solution for injection in pre-filled pen Each pre-filled pen of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a*. 
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Vsak injekcijski peresnik z 0,5 ml raztopine vsebuje 135 mikrogramov peginterferona alfa-2a*.
Measuring the dose of Pegasys 
Odmerjanje zdravila Pegasys
The pharmacokinetics of Pegasys were similar between healthy subjects and patients with hepatitis B or C. Comparable exposure and pharmacokinetic profiles were seen in cirrhotic (Child-Pugh Grade A) and non-cirrhotic patients. 
Pri zdravih prostovoljcih in bolnikih s hepatitisom B ali C je bila farmakokinetika zdravila Pegasys podobna.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 6 x 180 µg PRE-FILLED SYRINGES (WITHOUT BLUE BOX)Multipack 
ZUNANJA OVOJNINA- 6 x 180 µg NAPOLNJENE INJEKCIJSKE BRIZGE (BREZ MODREGA OKENCA) - skupno pakiranje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 6 x 135 µg PRE-FILLED SYRINGES (WITHOUT BLUE BOX)Multipack 
ZUNANJA OVOJNINA - 6 x 135 µg NAPOLNJENE INJEKCIJSKE BRIZGE (BREZ MODREGA OKENCA) - skupno pakiranje
Pegasys 180 micrograms solution for injection in pre-filled syringe EU/1/02/221/007 
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/02/221/007
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, epistaksa
Renal insufficiency 
Bolezni sečil ledvična insuficienca
Vertigo, earache 
vročinski valovi, žeja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 90 µg PRE-FILLED SYRINGE 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA- 1 x 90 µg NAPOLNJENA INJEKCIJSKA BRIZGA
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy. 
Pri bolnikih, ki so prejemali zdravilo Pegasys skupaj z ribavirinom, so poročali o boleznih zob in dlesni, ki lahko vodijo do izgube zob.
Dysuria, incontinence, urinary tract disorder 
Bolezni sečil disurija, inkontinenca, bolezen sečil
With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1. 
Za specifično aktivnost glede genotipa virusa hepatitisa C glejte poglavji 4.2 in 5.1.
Diabetes 
hemoglobin
Syncope, migraine, memory impairment, weakness, hypoaesthesia hyperaesthesi a, paraesthesia, tremor, taste disturbance, nightmares, somnolence 
Bolezni živčevja glavobol, omotica*, motnje koncentracije sinkopa, migrena, motnje spomina, oslabelost, hipestezija, hiperestezija, parestezija, tremor, motnje okusa,
Genotype 2 and 3 (N=96) 
Genotip B (n = 21)
Metabolism and nutrition disorders Decreased appetite 
Presnovne in prehranske motnje anoreksija dehidracija
Do not use Pegasys 
Zdravila Pegasys ne dajemo
Upper respiratory infection, bronchitis, fungal infection of the mouth and herpes (a common recurring viral infection affecting the lips, mouth) Blood disorders: Low platelet count (affecting the clotting ability), anaemia (low red cell count) and enlarged lymph glands 
Okužbe: glivične, virusne in bakterijske okužbe, okužba zgornjih dihal, bronhitis, glivična okužba v ustih in herpes (pogosta ponavljajoča se virusna okužba, ki prizadane ustnice in usta).
Gastrointestinal disorder 
Injiciranje raztopine
MARKETING AUTHORISATION NUMBERS Pegasys 180 micrograms solution for injection EU/1/02/221/003 
Pegasys 180 mikrogramov raztopina za injiciranje EU/1/02/221/003
Pegasys 180 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*. 
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Vsak injekcijski peresnik z 0,5 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a*.
HIV-HCV co-infected adult patients 
Odrasli bolniki, sočasno okuženi s HIV in HCV
The possibility of shortening treatment duration to 16 weeks in genotype 2 or 3 patients was examined based on a sustained virological response observed in patients with rapid virological response by week 4 in study NV17317 (see Table 17). 
V študiji NV17317 so proučevali možnost skrajšanja zdravljenja bolnikov, okuženih z genotipom 2 ali 3 na 16 tednov, glede na trajni virološki odziv, opažen pri bolnikih, ki so imeli hiter virološki odziv v
In the NV17424 (PEDS-C) study, previously untreated paediatric patients 5 to 17 years of age (55% <12 years old) with compensated CHC and detectable HCV RNA were treated with Pegasys 180 mcg x BSA/1.73 m2 once weekly for 48 weeks with or without ribavirin 15 mg/kg/day. 
(55 % < 12 let) s kompenziranim CHC in merljivo koncentracijo HCV RNA, bili zdravljeni z zdravilom Pegasys 180 µg/1,73 m2 telesne površine (TP) enkrat tedensko, 48 tednov in ribavirinom
Suicidal ideation, hallucinations 
nervoznost, zmanjšan libido misli o samomoru, halucinacije samomor,
Dose limiting toxicities were fatigue, elevated liver enzymes, neutropenia and thrombocytopenia, consistent with interferon therapy. 
Neželeni posledični učinki zdravljenja z interferoni, ki so omejevali odmerke, so bili utrujenost, zvišane vrednosti jetrnih encimov, nevtropenija in trombocitopenija.
In subjects older than 62 years, the absorption of Pegasys after a single subcutaneous injection of 180 micrograms was delayed but still sustained compared to young healthy subjects (tmax of 115 hours vs. 82 hours, older than 62 years vs. younger, respectively). 
Pri bolnikih, starejših od 62 let, je bil tmax 115 ur, pri mlajših pa 82 ur.
Pure red cell aplasia 
okvara žil mrežnice,
In patients who develop evidence of hepatic decompensation during treatment, Pegasys should be discontinued. 
Pri bolnikih, pri katerih se razvijejo ali poslabšajo oftalmološke motnje, je treba zdravljenje z zdravilom Pegasys prekiniti.
Consideration should be given to replacing zidovudine in a combination anti-retroviral therapy regimen if this is already established. 
Če je bila ugotovljena anemija, je smiselno razmisliti o zamenjavi zidovudina v kombinaciji protivirusnih zdravil.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 135 µg PRE-FILLED SYRINGES 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 4 x 135 µg NAPOLNJENE INJEKCIJSKE BRIZGE
Reproductive system disorders: Impotence (inability to maintain an erection) General disorders: Chest pain, flu-like illness, malaise (not feeling well), lethargy, hot flushes, thirst 
Splošne težave: bolečina v prsih, bolezen, podobna gripi, občutek slabosti (neugodno počutje), zaspanost, vročinski valovi, žeja.
Uncommon side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 100 people) are: 
Občasni neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 100 bolnikov) so:
Moderate (ANC: 0.749 - 0.5 x 109/l) and severe (ANC: < 0.5 x 109/l) neutropenia was observed respectively in 24% (216/887) and 5% (41/887) of patients receiving Pegasys 180 micrograms and ribavirin 1000/1200 milligrams for 48 weeks. 
9/l) pa pri 5 % (41/887) bolnikov, ki so prejemali zdravilo Pegasys v odmerku 180 mikrogramov in ribavirin v odmerku 1000/1200 miligramov 48 tednov.
Collect the necessary items before beginning: Included in the pack: 
Naslednje vrednosti lahko štejemo kot izhodiščne vrednosti ob začetku zdravljenja:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg VIAL 
ZUNANJA OVOJNINA - 1 x 180 µg VIALA
Weekly dose (mcg) 
Tedenski odmerek (mikrogrami)
Pegasys 180 micrograms solution for injection in pre-filled pen Each pre-filled pen of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*. 
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Vsaka napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 180 mikrogramov peginterferona alfa2a*.
Hypertension, supraventricular arrhythmias, congestive heart failure, chest pain and myocardial infarction have been associated with alfa interferon therapies, including Pegasys. 
Zdravljenje z interferoni, vključno z zdravilom Pegasys, povezujejo z neželenimi učinki, kot so hipertenzija, supraventrikularne aritmije, kongestivno srčno popuščanje, bolečina v prsih in miokardni infarkt.
Pegasys 135 micrograms solution for injection in pre-filled pen EU/1/02/221/011 
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/02/221/011
Pegasys 180 micrograms solution for injection in pre-filled pen EU/1/02/221/014 
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/02/221/014
COBAS AMPLICOR HBV MONITOR: HBV-DNA (IU/mL) = HBV-DNA 
COBAS AMPLICOR HBV MONITOR: HBV-DNA (i.e./ml) = HBV-DNA (kopije/ml)/5,26 ** Bolnike, ki so prešli na zdravljenje z zdravilom Pegasys po glavnem obdobju opazovanja in pred 24. tedenom obdobja spremljanja,
Chronic hepatitis B in adult patients 
Povzetek varnostnega profila Kronični hepatitis B pri odraslih bolnikih
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a. 
Ena napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 90 mikrogramov peginterferona alfa-2a.
Digestive system disorders: Stomach ulcer, inflammation of the pancreas 
Bolezni prebavil: razjeda na želodcu, vnetje trebušne slinavke.
NAME OF THE MEDICINAL PRODUCT Pegasys 90 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a 
Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
NAME OF THE MEDICINAL PRODUCT Pegasys 135 micrograms solution for injection in pre-filled pen Peginterferon alfa-2a 
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old. 
Pri novorojenčkih in otrocih do 3. leta starosti lahko povzroči toksične in anafilaktične reakcije.
Very rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10,000 people) are: 
Zelo redki neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 10.000 bolnikov) so:
Group B** Untreated (N=50) 
Genotip C (n = 34)
Rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 1000 people) are: 
Redki neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 1000 bolnikov) so:
Flushing Hypertension Cerebral haemorrhage, vasculitis 
mišičnoskeletna bolečina, mišični krči miozitis rabdomioliza
Female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded. 
Med zdravljenjem in 4 mesece po končanem zdravljenju morajo bolnice v rodni dobi uporabljati učinkovito kontracepcijsko zaščito.
Nervous system disorders 
Motnje jetrnega delovanja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg PRE-FILLED SYRINGES 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 4 x 180 µg NAPOLNJENI INJEKCIJSKI PERESNIKI
Thyroid function 
Status ciroze
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg PRE-FILLED SYRINGE 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 1 x 180 µg NAPOLNJENA INJEKCIJSKA BRIZGA
QUALITATIVE AND QUANTITATIVE COMPOSITION Pegasys 90 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a*. 
Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Vsaka napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 90 mikrogramov peginterferona alfa2a*.
Myositis 
Okence
Musculoskeletal pain 
Bolezni mišično-skeletnega sistema: vnetje mišic.
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a. 
En napolnjeni injekcijski peresnik z 0,5 ml raztopine vsebuje 135 mikrogramov peginterferona alfa-2a.
Pegasys Dose Modification 
Prilagajanje odmerka zdravila Pegasys
Sarcoidosis, thyroiditis 
Brez ciroze in s cirozo
Diarrhoea*, nausea*, abdominal pain* 
Bolezni prebavil driska*, navzea*,
Polska 
Nemčija
NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection Peginterferon alfa-2a 
Navodilo za uporabo Pegasys 180 mikrogramov raztopina za injiciranje peginterferon alfa-2a
The sustained viral response achieved with 16 weeks of treatment and with 24 weeks of treatment was also examined in a retrospective subgroup analysis of patients who were HCV RNA negative by week 4 and had a LVL at baseline (see Table 17). 
V retrospektivni analizi podskupine bolnikov, ki so bili HCV RNA negativni do 4. tedna in so imeli pred začetkom zdravljenja nizko virusno breme, so preučili tudi trajni virološki odziv, dosežen s 16
Digestive system disorders: Gastrointestinal bleeding Liver disorders: Poor functioning of the liver 
Bolezni jeter: slabo delovanje jeter.
Ask your doctor, hospital or pharmacist for an appropriate container. 
Primeren vsebnik lahko dobite pri svojem zdravniku, farmacevtu ali v bolnišnici.
Pegasys 90 micrograms solution for injection in pre-filled syringe The syringe contains graduation marks corresponding to 90 micrograms (mcg), 65 mcg, 45 mcg, 30 mcg, 20 mcg and 10 mcg. 
Injekcijska brizga vsebuje oznake, ki ustrezajo 90 mikrogramom (mcg ali µg), 65 µg, 45 µg, 30 µg,
Genotype 1 RVR Low viral load High viral load Genotype 1 non RVR 
Genotip 1, hiter virološki odziv nizko virusno breme visoko virusno breme
P=0.0006 P=0.11 P=0.002 
p = 0,002
Mania, bipolar disorders, homicidal ideation 
psihotične motnje manija, bipolarna motnja razpoloženja,
Hepatic impairment 
- brez srčnega obolenja
Abdominal pain upper, stomatitis, nausea, aphthous stomatitis, oral disorder 
stomatitis, navzea, aftozni stomatitis, bolezen ustne votline
Digestive system disorders: Diarrhoea, nausea, abdominal pain Skin disorders: Loss of hair, and skin reactions (including itching, dermatitis and dry skin) Muscle and bone disorders: Pain in joints and muscles General disorders: Fever, weakness, tiredness, shaking, chills, pain, injection site irritation and irritability (getting easily upset) 
Splošne težave: zvišana telesna temperatura, slabotnost, utrujenost, tresenje, mrazenje, bolečina, vnetje na mestu injiciranja in razdražljivost (hitro se vznemirite).
Keep the pre-filled syringe in the outer carton in order to protect from light 
Ne zamrzujte Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
Shortening the treatment duration in patients with genotype 1 and high viral load (HVL) (>800, 000 IU/ml) at baseline who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24 should be considered with even more caution since the limited data available suggest that this may significantly negatively impact the sustained virologic response. 
Hiter virološki odziv = nemerljiva koncentracija HCV RNA v tednu 4 in nemerljiva koncentracija HCV RNA v tednu 24 Čeprav so podatki omejeni, kažejo na to, da je skrajšanje zdravljenja na 24 tednov lahko povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 16).
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a. 
En napolnjeni injekcijski peresnik z 0,5 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 135 µg PRE-FILLED SYRINGE 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA- 1 x 135 µg NAPOLNJENA INJEKCIJSKA BRIZGA
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg PRE-FILLED PEN 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 1 x 180 µg NAPOLNJENI INJEKCIJSKI PERESNIK
● To remove air bubbles from the syringe, hold the syringe with the needle pointing up. 
● Injekcijsko brizgo držite pokončno, igla naj bo obrnjena navzgor, da boste lahko odstranili zračne mehurčke.
Very common side effects with the combination of Pegasys and ribavirin (may affect more than 1 in 10 people) are: 
Pogosti neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 10 bolnikov) so:
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a. 
Ena viala z 1 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a.
Suicide, psychotic disorder 
zmedenostjo in spremembami duševnega stanja.
Eye disorders 
očesni pruritis
Genotype 1 (N= 569) 
Genotip A (n = 9)
● a vial of Pegasys solution for injection Not included in the pack: 
Izpostavljenost zdravilu Pegasys je bila v raziskavah,
Genotype 4 non RVR 
Genotip 4, hiter virološki odziv
135 or 180 micrograms peginterferon alfa-2a. 
Pegasys 180 μg injekcija peginterferon alfa-2a s.c.
Sepsis 
Stevens
6 pre-filled syringes + 6 injection needles 135 micrograms/0.5 ml 
raztopina za injiciranje 12 napolnjenih injekcijskih peresnikov 135 mikrogramov/0,5 ml
Back pain, pain in extremity 
hematom na mestu vboda, bolečina
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 135 µg PRE-FILLED PEN 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA- 1 x 135 µg NAPOLNJENI INJEKCIJSKI PERESNIK
Assessment 
Odmerjanje
6 pre-filled syringes + 6 injection needles 180 micrograms/0.5 ml 
raztopina za injiciranje 12 napolnjenih injekcijskih peresnikov 180 mikrogramov/0,5 ml
Pegasys must be used with caution in patients with psoriasis, and in cases of onset or worsening of psoriatic lesions, discontinuation of therapy should be considered. 
Pri bolnikih s psoriazo moramo zdravilo Pegasys uporabljati previdno.
NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a 
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
Genotype 1 RVR Low viral load High viral load Genotype 4 RVR 
≥ 2 log10 znižanje HCV RNA < 2 log10 znižanje HCV RNA
How to store Pegasys 
Shranjevanje zdravila Pegasys
3 x 200 mg tablets A.M. 3 x 200 mg tablets P.M. 
3 x 200-mg tablete zvečer
Cerebral ischaemia 
Roche Austria GmbH
Vision blurred, eye pain, eye inflammation, xerophthalmia 
kseroftalmija krvavitev mrežnice očesna nevropatija, edem papile,
-10.6% [-15.5% ; -0.06%] P<0.0001 
Genotip 2 ali 3 65 % (443/679) 76 % (478/630) -10,6 % [-15,5 %;
Digestive system disorders: Stomach ulcer, inflammation of the pancreas Liver disorders: Liver failure, bile duct inflammation, fatty liver Muscle and bone disorders: Inflammation of the muscles Kidney disorders: Kidney failure 
Bolezni mišično-skeletnega sistema: bolečina v hrbtu, vnetje sklepov, mišična oslabelost, bolečina v kosteh, bolečina v vratu, bolečina v mišicah, mišični krči.
Vials 3 years. 
Viale 3 leta.
In some cases you may need a blood transfusion. 
V nekaterih primerih je lahko potrebna transfuzija.
- Serious blood infection, which can be fatal. 
- Resna okužba krvi, ki je lahko usodna.
The following information is intended for healthcare professionals only: 
INFORMACIJE NAMENJENE SAMO ZDRAVSTVENEMU OSEBJU :
Table 2 Study results Study GOG-0179 
Preglednica 2: Rezultati študije GOG-0179
If you are or think you might be pregnant, tell your doctor immediately. 
Če ste noseči ali mislite, da bi lahko bili noseči, morate to nemudoma povedati svojemu zdravniku.
Reactions have been mild and have not generally required specific therapy 
Reakcije so bile blage in praviloma niso zahtevale specifičnega zdravljenja.
If severe it may cause breathing difficulties. 
Če je huda, lahko povzroči težave z dihanjem.
This treatment cycle will normally be repeated every three weeks. 
Ta ciklus zdravljenja se po navadi ponavlja na tri tedne.
feet and throat. 
stopalih in žrelu.