natgillin/translations-raw huggingface dataset:
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) 
Poremećaji probavnog sustava: proljev, mučnina, bol u trbuhu Poremećaji kože: gubitak kose i reakcije na koži (uključujući svrbež, dermatitis i suhu kožu) Poremećaji mišića i kostiju: bolovi u zglobovima i mišićima
Pegasys dose 
Doza lijeka Pegasys
Treatment with interferon alfa-2a resulted in a statistically significant increase in abortifacient activity in rhesus monkeys. 
U rezus majmuna primjena interferona alfa-2a dovela je do statistički značajnoga povećanja pobačaja.
Pegasys 180 mcg Ribavirin 800 mg 16 weeks 
180 mikrograma i ribavirin 800 mg 16 tjedana
Low viral load High viral load 
Mala količina virusa Velika količina virusa
Pancytopenia Aplastic anaemia 
limfadenopatija pancitopenija aplastična anemija izolirana aplazija crvene krvne loze
Benzyl alcohol Sodium acetate Acetic acid Water for injections 
6.1 Popis pomoćnih tvari natrijev klorid polisorbat 80 benzilni alkohol natrijev acetat acetatna kiselina voda za injekcije
Treatment for 24 weeks may be considered in patients infected with - genotype 1 with low viral load (LVL) (≤ 800,000 IU/ml) at baseline or - genotype 4 who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24. 
- genotipom 1 s malom količinom virusa (LVL, engl. low viral load) (≤ 800 000 IU/ml) na početku liječenja ili - genotipom 4 koji su postali HCV RNK negativni u 4. tjednu i ostali negativni u 24. tjednu.
Pegasys 135 micrograms solution for injection in pre-filled syringe 4 years 
Pegasys 135 mikrograma otopina za injekciju u napunjenoj štrcaljki 4 godine.
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. 
Ovaj lijek se ne smije upotrijebiti ako primijetite da su napunjena brizgalica ili pakiranje oštećeni, ako je otopina zamućena ili u njoj plutaju čestice te ako nije bezbojna do svijetložuta.
For CHB patients, transient flares of ALT levels sometimes exceeding 10x ULN are not uncommon, and may reflect immune clearance. 
U bolesnika s kroničnim hepatitisom B česta je pojava kratkotrajnog naglog porasta razina ALT-a koje su ponekad čak 10-erostruko veće od GGN-a, što može biti znak imunološkog klirensa.
● Remove the needle guard from the syringe needle. 
Uklonite poklopac s igle koja se nalazi na štrcaljki.
Table 14: Sustained virological response based on genotype and pre-treatment viral load after Pegasys combination therapy with ribavirin in CHC patients 
Tablica 14: Trajni virološki odgovor temeljem genotipa i količine virusa prije liječenja a nakon primjene lijeka Pegasys u kombinaciji s ribavirinom u bolesnika s kroničnim hepatitisom C
It should be inspected visually for particulate matter and discoloration before administration. 
Prije primjene potrebno je vizualno provjeriti moguću prisutnost čestica i promjenu boje.
All treatment arms had 24 week treatment-free follow-up. 
Sve terapijske grupe praćene su 24 tjedna po završetku liječenja.
600 mg/day 
600 mg/dan
180 micrograms/0.5 ml 
4 napunjene brizgalice 180 mikrograma/0,5 ml
Suicide, psychotic disorder 
psihotični poremećaji manija,
Ribavirin 1000/1200 mg 72 Weeks (N = 473) SVR in Pts with VR at Wk 12 b 
72 tjedna (N = 473) SVR u bolesnika s VR-om u 12. tjednu b
Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml RVR = rapid viral response (HCV RNA undetectable) at week 4 
Mala količina virusa = ≤ 800 000 IU/ml; velika količina virusa = > 800 000 IU/ml RVR= brzi virološki odgovor (nemjerljiva razina HCV RNK) u 4. tjednu
Pegasys 135 micrograms solution for injection in pre-filled pen Pegasys 180 micrograms solution for injection in pre-filled pen 
Pegasys 135 mikrograma otopina za injekciju u napunjenoj brizgalici Pegasys 180 mikrograma otopina za injekciju u napunjenoj brizgalici
Pegasys 135 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a*. 
Pegasys 135 mikrograma otopina za injekciju u napunjenoj štrcaljki Svaka štrcaljka s 0,5 ml otopine sadrži 135 mikrograma peginterferona alfa-2a*.
*These adverse reactions were common (≥1/100 to < 1/10) in CHB patients treated with Pegasys monotherapy § Class label for interferon products, see below Pulmonary arterial hypertension. 
* Te su nuspojave česte (≥ 1/100 i < 1/10) u bolesnika s kroničnim hepatitisom B liječenih samo lijekom
MARKETING AUTHORISATION NUMBERS Pegasys 180 micrograms solution for injection EU/1/02/221/003 
Pegasys 180 mikrograma otopina za injekciju EU/1/02/221/003
Withhold Pegasys 
Pegasys
Alopecia, dermatitis, pruritis, dry skin 
Poremećaji kože i potkožnog tkiva alopecija, dermatitis, svrbež, suha koža psorijaza, urtikarija, ekcem,
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 90 mcg/0.5 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 90 μg/0,5 ml
Low viral load High viral load Genotype 4 (0/5) 
Mala količina virusa Velika količina virusa 3% (4/129)
Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with Pegasys. 
Molimo također pogledajte i Sažetak opisa svojstava lijekova koji se koriste u kombinaciji s lijekom
Ribavirin 1000/1200 mg 48 Weeks (N = 469) SVR in Pts with VR at Wk 12 b 
48 tjedana (N = 469) SVR u bolesnika s VR-om u 12. tjednu b
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mcg/0.5 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 180 μg/0,5 ml
Peginterferon alfa-2a serum concentrations are sustained throughout one full week (168 hours). 
Omjer najviše i najniže koncentracije nakon 48 tjedana liječenja iznosi 1,5 do 2. Serumske koncentracije peginterferona alfa-2a stalne su tijekom cijeloga tjedna (168 sati).
135 micrograms/0.5 ml 
1 napunjena brizgalica 135 mikrograma/0,5 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 90 µg PRE-FILLED SYRINGE 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 90 µg NAPUNJENA ŠTRCALJKA
Thrombocytopenia Platelet 25,000 to <50,000 cells/mm3: 2 level adjustment. 
Trombociti od 25 000 do < 50 000 stanica/mm 3: sniziti dozu za
Efficacy response in group C to Pegasys treatment was in line with that seen in group A. For paediatric patients, efficacy has not been established in HBV genotypes other than genotypes A-D. 
Kod pedijatrijskih je bolesnika djelotvornost ustanovljena samo za HBV genotipa A-D.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 135 µg PRE-FILLED SYRINGES (WITH BLUE BOX) - Multipack 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 12 x 135 µg NAPUNJENE ŠTRCALJKE (S PLAVIM OKVIROM) - Višestruko pakiranje
Following a single subcutaneous injection of Pegasys 180 micrograms in healthy subjects, serum concentrations of peginterferon alfa-2a are measurable within 3 to 6 hours. 
U zdravih ispitanika koncentracije peginterferona alfa-2a u serumu moguće je izmjeriti već 3 do 6 sati nakon jednokratne supkutane injekcije lijeka Pegasys u dozi od 180 mikrograma.
The following may be considered as baseline values for initiation of treatment: - Platelet count ≥ 90,000 cells/mm3 - ANC ≥ 1500 cells/mm3 
- trombociti ≥90 000 stanica/mm - ABN ≥1500 stanica/mm
For adults, dose reduction is recommended if the absolute neutrophil count (ANC) is 500 to < 750 cells/mm3. 
Hematološke nuspojave (također vidjeti tablicu 3) U odraslih se preporučuje smanjenje doze ako je apsolutni broj neutrofila (ABN) od 500 do
Dehydration 
migrena
Diarrhoea*, nausea*, abdominal pain* 
Poremećaji probavnog sustava proljev*, mučnina*, bol u trbuhu*
200 mg/day 
200 mg/dan
Pegasys 180 micrograms solution for injection Peginterferon alfa-2a 
Pegasys 180 mikrograma otopina za injekciju peginterferon alfa-2a
10% and 8% of patients receiving Pegasys monotherapy and combination therapy, respectively. 
3, primijećeno je u 10% bolesnika koji su primali samo Pegasys odnosno u 8% bolesnika koji su primali kombinirano liječenje.
Fluctuations in abnormalities of liver function tests are common in patients with CHC. 
U bolesnika s kroničnim hepatitisom C uobičajene su oscilacije u patološkim nalazima funkcije jetre.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED SYRINGES (WITH BLUE BOX) - Multipack 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 12 x 180 µg NAPUNJENE ŠTRCALJKE (S PLAVIM OKVIROM) - višestruko pakiranje
Component of a multipack, can't be sold separately. 
180 mikrograma/0,5 ml dio višestrukog pakiranja, ne može se prodavati zasebno
Very common side effects with the combination of Pegasys and ribavirin (may affect more than 1 in 10 people) are: 
Vrlo česte nuspojave pri primjeni kombiniranog liječenja lijekom Pegasys i ribavirinom (mogu se javiti u više od 1 na 10 osoba) su:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED PENS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 12 x 180 µg NAPUNJENE BRIZGALICE
Body weight kg (lbs) 
Tjelesna težina kg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 135 µg PRE-FILLED PENS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 12 x 135 µg NAPUNJENE BRIZGALICE
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 mikrograma otopina za injekciju u napunjenoj štrcaljki Pegasys 135 mikrograma otopina za injekciju u napunjenoj štrcaljki Pegasys 180 mikrograma otopina za injekciju u napunjenoj štrcaljki
Each vial of 1.0 ml solution contains 180 micrograms peginterferon alfa-2a. 
Jedna bočica s 1,0 ml otopine sadrži 180 mikrograma peginterferona alfa-2a.
There are no or limited amount of data from the use of peginterferon alfa-2a in pregnant women. 
Podaci o primjeni pegiliranoga interferona alfa-2a u trudnica ne postoje ili su ograničeni.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 6 x 180 µg PRE-FILLED SYRINGES (WITHOUT BLUE BOX)Multipack 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 6 x 180 µg NAPUNJENE ŠTRCALJKE (BEZ PLAVOG OKVIRA) - višestruko pakiranje
4 pre-filled syringes + 4 injection needles 135 micrograms/0.5 ml 
4 napunjene štrcaljke + 4 igle za injekciju 135 mikrograma/0,5 ml
One step dose modification (Approx. 7.5 mg/kg/day) 
Puna doza (približno 15 mg/kg/dan)
1 pre-filled syringe + 1 injection needle 90 micrograms/0.5 ml 
1 napunjena štrcaljka + 1 igla za injekciju 90 mikrograma/0,5 ml
Genotype 1 RVR Low viral load High viral load Genotype 1 non RVR 
Genotip 1 s RVR-om Mala količina virusa Velika količina virusa Genotip 1 bez RVR-a Mala količina virusa Velika količina virusa Genotip 4 s RVR-om
4 pre-filled syringes + 4 injection needles 180 micrograms/0.5 ml 
4 napunjene štrcaljke + 4 igle za injekciju 180 mikrograma/0,5 ml
Pegasys 180 micrograms solution for injection in pre-filled syringe 4 years 
Pegasys 180 mikrograma otopina za injekciju u napunjenoj štrcaljki 4 godine.
Dental and periodontal disorders 
Poremećaji zubi i desni
1 pre-filled syringe + 1 injection needle 180 micrograms/0.5 ml 
1 napunjena štrcaljka + 1 igla za injekciju 180 mikrograma/0,5 ml
1 pre-filled syringe + 1 injection needle 135 micrograms/0.5 ml 
1 napunjena štrcaljka + 1 igla za injekciju 135 mikrograma/0,5 ml
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 mikrograma otopina za injekciju u napunjenoj štrcaljki Svaka štrcaljka s 0,5 ml otopine sadrži 180 mikrograma peginterferona alfa-2a*.
Treatment discontinuation is recommended when platelet count decreases to levels < 25,000 cells/mm3. 
Kada razina trombocita padne na <25 000 stanica/mm 3, preporučuje se prekid liječenja.
1 x 200 mg tablets A.M. 
1 x 200 mg tableta prije podne
Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, dry mouth 
povraćanje, dispepsija, disfagija, ulceracija u usnoj šupljini,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 6 x 135 µg PRE-FILLED SYRINGES (WITHOUT BLUE BOX)Multipack 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 6 x 135 µg NAPUNJENE ŠTRCALJKE (BEZ PLAVOG OKVIRA) - višestruko pakiranje
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 135 µg PRE-FILLED SYRINGE 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 135 µg NAPUNJENA ŠTRCALJKA
Renal impairment 
Harada bolest
Neoplasms benign and malignant 
Dobroćudne i zloćudne novotvorine novotvorina jetre
Pegasys Dose Modification 
Prilagodba doze lijeka Pegasys
Myocardial infarction, congestive heart failure, cardiomyopat hy, angina, arrhythmia, atrial fibrillation, pericarditis, supraventricu lar tachycardia 
fibrilacija atrija, perikarditis, supraventrikularna tahikardija
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 mikrograma otopina za injekciju u napunjenoj brizgalici Svaka napunjena brizgalica s 0,5 ml otopine sadrži 180 mikrograma peginterferona alfa-2a*.
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). 
U ispitivanjima NV15942 i ML17131 (vidjeti tablicu 15) ispitivana je mogućnost skraćivanja trajanja terapije na 24 tjedna u bolesnika s genotipom 1 i 4 na temelju trajnog virološkog odgovora opaženog u bolesnika s brzim virološkim odgovorom u 4. tjednu.
Fertility 
Lamivudin
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 
Genotip 4 bez RVR-a mala količina virusa = ≤ 800 000 IU/ml; velika količina virusa = > 800 000 IU/ml RVR (eng. rapid viral response) = brzi virološki odgovor (nemjerljiv HCV RNK) u 4. tjednu i nemjerljiv HCV RNK u 24. tjednu
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 135 µg PRE-FILLED PEN 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 135 µg NAPUNJENA BRIZGALICA
HCV monoinfected patients and HBV monoinfected patients 
Bolesnici inficirani samo HCV-om ili samo HBV-om
Blood disorders: Pure red cell aplasia (a severe form of anemia where red blood cell production is decreased or stopped); it can result in symptoms such as feeling very tired with no energy Immune system disorders: Vogt Koyanagi Harada disease - a rare disease characterised by loss of vision, hearing and skin pigmentation; liver and kidney transplant rejections Psychiatric and nervous system disorders: Mania (episodes of exaggerated elevation of mood) and bipolar disorders (episodes of exaggerated elevation of mood alternating with sadness and hopelessness); thoughts about threatening the life of others, stroke Eye disorders: Rare form of retinal detachment with fluid in the retina Heart and blood vessel disorders: Peripheral ischaemia (insufficient blood supply to the extremities) Digestive system disorders: Ischaemic colitis (insufficient blood supply to the bowels), changes in the colour of the tongue 
Poremećaji imunološkog sustava: Vogt Koyanagi Harada bolest - rijetka bolest karakterizirana gubitkom vida, sluha i pigmentacije kože; odbacivanje jetrenog i bubrežnog presatka Psihijatrijski poremećaji i poremećaji živčanog sustava: manija (epizode pretjerano dobrog raspoloženja) i bipolarni poremećaji (epizode pretjerano dobrog raspoloženja izmjenjuju se s tugom i beznađem); razmišljanja o ugrožavanju života drugih ljudi, moždani udar.
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. 
* Pegasys 180 mikrograma i ribavirin 1000/1200 mg, 48 tj. u odnosu na Pegasys 180 mikrograma i ribavirin 800 mg, 48 tj.: Omjer izgleda (95% CI) = 1,52 (1,07 do 2,17) P-vrijednost (stratificirani Cochran-Mantel-Haenszel test) = 0,020
HIV-HCV co-infected adult patients 
Odrasli bolesnici s HIV-HCV koinfekcijom
Infections: Infection of the heart, infection of the external ear Blood disorders: Severe reduction in red blood cells, white blood cells and platelets Immune system disorders: Severe allergic reaction, systemic lupus erythematosus (an illness where the body attacks its own cells), rheumatoid arthritis (an autoimmune disease) Hormone system disorders: Diabetic ketoacidosis, a complication of uncontrolled diabetes Psychiatric and nervous system disorders: Suicide, psychotic disorders (severe problems with personality and deterioration in normal social functioning), coma (a deep prolonged unconsciousness), seizures, facial palsy (weakness of the facial muscle) Eye disorders: Inflammation and swelling of the optic nerve, inflammation of the retina, ulceration of the cornea 
Hormonski poremećaji: dijabetička ketoacidoza, komplikacija nekontrolirane šećerne bolesti Psihijatrijski poremećaji i poremećaji živčanog sustava poremećaji: samoubojstvo, psihotični poremećaji (teški problemi s osobnošću i pogoršanje normalnog funkcioniranja u društvu), koma (duboka i dugotrajna nesvijest), konvulzije, paraliza lica (slabost mišića lica)
NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection 
Pegasys 180 mikrograma otopina za injekciju
Each pre-filled syringe of 0.5 ml solution contains 90, 135 or 180 micrograms peginterferon alfa-2a. 
Svaka napunjena brizgalica s 0,5 ml otopine sadrži 135 mikrograma peginterferona alfa-2a*.
● the medicine is cloudy 
● je lijek mutan
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 
Poremećaji jetre: zatajenje jetre, upala žučnog kanala, masna jetra Poremećaji mišića i kostiju: upala mišića
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/016 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/016
● Select the injection site in the abdomen or thigh (except your navel or waistline). 
Odaberite mjesto u predjelu bedra ili trbuha (bilo koje osim pupka i struka) u koje ćete ubrizgati dozu.
* 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. 
D imala je veći udio bolesnika s početnom vrijednošću ALT-a < 1,5 x GGN (13/31) nego skupine bolesnika s drugim genotipovima (16/70).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 180 µg PRE-FILLED SYRINGE 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 180 µg NAPUNJENA ŠTRCALJKA
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna štrcaljka s 0,5 ml otopine sadrži 90 mikrograma peginterferona alfa-2a.
Flushing Hypertension Cerebral haemorrhage, vasculitis 
ječmenac, infekcija mokraćnog sustava, nazofaringitis
HIV-HCV co-infected patients 
Bolesnici koinficirani HIV-om i HCV-om
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. 
Na štrcaljki se nalaze oznake koje odgovaraju dozama od 135 mikrograma, 90 mikrograma i 45 mikrograma.
The occurrence of anaemia (haemoglobin <10 g/dl) has been observed in up to 15% of CHC patients in clinical trials on the combined treatment of Pegasys with ribavirin. 
U kliničkim ispitivanjima kombiniranog liječenja lijekom Pegasys i ribavirinom, opaženo je da se anemija (hemoglobin <10 g/dl) javila u do 15% bolesnika koji boluju od kroničnog hepatitisa C.
Each pre-filled pen of 0.5 ml solution contains 
Jedna napunjena brizgalica s 0,5 ml otopine sadrži 135 ili
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 90 µg PRE-FILLED SYRINGE 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 1 x 90 µg NAPUNJENA ŠTRCALJKA
Heart and blood vessel disorders: Heart attack, heart failure, heart pain, rapid heart rhythm, rhythm disorders or inflammation of the lining of the heart and cardiac muscle, bleeding in the brain and inflammation in the vessels 
Poremećaji oka: upala i natečenost optičkog živca, upala mrežnice, vrijed rožnice Poremećaji srca i krvnih žila: srčani udar, zatajenje srca, bol u srcu, brzi srčani ritam, poremećaji ritma ili upala srčane ovojnice i srčanog mišića, krvarenje u mozgu i upala krvnih žila Poremećaji dišnog sustava: intersticijska upala pluća (upala pluća uključujući smrtni ishod), krvni ugrušci u plućima
Retinal haemorrhage 
Tablični prikaz nuspojava
Exposure to Pegasys was decreased in studies following administration of Pegasys in the arm compared to administration in the abdomen and thigh. 
Ispitivanja koja su pratila izloženost lijeku Pegasys nakon njegove primjene u nadlakticu pokazuju da je ona bila niža nego u njegovoj primjeni u predjel trbuha i bedra.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 180 µg VIAL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 180 µg BOČICA
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. 
Farmakokinetika lijeka Pegasys bila je podjednaka u zdravih ispitanika i bolesnika s hepatitisom B ili C.
HCV RNA levels decline in a biphasic manner in responding patients with hepatitis C who have received treatment with 180 micrograms Pegasys. 
U bolesnika s hepatitisom C koji su nakon primjene lijeka Pegasys u dozi od 180 mikrograma postigli virološki odgovor, razine HCV RNK opadaju u dvije faze.
Hyperglycaemia, type 1 diabetes mellitus 
Poremećaji metabolizma i prehrane smanjen tek hiperglikemija, šećerna bolest tipa 1
Pegasys 180 mcg Ribavirin 800 mg 
* Pegasys 180 mikrograma i ribavirin 800 mg u odnosu na Pegasys 180 mikrograma:
Ascites 
Trombociti
1 x 200 mg tablets A.M. 1 x 200 mg tablets P.M. 
1 x 200 mg tableta prije podne 1 x 200 mg tableta poslije podne
Rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 1000 people) are: 
Rijetke nuspojave pri primjeni kombiniranog liječenja lijekom Pegasys i ribavirinom koje se (mogu se javiti u do 1 na 1000 osoba):
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. 
Na štrcaljki se nalaze oznake koje odgovaraju dozama od 180 mikrograma, 135 mikrograma i 90 mikrograma.
● use if medicine is cloudy, hazy, discoloured or has particles in it. 
● ne primjenjujte ako je lijek mutan, magličast, ako je promijenio boju ili sadrži vidljive čestice.
Very rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10,000 people) are: 
Vrlo rijetke nuspojave pri primjeni kombiniranog liječenja lijekom Pegasys i ribavirinom (mogu se javiti u do 1 na 10 000 osoba):
(all other genotypes). 
(genotip 2 i 3) odnosno 48 tjedana (svi drugi genotipovi).
HBV-DNA was measured by the COBAS AMPLICOR HBV 
Virološki odgovor definiran je kao nemjerljiva količina HCV RNK mjerena testom COBAS AMPLICOR