natgillin/translations-raw huggingface dataset:
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).
Ako bolesnik tijekom liječenja razvije kliničke simptome koji ukazuju na moguću disfunkciju štitnjače, mora se provjeriti razina TSH (vidjeti dio 4.8).
There are no data in paediatric patients coinfected with HCV/HIV or with renal impairment.
Nema podataka o primjeni u pedijatrijskih bolesnika s HIV-HCV koinfekcijom niti onih s oštećenjem bubrežne funkcije.
Recommendations for dose modifications of Pegasys for toxicities in the CHB and CHC paediatric populations are presented in Table 6.
Preporuke za prilagodbu doze lijeka Pegasys u slučaju toksičnosti kod pedijatrijske populacije s kroničnim hepatitisom B i kroničnim hepatitisom C prikazane su u tablici 6.
Patients with renal impairment
Bolesnici s cirozom
From the YV25718 study, 31 paediatric patients 3 to 17 years of age with CHB participated in the PK sub-study and received Pegasys according to a BSA category dosing regimen.
Ukupno je 31 pedijatrijski bolesnik s kroničnim hepatitisom B u dobi od 3 do 17 godina iz ispitivanja YV25718 sudjelovao u farmakokinetičkom podispitivanju i primao Pegasys u dozi određenoj prema tjelesnoj površini.
Common Uncommon Rare
Nepoznata učestalost
(N=88) 48 weeks
(N=88) 48 tjedana
135 or 180 micrograms peginterferon alfa-2a.
ili 180 mikrograma peginterferona alfa-2a.
(N=87) 48 weeks
(N=87) 48 tjedana
The first phase of decline occurs 24 to 36 hours after the first dose of Pegasys and is followed by the second phase of decline which continues over the next 4 to 16 weeks in patients who achieve a sustained response.
U bolesnika koji postignu trajan odgovor, do prve faze sniženja razine HCV RNK dolazi 24-36 sati nakon primjene prve doze lijeka Pegasys, nakon čega slijedi druga faza sniženja razine HCV RNK u sljedećih 4-16 tjedana.
1200 mg/day
1200 mg/dan
8) Dispose of pre-filled pen
8) Zbrinite napunjenu brizgalicu
Table 13: Virological response in CHC patients Pegasys monotherapy
Tablica 13: Virološki odgovor u bolesnika s kroničnim hepatitisom C Monoterapija lijekom Pegasys
< 250 cells/mm3 (or febrile neutropenia): discontinue treatment.
(ili febrilna neutropenija): obustaviti liječenje.
Pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis have been reported during therapy with Pegasys.
Tijekom liječenja lijekom Pegasys zamijećeni su plućni simptomi koji su uključivali dispneju, plućne infiltrate, upalu pluća i pneumonitis.
Pegasys 90 micrograms solution for injection in pre-filled syringe 3 years.
Pegasys 90 mikrograma otopina za injekciju u napunjenoj štrcaljki 3 godine.
Table 4: Pegasys dosing recommendations for paediatric patients with chronic hepatitis B and chronic hepatitis C
Tablica 4: Preporuke za doziranje lijeka Pegasys u pedijatrijskih bolesnika s kroničnim hepatitisom B i kroničnim hepatitisom C
Table 5: Pegasys dose modification recommendations in paediatric patients with chronic hepatitis B or chronic hepatitis C Starting dose (mcg)
Tablica 5: Preporuke za prilagodbu doze lijeka Pegasys u pedijatrijskih bolesnika s kroničnim hepatitisom B ili kroničnim hepatitisom C Početna doza (mikrogrami)
Pegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum
Pegasys je indiciran za liječenje HBeAg-pozitivnog kroničnog hepatitisa B u djece i adolescenata u dobi od 3 ili više godina koji nemaju cirozu ali imaju dokaz replikacije virusa i trajno povišene razine
Peginterferon alfa-2a
Interferon alfa-2b
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.
Na štrcaljki se nalaze oznake koje odgovaraju dozama od 90 mikrograma, 65 mikrograma, 45 mikrograma, 30 mikrograma, 20 mikrograma i 10 mikrograma.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mcg/1 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 180 μg/1 ml
Genotype 2 or 3 LVL with RVR**
Genotip 2 ili 3 LVL s RVR**
How to use Pegasys
Kako primjenjivati Pegasys
Genotype 1 HVL with RVR*
Genotip 1 HVL s RVR*
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
Tablica 17: Sveukupni trajni virološki odgovor, baziran na RVR do 4. tjedna, kod bolesnika s kroničnim hepatitisom C genotipa 2 ili 3 nakon primjene lijeka Pegasys u kombinaciji s ribavirinom
800 mg/day
800 mg/dan
How to store Pegasys
Kako čuvati Pegasys
● an injection needle Not included in the pack:
U pakiranju se ne nalazi:
No HBV-HIV co-infected patients were included in these clinical trials.
U ova klinička ispitivanja nisu bili uključeni bolesnici koinficirani HBV-om i
● Place the needle firmly on the tip of the syringe (4).
Čvrsto pričvrstite iglu na vrh štrcaljke (4).
For children and adolescents aged 3 to 17 years with CHB and having a BSA greater than 0.54 m2 and for children and adolescents aged 5 to 17 years with CHC and having a BSA greater than 0.71 m2, the recommended doses for Pegasys are provided in Table 4.
Body Surface Area, BSA) veća od 0,54 m2 te za djecu i adolescente s kroničnim hepatitisom C u dobi od 5 do 17 godina čija je tjelesna površina veća od 0,71 m2.
Do not use this medicine if you notice the syringe or needle packaging is damaged, if the solution is cloudy or if it has floating particles or if the medicine is any colour besides colourless to light yellow.
Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje štrcaljke ili igle oštećeno, ako je otopina zamućena ili u njoj plutaju čestice te ako nije bezbojna do svijetložuta.
The recommended dose of Pegasys in combination with ribavirin is 180 mcg once weekly by subcutaneous administration.
Preporučena doza lijeka Pegasys u kombinaciji s ribavirinom je 180 mikrograma jedanput tjedno primijenjena supkutano.
Tachycardia, oedema peripheral, palpitations,
Srčani poremećaji tahikardija, periferni edem, palpitacije infarkt miokarda,
400 mg/day
400 mg/dan
Table 19: Week 12 virological response (VR) and sustained virological response (SVR) in patients with virological response at week 12 after treatment with Pegasys and ribavirin combination therapy in nonresponders to peginterferon alfa-2b plus ribavirin Study MV17150 Pegasys 360/180 or 180 mcg
Tablica 19: Virološki odgovor (VR) u 12. tjednu i trajni virološki odgovor (SVR) u bolesnika s virološkim odgovorom u 12. tjednu nakon kombinirane primjene lijeka Pegasys i ribavirina koji nisu odgovorili na ranije liječenje peginterferonom alfa- 2b i ribavirinom
Table 6: Pegasys dose modification recommendations for toxicities in paediatric patients with chronic hepatitis B or chronic hepatitis C
Tablica 6: Preporuke za prilagodbu doze lijeka Pegasys u slučaju toksičnosti u pedijatrijskih bolesnika s kroničnim hepatitisom B ili kroničnim hepatitisom C
Do not shake.
Ne tresite je.
● 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.
Držite štrcaljku s iglom u bočici okrenutu prema gore, a zatim izvucite štrcaljku iz spoja, tako da duga igla ostane u bočici.
Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
Rizik od produljenja QTc intervala treba uzeti u obzir naročito u bolesnika koji primaju veće doze metadona.
a Patients who achieved viral suppression (undetectable HCV RNA, < 50 IU/ml) at week 12 were considered to have a virological response at week 12.
Bolesnicima s virološkim odgovorom u 12. tjednu smatrani su oni bolesnici u kojih je u 12. tjednu postignuta supresija virusa (nemjerljiv HCV RNK, <50 IU/ml).
(N=478) 48 weeks
(N=478) 48 tjedana
Early virological response by week 12, defined as a 2 log viral load decrease or undetectable levels of HCV RNA has been shown to be predictive for sustained response (see Tables 2 and 13).
Dokazano je da se kao pokazatelj trajnog odgovora javlja rani virološki odgovor do 12. tjedna, definiran kao smanjenje količine virusa za 2 log ili nemjerljiva razina HCV RNK (vidjeti tablice 2 i
Pegasys 180 micrograms solution for injection in pre-filled pen EU/1/02/221/014
Pegasys 180 mikrograma otopina za injekciju u napunjenoj brizgalici EU/1/02/221/014
Digestive system disorders: Gastrointestinal bleeding Liver disorders: Poor functioning of the liver
Poremećaji probavnog sustava: gastrointestinalno krvarenje
Pegasys is presented as a solution for injection in a vial (1 ml).
Pegasys je dostupan u obliku otopine za injekciju u napunjenoj brizgalici (0,5 ml).
Ribavirin 1000/1200 mg 72 or 48 Weeks (N = 942) Pts with VR at Wk 12 a
72 ili 48 tjedana (N = 942) Bolesnici s VR-om u 12. tjednu a
● Inject the solution by gently pushing the plunger all the way down.
Ubrizgajte otopinu lagano potiskujući klip do kraja.
Lamivudine 100 mg (N=271)
Pegasys mikrograma i placebo (N=271)
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
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 peginterferon alfa-2a
Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) have been rarely observed during alfa interferon therapy.
Za vrijeme liječenja alfa interferonima rijetko su zamjećivane snažne akutne reakcije preosjetljivosti (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksija).
The recommended dose for Pegasys is 180 micrograms once weekly given in combination with oral ribavirin or as monotherapy.
Odrasli bolesnici koji po prvi puta započinju liječenje Preporučena doza za Pegasys je 180 mikrograma jedanput tjedno u kombinaciji s peroralno primijenjenim ribavirinom ili kao monoterapija.
Psoriasis, urticaria, eczema, rash, sweating increased, skin disorder, photosensitivi ty reaction, night sweats
Poremećaji kože: osip, pojačano znojenje, psorijaza, koprivnjača, ekcem, osjetljivost na sunčevo svjetlo, noćno znojenje
Genotype 1 LVL with RVR*
Genotip 1 LVL s RVR*
For HIV-HCV patients receiving Pegasys and ribavirin combination therapy other undesirable effects have been reported in ≥ 1% to ≤ 2% of patients: hyperlactacidaemia/lactic acidosis, influenza, pneumonia,
Za ≥ 1% do ≤ 2% bolesnika zaraženih HIV-om i HCV-om na kombiniranom liječenju lijekom Pegasys i ribavirinom, prijavljene su i druge nuspojave: hiperlaktacidemija/laktična acidoza, gripa, upala pluća, afektivna labilnost, apatija, tinitus, bol u ždrijelu i grkljanu, heilitis, stečena lipodistrofija i kromaturija.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 135 mcg/0.5 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 135 μg/0,5 ml
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
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