FrancophonIA/ELRC3.0 huggingface dataset:
English: Also contains sodium chloride, polysorbate 80, benzyl alcohol (see leaflet for further information), sodium acetate, acetic acid and water for injections.
Croatian: Također sadrži natrijev klorid, polisorbat 80, benzilni alkohol (za daljnje informacije vidjeti uputu o lijeku ), natrijev acetat, acetatnu kiselinu i vodu za injekcije.
English: Serum concentrations of theophylline should be monitored and appropriate dose adjustments of theophylline made for patients taking theophylline and Pegasys concomitantly.
Croatian: U bolesnika koji istodobno uzimaju teofilin i Pegasys treba nadzirati koncentracije teofilina u serumu i prema potrebi prilagoditi dozu teofilina.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Subcutaneous use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku Za potkožnu primjenu
English: Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 180 micrograms/0.5 ml
Croatian: otopina za injekciju višestruko pakiranje: 12 (2 pakiranja s po 6) napunjenih štrcaljki + 12 igala za injekciju 180 mikrograma/0,5 ml
English: Odds Ratio (95% CI) = 2.89 (1.93 to 4.32), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0001 * Interferon alfa-2a 3 MIU & ribavirin 800 mg vs. Pegasys 180 mcg:
Croatian: omjer izgleda(95% CI) = 2,89 (1,93 do 4,32), P-vrijednost (stratificirani Cochran-Mantel-Haenszel test) = < 0,0001 * Interferon alfa-2a 3 MIU i ribavirin 800 mg u odnosu na Pegasys 180 mikrograma:
English: Adult chronic hepatitis C prior treatment non-responder patients In study MV17150, patients who were non-responders to previous therapy with pegylated interferon alfa-2b plus ribavirin were randomised to four different treatments:
Croatian: U ispitivanju MV17150 bolesnici koji nisu odgovorili na ranije liječenje pegiliranim interferonom alfa-2b i ribavirinom, randomizirani su u četiri različite terapijske grupe:
English: Educational problem
Croatian: Socijalne okolnosti poteškoće u obrazovanju
English: ● Remove the needle guard.
Croatian: Uklonite zaštitni poklopac igle.
English: In HIV-HCV co-infected patients, the clinical adverse reaction profiles reported for Pegasys, alone or in combination with ribavirin, were similar to those observed in HCV mono-infected patients.
Croatian: Prijavljeni profili kliničkih nuspojava za Pegasys, sam ili u kombinaciji s ribavirinom, u bolesnika istodobno zaraženih HIV-om i HCV-om slični su profilima zabilježenima u bolesnika zaraženih samo HCV-om.
English: Heart and blood vessel disorders: High blood pressure Breathing disorders: Wheezing
Croatian: Poremećaji srca i krvnih žila: povišeni krvni tlak
English: Cut-off (IU/mL)
Croatian: Genotip Granična vrijednost (IU/ml)
English: For HCV monoinfected patients and HIV-HCV co-infected patients, for treatment regimens, duration of therapy and study outcome see Tables 13, 14, 15 and Table 21, respectively.
Croatian: Za načine liječenja, trajanje terapije i rezultate ispitivanja bolesnika inficiranih samo HCV-om kao i za bolesnike koinficirane HIV-om i HCV-om, pogledajte u tablice 13, 14, 15, te tablicu 21.
English: Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 135 micrograms/0.5 ml
Croatian: otopina za injekciju višestruko pakiranje: 12 (2 pakiranja s po 6) napunjenih štrcaljki + 12 igala za injekciju 135 mikrograma/0,5 ml
English: 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
Croatian: U sponzoriranom ispitivanju CHIPS (Chronic Hepatitis C International Paediatric Study), 65 djece i adolescenata (6-18 godina) s kroničnom HVC infekcijom bilo je liječeno lijekom Pegasys u dozi od 100 mikrograma/m2 primijenjenim supkutano jedanput tjedno i ribavirinom 15 mg/kg/dan 24 tjedna (genotip 2 i 3) odnosno 48 tjedana (svi drugi genotipovi).
English: In study WV16241, the primary efficacy endpoints were ALT normalisation and HBVDNA below 2 x 104 copies/ml.
Croatian: U ispitivanju WV16241 primarni pokazatelji djelotvornosti bili su normalizacija ALT-a i HBV-DNK manja od 2 x 10
English: HBV genotype A B
Croatian: HBV genotipa
English: In these patients, tolerability to combination therapy and the presence of additional clinical or prognostic factors such as degree of fibrosis should be taken into account when considering deviations from standard 24 weeks treatment duration.
Croatian: U takvih bolesnika, prilikom razmatranja da li da se odstupi od standardnog 24-tjednog trajanja liječenja, treba uzeti u obzir podnošljivost kombiniranog liječenja, te prisutnost dodatnih kliničkih ili prognostičkih faktora kao što je stupanj fibroze.
English: Ask your doctor, hospital or pharmacist for an appropriate container.
Croatian: Odgovarajući spremnik zatražite od liječnika, u bolnici ili od ljekarnika.
English: Each syringe should be used by one person only and is for single use.
Croatian: Svaku štrcaljku smije koristiti samo jedna osoba i namijenjena je za jednokratnu primjenu.
English: Pegasys treatment may be initiated or continued if TSH levels can be maintained in the normal range by pharmaceutical means.
Croatian: Ako se razine TSH mogu farmaceutskim sredstvima održavati u granicama normale, moguće je započeti/nastaviti liječenje lijekom Pegasys.
English: Placebo 48 weeks
Croatian: 180 mikrograma i placebo 48 tjedana
English: Overall Low viral load High viral load Genotype 1/4 Low viral load High viral load Genotype 2/3 Low viral load High viral load Cirrhosis Status Cirrhosis Noncirrhosis Best Response during Previous Treatment ≥2log10 decline in HCV RNA <2log10 decline in HCV RNA Missing best previous response
Croatian: Sveukupno Mala količina virusa Velika količina virusa Genotip 1/4 Mala količina virusa Velika količina virusa Genotip 2/3 Mala količina virusa Velika količina virusa Stanje ciroze Ciroza Bez ciroze Najbolji odgovor tijekom ranijeg liječenja Smanjenje HCV RNK ≥ 2log10 Smanjenje HCV RNK< 2log10 Nema najboljeg prethodnog odgovora Velika količina virusa = > 800 000 IU/ml; mala količina virusa = ≤ 800 000 IU/ml a
English: ● Visually inspect the solution prior to administration: do not use if it is discoloured or if particles are present.
Croatian: Prije primjene pregledajte otopinu; ne upotrebljavajte je ako se boja promijenila ili su u otopini prisutne čestice.
English: Absent Slight Moderate
Croatian: Ascites nema blagi umjereni
English: Your next injection will be on the Monday, 5 days later after the Wednesday injection.
Croatian: Iduću injekciju trebate primiti u ponedjeljak, 5
English: ALT <1xULN >=1xULN<1.5xULN >=1.5xULN<2xULN >=2xULN<5xULN >=5xULN<10xULN >=10xULN
Croatian: ALT < 1 x GGN ≥ 1 x GGN< 1,5 x GGN ≥ 1,5 x GGN< 2 x GGN ≥ 2 x GGN< 5 x GGN ≥ 5 x GGN< 10 x GGN ≥ 10 x GGN
English: Odds Ratio (95% CI) = 0.53 (0.33 to 0.85), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0084
Croatian: omjer izgleda (95% CI) = 0,53 (0,33 do 0,85), P-vrijednost (stratificirani Cochran-Mantel-Haenszel test) = < 0,0084
English: Psychiatric and nervous system disorders: Feeling depressed (feeling low, feeling bad about yourself or feeling hopeless), anxiety, inability to sleep, headache, difficulty concentrating and dizziness Breathing disorders: Cough, shortness of breath
Croatian: Psihijatrijski poremećaji i poremećaji živčanog sustava: osjećaj depresije (osjećaj potištenosti, utučenosti ili beznađa), tjeskoba, nesanica, glavobolja, teškoće s koncentracijom i omaglica Poremećaji dišnog sustava: kašalj, nedostatak zraka
English: Pegasys treatment has been associated with decreases in platelet count, which returned to pretreatment levels during the post-treatment observation period (see section 4.8).
Croatian: Liječenje lijekom Pegasys povezano je s padom broja trombocita koji bi se u razdoblju praćenja nakon prestanka primjene lijeka vratio na razine prije liječenja (vidjeti dio 4.8).
English: D-79639 Grenzach- Wyhlen Germany
Croatian: D-79639 Grenzach- Wyhlen Njemačka
English: Paediatric patients treated with Pegasys plus ribavirin combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline.
Croatian: U pedijatrijskih bolesnika liječenih kombinacijom lijeka Pegasys i ribavirina, nakon 48 tjedana liječenja došlo je do kašnjenja u prirastu tjelesne težine i visine u odnosu na početne vrijednosti.
English: (copies/mL) / 5.26) ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
Croatian: ** Bolesnici koji su prešli na liječenje lijekom Pegasys nakon glavnog razdoblja promatranja i prije 24. tjedna praćenja smatrali su se bolesnicima bez odgovora.
English: As with other alfa interferons, prolongation of the menstrual cycle was observed following administration of peginterferon alfa-2a to female monkeys.
Croatian: Kao i kod drugih alfa interferona, nakon primjene peginterferona alfa-2a u ženki majmuna zamijećeno je produljenje menstrualnoga ciklusa.
English: Limited safety data are available in co-infected patients with CD4+ cell counts <200/µl.
Croatian: Za bolesnike istodobno zaražene HIV-om i HCV-om s brojem CD4+ stanica < 200/µl, dostupni su ograničeni podaci o sigurnosti.
English: By HBV-DNA (IU/mL) decline from baseline to week 12
Croatian: Prema sniženju razine HBV DNK (IU/ml) od početka ispitivanja do 12. tjedna
English: Response by week
Croatian: Odgovor do 12. tjedna
English: Measuring the dose of Pegasys
Croatian: Mjerenje doze lijeka Pegasys
English: Hormone system disorders: Overactive and underactive thyroid gland Psychiatric and nervous system disorders: Mood /emotion changes, aggression, nervousness, decreased sexual desire, poor memory, fainting, decreased muscle strength, migraine, numbness, tingling, burning sensation, tremor, changes in the sense of taste, nightmares, sleepiness Eye disorders: Blurry vision, eye pain, eye inflammation and dry eyes
Croatian: Hormonski poremećaji: pojačana i smanjena aktivnost štitne žlijezde Psihijatrijski poremećaji i poremećaji živčanog sustava: promjene u raspoloženju/emocijama, agresija, nervoza, smanjenje seksualne želje, loše pamćenje, nesvjestica, smanjena snaga mišića, migrena, obamrlost, trnci, osjećaj peckanja, nevoljno drhtanje, promjene u okusu, noćne more, pospanost Poremećaji oka: zamućen vid, bol u oku, upala oka, suhoća očiju Poremećaji uha: bol u ušima
English: Ribavirin 800 mg 48 weeks
Croatian: 3 MIU i ribavirin 800 mg 48 tjedana
English: • Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 36 weeks
Croatian: • Pegasys 360 mikrograma/tjedan kroz 12 tjedana, a nakon toga 180 mikrograma/tjedan kroz sljedećih 36 tjedana
English: Treatment-experienced adult patients
Croatian: Odrasli bolesnici koji su ranije liječeni
English: 180 micrograms/1 ml
Croatian: 1 bočica 180 mikrograma/1 ml
English: Chronic hepatitis B in adult patients
Croatian: Kronični hepatitis B u odraslih bolesnika
English: Bronchitis, upper respiratory infection, oral candidiasis, herpes simplex, fungal, viral and bacterial infections
Croatian: Infekcije i infestacije bronhitis, infekcija gornjeg dišnog sustava, oralna kandidijaza, herpes simpleks, gljivične, virusne i bakterijske infekcije upala pluća, infekcija kože endokarditis, upala vanjskog uha sepsa
English: Refer also to the package leaflets of any other medicines that are used in combination with Pegasys.
Croatian: Također pogledajte i upute o lijeku svih ostalih lijekova koji se koriste u kombinaciji s lijekom
English: It is available in packs containing containing 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes.
Croatian: Lijek je dostupan u pakiranju s 1, 4 ili višestrukom pakiranju s 12 ( 2 pakiranja s po 6) napunjenih štrcaljki.
English: Decrease in platelets below 50,000 cells/mm3 was observed in
Croatian: Smanjenje broja trombocita na manje od 50 000 stanica/mm
English: 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.
Croatian: Srednja vrijednost promjene Z-rezultata za tjelesnu visinu i težinu za određenu dob u 48. tjednu liječenja u ispitivanju YV25718 iznosila je -0,07 odnosno -0,21 (n=108 odnosno n=106) u bolesnika liječenih lijekom Pegasys, u usporedbi s -0,01 odnosno -0,08 (n=47 za oba parametra) u neliječenih bolesnika.
English: In case of intolerance to ribavirin, Pegasys monotherapy should be continued.
Croatian: U bolesnika koji ne podnose ribavirin, liječenje treba nastaviti samo lijekom Pegasys.
English: Also contains sodium chloride, polysorbate 80, benzyl alcohol (see leaflet for futher information), sodium acetate, acetic acid and water for injections.
Croatian: Također sadrži natrijev klorid, polisorbat 80, benzilni alkohol (za daljnje informacije vidjeti uputu o lijeku), natrijev acetat, acetatnu kiselinu i vodu za injekcije.
English: ● Remove the syringe from the wrapping.
Croatian: Izvucite štrcaljku iz omota.
English: Pegasys pre-filled pen
Croatian: Pegasys napunjenu brizgalicu
English: 6) Place the pre-filled pen on the injection site
Croatian: 5) Uklonite zatvarač 6) Postavite napunjenu brizgalicu na mjesto injekcije
English: 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.
Croatian: mala količina virusa = ≤ 800 000 IU/ml; velika količina virusa = > 800 000 IU/ml * 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 * Pegasys 180 mikrograma i ribavirin 1000/1200 mg, 48 tj. u odnosu na Pegasys 180 mikrograma i ribavirin 1000/1200 mg, 24 tj.: Omjer izgleda (95% CI) = 2,12 (1,30 do 3,46) P-vrijednost (stratificirani Cochran-Mantel-Haenszel test) = 0,002
English: • Pegasys 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 60 weeks
Croatian: • Pegasys 360 mikrograma/tjedan kroz 12 tjedana, a nakon toga 180 mikrograma/tjedan kroz sljedećih 60 tjedana
English: Genotype 1 RVR Low viral load High viral load Genotype 4 RVR
Croatian: Genotip 1 s RVR-om Mala količina virusa Velika količina virusa Genotip 4 s RVR-om
English: Ribavirin dose
Croatian: Doza ribavirina
English: Patients with cirrhosis were not enrolled in this study.
Croatian: U ispitivanje nisu bili uključeni bolesnici s cirozom.
English: A puncture-proof container with lid for safe disposal of used pens
Croatian: Spremnik s poklopcem koji se ne može probušiti za sigurno odlaganje iskorištenih brizgalica Koraci u postupku:
English: HBsAg > 20,000 HBV DNA > 6.5 log10
Croatian: HBsAg > 20 000 HBV DNK > 6,5 log10
English: Available in packs of 1 pre-filled syringe.
Croatian: Lijek je dostupan u pakiranju s 1 napunjenom štrcaljkom.
English: Dyspnoea, epistaxis
Croatian: povraćanje, dispepsija,
English: Site of administration
Croatian: Mjesto primjene
English: Use with ribavirin
Croatian: Primjena s ribavirinom
English: 25,000 to cells/mm cells/mm3
Croatian: 25 000 do stanica/mm stanica/mm
English: Undesirable effects reported in clinical studies are grouped according to frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Croatian: U tablici 9 nalazi se sažetak prijavljenih nuspojava za liječenje samo lijekom Pegasys u odraslih bolesnika s kroničnim hepatitisom B ili C i za kombinirano liječenje lijekom Pegasys i ribavirinom u bolesnika s kroničnim hepatitisom C. Nuspojave prijavljene u kliničkim ispitivanjima grupirane su prema učestalosti određenoj na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
English: Predictability of response and non-response with Pegasys and ribavirin dual therapy - treatmentexperienced patients
Croatian: Predvidljivost odgovora i izostanka odgovora s dvojnom terapijom lijeka Pegasys i ribavirina - kod bolesnika koji po prvi puta započinju liječenje
English: The development of auto-antibodies and autoimmune disorders has been reported during treatment with alfa interferons.
Croatian: Za vrijeme liječenja alfa interferonima zamijećen je nastanak autoantitijela i autoimunih poremećaja.
English: High viral load = > 800,000 IU/ml, low viral load = ≤ 800,000 IU/ml.
Croatian: mala količina virusa = ≤ 800 000 IU/ml; velika količina virusa = > 800 000 IU/ml
English: HBsAg > 20,000 HBV DNA > 8 log10
Croatian: HBsAg > 20 000 HBV DNK > 8 log10
English: The recommended dosage for Pegasys, alone or in combination with ribavirin, is 180 micrograms once weekly subcutaneously for 48 weeks.
Croatian: Preporučena doza lijeka Pegasys, u monoterapijskoj primjeni ili u kombinaciji s ribavirinom, iznosi 180 mikrograma jedanput tjedno, primijenjenog supkutano kroz 48 tjedana.
English: Female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Croatian: Bolesnice u reproduktivnoj dobi moraju koristiti učinkovite mjere kontracepcije za vrijeme liječenja i 4 mjeseca nakon prestanka liječenja.
English: 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.
Croatian: U bolesnika zaraženih HCV-om genotipa 1 tjelesne mase < 75 kg potrebno je primijeniti dnevnu dozu od 1000 mg ribavirina, a u onih čija je težina ≥75 kg potrebno je primijeniti dnevnu dozu od 1200 mg ribavirina.
English: (N=444) 48 weeks
Croatian: (N=444) 48 tjedana
English: 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*.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Pegasys 90 mikrograma otopina za injekciju u napunjenoj štrcaljki Svaka štrcaljka s 0,5 ml otopine sadrži 90 mikrograma peginterferona alfa-2a*.
English: Each pen should be used by one person only and is for single use.
Croatian: Svaku brizgalicu smije koristiti samo jedna osoba i namijenjena je za jednokratnu primjenu.
English: NOTE: The cap contains a loose-fitting metal tube.
Croatian: Na zatvaraču se nalazi labavi metalni cilindar.
English: 1000 mg/day
Croatian: 1000 mg/dan
English: 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
Croatian: Tablica 9: Prijavljene nuspojave pri liječenju samo lijekom Pegasys u bolesnika s kroničnim hepatitisom B ili C, ili pri kombiniranoj terapiji lijekom Pegasys i ribavirinom u bolesnika s kroničnim hepatitisom C tijekom kliničkih ispitivanja i nakon stavljanja lijeka u promet Organski sustav
English: *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
Croatian: *RVR (engl. rapid viral response) = brzi virološki odgovor (nemjerljiv HCV RNK) u 4. tjednu i nemjerljiv HCV RNK u 24. tjednu; **RVR = brz virološki odgovor (HCV RNK negativan) do 4. tjedna LVL = ≤ 800 000 IU/ml; HVL = > 800 000 IU/ml
English: For patients <75 kg and ≥75 kg, 1000 mg daily and 1200 mg daily of ribavirin, respectively, and regardless of genotype, should be administered.
Croatian: U bolesnika čija je težina < 75 kg potrebno je primijeniti dnevnu dozu od 1000 mg ribavirina, a u onih čija je težina ≥75 kg potrebno je primijeniti dnevnu dozu od 1200 mg ribavirina bez obzira na genotip virusa.
English: Reproductive system and breast disorders
Croatian: Poremećaji reproduktivnog sustava i dojki vaginalni iscjedak
English: Hypoglycaemia, hyperglycaemia and diabetes mellitus have been observed with Pegasys (see section 4.8).
Croatian: U bolesnika liječenih lijekom Pegasys zamijećene su pojave hipoglikemije, hiperglikemije i dijabetesa melitusa (vidjeti dio 4.8).
English: Table 15: Sustained virological response based on rapid viral response at week 4 for genotype 1 and 4 after Pegasys combination therapy with ribavirin in CHC patients
Croatian: Tablica 15: Trajni virološki odgovor zasnovan na brzom virološkom odgovoru (RVR) u 4. tjednu u bolesnika s kroničnim hepatitisom C genotipa 1 i 4 nakon kombinirane terapije lijekom Pegasys i ribavirinom
English: 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 ALT levels.
Croatian: 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 ALT-a u serumu.
English: Placebo (N=177)
Croatian: Pegasys mikrograma i placebo (N=177)
English: Genotype 2 or 3 HVL with RVR**
Croatian: Genotip 2 ili 3 HVL s RVR**
English: Genotype 2 or 3 without RVR**
Croatian: Genotip 2 ili 3 bez RVR**
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane anoreksija dehidracija
English: Pegasys 135 micrograms solution for injection in pre-filled syringe EU/1/02/221/005
Croatian: Pegasys 135 mikrograma otopina za injekciju u napunjenoj štrcaljki EU/1/02/221/005
English: Digestive system disorders: Stomach ulcer, inflammation of the pancreas
Croatian: Poremećaji probavnog sustava: vrijed želuca, upala gušterače
English: Treatment response for HBeAg-positive patients was defined as HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) + HBV DNA <2,000 IU/mL at 6 months post-treatment and treatment response for HBeAg-negative patients was defined as HBV DNA < 2,000 IU/mL + ALT normalization at 6 months posttreatment.
Croatian: NPV= negativna prediktivna vrijednost; Osjetljivost = % svih bolesnika s odgovorom koji nisu ispunili kriterije za prekid liječenja; Specifičnost = % svih bolesnika bez odgovora koji su ispunili kriterije za prekid liječenja (a) Odgovor na liječenje u HBeAg-pozitivnih bolesnika definiran je kao HBeAg serokonverzija (definirana kao nestanak HBeAg i prisutnost anti-HBe protutijela) + HBV DNK < 2000 IU/ml 6 mjeseci nakon liječenja, dok je odgovor na liječenje u HBeAg-negativnih bolesnika definiran kao HBV DNK < 2000 IU/ml + normalizacija ALT-a 6 mjeseci nakon liječenja.
English: It is available in packs containing 1, 4 or 12 pre-filled pens.
Croatian: Dostupan je u pakiranju s 1, 4 ili 12 napunjenih brizgalica.
English: Suicidal ideation, hallucinations
Croatian: nervoza, smanjen libido samoubilačke misli, halucinacije samoubojstvo,
English: ALT levels.
Croatian: 2 razine.
English: 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).
Croatian: Ako bolesnik tijekom liječenja razvije kliničke simptome koji ukazuju na moguću disfunkciju štitnjače, mora se provjeriti razina TSH (vidjeti dio 4.8).
English: There are no data in paediatric patients coinfected with HCV/HIV or with renal impairment.
Croatian: Nema podataka o primjeni u pedijatrijskih bolesnika s HIV-HCV koinfekcijom niti onih s oštećenjem bubrežne funkcije.
English: Recommendations for dose modifications of Pegasys for toxicities in the CHB and CHC paediatric populations are presented in Table 6.
Croatian: 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.
English: Patients with renal impairment
Croatian: Bolesnici s cirozom