FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3 provides guidelines for discontinuation based on the patient's indirect bilirubin concentration.
Croatian: Tablici 3 navode se smjernice za prekid primjene na temelju bolesnikove koncentracije indirektnog bilirubina.
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Croatian: Odgovor na liječenje u oba ispitivanja prikazan je u Tablici 11. Ispitivanje 1 (RIBAVIC; P01017) bilo je randomizirano, multicentrično kliničko ispitivanje u koje je uključeno 412 prethodno neliječenih odraslih bolesnika s kroničnim hepatitisom C koji su istodobno bili zaraženi HIV-om.
English: Any potential for interactions may persist for up to two months (five half-lives for Rebetol) after cessation of Rebetol therapy due to the long half-life (see section 5.2).
Croatian: Zbog dugog poluvijeka ribavirina, mogućnost nastanka interakcija postoji u razdoblju od najdulje 2 mjeseca (5 poluvjekova lijeka Rebetol) nakon prestanka terapije lijekom Rebetol (vidjeti dio 5.2).
English: Number of 200 mg capsules
Croatian: Broj kapsula od 200 mg
English: Date of first authorisation: 07 May 1999 Date of latest renewal: 23 April 2009
Croatian: Datum prvog odobrenja: 7. svibnja 1999.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials, sustained virological response rates in children and adolescents were similar to those in adults.
Croatian: Populaciju uključenih bolesnika pretežno su činila djeca s blagim do umjereno teškim hepatitisom C. U ta su dva multicentrična ispitivanja stope trajnog virološkog odgovora u djece i adolescenata bile slične onima u odraslih.
English: Each Rebetol capsule contains 40 mg of lactose.
Croatian: Jedna kapsula lijeka Rebetol sadrži 40 mg laktoze.
English: Non-responders to prior therapy with pegylated interferon alpha/ribavirin were less likely to achieve a week 12 response to retreatment than non-responders to non-pegylated interferon alpha/ribavirin (12.4 % vs. 28.6 %).
Croatian: Vjerojatnost da će postići odgovor na ponovljeno liječenje u 12. tjednu bila je manja u bolesnika koji nisu uspješno odgovorili na prethodno liječenje pegiliranim interferonom alfa/ribavirinom nego u bolesnika koji nisu uspješno odgovorili na liječenje nepegiliranim interferonom alfa/ribavirinom (12,4% u odnosu na 28,6%).
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b The safety of Rebetol capsules is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied Rebetol in combination with interferon alfa-2b, two trials studied Rebetol in combination with peginterferon alfa-2b.
Croatian: Dvojna terapija peginterferonom alfa-2b ili interferonom alfa-2b Sigurnost Rebetol kapsula procijenjena je na temelju podataka prikupljenih u četiri klinička ispitivanja u bolesnika koji prethodno nisu bili liječeni interferonom: u dva ispitivanja proučavao se Rebetol u kombinaciji s interferonom alfa-2b, a u preostala dva ispitivanja u kombinaciji s peginterferonom alfa-2b.
English: Carrat F, Bani-Sadr F, Pol S et al. JAMA 2004; 292(23): 2839-2848.
Croatian: JAMA 2004; 292(23): 2839-2848.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known.
Croatian: Nuspojave su razvrstane prema organskim sustavima i kategorijama učestalosti definiranima 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), nepoznato.
English: (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
Croatian: To je smanjenje bilo značajno u bolesnika koji su odgovorili na liječenje (-0,3 za Metavir te -1,2 za Ishak) te stabilno (-0,1 za Metavir te -0,2 za Ishak) u bolesnika bez odgovora.
English: METAVIR Fibrosis score F2
Croatian: METAVIR ocjena fibroze
English: Table 8 Virologic Response at End of Treatment, Sustained Virologic Response and Relapse by HCV Genotype and Viral Load* Rebetol 800-1,400 mg/day plus peginterferon alfa-2b 1.5 g/kg once weekly End of Treatment Response
Croatian: Tablica 8 Virološki odgovor na kraju liječenja, trajan virološki odgovor i relaps prema HCV genotipu i virusnom opterećenju* Rebetol 800-1400 mg/dan + peginterferon alfa-2b 1,5 μg/kg jedanput na tjedan Odgovor na kraju liječenja Trajan virološki odgovor
English: The additional following side effectshave occurred with the combination of this medicineand an alpha interferon product in adults but not in children:
Croatian: Sljedeće dodatne nuspojave nastupile su kod primjene ovog lijeka u kombinaciji s alfa interferonom u odraslih bolesnika, ali ne i u djece:
English: • Haemoglobin
Croatian: • Hemoglobin
English: Extreme care must be taken to avoid pregnancy in partners of male patients taking Rebetol (see sections 4.3, 4.4 and 5.3).
Croatian: Potrebno je strogo paziti da se izbjegne trudnoća u žena čiji partneri uzimaju Rebetol (vidjeti dijelove 4.3, 4.4 i 5.3).
English: In children and adolescent patients receiving body surface area-adjusted dosing of peginterferon alfa-2b at 60 µg/m2/week, the log transformed ratio estimate of exposure during the dosing interval is predicted to be 58 % (90 % CI: 141-177 %) higher than observed in adults receiving 1.5 µg/kg/week.
Croatian: Predviđa se da će u djece i adolescenata koji primaju dozu peginterferona alfa-2b od 60 µg/m2/tjedan, prilagođenu prema tjelesnoj površini, logaritamski transformiran procijenjeni omjer izloženosti lijeku u intervalu doziranja biti 58% (90% CI: 141-177%) veći od onog zabilježenog u odraslih koji primaju dozu od 1,5 µg/kg/tjedan.
English: *Genotype 1 receive 48 weeks treatment **Genotype 2, 3 receive 24 weeks treatment ***The presented results are from a single point of time.
Croatian: *Genotip 1 liječi se 48 tjedana **Genotip 2, 3 liječe se 24 tjedna
English: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and Rebetol, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Croatian: Tijekom kombinirane terapije pegiliranim interferonom alfa-2b i lijekom Rebetol u razdoblju do 48 tjedana zabilježen je zastoj u rastu, koji je u nekih bolesnika rezultirao smanjenom visinom (vidjeti dio 4.4).
English: Do not use this medicine after the expiry date which is stated on the label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake "EXP".
English: Predictability of sustained virological response in naïve patients Virological response by week 12 is defined as at least 2-log viral load decrease or undetectable levels of HCV-RNA.
Croatian: Predvidljivost trajnog virološkog odgovora u bolesnika koji prethodno nisu bili liječeni Virološki odgovor do 12. tjedna definira se kao smanjenje količine virusa za najmanje 2 log ili kao nemjerljiva razina HCV-RNK.
English: Rebetol in combination with Direct Antiviral Agent (DAA):
Croatian: Rebetol u kombinaciji s antivirotikom koji djeluje direktno:
English: The following side effects have been reported with the combination of this medicine hard capsules and an alpha interferon product in adults:
Croatian: Sljedeće su nuspojave prijavljene kod primjene kombinacije tvrdih kapsula ovog lijeka s alfa interferonima u odraslih:
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN( ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation (see sections 4.2, 4.4, and 5.1).
Croatian: Rebetol je u kombinaciji s drugim lijekovima indiciran za liječenje kroničnog hepatitisa C u pedijatrijskih bolesnika (djece u dobi od 3 ili više godina i adolescenata) koji prethodno nisu bili liječeni i koji nemaju dekompenzaciju jetre (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Endocrine disorders Very common:
Croatian: Endokrini poremećaji vrlo često:
English: A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with Rebetol) are also listed for reference in Table 5.
Croatian: U Tablici 5 je za informaciju naveden i određen broj nuspojava koje se općenito pripisuju interferonskoj terapiji, ali su prijavljene u sklopu liječenja hepatitisa C (u kombinaciji s lijekom Rebetol).
English: The pharmacokinetics of Rebetol (dose-normalized) in this trial was similar to those reported in a prior study of Rebetol in combination with interferon alfa-2b in children and adolescent patients and in adult patients.
Croatian: Farmakokinetika lijeka Rebetol (normalizirana po dozi) u ovom je ispitivanju bila slična onoj iz prethodnog ispitivanja lijeka Rebetol u kombinaciji s interferonom alfa-2b u djece i adolescenata te slična farmakokinetici u odraslih bolesnika.
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Croatian: U bolesnika u kojih se razvija dekompenzacija jetre mora se odmah prekinuti primjenu lijekova protiv hepatitisa te ponovno razmotriti primjerenost antiretrovirusne terapije.
English: The combination of Rebetol and other medicines is used to treat patients who have chronic hepatitis C (HCV).
Croatian: Kombinacija lijeka Rebetol i drugih lijekova koristi se za liječenje bolesnika s kroničnim hepatitisom C (HCV).
English: In 3-and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm occurred at doses of 15 mg/kg and above.
Croatian: U istraživanjima učinaka ribavirina na testise i spermije u miševa u trajanju od 3 i 6 mjeseci, patološke su se promjene na spermijima dogodile pri dozama od 15 mg/kg i više.
English: For HCV/HIV co-infected patients receiving Rebetol in combination with peginterferon alfa-2b, other adverse reactions (that were not reported in mono-infected patients) which have been reported in the studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Croatian: Bolesnici s istodobnom infekcijom HCV-om i HIV-om U bolesnika s istodobnom infekcijom HCV-om i HIV-om koji primaju Rebetol u kombinaciji s peginterferonom alfa-2b, ostale nuspojave (koje nisu bile prijavljene u bolesnika s monoinfekcijom) prijavljene u ispitivanjima s učestalošću od >5% uključivale su: oralnu kandidijazu (14%), stečenu lipodistrofiju (13%), smanjen broj CD4 limfocita (8%), smanjen tek (8%), povišene vrijednosti gama-glutamiltransferaze (9%), bol u leđima (5%), povišene vrijednosti amilaze u krvi (6%), povišene vrijednosti mliječne kiseline u krvi (5%), citolitički hepatitis (6%), povišene vrijednosti lipaze (6%) i bol u udovima (6%).
English: Headache, dizziness, dry mouth, concentration impaired
Croatian: glavobolja, omaglica, suha usta, narušena koncentracija često:
English: Alopecia, pruritus, skin dry, rash
Croatian: alopecija, pruritus, suha koža, osip često:
English: The capsule shell imprint contains shellac, propylene glycol, ammonium hydroxide, colouring agent (E 132).
Croatian: Oznake otisnute na kapsuli sadrže šelak, propilenglikol, amonijev hidroksid i boju (E132).
English: A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in two previously mentioned multicentre trials.
Croatian: U 5-godišnje dugoročno opservacijsko ispitivanje praćenja uključena su 94 pedijatrijska bolesnika s kroničnim hepatitisom C nakon završetka liječenja u multicentričnom ispitivanju.
English: Each mL of oral solution contains 40 mg of ribavirin.
Croatian: Jedan ml oralne otopine sadrži 40 mg ribavirina.
English: Conflicting findings are reported in literature on co-administration between abacavir and Rebetol.
Croatian: U literaturi su prijavljena proturječna izvješća u vezi istodobne primjene abakavira i lijeka Rebetol.
English: Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with non-pegylated interferon alfa-2b (with or without Rebetol) and pegylated interferon alfa-2b (with or without Rebetol), respectively.
Croatian: Dva su velika ispitivanja dugotrajnog praćenja nakon liječenja uključila 1071 bolesnika iz prethodnih ispitivanja s nepegiliranim interferonom alfa-2b (sa ili bez lijeka Rebetol) i 567 bolesnika iz ispitivanja s pegiliranim interferonom alfa-2b (sa ili bez lijeka Rebetol).
English: If the patient weighs this many kg
Croatian: Ako je tjelesna težina bolesnika (kg)
English: 1 bottle of 100 mL 10 mL oral dosing syringe
Croatian: 1 bočica od 100 ml dozirna štrcaljka za primjenu kroz usta od 10 ml
English: Tachycardia, palpitations
Croatian: tahikardija, palpitacije
English: Measure: You can measure the dose with the oral dosing syringe provided.
Croatian: Odmjeravanje doze: Dozu možete odmjeriti pomoću štrcaljke za usta priložene u pakiranju.
English: Name and address of the manufacturer responsible for batch release for the oral solution
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet za oralnu otopinu
English: Pigmentation disorder, dermatitis atopic, skin exfoliation Musculoskeletal and connective tissue disorders Very common:
Croatian: poremećaj pigmentacije, atopički dermatitis, ljuštenje kože Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često:
English: Haematological abnormalities were more frequently reported in patients receiving Rebetol in combination with peginterferon alfa-2b when compared to patients receiving Rebetol in combination with interferon alfa-2b.
Croatian: Hematološki poremećaji prijavljeni su češće u bolesnika koji su primali Rebetol u kombinaciji s peginterferonom alfa-2b nego u bolesnika koji su primali Rebetol u kombinaciji s interferonom alfa-2b.
English: Nervous system disorders Very common:
Croatian: Poremećaji živčanog sustava vrlo često:
English: * Since Rebetol has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using Rebetol in combination with interferon alfa-2b (pegylated or non-pegylated).
Croatian: * Kako se Rebetol uvijek propisuje u kombinaciji s alfa interferonom te nije moguće točno kvantificirati navedene nuspojave prijavljene nakon stavljanja lijeka u promet, gore prijavljena kategorija učestalosti predstavlja učestalost iz kliničkih ispitivanja u kojima se Rebetol primjenjivao u kombinaciji s interferonom alfa-2b (pegiliranim ili nepegiliranim).
English: Uric acid may increase with Rebetol due to haemolysis; therefore, the potential for development of gout must be carefully monitored in pre-disposed patients.
Croatian: Zbog hemolize uslijed uzimanja lijeka Rebetol može doći do povišenja koncentracije uratne kiseline; stoga se bolesnike s predispozicijom mora pažljivo promatrati zbog mogućeg razvoja gihta.
English: Rebetol must not be used by females who are pregnant (see sections 4.3 and 5.3).
Croatian: Trudnice ne smiju uzimati Rebetol (vidjeti dijelove 4.3 i 5.3).
English: Metabolism and nutrition disorders Very common:
Croatian: Poremećaji metabolizma i prehrane vrlo često:
English: P1.5/R Rebetol (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg) P0.5/R Rebetol (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg) I/R
Croatian: P 1,5/R Rebetol (800 mg) + peginterferon alfa-2b (1,5 mikrograma/kg) P 0,5/R Rebetol (1000/1200 mg) + peginterferon alfa-2b (1,5 do 0,5 mikrograma/kg) I/R
English: United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
Croatian: Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
English: - Retreatment of relapse patients with Rebetol and interferon alfa-2b combination treatment Two trials examined the use of Rebetol and interferon alfa-2b combination treatment in relapse patients (C95-144 and I95-145); 345 chronic hepatitis patients who had relapsed after previous interferon treatment were treated for six months with a six month follow-up.
Croatian: U dva se klinička ispitivanja proučavala primjena kombinirane terapije lijekom Rebetol i interferonom alfa-2b u bolesnika s relapsom (C95-144 and I95-145); 345 bolesnika s kroničnim hepatitisom s relapsom bolesti nakon prethodnog liječenja interferonom liječeno je tijekom 6 mjeseci i naknadno praćeno još 6 mjeseci.
English: The following side effects have been reported with the combination of this medicine and an interferon alfa-2b product in children and adolescents:
Croatian: Sljedeće su nuspojave prijavljene tijekom liječenja kombinacijom ovog lijeka i interferona alfa-2b u djece i adolescenata:
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials, sustained virological response rates in children and adolescents were similar to those in adults (see Table 7).
Croatian: Populaciju uključenih bolesnika pretežno su činila djeca s blagim do umjereno teškim hepatitisom C. U ta su dva multicentrična ispitivanja stope trajnog virološkog odgovora u djece i adolescenata bile slične onima u odraslih (vidjeti Tablicu 7).
English: Rebetol 200 mg capsules ribavirin
Croatian: Rebetol 200 mg kapsule ribavirin
English: Dose reduction of Rebetol depends on the initial Rebetol posology which depends on the medicinal product that is used in combination with Rebetol.
Croatian: Smanjenje doze lijeka Rebetol ovisi o početnom doziranju lijeka Rebetol, koje pak ovisi o lijeku s kojim se Rebetol kombinira.
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of Rebetol and pegylated interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Croatian: Populacija uključena u ispitivanje uglavnom se sastojala od djece s blagim do umjerenim hepatitisom C. Zbog nedostatka podataka u djece s ozbiljno progresivnom bolešću i mogućih nuspojava, omjer koristi i rizika kombinacije lijeka Rebetol i pegiliranog interferona alfa-2b u ovoj se populaciji mora pažljivo razmotriti (vidjeti dijelove 4.1, 4.4 i 4.8).
English: HCV-RNA negative or ≥ 1 log decrease in viral load
Croatian: HCV-RNK negativna ili virusno opterećenje manje za ≥1 log
English: - The active substance is ribavirin 40 mg/mL.
Croatian: - Djelatna tvar je ribavirin, 40 mg/ml.
English: Skin and subcutaneous tissue disorders Very common:
Croatian: Poremećaji kože i potkožnog tkiva vrlo često:
English: Oral formulations of Rebetol monotherapy have been investigated as therapy for chronic hepatitis C in several clinical trials.
Croatian: Peroralni oblici lijeka Rebetol ispitivani su u nekoliko kliničkih ispitivanja kao monoterapija za kronični hepatitis C.
English: Usual dosage to be used with interferon alfa-2b or peginterferon alfa-2b in children above 3 years of age and adolescents
Croatian: Uobičajene doze koje se primjenjuju u kombinaciji s interferonom alfa-2b ili peginterferonom alfa-2b u djece starije od 3 godine i adolescenata
English: Both the Metavir score and Ishak grade decreased among subjects treated with Rebetol in combination with peginterferon alfa-2b.
Croatian: I Metavir izračun i stupanj po Ishaku smanjili su se u ispitanika liječenih lijekom Rebetol u kombinaciji s peginterferonom alfa-2b.
English: This product contains sucrose and sorbitol.
Croatian: Ovaj lijek sadrži saharozu i sorbitol.
English: • Rebetol (1,000/1,200 mg/day) + interferon alfa-2b (3 MIU three times a week) (n = 505).
Croatian: • Rebetol (1000/1200 mg/dan) + interferon alfa-2b (3 MIU triput na tjedan) (n=505).
English: Three trials examined the use of interferon in naïve patients, two with Rebetol + interferon alfa-2b (C95-132 and I95-143) and one with Rebetol + peginterferon alfa-2b (C/I98-580).
Croatian: U tri se ispitivanja proučavala primjena interferona u bolesnika koji prethodno nisu bili liječeni i to u dva ispitivanja primjena lijeka Rebetol u kombinaciji s interferonom alfa-2b (C95-132 i I95-143), a u jednom primjena lijeka Rebetol u kombinaciji s peginterferonom alfa-2b (C/I98-580).
English: Table 12 Rates of Response to retreatment in prior treatment failures Patients with undetectable HCV-RNA at treatment week 12 and SVR upon retreatement interferon alpha/ribavirin peginterferon alpha/ribavirin
Croatian: Tablica 12 Stope odgovora na ponovljeno liječenje nakon neuspjeha prethodnog liječenja Bolesnici s nemjerljivom HCV-RNK u 12. tjednu liječenja i SVR-om nakon ponovljenog liječenja interferon alfa/ribavirin peginterferon alfa/ribavirin Ukupna populacija*
English: Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol as some combination regimens do not adhere to the Rebetol dosing guidance provided in Table 1.
Croatian: Molimo pročitajte odgovarajuće Sažetke opisa svojstava lijeka za lijekove koji se primjenjuju u kombinaciji s lijekom Rebetol jer neki režimi kombiniranog liječenja ne podliježu smjernicama za doziranje lijeka Rebetol navedenima u Tablici 1.
English: Two trials have been conducted in patients co-infected with HIV and HCV.
Croatian: Bolesnici s istodobnom infekcijom HCV-om i HIV-om Provedena su dva ispitivanja u bolesnika s istodobnom infekcijom virusima HIV i HCV.
English: Rebetol 200 mg capsules
Croatian: Rebetol 200 mg kapsule
English: Please refer to the SmPC of the corresponding DAA for a full description of the clinical data with such combination.
Croatian: Molimo pročitajte Sažetak opisa svojstava lijeka za odgovarajući antivirotik koji djeluje direktno za cjelovit opis kliničkih podataka kod takve kombinacije.
English: Rebetol (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
Croatian: Rebetol (1000/1200 mg) + interferon alfa--2b (3 milijuna IU)
English: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite
Croatian: hiperglikemija, hiperuricemija, hipokalcijemija, dehidracija, pojačan tek manje često:
English: Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa/ribavirin treatment.
Croatian: Potreban je oprez u HIV-pozitivnih bolesnika istodobno zaraženih HCV-om koji uz liječenje interferonom alfa-2b/ribavirinom primaju i nukleozidne inhibitore reverzne transkriptaze (NRTI) (osobito ddI i d4T).
English: The use of pegylated alpha interferons and Rebetol concomitantly with azathioprine should be avoided.
Croatian: Treba izbjegavati istodobnu primjenu pegiliranih alfa interferona i lijeka Rebetol s azatioprinom.
English: Do not use this medicine after the expiry date which is stated on the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake "EXP".
English: Daily Rebetol dose
Croatian: Dnevna doza lijeka Rebetol
English: - The active substance is ribavirin 200 mg. - The other ingredients are microcrystalline cellulose, lactose monohydrate (40 mg), croscarmellose sodium, magnesium stearate.
Croatian: - Drugi sastojci su: mikrokristalična celuloza, laktoza hidrat (40 mg), umrežena karmelozanatrij, magnezijev stearat.