FrancophonIA/ELRC3.0 huggingface dataset:
English: If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of Rebetol to the foetus (see section 4.4).
Croatian: Ako bolesnica zatrudni tijekom liječenja ili unutar 4 mjeseca po prestanku liječenja, mora biti obaviještena o značajnom teratogenom riziku lijeka Rebetol za fetus (vidjeti dio 4.4).
English: Patients with low CD4 counts
Croatian: Bolesnici s malim brojem CD4 stanica
English: Response at Treatment Week
Croatian: Odgovor u navedenom tjednu liječenja
English: White, opaque and imprinted with blue ink.
Croatian: Bijela, neprozirna s oznakama otisnutima plavom bojom.
English: Results of these investigations showed that Rebetol monotherapy had no effect on eliminating hepatitis virus (HCV-RNA) or improving hepatic histology after 6 to 12 months of therapy and 6 months of follow-up.
Croatian: Rezultati tih ispitivanja pokazali su da monoterapija lijekom Rebetol nije imala učinka na uklanjanje virusa hepatitisa (HCV-RNK) niti na poboljšanje histološkog stanja jetre nakon 6 do 12 mjeseci liječenja i 6 mjeseci naknadnog praćenja.
English: No response at Treatment Week
Croatian: Bez odgovora u navedenom tjednu liječenja
English: Table 9 Virologic response at treatment week 12, end of treatment response, relapse rate* and Sustained Virologic Response (SVR) Treatment group
Croatian: Tablica 9 Virološki odgovor u 12. tjednu liječenja, odgovor na kraju liječenja, stopa relapsa* i trajan virološki odgovor (SVR) Liječena skupina
English: This solution is packaged in 118 mL size amber glass bottles containing 100 mL of oral solution.
Croatian: Ova otopina pakirana je u smeđe staklene bočice od 118 ml, koje sadrže 100 ml oralne otopine.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy in children and adolescents:
Croatian: Prihvatljive početne vrijednosti koje se mogu koristiti kao smjernice prije početka liječenja lijekom Rebetol u djece i adolescenata su:
English: If you take more Rebetol than you should Tell your doctor or pharmacist as soon as possible.
Croatian: Ako uzmete više lijeka Rebetol nego što ste trebali Što prije obavijestite svog liječnika ili ljekarnika.
English: There is no evidence that Rebetol interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
Croatian: Nema dokaza o postojanju interakcija između lijeka Rebetol i nenukleozidnih inhibitora reverzne transkriptaze ili inhibitora proteaze.
English: The selection of Rebetol formulation is based on individual characteristics of the patient.
Croatian: Odabir formulacije lijeka Rebetol ovisi o osobinama pojedinog bolesnika.
English: Rebetol contains lactose
Croatian: Rebetol sadrži laktozu
English: Pancytopenia: Rebetol can cause a decrease in your platelet and red and white blood cell count when used in combination with peginterferon.
Croatian: Pancitopenija: Rebetol može uzrokovati smanjenje broja krvnih pločica, crvenih i bijelih krvnih stanica kada se koristi u kombinaciji s peginterferonom.
English: EU/1/99/107/001 84 hard capsules EU/1/99/107/005 112 hard capsules EU/1/99/107/002 140 hard capsules EU/1/99/107/003 168 hard capsules
Croatian: EU/1/99/107/001 84 tvrde kapsule EU/1/99/107/005 112 tvrdih kapsula EU/1/99/107/002 140 tvrdih kapsula EU/1/99/107/003 168 tvrdih kapsula
English: 84 hard capsules 112 hard capsules 140 hard capsules 168 hard capsules
Croatian: 84 tvrde kapsule 112 tvrdih kapsula 140 tvrdih kapsula 168 tvrdih kapsula
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Rebetol must be discontinued immediately and appropriate medical therapy instituted.
Croatian: Ako se razvije akutna reakcija preosjetljivosti (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksija), odmah se mora prekinuti davanje lijeka Rebetol i započeti odgovarajuće liječenje.
English: Sustained Response
Croatian: Trajan odgovor
English: Patients who were HCV-RNA negative at Treatment week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
Croatian: Bolesnici koji su imali negativan nalaz HCV-RNK u 12. tjednu liječenja nastavili su s liječenjem tijekom 48 tjedana te ih se pratilo još 24 tjedna po završetku liječenja.
English: No pharmacokinetic interaction appears between Rebetol and hepatic function (see section 5.2).
Croatian: Čini se da nema farmakokinetičke interakcije između lijeka Rebetol i funkcije jetre (vidjeti dio 5.2).
English: Any subject with missing data in and after the follow-up week 12 window was considered to be a non-responder at week 24 of follow-up.
Croatian: Za sve ispitanike s nedostatkom podataka tijekom i nakon 12. tjedna praćenja smatralo se da nemaju odgovor u 24. tjednu praćenja.
English: Genotype 2/3 67.9 (74/109) 70.3 (52/74)
Croatian: Genotip 2/3 67,9 (74/109) 70,3 (52/74)
English: Rebetol capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Croatian: Rebetol kapsule primjenjuju se peroralno svakoga dana, u dvije podijeljene doze (ujutro i navečer), uz obrok.
English: 4 capsules Refer to adult dose recommendations
Croatian: 4 kapsule Vidjeti preporuke za doziranje u odraslih
English: Other medicines with Rebetol
Croatian: Drugi lijekovi i Rebetol
English: As the solution fills the syringe, you will see the numbers on the rod go up, such as 1.5 mL, 2.0 mL, 2.5 mL, etc.
Croatian: Kako tekućina bude punila štrcaljku, na klipu će se pojavljivati sve veća brojka, npr. 1,5 ml, 2,0 ml, 2,5 ml itd.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji je opisan u Modulu 1.8.2.
English: Rebetol does not inhibit cytochrome P450 enzymes.
Croatian: Rebetol ne inhibira enzime citokroma P450.
English: Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % vs. 1 %) during treatment and during the 6 month follow-up after treatment.
Croatian: Nadalje, suicidalne misli ili pokušaji samoubojstva su tijekom liječenja i tijekom šestomjesečnog praćenja nakon liječenja prijavljeni češće nego u odraslih bolesnika (2,4% u odnosu na 1%).
English: It is possible that the decreased bioavailability in this study was due to delayed transit of Rebetol or modified pH.
Croatian: Moguće je da je smanjena bioraspoloživost u ovom ispitivanju bila posljedica odgođenog tranzita lijeka Rebetol ili promijenjenog pH.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Croatian: Ispitivanje 2 (P02080) bilo je randomizirano ispitivanje provedeno u jednom centru, u koje je uključeno 95 prethodno neliječenih odraslih bolesnika s kroničnim hepatitisom C koji su istodobno bili zaraženi HIV-om.
English: Rebetol contains the active substance ribavirin.
Croatian: Rebetol sadrži djelatnu tvar ribavirin.
English: This medicine contains sucrose and sorbitol, these are types of sugars.
Croatian: Ovaj lijek sadrži saharozu i sorbitol, a to su vrste šećera.
English: Patients treated with Rebetol and zidovudine are at increased risk of developing anaemia; therefore, the concomitant use of Rebetol with zidovudine is not recommended (see section 4.5).
Croatian: Bolesnici liječeni lijekom Rebetol i zidovudinom imaju povećan rizik za razvoj anemije; stoga se ne preporučuje istodobna primjena lijeka Rebetol sa zidovudinom (vidjeti dio 4.5).
English: If a patient has a serious adverse reaction potentially related to Rebetol, the Rebetol dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Croatian: Ako bolesnik ima ozbiljnu nuspojavu koja bi mogla biti povezana s lijekom Rebetol, dozu lijeka Rebetol treba prilagoditi ili po potrebi prekinuti njegovu primjenu dok se nuspojava ne povuče ili dok se njezina težina ne smanji.
English: Rebetol oral solution 100 mL is packaged in 118 mL amber glass bottles (coloured EP Type IV glass, Ph Eur.
Croatian: Rebetol oralna otopina od 100 ml pakirana je u smeđe staklene bočice od 118 ml (obojano staklo EP tipa IV, Ph.
English: Note: For patients who weigh < 47 kg, or are unable to swallow capsules, please refer to the SmPC for Rebetol 40 mg/mL oral solution.
Croatian: Napomena: Za bolesnike tjelesne težine <47 kg ili bolesnike koji ne mogu progutati kapsule, molimo pročitajte Sažetak opisa svojstava lijeka za Rebetol 40 mg/ml oralnu otopinu.
English: Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Croatian: Nakon peroralne primjene jedne doze ribavirin se brzo apsorbira (prosječan Tmax = 1,5 sati), nakon čega slijedi brza raspodjela i produljena faza eliminacije (nakon jedne doze poluvrijeme apsorpcije iznosi 0,05 sati, poluvrijeme distribucije 3,73 sata, a poluvrijeme eliminacije 79 sati).
English: The sustained response at the end of follow-up was significantly increased by the addition of Rebetol to interferon alfa-2b (41 % vs 16 %, p < 0.001).
Croatian: Trajan odgovor na liječenje na kraju razdoblja praćenja značajno se povećao dodavanjem lijeka Rebetol interferonu alfa-2b (41% u odnosu na 16%, p <0,001).
English: Patients who weigh > 47 kg and are able to swallow capsules may take the equivalent dose of ribavirin 200 mg capsules in two divided doses (Please see SmPC for Rebetol capsules).
Croatian: Bolesnici tjelesne težine >47 kg koji mogu progutati kapsule mogu uzimati ekvivalentnu dozu ribavirin kapsula od 200 mg u dvije podijeljene doze (Molimo pročitajte Sažetak opisa svojstava lijeka za Rebetol kapsule).
English: Among those patients with elevated uric acid levels, very few patients treated with the combination developed clinical gout, none of which required treatment modification or discontinuation from the clinical trials.
Croatian: Među bolesnicima s povišenim vrijednostima mokraćne kiseline vrlo je mali broj onih liječenih kombiniranom terapijom razvilo kliničku sliku gihta, a niti u jednog od tih bolesnika nije bilo potrebno modificirati liječenje ili isključiti bolesnika iz ispitivanja.
English: Table 6 Sustained virological response rates (n a,b
Croatian: Tablica 6 Stope trajnog virološkog odgovora (n a,b
English: Females of childbearing potential must use an effective contraceptive during treatment and for four months after treatment has been concluded; routine monthly pregnancy tests must be performed during this time.
Croatian: Žene reproduktivne dobi moraju koristiti pouzdanu kontracepciju za vrijeme liječenja i tijekom 4 mjeseca nakon završetka liječenja; svakog se mjeseca tijekom navedenog perioda moraju rutinski obavljati testovi na trudnoću.
English: In a single dose, crossover study of ribavirin in healthy adult subjects, the capsule and oral solution formulations were found to be bioequivalent.
Croatian: U križnom ispitivanju jednokratnih doza ribavirina u zdravih odraslih bolesnika, utvrđeno je da su kapsule i oralna otopina bioekvivalentne.
English: There were some cases of more severe neutropenia in patients treated with Rebetol in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]); WHO grade 3 leukopenia was also reported in 7 % of this treatment group.
Croatian: Bilo je slučajeva teže neutropenije u bolesnika liječenih lijekom Rebetol u kombinaciji s peginterferonom alfa-2b (SZO stupanj 3:39 od 186 [21%] bolesnika; i SZO stupanj 4: 13 od 186 bolesnika [7%]); leukopenija SZO stupnja 3 također je prijavljena u 7% bolesnika u ovoj terapijskoj skupini.
English: Rebetol (8001,200 mg/day)
Croatian: Rebetol (800-1200 mg/dan)
English: Mitochondrial toxicity and lactic acidosis:
Croatian: Mitohondrijska toksičnost i laktacidoza:
English: The exacerbation of anaemia due to Rebetol has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated.
Croatian: Egzacerbacija anemije uzrokovana lijekom Rebetol prijavljena je kada je u režim liječenja HIV infekcije bio uključen zidovudin, iako točan mehanizam još treba razjasniti.
English: If the abnormality is reversed, Rebetol may be restarted at 600 mg daily, and further increased to 800 mg daily at the discretion of the treating physician.
Croatian: Ako se vrijednosti vrate u normalu, liječenje lijekom Rebetol može se ponovno započeti dozom od 600 mg na dan, koja se prema odluci nadležnog liječnika može dodatno povećati na 800 mg na dan.
English: Patients whose dose of Rebetol is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Croatian: Bolesnici kojima je doza lijeka Rebetol smanjena na dnevnu dozu od 600 mg uzimaju jednu kapsulu od 200 mg ujutro i dvije kapsule od 200 mg navečer.
English: - Genotoxicity: Rebetol induces genotoxicity (see section 5.3).
Croatian: - Genotoksičnost: Rebetol inducira genotoksičnost (vidjeti dio 5.3).
English: Treatment with Rebetol in combination with peginterferon alfa-2b was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Croatian: Liječenje lijekom Rebetol u kombinaciji s peginterferonom alfa-2b bilo je povezano sa smanjenjem apsolutnog broja CD4+ stanica unutar prva 4 tjedna, no bez smanjenja postotka CD4+ stanica.
English: You or your female partner must use an effective contraceptive during the time you are taking Rebetol and for 7 months after stopping treatment.
Croatian: Vi ili Vaša partnerica morate koristiti učinkovitu kontracepciju za vrijeme Vašeg liječenja lijekom Rebetol i tijekom 7 mjeseci nakon prestanka liječenja.
English: The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5 % vs. 14 %, for dose modification 18 % vs. 49 %.
Croatian: Šestomjesečno liječenje u ovom ispitivanju podnosilo se bolje nego jednogodišnje liječenje u pivotalnom ispitivanju kombinirane terapije; prekid liječenja zabilježen je u 5% u odnosu na 14% bolesnika, a prilagodba doze u 18% u odnosu na 49% bolesnika.
English: In individual cases where the benefit of administering Rebetol concomitantly with azathioprine warrants the potential risk, it is recommended that close hematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicines should be stopped (see section 4.4).
Croatian: U pojedinačnim slučajevima, kada korist od uzimanja lijeka Rebetol zajedno s azatioprinom opravdava mogući rizik, preporučuje se pomno nadzirati hematološke parametre za vrijeme istodobnog uzimanja azatioprina kako bi se otkrili znakovi mijelotoksičnosti, kada liječenje tim lijekovima treba prekinuti (vidjeti dio 4.4).
English: Table 13 Sustained virological response rates (n a,b
Croatian: Tablica 13 Stope trajnog virološkog odgovora (n a,b
English: The pharmacokinetics of Rebetol and interferon alfa-2b (dose-normalized) is similar in adults and children or adolescents.
Croatian: Farmakokinetika lijeka Rebetol i interferona alfa-2b (normalizirana po dozi) slična je u odraslih i djece ili adolescenata.
English: Thus, Rebetol must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Croatian: Stoga se Rebetol mora primjenjivati uz oprez u bolesnika s od ranije postojećom srčanom bolešću (vidjeti dio 4.3).
English: EU/1/99/107/001 (84 hard capsules) EU/1/99/107/005 (112 hard capsules) EU/1/99/107/002 (140 hard capsules) EU/1/99/107/003 (168 hard capsules)
Croatian: EU/1/99/107/001 (84 tvrde kapsule) EU/1/99/107/005 (112 tvrdih kapsula) EU/1/99/107/002 (140 tvrdih kapsula) EU/1/99/107/003 (168 tvrdih kapsula)
English: Usual daily Rebetol dose
Croatian: Uobičajena dnevna doza lijeka Rebetol
English:  11 g/dL (females);  12 g/dL (males)
Croatian: ≥11 g/dl (djevojčice); ≥12 g/dl (dječaci)
English: The capsule shell contains gelatine, titanium dioxide.
Croatian: Ovojnica kapsule sadrži želatinu, titanijev dioksid.
English: The child-resistant cap has inner and outer polypropylene shells.
Croatian: Sigurnosni zatvarač za djecu ima unutarnju i vanjsku polipropilensku ovojnicu.
English: * Any subject with an undetectable HCV-RNA level at the follow-up week 12 visit and missing data at the follow-up week 24 visit was considered a sustained responder.
Croatian: * Za sve ispitanike s nemjerljivom razinom HCV-RNK u 12. tjednu praćenja i nedostatkom podataka u 24. tjednu praćenja smatralo se da imaju trajan odgovor.
English: Rebetol contains sucrose and sorbitol
Croatian: Rebetol sadrži saharozu i sorbitol
English: A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Croatian: Ukupno je liječeno 107 bolesnika, među kojima je bilo 52% ženskog spola, 89% bijelaca, 67% s HCV genotipom 1 i 63% mlađih od 12 godina.
English: Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
Croatian: Neuspjeh prethodne terapije definirao se kao relaps ili izostanak odgovora (pozitivan nalaz HCV-RNK nakon najmanje 12 tjedana liječenja).
English: Reminder: This medicine is used in combination with other medicines for hepatitis C virus infection.
Croatian: Podsjetnik: Ovaj lijek se koristi u kombinaciji s drugim lijekovima za liječenje infekcije virusom hepatitisa C.
English: The rod is marked with 0.5 mL markings starting at 1.5 mL (at the very top of the rod) and ending at 10 mL.
Croatian: Na klipu se nalaze oznake na svakih 0,5 ml, počevši od oznake za 1,5 ml (na samom vrhu klipa) pa sve do oznake za 10 ml.
English: Calibrations are marked at 0.5 mL increments from 1.5 mL to 10 mL.
Croatian: Ima oznake svakih 0,5 ml, u rasponu od 1,5 ml do 10 ml.
English: The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Croatian: Liječenje je trajalo 48 tjedana, a razdoblje naknadnog praćenja 6 mjeseci, osim u bolesnika inficiranih genotipovima 2 ili 3 i virusnim opterećenjem < 800 000 IU/ml (Amplicor), koji su liječeni 24 tjedna i naknadno praćeni 6 mjeseci.
English: Overall, approximately 36 % (821/2,286) of patients had undetectable plasma HCV-RNA levels at week 12 of therapy measured using a research-based test (limit of detection 125 IU/mL).
Croatian: Sveukupno je razina HCV-RNK u plazmi bila nemjerljiva u oko 36% (821/2286) bolesnika u 12. tjednu liječenja, mjereno pomoću testa utemeljenog na istraživanju (granica detekcije 125 IU/ml).
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme* Musculoskeletal and connective tissue disorders Very common:
Croatian: Stevens-Johnsonov sindrom*, toksična epidermalna nekroliza*, multiformni eritem* Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često:
English: REBETOL - 84, 112, 140, 168 hard capsules
Croatian: Rebetol - 84, 112, 140, 168 tvrdih kapsula
English: If week 12 HCV-RNA is positive and decreased ≥ 2 log10 from baseline, then retest HCV-RNA at week 24 and if positive, patients to stop therapy.
Croatian: Ako je u 12. tjednu HCV-RNK pozitivna i smanjena za ≥2 log10 od početne vrijednosti, HCV-RNK se ponovno određuje u 24. tjednu i ako je pozitivna, bolesniku se prekida liječenje.
English: Rebetol, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-methylthioinosine monophosphate (6-MTIMP), which has been associated with myelotoxicity in patients treated with azathioprine.
Croatian: Rebetol svojim inhibicijskim učinkom na inozin monofosfat dehidrogenazu može interferirati s metabolizmom azatioprina, što može dovesti do nakupljanja 6-metiltioinozin monofosfata (6-MTIMP), koje se u bolesnika liječenih azatioprinom povezuje s mijelotoksičnošću.
English: The 10 mL oral dosing syringe consists of a natural polyethylene barrel, with a white polystyrene plunger rod.
Croatian: Štrcaljka za usta od 10 ml sastoji se od tijela od prirodnog polietilena i bijelog polistirenskog klipa.
English: If you have been told by your doctor that you have an intolerance to some sugars, discuss with your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: 3 years After first opening: the medicinal product should be used within one month.
Croatian: 3 godine Lijek se mora upotrijebiti u roku od mjesec dana nakon prvog otvaranja.
English: For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available.
Croatian: Za pedijatrijske bolesnike (djecu i adolescente) tjelesne težine manje od 47 kg ovaj je lijek dostupan u obliku oralne otopine.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebali uzimati ovaj lijek.
English: The bioavailability of Rebetol 600 mg was decreased by co-administration with an antacid containing magnesium, aluminium and simethicone; AUCtf decreased 14 %.
Croatian: Bioraspoloživost doze lijeka Rebetol od 600 mg bila je smanjena prilikom istodobne primjene antacida koji sadrže magnezij, aluminij i simetikon; AUCtf se smanjio za 14%.
English: These criteria were used in the protocol: If week 12 HCV-RNA is positive and < 2 log10 decrease from baseline, patients to stop therapy.
Croatian: U protokolu su korišteni sljedeći kriteriji: ako je 12. tjednu HCV-RNK pozitivna i smanjena za <2 log10 od početne vrijednosti, bolesniku se liječenje prekida.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 %  12 years of age.
Croatian: Ukupno je uključeno 118 bolesnika: 57% muškog spola, 80% bijelaca i 78% s HCV genotipom 1, 64% u dobi od ≤ 12 godina.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) često:
English: * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, Rebetol dose should be reduced to 600 mg/day (administered as one 200 mg capsule in the morning and two 200 mg capsules in the evening).
Croatian: *U bolesnika koji primaju dozu od 1000 mg (<75 kg) ili 1200 mg (>75 kg), dozu lijeka Rebetol treba smanjiti na 600 mg/dan (primjenjenu kao jedna kapsula od 200 mg ujutro i dvije kapsule od 200 mg navečer).
English: How to use Rebetol
Croatian: Kako uzimati Rebetol
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding must be discontinued prior to initiation of treatment.
Croatian: Zbog mogućnosti razvoja nuspojava u dojenčadi, dojenje se mora prekinuti prije početka liječenja.
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy:
Croatian: Prihvatljive početne vrijednosti koje se mogu koristiti kao smjernice prije početka liječenja lijekom
English: nd dose reduction of Rebetol is by an additional 200 mg/day.
Croatian: Ako je potrebno, drugo smanjenje doze je za dodatnih 200 mg/dan.
English: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Croatian: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com