FrancophonIA/ELRC3.0 huggingface dataset:
English: • have another liver problem in addition to hepatitis C infection.
Croatian: • imate dodatnu bolest jetre uz zarazu virusom hepatitisa C
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 ribavirin 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 ribavirina za fetus (vidjeti dio 4.4).
English: Patients with impaired renal function should be more carefully monitored with respect to the development of anaemia.
Croatian: Bolesnike s oštećenom bubrežnom funkcijom potrebno je pažljivije nadzirati zbog mogućeg razvoja anemije.
English: Table 13 Sustained virological response rates (na,b (%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
Croatian: Tablica 13 Stope trajnog virološkog odgovora (na,b ( %)) u djece i adolescenata koji nisu bili prethodno liječeni, prema genotipu i trajanju liječenja - svi ispitanici n = 107 24 tjedna
English: 3 capsules a
Croatian: 4 kapsule b
English: Ribavirin (Ribavirin Mylan) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Croatian: Ribavirin Mylan je sintetski analog nukleozida koji je pokazao aktivnost in vitro protiv nekih RNK i DNK virusa.
English: Children and adolescents are particularly prone to develop depression when being treated with ribavirin and interferon alpha.
Croatian: Djeca i adolescenti osobito su skloni razvoju depresije tijekom liječenja ribavirinom i interferonom alfa.
English: Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity occurred within one or two spermatogenic cycles (see section 4.6).
Croatian: Nakon prestanka liječenja dolazi do potpunog oporavka od testikularne toksičnosti izvazvane ribavirinom unutar jednog ili dva ciklusa spermatogeneze (vidjeti dio 4.6).
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Ribavirin Mylan therapy:
Croatian: Prihvatljive početne vrijednosti koje se mogu koristiti kao smjernice prije početka terapije lijekom Ribavirin Mylan su:
English: If a patient has a serious adverse reaction potentially related to ribavirin, the dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Croatian: Ako bolesnik ima ozbiljnu nuspojavu koja je potencijalno povezana s ribavirinom, dozu treba izmijeniti ili prekinuti doziranje dok se nuspojava ne povuče ili smanji njena ozbiljnost.
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: Ribavirin se nakon peroralne primjene jedne doze brzo apsorbira (aritmetička sredina Tmax = 1,5 sati), nakon čega slijedi brza distribucija i produljene faze eliminacije (nakon jedne doze poluvrijeme apsorpcije iznosi 0,05 sati, poluvrijeme distribucije 3,73 sata, a poluvrijeme eliminacije 79 sati).
English: Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of ribavirin.
Croatian: Stoga se preporučuje procjena funkcije bubrega u svih bolesnika prije uvođenja ribavirina.
English: The safety and efficacy of ribavirin used together with direct-acting-anti-virals in these patients has not been established.
Croatian: Sigurnost i djelotvornost ribavirina kad se primjenjuje zajedno s izravno djelujućim antivirusnim lijekovima u ovih bolesnika nisu utvrđeni.
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin Mylan must be discontinued immediately and appropriate medical therapy instituted.
Croatian: Ako se razvije akutna reakcija preosjetljivosti (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksija), mora se odmah prekinuti davanje lijeka Ribavirin Mylan i započeti odgovarajuću medicinsku terapiju.
English: Do not take Ribavirin Mylan Do not take Ribavirin Mylan if any of the following apply to you or the child you are caring for.
Croatian: Nemojte uzimati Ribavirin Mylan ako se bilo što od navedenog odnosi na Vas ili dijete o kojem skrbite.
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Croatian: Možda ćete htjeti zamoliti člana obitelji ili bliskog prijatelja da Vam pomognu primijetiti znakove depresije ili promjene u ponašanju.
English: Genotype 2/3 88.9 (72/81)
Croatian: Genotip 2/3 88,9 (72/81)
English: Dose reduction in paediatric patients without cardiac disease follows the same guidelines as adult patients without cardiac disease regarding haemoglobin levels (Table 2).
Croatian: Za smanjenje doze u pedijatrijskih bolesnika bez bolesti srca slijedite iste smjernice kao za odrasle bolesnike bez bolesti srca bez obzira na razine hemoglobina (Tablica 2).
English: Please refer also to the relevant product information for antiretroviral medicinal products.
Croatian: Molimo pročitati i odgovarajuće informacije o antiretrovirusnim lijekovima.
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 učinkovitu kontracepciju za vrijeme liječenja i tijekom 4 mjeseca nakon završetka liječenja; svakog se mjeseca tijekom navedenog perioda moraju rutinski obavljati testovi na trudnoću.
English: This decline was significant among responders (0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among nonresponders.
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: If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Croatian: Ako Vaša partnerica nije trudna, ali je reproduktivne dobi, mora obavljati test na trudnoću svakog mjeseca za vrijeme Vašeg liječenja te tijekom sedam mjeseci nakon prestanka liječenja.
English: • are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
Croatian: • žena u reproduktivnoj dobi (pogledajte dio “Trudnoća i dojenje”)
English: If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Croatian: U tom slučaju mora im se savjetovati da nakon povraćanja temeljito isperu usta.
English: > 5 mg/dL (for > 4 weeks) (children and adolescents treated with interferon alfa-2b) or > 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
Croatian: > 5 mg/dl (tijekom > 4 tjedna) (djeca i adolescenti liječeni interferonom alfa-2b) ili > 4 mg/dl (tijekom > 4 tjedna) (djeca i adolescenti liječeni peginterferonom alfa-2b)
English: The Ribavirin Mylan hard capsule is a white, opaque, hard capsule imprinted with green ink.
Croatian: Tvrda kapsula lijeka Ribavirin Mylan je bijela, neprozirna tvrda kapsula s oznakama otisnutima zelenom bojom.
English: This appears to be due to reduction of apparent clearance in these patients.
Croatian: Čini se da je to posljedica smanjenog klirensa u tih bolesnika.
English: Severe adverse reactions were reported in 7 % (8/107) of all subjects and included injection site pain (1 %), pain in extremity (1 %), headache (1 %), neutropenia (1 %), and pyrexia (4 %).
Croatian: Teške nuspojave prijavljene su u 7 % svih ispitanika (8/107) i uključivale su bol na mjestu injiciranja (1 %), bol u ekstremitetima (1 %), glavobolju (1 %), neutropeniju (1 %) i pireksiju (4 %).
English: Ribavirin has two pathways of metabolism: 1) a reversible phosphorylation pathway; 2) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxyacid metabolite.
Croatian: Dva su puta metabolizma lijeka Ribavirin Mylan: 1) put reverzibilne fosforilacije; 2) put razgradnje koji uključuje deribozilaciju i hidrolizu amida, u kojem nastaje metabolit triazol karboksilna kiselina.
English: Please refer to the Package Leaflet of (peg)interferon alfa for more detailed information on these safety issues.
Croatian: Pogledajte Uputu o lijeku za (peg)interferon alfa radi više pojedinosti o ovim sigurnosnim pitanjima.
English: Suicide attempts, panic attack, hallucination
Croatian: pokušaji samoubojstva, napad panike, halucinacija rijetko:
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Croatian: Važne nuspojave koje su se pojavile tijekom liječenja u ovoj populaciji bolesnika bile su nervoza (8 %), agresivnost (3 %), ljutnja (2 %), depresija/depresivno raspoloženje (4 %) i hipotireoza (3 %), a pet je ispitanika primalo levotiroksin za liječenje hipotireoze/povišenog TSH-a.
English: Thus, Ribavirin Mylan must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Croatian: Stoga se Ribavirin Mylan mora primjenjivati uz oprez u bolesnika s od ranije postojećom srčanom bolešću (vidjeti dio 4.3).
English: If you are caring for a child and your doctor decides not to defer combination treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is important to understand that this combination therapy induces a growth inhibition that may be irreversible in some patients.
Croatian: Ako skrbite za dijete i Vaš liječnik odluči da se liječenje kombinacijom s peginterferonom alfa-2b ili interferonom alfa-2b ne odgađa do odrasle dobi, važno je razumjeti da ta kombinacija izaiva inhibiciju rasta koja u nekih bolesnika može biti nepovratna.
English: Dosing for children above 3 years of age and adolescents depends on how much the person weighs and the medicines that are used in combination.
Croatian: Doziranje za djecu stariju od tri godine i adolescente ovisi o tjelesnoj težini bolesnika i drugim lijekovima koji se primjenjuju u kombinaciji.
English: Interferon medicine that is used in combination with Ribavirin Mylan may cause unusual tiredness; if you are injecting this medicine yourself or giving it to a child, use it at bedtime.
Croatian: Interferoni koji se daju u kombinaciji s lijekom Ribavirin Mylan mogu prouzročiti neuobičajeni umor; ako sebi ili djetetu sami dajete injekciju interferona, učinite to prije spavanja.
English: The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14%.
Croatian: Bioraspoloživost doze ribavirina od 600 mg bila je smanjena prilikom istodobne primjene antacida koji sadrže magnezij, aluminij i simetikon; AUCtf se smanjio za 14 %.
English: Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Croatian: Genotoksična aktivnost opažena je u testu s mišjim limfomom te pri dozama od 20-200 mg/kg u mikronukleusnom testu na miševima.
English: There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin.
Croatian: Čini se kako nema značajnih učinaka na farmakokinetiku ribavirina povezanih s dobi.
English: Table 9 Virologic response at treatment week 12, end of treatment response, relapse rate* and Sustained Virologic Response (SVR)
Croatian: Tablica 9 Virološki odgovor u 12. tjednu liječenja, odgovor na kraju liječenja, stopa relapsa* i trajan virološki odgovor (SVR)
English: All patients in selected chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Croatian: Svim bolesnicima uključenima u odabrana ispitivanja kroničnog hepatitisa C učinjena je biopsija jetre prije uključenja, no u nekim je slučajevima (tj. u bolesnika s genotipom 2 ili 3) moguće započeti liječenje bez histološke potvrde.
English: If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Croatian: Pojave li se takvi simptomi, nadležni liječnik mora biti svjestan moguće ozbiljnosti ovih nuspojava te se mora razmotriti potreba za odgovarajućim terapijskim zbrinjavanjem.
English: Pharmacotherapeutic group: antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors, ATC code: J05AB04.
Croatian: Farmakoterapijska skupina: antivirotici za sistemsku uporabu, nukleozidi i nukleotidi osim inhibitora reverzne transkriptaze, ATK oznaka J05AB04.
English: There are no special storage conditions for capsules packed in blisters.
Croatian: Za kapsule u blisterima nema posebnih uvjeta čuvanja.
English: Although ribavirin has no direct cardiovascular effects, anaemia associated with ribavirin may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both.
Croatian: Iako ribavirin nema izravnih kardiovaskularnih učinaka, anemija povezana s ribavirinom može dovesti do pogoršanja srčane funkcije ili egzacerbacije simptoma koronarne bolesti, ili oboje.
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of ribavirin is available.
Croatian: Za djecu ili adolescente koji ne mogu progutati tvrdu kapsulu ribavirin je dostupan u obliku peroralne otopine.
English: Patients with substance use/abuse:
Croatian: Bolesnici koji uzimaju/zlorabe sredstva ovisnosti:
English: By Week 12*** (n= 915)
Croatian: 12. tjedna (n= 215)
English: The capsule shell contains gelatine and titanium dioxide (E171).
Croatian: Ovojnica kapsule sadrži želatinu i titanijev dioksid (E171).
English: The exacerbation of anaemia due to ribavirin 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 ribavirinom prijavljena je kada je u režim liječenja HIV infekcije bio uključen zidovudin, iako točan mehanizam još treba razjasniti.
English: Limited safety data (N = 25) are available in co-infected patients with CD4+ cell counts < 200/µl (see section 4.4).
Croatian: . Ograničeni podaci o sigurnosti su dostupni (N = 25) za bolesnike s istodobnom infekcijom u kojih je broj CD4+ stanica < 200/µl (vidjeti dio 4.4).
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: Trajanje terapije je bilo 48 tjedana, a period 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, uz period naknadnog praćenja od 6 mjeseci.
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 genotipom 1, 64 % u dobi od ≤ 12 godina.
English: Ribavirin transport in non-plasma compartments has been most extensively studied in red cells, and has been identified to be primarily via an es-type equilibrative nucleoside transporter.
Croatian: Prijenos ribavirina u neplazmatske odjeljke najopsežnije se istraživao na eritrocitima te je utvrđeno da se odvija prvenstveno putem ekvilibracijskog nukleozidnog prijenosnika es-tipa.
English: Early intervention for re-emergence or development of psychiatric disorders and substance use is recommended.
Croatian: Preporučuje se rana intervencija u slučaju ponovne pojave ili razvoja psihijatrijskih poremećaja i uživanja sredstava ovisnosti.
English: Periodontal disorder, dental disorder, tongue pigmentation
Croatian: poremećaj parodonta, dentalni poremećaji, pigmentacija jezika
English: In the treatment phase of this study, the most prevalent adverse reactions in all subjects were pyrexia (80 %), headache (62 %), neutropenia (33 %), fatigue (30 %), anorexia (29 %) and injection-site erythema (29 %).
Croatian: U terapijskoj fazi ovog ispitivanja ovog ispitivanja, nuspojave s najvećom prevalencijom u svih ispitanika su bile pireksija (80 %), glavobolja (62 %), neutropenija (33 %), umor (30 %), anoreksija (29 %) i eritem na mjestu injiciranja (29 %).
English: Tabulated list of adverse reactions in paediatric population
Croatian: Tablični popis nuspojava u pedijatrijske populacije
English: Ribavirin Mylan capsules are packaged in:
Croatian: Kapsule lijeka Ribavirin Mylan su pakirane u:
English: Based on published data, single-dose ribavirin pharmacokinetics was altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance >90 ml/minute).
Croatian: Na temelju objavljenih podataka, farmakokinetika ribavirina nakon jedne doze bila je izmijenjena (povećani AUCtf i Cmax) u bolesnika s oštećenom funkcijom bubrega u usporedbi s kontrolnim ispitanicima (klirens kreatinina > 90 ml/min).
English: Excipient with known effect: each hard capsule contains 15 mg of lactose monohydrate.
Croatian: Pomoćna tvar(i) s poznatim učinkom: jedna tvrda kapsula sadrži 15 mg laktoze hidrata.
English: The mean AUCtf was threefold greater in subjects with creatinine clearance between 10 and 30 mL/min compared with control subjects.
Croatian: Srednji AUCtf bio je tri puta veći u ispitanika s klirensom kreatinina između 10 i 30 ml/min u usporedbi s kontrolnim ispitanicima.
English: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µl.
Croatian: Među bolesnicima istodobno zaraženima HCV-om i HIV-om malo je dostupnih podataka o djelotvornosti i sigurnosti (N = 25) za ispitanike s brojem CD4 stanica manjim od 200 stanica/μl.
English: - Genotoxicity: ribavirin induces genotoxicity (see section 5.3).
Croatian: - Genotoksičnost: ribavirin inducira genotoksičnost (vidjeti dio 5.3).
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: Ispitivanje 1 (RIBAVIC; P01017) bilo je randomizirano i multicentrično provedeno ispitivanje, u koje je uključeno 412 prethodno neliječenih odraslih bolesnika s kroničnim hepatitisom C koji su istodobno bili zaraženi HIV-om.
English: Reminder: This medicine is used in combination with interferon alfa-2b for hepatitis C virus infection.
Croatian: Podsjetnik: Ovaj lijek primjenjuje se u kombinaciji s interferonom alfa-2b za virusnu infekciju hepatitisom C.
English: What you need to know before you take Ribavirin Mylan
Croatian: Što morate znati prije nego počnete uzimati Ribavirin Mylan
English: Patients treated with ribavirin and zidovudine are at increased risk of developing anaemia; therefore, the concomitant use of ribavirin with zidovudine is not recommended (see section 4.5).
Croatian: Bolesnici liječeni ribavirinom i zidovudinom imaju povećan rizik za razvoj anemije; stoga se ne preporučuje istodobna primjena ribavirina sa zidovudinom (vidjeti dio 4.5).
English: There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa.
Croatian: Nekoliko je ozbiljnih nuspojava povezano s kombiniranom terapijom ribavirina s (peg)interferonom alfa.
English: The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation (> 15 percentile decrease in height percentile as compared to baseline) in 21 % (n=20) of children despite being off treatment for more than 5 years.
Croatian: Dugoročni podaci u djece liječene kombiniranom terapijom standardnim interferonom/ribavirinom također ukazuju na značajno zaostajanje u rastu (smanjenje za >15 percentila na percentilnoj krivulji rasta u usporedbi s početnom vrijednošću) u 21 % (n=20) djece, unatoč tome što je od liječenja prošlo više od 5 godina.
English: The study results are summarized in Table 14.
Croatian: Rezultati ispitivanja sažeti su u Tablici 14).
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were coinfected with HIV.
Croatian: Ispitivanje 2 (P02080) bilo je randomizirano, monocentrično ispitivanje, u koje je uključeno 95 prethodno neliječenih odraslih bolesnika s kroničnim hepatitisom C koji su istodobno bili zaraženi HIV-om.
English: In individual cases where the benefit of administering ribavirin 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 primjene ribavirina istodobno s azatioprinom opravdava mogući rizik, preporučuje se pomno nadzirati hematološke parametre za vrijeme istodobnog uzimanja azatioprina kako bi se otkrili znakovi mijelotoksičnosti, kada se liječenje tim lijekovima mora prekinuti (vidjeti dio 4.4).
English: Additionally, patients receiving zidovudine with ribavirin in combination with alpha interferons could be at increased risk of developing anaemia (low number of red blood cells).
Croatian: Osim toga, bolesnici koji se liječe zidovudinom i ribavirinom u kombinaciji s alfa interferonima mogu imati povećan rizik za razvoj anemije (malen broj crvenih krvnih stanica).
English: The use of Ribavirin Mylan is contraindicated during pregnancy.
Croatian: Primjena lijeka Ribavirin Mylan kontraindicirana je tijekom trudnoće.
English: This benefit was maintained irrespective of standard predictors of response to interferon alfa-2b such as virus level, HCV genotype and histological staging.
Croatian: Ovo je poboljšanje održano bez obzira na standardne pretkazatelje odgovora na interferon alfa-2b kao što su razina virusa, HCV genotip i histološki stadij.
English: Case by case benefit/risk assessment in children: The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Croatian: Procjena omjera koristi i rizika za svako pojedino dijete: Očekivanu korist od liječenja mora se pažljivo odvagnuti u odnosu na nalaze o sigurnosti primjene u djece i adolescenata zabilježene u kliničkim ispitivanjima (vidjeti dijelove 4.8 i 5.1).
English: In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when ribavirin is administered.
Croatian: U HIV-pozitivnoj populaciji koja prima NRTI, liječnici moraju pažljivo kontrolirati pokazatelje mitohondijske toksičnosti i laktacidoze nakon primjene ribavirina.
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: Genotype 2/3 67.9 (74/109)
Croatian: Genotip 2/3 67,9 (74/109)
English: Ribavirin is embryotoxic or teratogenic, or both, at doses well below the recommended human dose in all animal species in which studies have been conducted.
Croatian: Ribavirin je pokazao embriotoksične ili teratogene učinke, ili oboje, u svih životinjskih vrsta u kojih su provedena istraživanja pri dozama koje su znatno niže od preporučene doze za ljude.