natgillin/translations-raw huggingface dataset:
14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 84 film-coated tablets 112 film-coated tablets 140 film-coated tablets 168 film-coated tablets
14 filmom obloženih tableta 28 filmom obloženih tableta 42 filmom obložene tablete 56 filmom obloženih tableta 84 filmom obložene tablete 112 filmom obloženih tableta 140 filmom obloženih tableta 168 filmom obloženih tableta
Bipolar disorder*
bipolarni poremećaj*
Anaemia occurs shortly after initiation of dosing, but is rapidly reversible upon cessation of treatment.
Anemija se razvija ubrzo nakon početka primjene, ali se brzo povlači nakon prekida liječenja.
There was no improvement in terms of fibrosis observed in this study.
U ovom ispitivanju nije opaženo poboljšanje fibroze.
The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Smanjenje broja CD4+ stanica bilo je reverzibilno nakon smanjenja doze ili prestanka liječenja.
Haemoglobin Adult: ≥ 12 g/dL (females); ≥ 13 g/dL (males) Children and adolescents: ≥ 11 g/dL (females); ≥ 12 g/dL (males)
Odrasli: ≥ 12 g/dl (žene); ≥ 13 g/dl (muškarci) Djeca i adolescenti: ≥ 11 g/dl (djevojčice); ≥ 12 g/dl (dječaci)
Do not take Ribavirin Teva Pharma B.V. if any of the following apply to you or the child you are caring for.
Nemojte uzimati Ribavirin Teva Pharma B.V. ako se bilo što od navedenog odnosi na Vas ili dijete o kojem skrbite.
At the end of the recovery period, tibial and femoral changes were minimal although generally statistically significant compared to controls in males at all dose levels and in females dosed with the two highest doses compared to controls.
Na kraju razdoblja oporavka tibijalne i femoralne promjene bile su minimalne, premda u pravilu statistički značajne u odnosu na kontrole, pri svim primijenjenim dozama u mužjaka te pri dvije najviše doze u ženki.
Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Laboratorijske pretrage moraju se napraviti u 2. i 4. tjednu liječenja, a nakon toga periodički, prema kliničkoj procjeni.
Hepatotoxicity (including fatalities)*
hepatotoksičnost (uključujući smrtne ishode)*
Haemoglobin in patients with No Cardiac Disease
Hemoglobin u bolesnika bez srčane bolesti
Seizure (convulsion)*
napadaji (konvulzije)*
Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Dodavanje liječenja alfa interferonom samim ili u kombinaciji s ribavirinom može povećati rizik u ovoj podskupini bolesnika.
Ribavirin accumulates intracellularly and is cleared from the body very slowly.
Ribavirin se nakuplja unutar stanica i vrlo sporo se uklanja iz organizma.
In the cases in which no specific dose recommendation is made, the following dose should be used: Patient weight: < 75 kg =1,000 mg and > 75 kg = 1,200 mg.
U slučajevima kada nema posebnih preporuka za doziranje, treba primijeniti sljedeću dozu: Tjelesna težina bolesnika: <75 kg=1000 mg, a >75 kg=1200 mg.
Dose modifications were required in 30 % of patients, most commonly for anaemia and neutropenia.
Prilagodba doze bila je potrebna u 30% bolesnika, najčešće zbog anemije i neutropenije.
Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
plućni infiltrati*, pneumonitis*, intersticijski pneumonitis*
Reminder: This medicine is only to be used in combination with other medicines for hepatitis C virus infection.
Podsjetnik: Ovaj lijek se koristi u kombinaciji s drugim lijekovima za liječenje infekcije virusom hepatitisa C.
Adults:
Odrasli:
The other ingredients are
Drugi sastojci su:
Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Nadalje, 98% bolesnika (51/52) s normalnim razinama ALT-a u 24. tjednu praćenja održalo je normalne razine ALT-a na zadnjoj posjeti.
There are no data in children or adolescents with a history of cardiac disease.
Nema podataka u djece ili adolescenata sa srčanom bolešću u anamnezi.
Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Muškarce čije su partnerice trudne mora se uputiti da koriste kondom kako bi se prijenos ribavirina u tijelo partnerice smanjio na najmanju moguću mjeru.
Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.
Primjena analoga nukleozida, samih ili u kombinaciji s drugim nukleozidima, izazvala je laktacidozu.
The clearance model developed showed that body weight, gender, age, and serum creatinine were the main covariates.
Dobiveni model klirensa pokazao je da su tjelesna težina, spol, dob i serumski kreatinin bile glavne kovarijable.
Standard blood tests will be taken to check your blood, kidney and liver function.
Standardnim pretragama krvi provjerit će se krvna slika, funkcija bubrega i jetre.
Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
Liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju kroničnog hepatitisa C.
Effects of these covariates on ribavirin clearance appear to be of limited clinical significance due to the substantial residual variability not accounted for by the model.
Čini se da učinci ovih kovarijabli na klirens ribavirina imaju ograničen klinički značaj zbog znatne rezidualne varijabilnosti koju model nije objasnio.
Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Konačna visina u odrasloj dobi bila je dostupna za 14 navedene djece te se pokazalo da njih 12 i dalje ima deficite rasta za >15 percentila, 10 do 12 godina nakon završetka liječenja.
Neoplasm unspecified
nespecificirane novotvorine
HCV Genotype
HCV genotip
Women of childbearing potential/contraception in males and females
Žene reproduktivne dobi/kontracepcija u muškaraca i žena
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Srčane aritmije (prvenstveno supraventrikularne) obično dobro reagiraju na standardnu terapiju, ali mogu zahtijevati prekid terapije.
- Breast-feeding - History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months (see section 4.4).
- Dojenje - Teška srčana bolest u anamnezi, uključujući nestabilnu ili nekontroliranu srčanu bolest u prethodnih 6 mjeseci (vidjeti dio 4.4).
A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 % ≤ 12 years of age.
U ispitivanje je ukupno uključeno 118 bolesnika: 57% muškaraca, 80% bijelaca i 78% s genotopinom 1 te 64 % ≤12 godina.
Discontinue breastfeeding before starting to take this medicine.
Prekinite dojenje prije početka uzimanja ovog lijeka.
Sarcoidosis*, rheumatoid arthritis (new or aggravated)
sarkoidoza*, reumatoidni artritis (novootkriveni ili pogoršanje)
These doses in animals produce systemic exposures well below those achieved in humans at therapeutic doses.
Ove doze u životinja dovode do sustavne izloženosti znatno manje od one koja se postiže pri terapijskim dozama u ljudi.
This medicinal product requires no special storage conditions.
Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
Ribavirin concentration in seminal fluid is approximately two-fold higher compared to serum.
Koncentracija ribavirina u sjemenoj tekućini je približno dva puta veća u usporedbi s koncentracijom u serumu.
Nucleoside analogues
Analozi nukleozida
Genotype 1
Genotip 1
This would be particularly important in patients with a known history of zidovudine induced anaemia.
To je osobito važno u bolesnika koji u anamnezi imaju anemiju uzrokovanu zidovudinom.
Steatosis was significantly improved in patients infected with HCV Genotype 3.
Steatoza se značajno poboljšala u bolesnika inficiranih genotipom 3 HCV-a.
Discontinue ribavirin if:
Prekinuti primjenu ribavirina ako je:
The selection of ribavirin formulation is based on individual characteristics of the patient.
Odabir formulacije ribavirina ovisi o osobinama pojedinog bolesnika.
Ribavirin plus interferon
Ribavirin uz interferon
Ribavirin is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Ribavirin je sintetski analog nukleozida koji je pokazao aktivnost in vitro protiv nekih RNK i DNK virusa.
Acceptable baseline values that may be considered as a guideline prior to initiation of ribavirin therapy:
Prihvatljive početne vrijednosti koje se mogu koristiti kao smjernice prije početka liječenja ribavirinom su:
This medicine does not effect your ability to drive or use machines; however, other medicines used in combination with Ribavirin Teva Pharma B.V. may cause sleepiness, tiredness or confusion.
Ovaj lijek ne utječe na sposobnost upravljanja vozilima ili strojevima; međutim, drugi lijekovi koji se primjenjuju u kombinaciji s lijekom Ribavirin Teva Pharma B.V. mogu uzrokovati pospanost, umor ili smetenost.
This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Takvo djelovanje može povećati rizik od nastanka laktacidoze prouzročene analozima purinskih nukleozida (npr. didanozinom ili abakavirom).
Tmax (hr) Cmax (ng/mL) AUC* Apparent clearance L/hr/kg
Tmax (h) Cmax (ng/ml) AUC* Prividni klirens l/h/kg
The salient safety issue of ribavirin is haemolytic anaemia occurring within the first weeks of therapy.
Najistaknutiji sigurnosni problem povezan s primjenom ribavirina je hemolitička anemija, koja se javlja tijekom prvih tjedana liječenja.
The major treatment-related change was a reversible mild to moderate anaemia, the severity of which was greater than that produced by either active substance alone.
Glavna promjena povezana s liječenjem bila je reverzibilna blaga do umjerena anemija, čija je težina bila veća od one izazvane svakom od tih djelatnih tvari posebno.
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.
Doziranje u djece starije od 3 godine i adolescenata ovisi o tjelesnoj težini bolesnika i lijekovima koji se uzimaju u kombinaciji.
Extreme care must be taken to avoid pregnancy in female patients (see section 5.3).
Potrebno je strogo paziti da se izbjegne trudnoća u bolesnica (vidjeti dio 5.3).
Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme*
Stevens-Johnsonov sindrom*, toksična epidermalna nekroliza*, multiformni eritem*
Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with ribavirin and for seven months after treatment.
Iako podaci prikupljeni prospektivnim praćenjem oko 300 trudnoća u kojima je otac primao ribavirin nisu pokazali povećan rizik od malformacija u usporedbi s općom populacijom niti ikakvu specifičnu vrstu malformacija, mora se savjetovati bolesnicima muškog spola ili njihovim partnericama u reproduktivnoj dobi da koriste djelotvornu kontracepciju tijekom liječenja ribavirinom i još sedam mjeseci nakon završetka liječenja.
In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
U kliničkom ispitivanju C/I98-580 je 1530 bolesnika koji prethodno nisu bili liječeni liječeno godinu dana jednom od sljedećih kombinacija:
Genotoxicity studies have demonstrated that ribavirin does exert some genotoxic activity.
Ispitivanja genotoksičnosti pokazala su da ribavirin ima određeno genotoksično djelovanje.
Ribavirin dose (mg/kg)
Doza ribavirina (mg/kg)
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.
Prijenos ribavirina u neplazmatske odjeljke najviše se istraživao na crvenim krvnim stanicama te je utvrđeno da se on odvija prvenstveno putem ekvilibracijskog nukleozidnog prijenosnika es-tipa.
In terms of activity, about one-third of sustained responders showed improvement and none showed worsening.
Što se tiče aktivnosti bolesti, do poboljšanja je došlo u približno jedne trećine, dok pogoršanje nije nastupilo niti u jednog bolesnika s trajnim odgovorom.
Decrease in mean height percentile at year 1 of long term follow-up was most prominent in prepubertal age children.
Posječno smanjenje na percentilnoj krivulji rasta nakon godinu dana dugoročnog praćenja bilo je najizraženije u djece pretpubertetske dobi.
Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare
neuobičajeno ponašanje, depresivno raspoloženje, emocionalni poremećaj, strah, noćne more
Ribavirin must be used in combination with other medicinal products (see section 5.1).
Ribavirin se mora primjenjivati u kombinaciji s drugim lijekovima (vidjeti dio 5.1).
For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available.
Za pedijatrijske bolesnike (djecu i adolescente) težine manje od 47 kg ovaj je lijek dostupan u obliku otopine.
Caution is therefore warranted in the treatment of patients with low CD4 counts.
Stoga se nalaže oprez u liječenju bolesnika s malim brojem CD4 stanica.
Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of ribavirin.
Stoga se preporučuje provjeriti funkciju bubrega u svih bolesnika prije početka liječenja ribavirinom.
Ribavirin Teva Pharma B.V. is available in different pack sizes containing 14, 28, 42, 56, 84, 112, 140 or 168 tablets.
Ribavirin Teva Pharma B.V. je dostupan u različitim veličinama pakiranja koja sadrže 14, 28, 42, 56, 84, 112, 140 ili 168 tableta.
Prior to initiation of treatment with ribavirin the physician must comprehensively inform both male and female patients of the teratogenic risk of ribavirin, the necessity of effective and continuous contraception, the possibility that contraceptive methods may fail and the possible consequences of pregnancy should it occur during or following treatment with ribavirin (see section 4.6).
Prije početka liječenja ribavirinom, liječnik mora i bolesnicima i bolesnicama detaljno objasniti teratogeni rizik primjene ribavirina, potrebu za učinkovitom i kontinuiranom kontracepcijom, mogućnost neuspjeha kontracepcijskih metoda i moguće posljedice trudnoće ako ona nastupi tijekom ili nakon liječenja ribavirinom (vidjeti dio 4.6).
The purpose of the studies was to evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes.
Svrha ispitivanja bila je procjena postojanosti trajnog virološkog odgovora (SVR) i utjecaja kontinuirano negativnog nalaza virusa na klinički ishod.
Clearance increased as a function of body weight and was reduced at ages greater than 40 years.
Klirens se povećavao s povećanjem tjelesne težine, a bio je smanjen u bolesnika starijih od 40 godina.
You must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Morate imati negativan test na trudnoću prije liječenja, svaki mjesec tijekom liječenja i tijekom 4 mjeseca nakon prestanka liječenja.
1 tablet in the morning and 2 tablets in the evening
1 tableta ujutro i 2 tablete navečer
In the pivotal clinical efficacy trial, patients were instructed to take ribavirin with food to achieve the maximal plasma concentration of ribavirin.
U pivotalnom kliničkom ispitivanju djelotvornosti bolesnicima se savjetovalo da uzimaju ribavirin s hranom kako bi se postigle maksimalne koncentracije ribavirina u plazmi.
Transfer into seminal fluid
Prijenos u sjemenu tekućinu
Results of these investigations showed that ribavirin 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.
Rezultati tih ispitivanja pokazali su da monoterapija ribavirinom 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.
Ribavirin (800 mg/day)
Ribavirin (800 mg/dan)
There is a linear relationship between dose and AUCtf following single doses of 200-1,200 mg ribavirin.
Odnos između doze i AUCtf je linearan nakon primjene jednokratnih doza od 200 do 1200 mg ribavirina.
Please refer to the Package Leaflet of (peg)interferon alfa for more detailed information on these safety issues.
Molimo pročitajte Uputu o lijeku za (peg)interferon alfa za detaljnije informacije o tim sigurnosnim problemima.
Due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis, the use of ribavirin and didanosine is not recommended and the use of ribavirin and stavudine should be avoided.
Zbog rizika od laktacidoze (nakupljanje mliječne kiseline u tijelu) i upale gušterače, ne preporučuje se istodobna primjena ribavirina i didanozina, a istodobnu primjenu ribavirina i stavudina treba izbjegavati.
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.
Ribavirin ima dva metabolička puta: 1) put reverzibilne fosforilacije i 2) put razgradnje koji uključuje deribozilaciju i hidrolizu amida, u kojem nastaje metabolit triazol karboksilna kiselina.
Acute hypersensitivity
Akutna preosjetljivost
In addition, injection site disorders, pyrexia, anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Osim toga, promjene na mjestu injekcije, pireksija, anoreksija, povraćanje i emocionalna labilnost javljali su se češće u djece i adolescenata nego u odraslih bolesnika.
Any patient developing significant liver function abnormalities during treatment must be monitored closely.
Svaki bolesnik koji razvije značajne poremećaje funkcije jetre tijekom liječenja mora se strogo nadzirati.
2 tablets in the morning and 2 tablets in the evening or 1 (400 mg) tablet in the morning and 1 (400 mg) tablet in the evening See adult dose
2 tablete ujutro i 2 tablete navečer ili 1 (400 mg) tableta ujutro i 1 (400 mg) tableta navečer
Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “Laboratory tests” and section 4.8).
Premda se većina tih poremećaja može zbrinuti smanjivanjem doze, potrebno je pažljivo nadzirati hematološke parametre u ovoj populaciji bolesnika (vidjeti dio 4.2, "Laboratorijski nalazi" u nastavku te dio 4.8).
Ribavirin Teva Pharma B.V. must be used in combination therapy as described in section 4.1.
Ribavirin Teva Pharma B.V. se mora primjenjivati u kombiniranoj terapiji kao što je opisano u dijelu 4.1.
Nephrotic syndrome*
nefrotski sindrom*
• are a male and your female partner is of childbearing age (see section “Pregnancy and breast feeding”).
• muškarac, a Vaša partnerica je u reproduktivnoj dobi (vidjeti dio "Trudnoća i dojenje").
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.
Iako ribavirin nema izravnih kardiovaskularnih učinaka, anemija povezana s ribavirinom može dovesti do slabljenja srčane funkcije ili pogoršanja simptoma koronarne bolesti, ili oboje.
Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
Odrasle bolesnike s kongestivnim zatajenjem srca ili infarktom miokarda u anamnezi i/ili prethodnim ili postojećim poremećajima srčanog ritma mora se pomno nadzirati.
Because of the potential for adverse reactions in breast-fed infants, breast-feeding must be discontinued prior to initiation of treatment.
Zbog mogućnosti razvoja nuspojava u dojenčadi dojenje se mora prekinuti prije početka liječenja.
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.
Ako Vaša partnerica nije trudna, ali je u reproduktivnoj dobi, mora napraviti test na trudnoću svaki mjesec za vrijeme Vašeg liječenja te tijekom 7 mjeseci nakon prestanka liječenja.
Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Farmakološki, ribavirin dovodi do porasta fosforiliranih metabolita purinskih nukleozida in vitro.
Ribavirin does not inhibit cytochrome P450 enzymes.
Ribavirin ne inhibira enzime citokroma P450.
Sustained virological response in previously untreated children and adolescents
Tablica 9 Trajan virološki odgovor u djece i adolescenata koji prethodno nisu bili liječeni
Absorption is extensive with approximately 10 % of a radiolabelled dose excreted in the faeces.
Apsorpcija je opsežna, a oko 10% radioaktivno označene doze izlučuje se fecesom.
Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity occurred within one or two spermatogenic cycles (see section 4.6).
Nakon prestanka liječenja dolazi do zapravo potpunog oporavka od testikularne toksičnosti izvazvane ribavirinom unutar jednog ili dva ciklusa spermatogeneze (vidjeti dio 4.6).
Neuropathy, peripheral neuropathy
neuropatija, periferna neuropatija rijetko:
The safety and efficacy of ribavirin used together with direct-acting-anti-virals in these patients has not been established.
Sigurnost i djelotvornost ribavirina u kombinaciji s antiviroticima koji djeluju direktno nisu ustanovljene u tih bolesnika.
Daily ribavirin dose
Dnevna doza ribavirina
Dose modification for paediatric patients
Prilagodba doze u pedijatrijskih bolesnika
There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin.
Čini se da dob nema značajnog utjecaja na farmakokinetiku ribavirina.
Dosing of ribavirin for children and adolescent patients is determined by the patient body weight.
Doziranje ribavirina za djecu i adolescente utvrđuje se na osnovi tjelesne težine bolesnika.
• are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
• žena u reproduktivnoj dobi (vidjeti dio "Trudnoća i dojenje").
The decline of height, weight and BMI Z scores observed during the treatment phase in comparison to a normative population did not fully recover at the end of long-term follow-up period for children treated with 48 weeks of therapy (see section 4.4).
Smanjenje Z-vrijednosti za visinu, tjelesnu težinu i BMI primijećeno tijekom razdoblja liječenja u usporedbi s normativnom populacijom nije se potpuno oporavilo do kraja razdoblja dugotrajnog praćenja u djece liječene 48 tjedana (vidjeti dio 4.4).
For children or adolescents who cannot swallow a film-coated tablet, an oral solution of ribavirin is available.
Za djecu ili adolescente koji ne mogu progutati filmom obloženu tabletu, ribavirin je dostupan u obliku oralne otopine.
This appears to be due to reduction of apparent clearance in these patients.
Čini se da je to posljedica smanjenog prividnog klirensa u tih bolesnika.
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Ujedinjeno Kraljevstvo
Sustained response was assessed by the response rate six months after the cessation of treatment.
1. Trajan odgovor na liječenje procijenjen je na temelju stope odgovora 6 mjeseci nakon prestanka liječenja.
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).
Ako bolesnica zatrudni tijekom liječenja ili unutar četiri mjeseca po prestanku liječenja, mora biti obaviještena o značajnom teratogenom riziku ribavirina za fetus (vidjeti dio 4.4).