FrancophonIA/ELRC3.0 huggingface dataset:
English: Another approximately 4% had a transient decrease below the lower limit of normal.
Croatian: Još je oko 4 % djece imalo prolazno sniženje vrijednosti TSH-a ispod donje granice normale.
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Croatian: Smanjenje broja CD4+ stanica bilo je reverzibilno nakon smanjenja doze ili prestanka terapije.
English: Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Croatian: Muškarce čije su partnerice trudne mora se uputiti da koriste kondom kako bi se prijenos ribavirina partnericama smanjio na najmanju moguću mjeru
English: • Psychiatric and central nervous system effects (such as depression, suicidal thoughts, attempted suicide and aggressive behaviour, etc.).
Croatian: • psihijatrijske i učinke na središnji živčani sustav (kao što su depresija, suicidalne misli, pokušaji samoubojstva i agresivno ponašanje, itd.).
English: There are no data in children or adolescents with a history of cardiac disease.
Croatian: Nema podataka za djecu ili adolescente s anamnezom srčane bolesti.
English: For males, clearance was approximately 20 % higher than for females.
Croatian: U muškaraca je klirens bio oko 20 % viši nego u žena.
English: The regimen administered should be selected based on the anticipated efficacy and safety of the combination treatment for an individual patient (see section 5.1).
Croatian: Primjenjeni režim se mora odabrati na temelju očekivane djelotvornosti i sigurnosti kombiniranog liječenja za pojedinog bolesnika (vidjeti dio 5.1).
English: Women of childbearing potential/contraception in males and females
Croatian: Žene u reproduktivnoj dobi/kontracepcija u muškaraca i žena
English: These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 10).
Croatian: Pokazalo se da ove vremenske točke (4. i 12. tjedan liječenja) imaju prediktivnu vrijednost za trajan odgovor (Tablica 10).
English: Paediatric population No data are available in children below 3 years of age.
Croatian: Nema podataka za djecu mlađu od tri godine.
English: 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.
Croatian: Na kraju razdoblja oporavka tibijalne i femoralne promjene bile su minimalne, premda u pravilu statistički značajne u odnosu na kontrole, pri svim primijenjenim razinama doze u mužjaka te pri dvije najviše doze u ženki.
English: Conventional carcinogenicity rodent studies with low exposures compared to human exposure under therapeutic conditions (factor 0.1 in rats and 1 in mice) did not reveal tumorigenicity of ribavirin.
Croatian: Konvencionalna ispitivanja kancerogenosti u glodavaca pri niskoj izloženosti u usporedbi s izloženosti u ljudi u terapijskim uvjetima (faktor 0,1 u štakora i 1 u miševa) nisu pokazala tumorogeničnost ribavirina.
English: Bilirubin - Indirect
Croatian: Indirektni bilirubin
English: Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Croatian: Laboratorijske pretrage moraju se napraviti u 2. i 4. tjednu terapije, a kasnije povremeno, prema kliničkoj procjeni.
English: Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
Croatian: Bolesnici moraju temeljito prati zube dva puta dnevno i redovito obavljati preglede zuba.
English: The response to treatment in both of these trials is presented in Table 11.
Croatian: Odgovor na liječenje u oba ispitivanja prikazan je u tablici (Tablica 11).
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 intolerancije galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne smiju uzimati ovaj lijek.
English: Ribavirin 15 mg/kg/day as 2 divided doses (n = 17)
Croatian: Ribavirin 15 mg/kg/dan u 2 podijeljene doze (n = 17)
English: Cardiac status must be assessed before start of therapy and monitored clinically during therapy; if any deterioration occurs, therapy must be stopped (see section 4.2).
Croatian: Srčani status se mora procijeniti prije početka terapije i klinički pratiti tijekom terapije; dođe li do bilo kakvog pogoršanja, terapija se mora prekinuti (vidjeti dio 4.2).
English: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Croatian: Nadalje, 98 % bolesnika (51/52) s normalnim razinama ALT-a u 24. tjednu praćenja održalo je normalne razine ALT-a na zadnjoj posjeti.
English: If it gets worse, your doctor will decide whether or not your Ribavirin Mylan treatment needs to be changed.
Croatian: Ako se infekcija pogoršava, liječnik će odlučiti treba li promijeniti liječenje lijekom Ribavirin Mylan ili ne.
English: Ribavirin Dose (mg/kg)
Croatian: Doza ribavirina (mg/kg)
English: In addition these events have occurred in patients taking Ribavirin Mylan:
Croatian: Uz to, sljedeći su se događaji javili u bolesnika koji su uzimali Ribavirin Mylan:
English: This medicine stops the multiplication of hepatitis C virus.
Croatian: Taj lijek zaustavlja umnažanje virusa hepatitisa C.
English: − It is important to consider that the combination therapy induced a growth inhibition that resulted in reduced height in some patients.
Croatian: - Važno je uzeti u obzir da kombinirana terapija izaziva inhibiciju rasta koja je prouzročila smanjenje visine u određenih bolesnika..
English: - If you have or develop severe kidney or liver problems, this treatment will be stopped.
Croatian: - Ako imate ozbiljne probleme s bubrezima ili jetrom ili se oni razviju, ovo će se liječenje prekinuti.
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Croatian: Takva aktivnost može povećati rizik od nastanka laktacidoze uzrokovane analozima purinskih nukleozida (npr. didanozinom ili abakavirom).
English: *AUC12 (ng.hr/ml) for ribavirin; AUC0-24 (IU.hr/ml) for interferon alfa-2b
Croatian: * AUC12 (ng.h/ml) za ribavirin; AUC0-24 (IU.h/ml) za interferon alfa-2b
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm was observed in
Croatian: U Ispitivanju 1 (vidjeti dio 5.1) smanjenje apsolutnog broja neutrofila ispod vrijednosti od 500 stanica/mm opaženo je u 4 %
English: Genotoxicity studies have demonstrated that ribavirin does exert some genotoxic activity.
Croatian: Ispitivanja genotoksičnosti pokazala su da ribavirin ima određenu genotoksičnu aktivnost.
English: If the abnormality is reversed, ribavirin may be restarted at 600 mg daily, and further increased to 800 mg daily at the discretion of the treating physician.
Croatian: Ako je abnormalnost riješena, ribavirin se ponovno može početi primjenjivati u dozi od 600 mg dnevno i dalje povisiti do 800 mg dnevno prema mišljenju liječnika.
English: 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 Mylan and for seven months after treatment.
Croatian: 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 lijekom Ribavirin Mylan i još sedam mjeseci nakon završetka liječenja.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Croatian: Srčane aritmije (prvenstveno supraventrikularne) obično imaju dobar odgovor na standardnu terapiju, ali mogu zahtijevati prekid terapije.
English: Among 480 patients with > 2 log viral reduction but detectable virus at week 12, altogether 188 patients continued therapy.
Croatian: Od 480 bolesnika sa virusnim smanjenjem za > 2 log, ali mjerljivim virusom u 12. tjednu, ukupno ih je 188 nastavilo liječenje.
English: The ratio of whole blood:plasma ribavirin concentrations is approximately 60:1; the excess of ribavirin in whole blood exists as ribavirin nucleotides sequestered in erythrocytes.
Croatian: Omjer koncentracije ribavirina u punoj krvi u odnosu na plazmu iznosi oko 60:1; višak ribavirina u punoj krvi postoji kao nukleotidi ribavirina sekvestrirani u eritrocitima.
English: Extreme care must be taken to avoid pregnancy in female patients (see section 5.3).
Croatian: Mora se strogo paziti da se izbjegne trudnoća u bolesnica (vidjeti dio 5.3).
English: Reduce only interferon alfa-2b dose (see note 2) if:
Croatian: Smanjiti samo dozu interferona alfa-2b (vidjeti napomenu 2) ako je:
English: What Ribavirin Mylan is and what it is used for What you need to know before you take Ribavirin Mylan How to take Ribavirin Mylan Possible side effects
Croatian: Što je Ribavirin Mylan i za što se koristi Što morate znati prije nego počnete uzimati Ribavirin Mylan Kako uzimati Ribavirin Mylan Moguće nuspojave
English: 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).
Croatian: Prije započinjanja liječenja ribavirinom liječnik mora iscrpno obavijestiti i bolesnike i bolesnice o teratogenom riziku ribavirina, o nužnosti primjene učinkovite i stalne kontracepcije, mogućnosti da metode kontracepcije ne budu uspješne te o mogućim posljedicama na trudnoću ako do nje dođe tijekom ili nakon liječenja ribavirinom (vidjeti dio 4.6).
English: The salient safety issue of ribavirin is haemolytic anaemia occurring within the first weeks of therapy.
Croatian: Istaknuti je sigurnosni problem ribavirina hemolitička anemija koja se pojavljuje u prvih nekoliko tjedana terapije.
English: Tmax (hr) Cmax (ng/ml) AUC* Apparent clearance l/hr/kg
Croatian: Tmax (h) Cmax (ng/ml) AUC* Prividni klirens l/h/kg
English: What Ribavirin Mylan is and what it is used for
Croatian: Što je Ribavirin Mylan i za što se koristi
English: The selection of formulation is based on individual characteristics of the patient (see section 4.1).
Croatian: Odabir formulacije ovisi o osobinama pojedinog bolesnika (vidjeti dio 4.1).
English: Twenty-four % had bridging fibrosis or cirrhosis (Knodell 3/4).
Croatian: 24 % bolesnika imalo je premoštavajuću fibrozu ili cirozu jetre (Knodell 3/4).
English: interferon alpha/ribavirin peginterferon alpha/ribavirin
Croatian: interferon alfa/ribavirin peginterferon alfa/ribavirin
English: 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).
Croatian: Smanjenje visine, težine i ITM Z rezultata primijećenih u fazi liječenja u usporedbi s normativnom populacijom nije se u potpunosti normaliziralo na kraju razdoblja dugotrajnog praćenja za djecu liječenu terapijom od 48 tjedana (vidjeti dio 4.4).
English: 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.
Croatian: Zbog rizika od laktacidoze (nakupljanja mliječne kiseline u tijelu) i upale gušterače, ne preporučuje se istodobna primjena ribavirina i didanozina, a istodobnu primjenu ribavirina i stavudina treba izbjegavati.
English: You should brush your teeth thoroughly twice daily and have regular dental examinations.
Croatian: Zube trebate prati dva puta dnevno te ići na redovite stomatološke preglede.
English: By reporting side effects, you can also help provide more information on the safety of this medicine.
Croatian: Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: Dose modification for adults
Croatian: Prilagodba doze za odrasle
English: Among patients with undetectable HCV-RNA at the end of treatment, the relapse rate was 24 %.
Croatian: Među bolesnicima u kojih je na kraju liječenja HCV-RNK bio nemjerljiv, stopa relapsa bila je 24 %.
English: An increase in uric acid and indirect bilirubin values associated with haemolysis were also observed in some patients.
Croatian: Povećanje vrijednosti mokraćne kiseline i indirektnog bilirubina povezano s hemodijalizom također je opaženo u nekih bolesnika.
English: 4 capsules b Refer to adult dose recommendations a1 morning, 2 evening 2 morning, 2 evening
Croatian: Vidjeti preporuke za doziranje za odrasle a1 ujutro, 2 navečer 2 ujutro, 2 navečer
English: In addition, injection site disorders, pyrexia, anorexia, vomiting, and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Croatian: Osim toga, poremećaji na mjestu injiciranja, pireksija, anoreksija, povraćanje i emocionalna labilnost javljali su se češće u djece i adolescenata nego u odraslih bolesnika.
English: Dose modification for paediatric patients
Croatian: Prilagodba doze za pedijatrijske bolesnike
English: Ribavirin was active in the Balb/3T3 in vitro Transformation Assay.
Croatian: Ribavirin Mylan je bio aktivan u Balb/3T3 in vitro transformacijskom testu.
English: Note: For patients who weigh < 47 kg, or are unable to swallow capsules, ribavirin oral solution is available and should be used if appropriate.
Croatian: Napomena: za pacijente tjelesne težine < 47 kg ili one koji ne mogu (pro)gutati kapsule, dostupna je oralna otopina ribavirina koju se mora koristiti ako je to potrebno.
English: Ribavirin in combination with Direct Antiviral Agent (DAA):
Croatian: Ribavirin u kombinaciji s izravnim protuvirusnim sredstvom (DAA):
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove http://www.ema.europa.eu.
English: Ribavirin accumulates intracellularly and is cleared from the body very slowly.
Croatian: Ribavirin Mylan se nakuplja unutarstanično i vrlo sporo se uklanja iz organizma.
English: • Genotype 1: Treatment should be continued for another six month period (i.e., a total of one year) in patients who exhibit negative HCV-RNA after six months of treatment.
Croatian: • Genotip 1: Liječenje treba nastaviti tijekom daljnjih 6 mjeseci (primjerice, tijekom ukupno godinu dana) u bolesnika koji iskazuju negaitvnu HCV-RNK nakon 6 mjeseci liječenja.
English: 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.
Croatian: Rezultati tih pretraga 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.
English: During those clinical trials in which patients were treated for one year, patients who failed to show a virological response after six months of treatment (HCV-RNA below lower limit of detection) were unlikely to become sustained virological responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
Croatian: Tijekom tih kliničkih ispitivanja u kojima su bolesnici liječeni godinu dana, nije bilo vjerojatno da će bolesnici koji nisu pokazali virološki odgovor nakon 6 mjeseci liječenja (HCV-RNK ispod najniže granice detekcije) postići trajan virološki odgovor (HCV-RNK ispod najniže granice detekcije 6 mjeseci nakon prestanka liječenja).
English: − This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV-co-infection), as well as prognostic factors of response (HCV genotype and viral load).
Croatian: Rizik se mora odvagnuti u odnosu na karakteristike bolesti u djeteta, kao što su dokaz progresije bolesti (naročito fibroza), popratne bolesti koje mogu negativno utjecati na progresiju bolesti (kao što je istodobna infekcija HIV-om) te prognostički faktori odgovora (HCV genotip i virusno opterećenje).
English: No pharmacokinetic interaction appears between ribavirin and hepatic function (see section 5.2).
Croatian: Čini se da nema farmakokinetičke interakcije između ribavirina i jetrene funkcije (vidjeti dio 5.2).
English: Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Croatian: Potražite hitnu skrb ako primijetite da postajete depresivni ili imate suicidalne misli ili promjene u ponašanju.
English: Duration of treatment in children and adolescents
Croatian: Trajanje liječenja u djece i adolescenata
English: 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.
Croatian: Konačna visina u odrasloj dobi bila je dostupna za 14 od te djece i pokazala je da ih je 12 nastavilo imati deficit visine > 15 percentila 10 do 12 godina nakon kraja liječenja.
English: • are a male and your female partner is of childbearing age (see section “Pregnancy and breast feeding”)
Croatian: • muškarac, a Vaša partnerica je reproduktivne dobi (pogledajte dio “Trudnoća i dojenje”)
English: Long-term data available in children treated with the combination therapy of pegylated interferon/ribavirin are indicative of substantial growth retardation.
Croatian: Dugoročni podaci u djece liječene kombiniranom terapijom pegiliranim interferonom/ribavirinom ukazuju na značajno zaostajanje u rastu.
English: Preclinical data - Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section 5.3).
Croatian: Pretklinički podaci - Plodnost: u istraživanjima na životinjama ribavirin je imao reverzibilne učinke na spermatogenezu (vidjeti dio 5.3).
English: Dosing of ribavirin for children and adolescent patients is determined by the patient body weight.
Croatian: Doziranje ribavirina za djecu i adolescente utvrđuje se prema tjelesnoj težini bolesnika.
English: Absorption is extensive with approximately 10% of a radiolabelled dose excreted in the faeces.
Croatian: Apsorpcija je ekstenzivna, a otprilike 10 % radioaktivno označene doze izlučuje se fecesom.
English: In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
Croatian: U kliničkom ispitivanju C/I98-580 na 1530 bolesnika koji prethodno nisu bili liječeni, primjenjeno je liječenje u trajanju od godinu dana jednom od sljedećih kombinacija:
English: 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.
Croatian: U slučaju da preporuke doza nisu utvrđene, treba primijeniti sljedeće doze: Tjelesna težina bolesnika: < 75 kg = 1.000 mg i > 75 kg = 1.200 mg.
English: 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).
Croatian: 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).
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 umjerenim hepatitisom C. U ta su dva multicentrična ispitivanja stope trajnog virološkog odgovora u djece i adolescenata bile slične onima u odraslih.
English: Some people get depressed when taking Ribavirin in combination treatment with an interferon, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Croatian: Neki su bolesnici postali depresivni za vrijeme uzimanja lijeka Ribavirin Mylan u kombinaciji s interferonom, a u nekim su slučajevima razmišljali o ugrožavanju života drugih ljudi, o samoubojstvu ili su iskazivali agresivno ponašanje (ponekad usmjereno protiv drugih).
English: Children and adolescents must not take combination therapy with Ribavirin Mylan and alpha interferon when there is existence or history of serious nervous or mental problems, such as severe depression, thoughts of suicide or attempted suicide.
Croatian: Djeca i adolescenti ne smiju uzimati kombiniranu terapiju lijekomRibavirin Mylan i alfa interferonom ako imaju ili su imali teške živčane ili psihičke poremećaje, kao što su teška depresija, misli o samoubojstvu ili su pokušali izvršiti samoubojstvo.
English: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
Croatian: Odrasle bolesnike s anamnezom kongestivnog zatajenja srca ili infarkta miokarda, i/ili prethodnim ili postojećim poremećajima srčanog ritma mora se pomno nadzirati.
English: In subjects with creatinine clearance between 30 and 50 mL/min, AUCtf was twofold greater compared with control subjects.
Croatian: U ispitanika s klirensom kreatinina između 30 i 50 ml/min, AUCtf bio je dva puta veći u usporedbi s kontrolnim ispitanicima.
English: There are no data for paediatric patients with cardiac disease (see section 4.4).
Croatian: Nema podataka za pedijatrijske bolesnike s bolesti srca (vidjeti dio 4.4).
English: Ribavirin has been shown to produce high inter- and intra-subject pharmacokinetic variability following single oral doses (intrasubject variability of approximately 30% for both AUC and Cmax), which may be due to extensive first pass metabolism and transfer within and beyond the blood compartment.
Croatian: Ribavirin dokazano dovodi do velike interindividualnu i intraindividualnu farmakokinetičke varijabilnosti nakon primjene jedne peroralne doze (intraindividualna varijabilnost iznosi otprilike 30 % za AUC i za Cmax), što može biti posljedica opsežnog metabolizma prvog prolaza i prijelaza unutar i izvan krvnog odjeljka.
English: However, ribavirin systemic exposure of a female partner after sexual intercourse with a treated patient has been estimated and remains extremely limited compared to therapeutic plasma concentration of ribavirin.
Croatian: Međutim, procijenjena je sistemska izloženost ribavirinu partnerice nakon spolnog odnosa s liječenim bolesnikom, koja je i dalje iznimno mala u usporedbi s terapijskom koncentracijom ribavirina u plazmi.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenu u dijelu 6.1.
English: Pack sizes of 84, 112, 140 and 168 capsules.
Croatian: Pakovanja od 84, 112, 140 i 168 kapsula.
English: Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e.g. TSH).
Croatian: Djecu i adolescente mora se nadzirati svaka 3 mjeseca kako bi se uočili znakovi poremećene funkcije štitnjače (npr. TSH).