FrancophonIA/ELRC3.0 huggingface dataset:
English: This was further confirmed by the population pharmacokinetic analysis (absence of relationship between vinflunine clearance and biology markers of hepatic impairment).
Slovenian: To so dodatno potrdili s populacijsko farmakokinetično analizo (odsotnost povezave med očistkom vinflunina in biološkimi označevalci okvare jeter).
English: You may want to seek counseling on sperm storage before starting your therapy.
Slovenian: Če želite, se posvetujte glede shrambe sperme pred začetkom zdravljenja.
English: Vinflunine is moderately bound to human plasma proteins (67.2±1.1%) with a ratio between plasma and whole blood concentrations of 0.80±0.12.
Slovenian: Vinflunin se zmerno veže na beljakovine človeške plazme (67,2±1,1 %) tako, da je razmerje med koncentracijo v plazmi in polni krvi 0,80±0,12.
English: What you need to know before you use Javlor Do not use Javlor
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Javlor Ne uporabljate zdravila Javlor
English: The excretion of vinflunine and its metabolites occurs through faeces (2/3) and urine (1/3).
Slovenian: Izločanje vinflunina in njegovih presnovkov je preko blata (2/3) in urina (1/3).
English: Vinflunine is eliminated following a multi-exponential concentration decay, with a terminal half-life (t1/2) close to 40 h. DVFL is slowly formed and more slowly eliminated than vinflunine (t1/2 of approximately 120 h).
Slovenian: Vinflunin se eliminira z večeksponentnim koncentracijskim razpadom s terminalno razpolovno dobo (t1/2) približno 40 h. DVFL se tvori počasi in se eliminira počasneje od vinflunina (t1/2 približno 120 h).
English: The diluted solution should be protected from light until administration (see section 6.3).
Slovenian: Razredčeno raztopino morate zavarovati pred svetlobo vse do dajanja (glejte poglavje 6.3).
English: It is unknown whether vinflunine or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se vinflunin oz. njegovi presnovki izločajo v materinem mleku.
English: Binding to alpha-1 acid glycoprotein and to platelets is negligible (< 5%).
Slovenian: Vezava na alfa-1 kisli glikoprotein in trombocite je zanemarljiva (<5 %).
English: Javlor should be administered by a 20-minute intravenous infusion and NOT be given by rapid intravenous bolus.
Slovenian: Zdravilo Javlor morate dati z 20-minutno infuzijo in NIKOLI s hitrim intravenskim bolusom.
English: The recommended dose in adult patients is 320 mg/m² body surface (this is calculated by the doctor based on your weight and your height).
Slovenian: Priporočeni odmerek za odraslega bolnika je 320 mg/m² telesne površine (ki jo zdravnik izračuna iz vaše telesne mase in višine).
English: Javlor is a concentrate that has to be diluted before administration.
Slovenian: Zdravilo Javlor je koncentrat, ki ga je treba pred uporabo razredčiti.
English: Patients at high risk of constipation (concomitant treatment with opiates, peritoneal carcinomas, abdominal masses, prior major abdominal surgery) should be medicated with an osmotic laxative from day 1 to day 7 administered once a day in the morning before breakfast.
Slovenian: Bolniki z velikim tveganjem zaprtosti (sočasno zdravljenje z opiati, peritonealni karcinomi, abdominalne mase, predhodni obsežni abdominalni kirurški poseg) morajo od 1. do 7. dneva zdravljenja prejemati ozmotski laksativ enkrat na dan, in sicer zjutraj pred zajtrkom.
English: Platelets < 100,000/mm3(see section 4.4).
Slovenian: Trombociti <100.000/mm3 (glejte poglavje 4.4).
English: Ischaemic cardiac events may occur, especially in patients who have underlying cardiac disease.
Slovenian: Lahko pride do ishemičnih srčnih dogodkov, zlasti pri bolnikih z obstoječo srčno boleznijo.
English: Rare cases of Posterior Reversible Encephalopathy Syndrome have been reported (see section 4.4).
Slovenian: Opaženi so bili redki primeri posteriornega reverzibilnega encefalopatičnega sindroma (glejte poglavje 4.4).
English: Elderly patients (≥ 75 years)
Slovenian: Starostniki (≥75 let)
English: Table 3: Dose adjustments due to toxicity in renal impaired or elderly patients
Slovenian: Tabela 3: Prilagajanje odmerka zaradi toksičnosti pri bolnikih z okvaro ledvic ali pri starejših bolnikih
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
English: Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening” (see Table 2 in section 4.2).
Slovenian: Stopnja 2 je definirana kot »zmerna«, stopnja 3 kot «huda«, stopnja 4 pa kot »življenjsko nevarna« (glejte tabelo 2 v poglavju 4.2).
English: Posterior Reversible Encephalopathy Syndromea
Slovenian: Posteriorni reverzibilni encefalopatični sindrom (PRES)
English: Vinflunine doses were adjusted according to 3 age groups as shown below:
Slovenian: Odmerki vinflunina so bili glede na 3 starostne skupine prilagojeni, kot je prikazano spodaj:
English: Content of the pack and other information What Javlor contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Javlor
English: Caution should be exercised in patients with a history of cardiac disease and the benefit / risk assessment should be carefully evaluated regularly.
Slovenian: Pri bolnikih z anamnezo srčne bolezni je potrebna previdnost in redno vrednotenje koristnih učinkov ter tveganja.
English: From a microbiological point of view, the product should be used immediately after dilution.
Slovenian: Z mikrobiološkega vidika morate zdravilo uporabiti nemudoma po redčenju.
English: In the absence of any haematological toxicity during the first cycle causing treatment delay or dose reduction, the dose will be increased to 320 mg/m² every 3 weeks for the subsequent cycles.
Slovenian: Če med prvim ciklom ne ugotovite nobene hematološke toksičnosti, zaradi katere bi zdravljenje odložili ali zmanjšali odmerek, v naslednjih ciklih povečajte odmerek na 320 mg/m² vsake 3 tedne.
English: Pack size of 1 and 10 vials.
Slovenian: Velikosti pakiranja po 1 in 10 vial.
English: Chemical and physical in-use stability has been demonstrated for the diluted medicinal product as follows:
Slovenian: Kemijska in fizikalna stabilnost med uporabo sta bili dokazani za redčeno zdravilo, in sicer:
English: Pharmacotherapeutic group: antineoplasic agents, vinca alkaloids and analogues, ATC code: L01CA05
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, alkaloidi rožnatega zimzelena in analogi, oznaka ATC: L01CA05
English: What Javlor is and what it is used for
Slovenian: Kaj je zdravilo Javlor in zakaj ga uporabljamo
English: Instructions for administration should be followed as described in section 6.6.
Slovenian: Upoštevati morate navodila za dajanje, ki so opisana v poglavju 6.6.
English: • The patency should be assessed frequently and extravasation precautions should be maintained throughout the infusion.
Slovenian: • pogosto preverjajte pretočnost in ves čas infundiranja izvajajte varnostne ukrepe za primer ekstravazacije.
English: This is further confirmed by the population pharmacokinetic analysis (56 patients with CrCl between 20 mL/min and 60 mL/min), showing that vinflunine clearance is influenced by the creatinine clearance value (Cockcroft and Gault formula).
Slovenian: To so dodatno potrdili s populacijsko farmakokinetično analizo (56 bolnikov z OK med 20 ml/min in 60 ml/min), kar kaže na očistek vinflunina vpliva vrednost očistka kreatinina (formula po Cockcroftu in Gaultu).
English: There is no known antidote for vinflunine overdose.
Slovenian: Ni znanega antidota za preveliko odmerjanje z vinfluninom.
English: 2 NCI CTC Grade 3 nausea is defined as no significant intake, requiring intravenous fluids.
Slovenian: 2 Navzea 3. stopnje po NCI CTC je definirana kot nepomemben vnos, ki zahteva intravensko dodajanje tekočin.
English: Imaging distribution studies following radioactive vinflunine in rats, illustrated that the compound levels in lungs, kidneys, liver, salivary and endocrine glands, and gastrointestinal tract were rapidly higher than those in blood.
Slovenian: Študije slikovne porazdelitve po odmerku radioaktivnega vinflunina pri podganah so pokazale, da koncentracije spojine v pljučih, ledvicah, jetrih, slinavkah in endokrinih žlezah ter prebavilih hitreje narastejo kot v krvi.
English: Blood exposure to vinflunine (AUC), significantly correlated with severity of leucopenia, neutropenia and fatigue.
Slovenian: Krvna izpostavljenost vinfluninu (AUC) se dobro ujema z resnostjo levkopenije, nevtropenije in utrujenosti.
English: - if you are allergic to the active substance (vinflunine) or to other vinca alkaloids (vinblastine,
Slovenian: - če ste alergični na zdravilno učinkovino (vinflunin) ali na druge alkaloide rožnatega zimzelena
English: Clinical and radiological features usually resolved rapidly without sequelae after treatment discontinuation.
Slovenian: Klinični in radiološki znaki po prekinitvi zdravljenja običajno hitro izginejo brez posledic.
English: Infection with Grade 3/4 neutropenia was observed in 2.8 % of patients.
Slovenian: Okužbo z nevtropenijo stopnje 3/4 so opazili pri 2,8 % bolnikov.
English: It is most unlikely that you will be asked to store this medicine yourself.
Slovenian: Tega zdravila vam ne bo potrebno shranjevati.
English: Adverse reactions are listed below by System Organ Class, frequency and grade of severity (NCI CTC version 2.0).
Slovenian: V spodnji preglednici so navedeni neželeni učinki po organskem sistemu, pogostnosti in stopnji resnosti (NCI CTC različica 2.0).
English: When infused through a peripheral vein, vinflunine can induce Grade 1 (22% of the patients, 14.1% of the cycles), Grade 2 (11.0% of the patients, 6.8% of the cycles) or Grade 3 (0.8% of the patients, 0.2% of the cycles) venous irritation.
Slovenian: Pri infundiranju v periferno veno lahko vinflunin inducira vensko draženje stopnje 1 (22 % bolnikov, 14,1 % ciklov), stopnje 2 (11,0 % bolnikov, 6,8 % ciklov) ali stopnje 3 (0,8 % bolnikov, 0,2 % ciklov).
English: Febrile neutropenia defined as ANC < 1,000/mm3and fever ≥ 38.5°C of unknown origin without clinically microbiologically documented infection (NCI CTC version 2.0) was observed in 5.2% of patients.
Slovenian: Febrilno nevtropenijo, ki je bila opredeljena kot AŠN <1.000/mm3 z zvišano telesno temperaturo ≥38,5 °C neznanega vzroka brez klinično mikrobiološko dokumentirane okužbe (NCI CTC različica 2.0), so opazili pri 5,2 % bolnikov.
English: All metabolites identified are formed by the cytochrome CYP3A4 isoenzyme, except for 4-O-deacetylvinflunine (DVFL), the only active metabolite and main metabolite in blood which is formed by multiple esterases.
Slovenian: Vse ugotovljene presnovke tvori izoencim citokrom CYP3A4, razen 4Odeacetilvinflunina (DVFL), ki je edini aktivni presnovek ter glavni presnovek v krvi.
English: Posology The recommended dose is 320 mg/m² vinflunine as a 20 minute intravenous infusion every 3 weeks.
Slovenian: Odmerjanje Priporočeni odmerek je 320 mg/m² vinflunina v obliki 20-minutne intravenske infuzije vsake 3 tedne.
English: The main toxic effect due to an overdose with vinflunine is bone marrow suppression with a risk of severe infection.
Slovenian: Glavni toksični učinek v primeru prevelikega odmerjanja z vinfluninom je supresija kostnega mozga s tveganjem hude okužbe.
English: A pharmacokinetic and tolerability phase I study in patients with altered liver functions test has been completed (see section 5.2).
Slovenian: Zaključena je farmakokinetična in študija prenašanja I faze pri bolnikih s spremenjenimi preizkusi jetrnih funkcij (glejte točko 5.2).
English: Frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Slovenian: Pogostnost neželenih reakcij je opredeljena z naslednjimi dogovorjenimi skupinami: zelo pogosti (≥1/10); pogosti (≥1/100, <1/10); občasni (≥1/1.000,< 1/100);
English: Therefore, regular monitoring of serum sodium levels is recommended during treatment with vinflunine.
Slovenian: Zato je med zdravljenjem z vinfluninom priporočljivo redno spremljanje ravni natrija v serumu.
English: A pharmacokinetic interaction between vinflunine and pegylated/liposomal doxorubicin was observed, resulting in a 15% to 30% apparent increase in vinflunine exposure and a 2 to 3-fold apparent decrease of doxorubicin AUC, whereas for doxorubicinol, the concentrations of the metabolite were not affected.
Slovenian: Opazili so farmakokinetične interakcije med vinfluninom in pegeliranim/liposomskim doksorubicinom, ki povzroči od 15 % do 30 % navidezno zvišanje izpostavljenosti vinfluninu ter od 2 do 3-kratno navidezno zmanjšanje AUC doksorubicina, medtem ko so koncentracije presnovka doksorubicinola ostale nespremenjene.
English: Preclinical data revealed moderate to severe neutropenia and mild anaemia, in all species tested, with liver toxicity in dogs and rats (characterized by dose-dependent increases in liver transaminases and hepatic necrosis/hepatocellular alterations at high doses).
Slovenian: Predklinični podatki so pokazali zmerno do hudo nevtropenijo ter blago anemijo pri vseh preskušenih vrstah ter jetrno toksičnost pri psih in podganah (z katero so bila značilna od odmerka odvisna zvišanja ravni jetrnih transaminaz ter hepatična nekroza/hepatocelularne spremembe pri velikih odmerkih).
English: 2nd consecutive event
Slovenian: Drugi zaporedni dogodek
English: The following information is intended for medical or healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: NAVODILO ZA UPORABO
English: - “Syndrome of inappropriate antidiuretic hormone secretion”, which is a condition that causes low levels of blood sodium - tumour pain.
Slovenian: - »sindrom neustreznega izločanja antidiuretičnega hormona« - stanje, ki povzroči nizke ravni natrija v krvi,
English: Protein binding mainly involves high density lipoproteins and serum albumin and is non-saturable on the range of vinflunine concentrations observed in patients.
Slovenian: Vezava na beljakovine obsega lipoproteine visoke gostote in serumski albumin ter je nenasičeno v razponu koncentracij vinflunina pri bolnikih.
English: • The Javlor solution for infusion should be infused over 20 minutes.
Slovenian: • Infuzija zdravila Javlor raztopina za injiciranje naj traja 20 minut.
English: It comes in clear glass vials closed by a rubber stopper containing 2 mL, 4 mL or 10 mL of concentrate.
Slovenian: Dobavlja se v z gumastim zamaškom zaprtih vialah iz prozornega stekla z 2 ml, 4 ml ali 10 ml koncentrata.
English: During the pre- and post-natal development study in rat, vinflunine induced malformations of the uterus and vagina in 2 females, and adversely affected mating and/or ovule implantation and markedly lowered the number of concepti.
Slovenian: V študiji prenatalnega in postnatalnega razvoja pri podganah je vinflunin induciral malformacije maternice in nožnice pri 2 samicah ter negativno vplival na parjenje in/ali vsaditev jajčeca ter zmanjšal število zanositev.
English: Mucositis Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening”.
Slovenian: Mukozitis 2. stopnje je definiran kot ”zmeren”, 3. stopnje kot ”hud” in 4. stopnje kot ”življenjsko nevaren”.
English: Severe anaemia and thrombocytopenia were less common (respectively 8.8 and 3.1 %).
Slovenian: Huda anemija in trombocitopenija sta bili redkejši (8,8 % oz. 3,1 %).
English: Special attention is recommended when vinflunine is administered to patients with prior history of myocardial infarction/ischaemia or angina pectoris (see section 4.8).
Slovenian: Posebna pozornost je priporočljiva, če vinflunin dajete bolniku z anamnezo miokardnega infarkta/ishemije ali angine pektoris (glejte poglavje 4.8).
English: Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with vinflunine.
Slovenian: Pred zdravljenjem se morajo bolniki posvetovati o možnosti shranjevanja sperme zaradi možnosti ireverzibilne neplodnosti zaradi terapije z vinfluninom.
English: You should not be given Javlor if you are pregnant, unless it is absolutely necessary.
Slovenian: Če ste noseči, ne smete prejeti zdravila Javlor, razen če je to nujno potrebno.
English: Median PFS was 3.0 months (vinflunine + BSC) vs 1.5 months (BSC) (p=0.0012).
Slovenian: Mediana preživetja brez napredovanja bolezni je bila 3,0 meseca (vinflunin + NPO) oz. 1,5 meseca (NPO) (p=0,0012).
English: The pharmacokinetic results of this study indicated a reduction of vinflunine clearance when CrCl is decreased.
Slovenian: Farmakokinetični rezultati te študije kažejo, da se pri zmanjšanem OK
English: Neutropenia Grade 4 (ANC < 500/mm3) > 7 days
Slovenian: Nevtropenija stopnje 4 (AŠN <500/mm3), ki traja >7 dni
English: Grade 3 vomiting as ≥ 6 episodes in 24 hours over pretreatment; or need for intravenous fluids.
Slovenian: Bruhanje 3. stopnje je definirano z ≥ 6 dogodki v 24 urah po predzdravljenju ali s potrebo po intravenskem dodajanju tekočin.
English: In vivo, vinflunine displays significant antitumor activity against a broad spectrum of human xenografts in mice both in terms of survival prolongation and tumour growth inhibition.
Slovenian: Vinflunin ima in vivo znatno protitumorsko aktivnost proti širokemu spektru človeških ksenogenskih presadkov v miših v obliki podaljšanja preživetja in zavrtja rasti tumorja.
English: In clinical studies, patients with CrCl (creatinine clearance) > 60 mL/min were included and treated at the recommended dose.
Slovenian: V klinične študije so bili vključeni bolniki z OK (očistek kreatinina) >60 ml/min, ki so bili tudi zdravljeni s priporočenim odmerkom.
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Slovenian: Pri vseh prenosih morate natančno upoštevati aseptične tehnike in po možnosti uporabiti zaščitno komoro z navpičnim laminarnim tokom zraka.
English: A phase I study evaluating the effect of ketoconazole treatment (a potent CYP3A4 inhibitor) on vinflunine pharmacokinetics indicated that co-administration of ketoconazole (400 mg orally once daily for 8 days) resulted in a 30% and 50% increase in blood exposures to vinflunine and its metabolite 4Odeacetyl-vinflunine (DVFL), respectively.
Slovenian: V študiji I. faze, kjer so preučevali učinek zdravljenja s ketokonazolom (močnim zaviralcem CYP3A4) na farmakokinetiko vinflunina, je bilo nakazano, da sočasna uporaba ketokonazola (400 mg peroralno enkrat dnevno 8 dni) povzroči 30 % povečanje krvne izpostavitve vinfluninu oz. 50 % povečanje krvne izpostavitve njegovemu presnovku 4Odeacetil-vinfluninu (DVFL).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi o citotoksičnih zdravilih.
English: - with transaminases ≤ 2.5xULN ( < 5xULN only in case of liver metastases).
Slovenian: - pri bolnikih s transaminazami ≤ 2,5x ZMNR (zgornja meja normale) ( < 5x ZMNR samo v primerih jetrnih metastaz.)
English: Javlor is for single use only.
Slovenian: Zdravilo Javlor je samo za enkratno uporabo.
English: Vinflunine clearance was significantly decreased in patients ≥ 80 years old as compared to a control group of younger patients < 70 years.
Slovenian: Očistek vinflunina se je, glede na kontrolno skupino mlajših bolnikov <70 let, bistveno zmanjšal pri bolnikih, starejših od 80 let.
English: Nevertheless, vinflunine should be used with caution in patients with increase of the proarrhythmic risk (e.g. congestive heart failure, known history of QT interval prolongation, hypokalaemia) (see section 4.8).
Slovenian: Kljub temu je treba zdravilo Javlor previdno uporabljati pri bolnikih z večjim proaritmijskim tveganjem (npr. srčno popuščanje, anamneza podaljšanja intervala QT, hipokalemija) (glejte poglavje 4.8).
English: Pharmacokinetics of vinflunine was not modified for patients 70 ≤ age < 75 years and 75 ≤ age < 80 years.
Slovenian: Farmakokinetika vinflunina ni bila spremenjena pri bolnikih starosti med 70 in 75 let in starosti med 75 in 80 let.
English: Febrile Neutropenia (ANC < 1,000/mm3 and fever ≥ 38,5 °C)
Slovenian: Febrilna nevtropenija (AŠN <1.000/mm3 in zvišana telesna temperatura ≥38,5 °C)
English: Day 1 treatment administration
Slovenian: Izvajanje zdravljenja - 1 dan
English: Grade 3/4 ileus reported in 1.9% of patients was reversible when managed by medical care.
Slovenian: Pri 1,9 % bolnikov so ugotovili ileus stopnje 3/4, ki je bil reverzibilen po zdravstveni oskrbi.
English: In the multi-centre, open-label controlled phase III clinical trial, 253 patients were randomised to treatment with vinflunine + BSC (best supportive care) and 117 patients to the BSC arm.
Slovenian: V multicentričnem, nezaslepljenem kontroliranem kliničnem preskušanju III. faze so naključno razporedili 253 bolnikov v skupino, ki se je zdravila z vinfluninom + NPO (najboljša podporna oskrba), 11 bolnikov pa v skupino, ki je prejemala le NPO.
English: Vinflunine pharmacokinetics was not modified in those patients, however based on hepatic biologic parameter modifications following vinflunine administration (gamma glutamyl transferases (GGT), transaminases, bilirubin), the dose recommendations are as follows:
Slovenian: Farmakokinetika vinflunina se pri teh bolnikih ne spremeni, na spremembah jetrnih bioloških parametrov (gama-glutamil-transferaze (GGT), transaminaze, bilirubin)
English: - Delay until recovery to mild toxicity or none, or to initial baseline status and adjust the dose if necessary (see table 2) - Discontinuation if recovery has not occurred within 2 weeks
Slovenian: - Odložite do vrnitve na blago ali nikakršno toksičnost ali na začetno osnovno stanje in, če je potrebno, odmerek prilagodite (glejte tabelo 2).
English: In a population pharmacokinetic analysis in 372 patients (656 pharmacokinetic profiles), the total blood clearance was 40 l/h with low inter and intra-individual variability (25% and 8%, respectively, expressed as coefficient of variation).
Slovenian: V populacijski farmakokinetični analizi pri 372 bolnikih (656 farmakokinetičnih profilov) je bil skupni krvni očistek 40 l/min z nizko variabilnostjo med preiskovanci (koeficient variacije 25 %) in pri posameznem preiskovancu (koeficient variacije 8 %).
English: The typical clinical symptoms are, with various degrees: neurological (headache, confusion, seizure, visual disorders), systemic (hypertension), and gastrointestinal (nausea, vomiting).
Slovenian: Značilni, različno močno izraženi klinični simptomi so: nevrološki (glavobol, zmedenost, krči, motnje vida), sistemski (hipertenzija) in gastrointestinalni (navzea, bruhanje).
English: Javlor is a clear, colourless to pale yellow solution.
Slovenian: Zdravilo Javlor je bistra, brezbarvna do bledo rumena raztopina.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: C. DRUGI POGOJI ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Both male and female patients should take adequate contraceptive measures up to three months after the discontinuation of the therapy.
Slovenian: Kontracepcija pri moških in ženskah Moški in ženske morajo uporabljati primerno kontracepcijo še tri mesece po prekinitvi zdravljenja.