FrancophonIA/ELRC3.0 huggingface dataset:
English: Since the number of subjects who were not Caucasian comprised only < 3% of the total population (6 Black, 219 Caucasian), race was not evaluated as a covariate in the population pharmacokinetic analysis.
Slovenian: Število bolnikov, ki niso bili belci, je znašalo manj kot 3 % celotne populacije (6 črnopoltih, 219 belcev), rase niso ocenjevali kot kovariante v populacijski farmakokinetični analizi.
English: • if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Erivedge Pregnancy Prevention Programme,
Slovenian: • bi lahko zanosili, pa ne morete ali nočete uporabljati potrebnih ukrepov za preprečitev nosečnosti, ki so navedeni v Programu preprečevanja nosečnosti med uporabo zdravila Erivedge;
English: In order to assist health care providers and patients to avoid embryonic and foetal exposure to Erivedge the Marketing Authorisation Holder will provide educational materials (Erivedge Pregnancy Prevention Programme) to reinforce the potential risks associated with the use of Erivedge.
Slovenian: Da bi zdravstvenim delavcem in bolnikom pomagal preprečiti izpostavljenost zarodka in ploda zdravilu Erivedge, bo imetnik dovoljenja za promet z zdravilom priskrbel izobraževalna gradiva (Program preprečevanja nosečnosti med uporabo zdravila Erivedge), v katerih bo poudaril mogoča tveganja, povezana z uporabo zdravila Erivedge.
English: Basal cell carcinoma develops when DNA in normal skin cells becomes damaged and the body cannot repair the damage.
Slovenian: Kako deluje zdravilo Erivedge Bazalnocelični karcinom nastane, ko se DNK v normalnih kožnih celicah okvari in telo ne more okvare popraviti.
English: • Hormonal depot injection,
Slovenian: • kontracepcijsko depo injekcijo,
English: Due to the long drug elimination half-life, these events may occur or progress after drug discontinuation.
Slovenian: Zaradi dolgega razpolovnega časa izločanja se lahko ta neželena učinka pojavita ali napredujeta tudi po prenehanju jemanja zdravila.
English: Some medicines may affect how Erivedge works, or make it more likely that you will have side effects.
Slovenian: Nekatera zdravila lahko vplivajo na delovanje zdravila Erivedge ali povečajo verjetnost, da se pojavijo neželeni učinki.
English: Other medicines and Erivedge
Slovenian: Druga zdravila in zdravilo Erivedge
English: If the patient has developed any of these reactions with the use of vismodegib, treatment with vismodegib must not be restarted in this patient at any time.
Slovenian: Če se je pri bolniku med uporabo vismodegiba pojavil kateri koli od teh neželenih učinkov, se pri njem zdravljenja z vismodegibom ne sme več ponovno uvesti.
English: In general, the tolerability of Erivedge in repeat-dose toxicity studies in rats and dogs was limited by nonspecific manifestations of toxicity including decreased body weight gain and food consumption.
Slovenian: Na splošno so prenašanje zdravila Erivedge v študijah toksičnosti s ponavljajočimi se odmerki pri podganah in psih omejile nespecifične manifestacije toksičnosti, vključno z zmanjšanim pridobivanjem telesne mase in manjšim uživanjem hrane.
English: In an embryo-foetal development study in which pregnant rats were administered vismodegib daily during organogenesis, vismodegib crossed the placenta and was severely toxic to the conceptus.
Slovenian: V študiji embrio-fetalnega razvoja, v kateri so brejim podganam med obdobjem organogeneze dajali vismodegib vsak dan, je vismodegib prehajal skozi placento in je bil izredno toksičen za konceptus.
English: The volume of distribution for vismodegib is low, ranging from 16.4 to 26.6 L. In vitro binding of vismodegib to human plasma proteins is high (97 %) at clinically relevant concentrations.
Slovenian: Volumen porazdelitve vismodegiba je majhen in sega od 16,4 do 26,6 l. Vezava vismodegiba na človeške plazemske beljakovine je in vitro ob klinično pomembnih koncentracijah velika (97-%).
English: • Women who are pregnant or breast-feeding (see sections 4.4 and 4.6).
Slovenian: • Nosečnice in doječe ženske (glejte poglavji 4.4 in 4.6).
English: • Description of the pregnancy prevention programme and categorisation of patients based on sex and childbearing potential
Slovenian: • opis programa preprečevanja nosečnosti in kategorizacijo bolnikov glede na spol in rodno dobo
English: Effects on post-natal development
Slovenian: Vplivi na postnatalni razvoj
English: If you stop taking Erivedge
Slovenian: Če ste prenehali jemati zdravilo Erivedge
English: Concomitant treatment with strong CYP inducers (e.g. rifampicin, carbamazepine or phenytoin) should be avoided, as a risk for decreased plasma concentrations and decreased efficacy of vismodegib cannot be excluded (see also section 4.5).
Slovenian: Treba se je izogibati sočasnemu zdravljenju z močnimi induktorji CYP (npr. rifampicinu, karbamazepinu ali fenitoinu), saj ni mogoče izključiti tveganja za znižane plazemske koncentracije in zmanjšano učinkovitost vismodegiba (glejte tudi poglavje 4.5).
English: Fertility impairment in human males is not expected (see Section 5.3).
Slovenian: Okvara plodnosti pri moških ni pričakovana (glejte poglavje 5.3).
English: • a change in the way things taste or the complete loss of taste,
Slovenian: • spremenjeno okušanje ali popolna izguba okusa, • zaprtje,
English: Repeat-dose toxicity
Slovenian: Toksičnost ponavljajočih se odmerkov
English: As shown in the waterfall plots in figures 1 and 2, which chart maximum reduction in target lesion(s) size for each patient, the majority of patients in both cohorts experienced tumour shrinkage as assessed by the IRF.
Slovenian: Kot kažeta stolpičasta diagrama na slikah 1 in 2, ki prikazujeta največje zmanjšanje ciljne lezije/ciljnih lezij za vsakega bolnika, so se tumorji po oceni IRF zmanjšali pri večini bolnikov v obeh skupinah.
English: Talk to your doctor or pharmacist before taking Erivedge if you have questions on the information in this section:
Slovenian: Preden boste vzeli zdravilo Erivedge, se posvetujte z zdravnikom ali farmacevtom, če imate vprašanja o informacijah v tem odstavku:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not crush, open or chew the capsule Read the package leaflet before use Oral use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Kapsul ne drobite, odpirajte ali žvečite Pred uporabo preberite priloženo navodilo peroralna uporaba
English: • Emergency contact phone numbers
Slovenian: • Kontaktne telefonske številke v primeru nujnega stanja.
English: Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Slovenian: Optimalno trajanje zdravljenja je različno za vsakega posameznega bolnika.
English: • Local contact details for reporting of any suspected pregnancy
Slovenian: • lokalni kontaktni podatki za poročanje ob katerem koli sumu na nosečnost
English: Persistent lack of menses during treatment with Erivedge should be assumed to indicate pregnancy until medical evaluation and confirmation.
Slovenian: Odsotnost menstruacij med zdravljenjem z zdravilom Erivedge je treba šteti za indikacijo nosečnosti do kliničnega ovrednotenja in potrditve.
English: • has spread to areas nearby (called “locally advanced” basal cell carcinoma) and your doctor decides that treatment with surgery or radiation is inappropriate.
Slovenian: • razširil v okoliške predele (takšen rak imenujemo "lokalno napredovali" bazalnocelični karcinom), zdravnik pa presodi, da zdravljenje z operacijo ali obsevanjem ni primerno.
English: ******Cases of SCAR (including SJS/TEN, DRESS and AGEP) have been reported in patients during post-marketing use.
Slovenian: ******O primerih hudih kožnih neželenih učinkov (vključno s SJS/TEN, DRESS in AGEP) so pri bolnikih poročali po prihodu zdravila na trg.
English: Population pharmacokinetic analyses suggest that age did not have a clinically significant impact on steady-state concentration of vismodegib.
Slovenian: Populacijske farmakokinetične analize kažejo, da starost ni klinično pomembno vplivala na koncentracijo vismodegiba v stanju dinamičnega ravnovesja.
English: It may also lead to the death of the unborn baby.
Slovenian: Povzroči lahko tudi, da še nerojeni otrok umre.
English: The extent to which vismodegib is excreted in breast milk is not known.
Slovenian: Ni znano, v kolikšni meri se vismodegib izloča v materino mleko.
English: Due to its potential to cause serious developmental defects women must not breast-feed while taking Erivedge and for 24 months after the final dose (see sections 4.3 and 5.3).
Slovenian: Ker lahko povzroči resne razvojne napake, ženske ne smejo dojiti med jemanjem zdravila Erivedge in še 24 mesecev po zadnjem odmerku tega zdravila (glejte poglavji 4.3 in 5.3).
English: • Periodic Safety Update Reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: In clinical trials with aBCC, approximately 40 % of patients were of geriatric age (≥ 65 years).
Slovenian: V kliničnih preskušanjih napredovalega bazalnoceličnega karcinoma je bilo približno 40 % bolnikov geriatrične starosti (≥ 65 let).
English: Problems with growing teeth and bones were seen in animal studies with this medicine.
Slovenian: V študijah s tem zdravilom na živalih so opažali težave z rastjo zob in kosti.
English: As part of the Erivedge Pregnancy Prevention Programme, all patients will receive a:
Slovenian: V okviru Programa preprečevanja nosečnosti med uporabo zdravila Erivedge bodo vsi bolniki prejeli: knjižico za bolnika,
English: Prior to launch in each Member State, the Marketing Authorisation Holder (MAH) shall agree the following with the National Competent Authority:
Slovenian: Imetnik dovoljenja za promet se mora v vsaki državi članici pred prihodom zdravila na trg s pristojnim nacionalnim organom dogovoriti sledeče:
English: • She must be able to comply with effective contraceptive measures,
Slovenian: • mora biti sposobna zadostiti vsem zahtevam glede učinkovite kontracepcije;
English: Before starting the treatment, ask your doctor if you are able to become pregnant.
Slovenian: Pred začetkom zdravljenja se z zdravnikom posvetujte o tem, ali je mogoče, da zanosite.
English: The use of Erivedge in children and adolescents under the age of 18 years is not recommended.
Slovenian: Zdravila Erivedge ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: In vitro binding to AAG is saturable at clinically relevant concentrations.
Slovenian: Vezava na AAG je in vitro pri klinično pomembnih koncentracijah saturabilna.
English: In addition, in the vismodegib general toxicity studies up to 26-week in sexually mature rats and dogs, no effects on male reproductive organs were observed.
Slovenian: Poleg tega v študijah splošne toksičnosti vismodegiba na spolno zrelih psih in podganah do 26. tedna niso opazili učinkov na reproduktivne organe samcev.
English: • has spread to other parts of the body (called “metastatic” basal cell carcinoma)
Slovenian: • razširil v druge dele telesa (takšen rak imenujemo "metastatski" bazalnocelični karcinom),
English: Each hard capsule contains 71.5 mg lactose monohydrate per capsule.
Slovenian: Ena trda kapsula vsebuje 71,5 mg laktoze monohidrata na kapsulo.
English: If you are not sure, talk to your doctor or pharmacist before taking Erivedge.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden boste vzeli zdravilo Erivedge.
English: Treatment interruptions of up to 4 weeks were allowed based on individual tolerability.
Slovenian: Glede na posameznikovo prenašanje zdravila so dovoljevali prekinitve zdravljenja do 4 tednov.
English: • The need for adequate contraceptive measures
Slovenian: • potreba po ustrezni kontracepcijski zaščiti
English: Post-natal development
Slovenian: Postnatalni razvoj
English: Do not use while pregnant or breast-feeding You must follow the Erivedge Pregnancy Prevention Programme
Slovenian: Ne uporabljajte med nosečnostjo in dojenjem Upoštevati morate Program preprečevanja nosečnosti med uporabo zdravila Erivedge
English: However, irreversible defects in growing teeth and premature closure of the femoral epiphyseal plate, observed in rat toxicity studies at clinically relevant exposures, represent risks to post-natal development.
Slovenian: Vendar pa ireverzibilne okvare v rasti zob in prezgodnje zaprtje stegnenične epifizne plošče, ki so jih v študijah toksičnosti na podganah opažali pri klinično pomembnih izpostavljenostih, pomenijo tveganje za postnatalni razvoj.
English: The exposure in female rats at 100 mg/kg corresponds to 1.2-fold of the steady-state AUC0-24h at the recommended human dose.
Slovenian: Izpostavljenost pri podganjih samicah pri odmerkih 100 mg/kg ustreza 1,2-kratniku površine pod krivuljo AUC0-24h v stanju dinamičnega ravnovesja pri priporočenem odmerku za človeka.
English: Vismodegib and associated metabolic products are eliminated primarily by the hepatic route.
Slovenian: Vismodegib in z njim povezani presnovki se odstranijo predvsem po jetrni poti.
English: Erivedge may cause severe birth defects.
Slovenian: Zdravilo Erivedge lahko povzroči hude prirojene napake.
English: • ezetimibe and statins , such as atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin used for high cholesterol,
Slovenian: • ezetimib in statine, kot so atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin uporabljajo se za zdravljenje zvišanega holesterola,
English: After a single oral dose, vismodegib has a terminal half-life of ca. 12 days.
Slovenian: Po enkratnem peroralnem odmerku ima vismodegib končni razpolovni čas približno 12 dni.
English: • locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).
Slovenian: • s simptomatskim metastatskim bazalnoceličnim karcinomom, • z lokalno napredovalim bazalnoceličnim karcinomom, neprimernim za operacijo ali radioterapijo (glejte poglavje 5.1).
English: HCPs must educate the patients so they understand and acknowledge all the conditions of the Erivedge Pregnancy Prevention Programme.
Slovenian: Zdravstveni delavci morajo bolnike poučiti tako, da razumejo in sprejmejo vse zahteve Programa za preprečevanje nosečnosti med uporabo zdravila Erivedge.
English: Some women taking Erivedge have stopped having periods.
Slovenian: Nekatere ženske, ki so jemale zdravilo Erivedge, niso imele več menstruacij.
English: PD = progressive disease, SD = stable disease, PR = partial response.
Slovenian: NB = napredovanje bolezni, SB = stabilna bolezen, DO = delni odziv.
English: • Do not store above 30 °C.
Slovenian: • Shranjujte pri temperaturi do 30 °C.
English: Thus inhibition of CYP enzymes by vismodegib in vivo may be excluded.
Slovenian: Tako lahko zaviranje encimov CYP s strani vismodegiba in vivo izključimo.
English: Posology The recommended dose is one 150 mg capsule taken once daily.
Slovenian: Odmerjanje Priporočeni odmerek je ena 150 mg kapsula enkrat na dan.
English: In the laBCC cohort, tumour response was assessed based on visual assessment of external tumour and ulceration, tumour imaging (where appropriate), and tumour biopsy.
Slovenian: V kohorti z lokalno napredovalim bazalnoceličnim karcinomom so odziv tumorja ocenjevali na podlagi vizualne ocene zunanjega tumorja in ulceracij, slikanja tumorja (kjer je bilo to ustrezno) in biopsije tumorja.
English: • Red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
Slovenian: • rdeč, luskast, razširjen izpuščaj s podkožnimi bulicami in mehurji, ki ga spremlja zvišana telesna temperatura ob začetku zdravljenja (akutna generalizirana eksantemska pustuloza).
English: • lack of energy or weakness (asthenia),
Slovenian: • pomanjkanje energije ali šibkost (astenija),
English: Erivedge is a highly permeable compound with low aqueous solubility (BCS Class 2).
Slovenian: Zdravilo Erivedge je zelo permeabilna spojina z majhno vodotopnostjo (razred 2 po biofarmacevtskem klasifikacijskem sistemu).
English: After continuous once-daily dosing, the pharmacokinetics of vismodegib appears to be nonlinear due to saturable absorption and saturable protein binding.
Slovenian: Po neprekinjeni uporabi enkrat na dan je farmakokinetika vismodegiba nelinearna zaradi saturabilne absorpcije in saturabilne vezave na beljakovine.
English: • you must take precautions so that you do not become pregnant while taking Erivedge
Slovenian: • morate upoštevati previdnostne ukrepe, da med jemanjem zdravila Erivedge ne boste zanosili.
English: In addition, in the vismodegib general 26-week toxicity study, decreased number of corpora lutea was observed at 100 mg/kg/day; the effect was not reversed by the end of an 8 week recovery period.
Slovenian: Poleg tega so v 26-tedenski študiji splošne toksičnosti vismodegiba pri odmerkih 100 mg/kg/dan opazili zmanjšano število rumenih telesc; učinek se do konca 8-tedenskega okrevanja ni izkazal kot reverzibilen.
English: What you need to know before you take Erivedge
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Erivedge 3.
English: Metastatic BCC was defined as BCC that had spread beyond the skin to other parts of the body, including the lymph nodes, lung, bones and/or internal organs.
Slovenian: Metastatski bazalnocelični karcinom je bil opredeljen kot bazalnocelični karcinom, ki se je razširil iz kože v druge dele telesa, vključno z bezgavkami, pljuči, kostmi in/ali notranjimi organi.
English: • Distribution of the product
Slovenian: • distribucije zdravila
English: After oral administration of a radiolabelled dose, vismodegib is absorbed and slowly eliminated by a combination of metabolism and excretion of parent drug substance, the majority of which is recovered in the faeces (82 % of the administered dose), with 4.4 % of the administered dose recovered in urine.
Slovenian: Po peroralni uporabi radioaktivno označenega odmerka se vismodegib absorbira in počasi odstrani s kombinacijo presnove in izločanja izvorne učinkovine, od katerega se večina (82 % uporabljenega odmerka) pojavi v blatu, 4,4 % uporabljenega odmerka pa v urinu.
English: **Includes preferred terms: liver function test abnormal, blood bilirubin increased, gamma-glutamyl transferase increased, aspartate aminotransferase increased, alkaline phosphatase increased, liver hepatic enzyme increased.
Slovenian: **Vključuje termine: nenormalne vrednosti jetrnih testov, zvišan bilirubin v krvi, zvišana gama glutamiltransferaza, zvišana aspartat aminotransferaza, zvišana alkalna fosfataza, zvišani jetrni encimi.
English: Erivedge is indicated for the treatment of adult patients with:
Slovenian: 4.1 Terapevtske indikacije Zdravilo Erivedge je indicirano za zdravljenje odraslih bolnikov:
English: Like all medicines, Erivedge can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Erivedge neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Results from a clinical study demonstrated a 57% increase in vismodegib unbound drug concentrations on day 7 after co-treatment with 400 mg fluconazole (a moderate CYP2C9 inhibitor) daily, but this interaction is not expected to be clinically significant.
Slovenian: Izsledki klinične študije so pokazali 57-% zvečanje koncentracij nevezanega vismodegiba 7. dan po sočasnem zdravljenju s 400 mg flukonazola (zmernega zaviralca CYP2C9) na dan, a ni pričakovati, da bi bila ta interakcija klinično pomembna.
English: • Liver injury Serious skin reactions:
Slovenian: • resne kožne reakcije:
English: Do not take Erivedge if you are pregnant, think you may be pregnant, or are planning to become pregnant during the course of treatment or during the 24 months after your final dose of this medicine.
Slovenian: Ne jemljite zdravila Erivedge, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev med zdravljenjem ali v 24 mesecih po zadnjem odmerku tega zdravila.
English: ***** Cases of drug induced liver injury have been reported in patients during post-marketing use.
Slovenian: *****O primerih okvare jeter zaradi zdravil so pri bolnikih poročali po prihodu zdravila na trg.
English: Excipients Erivedge capsules contain lactose monohydrate.
Slovenian: Kapsule zdravila Erivedge vsebujejo laktozo monohidrat.
English: You must not become pregnant while taking this medicine.
Slovenian: Med jemanjem tega zdravila ne smete zanositi.
English: Erivedge should only be prescribed by or under the supervision of a specialist physician experienced in the management of the approved indication.
Slovenian: Zdravilo Erivedge sme predpisati le zdravnik specialist, ki ima izkušnje z vodenjem zdravljenja pri odobreni indikaciji, oziroma se ga sme predpisati le pod nadzorstvom takšnega zdravnika.
English: If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose.
Slovenian: Bolnikom je treba naročiti, naj v primeru, da pozabijo vzeti odmerek zdravila, pozabljenega odmerka ne vzamejo, temveč naj jemanje nadaljujejo z naslednjim odmerkom po urniku.
English: What Erivedge is Erivedge is an anti-cancer medicine and contains the active substance vismodegib.
Slovenian: Erivedge je zdravilo za zdravljenje raka in vsebuje učinkovino vismodegib.
English: The majority of patients were male (57%); 8% had mBCC whereas 92% had laBCC.
Slovenian: Večina bolnikov je bila moških (57 %): 8 % jih je imelo metastatski bazalnocelični karcinom, medtem ko jih je 92 % imelo lokalno napredovali bazalnocelični karcinom.
English: • if you are also taking St John's wort (Hypericum perforatum) - a herbal medicine used for depression (see “Other medicines and Erivedge”).
Slovenian: • jemljete tudi šentjanževko (Hypericum perforatum) - zeliščno zdravilo, ki se uporablja za zdravljenje depresije (glejte Druga zdravila in zdravilo Erivedge).
English: No dose adjustment is required in patients ≥ 65years of age (see section 5.2).
Slovenian: Bolnikom, starim 65 let ali več, odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: • Brief background on Erivedge, its licensed indication and posology
Slovenian: • kratko ozadje o zdravilu Erivedge, njegovo indikacijo in odmerjanje
English: In vitro studies indicate that vismodegib has the potential to act as an inhibitor of breast cancer resistance protein (BCRP).
Slovenian: Študije in vitro kažejo, da ima vismodegib zmožnost, da deluje kot zaviralec beljakovine BCRP
English: Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Acute Generalised Exanthematous Pustulosis (AGEP)******
Slovenian: Stevens-Johnsonov sindrom (SJS) / toksična epidermalna nekroliza (TEN), reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) in akutna generalizirana eksantemska pustuloza (AGEP)******
English: A post-approval, open-label, non-comparative, multicenter, phase II clinical trial (MO25616) was conducted in 1232 patients with advanced BCC, of whom 1215 patients were evaluable for efficacy and safety with laBCC (n = 1119) or mBCC (n = 96).
Slovenian: Odprto, multicentrično preskušanje faze II brez primerjalne skupine (MO25616), ki je bilo zaveza pri pridobitvi dovoljenja za promet z zdravilom, je potekalo pri 1232 bolnikih z napredovalim bazalnoceličnim karcinomom, od tega so učinkovitost in varnost lahko ocenili pri 1215 bolnikih z lokalno napredovalim bazalnoceličnim karcinomom (n = 1119) ali metastatskim bazalnoceličnim karcinomom (n = 96).
English: If you are able to become pregnant:
Slovenian: Če obstaja možnost, da bi zanosili:
English: • To return unused capsules at the end of the treatment (disposal will depend on local requirements)
Slovenian: • Vrniti neporabljene kapsule po zaključku zdravljenja (odstranjevanje zdravila je odvisno od lokalnih zahtev).