FrancophonIA/ELRC3.0 huggingface dataset:
English: Progressive multifocal leukoencephalopathy (PML) If you believe your MS is getting worse or if you notice any new symptoms, for example changes in mood or behaviour, memory lapses, speech and communication difficulties, talk to your doctor as soon as possible.
Slovenian: Če imate občutek, da se vaša MS slabša ali opazite nove simptome, na primer spremembe v razpoloženju ali vedenju, izgubo spomina, težave z govorom in komuniciranjem, se čim prej pogovorite z zdravnikom.
English: The incidence of affected mouse foetuses in this study was in the same range of spontaneous incidence of amelia and phocomelia in this strain of mice.
Slovenian: Pogostnost prizadetih mišjih zarodkov v tej študiji je bila v istem razponu kot spontana pogostnost amelije in fokomelije v tem rodu miši.
English: If your doctor believes that MAVENCLAD is essential for you, your doctor will advise you to stop breast-feeding.
Slovenian: Če zdravnik meni, da je zdravilo MAVENCLAD za vas bistvenega pomena, vam bo svetoval, da nehate dojiti.
English: Do not use MAVENCLAD together with other medicines for MS unless specifically advised by your doctor.
Slovenian: Ne uporabljajte zdravila MAVENCLAD skupaj z drugimi zdravili za MS, razen če vam tega ni posebej svetoval zdravnik.
English: Cladribine and/or its phosphorylated metabolites are substantially accumulated and retained in human lymphocytes.
Slovenian: Kladribin in/ali njegovi fosforilirani presnovki se v veliki meri kopičijo in zadržujejo v človeških limfocitih.
English: Patients with current active malignancies must not receive Mavenclad treatment;
Slovenian: se bolniki z obstoječimi aktivnimi malignostmi ne smejo zdraviti z zdravilom Mavenclad;
English: Treatment with MAVENCLAD should not be initiated within 4 to 6 weeks after vaccination with live or attenuated live vaccines because of a risk of active vaccine infection.
Slovenian: Zdravljenja z zdravilom MAVENCLAD se ne sme uvesti v roku 4 do 6 tednov po cepljenju z živimi ali oslabljenimi živimi cepivi zaradi tveganja okužbe z aktivnim cepivom.
English: Tablets must be swallowed whole and not chewed or allowed to dissolve in your mouth.
Slovenian: Tablete morate pogoltniti cele in jih ne smete žvečiti ali pustiti, da se razpustijo v ustih.
English: The Patient Guide should include an introduction to Mavenclad treatment, its side effects, potential risks and information on pregnancy prevention.
Slovenian: Vodnik za bolnika naj vključuje uvod v zdravljenje z zdravilom Mavenclad, njegove neželene učinke, možna tveganja in informacije o preprečevanju nosečnosti.
English: The distribution of cladribine across biological membranes is facilitated by various transport proteins, including ENT1, CNT3 and BCRP.
Slovenian: Porazdelitev kladribina preko bioloških membran olajšajo različne transportne beljakovine, vključno z ENT1, CNT3 in BCRP.
English: Only traces of other metabolites could be found in plasma and in urine.
Slovenian: Druge presnovke je mogoče najti v plazmi in v urinu le v sledeh.
English: The remaining patients were pre-treated with either interferon beta-1a, interferon beta-1b, glatiramer acetate or natalizumab.
Slovenian: Preostali bolniki so bili predhodno zdravljeni bodisi z interferonom beta-1a, interferonom beta-1b, glatiramer acetatom ali natalizumabom.
English: What MAVENCLAD is and what it is used for What you need to know before you take MAVENCLAD How to take MAVENCLAD Possible side effects
Slovenian: Kaj je zdravilo MAVENCLAD in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo MAVENCLAD Kako jemati zdravilo MAVENCLAD Možni neželeni učinki
English: If you miss a dose and you remember on the same day you were supposed to take it
Slovenian: Če izpustite odmerek in se tega spomnite še isti dan, ko bi ga morali vzeti
English: The volume of distribution is large, indicating extensive tissue distribution and intracellular uptake.
Slovenian: Volumen porazdelitve je velik, kar kaže na ekstenzivno porazdelitev v tkivih in intracelularni privzem.
English: Over two thirds of the study patients were treatment-naive for MS disease-modifying drugs (DMDs).
Slovenian: Več kot dve tretjini bolnikov, ki so bili vključeni v študijo se pred tem ni zdravilo z zdravili za MS, ki spreminjajo potek bolezni (disease-modifying drugs - DMD).
English: Symptoms of infections can include: fever, aching, painful muscles, headache, generally feeling unwell or loss of appetite.
Slovenian: Simptomi okužbe lahko vključujejo: zvišano telesno temperaturo, bolečine, boleče mišice, glavobol, splošno slabo počutje ali izgubo apetita.
English: Following both oral and intravenous administration, the parent compound cladribine was the main component present in plasma and urine.
Slovenian: Tako po peroralnem kot po intravenskem dajanju je bila izhodna spojina kladribina glavna sestavina, prisotna v plazmi in urinu.
English: For treatment decisions based on the patient's lymphocyte counts, see section 4.2 and subsection 'Infections' below.
Slovenian: Za odločitve o zdravljenju na podlagi bolnikovega števila limfocitov glejte poglavje 4.2 in spodnje podpoglavje 'Okužbe'.
English: The European Medicines Agency has waived the obligation to submit the results of studies with MAVENCLAD in all subsets of the paediatric population in multiple sclerosis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom MAVENCLAD za vse podskupine pediatrične populacije z multiplo sklerozo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Do not start MAVENCLAD together with medicines that weaken your immune system or reduce the production of blood cells by your bone marrow.
Slovenian: Ne začnite jemati zdravila MAVENCLAD skupaj z zdravili, ki slabijo vaš imunski sistem ali zmanjšajo proizvodnjo krvnih celic v vašem kostnem mozgu.
English: Non-clinical safety pharmacological and toxicological assessment of cladribine in animal models relevant for the safety assessment of cladribine did not yield significant findings other than those predicted by the pharmacologic mechanism of cladribine.
Slovenian: Predklinična farmakološka in toksikološka ocena varnosti kladribina na živalskih modelih, pomembna za oceno varnosti kladribina, ni pokazala pomembnih ugotovitev, razen tistih, ki so bile pričakovane zaradi farmakološkega mehanizma kladribina.
English: Prior to launch of Mavenclad (cladribine) in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials (EM), including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Slovenian: Pred uvedbo zdravila Mavenclad (kladribin) se mora imetnik dovoljenja za promet v vsaki državi članici s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva, vključno s komunikacijskimi mediji, načini razdeljevanja in drugimi vidiki programa.
English: You will be given MAVENCLAD as two treatment courses over 2 years.
Slovenian: Zdravilo MAVENCLAD boste dobili v dveh ciklusih zdravljenja v obdobju 2 let.
English: The doctor will also do blood tests during and after treatment to check that you can continue to take MAVENCLAD, and that you are not developing any complications from the treatment.
Slovenian: Zdravnik bo krvne preiskave opravil tudi med zdravljenjem in po njem, da preveri, ali lahko nadaljujete z jemanjem zdravila MAVENCLAD in da se pri vas niso pojavili kakršni koli zapleti zaradi zdravljenja.
English: Inhibition of these enzymes or genetic polymorphisms (e.g. CYP2D6, CYP2C9 or CYP2C19) are not expected to result in clinically significant effects on cladribine pharmacokinetics or exposure.
Slovenian: Ne pričakuje se, da bi zaviranje teh encimov ali genetskih polimorfizmov (npr. CYP2D6, CYP2C9 ali CYP2C19) povzročilo klinično pomembne učinke na farmakokinetiko kladribina ali izpostavljenost kladribinu.
English: Table 3 shows how many tablets (1 or 2 tablets) you have to take on each day.
Slovenian: Preglednica 3 prikazuje število tablet (1 ali 2 tableti), ki ju morate vzeti v določenem dnevu.
English: Very rare (<1/10,000)
Slovenian: Zelo redki (< 1/10.000)
English: Following oral administration, cladribine is rapidly absorbed.
Slovenian: Po peroralnem dajanju se kladribin hitro absorbira.
English: If you have been vaccinated within the last 4 to 6 weeks, MAVENCLAD therapy must be delayed.
Slovenian: Če ste se v zadnjih 4 do 6 tednih cepili, je treba zdravljenje z zdravilom MAVENCLAD prestaviti.
English: Cladribine is a nucleoside analogue of deoxyadenosine.
Slovenian: Kladribin je nukleozidni analog deoksiadenozina.
English: Each tablet contains 64 mg sorbitol.
Slovenian: Ena tableta vsebuje 64 mg sorbitola.
English: This is important because MAVENCLAD may seriously harm your baby.
Slovenian: To je pomembno, ker zdravilo MAVENCLAD lahko resno škoduje vašemu otroku.
English: Subsequent phosphorylation of cladribine to its active triphosphate form, 2-chlorodeoxyadenosine triphosphate (Cd-ATP), is particularly efficiently achieved in lymphocytes, due to their constitutively high deoxycytidine kinase (DCK) and relatively low 5'-nucleotidase (5'-NTase) levels.
Slovenian: Naknadna fosforilacija kladribina v njegovo aktivno trifosfatno obliko 2-klorodeoksiadenozin trifosfat (Cd-ATP) je posebej učinkovito dosežena v limfocitih, zaradi njihovih osnovno visokih ravni deoksicitidin kinaze (dCK) in relativno nizkih ravni 5'-nukleotidaze (5'-NTaza).
English: Dose in mg (number of 10 mg tablets) per treatment week kg
Slovenian: Odmerek v mg (število 10 mg tablet) na teden zdravljenja kg
English: - The other ingredients are hydroxypropylbetadex, sorbitol and magnesium stearate.
Slovenian: - Druge sestavine so hidroksipropilbetadeks, sorbitol in magnezijev stearat.
English: Receive counselling before starting the treatment (consisting of two treatment courses administered at the beginning of two consecutive years) both in year 1 and year 2;
Slovenian: prejmejo svetovanje pred začetkom zdravljenja (sestavljeno iz dveh ciklov zdravljenja, ko bolnik zdravilo prejema na začetku dveh zaporednih let) tako 1. leto kot 2. leto;
English: A missed dose must be taken as soon as remembered on the same day according to the treatment schedule.
Slovenian: Izpuščeni odmerek je treba nadoknaditi takoj, ko se bolnik tega spomni, istega dne v skladu z režimom zdravljenja.
English: Caution: Do not remove the tray from the carton.
Slovenian: Pozor: Nosilca ne odstranite iz škatle.
English: Based on pooled population pharmacokinetic data from various studies, the median values for elimination were 22.2 L/h for renal clearance and 23.4 L/h for non-renal clearance.
Slovenian: Na podlagi populacijskih farmakokinetičnih podatkov, združenih iz različnih študij, je bila mediana vrednost za izločanje 22,2 l/h za ledvični očistek in 23,4 l/h za neledvični očistek.
English: It is not known whether cladribine is excreted in human milk.
Slovenian: Ni znano, ali se kladribin izloča v materino mleko.
English: It is expected that most patients recover to either normal lymphocyte counts or grade 1 lymphopenia within 9 months.
Slovenian: Pričakovati je, da v roku 9 mesecev večina bolnikov okreva bodisi na normalno število limfocitov ali na limfopenijo 1. stopnje.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Do not take MAVENCLAD and talk to your doctor or pharmacist if you are unsure if any of the above applies to you.
Slovenian: Ne jemljite zdravila MAVENCLAD in se posvetujte z zdravnikom ali farmacevtom, če ste negotovi, ali kar koli od naštetega velja za vas.
English: Cladribine is a prodrug that has to be phosphorylated intracellularly to become biologically active.
Slovenian: Kladribin je predzdravilo, ki se mora intracelularno fosforilirati, da postane biološko učinkovito.
English: Following completion of the 2 treatment courses, no further cladribine treatment is required in years 3 and 4 (see section 5.1).
Slovenian: Po zaključku 2 ciklusov zdravljenja nadaljnje zdravljenje s kladribinom v 3. in 4. letu ni potrebno (glejte poglavje 5.1).
English: In vivo clastogenicity in mice was detected at 10 mg/kg, which was the lowest dose tested.
Slovenian: Klastogenost in vivo pri miših so zaznali pri 10 mg/kg, kar je bil najmanjši testirani odmerek.
English: Tell your doctor immediately if you get symptoms of shingles, a common complication of MAVENCLAD (see section 4), which may need specific treatment.
Slovenian: Takoj povejte zdravniku, če imate simptome pasovcaa, pogostega zapleta pri zdravilu MAVENCLAD (glejte poglavje 4), za katerega bo morda potrebno posebno zdravljenje.
English: This is important because MAVENCLAD can seriously harm your baby.
Slovenian: To je pomembno, ker lahko zdravilo MAVENCLAD resno škoduje vašemu otroku.
English: In hepatic in vitro systems, negligible metabolism of cladribine was observed (at least 90% was unchanged cladribine).
Slovenian: V jetrnih sistemih in vitro so opazili zanemarljivo presnovo kladribina (vsaj 90 % je bilo nespremenjenega kladribina).
English: 110 kg and above
Slovenian: 110 kg in več
English: Day 1 Day 2 Day 3 Day 4 Day 5
Slovenian: 1. dan 2. dan 3. dan 4. dan 5. dan
English: - if you have active tuberculosis or liver inflammation (hepatitis).
Slovenian: - če imate aktivno tuberkulozo ali vnetje jeter (hepatitis).
English: What MAVENCLAD is and what it is used for
Slovenian: Kaj je zdravilo MAVENCLAD in za kaj ga uporabljamo
English: If the lymphocyte count is below
Slovenian: Če je število limfocitov pod
English: Safety and efficacy of MAVENCLAD in combination with other disease-modifying treatments for MS have not been established.
Slovenian: Varnost in učinkovitost zdravila MAVENCLAD v kombinaciji z drugimi oblikami zdravljenja, ki spreminjajo potek MS, nista bili dokazani.
English: • An introduction to Mavenclad, reminding the prescriber to consider the Patient Guide while discussing Mavenclad treatment with the patient, to support the early identification of sign and symptoms of adverse reactions and their timely treatment;
Slovenian: • uvod v zdravljenje z zdravilom Mavenclad, ki zdravnika, ki bo zdravilo predpisoval, opozori, da naj med pogovorom z bolnikom glede uporabe zdravila Mavenclad upošteva vodnik za bolnika v podporo zgodnjega odkrivanja znakov in simptomov neželenih učinkov in njihovega pravočasnega zdravljenja;
English: The carcinogenic potential of cladribine was assessed in a long-term 22-month study with subcutaneous administration in mice and in a short-term 26-week study by oral route in transgenic mice.
Slovenian: Kancerogeni potencial kladribina so ocenili v dolgoročni 22-mesečni študiji s subkutano uporabo pri miših in v kratkoročni 26-tedenski študiji s peroralno uporabo pri transgenih miših.
English: MAVENCLAD tablets are white, round, biconvex tablets engraved with 'C' on one side and '10' on the other side.
Slovenian: Zdravilo MAVENCLAD so bele, okrogle, bikonveksne tablete z vtisnjeno oznako 'C' na eni strani in '10' na drugi.
English: • at least 800 cells/mm³ before initiating MAVENCLAD in year 2.
Slovenian: • najmanj 800 celic/mm³ pred uvedbo zdravila MAVENCLAD v 2. letu.
English: Do not take MAVENCLAD:
Slovenian: Ne jemljite zdravila MAVENCLAD:
English: MAVENCLAD is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features (see section 5.1).
Slovenian: Zdravilo MAVENCLAD je indicirano za zdravljenje odraslih bolnikov z zelo aktivno recidivno multiplo sklerozo (MS), kot je opredeljena s kliničnimi ali slikovnimi značilnostmi (glejte poglavje 5.1).
English: Patients treated with MAVENCLAD should be advised to follow standard cancer screening guidelines.
Slovenian: Bolnikom, ki prejemajo MAVENCLAD, je treba svetovati, da upoštevajo standardne smernice glede presejalnih pregledov za raka.
English: In a study of the intracellular pharmacokinetics of Cd-AMP and Cd-ATP in patients with chronic myelogenous leukaemia, the levels of Cd-ATP were approximately half of the Cd-AMP levels.
Slovenian: V študiji intracelularne farmakokinetike Cd-AMP in Cd-ATP pri bolnikih s kronično mielogeno levkemijo so bile ravni Cd-ATP približno polovica ravni Cd-AMP.
English: Changing treatments
Slovenian: Spreminjanje zdravljenja
English: Pharmacokinetic interactions
Slovenian: Farmakokinetične interakcije
English: Caution is recommended when MAVENCLAD is used in elderly patients, taking into account the potential greater frequency of decreased hepatic or renal function, concomitant diseases and other medicinal therapies.
Slovenian: Pri uporabi zdravila MAVENCLAD pri starejših bolnikih se priporoča previdnost, pri čemer je treba upoštevati možno večjo pogostnost zmanjšanega delovanja jeter ali ledvic, sočasne bolezni in druge oblike zdravljenja.
English: Such medicines include alemtuzumab, daclizumab, dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta, natalizumab or teriflunomide.
Slovenian: Takšna zdravila vključujejo alemtuzumab, daklizumab, dimetilfumarat, fingolimod, glatiramer acetat, interferon beta, natalizumab ali teriflunomid.
English: - Push your tablet(s) through the blister and swallow immediately.
Slovenian: - Tableto(i) potisnite skozi pretisni omot in jo(ju) takoj pogoltnite.
English: Lymphopenia is known to be dosedependent (see sections 4.4 and 4.8).
Slovenian: Za limfopenijo se ve, da je odvisna od odmerka (glejte poglavji 4.4 in 4.8).
English: MAVENCLAD does not affect your ability to drive or use machines.
Slovenian: Zdravilo MAVENCLAD ne vpliva na vašo sposobnost vožnje in upravljanja strojev.
English: Based on human experience with other substances inhibiting DNA synthesis, cladribine could cause congenital malformations when administered during pregnancy.
Slovenian: Na podlagi izkušenj pri ljudeh z drugimi učinkovinami, ki zavirajo sintezo DNA, lahko kladribin povzroči kongenitalne malformacije, če ga jemljejo nosečnice.
English: The tablets must be taken with water, and swallowed without chewing.
Slovenian: Tablete je treba jemati z vodo in zaužiti cele, brez žvečenja.
English: Treatment with MAVENCLAD has been shown to reduce flare-ups of symptoms and to slow down progression of disability.
Slovenian: Izkazalo se je, da zdravljenje z zdravilom MAVENCLAD zmanjša izbruhe simptomov in upočasni napredovanje prizadetosti.
English: The safety and efficacy of MAVENCLAD in patients below the age of 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila MAVENCLAD pri bolnikih, mlajših od 18 let, nista bili dokazani.
English: The use of MAVENCLAD with interferon beta results in an increased risk of lymphopenia.
Slovenian: Uporaba zdravila MAVENCLAD v kombinaciji z interferonom beta privede do povečanega tveganja za limfopenijo.
English: Contraception
Slovenian: Kontracepcija
English: The mean duration of MS prior to study enrolment was 8.7 years, and the median baseline neurological disability based on Kurtzke Expanded Disability Status Scale (EDSS) score across all treatment groups was 3.0 (range 0 to 6.0).
Slovenian: Povprečno trajanje MS pred vključitvijo v študijo je bilo 8,7 let, mediana izhodiščna ocena nevrološke prizadetosti po Kurtzkejevi Razširjeni lestvici nevrološke prizadetosti (Expanded Disability Status Scale - EDSS) v vseh skupinah zdravljenja je bila 3,0 (razpon 0 do 6,0).
English: Moderate or severe renal impairment (creatinine clearance <60 mL/min) (see section 5.2).
Slovenian: Zmerna ali huda okvara delovanja ledvic (očistek kreatinina < 60 ml/min) (glejte poglavje 5.2).
English: Pregnancy and breast-feeding (see section 4.6).
Slovenian: Nosečnost in dojenje (glejte poglavje 4.6).
English: Initiation of treatment with MAVENCLAD must be postponed for 4 to 6 weeks to allow for the full effect of vaccination to occur.
Slovenian: Uvedbo zdravljenja z zdravilom MAVENCLAD je treba odložiti za 4 do 6 tednov, da nastopi polni učinek cepljenja.
English: Oriented polyamide (OPA)/aluminium (Al)/polyvinyl chloride (PVC) - aluminium (Al) blister sealed in a cardboard wallet and fixed in a child-resistant outer carton.
Slovenian: Pretisni omot iz orientiranega poliamida (OPA)/aluminija (Al)/polivinilklorida (PVC) - aluminija (Al), zavarjen v kartonski zgibanki in pritrjen v za otroke varni škatli.
English: Teratogenicity/adverse pregnancy outcomes, to ensure that female patients of child bearing potential / partners of male patients receiving Mavenclad: a.
Slovenian: Teratogenost/neželeni izidi nosečnosti, za zagotavljanje, da bolnice v rodni dobi/partnerke bolnikov, ki se zdravijo z zdravilom Mavenclad: a.
English: In this extension study, 806 patients received either placebo or a cumulative dose of cladribine 3.5 mg/kg (in a regimen similar to that used in CLARITY) over the 96-week study period.
Slovenian: V tej podaljšani študiji je 806 bolnikov prejemalo bodisi placebo ali skupni odmerek kladribina 3,5 mg/kg (v podobnem režimu kot v študiji CLARITY) v obdobju 96-tedenske študije.
English: In mice, there were no effects on fertility or the reproductive function of offspring.
Slovenian: Pri miših niso opazili učinkov na plodnost ali sposobnost razmnoževanja potomstva.
English: In vitro studies indicate that cladribine efflux is only minimally P-gp related.
Slovenian: Študije in vitro kažejo, da je efluks kladribina le minimalno povezan s P-gp.
English: Your doctor may delay treatment, or interrupt it, until the infection clears up.
Slovenian: Morda bo zdravnik zdravljenje preložil ali ga prekinil, dokler se okužba ne pozdravi.
English: The primary apoptosis-inducing mechanism of action of Cd-ATP has direct and indirect actions on DNA synthesis and mitochondrial function.
Slovenian: Primarni mehanizem delovanja Cd-ATP, ki inducira apoptozo, ima posreden in neposreden vpliv na sintezo DNA in delovanje mitohondrijev.
English: It is known that the more medicine you take the less lymphocytes may be present in your body, resulting in lymphopenia (see section 4).
Slovenian: Znano je, da z naraščanjem količine zdravila pada število limfocitov v vašem telesu, kar lahko povzroči limfopenijo (glejte poglavje 4).
English: The recommended cumulative dose of MAVENCLAD is 3.5 mg/kg body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Slovenian: Priporočeni skupni odmerek zdravila MAVENCLAD je 3,5 mg/kg telesne mase v 2 letih, ki se da kot 1 ciklus zdravljenja z 1,75 mg/kg na leto.
English: Blood transfusions
Slovenian: Transfuzija krvi
English: If you change from MAVENCLAD to other MS treatments, talk to your doctor.
Slovenian: Pri prehodu z zdravila MAVENCLAD na drugo zdravljenje MS se pogovorite z zdravnikom.
English: Use of oral cladribine in patients weighing less than 40 kg has not been investigated.
Slovenian: Uporabe peroralnega kladribina pri bolnikih s telesno maso pod 40 kg niso raziskali.
English: Number of tablets to take Year 1 treatment course
Slovenian: Število tablet, ki jih morate jemati 1. leto ciklusa zdravljenja
English: Women who become pregnant under therapy with MAVENCLAD should discontinue treatment.
Slovenian: Ženske, ki med zdravljenjem z zdravilom MAVENCLAD zanosijo, morajo prekiniti zdravljenje.
English: Because of the rapid and extensive intracellular and tissue distribution, haemodialysis is unlikely to eliminate cladribine to a significant extent.
Slovenian: Zaradi hitre in ekstenzivne intracelularne porazdelitve in porazdelitve v tkivih je malo verjetno, da bi hemodializa kladribin odstranila v pomembni meri.
English: The metabolite 2-chloroadenine was a minor metabolite both in plasma and in urine, e.g. accounting only for ≤3% of plasma parent drug exposure after oral administration.
Slovenian: Presnovek 2-kloroadenin je bil manj pomemben presnovek tako v plazmi kot v urinu, predstavlja npr. samo ≤ 3 % izpostavljenosti matičnemu zdravilu v plazmi po peroralni uporabi.