FrancophonIA/ELRC3.0 huggingface dataset:
English: If you change from other MS treatments to MAVENCLAD, your doctor will check that your blood cell counts (lymphocytes) are normal before you start treatment.
Slovenian: Pri prehodu z drugega zdravljenja MS na zdravilo MAVENCLAD bo zdravnik pred začetkom zdravljenja preveril, da je število vaših krvnih celic (limfocitov) normalno.
English: Testicular degeneration and reversible decrease in spermatozoa with rapid progressive motility were also seen in the monkey.
Slovenian: Tudi pri opicah so opazili testikularno degeneracijo in reverzibilno zmanjšanje števila spermatozojev s hitro napredujočo gibljivostjo.
English: Take the missed dose on the next day and extend the number of days in that treatment week.
Slovenian: Izpuščeni odmerek vzemite naslednji dan in podaljšajte število dni v tednu zdravljenja.
English: Immunosuppressive medicinal products
Slovenian: Imunosupresivna zdravila
English: In clinical studies and long-term follow-up of patients treated with a cumulative dose of 3.5 mg/kg oral cladribine, events of malignancies were observed more frequently in cladribine-treated patients (10 events in 3,414 patient-years [0.29 events per 100 patient-years]) compared to patients who received placebo (3 events in 2,022 patient-years [0.15 events per 100 patient-years]) (see section 4.4).
Slovenian: V kliničnih študijah in pri dolgotrajnem spremljanju bolnikov, ki so kladribin prejemali peroralno v skupnem odmerku 3,5 mg/kg, so o malignostih pogosteje poročali pri bolnikih, ki so prejemali kladribin (10 dogodkov na 3.414 bolnikov-let [0,29 dogodka na 100 bolnikov-let]), kot pri bolnikih, ki so prejemali placebo (3 dogodki na 2.022 bolnikov-let [0,15 dogodka na 100 bolnikov-let]) (glejte poglavje 4.4).
English: Potent ENT1, CNT3 and BCRP transporter inhibitors
Slovenian: Močni zaviralci prenašalcev ENT1, CNT3 in BCRP
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Slovenian: POSTOPEK IN POT UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: Patients taking cladribine compared to the placebo treatment group had 86% relative reduction in the mean number of T1 Gd+ lesions (adjusted mean number for cladribine 3.5 mg/kg, and placebo groups were 0.12 and 0.91, respectively), 73% relative reduction in the mean number of active T2 lesions (adjusted mean number for cladribine 3.5 mg/kg, and placebo groups were 0.38 and 1.43, respectively) and 74% relative reduction in the mean number of combined unique lesions per patient per scan (adjusted mean number for cladribine 3.5 mg/kg, and placebo groups were 0.43 and 1.72, respectively) (p <0.001 across all 3 MRI outcomes).
Slovenian: Bolniki, ki so prejemali kladribin, so imeli v primerjavi s skupino, zdravljeno s placebom, relativno zmanjšanje povprečnega števila lezij T1 Gd+ za 86 % (prilagojeno povprečno število za kladribin 3,5 mg/kg je bilo 0,12, za skupino s placebom pa 0,91), relativno zmanjšanje povprečnega števila aktivnih lezij T2 za 73 % (prilagojeno povprečno število za kladribin 3,5 mg/kg je bilo 0,38, za skupino s placebom pa 1,43) in relativno zmanjšanje povprečnega števila skupnega števila posameznih lezij na bolnika na slikanje za 74 % (prilagojeno povprečno število za kladribin 3,5 mg/kg je bilo 0,43, za skupino s placebom pa 1,72) (p < 0,001 v vseh 3 izidih slikanj z MR).
English: A chlorine substitution in the purine ring protects cladribine from degradation by adenosine deaminase, increasing the intracellular residence time of the cladribine prodrug.
Slovenian: Substitucija s klorom v purinskem obroču zaščiti kladribin pred razgradnjo z adenozin deaminazo, in poveča intracelularni čas zadrževanja predzdravila kladribina.
English: When switching from another MS medicinal product, a baseline MRI should be performed (see subsection 'Infections' above).
Slovenian: Pri prehodu z drugega zdravila za MS je treba opraviti izhodiščno slikanje z MR (glejte zgornje podpoglavje 'Okužbe').
English: Discontinuation of MAVENCLAD may need to be considered.
Slovenian: Morda bo treba razmisliti o prekinitvi zdravljenja z zdravilom MAVENCLAD.
English: A delay in initiation of cladribine should also be considered in patients with an acute infection until the infection is fully controlled.
Slovenian: Pri bolnikih z akutno okužbo je treba razmisliti o preložitvi uvedbe kladribina, dokler okužba ni popolnoma pod nadzorom.
English: If the number of tablets in your pack(s) is different from the number shown for your weight in the table below, speak to your doctor.
Slovenian: Povejte zdravniku, če se število tablet v pakiranju(-jih) razlikuje od števila tablet, prikazanega za vašo telesno maso v spodnji preglednici.
English: If a tablet is left on a surface, or if a broken or fragmented tablet is released from the blister, the area must be thoroughly washed.
Slovenian: Površino, na kateri je ležala tableta, ali katere se je dotaknila zlomljena ali zdrobljena tableta ob odstranitvi iz pretisnega omota, skrbno očistite.
English: Therefore, MAVENCLAD is contraindicated in these patients (see section 4.3).
Slovenian: Zato je zdravilo MAVENCLAD kontraindicirano pri teh bolnikih (glejte poglavje 4.3).
English: Infections and infestations
Slovenian: Infekcijske in parazitske bolezni
English: Additive haematological adverse reactions may be expected if cladribine is administered prior to or concomitantly with other substances that affect the haematological profile (see section 4.5).
Slovenian: Aditivne hematološke neželene učinke lahko pričakujemo, če se kladribin daje pred drugimi snovmi, ki vplivajo na hematološki profil, ali skupaj z njimi (glejte poglavje 4.5).
English: No dedicated studies have been conducted in patients with renal impairment.
Slovenian: Namenskih študij pri bolnikih z ledvično okvaro niso izvedli.
English: Each treatment course consists of 2 treatment weeks, which are one month apart at the beginning of each treatment year.
Slovenian: En ciklus zdravljenja vključuje 2 tedna zdravljenja, s presledkom enega meseca, na začetku vsakega leta zdravljenja.
English: • In the long-term carcinogenicity study in mice, the highest dose used was 10 mg/kg, which was seen to be genotoxic in the mouse micronucleus study (equivalent to approximately 16-fold the expected human exposure in AUC in patients taking the maximum daily dose of 20 mg cladribine).
Slovenian: • V dolgoročni študiji kancerogenosti pri miših je bil uporabljen največji odmerek 10 mg/kg (kar je enakovredno približno 16-kratni pričakovani izpostavljenosti na podlagi AUC pri bolnikih, ki jemljejo največji dnevni odmerek 20 mg kladribina), ki je bil v študijah mikronukleusov pri miših dokazano genotoksičen.
English: For some weight ranges the number of tablets may vary from one treatment week to the next.
Slovenian: Za nekatere razpone telesne mase se lahko število tablet od enega do drugega tedna zdravljenja spreminja.
English: In women of childbearing potential, pregnancy must be excluded before the initiation of MAVENCLAD in year 1 and year 2, and prevented by use of effective contraception during cladribine treatment and for at least 6 months after the last dose.
Slovenian: Pri ženskah v rodni dobi je treba pred uvedbo zdravila MAVENCLAD v 1. in 2. letu izključiti nosečnost ter jo med zdravljenjem s kladribinom in še vsaj 6 mesecev po zadnjem odmerku preprečiti z uporabo učinkovite kontracepcije.
English: See also 'Pregnancy and breast-feeding'.
Slovenian: Glejte tudi 'Nosečnost in dojenje'.
English: Therefore, it is recommended that administration of any other oral medicinal product be separated from that of MAVENCLAD by at least 3 hours during the limited number of days of cladribine administration.
Slovenian: Zato je priporočljivo, da med jemanjem katerega koli drugega peroralnega zdravila in zdravila MAVENCLAD pretečejo vsaj 3 ure, v tistih nekaj dneh, ko se jemlje kladribin.
English: In vitro, intra- versus extracellular accumulation ratios were found to be around 30 to 40 already 1 hour after cladribine exposure.
Slovenian: Ugotovili so, da je razmerje med intracelularnim in ekstracelularnim kopičenjem in vitro že 1 uro po izpostavljenosti kladribinu približno 30 do 40.
English: - rifampicin (used to treat certain types of infection), St. John's wort (used to treat depression) or corticosteroids (used to suppress inflammation).
Slovenian: - rifampicinom (uporablja se za zdravljenje določenih tipov vnetij), šentjanževko (uporablja se za zdravljenje depresij) ali kortikosteroidi (uporabljajo se za zaviranje vnetja).
English: Although the importance of hepatic function for the elimination of cladribine is considered negligible (see section 5.2), in the absence of data, use of MAVENCLAD is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh score >6).
Slovenian: Čeprav velja, da je pomembnost delovanja jeter za izločanje kladribina zanemarljiva (glejte poglavje 5.2), zaradi pomanjkanja podatkov uporaba zdravila MAVENCLAD pri bolnikih z zmerno ali hudo jetrno okvaro (ocena po Child-Pughu > 6) ni priporočljiva.
English: The effect on lymphocyte count is dose-dependent.
Slovenian: Učinek na število limfocitov je odvisen od odmerka.
English: LIST OF EXCIPIENTS Contains sorbitol.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje sorbitol.
English: Although the importance of hepatic function for the elimination of cladribine is considered negligible (see section 5.2), in the absence of data, use of MAVENCLAD is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh score >6) (see section 4.2).
Slovenian: Čeprav velja, da je pomembnost delovanja jeter za izločanje kladribina zanemarljiva (glejte poglavje 5.2), zaradi pomanjkanja podatkov uporaba zdravila MAVENCLAD pri bolnikih z zmerno ali hudo jetrno okvaro (ocena po Child-Pughu > 6) ni priporočljiva (glejte poglavje 4.2).
English: Interruption or delay of MAVENCLAD may be considered until proper resolution of the infection.
Slovenian: Razmisliti je treba o prekinitvi ali preložitvi zdravljenja z zdravilom MAVENCLAD, dokler se okužba ustrezno ne pozdravi.
English: Each tablet contains 10 mg cladribine.
Slovenian: Ena tableta vsebuje 10 mg kladribina.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of cladribine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 10 mg kladribina.
English: You will have blood tests before you start treatment to check that you can take MAVENCLAD.
Slovenian: Pred začetkom zdravljenja bodo opravili krvne preiskave in preverili, ali lahko jemljete zdravilo MAVENCLAD.
English: MAVENCLAD is contraindicated in pregnant women (see section 4.3).
Slovenian: Zdravilo MAVENCLAD je kontraindicirano pri nosečnicah (glejte poglavje 4.3).
English: 40 to <50
Slovenian: 40 do < 50
English: Use effective contraception during the treatment and for at least 6 months after the last dose.
Slovenian: med zdravljenjem in še vsaj 6 mesecev po zadnjem odmerku uporabljajo učinkovito kontracepcijo.
English: Therefore women of child bearing potential, using systemically acting hormonal contraceptives, should add a barrier method during cladribine treatment and up to 4 weeks after the last dose.
Slovenian: Zato morajo ženske v rodni dobi, ki uporabljajo sistemsko delujoče hormonske kontraceptive, med zdravljenjem s kladribinom in še do 4 tedne po zadnjem odmerku dodati tudi pregradno metodo.
English: Treatment week 1
Slovenian: 1. teden zdravljenja
English: There is evidence that cladribine can also cause direct caspase-dependent and -independent apoptosis via the release of cytochrome c and apoptosis-inducing factor into the cytosol of non-dividing cells.
Slovenian: Obstajajo dokazi, da kladribin s sproščanjem citokroma c in indukcijskega faktorja apoptoze v citosol nedelečih se celic lahko povzroči tudi neposredno od kaspaze odvisno in neodvisno apoptozo.
English: No studies have been conducted in patients with hepatic impairment.
Slovenian: Študij pri bolnikih z jetrno okvaro niso izvedli.
English: Year 1
Slovenian: 1. leto
English: Cladribine is incorporated into DNA strands and inhibits DNA synthesis and repair.
Slovenian: Kladribin se vgradi v verige DNA ter zavira sintezo in popravilo DNA.
English: Total number of tablets per treatment week
Slovenian: Preglednica 3 Skupno število tablet na teden zdravljenja
English: Talk to your doctor if you take hormonal contraceptives (e.g. "the pill").
Slovenian: Če jemljete hormonske kontraceptive (npr. "tabletko"), se posvetujte z zdravnikom.
English: MAVENCLAD is contraindicated in MS patients with active malignancies (see section 4.3).
Slovenian: Zdravilo MAVENCLAD je kontraindicirano pri bolnikih z MS z aktivnimi malignostmi (glejte poglavje 4.3).
English: Lymphocyte counts must be determined
Slovenian: Določiti je treba število limfocitov
English: Accordingly, the bioavailability, intracellular distribution and renal elimination of cladribine may theoretically be altered by potent ENT1 and CNT3 transporter inhibitors such as dilazep, nifedipine, nimodipine, cilostazol, sulindac or reserpine.
Slovenian: Glede na to lahko močni zaviralci prenašalcev ENT1 in CNT3, kot so dilazep, nifedipin, nimodipin, cilostazol, sulindak ali rezerpin, teoretično spremenijo biološko uporabnost, intracelularno distribucijo in ledvično izločanje kladribina.
English: 90 to <100
Slovenian: 90 do < 100
English: Men and women must use effective contraception during MAVENCLAD treatment and for at least 6 months after the last dose.
Slovenian: Moški in ženske morajo med zdravljenjem z zdravilom MAVENCLAD in še vsaj 6 mesecev po zadnjem odmerku uporabljati učinkovito kontracepcijo.
English: - If a tablet is left on a surface or if it breaks and fragments fall from the blister, the area must be thoroughly washed.
Slovenian: - Površino, na kateri je ležala tableta, ali se je tableta zlomila in so nanjo padli delci iz pretisnega omota, skrbno očistite.
English: less than 40 kg
Slovenian: 40 do manj kot 50 kg
English: What MAVENCLAD looks like and contents of the pack
Slovenian: Izgled zdravila MAVENCLAD in vsebina pakiranja
English: Intracellular half-life of Cd-AMP was 15 h. Intracellular half-life of Cd-ATP was 10 h.
Slovenian: Intracelularna razpolovna doba za Cd-ATP je bila 10 ur.
English: MAVENCLAD 10 mg tablets cladribine
Slovenian: MAVENCLAD 10 mg tablete kladribin
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS CARDBOARD WALLET
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU KARTONSKA ZGIBANKA
English: Because of the cladribine-induced reduction in lymphocyte count, additive haematological adverse reactions may be expected if cladribine is administered prior to or concomitantly with other substances that affect the haematological profile (e.g. carbamazepine).
Slovenian: Zaradi zmanjšanja števila limfocitov, ki ga povzroči kladribin, se lahko pri uporabi kladribina pred ali skupaj z drugimi zdravili, ki vplivajo na hematološki profil (npr. karbamazepin), pričakujejo aditivni hematološki neželeni učinki.
English: The incidence of herpes zoster was increased in patients on cladribine.
Slovenian: Pri bolnikih na kladribinu se je incidenca herpesa zostra povečala.
English: • In the short-term carcinogenicity study in Tg rasH2 mice, no cladribine-related increase in incidence of lymphoproliferative disorders or other tumour types was seen at any dose tested up to 30 mg/kg per day (equivalent to approximately 25-fold the expected human exposure in AUC in patients taking the maximum daily dose of 20 mg cladribine).
Slovenian: • V kratkoročni študiji pri miših Tg rasH2 pri nobenem od testiranih odmerkov do 30 mg/kg na dan (kar je enakovredno približno 25-kratniku pričakovane izpostavljenosti na podlagi AUC pri bolnikih, ki jemljejo največji dnevni odmerek 20 mg kladribina) niso opazili s kladribinom povezanega povečanja pogostnosti limfoproliferativnih bolezni ali drugih tipov tumorjev.
English: If two consecutive doses are missed, the same rule applies, and the number of days in the treatment week is extended by two days.
Slovenian: To pravilo velja tudi, če izpustimo dva zaporedna odmerka, število dni v tednu zdravljenja se v tem primeru podaljša za dva dni.
English: Duration of a treatment week
Slovenian: Trajanje tedenskega zdravljenja
English: • normal before initiating MAVENCLAD in year 1,
Slovenian: • normalno pred uvedbo zdravila MAVENCLAD v 1. letu,
English: Post-hoc analysis of time to 6-month confirmed EDSS progression resulted in a 47% reduction of the risk of disability progression in the cladribine 3.5 mg/kg compared to placebo (hazard ratio = 0.53, 95% CI [0.36, 0.79], p <0.05); in the placebo group the 10
Slovenian: V post-hoc analizi časa do 6-mesečnega potrjenega napredovanja EDSS je bilo tveganje za razvoj napredovanja prizadetosti v skupini s kladribinom 3,5 mg/kg zmanjšano za 47 % v primerjavi s skupino s placebom (razmerje tveganja = 0,53, 95-% IZ [0,36; 0,79], p < 0,05); v skupini s placebom je bil 10. percentil dosežen po 245. dneh, v skupini s kladribinom 3,5 mg/kg pa sploh ni bil dosežen.
English: 50 to <60
Slovenian: 50 do < 60
English: Table 2 MAVENCLAD 10 mg tablets per week day Total number of tablets per week
Slovenian: Preglednica 2 Število tablet zdravila MAVENCLAD 10 mg na dan v tednu
English: • The Patient Guide The Prescriber Guide should include:
Slovenian: Vodnik za zdravnika, ki bo zdravilo predpisoval, naj vključuje:
English: Haematotoxic medicinal products
Slovenian: Hematotoksična zdravila
English: 1st treatment week 1 or 2 tablets daily for 4 or 5 days, mid April
Slovenian: 1. teden zdravljenja 1 ali 2 tableti na dan, 4 ali 5 dni, sredi aprila
English: Take the missed dose on that day.
Slovenian: Izpuščeni odmerek vzemite še isti dan.
English: 70 to <80
Slovenian: 70 do < 80
English: A possible decrease in cladribine exposure should be considered if potent BCRP (e.g. corticosteroids) or P-gp (e.g. rifampicin, St. John's Wort) transporter inducers are co-administered.
Slovenian: Pri sočasnem dajanju močnih induktorjev BCRP (npr. kortikosteroidov) ali P-gp (npr. rifampicina, šentjanževke) je treba pomisiti na možno zmanjšano izpostavljenost kladribinu.
English: Particularly close monitoring of haematological parameters is recommended in patients who have been exposed to an overdose of cladribine.
Slovenian: Pri bolnikih, ki so bili izpostavljeni prevelikemu odmerku kladribina, se priporoča še posebej skrbno spremljanje hematoloških parametrov.
English: Talk to your doctor, if you are or have been treated with: - medicines which may affect your blood cells (for example carbamazepine, used to treat epilepsy).
Slovenian: - zdravili, ki lahko vplivajo na krvne celice (na primer karbamazepin, uporablja se za zdravljenje epilepsije).
English: MAVENCLAD is packed in a reclosable, child-resistant carton and must be kept out of the sight and reach of children.
Slovenian: Zdravilo MAVENCLAD je pakirano v za otroke varni škatli za večkratno zapiranje in ga je treba shranjevati nedosegljivo otrokom.
English: PHARMACEUTICAL FORM
Slovenian: FARMACEVTSKA OBLIKA tableta
English: A potential additive effect on the immune system should also be considered when such medicinal products are used after treatment with MAVENCLAD (see section 4.5).
Slovenian: Če se takšna zdravila uporablja po zdravljenju z zdravilom MAVENCLAD, je treba upoštevati tudi morebiten aditivni učinek na imunski sistem (glejte poglavje 4.5).
English: How to take MAVENCLAD
Slovenian: Kako jemati zdravilo MAVENCLAD
English: 80 to <90
Slovenian: 80 do < 90
English: Women of childbearing potential must prevent pregnancy by use of effective contraception during cladribine treatment and for at least 6 months after the last dose (see section 4.5).
Slovenian: Ženske v rodni dobi morajo med zdravljenjem s kladribinom in še vsaj 6 mesecev po zadnjem odmerku preprečiti nosečnost z uporabo učinkovite kontracepcije (glejte poglavje 4.5).
English: Common (≥1/100 to <1/10)
Slovenian: Pogosti (≥ 1/100 do < 1/10)
English: Single events of cancer have been observed in patients who had received cladribine in clinical studies.
Slovenian: Pri bolnikih, ki so v kliničnih študijah prejemali kladribin, so poročali o posameznih primerih raka.
English: You must not receive such vaccines during MAVENCLAD treatment.
Slovenian: Med zdravljenjem z zdravilom MAVENCLAD ne smete biti cepljeni s takšnimi cepivi.
English: Vaccination of antibody-negative patients is recommended prior to initiation of cladribine therapy.
Slovenian: Pred uvedbo zdravljenja s kladribinom se za bolnike, negativne na protitelesa, priporoča cepljenje.
English: MAVENCLAD contains sorbitol.
Slovenian: Zdravilo MAVENCLAD vsebuje sorbitol.
English: Patients received either placebo (n = 437), or a cumulative dose of cladribine of 3.5 mg/kg (n = 433) or 5.25 mg/kg body weight (n = 456) over the 96-week (2-year) study period in 2 treatment courses.
Slovenian: Bolniki so v obdobju 96-tedenske (2-letne) študije v 2 ciklusih zdravljenja prejemali bodisi placebo (n = 437), skupni odmerek kladribina 3,5 mg/kg (n = 433) ali 5,25 mg/kg telesne mase (n = 456).
English: 80 mg (8 tablets)
Slovenian: 80 mg (8 tablet)
English: 70 mg (7 tablets)
Slovenian: 70 mg (7 tablet)
English: 90 mg (9 tablets)
Slovenian: 90 mg (9 tablet)
English: Blood and lymphatic system disorders Very common: Lymphopenia.
Slovenian: tuberkuloza (glejte poglavje 4.4) Bolezni krvi in limfatičnega sistema Zelo pogosti: limfopenija Pogosti:
English: • before initiating MAVENCLAD in year 1,
Slovenian: • pred uvedbo zdravila MAVENCLAD v 1. letu,
English: An individual benefit-risk evaluation should be performed before initiating MAVENCLAD in patients with prior malignancy.
Slovenian: Pri bolnikih s predhodno malignostjo je treba pred uvedbo zdravila MAVENCLAD opraviti individualno oceno med koristmi in tveganji.
English: - The active substance is cladribine.
Slovenian: - Učinkovina je kladribin.
English: There is limited experience with overdose of oral cladribine.
Slovenian: Izkušnje s prevelikim odmerjanjem peroralnega kladribina so omejene.
English: • before initiating MAVENCLAD in year 2,
Slovenian: • pred uvedbo zdravila MAVENCLAD v 2. letu,
English: These include: - ciclosporin, cyclophosphamide and azathioprine (used to suppress the immune system, for example after organ transplantation); - methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis); - long-term corticosteroids (used to reduce inflammation, for example in asthma).
Slovenian: Ta vključujejo: ciklosporin, ciklofosfamid in azatioprin (uporabljajo se za zaviranje imunskega sistema, na primer po presaditvi organa); metotreksat (uporablja se za zdravljenje bolezni, kot sta luskavica ali revmatoidni artritis);
English: Hydroxypropylbetadex (2-hydroxypropyl-ß-cyclodextrin) Sorbitol
Slovenian: 6.1 Seznam pomožnih snovi hidroksipropilbetadeks (2-hidroksipropil-ß-ciklodekstrin) sorbitol magnezijev stearat
English: Treatment week 2
Slovenian: 2. teden zdravljenja
English: 2nd treatment week 1 or 2 tablets daily for 4 or 5 days, mid May
Slovenian: 2. teden zdravljenja 1 ali 2 tableti na dan, 4 ali 5 dni, sredi maja
English: Skin and subcutaneous tissue disorders Common:
Slovenian: zmanjšanje števila nevtrofilcev Bolezni kože in podkožja Pogosti:
English: Other disease-modifying medicinal products
Slovenian: Druga zdravila, ki spreminjajo potek bolezni
English: 100 mg (10 tablets)
Slovenian: 100 mg (10 tablet)
English: Uncommon (≥1/1,000 to <1/100)
Slovenian: Občasni (≥ 1/1.000 do < 1/100)
English: 60 to <70
Slovenian: 60 do < 70
English: What MAVENCLAD contains
Slovenian: Kaj vsebuje zdravilo MAVENCLAD
English: NAME OF THE MEDICINAL PRODUCT Cladribine 10 mg
Slovenian: IME ZDRAVILA Cladribine 10 mg
English: Child-resistant packaging.
Slovenian: Za otroke varno pakiranje.
English: 40 mg (4 tablets)
Slovenian: 40 mg (4 tablete)
English: Therefore, women using systemically acting hormonal contraceptives should add a barrier method during cladribine treatment and for at least 4 weeks after the last dose in each treatment year (see section 4.6).
Slovenian: Zato morajo ženske, ki uporabljajo sistemske hormonske kontraceptive, med zdravljenjem s kladribinom in še vsaj 4 tedne po zadnjem odmerku v vsakem letu zdravljenja dodatno uporabljati še pregradno metodo (glejte poglavje 4.6).