natgillin/translations-raw huggingface dataset:
- dilazep, nifedipine, nimodipine, reserpine, cilostazol or sulindac (used to treat the heart, high blood pressure, vascular conditions or inflammation), or eltrombopag (used to treat conditions associated with bleeding). 
- dilazepom, nifedipinom, nimodipinom, reserpinom, cilostazolom ali sulindakom (uporabljajo se za zdravljenje srca, visokega krvnega tlaka, žilnih bolezni ali vnetij), ali eltrombopagom (uporablja se za zdravljenje stanj, ki so povezana s krvavitvami).
In these patients, treatment with cladribine 3.5 mg/kg resulted in a reduction of the annualised relapse rate compared to placebo (0.03 versus 0.30, risk ratio: 0.11, p <0.05). 
Pri teh bolnikih je zdravljenje s kladribinom 3,5 mg/kg povzročilo zmanjšanje stopnje recidivov na letni ravni v primerjavi s placebom (0,03 v primerjavi z 0,30, razmerje tveganja: 0,11, p < 0,05).
Renal clearance of cladribine was shown to be dependent on creatinine clearance. 
Pokazalo se je, da je očistek kladribina odvisen od očistka kreatinina.
The dephosphorylation and deactivation of Cd-AMP is catalysed by cytoplasmic 5'-NTase. 
Defosforilacijo in deaktivacijo Cd-AMP katalizira citoplazemska 5´-NTaza.
NAME OF THE MARKETING AUTHORISATION HOLDER Merck Europe B.V. 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Merck Europe B.V.
As a result of a lower DCK/5'-NTase ratio other bone marrow derived cells are less affected than lymphocytes. 
Kot rezultat nižjega razmerja med dCK in 5'-NTazo so druge celice, ki izvirajo iz kostnega mozga, manj prizadete kot limfociti.
3 Pull out tray until it stops 
3 Izvlecite nosilec, dokler se ne zaustavi.
However, considering cladribine genotoxicity, male-mediated effects related to potential genetic alteration of differentiating sperm cells cannot be excluded. 
Vendar pa glede na genotoksičnost kladribina ni možno izključiti učinkov, ki preko moškega vplivajo na morebitne genetske spremembe diferencirajočih se spermijev.
The majority of patients in the placebo (87.0%) and the cladribine 3.5 mg/kg (91.9%) and 5.25 mg/kg (89.0%) treatment groups completed the full 96 weeks of the study. 
Večina bolnikov iz skupine, ki je prejemala placebo (87,0 %), in skupin, ki sta prejemali kladribin 3,5 mg/kg (91,9 %) in 5,25 mg/kg (89,0 %), je zaključila polnih 96 tednov študije.
The distribution of the total dose over the 2 years of treatment is provided in Table 1. 
Porazdelitev skupnega odmerka v 2 letih zdravljenja je razvidna iz preglednice 1.
When oral cladribine was given in fasted state, median Tmax was 0.5 h (range 0.5 to 1.5 h). 
Po dajanju peroralnega kladribina na tešče je bila mediana Tmax 0,5 h (razpon 0,5 do 1,5 h).
If lymphocyte counts drop below 200 cells/mm³, anti-herpes prophylaxis according to local standard practice should be considered during the time of grade 4 lymphopenia (see section 4.8). 
Če število limfocitov pade pod 200 celic/mm³, je treba v času limfopenije 4. stopnje razmisliti o profilaksi proti herpesu v skladu z lokalno standardno prakso (glejte poglavje 4.8).
Liver problems 
Težave z jetri
What you need to know before you take MAVENCLAD 
Kaj morate vedeti, preden boste vzeli zdravilo MAVENCLAD
A treatment week consists of 4 or 5 days on which you receive 1 or 2 tablets daily (see Table 1). 
Teden zdravljenja vključuje 4 ali 5 dni, na katere prejmete 1 ali 2 tableti na dan (glejte preglednico 1).
Initiation of cladribine treatment is contraindicated in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy with, e.g., methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids because of a risk of additive effects on the immune system (see section 4.3). 
Uvedba zdravljenja s kladribinom je kontraindicirana pri bolnikih z oslabljenim imunskim sistemom, vključno z bolniki, ki trenutno prejemajo imunosupresivno ali mielosupresivno terapijo, npr. z metotreksatom, ciklofosfamidom, ciklosporinom ali azatioprinom, ali ki kronično uporabljajo kortikosteroide, zaradi tveganja za aditivne učinke na imunski sistem (glejte poglavje 4.3).
MAVENCLAD contains the active substance cladribine, a cytotoxic (cell killing) substance that works mostly on lymphocytes, cells of the immune system that are involved in inflammation. 
Zdravilo MAVENCLAD vsebuje učinkovino kladribin, citotoksično snov (ki ubija celice), in deluje pretežno na limfocite, celice imunskega sistema, ki sodelujejo pri vnetju.
Acute short-term therapy with systemic corticosteroids can be administered during cladribine treatment. 
Med zdravljenjem s kladribinom je možna akutna kratkoročna terapija s sistemskimi kortikosteroidi.
Patients randomised to the 5.25 mg/kg cumulative dose received additional treatment at weeks 9 and 13 of the first year. 
Bolniki, randomizirani za prejemanje skupnega odmerka 5,25 mg/kg, so prejeli dodatno zdravljenje v 9. in 13. tednu prvega leta.
As shown in Table 3 above, higher cumulative doses did not add any clinically meaningful benefit, but were associated with a higher incidence in ≥grade 3 lymphopenia (44.9% in the 5.25 mg/kg group vs. 25.6 % in the 3.5 mg/kg group). 
Kot je prikazano v zgornji preglednici 3, večji skupni odmerki niso prinesli nobenih dodatnih klinično pomembnih prednosti, bili pa so povezani s povečano incidenco limfopenije ≥ 3. stopnje (44,9 % v skupini s 5,25 mg/kg v primerjavi s 25,6 % v skupini s 3,5 mg/kg).
You do not have to take the tablets at meal times. 
Tablet vam ni treba jemati v času obrokov.
Cladribine has the potential to penetrate the blood brain barrier. 
Kladribin lahko prehaja skozi krvno-možgansko bariero.
The role of hepatic function for the elimination of cladribine is considered negligible. 
Ocenjuje se, da je vloga jeter pri izločanju kladribina zanemarljiva.
In addition, the cladribine 3.5 mg/kg treatment group was statistically significantly superior to placebo with regard to number and relative reduction of T1 Gd+ lesions, active T2 lesions and combined unique lesions as demonstrated in brain MRI over the entire 96 weeks of the study. 
Poleg tega je bila skupina, zdravljena s kladribinom 3,5 mg/kg, statistično značilno boljša od placeba glede števila in relativnega zmanjšanja lezij T1 Gd+, aktivnih lezij T2 in skupnega števila posameznih lezij, kar so ugotavljali slikanjem možganov z MR ves čas 96-tedenske študije.
Inhibition of BCRP in the gastrointestinal tract may increase the oral bioavailability and systemic exposure of cladribine. 
Zaviranje BCRP v prebavilih lahko zviša peroralno biološko uporabnost in sistemsko izpostavljenost kladribinu.
• Important potential risks Progressive multifocal leukoencephalopathy (PML), opportunistic infections (other than PML and tuberculosis) and severe infections, to ensure awareness of signs and symptoms suggestive of these risks; Malignancies, to raise awareness on this risk because: a. 
Progresivna multifokalna levkoencefalopatija (PML), oportunistične okužbe (poleg PML in tuberkuloze) in hude okužbe, za zagotavljanje zavedanja znakov in simptomov, ki nakazujejo ta tveganja;
In dividing cells, Cd-ATP interferes with DNA synthesis via inhibition of ribonucleotide reductase and competes with deoxyadenosine triphosphate for incorporation into DNA by DNA polymerases. 
V delečih se celicah Cd-ATP moti sintezo DNA z zaviranjem ribonukleotidne reduktaze in tekmuje z deoksiadenozin trifosfatom za vgrajevanje v DNA s polimerazami DNA.
The primary target organs identified in the repeat-dose toxicology studies by parenteral routes (intravenous or subcutaneous) up to 1-year duration in mice and monkeys were the lymphoid and haematopoietic system. 
Primarni ciljni organi, opredeljeni v do eno leto trajajočih toksikoloških študijah s ponavljajočimi odmerki po parenteralnih potmeh (intravensko ali subkutano) pri miših in opicah sta bila limfni in krvotvorni sistem.
Cladribine was also assessed in a 1-year monkey study by the subcutaneous route. 
Kladribin so ocenili tudi v enoletni študiji pri opicah s subkutano uporabo.
In vitro studies showed negligible transporter-mediated uptake of cladribine into human hepatocytes. 
Študije in vitro so pokazale zanemarljiv privzem kladribina v humane hepatocite s pomočjo prenašalcev.
Initiation of cladribine treatment in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy (see section 4.5). 
Uvedba zdravljenja s kladribinom pri bolnikih z oslabljenim imunskim sistemom, vključno z bolniki, ki trenutno prejemajo imunosupresivno ali mielosupresivno zdravljenje (glejte poglavje 4.5).
• The treatment regimens; 
• režime zdravljenja;
2 consecutive doses (for example both Day 3 and Day 4 doses), take the missed doses for the next 2 days, and then extend the treatment week by 2 days. 
Če pozabite vzeti 2 zaporedna odmerka (na primer odmerka za 3. in 4. dan), vzemite izpuščena odmerka v naslednjih 2 dnevih, nato pa teden zdravljenja podaljšajte za 2 dni.
Shingles will need to be treated, and MAVENCLAD treatment may need to be stopped until the infection is cleared. 
Pasasti izpuščaj bo treba zdraviti in morda bo treba zdravljenje z zdravilom MAVENCLAD ustaviti, dokler okužba ne izzveni.
DCK is the rate limiting enzyme for conversion of the cladribine prodrug into its active triphosphate form, leading to selective depletion of dividing and non-dividing T and B cells. 
Encim dCK omejuje hitrost pretvorbe predzdravila kladribina v njegovo aktivno trifosfatno obliko, kar povzroči selektivno zmanjševanje delečih in nedelečih se celic T in B.
However, testicular effects were observed in mice and monkeys (see section 5.3). 
Vendar pa so pri miših in opicah opazili učinke na moda (glejte poglavje 5.3).
Very common (≥1/10) 
Zelo pogosti (≥ 1/10)
The effects of potent inducers of the efflux transporters BCRP and P-glycoprotein (P-gp) on the bioavailability and disposition of cladribine have not been formally studied. 
Učinkov močnih induktorjev izločevalnih prenašalcev BCRP in P-glikoproteina (P-gp) na biološko uporabnost in razporeditev kladribina niso uradno raziskovali.
Do not use this medicine after the expiry date which is stated on the label and the carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Treatment with MAVENCLAD must be initiated and supervised by a physician experienced in the treatment of MS. 
Zdravljenje z zdravilom MAVENCLAD lahko uvede in nadzira le zdravnik, ki ima izkušnje z zdravljenjem MS.
The incidence of herpes zoster was higher during the period of grade 3 or 4 lymphopenia (<500 to 200 cells/mm³ or <200 cells/mm³) compared to the time when the patients were not experiencing grade 3 or 4 lymphopenia (see section 4.4). 
Incidenca herpesa zostra je bila višja v obdobju limfopenije 3. ali 4. stopnje (< 500 do 200 celic/mm³ ali < 200 celic/mm³), v primerjavi z obdobjem, ko bolniki niso imeli limfopenije 3. ali 4. stopnje (glejte poglavje 4.4).
Patients randomised to the 3.5 mg/kg cumulative dose received a first treatment course at weeks 1 and 5 of the first year and a second treatment course at weeks 1 and 5 of the second year. 
Bolniki, randomizirani na prejemanje skupnega odmerka 3,5 mg/kg, so prvi ciklusu zdravljenja prejeli v 1. in 5. tednu prvega leta ter drugi ciklus zdravljenja v 1. in 5. tednu drugega leta.
Before initiation of treatment both in year 1 and year 2, women of childbearing potential and males who could potentially father a child should be counselled regarding the potential for serious risk to the foetus and the need for effective contraception. 
Pred uvedbo zdravljenja, tako v 1. letu kakor tudi v 2. letu, je treba ženskam v rodni dobi in moškim, ki bi morda lahko spočeli otroka, svetovati glede možnosti za resno tveganje za plod in potrebe po učinkoviti kontracepciji.
Active malignancy. 
Aktivna malignost.
Patients with relapsing-remitting MS receiving cladribine 3.5 mg/kg showed statistically significantly improvements in the annualised relapse rate, proportion of patients relapse-free over 96 weeks, proportion of patients free of sustained disability over 96 weeks and time to 3-month EDSS progression compared to patients on placebo (see Table 3). 
Pri bolnikih z recidivno remitentno MS, ki so prejemali kladribin 3,5 mg/kg, se je pokazalo statistično značilno izboljšanje v stopnji recidivov na letni ravni, deležu bolnikov brez recidiva v 96 tednih, deležu bolnikov s trajnim stanjem brez bolezni v 96 tednih in času do 3-mesečnega napredovanja EDSS v primerjavi z bolniki na placebu (glejte preglednico 3).
In clinical studies, events of malignancies were observed more frequently in cladribine-treated patients compared to patients who received placebo (see section 4.8). 
V kliničnih študijah so o malignostih pogosteje poročali pri bolnikih, ki so prejemali kladribin, kot pri bolnikih, ki so prejemali placebo (glejte poglavje 4.8).
A missed dose must not be taken together with the next scheduled dose on the following day. 
Naslednjega dne se izpuščenega odmerka ne sme vzeti skupaj z naslednjim načrtovanim odmerkom.
Across clinical studies, data with the proposed cumulative dose of 3.5 mg/kg body weight show a gradual improvement in the median lymphocyte counts back to the normal range at week 84 from the first dose of cladribine (approximately 30 weeks after the last dose of cladribine). 
V kliničnih študijah kažejo podatki ob uporabi skupnega odmerka 3,5 mg/kg telesne mase postopno izboljšanje medianega števila limfocitov nazaj na normalni razpon v 84. tednu po prvem odmerku kladribina (približno 30 tednov po zadnjem odmerku kladribina).
Post-hoc subgroup efficacy analyses have been conducted in patients with high disease activity treated with oral cladribine at the recommended 3.5 mg/kg cumulative dose. 
Post-hoc analize učinkovitosti v podskupini so izvedli pri bolnikih z veliko aktivnostjo bolezni, zdravljenih s peroralnim kladribinom v priporočenem skupnem odmerku 3,5 mg/kg.
HIV infection, active tuberculosis and active hepatitis must be excluded before initiation of cladribine (see section 4.3). 
Pred uvedbo kladribina je treba izključiti okužbo s HIV, aktivno tuberkulozo in aktivni hepatitis (glejte poglavje 4.3).
No studies have been conducted to evaluate the pharmacokinetics of cladribine in elderly or in paediatric MS patients, or in subjects with renal or hepatic impairment. 
Študij za ocenitev farmakokinetike kladribina pri starejših ali pediatričnih bolnikih z MS ali pri osebah z ledvično ali jetrno okvaro niso izvedli.
Haematological monitoring 
Hematološki nadzor
It is currently unknown whether cladribine may reduce the effectiveness of systemically acting hormonal contraceptives. 
Trenutno ni znano, ali lahko kladribin zmanjša učinkovitost sistemskih hormonskih kontraceptivov.
Administration of 10 mg cladribine resulted in a cladribine mean Cmax in the range of 22 to 29 ng/mL and corresponding mean AUC in the range of 80 to 101 ng•h/mL (arithmetic means from various studies). 
Po dajanju 10 mg kladribina je povprečna Cmax kladribina v razponu od 22 do 29 ng/ml in ustrezna povprečna AUC v razponu od 80 do 101 ng•h/ml (aritmetična sredina iz različnih študij).
CD8+ T cells have a less pronounced decrease and a faster recovery than CD4+ T cells, resulting in a temporarily decreased CD4 to CD8 ratio. 
Pri celicah T CD8+ je zmanjšanje manj izrazito in okrevanje hitrejše kot pri celicah T CD4+, posledica česar je začasno zmanjšanje razmerja med CD4 in CD8.
Across studies, the largest proportion of patients with grade 3 or 4 lymphopenia (<500 to 200 cells/mm³ or <200 cells/mm³) was seen 2 months after the first cladribine dose in each year, indicating a time gap between cladribine plasma concentrations and the maximum haematological effect. 
V študijah so največji delež bolnikov z limfopenijo 3. ali 4. stopnje (< 500 do 200 celic/mm³ ali < 200 celic/mm³) opazili 2 meseca po prvem odmerku kladribina v vsakem letu, kar kaže na časovno vrzel med plazemskimi koncentracijami kladribina in največjim hematološkim učinkom.
In the analyses of the CLARITY data, a consistent treatment effect on relapses was observed with the annualised relapse rate ranging from 0.16 to 0.18 in the cladribine groups and 0.47 to 0.50 in the placebo group (p <0.0001). 
V analizi podatkov iz študije CLARITY so opazili stalen učinek zdravljenja na recidive, s stopnjo recidiva na letni stopnji v razponu od 0,16 do 0,18 v skupinah s kladribinom in od 0,47 do 0,50 v skupini s placebom (p < 0,0001).
110 and above 
110 in več
- Ensure your hands are dry before picking up your tablet(s). 
- Prepričajte se, da imate suhe roke, preden primete tableto(i).
Potent BCRP and P-gp transporter inducers 
Močni induktorji prenašalcev BCRP in P-gp
Year 2 
2. leto
No increased incidence of lymphoproliferative disorders or other tumour types (apart from Harderian gland tumours, predominantly adenomas) was seen in mice. 
Pri miših niso opazili povečane pogostnosti limfoproliferativnih bolezni ali drugih tipov tumorjev (razen tumorjev Harderjeve žleze, pretežno adenomov).
Compared to the overall population, a greater effect was observed in time to 6-month sustained disability where cladribine reduced the risk of disability progression by 82% (hazard ratio = 0.18, 95% CI [0.07, 0.47]). 
V primerjavi s splošno populacijo so opazili večji učinek, kar zadeva čas do 6-mesečne trajne prizadetosti, kjer je kladribin zmanjšal tveganje za napredovanje prizadetosti za 82 % (razmerje tveganja = 0,18, 95-% IZ [0,07; 0,47]).
As cladribine interferes with DNA synthesis, adverse effects on human gametogenesis could be expected (see section 5.3). 
Ker kladribin ovira sintezo DNA, se lahko pričakujejo neželeni učinki na gametogenezo pri ljudeh (glejte poglavje 5.3).
The metabolism of cladribine was studied in MS patients following the administration of a single 10-mg tablet and a single 3-mg intravenous dose. 
Presnavljanje kladribina so preučili pri bolnikih z MS po dajanju enkratnega odmerka v obliki 10 mg tablete in enkratnega odmerka 3 mg intravensko.
Treatment with oral cladribine leads to rapid reductions in circulating CD4+ and CD8+ T cells. 
Zdravljenje s peroralnim kladribinom povzroči hitro zmanjšanje števila T celic CD4+ in CD8+ v obtoku.
Although the clinical relevance of such interactions is unknown, it is recommended that coadministration of potent ENT1, CNT3 or BCRP inhibitors be avoided during the 4- to 5-day cladribine treatment. 
Čeprav klinična pomembnost takšnih interakcij ni znana, je priporočljivo, da v času trajanja 4- do 5-dnevnega zdravljenja s kladribinom močnih zaviralcev ENT1, CNT3 ali BCRP ne dajete sočasno.
In vitro studies indicate that cladribine is a substrate of the equilibrative nucleoside (ENT1) and concentrative nucleoside (CNT3) transport proteins. 
Študije in vitro kažejo, da je kladribin substrat ravnotežnih nukleozidnih prenašalcev (ENT1; ENTEquilibrative Nucleoside Transporters) in koncentracijskih nukleozidnih (CNT3; CNTConcentrative Nucleoside Transporters).
How to store MAVENCLAD Contents of the pack and other information 
Shranjevanje zdravila MAVENCLAD Vsebina pakiranja in dodatne informacije
Cladribine did not induce gene mutation in bacteria or mammalian cells, but it was clastogenic causing chromosomal damage in mammalian cells in vitro at a concentration which was 17-fold above the expected clinical Cmax. 
Kladribin ni povzročil genske mutacije pri bakterijah ali celicah sesalcev, vendar je bil v koncentracijah, ki so bili 17-krat večje od pričakovane klinične Cmax, klastogen, in je na celicah sesalcev in vitro povzročil kromosomske poškodbe.
Decreases in neutrophil count, red blood cell count, haematocrit, haemoglobin or platelet count compared to baseline values have also been observed in clinical studies, although these parameters usually remain within normal limits. 
V kliničnih študijah so opazili tudi zmanjšanje števila nevtrofilcev, eritrocitov, hematokrita, hemoglobina ali trombocitov glede na izhodiščne vrednosti, čeprav ostanejo ti parametri običajno v normalnih mejah.
Switching to and from cladribine treatment 
Prehod na zdravljenje ali z zdravljenja s kladribinom
Lymphocyte counts must be 
Število limfocitov mora biti
In the case of a missed dose, the patient must take the missed dose on the following day, and extend the number of days in that treatment week. 
V primeru izpuščenega odmerka naj bolnik vzame izpuščeni odmerek naslednjega dne in podaljša število dni v tednu zdravljenja.
Year 2 treatment course 
2. leto ciklusa zdravljenja
After entering the target cells, cladribine is phosphorylated to cladribine monophosphate (Cd-AMP) by DCK (and also by deoxyguanosine kinase in the mitochondria). 
Po vstopu v ciljne celice se kladribin fosforilira v kladribin monofosfat (cladribine monophosphateCd-AMP) z dCK (kot tudi z deoksigvanozin kinazo v mitohondrijih).
Before initiation of treatment both in year 1 and year 2, women of childbearing potential and males who could potentially father a child should be counselled regarding the potential for serious risk to the foetus and the need for effective contraception (see section 4.6). 
Pred uvedbo zdravljenja, tako v 1. letu kakor tudi v 2. letu, je treba ženskam v rodni dobi in moškim, ki bi morda lahko spočeli otroka, svetovati glede možnosti za resno tveganje za plod in potrebe po učinkoviti kontracepciji (glejte poglavje 4.6).
You will be prescribed the correct number of tablets for each treatment week, based on your body weight as shown in Table 2. 
Na osnovi vaše telesne mase vam bodo predpisali pravo število tablet za vsak teden zdravljenja, kot je prikazano v preglednici 2.
In clinical studies, 20% to 25% of the patients treated with a cumulative dose of cladribine 3.5 mg/kg over 2 years as monotherapy developed transient grade 3 or 4 lymphopenia. 
V kliničnih študijah je pri 20 % do 25 % bolnikov, ki so se 2 leti zdravili s skupnim odmerkom kladribina 3,5 mg/kg kot samostojnim zdravilom, prišlo do prehodne limfopenije 3. ali 4. stopnje.
Cladribine did not affect the fertility of male mice, but observed testicular effects were reduced testicular weights and increased numbers of non-motile sperm. 
Kladribin ni vplival na plodnost pri mišjih samcih, vendar pa so opazili zmanjšanje mase mod in povečanje števila negibljivih spermijev.
Other medicines and MAVENCLAD 
Druga zdravila in zdravilo MAVENCLAD
2 Push and hold hooks 
2 Pritisnite in držite zatiča.
Cladribine has been shown to exert long-lasting effects by preferentially targeting lymphocytes and the autoimmune processes involved in the pathophysiology of MS. 
Pokazalo se je, da ima kladribin dolgotrajni protivnetni učinek s preferenčnim ciljnim delovanjem na limfocite in avtoimunske procese, ki sodelujejo v patofiziologiji MS.
Therefore, screening for latent infections, in particular tuberculosis and hepatitis B and C, must be performed prior to initiation of therapy in year 1 and year 2. 
Zato je treba pred uvedbo zdravljenja v 1. in 2. letu opraviti preiskave za latentne okužbe, še posebno tuberkulozo ter hepatitis B in C. Uvedbo zdravila MAVENCLAD je treba preložiti, dokler niso bile okužbe ustrezno zdravljene.
The largest proportion of patients with grade 3 or 4 lymphopenia was seen 2 months after the first cladribine dose in each year (4.0% and 11.3% of patients with grade 3 lymphopenia in year 1 and year 2, 0% and 0.4% of patients with grade 4 lymphopenia in year 1 and year 2). 
ali 4. stopnje so opazili 2 meseca po prvem odmerku kladribina v vsakem letu (4,0 % in 11,3 % bolnikov z limfopenijo 3. stopnje v 1. in 2. letu, 0 % in 0,4 % bolnikov z limfopenijo 4. stopnje v 1. in 2. letu).
Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding is contraindicated during treatment with MAVENCLAD and for 1 week after the last dose (see section 4.3). 
Zaradi možnih resnih neželenih učinkov pri dojenih otrocih je dojenje med zdravljenjem z zdravilom MAVENCLAD in še 1 teden po zadnjem odmerku kontraindicirano (glejte poglavje 4.3).