FrancophonIA/ELRC3.0 huggingface dataset:
English: Tuberculosis (see section 4.4).
Croatian: Vrlo rijetko: tuberkuloza (vidjeti dio 4.4).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of cladribine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 10 mg kladribina.
English: The most clinically relevant adverse reactions reported in MS patients who received cladribine at the recommended cumulative dose of 3.5 mg/kg over 2 years in clinical studies were lymphopenia and herpes zoster.
Croatian: Klinički najznačajnije nuspojave prijavljene u bolesnika s MS-om koji su primali kladribin u preporučenoj kumulativnoj dozi od 3,5 mg/kg tijekom 2 godine u kliničkim ispitivanjima bile su limfopenija i herpes zoster.
English: Renal clearance exceeded the glomerular filtration rate, indicating active renal tubular secretion of cladribine.
Croatian: Bubrežni klirens bio je veći od brzine glomerularne filtracije, što ukazuje na aktivnu tubularnu sekreciju kladribina.
English: Men and women must use effective contraception during MAVENCLAD treatment and for at least 6 months after the last dose.
Croatian: Muškarci i žene moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom MAVENCLAD i najmanje 6 mjeseci nakon zadnje doze.
English: Do not pop the tablets out of the blister.
Croatian: Nemojte vaditi tablete iz blistera.
English: MAVENCLAD contains sorbitol.
Croatian: MAVENCLAD sadrži sorbitol.
English: Year 2
Croatian: 2. godina
English: 2nd treatment week 1 or 2 tablets daily for 4 or 5 days, mid May
Croatian: 2. tjedan liječenja 1 ili 2 tablete dnevno tijekom 4 ili 5 dana, sredinom svibnja
English: Each treatment course consists of 2 treatment weeks, which are one month apart at the beginning of each treatment year.
Croatian: Svaki ciklus liječenja sastoji se od 2 tjedna liječenja u razmaku od mjesec dana na početku svake godine liječenja.
English: See also 'Pregnancy and breast-feeding'.
Croatian: Vidjeti također „Trudnoća i dojenje”.
English: 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.
Croatian: Bolesnici randomizirani u skupinu koja je primila 3,5 mg/kg kumulativne doze primili su prvi ciklus liječenja u 1. i 5. tjednu prve godine, a drugi ciklus liječenja u 1. i 5. tjednu druge godine.
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).
Croatian: Iako se smatra da je važnost funkcije jetre u eliminaciji kladribina zanemariva (vidjeti dio 5.2), u nedostatku podataka, ne preporučuje se primjena lijeka MAVENCLAD u bolesnika s umjerenim ili teškim oštećenjem jetre (Child-Pugh rezultat > 6).
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).
Croatian: Iako se smatra da je važnost funkcije jetre u eliminaciji kladribina zanemariva (vidjeti dio 5.2), u nedostatku podataka, ne preporučuje se primjena lijeka MAVENCLAD u bolesnika s umjerenim ili teškim oštećenjem jetre (Child-Pugh rezultat > 6) (vidjeti dio 4.2).
English: The incidence of herpes zoster was increased in patients on cladribine.
Croatian: Incidencija herpes zostera bila je povećana u bolesnika koji su uzimali kladribin.
English: How to take MAVENCLAD
Croatian: Kako uzimati MAVENCLAD
English: These included
Croatian: One su uključivale:
English: If you are male, you must use effective methods of contraception to prevent your partner from getting pregnant, whilst you are treated with MAVENCLAD and for 6 months after the last dose.
Croatian: Ako ste muškarac, morate koristiti učinkovite metode kontracepcije da Vaša partnerica ne bi zatrudnjela dok se liječite lijekom MAVENCLAD i tijekom 6 mjeseci nakon zadnje doze.
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.
Croatian: U žena reproduktivne dobi, trudnoća se mora isključiti prije početka liječenja lijekom MAVENCLAD i u 1. godini i u 2. godini te spriječiti korištenjem učinkovite kontracepcije tijekom liječenja kladribinom i najmanje 6 mjeseci nakon zadnje doze.
English: No increased incidence in lymphoproliferative disorders and no tumours were seen in this study.
Croatian: U tom ispitivanju nije opažena povećana incidencija limfoproliferativnih poremećaja, kao ni tumori.
English: 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.
Croatian: U ispitivanjima toksičnosti ponovljenih doza primijenjenih parenteralnim putem (intravenski i supkutano) u trajanju do godine, primarni ciljni organi utvrđeni u miševa i majmuna bili su limfoidni i krvotvorni sustav.
English: 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.
Croatian: U slučaju da propusti dozu, bolesnik mora uzeti propuštenu dozu sljedećeg dana i produljiti tjedan liječenja za taj jedan dan.
English: Shingles will need to be treated, and MAVENCLAD treatment may need to be stopped until the infection is cleared.
Croatian: Herpes zoster se treba liječiti, a liječenje lijekom MAVENCLAD možda treba prekinuti dok se infekcija ne povuče.
English: 40 to <50
Croatian: 40 do < 50
English: Each tablet contains 10 mg cladribine.
Croatian: Jedna tableta sadrži 10 mg kladribina.
English: A chlorine substitution in the purine ring protects cladribine from degradation by adenosine deaminase, increasing the intracellular residence time of the cladribine prodrug.
Croatian: Supstitucija klorom u purinskom prstenu štiti kladribin od razgradnje adenozin deaminazom, što produljuje vrijeme boravka prolijeka kladribina unutar stanica.
English: Initiation of MAVENCLAD should be delayed until the infection has been adequately treated.
Croatian: Početak liječenja lijekom MAVENCLAD potrebno je odgoditi sve dok se infekcija primjereno ne izliječi.
English: LIST OF EXCIPIENTS Contains sorbitol.
Croatian: POPIS POMOĆNIH TVARI Sadrži sorbitol.
English: Table 3
Croatian: Tablica 3
English: Interruption or delay of MAVENCLAD may be considered until proper resolution of the infection.
Croatian: Može se razmotriti prekid ili odgoda primjene lijeka MAVENCLAD dok se infekcija potpuno ne povuče.
English: After entering the target cells, cladribine is phosphorylated to cladribine monophosphate (Cd-AMP) by DCK (and also by deoxyguanosine kinase in the mitochondria).
Croatian: Nakon ulaska u ciljne stanice, DCK (kao i deoksigvanozin kinaza u mitohondrijima) fosforilira kladribin u kladribin-monofosfat (Cd-AMP).
English: 90 to <100
Croatian: 90 do < 100
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).
Croatian: To uključuje: - ciklosporin, cikofosfamid i azatioprin (primjenjuju se za supresiju imunološkog sustava, na primjer, nakon presađivanja organa); - metotreksat (primjenjuje se za liječenje stanja kao što su psorizaja ili reumatoidni artritis); - dugoročnu primjenu kortikosteroida (primjenjuju se za smanjenje upale, na primjer, kod astme).
English: Cladribine's mode of action is closely linked to a reduction in lymphocyte count.
Croatian: Način djelovanja kladribina usko je povezan sa smanjenjem broja limfocita.
English: Very common (≥1/10)
Croatian: Vrlo često (≥ 1/10)
English: Carcinogenicity
Croatian: Kancerogenost
English: Decrease in neutrophil count.
Croatian: smanjenje broja neutrofila.
English: MAVENCLAD contains sorbitol
Croatian: MAVENCLAD sadrži sorbitol
English: MAVENCLAD 10 mg tablets cladribine
Croatian: MAVENCLAD 10 mg tablete kladribin
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: • normal before initiating MAVENCLAD in year 1,
Croatian: • normalan prije započinjanja liječenja lijekom MAVENCLAD u 1. godini,
English: Haematotoxic medicinal products
Croatian: Hematotoksični lijekovi
English: Haematological monitoring
Croatian: Hematološko praćenje
English: If necessary, you will be vaccinated against shingles before you start treatment.
Croatian: Ako bude potrebno, prije nego što započnete s liječenjem bit ćete cijepljeni protiv herpes zostera.
English: MAVENCLAD is contraindicated in MS patients with active malignancies (see section 4.3).
Croatian: MAVENCLAD je kontraindiciran u bolesnika s MS-om koji imaju aktivnu zloćudnu bolest (vidjeti dio 4.3).
English: Distribution of dose
Croatian: Raspodjela doze
English: Lymphocyte counts must be determined
Croatian: Broj limfocita mora se odrediti:
English: Table 2
Croatian: Tablica 2
English: You must use effective methods of contraception to avoid becoming pregnant during MAVENCLAD treatment and for 6 months after taking the last dose.
Croatian: Morate koristiti učinkovite metode kontracepcije kako biste izbjegli trudnoću tijekom liječenja lijekom MAVENCLAD i 6 mjeseci nakon uzimanja zadnje doze.
English: 50 to <60
Croatian: 50 do < 60
English: Take the leaflet from the tray.
Croatian: Uzmite uputu iz plitice.
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).
Croatian: Žene reproduktivne dobi moraju spriječiti trudnoću korištenjem učinkovite kontracepcije tijekom liječenja kladribinom i najmanje 6 mjeseci nakon zadnje doze (vidjeti dio 4.5).
English: Do not take MAVENCLAD, if you are breast-feeding.
Croatian: Nemojte uzeti MAVENCLAD ako dojite.
English: 70 to <80
Croatian: 70 do < 80
English: Hydroxypropylbetadex (2-hydroxypropyl-ß-cyclodextrin) Sorbitol
Croatian: 6.1 Popis pomoćnih tvari hidroksipropilbetadeks (2-hidroksipropil-ß-ciklodekstrin) sorbitol magnezijev stearat
English: 80 to <90
Croatian: 80 do < 90
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.
Croatian: Stoga žene reproduktivne dobi, koje uzimaju hormonske kontraceptive sa sistemskim djelovanjem, trebaju dodati mehaničku metodu kontracepcije tijekom liječenja kladribinom te do 4 tjedna nakon zadnje doze.
English: Treatment week 1
Croatian: 1. tjedan liječenja
English: NAME OF THE MEDICINAL PRODUCT Cladribine 10 mg
Croatian: NAZIV LIJEKA Cladribine 10 mg
English: The bioavailability of 10 mg oral cladribine was approximately 40%.
Croatian: Bioraspoloživost 10 mg peroralnog kladribina iznosila je približno
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).
Croatian: Među njima su: ciklosporin, cikofosfamid i azatioprin (primjenjuju se za potiskivanje aktivnosti (supresiju) imunološkog sustava, na primjer, nakon presađivanja organa) metotreksat (primjenjuje se za liječenje stanja kao što su psorijaza ili reumatoidni artritis) dugoročna primjena kortikosteroida (primjenjuju se za smanjenje upale, na primjer, kod astme).
English: Rare (≥1/10,000 to <1/1,000)
Croatian: Rijetko (≥ 1/10 000 i < 1/1000)
English: Each tablet contains 64 mg sorbitol.
Croatian: Pomoćne tvari s poznatim učinkom Jedna tableta sadrži 64 mg sorbitola.
English: 80 mg (8 tablets)
Croatian: 80 mg (8 tableta)
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.
Croatian: Sukladno tome, jaki inhibitori prijenosnika ENT1 i CNT3, kao što su dilazep, nifedipin, nimodipin, cilostazol, sulindak ili rezerpin teoretski mogu promijeniti bioraspoloživost, unutarstaničnu raspodjelu i eliminaciju kladribina putem bubrega.
English: 70 mg (7 tablets)
Croatian: 70 mg (7 tableta)
English: Common (≥1/100 to <1/10)
Croatian: Često (≥ 1/100 i < 1/10)
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).
Croatian: Kurtzke Expanded Disability Status Scale, EDSS) u svim terapijskim skupinama iznosio je 3,0 (raspon od 0 do 6,0).
English: 90 mg (9 tablets)
Croatian: 90 mg (9 tableta)
English: 60 to <70
Croatian: 60 do < 70
English: 100 mg (10 tablets)
Croatian: 100 mg (10 tableta)
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
Croatian: Post hoc analiza vremena do potvrđene 6-mjesečne progresije prema EDSS-u pokazala je 47 %-tno smanjenje rizika od progresije onesposobljenosti u skupini koja je primila kladribin u dozi od 3,5 mg/kg u usporedbi sa skupinom koja je primila placebo (omjer hazarda = 0,53; 95 % CI [0,36; 0,79], p <0,05); u skupini koja je primila placebo, 10. percentila postignuta je nakon 245. dana te uopće nije bila postignuta tijekom trajanja ispitivanja u skupini koja je primila kladribin u dozi od 3,5 mg/kg.
English: Efficacy and safety of oral cladribine were evaluated in a randomised, double-blind, placebocontrolled clinical study (CLARITY) in 1,326 patients with relapsing-remitting MS. Study objectives were to evaluate the efficacy of cladribine versus placebo in reducing the annualised relapse rate (ARR) (primary endpoint), slowing disability progression and decreasing active lesions as measured by MRI.
Croatian: Djelotvornost i sigurnost peroralnog kladribina bile su procijenjene u randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju (CLARITY) u 1326 bolesnika s relapsnoremitirajućom MS-om.
English: How to store MAVENCLAD
Croatian: Kako čuvati MAVENCLAD
English: Intracellular half-life of Cd-AMP was 15 h. Intracellular half-life of Cd-ATP was 10 h.
Croatian: Unutarstanični poluvijek Cd-ATP-a iznosio je 10 sati.
English: • before initiating MAVENCLAD in year 1,
Croatian: • prije započinjanja liječenja lijekom MAVENCLAD u 1. godini,
English: • before initiating MAVENCLAD in year 2,
Croatian: • prije započinjanja liječenja lijekom MAVENCLAD u 2. godini,
English: At the level of cladribine absorption, the only conceivable interaction pathway of clinical relevance appears to be the breast cancer resistance protein (BCRP or ABCG2).
Croatian: Na razini apsorpcije kladribina, čini se da je protein otpornosti na lijekove povezan s rakom dojke (engl., breast cancer resistance protein, BCRP ili ATP-binding cassette sub-family G member 2, ABCG2) jedini zamislivi put klinički značajne interakcije.
English: Treatment week 2
Croatian: 2. tjedan liječenja
English: There is limited experience with overdose of oral cladribine.
Croatian: Iskustvo s predoziranjem peroralnim kladribinom je ograničeno.
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).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
English: Renal clearance of cladribine was shown to be dependent on creatinine clearance.
Croatian: Pokazalo se da bubrežni klirens kladribina ovisi o klirensu kreatinina.
English: As a result of a lower DCK/5'-NTase ratio other bone marrow derived cells are less affected than lymphocytes.
Croatian: Ostale stanice koje potječu iz koštane srži su, zbog nižeg omjera DCK/5'-NTaza, manje ugrožene nego limfociti.
English: Talk to your doctor if you take hormonal contraceptives (e.g. "the pill").
Croatian: Ako uzimate hormonske kontraceptive (npr. kontracepcijske tablete), obratite se svom liječniku.
English: Active malignancy.
Croatian: Aktivna zloćudna bolest.
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).
Croatian: Stoga bi žene koje uzimaju hormonske kontraceptive sa sistemskim djelovanjem trebale dodatno koristiti i mehaničku kontracepciju tijekom liječenja kladribinom te još najmanje 4 tjedna nakon zadnje doze u svakoj godini liječenja (vidjeti dio 4.6).
English: Note that for some weight ranges the number of tablets may vary from one treatment week to the next.
Croatian: Obratite pozornost na to da se za neke raspone tjelesne težine broj tableta u prvom i drugom tjednu može razlikovati.
English: 40 mg (4 tablets)
Croatian: 40 mg (4 tablete)
English: No studies have been conducted in patients with hepatic impairment.
Croatian: Nisu provedena ispitivanja u bolesnika s oštećenjem funkcije jetre.
English: 50 mg (5 tablets)
Croatian: 50 mg (5 tableta)
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.
Croatian: Stoga se tijekom ograničenog broja dana primjene kladribina preporučuje svaki drugi peroralni lijek primijeniti u razmaku od najmanje 3 sata od primjene lijeka MAVENCLAD.
English: MAVENCLAD is packed in a reclosable, child-resistant carton and must be kept out of the sight and reach of children.
Croatian: Vodič kroz korake uzimanja MAVENCLAD 10 mg tableta MAVENCLAD je pakiran u kutiju sigurnu za djecu za višekratno otvaranje i mora se čuvati izvan pogleda i dohvata djece.
English: 60 mg (6 tablets)
Croatian: 60 mg (6 tableta)
English: 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 4.5).
Croatian: Žene koje uzimaju hormonske kontraceptive sa sistemskim djelovanjem trebale bi dodatno koristiti i mehaničku kontracepciju tijekom liječenja kladribinom te još najmanje 4 tjedna nakon zadnje doze u svakoj godini liječenja (vidjeti dio 4.5).
English: Therefore, male patients must take precautions to prevent pregnancy of their partner during cladribine treatment and for at least 6 months after the last dose (see above).
Croatian: Stoga muški bolesnici moraju primijeniti mjere opreza kako bi spriječili trudnoću svoje partnerice tijekom liječenja kladribinom i najmanje 6 mjeseci nakon zadnje doze (vidjeti gore).
English: 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 (see section 4.5).
Croatian: Tijekom ograničenog broja dana primjene kladribina, preporučuje se svaki drugi lijek primijeniti u razmaku od najmanje 3 sata od primjene lijeka MAVENCLAD (vidjeti dio 4.5).
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 10 mg cladribine.
Croatian: NAVOĐENJE DJELATNE TVARI Jedna tableta sadrži 10 mg kladribina.
English: NAME OF THE MEDICINAL PRODUCT MAVENCLAD 10 mg tablets
Croatian: NAZIV LIJEKA MAVENCLAD 10 mg tablete
English: For some weight ranges the number of tablets may vary from one treatment week to the next.
Croatian: Za neke raspone tjelesne težine broj tableta u prvom i drugom tjednu liječenja može varirati.
English: See package leaflet for guidance.
Croatian: Pročitajte uputu o lijeku za smjernice.
English: Weight range
Croatian: Raspon tjelesne težine
English: Magnesium stearate
Croatian: Herpes zoster
English: Other disease-modifying medicinal products
Croatian: Drugi lijekovi koji mijenjaju tijek bolesti
English: Push (text to indicate the two hooks that have to be pressed for opening) QR code to be included www.mavenclad-instructions.com
Croatian: Unijeti QR kod www.mavenclad-instructions.com
English: 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.
Croatian: U bolesnika s visoko aktivnom bolešću liječenih peroralnim kladribinom u preporučenoj kumulativnoj dozi od 3,5 mg/kg provedene su post hoc analize djelotvornosti po podskupinama.
English: Treatment courses
Croatian: Ciklusi liječenja
English: Studies revealed a mean volume of distribution of cladribine in the range of 480 to 490 L. The plasma protein binding of cladribine is 20%, and independent of plasma concentration.
Croatian: Ispitivanja su otkrila da je srednja vrijednost volumena distribucije kladribina u rasponu od 480 do 490 l.
English: Therefore, male patients must take precautions to prevent pregnancy of their partner during cladribine treatment and for at least 6 months after the last dose.
Croatian: Stoga, muški bolesnici moraju primijeniti mjere opreza kako bi spriječili trudnoću u partnerice tijekom liječenja kladribinom i najmanje 6 mjeseci nakon zadnje doze.
English: Annualised relapse rate (95% CI) Relative reduction (cladribine vs. placebo) Proportion of patients relapse-free over 96 weeks Time to 3-month EDSS progression,
Croatian: Anualizirana stopa relapsa (95 % CI) Relativno smanjenje (kladribin naspram placeba) Udio bolesnika bez relapsa tijekom 96 tjedana Vrijeme do 3-mjesečne progresije prema EDSS-u, 10. percentila (mjeseci) Omjer hazarda (95 % CI) * p <0,001 u usporedbi s placebom
English: Cases of progressive multifocal leukoencephalopathy (PML) have been reported for parenteral cladribine in patients treated for hairy cell leukaemia with a different treatment regimen.
Croatian: U bolesnika koji su liječeni različitim terapijskim režimima zbog leukemije vlasastih stanica uz parenteralni kladribin zabilježeni su slučajevi progresivne multifokalne leukoencefalopatije (PML).
English: Male patients must take precautions to prevent pregnancy of their female partner during cladribine treatment and for at least 6 months after the last dose.
Croatian: Muški bolesnici moraju primijeniti mjere opreza kako bi spriječili trudnoću partnerice tijekom liječenja kladribinom i najmanje 6 mjeseci nakon zadnje doze.
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).
Croatian: Ako se kladribin primjenjuje prije ili istodobno s drugim tvarima koje utječu na hematološki profil, mogu se očekivati dodatne hematološke nuspojave (vidjeti dio 4.5).
English: Vaccination of antibody-negative patients is recommended prior to initiation of cladribine therapy.
Croatian: Prije početka terapije kladribinom, preporučuje se cijepiti bolesnike negativne na protutijela.
English: Uncommon (≥1/1,000 to <1/100)
Croatian: Manje često (≥ 1/1000 i < 1/100)
English: You will be prescribed the correct number of tablets for each treatment week, based on your body weight as shown in Table 2.
Croatian: Propisat će se Vam točan broj tableta za svaki tjedan liječenja na temelju
English: Hepatic impairment
Croatian: Zloćudne bolesti
English: Mutagenicity
Croatian: Mutagenost
English: NAME OF THE MEDICINAL PRODUCT MAVENCLAD 10 mg tablets cladribine
Croatian: NAZIV LIJEKA MAVENCLAD 10 mg tablete kladribin
English: No dedicated studies have been conducted in patients with renal impairment.
Croatian: Nisu provedena posebna ispitivanja u bolesnika s oštećenjem funkcije bubrega.