FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Maltese: Minħabba l-potenzjal ta' reazzjonijiet avversi serji fi trabi li qegћdin jiġu mreddgћin, it-treddigħ huwa kontraindikat waqt it-trattament b'MAVENCLAD u għal ġimgħa wara l-aħħar doża (ara sezzjoni 4.3).
English: • patients with 1 relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions,
Maltese: • pazjenti b'rikaduta waħda fis-sena ta' qabel u mill-inqas leżjoni T1 Gd+ waħda jew 9
English: Haematotoxic medicinal products
Maltese: Prodotti mediċinali ematotossiċi
English: Talk to your doctor if you take hormonal contraceptives (e.g. "the pill").
Maltese: Kellem lit-tabib tiegħek jekk qed tieħu kontraċettivi ormonali (eż. "il-pillola kontraċettiva").
English: • at least 800 cells/mm³ before initiating MAVENCLAD in year 2.
Maltese: • mill-inqas 800 ċellula/mm³ qabel il-bidu ta' MAVENCLAD f'sena 2.
English: Lymphopenia
Maltese: Limfopenija
English: Secondary progressive MS with relapses
Maltese: MS sekondarja progressiva b'irkadar
English: 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).
Maltese: Jekk l-għadd ta' limfoċiti jinżel taħt 200 ċellula/mm³, għandha tiġi kkunsidrata profilassi kontra l-herpes skont il-prattika normali lokali matul iż-żmien ta' limfopenija ta' grad 4 (ara sezzjoni 4.8).
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.
Maltese: Twettqu analiżijiet post-hoc tal-effikaċja ta' sottogrupp f'pazjenti b'attività għolja tal-marda ittrattati bi cladribine orali bid-doża kumulattiva rakkomandata ta' 3.5 mg/kg.
English: In vivo clastogenicity in mice was detected at 10 mg/kg, which was the lowest dose tested.
Maltese: Klastoġeniċità in vivo fil-ġrieden kienet osservata b'10 mg/kg, li kienet linqas doża ttestjata.
English: In a male mouse fertility study, malformed foetuses with agenesis of portions of appendage(s) distal the humerus and/or femur were seen.
Maltese: Fi studju dwar il-fertilità fi ġrieden irġiel, kienu osservati feti malformati b'aġenesi ta' porzjonijiet ta' appendiġi fittarf tal-humerus u/jew tal-wirk.
English: Patients with hereditary problems of fructose intolerance should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallfructose m'għandhomx jieħdu din il-mediċina.
English: Patients randomised to the 5.25 mg/kg cumulative dose received additional treatment at weeks 9 and 13 of the first year.
Maltese: Pazjenti li ntgħażlu b'mod każwali għad-doża kumulattiva ta' 5.25 mg/kg irċivew trattament addizzjonali f'ġimgħat 9 u 13 tal-ewwel sena.
English: Inhibition of BCRP in the gastrointestinal tract may increase the oral bioavailability and systemic exposure of cladribine.
Maltese: Inibizzjoni ta' BCRP fil-passaġġ gastrointestinali tista' żżid il-bijodisponibilità orali u l-esponiment sistemiku għal cladribine.
English: 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).
Maltese: L-akbar proporzjon ta' pazjenti b'limfopenija ta' grad 3 jew 4 kien osservat xahrejn wara l-ewwel doża ta' cladribine f'kull sena (4.0% u 11.3% talpazjenti b'limfopenija ta' grad 3 f'sena 1 u sena 2, 0% u 0.4% tal-pazjenti b'limfopenija ta' grad 4 f'sena 1 u sena 2).
English: In clinical studies, events of malignancies were observed more frequently in cladribine-treated patients compared to patients who received placebo (see section 4.8).
Maltese: Fi studji kliniċi, avvenimenti ta' tumuri malinni kienu osservati b'mod aktar frekwenti f'pazjenti trattati bi cladribine meta mqabbla ma' pazjenti li rċevew plaċebo (ara sezzjoni 4.8).
English: In patients with mild renal impairment (creatinine clearance 60 to 89 mL/min), no dosage adjustment is considered necessary (see section 5.2).
Maltese: F'pazjenti b'indeboliment ħafif tal-kliewi (tneħħija tal-kreatinina ta' 60 sa 89 mL/min) ma kienx ikkunsidrat neċessarju aġġustament fid-dożaġġ (ara sezzjoni 5.2).
English: In vitro studies showed negligible transporter-mediated uptake of cladribine into human hepatocytes.
Maltese: Studji in vitro wrew assorbiment medjat minn trasportatur negliġibbli ta' cladribine fl-epatoċiti umani.
English: 1st treatment week 1 or 2 tablets daily for 4 or 5 days, mid April
Maltese: 1 jew 2 pilloli kuljum għal 4 jew 5 ijiem, f'nofs April
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.
Maltese: Hija rakkomandata kawtela meta MAVENCLAD jintuża f'pazjenti anzjani, b'konsiderazzjoni ta' frekwenza potenzjalment akbar ta' funzjoni tal-fwied jew tal-kliewi mnaqqsa, mard ieħor fl-istess waqt u terapiji mediċinali oħra.
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.
Maltese: L-aktar reazzjonijiet avversi klinikament rilevanti rrappurtati f'pazjenti b'MS li rċivew cladribine bħala doża kumulattiva rakkomandata ta' 3.5 mg/kg fuq medda ta' sentejn fi studji kliniċi kienu limfopenija u herpes zoster.
English: Use of oral cladribine in patients weighing less than 40 kg has not been investigated.
Maltese: L-użu ta' cladribine orali f'pazjenti li jiżnu inqas minn 40 kg ma ġiex investigat.
English: Other medicines and MAVENCLAD
Maltese: Mediċini oħra u MAVENCLAD
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.
Maltese: F'nisa li jistgħu joħorġu tqal, it-tqala għandha tiġi eskluża qabel il-bidu ta' MAVENCLAD f'sena 1 u sena 2, u evitata bl-użu ta' kontraċettiv effettiv waqt it-trattament bi cladribine u għal mill-inqas 6 xhur wara l-aħħar doża.
English: In resting cells cladribine causes DNA single-strand breaks, rapid nicotinamide adenine dinucleotide consumption, ATP depletion and cell death.
Maltese: F'ċelluli li jkunu qed jistrieħu, cladribine jikkawża qtugħ f'single-strand tad-DNA, konsum rapidu ta' nicotinamide adenine dinucleotide, nuqqas ta' ATP u mewt taċ-ċellula.
English: It is currently unknown whether Mavenclad may reduce the effectiveness of systemically acting hormonal contraceptives.
Maltese: Bħalissa mhux magħruf jekk Mavenclad jistax inaqqas l-effettività ta' kontraċettivi ormonali li jaġixxu b'mod sistemiku.
English: Other common side effects - may affect up to 1 in 10 people - cold sore (oral herpes) - rash - hair loss - reduction in the number of certain white blood cells (neutrophils)
Maltese: Effetti sekondarji komuni oħrajn - jistgħu jaffettwaw sa persuna waħda minn kull 10 - ponta tad-deni (herpes orali) - raxx - telf ta' xagħar - tnaqqis fin-numru ta' ċerti ċelluli bojod tad-demm (newtrofili)
English: Very rare (<1/10,000)
Maltese: Rari ħafna (<1/10,000)
English: If you get pregnant more than 6 months after the last dose in year 1, no safety risk is expected but this will mean that you cannot receive treatment with MAVENCLAD while you are pregnant.
Maltese: Jekk toħrog tqila aktar minn 6 xhur wara l-aħħar doża f'sena 1, ma huwa mistenni l-ebda riskju għassigurtà iżda dan ifisser li inti ma tistax tirċievi trattament b'MAVENCLAD waqt li tkun tqila.
English: 110 and above
Maltese: 110 u aktar
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.
Maltese: Għandu jiġi kkunsidrat tnaqqis possibbli fl-esponiment għal cladribine jekk indutturi qawwija tat-trasportaturi BCRP (eż. kortikosterojdi) jew P-gp (eż. rifampicin, St.
English: 2nd treatment week 1 or 2 tablets daily for 4 or 5 days, mid May
Maltese: 1 jew 2 pilloli kuljum għal 4 jew 5 ijiem, f'nofs Mejju
English: 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).
Maltese: Pazjenti b'MS li tirkadi u tbatti li kienu qed jirċievu cladribine 3.5 mg/kg urew titjib statistikament sinifikanti fir-rata ta' rikaduti fis-sena, proporzjon ta' pazjenti li ma kellhomx rikaduta matul 96 ġimgħa, proporzjon ta' pazjenti li ma kellhomx diżabilità sostnuta matul 96 ġimgħa u ż-żmien salprogressjoni ta' EDSS ta' 3 xhur imqabbla ma' pazjenti fuq il-plaċebo (ara Tabella 3).
English: Because of these expression levels, cells of the innate immune system are less affected than cells of the adaptive immune system.
Maltese: Minħabba dawn il-livelli ta' espressjoni, ċelluli tas-sistema immuni intrinsika huma inqas affettwati minn ċelluli tas-sistema immuni adattiva.
English: Swallow tablet(s) with water.
Maltese: Ibla l-pillola(i) mal-ilma.
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).
Maltese: Dawn jinkludu: ciclosporin, cyclophosphamide u azathioprine, (li jintużaw biex irażżnu s-sistema immuni, pereżempju wara trapjant ta' organu); methotrexate, (li jintuża għat-trattament ta' kundizzjonijiet bħal psorjasi jew artrite rewmatojde);
English: 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.
Maltese: Barra dan, il-grupp ta' trattament bi cladribine 3.5 mg/kg kien superjuri għal plaċebo b'mod statistikament sinifikanti fir-rigward tan-numru u t-tnaqqis relattiv ta' leżjonijiet T1 Gd+, leżjonijiet T2 attivi u leżjonijiet uniċi kombinati kif muri fuq MRI tal-moħħ fuq il-perjodu kollu ta' 96 ġimgħa tal-istudju.
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.
Maltese: Fi studju dwar il-farmakokinetika intraċellulari ta' Cd-AMP u Cd-ATP f'pazjenti b'lewkimja majeloġena kronika, il-livelli ta' Cd-ATP kienu ta' madwar in-nofs tal-livelli ta' Cd-AMP.
English: Shingles
Maltese: Anzjani
English: These may be the symptoms of a rare brain disorder caused by infection and called progressive multifocal leukoencephalopathy (PML).
Maltese: Lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy)
English: Skin and subcutaneous tissue disorders Common:
Maltese: OĦRA, JEKK MEĦTIEĠA Sustanza ċitotossika:
English: When administered with a high-fat meal, cladribine absorption was delayed (median Tmax 1.5 h, range 1 to 3 h) and Cmax was reduced by 29% (based on geometric mean), while AUC was unchanged.
Maltese: Meta jingħata ma' ikla b'kontetut għoli ta' xaħam, l-assorbiment ta' cladribine ġie ttardjat (Tmax medjan ta' 1.5 sigħat, medda minn 1 sa 3 sigħat) u s-Cmax tnaqqas b'29% (abbażi tal-medja ġeometrika), waqt li l-AUC ma nbidilx.
English: If you change from MAVENCLAD to other MS treatments, talk to your doctor.
Maltese: Jekk tibdel minn MAVENCLAD għal trattamenti oħra għal MS, kellem lit-tabib tiegħek.
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.
Maltese: Id-doża kumulattiva rakkomandata ta' MAVENCLAD hija 3.5 mg/kg ta' piż tal-ġisem fuq medda ta' sentejn, mogħtija bħala kors ta' trattament wieħed ta' 1.75 mg/kg kull sena.
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).
Maltese: Għalkemm l-importanza tal-funzjoni tal-fwied għall-eliminazzjoni ta' cladribine hija kkunsidrata bħala negliġibbli (ara sezzjoni 5.2), fin-nuqqas ta' data, l-użu ta' MAVENCLAD mhux rakkomandat f'pazjenti b'indeboliment moderat jew sever tal-fwied (punteġġ Child-Pugh ta' >6) (ara sezzjoni 4.2).
English: MAVENCLAD tablets are white, round, biconvex tablets engraved with 'C' on one side and '10' on the other side.
Maltese: Il-pilloli MAVENCLAD huma bojod, tondi, bikonvessi, imnaqqxa b''C' fuq naħa waħda u ‘10' fuq in-naħa l-oħra.
English: The safety and efficacy of MAVENCLAD in patients below the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' MAVENCLAD f'pazjenti ta' età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
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.
Maltese: Studji wrew volum ta' distribuzzjoni medju ta' cladribine fil-firxa ta' 480 sa 490 L.
English: The Patient Guide should include an introduction to Mavenclad treatment, its side effects, potential risks and information on pregnancy prevention.
Maltese: Il-Gwida għall-Pazjent għandha tinkludi introduzzjoni għat-trattament ta' Mavenclad, l-effetti sekondarji tiegħu, riskji potenzjali u informazzjoni dwar il-prevenzjoni tat-tqala.
English: Following completion of the 2 treatment courses, no further cladribine treatment is required in years 3 and 4 (see section 5.1).
Maltese: Wara t-tlestija taż-żewġ korsijiet ta' trattament, mhux meħtieġ aktar trattament bi cladribine f'sena 3 u 4 (ara sezzjoni 5.1).
English: Tell your doctor immediately if you get symptoms of shingles, a common complication of MAVENCLAD (see section 4), which may need specific treatment.
Maltese: Għid lit-tabib tiegħek immedjatament jekk ikollok sintomi ta' ħruq ta' Sant'Antnin, komplikazzjoni komuni ta' MAVENCLAD (ara sezzjoni 4), li jista' jeħtieġ trattament speċifiku.
English: Mutagenicity
Maltese: Mutaġeniċità
English: The lymphocyte counts of more than 75% of patients returned to the normal range by week 144 from the first dose of cladribine (approximately 90 weeks after the last dose of cladribine).
Maltese: L-għadd tal-limfoċiti ta' aktar minn 75% tal-pazjenti reġa' lura għall-medda normali sa ġimgħa 144 wara l-ewwel doża ta' cladribine (bejn wieħed u ieħor 90 ġimgħa wara l-aħħar doża ta' cladribine).
English: 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).
Maltese: L-inċidenza ta' herpes zoster kienet ogħla matul il-perjodu ta' limfopenija ta' grad 3 jew 4 (<500 sa 200 ċellula/mm³ jew <200 ċellula/mm³) meta mqabbel maż-żmien meta lpazjenti ma kellhomx limfopenija ta' grad 3 jew 4 (ara sezzjoni 4.4).
English: Malignancies
Maltese: Kanċer
English: To decrease the risk for severe lymphopenia, lymphocyte counts must be determined before, during and after cladribine treatment (see section 4.4) and strict criteria for initiating and continuing cladribine treatment must be followed (see section 4.2).
Maltese: Biex jitnaqqas ir-riskju ta' limfopenija severa, l-għadd ta' limfoċiti għandu jiġi determinat qabel, waqt u wara t-trattament bi cladribine (ara sezzjoni 4.4) u għandhom jiġu segwiti kriterji stretti biex wieħed jibda u jkompli t-trattament bi cladribine (ara sezzjoni 4.2).
English: 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.
Maltese: Matul studji, l-akbar proporzjon ta' pazjenti b'limfopenija ta' grad 3 jew 4 (<500 sa 200 ċellula/mm³ jew <200 ċellula/mm³) kien osservat xahrejn wara l-ewwel doża ta' cladribine kull sena, li jindika spazju ta' żmien bejn il-konċentrazzjonijiet ta' cladribine fil-plażma u l-effett ematoloġiku massimu.
English: Re-initiation of therapy after year 4 has not been studied.
Maltese: Bidu mill-ġdid tat-terapija wara sena 4 ma ġiex studjat.
English: Treatment week 2
Maltese: Ġimgħa ta' trattament 2
English: Acute short-term therapy with systemic corticosteroids can be administered during cladribine treatment.
Maltese: Terapija akuta għal żmien qasir b'kortikosterojdi sistemici tista' tingħata waqt it-trattament bi cladribine.
English: 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.
Maltese: Cladribine huwa inkorporat fi strands tad-DNA u jinibixxi s-sintesi u t-tiswija tad-DNA. Cladribine ma induċiex mutazzjoni tal-ġeni f'batterji jew ċelluli mammiferi, iżda kien klastoġeniku u kkawża ħsara lill-kromosomi f'ċelluli mammiferi in vitro f'konċentrazzjoni li kienet 17-il darba ogħla misCmax klinika mistennija.
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.
Maltese: L-għanijiet tal-istudju kienu li tiġi evalwata l-effikaċja ta' cladribine kontra l-plaċebo biex inaqqas ir-rata annwali ta' rikaduti (ARR - annualised relapse rate) (punt finali primarju), inaqqas il-progressjoni tad-diżabilità u jnaqqas il-leżjonijiet attivi kif imkejla permezz ta' MRI.
English: LIST OF EXCIPIENTS Contains sorbitol.
Maltese: TA' EĊĊIPJENTI Fih sorbitol.
English: 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).
Maltese: Kif muri fit-Tabella 3 hawn fuq, dożi kumulattivi ogħla ma żiedu l-ebda benefiċċju klinikament sinifikanti, iżda kienu assoċjati ma' inċidenza ogħla ta' limfopenija ta' ≥grad 3 (44.9% fil-grupp ta' 5.25 mg/kg vs. 25.
English: Following oral administration, cladribine is rapidly absorbed.
Maltese: Wara l-għoti orali, cladribine jiġi assorbit malajr.
English: A drug interaction study in MS patients showed that the bioavailability of 10 mg oral cladribine was not altered when co-administered with pantoprazole.
Maltese: Studju dwar interazzjonijiet ta' mediċina ma' oħra f'pazjenti b'MS wera li l-bijodisponibilità ta' 10 mg cladribine orali ma nbidlitx meta ngħata flimkien ma' pantoprazole.
English: Do not store the tablets in a different container.
Maltese: Taħżinx il-pilloli f'kontenitur differenti.
English: - if you have active tuberculosis or liver inflammation (hepatitis).
Maltese: - jekk għandek tuberkulożi attiva jew infjammazzjoni fil-fwied (epatite).
English: Dose in mg (number of 10 mg tablets) per treatment week kg
Maltese: Doża f'mg (numru ta' pilloli ta' 10 mg) f'kull ġimgħa ta' trattament kg
English: If necessary, the treatment course in year 2 can be delayed for up to 6 months to allow for recovery of lymphocytes.
Maltese: Jekk ikun meħtieġ, il-kors ta' trattament f'sena 2 jista' jiġi ttardjat sa 6 xhur biex ikun permess lirkupru tal-limfoċiti.
English: - if you have moderate or severe kidney problems.
Maltese: - jekk għandek problemi moderati jew severi tal-kliewi.
English: MS is a disease in which inflammation destroys the protective sheath around the nerves.
Maltese: MS hija marda li fiha l-infjammazzjoni teqred il-kisja protettiva madwar in-nervituri.
English: The primary apoptosis-inducing mechanism of action of Cd-ATP has direct and indirect actions on DNA synthesis and mitochondrial function.
Maltese: Il-mekkaniżmu ta' azzjoni primarja ta' induzzjoni ta' apoptosi ta' Cd-ATP għandu azzjonijiet diretti u indiretti fuq is-sintesi tad-DNA u l-funzjoni tal-mitokondrija.
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.
Maltese: F'dan l-istudju ta' estensjoni, 806 pazjenti rċivew plaċebo jew doża kumulattiva ta' cladribine 3.5 mg/kg (f'kors ta' dożaġġ simili għal dak użat fi CLARITY) matul il-perjodu tal-istudju ta' 96 ġimgħa.
English: It is currently unknown whether cladribine may reduce the effectiveness of systemically acting hormonal contraceptives.
Maltese: Bħalissa mhux magħruf jekk cladribine jistax inaqqas l-effettività ta' kontraċettivi ormonali li jaġixxu b'mod sistemiku.
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).
Maltese: Għalkemm l-importanza tal-funzjoni tal-fwied għall-eliminazzjoni ta' cladribine hija kkunsidrata bħala negliġibbli (ara sezzjoni 5.2), fin-nuqqas ta' data, l-użu ta' MAVENCLAD mhux rakkomandat f'pazjenti b'indeboliment moderat jew sever tal-fwied (punteġġ Child-Pugh ta' >6).
English: A small study in cancer patients has shown a cerebrospinal fluid/plasma concentration ratio of approximately 0.25.
Maltese: Studju żgħir f'pazjenti bil-kanċer wera proporzjon ta' fluwidu ċerebrospinali/konċentrazzjoni fil-plażma ta' madwar 0.25.
English: Cladribine and/or its phosphorylated metabolites are substantially accumulated and retained in human lymphocytes.
Maltese: Cladribine u/jew il-metaboliti fosforilati tiegħu jakkumulaw u jinżammu b'mod sostanzjali fillimfoċiti umani.
English: Adverse reactions described in the list below are derived from pooled data from clinical studies in MS in which oral cladribine was used as monotherapy at a cumulative dose of 3.5 mg/kg.
Maltese: Ir-reazzjonijiet avversi deskritti fil-lista hawn taħt ġejjin minn data miġbura minn studji kliniċi f'MS fejn cladribine orali intuża bħala monoterapija b'doża kumulattiva ta' 3.5 mg/kg.
English: Patients with lymphocyte counts below 500 cells/mm³ should be actively monitored for signs and symptoms suggestive of infections, in particular herpes zoster.
Maltese: Il-pazjenti b'għadd ta' limfoċiti inqas minn 500 ċellula/mm³ għandhom jiġu mmonitorjati b'mod attiv għal sinjali u sintomi li jissuġġerixxu infezzjonijiet, speċjalment herpes zoster.
English: 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.
Maltese: Għalkemm, ir-rilevanza klinika ta' dawn l-interazzjonijiet mhijiex magħrufa, hu rakkomandat li l-għoti flimkien ta' inibituri qawwija ta' ENT1, CNT3 jew BCRP jiġi evitat matul it-trattament ta' 4 sa 5 ijiem bi cladribine.
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,
Maltese: Tnaqqis relattiv (cladribine vs. plaċebo) Proporzjon ta' pazjenti li ma kellhomx rikaduta matul 96 ġimgħa
English: This leaflet was last revised in {MM/YYYY}.
Maltese: - ċertu tipi ta' tilqim (tilqim ħaj u ħaj attenwat).