FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited experience with overdose of oral cladribine.
Maltese: Hemm esperjenza limitata b'doża eċċessiva ta' cladribine orali.
English: 70 mg (7 tablets)
Maltese: 70 mg (7 pilloli)
English: Latent infections may be activated, including tuberculosis or hepatitis.
Maltese: Infezzjonijiet mhux attivi jistgħu jiġu attivati, inklużi t-tuberkulożi jew l-epatite.
English: 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).
Maltese: L-għoti ta' 10 mg cladribine 10 mg irriżulta f'Cmax medja ta' cladribine fil-medda ta' 22 sa 29 ng/mL u AUC medja li tikkorrispondi fil-medda ta' 80 sa 101 ng•siegħa/mL (medji aritmetiċi minn diversi studji).
English: 80 to <90
Maltese: 80 sa <90
English: The non-renal part of the elimination of cladribine (approximately 50%) consists of negligible hepatic metabolism and of extensive intracellular distribution and trapping of the active cladribine principle (Cd-ATP) within the targeted intracellular compartment (i.e. the lymphocytes) and subsequent elimination of intracellular Cd-ATP according to the life-cycle and elimination pathways of these cells.
Maltese: Il-parti ta' eliminazzjoni mhux mill-kliewi ta' cladribine (bejn wieħed u ieħor 50%) tikkonsisti minn metaboliżmu negliġibbli fil-fwied u distribuzzjoni estensiva intraċellulari u qbid tal-prinċipju attiv ta' cladribine (Cd-ATP) fil-kompartiment intraċellulari immirat (jiġifieri l-limfoċiti) u eliminazzjoni sussegwenti ta' Cd-ATP intraċellulari skont iċ-ċiklu tal-ħajja u r-rotot tal-eliminazzjoni ta' dawn iċċelluli.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Merck Europe B.V.
Maltese: FIS-SUQ Merck Europe B.V.
English: 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.
Maltese: L-effetti ta' indutturi qawwija tat-trasportaturi tal-effluss BCRP u l-glikoproteina P (P-gpP-glycoprotein) fuq il-bijodisponibilità u d-dispożizzjoni ta' cladribine ma ġewx studjati b'mod formali.
English: Treatment week 1
Maltese: Ġimgħa ta' trattament 1
English: Pregnancy and breast-feeding (see section 4.6).
Maltese: Tqala u treddigħ (ara sezzjoni 4.6).
English: The use of MAVENCLAD with interferon beta results in an increased risk of lymphopenia.
Maltese: L-użu ta' MAVENCLAD ma' interferon beta jwassal għal riskju miżjud ta' limfopenija.
English: 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]).
Maltese: 0001). Meta mqabbel mal-popolazzjoni ġenerali, kien osservat effett akbar fiż-żmien sa diżabilità sostnuta ta' 6 xhur fejn cladribine naqqas ir-riskju ta' progressjoni tad-diżabilità bi 82% (proporzjon ta' periklu = 0.18, CI ta' 95% [0.07, 0.47]).
English: Example: if you have to take 8 tablets, you would take 2 tablets on Day 1, Day 2, Day 3, then 1 tablet on Day 4 and Day 5.
Maltese: Eżempju: jekk għandek bżonn tieħu 8 pilloli, inti se tieħu 2 pilloli f'Jum 1, Jum 2, Jum 3, imbagħad pillola waħda f'Jum 4 u Jum 5.
English: See also 'Other medicines and MAVENCLAD'.
Maltese: Ara wkoll ‘Mediċini oħra u MAVENCLAD'.
English: NAME OF THE MEDICINAL PRODUCT Cladribine 10 mg
Maltese: IL-PRODOTT MEDIĊINALI Cladribine 10 mg
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
Maltese: Analiżi post-hoc taż-żmien sa progressjoni kkonfermata ta' EDSS ta' 6 xhur irriżulta fi tnaqqis ta' 47% fir-riskju ta' progressjoni tad-diżabilità fil-grupp ta' cladribine 3.5 mg/kg meta mqabbel mal-plaċebo (proporzjon ta' periklu = 0.53, CI ta' 95% [0.36, 0.79], p <0.05); fil-grupp tal-plaċebo l-10 perċentil intlaħaq wara 245 jum, u ma ntlaħaqx matul il-perjodu tal-istudju fil-grupp ta' cladribine 3.5 mg/kg.
English: The distribution of cladribine across biological membranes is facilitated by various transport proteins, including ENT1, CNT3 and BCRP.
Maltese: Id-distribuzzjoni ta' cladribine minn naħa għal oħra tal-membrani bijoloġiċi hija ffaċilitata minn diversi proteini tat-trasport, inklużi ENT1, CNT3 u BCRP.
English: 40 mg (4 tablets)
Maltese: 40 mg (4 pilloli)
English: Inhibition of these enzymes or genetic polymorphisms (e.g. CYP2D6, CYP2C9 or CYP2C19) are not expected to result in clinically significant effects on cladribine pharmacokinetics or exposure.
Maltese: Inibizzjoni ta' dawn l-enzimi jew polimorfiżmi ġenetiċi (eż. CYP2D6, CYP2C9 jew CYP2C19) mhumiex mistennija li jwasslu għal effetti klinikament sinifikanti fuq il-farmakokinetika jew l-esponiment għal cladribine.
English: Potent BCRP and P-gp transporter inducers
Maltese: Indutturi qawwija tat-trasportaturi BCRP u P-gp
English: MAVENCLAD is contraindicated in MS patients with active malignancies (see section 4.3).
Maltese: MAVENCLAD huwa kontraindikat f'pazjenti b'MS b'tumuri malinni attivi (ara sezzjoni 4.3).
English: 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).
Maltese: F'dawn il-pazjenti, it-trattament bi cladribine 3.5 mg/kg wassal għal tnaqqis fir-rata ta' rikaduti fissena meta mqabbel ma' plaċebo (0.03 kontra 0.30, proporzjon ta' riskju: 0.11, p <0.05).
English: MAVENCLAD is for oral use.
Maltese: MAVENCLAD huwa għal użu orali.
English: Uncommon (≥1/1,000 to <1/100)
Maltese: Mhux komuni (≥1/1,000 sa <1/100)
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.
Maltese: Għalhekk, il-bijodisponibilità, distribuzzjoni intraċellulari u l-eliminazzjoni mill-kliewi ta' cladribine teoretikament jistgħu jinbidlu permezz ta' inibituri qawwija tat-trasportaturi ENT1 u CNT3 bħal dilazep, nifedipine, nimodipine, cilostazol, sulindac jew reserpine.
English: Patients with secondary progressive MS were excluded in the CLARITY study.
Maltese: Pazjenti b'MS sekondarja progressiva kienu esklużi mill-istudju CLARITY.
English: MAVENCLAD contains hydroxypropylbetadex, which may be available for complex formation with other medicinal products, potentially leading to an increase in bioavailability of such a product (especially medicinal products with low solubility, see section 5.2).
Maltese: MAVENCLAD fih hydroxypropylbetadex, li jista' jkun disponibbli għall-formazzjoni ta' kumpless ma' prodotti mediċinali oħra, li potenzjalment iwassal għal żieda fil-bijodisponibilità ta' dak ilprodott (speċjalment prodotti mediċinali b'solubilità baxxa, ara sezzjoni 5.2).
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).
Maltese: Fi studji kliniċi u segwitu fit-tul ta' pazjenti trattati b'doża kumulattiva ta' 3.5 mg/kg ta' cladribine orali, avvenimenti ta' tumuri malinni kienu osservati b'mod aktar frekwenti f'pazjenti trattati bi cladribine (10 avvenimenti fi 3,414-il sena ta' pazjent [0.29 avveniment kull 100 sena ta' pazjent]) mqabbla ma' pazjenti li rċevew plaċebo (3 avvenimenti f'2,022 sena ta' pazjent [0.15 avvenimenti kull 100 sena ta' pazjent]) (ara sezzjoni 4.4).
English: Child-resistant packaging.
Maltese: Mhux applikabbli.
English: There is limited experience with overdose of MAVENCLAD.
Maltese: Hemm esperjenza limitata b'doża eċċessiva ta' MAVENCLAD.
English: • 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.
Maltese: Lewkoenċefalopatija multifokali progressiva (PML - Progressive multifocal leukoencephalopathy), infezzjonijiet opportunistiċi (minbarra PML u tuberkulosi) u infezzjonijiet severi, biex jiġi żgurat għarfien ta' sinjali u sintomi li jissuġġerixxu dawn ir-riskji;
English: In vitro studies indicate that cladribine is a substrate of the equilibrative nucleoside (ENT1) and concentrative nucleoside (CNT3) transport proteins.
Maltese: Studji in vitro jindikaw li cladribine huwa sottostrat tal-proteini tat-trasport nucleoside ekwilibrattiv (ENT1) u nucleoside konċentrattiv (CNT3).
English: 50 mg (5 tablets)
Maltese: 50 mg (5 pilloli)
English: The safety database from these studies comprises 923 patients.
Maltese: Id-database tas-sigurtà minn dawn l-istudji tinkludi 923 pazjent.
English: HIV infection, active tuberculosis and active hepatitis must be excluded before initiation of cladribine (see section 4.3).
Maltese: Infezzjoni bl-HIV, tuberkulożi attiva u epatite attiva għandhom jiġu esklużi qabel jinbeda cladribine (ara sezzjoni 4.3).
English: Dose
Maltese: Doża
English: 60 mg (6 tablets)
Maltese: 60 mg (6 pilloli)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: Each tablet contains 10 mg cladribine.
Maltese: Kull pillola fiha 10 mg cladribine.
English: - 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).
Maltese: - dilazep, nifedipine, nimodipine, reserpine, cilostazol jew sulindac (li jintużaw għat-trattament tal-qalb, pressjoni għolja, kundizzjonijiet vaskulari jew infjammazzjoni), jew eltrombopag (li jintuża biex jittratta kundizzjonijiet assoċjati ma' ħruġ ta' demm).
English: 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).
Maltese: Il-bidu ta' trattament bi cladribine huwa kontraindikat f'pazjenti immunokompromessi, li jinkludu pazjenti li attwalment ikunu qed jirċievu terapija immunosoppressiva jew majelosoppressiva bi, eż., methotrexate, cyclophosphamide, cyclosporine jew azathioprine, jew użu kroniku ta' kortikosterojdi minħabba riskju ta' effetti addittivi fuq is-sistema immuni (ara sezzjoni 4.3).
English: • normal before initiating MAVENCLAD in year 1,
Maltese: • normali qabel il-bidu ta' MAVENCLAD f'sena 1,
English: The primary objective of this study was safety, while efficacy endpoints were exploratory.
Maltese: Lgħan ewlieni ta' dan l-istudju kien is-sigurtà, waqt li punti finali tal-effikaċja kienu esploratorji.
English: Changing treatments
Maltese: Bidla tat-trattamenti
English: Harderian gland tumours are not considered to be of clinical relevance, as humans do not have comparable anatomical structures.
Maltese: Tumuri tal-glandola Harderian mhux meqjusa li huma ta' rilevanza klinika, għax il-bnedmin m'għandhomx strutturi anatomiċi komparabbli.
English: Very common (≥1/10)
Maltese: Komuni ħafna (≥1/10)
English: 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.
Maltese: Fi studji kliniċi, 20% sa 25% tal-pazjenti ttrattati b'doża kumulattiva ta' cladribine ta' 3.5 mg/kg fuq medda ta' sentejn bħala monoterapija żviluppaw limfopenija temporanja ta' grad 3 jew 4.
English: Use of MAVENCLAD is not recommended in patients below the age of 18 years, because it has not been investigated in this age group.
Maltese: Użu ta' MAVENCLAD mhux rakkomandat f'pazjenti ta' età inqas minn 18-il sena, minħabba li ma ġiex investigat f'dan il-grupp ta' età.
English: • An introduction to Mavenclad, reminding the prescriber to consider the Patient Guide while discussing Mavenclad treatment with the patient, to support the early identification of sign and symptoms of adverse reactions and their timely treatment;
Maltese: • Introduzzjoni għal Mavenclad, li tfakkar lill-persuni li jippreskrivu biex jikkunsidraw il-Gwida għall-Pazjent waqt li jiddiskutu t-trattament ta' Mavenclad mal-pazjent, biex jappoġġjaw lidentifikazzjoni bikrija ta' sinjal u sintomi ta' reazzjonijiet avversi u t-trattament f'waqtu tagħhom;
English: Other target organs after longer administration (14 cycles) of cladribine to monkeys by subcutaneous route were the kidneys (karyomegaly of renal tubular epithelium), adrenals (cortex atrophy and decreased vacuolation), gastrointestinal tract (mucosa atrophy) and testes.
Maltese: Organi oħra mmirati wara għoti aktar fit-tul (14-il ċiklu) ta' cladribine lil xadini b'għoti taħt il-ġilda kienu l-kliewi (karjomegalija talepitelju tat-tubi ż-żgħar tal-kliewi), adrenali (atrofija tal-kortex u tnaqqis fil-preżenza ta' vacuoles), passaġġ gastrointestinali (atrofija tal-mukoża) u t-testikoli.
English: • 2 and 6 months after start of treatment in each treatment year.
Maltese: • 2 u 6 xhur wara l-bidu tat-trattament f'kull sena ta' trattament.
English: If you have been vaccinated within the last 4 to 6 weeks, MAVENCLAD therapy must be delayed.
Maltese: Jekk tkun tlaqqamt fl-aħħar 4 sa 6 ġimgħat, it-terapija b'MAVENCLAD għandha tiġi ttardjata.
English: A treatment week consists of 4 or 5 days on which you receive 1 or 2 tablets daily (see Table 1).
Maltese: Ġimgħa ta' trattament tikkonsisti minn 4 jew 5 ijiem li fihom tirċievi pillola 1 jew 2 kuljum(ara t-Tabella 1).
English: In vitro, intra- versus extracellular accumulation ratios were found to be around 30 to 40 already 1 hour after cladribine exposure.
Maltese: In vitro, proporzjonijiet ta' akkumulazzjoni intraċellulari kontra extraċellulari nstabu li diġà kienu madwar 30 sa 40, siegħa wara esponiment għal cladribine.
English: Subsequent phosphorylation of cladribine to its active triphosphate form, 2-chlorodeoxyadenosine triphosphate (Cd-ATP), is particularly efficiently achieved in lymphocytes, due to their constitutively high deoxycytidine kinase (DCK) and relatively low 5'-nucleotidase (5'-NTase) levels.
Maltese: Sostituzzjoni ta' chlorine fiċ-ċirku purine tipproteġi cladribine minn degradazzjoni permezz ta' adenosine deaminase, u żżid iż-żmien ta' residenza intraċellulari tal-promediċina cladribine. Fosforilazzjoni sussegwenti ta' cladribine għallforma attiva triphosphate tiegħu, 2-chlorodeoxyadenosine triphosphate (Cd-ATP), tinkiseb b'mod partikolarment effiċjenti fil-limfoċiti, minħabba livelli għolja b'mod kostituttiv ta' deoxycytidine kinase (DCK) u livelli relattivament baxxi ta' 5'-nucleotidase (5'-NTase) tagħhom.
English: 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.
Maltese: F'ċelluli li jkunu qed jiddividu, Cd-ATP jinterferixxi mas-sintesi tad-DNA permezz ta' inibizzjoni ta' ribonucleotide reductase u jikkompeti ma' deoxyadenosine triphosphate għall-inkorporazzjoni fid-DNA permezz ta' DNA polymerases.
English: Lymphopenia is known to be dosedependent (see sections 4.4 and 4.8).
Maltese: Limfopenija hija magħrufa li tiddependi mid-doża (ara sezzjonijiet 4.4 u 4.8).
English: Hepatic impairment
Maltese: Infezzjonijiet u infestazzjonijiet
English: 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).
Maltese: Fl-analiżijiet ta' data minn CLARITY, kien osservat effett konsistenti tat-trattament fuq ir-rikaduti bir-rata ta' rikaduti fis-sena tvarja minn 0.16 sa 0.18 fil-gruppi ta' cladribine u 0.47 sa 0.50 fil-grupp tal-plaċebo (p <0.
English: MS pathology involves a complex chain of events in which different immune cell types, including autoreactive T and B cells play a key role.
Maltese: Il-patoloġija ta' MS tinvolvi katina kumplessa ta' avvenimenti li fihom tipi differenti ta' ċelluli immuni, inklużi ċelluli T u B awtoreattivi għandhom rwol ewlieni.
English: Initiation of cladribine treatment in immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy (see section 4.5).
Maltese: Bidu ta' trattament b'cladribine f'pazjenti immunokompromessi, li jinkludu pazjenti li jkunu qed jirċievu terapija immunosoppressiva jew majelosoppressiva (ara sezzjoni 4.5).
English: A population kinetic analysis did not show any effect of age (range 18 to 65 years) or gender on cladribine pharmacokinetics.
Maltese: Analiżi kinetika tal-popolazzjoni ma wriet l-ebda effett tal-età (medda 18 sa 65 sena) jew tas-sess fuq il-farmakokinetika ta' cladribine.
English: Table 2 MAVENCLAD 10 mg tablets per week day Total number of tablets per week
Maltese: Tabella 2 Pilloli ta' MAVENCLAD 10 mg f'kull ġurnata tal-ġimgħa Numru totali ta' pilloli kull ġimgħa
English: The magnitude of the effect in reducing the frequency of relapses and slowing disability progression in patients receiving the 3.5 mg/kg dose over 2 years was maintained in years 3 and 4 (see section 4.2).
Maltese: Id-daqs tal-effett ta' tnaqqis fil-frekwenza ta' rikaduti u tnaqqis fil-progressjoni tad-diżabilità f'pazjenti li kienu qed jirċievu d-doża ta' 3.5 mg/kg fuq medda ta' sentejn inżamm fi snin 3 u 4 (ara sezzjoni 4.2).
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).
Maltese: Fil-livell ta' assorbiment ta' cladribine, l-unika rotta ta' interazzjoni immaġinabbli ta' rilevanza klinika tidher li hija l-proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein jew ABCG2).
English: Cladribine is a prodrug that has to be phosphorylated intracellularly to become biologically active.
Maltese: Cladribine huwa promediċina li jrid ikun phosphorylated fiċ-ċelluli biex isir attiv bijoloġikament.
English: In the overall study population, the median age was 39 years (range 18 to 65), and the female to male ratio was approximately 2:1.
Maltese: Fil-popolazzjoni globali tal-istudju, l-età medjana kienet ta' 39 sena (medda minn 18 sa 65 sena), u proporzjon ta' nisa u irġiel kien ta' madwar 2:1.
English: Variations in the expression levels of DCK and 5'-NTases between immune cell subtypes may explain differences in immune cell sensitivity to cladribine.
Maltese: Varjazzjonijiet fil-livelli ta' espressjoni ta' DCK u 5'-NTases bejn sottotipi ta' ċelluli immuni jistgħu jispjegaw differenzi fis-sensittività taċ-ċelluli immuni għal cladribine.
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).
Maltese: It-tul ta' żmien medju ta' MS qabel ir-reġistrazzjoni fl-istudju kien ta' 8.7 snin, u l-medjan fil-linja bażi ta' diżabilità newroloġika bbażat fuq il-punteġġ tal-Iskala Estiża tal-Istat tad-Diżabilità (EDSS - Expanded Disability Status Scale) ta' Kurtzke fil-gruppi kollha tat-trattament kien ta' 3.0 (medda minn 0 sa 6.0).
English: Dose and time dependence
Maltese: Dipendenza mid-doża u ħin
English: The distribution of the total dose over the 2 years of treatment is provided in Table 1.
Maltese: Id-distribuzzjoni tad-doża totali fuq is-sentejn ta' trattament hija pprovduta f'Tabella 1.
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).
Maltese: • Fl-istudju fuq żmien qasir dwar il-karċinoġeniċità fi ġrieden Tg rasH2, ma kienet osservata lebda żieda relatata ma' cladribine fl-inċidenza ta' disturbi limfoproliferattivi jew tipi ta' tumuri oħra kienu fl-ebda doża ttestjata sa 30 mg/kg kuljum (ekwivalenti għal madwar 25 darba lesponiment mistenni fil-bniedem fl-AUC f'pazjenti li jieħdu d-doża massima ta' kuljum ta' 20 mg cladribine).
English: 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.
Maltese: MAVENCLAD fih is-sustanza attiva cladribine, sustanza ċitotossika (li toqtol iċ-ċelluli) li taħdem laktar fuq limfoċiti, ċelluli tas-sistema immuni li huma involuti fl-infjammazzjoni.
English: Active malignancy.
Maltese: Tumur malinn attiv.
English: The metabolite 2-chloroadenine was a minor metabolite both in plasma and in urine, e.g. accounting only for ≤3% of plasma parent drug exposure after oral administration.
Maltese: Il-metabolit 2-chloroadenine kien metabolit minuri kemm fil-plażma kif ukoll fl-awrina, eż. responsabbli biss għal ≤3% ta' esponiment għall-mediċina oriġinali fil-plażma wara għoti mill-ħalq.
English: Cladribine pharmacokinetics were studied following oral and intravenous administration in MS patients and patients with malignancies, and in in vitro systems.
Maltese: Il-farmakokinetika ta' cladribine ġiet studjata wara l-għoti orali u ġol-vini f'pazjenti b'MS u pazjenti b'tumuri malinni, u f'sistemi in vitro.
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.
Maltese: Il-pazjenti rċivew plaċebo (n = 437), jew doża kumulattiva ta' cladribine ta' 3.5 mg/kg (n = 433) jew 5.25 mg/kg ta' piż tal-ġisem (n = 456) fuq il-perjodu tal-istudju ta' 96 ġimgħa (sentejn) f'2 korsijiet ta' trattament.
English: For details, see Tables 1 and 2 below.
Maltese: Għad-dettalji, ara Tabelli 1 u 2 hawn taħt.
English: Clinically relevant interactions with inhibitors of P-gp are not expected.
Maltese: Mhumiex mistennija interazzjonijiet klinikament rilevanti ma' inibituri ta' P-gp.
English: Prior to launch of Mavenclad (cladribine) in each Member State (MS) the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials (EM), including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Maltese: Qabel it-tqegħid fis-suq ta' Mavenclad (cladribine) f'kull Stat Membru (MS - Member State), idDetentur tal-Awtorizzazzjoni għat-Tqegħid fis-suq (MAH - Marketing Authorisation Holder) għandu jaqbel dwar il-kontenut u d-disinn tal-materjal edukattiv (EM - educational materials), inklużi mezzi ta' komunikazzjoni, modalitajiet ta' distribuzzjoni u kwalunkwe aspetti oħra tal-programm, malAwtorità Nazzjonali Kompetenti (NCA - National Competent Authority).
English: MAVENCLAD is contraindicated in pregnant women (see section 4.3).
Maltese: MAVENCLAD huwa kontraindikat f'nisa tqal (ara sezzjoni 4.3).
English: Based on pooled population pharmacokinetic data from various studies, the median values for elimination were 22.2 L/h for renal clearance and 23.4 L/h for non-renal clearance.
Maltese: Abbażi ta' data farmakokinetika tal-popolazzjoni miġbura minn diversi studji, il-valuri medjani għalleliminazzjoni kienu ta' 22.2 L/siegħa għal tneħħija mill-kliewi u 23.4
English: NAME OF THE MEDICINAL PRODUCT MAVENCLAD 10 mg tablets
Maltese: MAVENCLAD 10 mg pilloli