FrancophonIA/ELRC3.0 huggingface dataset:
English: An embryofetal development study in pregnant rats did not indicate a teratogenic effect attributed to the co-administration of linagliptin and metformin at AUC exposure levels up to 4 and 30 times human exposure, respectively.
Maltese: Studju dwar l-iżvilupp embrijufetali f'firien tqal ma indikax effett teratoġeniku attribwit għall-għoti flimkien ta' linagliptin u metformin f'livelli ta' esponiment tal-AUC sa 4 u 30 darba tal-esponiment fil-bniedem, rispettivament.
English: Baseline (mean) Change from baseline (adjusted mean)
Maltese: Linja Bażi (medja) Bidla mil-linja bażi (medja aġġustata)
English: Jentadueto may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section ‘Warnings and precautions').
Maltese: Jentadueto jista' jikkawża effett sekondarju rari ħafna, (jista' jaffettwa sa persuna 1 minn kull 10,000 li qed jużawh), iżda serju ħafna li jissejjaħ aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' Jentadueto ġie assoċjat ma' riskju li tiżviluppa pankreatite akuta.
English: - Linagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4
Maltese: dipeptidyl peptidase-4).
English: Investigations Amylase increased uncommon
Maltese: Investigazzjonijiet Żieda ta' amylase mhux komuni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/026 14 film-coated tablets EU/1/12/780/027 60 film-coated tablets EU/1/12/780/028 180 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/780/026 14-il pillola miksija b'rita EU/1/12/780/027 60 pillola miksija b'rita EU/1/12/780/028 180 pillola miksija b'rita
English: Bullous pemphigoid
Maltese: Indeboliment tal-fwied
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljata fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were not associated with a dose dependent increase in adverse events.
Maltese: Waqt il-provi kliniċi kkontrollati f'persuni b'saħħithom, dożi waħidhom sa 600 mg ta' linagliptin (ekwivalenti għal 120 darba tad-doża rrakkomandata) ma kinux assoċjati ma' żieda li tiddependi mid-doża f'avvenimenti avversi.
English: In humans, independently of its action on glycaemia, metformin hydrochloride has favourable effects on lipid metabolism.
Maltese: Fil-bnedmin, indipendentement mill-azzjoni tiegħu fuq il-gliċemija, metformin hydrochloride għandu effetti favorevoli fuq il-metaboliżmu tal-lipidi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/012 14 film-coated tablets EU/1/12/780/013 60 film-coated tablets EU/1/12/780/014 180 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/780/012 14-il pillola miksija b'rita EU/1/12/780/013 60 pillola miksija b'rita EU/1/12/780/014 180 pillola miksija b'rita
English: Change in clinical status of patients with previously controlled type 2 diabetes As Jentadueto contains metformin, a patient with previously well controlled type 2 diabetes on Jentadueto who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Maltese: Tabella 2 Reazzjonijiet avversi rrappurtati f'pazjenti li rċivew linagliptin+metformin waħedhom (bħala komponenti waħedhom jew f'kombinazzjoni) jew bħala terapija aġġuntiva ma' terapiji oħra kontra d-dijabete fi prova klinika u minn esperjenza wara t-tqegħid fis-suq Klassifika tas-sistemi u tal-organi Reazzjoni avversa
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/1,000 mg film-coated tablets Linagliptin/metformin hydrochloride
Maltese: Jentadueto 2.5 mg/1,000 mg pilloli miksija b'rita Linagliptin/metformin hydrochloride
English: Co-administration of multiple daily doses of 5 mg linagliptin with multiple doses of 0.25 mg digoxin had no effect on the pharmacokinetics of digoxin in healthy subjects.
Maltese: L-għoti flimkien ta' dożi multipli ta' 5 mg ta' linagliptin ma' dożi multipli ta' 0.25 mg ta' digoxin ma kellu l-ebda effett fuq il-farmakokinetika ta' digoxin f'persuni b'saħħithom.
English: Total daily dose of linagliptin is equal to 5 mg
Maltese: Id-doża totali ta' linagliptin hi ta' 5 mg kuljum.
English: - Very rare (may affect up to 1 in 10,000 people): decreased vitamin B12 levels, hepatitis (a problem with your liver), skin reaction as redness of the skin (erythema).
Maltese: vitamina B12, disturbi fil-funzjoni tal-fwied, epatite (problema fil-fwied), reazzjoni tal-ġilda bħal ħmura tal-ġilda (eritema).
English: Package size
Maltese: Daqs tal-pakkett
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Mnejn jingħata Il-pakkett
English: EU Number
Maltese: Qawwa
English: 14 October 2016 EMA/610687/2016 EMEA/H/C/004080
Maltese: 14 ta' Ottubru 2016 EMA/610687/2016 EMEA/H/C/004080
English: • community-acquired pneumonia (infection of the lungs caught away from hospital);
Maltese: • pulmonite akkwiżita mill-komunità (infezzjoni tal-pulmuni mhux akkwiżita mill-isptar);
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni inizjali pprovduta millkumpanija u fformula lista ta' mistoqsijiet.
English: Ertapenem Hospira is an antibiotic medicine that contains the active substance ertapenem.
Maltese: Ertapenem Hospira huwa mediċina antibijotika li fiha s-sustanza attiva ertapenem.
English: Ertapenem Hospira was also expected to be used to prevent infection at the site of colorectal surgery (surgery in the lower part of the bowel, including the rectum and anus).
Maltese: Ertapenem Hospira kien mistenni wkoll li jintuża biex jipprevjeni l-infezzjoni fis-sit ta' kirurġija kolorettali (kirurġija fil-parti ta' isfel tal-musrana, inkluż ir-rektum u l-anus).
English: • infections in the abdomen;
Maltese: • infezzjonijiet fl-addome;
English: On 13 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ertapenem Hospira, for the treatment of certain infections and for the prevention of infection in colorectal surgery.
Maltese: Fit-13 ta' Settembru 2016, Hospira UK Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Ertapenem Hospira, għall-kura ta' ċerti infezzjonijiet u għallprevenzjoni tal-infezzjoni fil-kirurġija kolorettali.
English: Ertapenem Hospira was developed as a ‘generic medicine'.
Maltese: Ertapenem Hospira kien żviluppat bħala ‘mediċina ġenerika'.
English: What is Ertapenem Hospira?
Maltese: X'inhu Ertapenem Hospira?
English: No further studies were carried out because Ertapenem Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Invanz.
Maltese: Ma twettqux aktar studji peress li Ertapenem Hospira huwa mediċina ġenerika li tingħata permezz ta' infużjoni u fiha l-istess sustanza attiva tal-mediċina ta' referenza, Invanz.
English: The active substance in Ertapenem Hospira and Invanz, ertapenem, belongs to a group of antibiotics known as ‘carbapenems'.
Maltese: Issustanza attiva f'Ertapenem Hospira u f'Invanz, ertapenem, tappartjeni għal grupp ta' antibijotiċi magħrufin bħala 'carbapenems'.
English: Ertapenem Hospira is expected to work in the same way as the reference medicine, Invanz.
Maltese: Ertapenem Hospira huwa mistenni li jaħdem bl-istess mod bħall-mediċina ta' referenza, Invanz.
English: • gynaecological infections;
Maltese: • infezzjonijiet ġinekoloġiċi;
English: • foot infections in diabetes patients.
Maltese: • infezzjonijiet fis-saqajn f'pazjenti bid-dijabete.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ertapenem Hospira could not have been approved for the treatment of infections and for the prevention of infection in colorectal surgery.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Ertapenem Hospira ma setax jiġi approvat għall-kura tal-infezzjonijiet u għall-prevenzjoni tal-infezzjoni f'kirurġija kolorettali.
English: Ertapenem Hospira was expected to be used in adults and children aged over 3 months to treat the following infections, if caused by bacteria likely to be killed by ertapenem:
Maltese: Ertapenem Hospira kien mistenni li jintuża f'persuni adulti u tfal minn 3 xhur 'il fuq għall-kura talinfezzjonijiet li ġejjin, jekk ikunu kkawżati minn batterji li x'aktarx jiġu maqtula b'ertapenem:
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta' mistoqsijiet u tweġibiet hawnhekk.
English: This means that Ertapenem Hospira was intended to be similar to a ‘reference medicine' already authorised in the European Union called Invanz.
Maltese: Dan ifisser li Ertapenem Hospira kien maħsub biex ikun simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea msejħa Invanz.
English: What was Ertapenem Hospira expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Ertapenem Hospira?
English: Ertapenem attaches to certain proteins on the surface of the bacteria cells.
Maltese: Ertapenem teħel ma' ċerti proteini fil-wiċċ taċ-ċelloli tal-batterji.
English: Rash, alopecia.
Maltese: Raxx, alopeċja.
English: Placebo (n = 437)
Maltese: Plaċebo (n = 437)
English: Parameter
Maltese: Parametru
English: Tuberculosis (see section 4.4).
Maltese: Tuberkulożi (ara sezzjoni 4.4).
English: R-Pharm Germany GmbH Heinrich-Mack-Strasse 35 89257 Illertissen Germany
Maltese: R-Pharm Germany GmbH Heinrich-Mack-Strasse 35 89257 Illertissen Il-Ġermanja
English: Oral herpes, dermatomal herpes zoster.
Maltese: Herpes orali, herpes zoster dermatomali
English: Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands
Maltese: Gustav Mahlerplein 102 1082 MA Amsterdam
English: EU/1/17/1212/001 EU/1/17/1212/002 EU/1/17/1212/003 EU/1/17/1212/004 EU/1/17/1212/005 EU/1/17/1212/006
Maltese: EU/1/17/1212/001 EU/1/17/1212/002 EU/1/17/1212/003 EU/1/17/1212/004
English: 1 tablet 4 tablets 5 tablets 6 tablets 7 tablets 8 tablets
Maltese: 1 pillola 4 pilloli 5 pilloli 6 pilloli 7 pilloli 8 pilloli
English: EU/1/17/1212/001 - 1 tablet EU/1/17/1212/002 - 4 tablets EU/1/17/1212/003 - 5 tablets EU/1/17/1212/004 - 6 tablets EU/1/17/1212/005 - 7 tablets EU/1/17/1212/006 - 8 tablets
Maltese: EU/1/17/1212/002 - 4 pilloli EU/1/17/1212/003 - 5 pilloli EU/1/17/1212/004 - 6 pilloli EU/1/17/1212/005 - 7 pilloli EU/1/17/1212/006 - 8 pilloli
English: Pharmacotherapeutic group: Selective Immunosuppressants, ATC code: L04AA40
Maltese: Immunosoppressanti selettivi, Kodiċi ATC: L04AA40
English: NerPharMa S.R.L.
Maltese: S.R.L.
English: • Information on pregnancy prevention.
Maltese: • Informazzjoni dwar il-prevenzjoni tat-tqala.
English: Cladribine cumulative dose 3.5 mg/kg (n = 433)
Maltese: Doża kumulattiva ta' cladribine 3.5 mg/kg (n = 433)
English: - The active substance is cladribine.
Maltese: - Is-sustanza attiva hi cladribine.
English: Cladribine is a nucleoside analogue of deoxyadenosine.
Maltese: Cladribine huwa analogu nucleoside ta' deoxyadenosine.
English: Consultation with a haematologist is advised.
Maltese: Konsultazzjoni ma' ematoloġista hi rakkomandata.
English: Viale Pasteur, 10 20014 Nerviano (MI) Italy
Maltese: Viale Pasteur, 10 20014
English: 110 kg and above
Maltese: 110 kg u iżjed
English: Immunosuppressive medicinal products
Maltese: Prodotti mediċinali immunosoppressivi
English: Reproduction toxicity
Maltese: Tossiċità riproduttiva
English: Active chronic infection (tuberculosis or hepatitis).
Maltese: Infezzjoni attiva kronika (tuberkulożi jew epatite).
English: Pack sizes of 1, 4, 5, 6, 7 or 8 tablets.
Maltese: Daqsijiet tal-pakkett ta' 1, 4, 5, 6, 7, jew 8 pilloli.
English: Table 3 Clinical outcomes in the CLARITY study (96 weeks)
Maltese: Tabella 3 Riżultati kliniċi fl-istudju CLARITY (96 ġimgħa)
English: Hormonal contraceptives
Maltese: Kontraċettivi ormonali
English: less than 40 kg
Maltese: Inqas minn 40 kg
English: Such medicines include alemtuzumab, daclizumab, dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta, natalizumab or teriflunomide.
Maltese: Dawn il-mediċini jinkludu alemtuzumab, daclizumab, dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta, natalizumab jew teriflunomide.
English: Each tablet contains 64 mg sorbitol.
Maltese: Kull pillola fiha 64 mg sorbitol.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 August 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Awwissu 2017
English: Cd-AMP is further phosphorylated to cladribine diphosphate (Cd-ADP) and cladribine triphosphate (Cd-ATP).
Maltese: Cd-AMP jiġi phosphorylated b'mod addizzjonali għal cladribine diphosphate (Cd-ADP) u cladribine triphosphate (Cd-ATP).
English: 100 to <110
Maltese: 100 sa <110
English: INFORMATION IN BRAILLE mavenclad
Maltese: INFORMAZZJONI BIL-BRAILLE mavenclad
English: The observed embryolethal and teratogenic effects are consistent with the pharmacologic mechanisms of cladribine.
Maltese: L-effetti embrijoletali u teratoġeniċi osservati huma konsistenti mal-mekkaniżmi farmakoloġiċi ta' cladribine.
English: Do not take MAVENCLAD:
Maltese: Tiħux MAVENCLAD:
English: MAVENCLAD is a medicine used to treat multiple sclerosis (MS) in adults.
Maltese: MAVENCLAD huwa mediċina użata biex tittrata sklerożi multipla (MS - multiple sclerosis) f'persuni adulti.
English: Fructose intolerance
Maltese: Intolleranza għall-fructose
English: Cladribine is not a relevant substrate to cytochrome P450 enzymes and does not show significant potential to act as inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4.
Maltese: Clabridine mhux sottostrat rilevanti għall-enzimi taċ-ċitokromju P450 u ma jurix potenzjal sinifikanti biex jaġixxi bħala inibitur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 u CYP3A4.
English: Rare (≥1/10,000 to <1/1,000)
Maltese: Rari (≥1/10,000 sa <1/1,000)
English: Example: if you weigh 85 kg and are about to start treatment week 1, you will be given 8 tablets.
Maltese: Eżempju: jekk inti tiżen 85 kg u se tibda ġimgħa 1 tat-trattament, se tingħata 8 pilloli.
English: Distribution of dose
Maltese: Distribuzzjoni tad-doża
English: Potent ENT1, CNT3 and BCRP transporter inhibitors
Maltese: Inibituri qawwija tat-trasportaturi ENT1, CNT3 u BCRP
English: Infection with human immunodeficiency virus (HIV).
Maltese: Infezzjoni bil-virus uman tal-immunodefiċjenza (HIV - human immunodeficiency virus).
English: In hepatic in vitro systems, negligible metabolism of cladribine was observed (at least 90% was unchanged cladribine).
Maltese: F'sistemi epatiċi in vitro, kien osservat metaboliżmu negliġibbli ta' cladribine (mill-inqas 90% kien cladribine mhux mibdul).
English: MAVENCLAD 10 mg tablets cladribine
Maltese: MAVENCLAD 10 mg pilloli cladribine
English: The remaining patients were pre-treated with either interferon beta-1a, interferon beta-1b, glatiramer acetate or natalizumab.
Maltese: Il-kumplament tal-pazjenti kienu ttrattati minn qabel b'interferon beta-1a, interferon beta-1b, glatiramer acetate jew natalizumab.
English: When oral cladribine was given in fasted state, median Tmax was 0.5 h (range 0.5 to 1.5 h).
Maltese: Meta cladribine orali ingħata fi stat sajjem, Tmax medjan kien ta' 0.5 siegħa (medda 0.5 sa 1.5 sigħat).
English: MAVENCLAD contains sorbitol.
Maltese: MAVENCLAD fih sorbitol.
English: Pharmacokinetic interactions
Maltese: Interazzjonijiet farmakokinetiċi
English: Oriented polyamide (OPA)/aluminium (Al)/polyvinyl chloride (PVC) - aluminium (Al) blister sealed in a cardboard wallet and fixed in a child-resistant outer carton.
Maltese: Folja magħmula minn oriented polyamide (OPA)/aluminium (Al)/polyvinyl chloride (PVC)aluminium (Al) issiġillata f'portafoll tal-kartun u mwaħħla f'kartuna ta' barra li ma tinfetaħx mit-tfal.
English: Year 1
Maltese: Sena 1
English: Moderate or severe renal impairment (creatinine clearance <60 mL/min) (see section 5.2).
Maltese: Indeboliment moderat jew sever tal-kliewi (tneħħija tal-kreatinina ta' <60 mL/min) (ara sezzjoni 5.2).
English: Day 1 Day 2 Day 3 Day 4 Day 5
Maltese: Jum 1 Jum 2 Jum 3 Jum 4 Jum 5
English: Cladribine can reduce the body's immune defence and may increase the likelihood of infections.
Maltese: Cladribine jista' jnaqqas id-difiża immuni tal-ġisem u jista' jżid il-probabbiltà ta' infezzjonijiet.
English: Known BCRP inhibitors, which may alter the pharmacokinetics of BCRP substrates by 20% in vivo, include eltrombopag.
Maltese: Inibituri magħrufa ta' BCRP, li jistgħu jbiddlu l-farmakokinetika ta' sottostrati ta' BCRP b'20% in vivo, jinkludu eltrombopag.
English: MAVENCLAD contains sorbitol
Maltese: MAVENCLAD fih sorbitol
English: 60 to <70
Maltese: 60 sa <70
English: 50 to <60
Maltese: 50 sa <60
English: Day 3
Maltese: Jum 3
English: - The other ingredients are hydroxypropylbetadex, sorbitol and magnesium stearate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma hydroxypropylbetadex, sorbitol u magnesium stearate.
English: A supportive study in patients treated with cladribine as an add-on to interferon-beta vs. placebo + interferon-beta also included a limited number of patients with secondary progressive MS (26 patients).
Maltese: Studju ta' appoġġ f'pazjenti ttrattati bi cladribine bħala żieda ma' interferon-beta kontra plaċebo + interferon-beta inkluda wkoll numru limitat ta' pazjenti b'MS sekondarja progressiva (26 pazjent).
English: Common (≥1/100 to <1/10)
Maltese: Komuni (≥1/100 sa <1/10)
English: List of adverse reactions
Maltese: Lista ta' reazzjonijiet avversi
English: 90 to <100
Maltese: 90 sa <100
English: 40 to <50
Maltese: 40 sa <50
English: 70 to <80
Maltese: 70 sa <80
English: Push (text to indicate the two hooks that have to be pressed for opening) QR code to be included www.mavenclad-instructions.com
Maltese: Il-Kodiċi QR irid jiġi inkluż www.mavenclad-instructions.com
English: Treatment with oral cladribine leads to rapid reductions in circulating CD4+ and CD8+ T cells.
Maltese: It-trattament bi cladribine orali jwassal għal tnaqqis rapidu ta' ċelluli T CD4+ u CD8+ fiċċirkolazzjoni.
English: Year 2
Maltese: Sena 2
English: White, round, biconvex tablets of 8.5 mm diameter, engraved with 'C' on one side and '10' on the other side.
Maltese: Pilloli bojod, tondi, bikonvessi b'dijametru ta' 8.5 mm, imnaqqxa b''C' fuq naħa waħda u ‘10' fuq in-naħa l-oħra.
English: • Additional risk minimisation measures
Maltese: • Riskji potenzjali importanti
English: Intracellular half-life of Cd-AMP was 15 h. Intracellular half-life of Cd-ATP was 10 h.
Maltese: Il-Half-life intraċellulari ta' Cd-ATP kienet 10 sigħat.
English: Very rare side effect - may affect up to 1 in 10,000 people - tuberculosis
Maltese: Effett sekondarju rari ħafna - jistgħu jaffettwaw sa persuna waħda minn kull 10,000 - tuberkulożi
English: Each pack contains 1, 4, 5, 6, 7 or 8 tablets in a blister, sealed in a cardboard wallet and fixed in a child-resistant carton.
Maltese: Kull pakkett fih 1, 4, 5, 6, 7 jew 8 pilloli f'folja, issiġillata f'portafoll tal-kartun u mwaħħla f'kartuna li ma tinfetaħx mit-tfal.
English: Cladribine reduces CD19+ B cells and CD16+/CD56+ natural killer cells, which also recover faster than CD4+ T cells.
Maltese: CD4+, li jwassal għal tnaqqis temporanju fil-proporzjon ta' CD4 għal CD8. Cladribine inaqqas ċelluli B CD19+ u ċelluli natural killer CD16+/CD56+, li wkoll jirkupraw b'rata aktar mgħaġġla minn ċelluli T CD4+.
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.
Maltese: Każijiet ta' lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy) kienu rrappurtati għal cladribine parenterali f'pazjenti trattati għal lewkimja taċ-ċellula hairy (hairy cell leukaemia) b'kors ta' trattament differenti.
English: MAVENCLAD is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features (see section 5.1).
Maltese: MAVENCLAD huwa indikat għat-trattament ta' pazjenti adulti bi sklerożi multipla attiva ħafna li tirkadi (MS - multiple sclerosis) kif definit minn karatteristiċi kliniċi jew immaġni (ara sezzjoni 5.1).
English: After entering the target cells, cladribine is phosphorylated to cladribine monophosphate (Cd-AMP) by DCK (and also by deoxyguanosine kinase in the mitochondria).
Maltese: Wara li jidħol fiċ-ċelluli mmirati, cladribine jiġi phosphorylated għal cladribine monophosphate (Cd-AMP) minn DCK (u wkoll minn deoxyguanosine kinase fil-mitokondrija).
English: 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.
Maltese: Il-maġġoranza tal-pazjenti fil-gruppi ta' trattament bi plaċebo (87.0%) u cladribine 3.5 mg/kg (91.9%) u 5.25 mg/kg (89.0%) temmew is-96 ġimgħa sħaħ tal-istudju.
English: Grade 4 lymphopenia was seen in less than 1% of the patients.
Maltese: Limfopenija ta' grad 4 kienet osservata f'inqas minn 1% tal-pazjenti.
English: 80 mg (8 tablets)
Maltese: 80 mg (8 pilloli)
English: 90 mg (9 tablets)
Maltese: 90 mg (9 pilloli)
English: 100 mg (10 tablets)
Maltese: 100 mg (10 pilloli)
English: Cladribine has no clinically meaningful inductive effect on CYP1A2, CYP2B6 and CYP3A4 enzymes.
Maltese: Clabridine m'għandu l-ebda effett induttiv klinikament sinifikanti fuq l-enzimi CYP1A2, CYP2B6 u CYP3A4.
English: Patients taking cladribine compared to the placebo treatment group had 86% relative reduction in the mean number of T1 Gd+ lesions (adjusted mean number for cladribine 3.5 mg/kg, and placebo groups were 0.12 and 0.91, respectively), 73% relative reduction in the mean number of active T2 lesions (adjusted mean number for cladribine 3.5 mg/kg, and placebo groups were 0.38 and 1.43, respectively) and 74% relative reduction in the mean number of combined unique lesions per patient per scan (adjusted mean number for cladribine 3.5 mg/kg, and placebo groups were 0.43 and 1.72, respectively) (p <0.001 across all 3 MRI outcomes).
Maltese: 12 u 0.91, rispettivament), tnaqqis relattiv ta' 73% fin-numru medju ta' leżjonijiet T2 attivi (in-numru medju aġġustat għall-gruppi ta' cladribine 3.5 mg/kg, u plaċebo kien ta' 0.38 u 1.43, rispettivament), u tnaqqis relattiv ta' 74% fin-numru medju ta' leżjonijiet uniċi kkombinati għal kull pazjent f'kull skan (in-numru medju aġġustat għall-gruppi ta' cladribine 3.5 mg/kg, u plaċebo kien ta' 0.43 u 1.72, rispettivament)
English: Cladribine did not affect the fertility of male mice, but observed testicular effects were reduced testicular weights and increased numbers of non-motile sperm.
Maltese: Cladribine ma affettwax il-fertilità ta' ġrieden irġiel, iżda effetti testikulari osservati kienu piżijiet testikulari mnaqqsa u żieda fin-numru ta' sperma li ma tiċċaqlaqx.
English: Single events of cancer have been observed in patients who had received cladribine in clinical studies.
Maltese: Avvenimenti uniċi ta' kanċer kienu osservati f'pazjenti li rċevew cladribine fi studji kliniċi.