FrancophonIA/ELRC3.0 huggingface dataset:
English: 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets
Maltese: 30 pillola miksija b'rita 60 pillola miksija b'rita 90 pillola miksija b'rita
English: Hepatic disease
Maltese: Riżultati kliniċi
English: CELSENTRI with products that are potent CYP3A inhibitors (with or without a CYP3A inducer)
Maltese: CELSENTRI ma' prodotti li huma inibituri potenti ta' CYP3A (bi jew mingħajr induttur ta' CYP3A)
English: Medicines containing St. John's Wort (Hypericum perforatum) are likely to prevent CELSENTRI
Maltese: John's Wort (Hypericum perforatum) x'aktarx li jtellfu CELSENTRI milli jaħdem kif suppost.
English: Placebo + OBT
Maltese: OBT waħdu
English: Maraviroc has no antiviral activity in vitro against viruses which can use CXCR4 as their entry coreceptor (dual-tropic or CXCR4-tropic viruses, collectively termed ‘CXCR4-using' virus below).
Maltese: Maraviroc ma għandu ebda attività antivirali in vitro kontra virusis li jistgħu jużaw CXCR4 bħala lko-riċettur tad-dħul tagħhom (virus tropiku doppju jew CXCR4-tropiku, flimkien issir referenza għalihom bħala virus ‘li juża CXCR4' hawn taħt).
English: The highest dose administered in clinical studies was 1,200 mg.
Maltese: L-ogħla doża mogħtija fl-istudji kliniċi kienet 1,200 mg.
English: Table 4 shows the incidence ≥1% of Grade 3-4 Abnormalities (ACTG Criteria) based on the maximum shift in laboratory test values without regard to baseline values.
Maltese: Tabella 4 turi l-inċidenza ≥1% ta' anormalitajiet ta' Grad 3-4 (kriterji ACTG) ibbażata fuq iċ-ċaqliq massimu fil-valuri tat-test fil-laboratorju mingħajr ma jitqiesu l-valuri bażiċi.
English: Midazolam 7.5 mg Single Dose (maraviroc 300 mg BID)
Maltese: SEDATTIVI Benzodiazepines Midazolam 7.5 mg doża waħda (maraviroc 300 mg BID)
English: The initial dose of maraviroc was scaled from adult doses using a body surface area (BSA) of 1.73 m2 to children and adolescent BSA (m2)-based bands.
Maltese: body surface area) ta' 1.73m2 għat-tfal u faxex ibbażati fuq il-BSA (m2) għall-adoloxxenti.
English: Studies in Treatment-Experienced Paediatric Patients Infected with CCR5-tropic Virus
Maltese: Studji fuq Pazjenti Pedjatriċi Esperjenzati bil-Kura Infettati bil-Virus CCR5-tropiku
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Maltese: Għalkemm l-etjoloġija hija meqjusa li għandha aktar minn fattur wieħed (inkluż użu ta' kortikosterojdi, il-konsum tal-alkoħol, immunosuppressjoni qawwija, indiċi tal-piż tal-ġisem ogħla), każijiet ta' osteonekrożi ġew irrapportati b'mod patikolari f'pazjenti bil-marda tal-HIV fi stat avvanzat u/jew esponiment għat-terapija ta' kombinazzjoni antiretrovirali (CART) għal perjodu ta' żmien twil.
English: CELSENTRI 25 mg film-coated tablets maraviroc
Maltese: CELSENTRI 25 mg pilloli miksijin b'rita maraviroc
English: Maraviroc should only be used when only CCR5-tropic HIV-1 is detectable (i.e. CXCR4 or dual/mixed tropic virus not detected) as determined by an adequately validated and sensitive detection method (see sections 4.1, 4.2 and 5.1).
Maltese: Maraviroc għandu jintuża biss meta jinstab HIV-1 CCR5-tropiku (i.e. CXCR4 jew virus tropiku doppju/mħallat ma jinstabux) kif stabbilit b'metodu adegwatament sensittiv u validat li jinnota lpreżenza tal-virus (ara sezzjonijiet 4.1, 4.2 u 5.1).
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV li jkollhom defiċjenza immuni severa fil-mument tal-bidu ta' terapija antiretrovirali kkombinata (CART), tista' tiżviluppa reazzjoni infjammatorja għal infezzjonijiet opportunistiċi bla sintomi jew residwi.
English: A relatively small number of individuals receiving maraviroc-containing therapy have failed with phenotypic resistance (i.e. the ability to use drug-bound CCR5 with MPI <95%).
Maltese: Numru relattivament żgħir ta' individwi li rċivew terapija li kien fiha maraviroc ma rnexxewx b'reżistenza fenotipika (jiġifieri, il-ħila li jintuża CCR5 relatat mal-mediċina b'MPI <95%).
English: Male Sex
Maltese: FEJN MA
English: 70 subjects (Child-Pugh Class A, n=64; Child-Pugh Class B, n=6) were randomized to the maraviroc group and 67 subjects (Child-Pugh Class A, n=59; Child-Pugh Class B, n=8) were randomized to the placebo group.
Maltese: Is-sigurtà epatika ta' maraviroc flimkien ma' aġenti antiretrovirali oħra fl-invidwidi infettati bl-HIV-1 CCR5-tropika b'HIV RNA <50 kopja/mL, koinfettati bil-Virus tal-Epatite Ċ u jew tal-Epatite B ġiet evalwata fi studju multiċentriku, randomized, double blind, ikkontrollat mill-plaċebo. 70 individwu (Child Pugh Klassi A, n=64; Child Pugh Klassi B, n=6) ġew randomizzati għall-grupp ta' maraviroc u 67 indivdwu (Child Pugh Klassi A, n=59; Child Pugh Klassi B, n=8) ġew randomizzati għall-grupp tal-plaċebo.
English: Hyperbilirubinaemia, gammaglutamyltransferase increased uncommon
Maltese: Iperbilirubinimja, żieda fil-gammaglutamyltransferase mhux komuni
English: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 180 film-coated tablets.
Maltese: Fliexken magħmulin minn polyethylene ta' densità għolja (HDPE) b'għatu tal-polypropylene reżistenti għat-tfal (CR) u siġill ta' fojl tal-aluminju/ polyethylene b'induzzjoni termika li fihom 180 pillola miksija b'rita.
English: Maraviroc AUC12: ↔ 1.03
Maltese: Maraviroc AUC12: ↔ 1.03 Maraviroc Cmax: ↔ 1.03
English: CELSENTRI 300 mg film-coated tablets
Maltese: CELSENTRI 300 mg pilloli miksijin b'rita
English: In the remaining 36 patients, there was no evidence of virus with reduced sensitivity as identified by exploratory virology analyses on a representative group.
Maltese: Fil-bqija tal-pazjenti, 36, ma kienx hemm evidenza ta' virus b'sensittività mnaqqsa, kif identifikat b'analiżi viroloġika esploratorja fuq grupp rappreżentattiv ta' pazjenti.
English: Mean change from baseline (log copies/mL) Percentage of patients with HIV-1 RNA <400 copies/mL
Maltese: Bidla medja mil-linja bażi (log10 kopji/mL) Perċentwal ta' pazjenti b'HIV-1 RNA <400 kopja/mL
English: Maraviroc did not impair mating or fertility of male or female rats, and did not affect sperm of treated male rats up to 1000 mg/kg.
Maltese: Maraviroc ma indebolixxiex it-tgħammir jew il-fertilità tal-firien irġiel jew nisa, u ma affettwax lisperma ta' firien irġiel ikkurati b'sa 1000 mg/kg.
English: • rash (see also ‘Serious allergic or skin reactions' earlier in section 4)
Maltese: • raxx (ara wkoll “Reazzjonijiet allerġiċi jew reazzjonijiet tal-ġilda serji” aktar kmieni f'sezzjoni 4)
English: Severe skin and hypersensitivity reactions
Maltese: Reazzjonijiet severi tal-ġilda u ta' sensittività eċċessiva
English: Each ml of oral solution contains 20 mg maraviroc
Maltese: Kull ml ta' soluzzjoni orali fih 20 mg maraviroc.
English: 90 film-coated tablets.
Maltese: FARMAĊEWTIKA U KONTENUT 90 pillola miksijin b'rita.
English: The effects of moderate hepatic impairment may be underestimated due to limited data in patients with decreased metabolic capacity and higher renal clearance in these subjects.
Maltese: L-effetti ta' indeboliment moderat tal-fwied jista' jkun stmat anqas milli veru hu minħabba informazzjoni limitata fuq pazjenti b'kapaċità metabolika mnaqqsa u tneħħija renali għolja aktar f'dawn l-individwi.
English: Signs include:
Maltese: Armi sa:
English: Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 150 mg film-coated tablets
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Tikketta fuq il-kisja ta' barra fuq pakketti multipli ta' 180 (2 pakketti ta' 90 pillola miksija b'rita) miksija f'folja trasparenti - bil-kaxxa l-blu - pilloli miksijin b'rita ta' 150 mg
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Maltese: Kienu rrappurtati każijiet ta' osteonekrosi, speċjalment f'pazjenti b'fatturi ta' riskju rikonoxxuti b'mod ġenerali, mard avanzat tal-HIV jew esponiment fuq perijodu ta' żmien twil għal terapija antiretrovirali kombinata (CART).
English: LIPID LOWERING MEDICINAL PRODUCTS Statins
Maltese: PRODOTTI MEDIĊINALI LI JNAQQSU IL-LIPIDI FID-DEMM Statins
English: CELSENTRI 150 mg film-coated tablets
Maltese: CELSENTRI 150 mg pilloli miksijin b'rita
English: Studies in Treatment-Naïve Adult Patients Infected with CCR5-tropic Virus
Maltese: Studji fuq Pazjenti Adulti Esperjenzati bil-Kura Infettati bil-Virus Mhux CCR5-tropiku
English: CELSENTRI 300 mg film-coated tablets maraviroc
Maltese: TAL-PRODOTT MEDIĊINALI Celsentri 300 mg pilloli miksijin b'rita maraviroc
English: Celsentri 150 mg film-coated tablets maraviroc
Maltese: TAL-PRODOTT MEDIĊINALI Celsentri 150 mg pilloli miksijin b'rita maraviroc
English: The pharmacokinetics of oral maraviroc are not dose proportional over the dose range.
Maltese: Ilfarmakokinetika ta' maraviroc orali mhijiex proporzjonali mad-doża fuq il-medda tad-doża.
English: Each film-coated tablet contains 75 mg of maraviroc.
Maltese: Kull pillola miksija b'rita fiha 75 mg ta' maraviroc.
English: Blister Strip of 10 tablets of 300 mg maraviroc film-coated tablets
Maltese: Strixxa tal-Folji ta' 10 x 300 mg maraviroc pilloli miksijin b'rita
English: ANTI-INFECTIVES
Maltese: ANTIKONVULSANTI
English: Since maraviroc is moderately protein bound, dialysis may be beneficial in removal of this medicine.
Maltese: Billi maraviroc jeħel moderatament mal-proteini tad-demm, dijalisi tista' tkun utli fit-tneħħija ta' din il-mediċina.
English: Prolongation of the QT interval was seen in dogs and monkeys at plasma concentrations 6 and 12 times, respectively, those expected in humans at the maximum recommended dose of 300 mg twice daily.
Maltese: Titwil ta' l-intervall QT ġie muri fil-klieb u x-xadini b'konċentrazzjonijiet fil-plasma ta' 6 u 12-il darba aktar, rispettivament, minn dawk mistennija fil-bniedem bid-doża massima rakkomandata ta' 300 mg darbtejn kuljum.
English: Renal failure, proteinuria uncommon
Maltese: Effett potenzjali fuq l-immunità
English: Primary pharmacological activity (CCR5 receptor affinity) was present in the monkey (100% receptor occupancy) and limited in the mouse, rat, rabbit and dog.
Maltese: L-attività farmakoloġika primarja (l-affinità tar-riċettur CCR5) kienet preżenti fix-xadina (okkupazzjoni ta' 100 % tar-riċettur) u limitata fil-ġurdien, fil-far, fil-fenek u fil-kelb.
English: 1Based on GeneSeq resistance assay.
Maltese: Ibbażat fuq analiżi ta' reżistenza GeneSeq.
English: Paediatric patients (children younger than 2 years of age or weighing less than 10 kg) The safety and efficacy of CELSENTRI in children younger than 2 years of age or weighing less than 10 kg has not been established (see section 5.2).
Maltese: Pazjenti pedjatriċi (tfal iżgħar minn sentejn u li jiżnu inqas minn 10 kg) Is-sigurtà u effikaċja ta' CELSENTRI fi tfal iżgħar minn sentejn jew li jiżnu inqas minn 10 kg ma ġewx determinati (ara sezzjoni 5.2).
English: Celsentri 300 mg film-coated tablets maraviroc
Maltese: CELSENTRI 300 mg pilloli miksijin b'rita maraviroc
English: In addition, an increase in hepatic adverse reactions with maraviroc was observed during studies of treatment-experienced subjects with HIV infection, although there was no overall increase in ACTG Grade 3/4 liver function test abnormalities (see section 4.8).
Maltese: Barra minn hekk, ġiet osservata żieda fir-reazzjonijiet avversi tal-fwied b'maraviroc waqt studji fuq individwi b'infezzjoni tal-HIV, li ħadu kura qabel, għalkemm ma kien hemm l-ebda żieda ġenerali ta' anormalitajiet ACTG tal-Grad 3/4 minn riżultati ta' testijiet talfunzjoni tal-fwied (ara sezzjoni 4.8).
English: Each film-coated tablet contains 25 mg of maraviroc.
Maltese: Kull pillola miksija b'rita fiha 25 mg ta' maraviroc.
English: CELSENTRI 25 mg film-coated tablets
Maltese: U KWANTITATTIVA CELSENTRI 25 mg pilloli miksijin b'rita
English: Tipranavir/ritonavir concentrations were consistent with historical data.
Maltese: Il-konċentrazzjonijiet ta' Tipranavir/ritonavir kienu konsistenti mad-dejta li nġabret fil-passat.
English: However, no clinically significant QT prolongation compared to placebo + OBT was seen in the Phase 3 clinical studies using the recommended dose of maraviroc or in a specific pharmacokinetic study to evaluate the potential of maraviroc to prolong the QT interval.
Maltese: Madankollu, ma deher l-ebda titwil klinikament sinifikanti fil-QT meta mqabbel ma' OBT waħdu fl-istudji kliniċi ta' Fażi 3 bl-użu tad-doża rakkomandata ta' maraviroc jew fi studju farmakokinetiku speċifku biex jiġi evalwat il-potenzjal ta' maraviroc li jtawwal l-intervall QT.
English: Maraviroc is a substrate for the transporters P-glycoprotein and OATP1B1, but the effect of these transporters on the exposure to maraviroc is not known.
Maltese: Maraviroc hu sottostrat għat-trasportaturi tal-glikoproteina-P u OATP1B1, iżda l-effett ta' dawn ittrasportaturi fuq l-esponiment għal maraviroc mhuwiex magħruf.
English: All subjects (n = 103) received maraviroc twice daily and OBT.
Maltese: L-individwi kollha (n = 103) irċivew maraviroc darbtejn kuljum u OBT.
English: Mutations were found to accumulate in the gp120 envelope glycoprotein (the viral protein that binds to the CCR5 co-receptor).
Maltese: Instab li l-mutazzjonijiet jakkumulaw fil-glikoproteina envelop gp120 (il-proteina virali li tingħaqad mal-ko-riċettur CCR5).
English: 1Based on GSS.
Maltese: MOTIVATE 1 u MOTIVATE 2.
English: Dialysis had a minimal effect on exposure in subjects with ESRD.
Maltese: Id-dijalisi kellha effett minimu fuq esponiment f'individwi bil-ESRD.
English: Carton for blister pack containing 300 mg maraviroc film-coated tablets
Maltese: Kull pillola miksija b'rita fiha 300 mg ta' maraviroc.
English: High density polyethylene (HDPE) bottle, with a child resistant closure, containing 230 mL maraviroc 20 mg/mL solution.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Flixkun magħmul minn polyethylene ta' densità għolja (HDPE) b'għatu tal-polypropylene reżistenti għat-tfal (CR) li fih 230 mL maraviroc 20 mg/mL soluzzjoni.
English: Stop taking CELSENTRI.
Maltese: Tiħux CELSENTRI:
English: The maravirocresistant viruses remained CCR5-tropic and there was no conversion from a CCR5-tropic virus to a CXCR4-using virus.
Maltese: Il-virusis reżistenti għal maraviroc baqgħu CCR5-tropiċi u ma kien hemm l-ebda qalba minn virus CCR5tropiku għal virus li juża CXCR4.
English: Cmax: ↔ 0.99
Maltese: Amprenavir Cmax: ↓ 0.66
English: Zidovudine AUC12: ↔ 0.98
Maltese: Zidovudine AUC12: ↔ 0.98 Zidovudine Cmax: ↔ 0.92
English: Amprenavir AUC12: ↓ 0.65 Amprenavir Cmax: ↓ 0.66
Maltese: Etravirine AUC12: ↔ 1.06 Etravirine Cmax: ↔ 1.05
English: There is no data on the effects of maraviroc on human fertility.
Maltese: M'hemmx dejta dwar l-effetti ta' Maraviroc fuq il-fertilità tal-bniedem.
English: Rifabutin is considered to be a weaker inducer than rifampicin.
Maltese: Rifabutin hu kkunsidrat bħala induttur aktar dgħajjef minn rifampicin.
English: Limited data are available for coadministration with nelfinavir.
Maltese: Ma kienx hemm interazzjonijiet klinikament sinifikanti.
English: Studies in Treatment-Experienced Adult Patients Infected with CCR5-tropic Virus
Maltese: Studji fuq Pazjenti Adulti li Diġà ħadu l-Kura Qabel Infettati bil-Virus CCR5-tropiku
English: Background resistance to other classes of antiretrovirals have been shown to be similar in previously undetected CXCR4-tropic virus of the minor viral population, as that found in CCR5-tropic virus.
Maltese: Sfond ta' reżistenza għal klassijiet antiretrovirali oħra intwera li kien jixxiebah fil-virus tropiku CXCR4 tal-populazzjoni virali minuri li l-preżenza tiegħu ma kinitx ġiet innutata qabel, daqs dak li nstab fil-virus tropiku CCR5.
English: In adult patients with a creatinine clearance of <80 mL/min, who are also receiving potent CYP3A4 inhibitors, the dose interval of maraviroc should be adjusted to 150 mg once daily (see sections 4.4 and 4.5).
Maltese: F'pazjenti adulti bi tneħħija tal-kreatinina ta' <80 mL/min, li jkunu qegħdin jirċievu wkoll inibituri qawwija ta' CYP3A4, l-intervall tad-doża ta' maraviroc għandu jiġi aġġustat għal 150 mg darba kuljum (ara sezzjonijiet 4.4 u 4.5).
English: INSTRUCTIONS ON USE 16.
Maltese: Effetti sekondarji possibbli 6.
English: gskcyprus@gsk.com
Maltese: • Is-sustanzi l-oħra huma:
English: Component of a multipack, cannot be sold seperately.
Maltese: Parit minn pakkett multiplu, ma jistgħux jinbiegħu separatament.
English: Etravirine AUC12: ↔ 1.00
Maltese: Etravirine AUC12: ↔ 1.00 Etravirine Cmax: ↔ 1.08
English: The pharmacokinetics of maraviroc is dependent on CYP3A5 activity and expression level, which can be modulated by genetic variation.
Maltese: Il-farmakokinetika ta' maraviroc hija dipendenti fuq l-attività u l-livell ta' espressjoni ta' CYP3A5, li jista' jiġi mmodulat minn varjazzjoni ġenetika.
English: Subjects received 150 mg of maraviroc at different dose frequencies (healthy volunteers - every 12 hours; mild renal impairment - every 24 hours; moderate renal impairment - every 48 hours).
Maltese: L-individwi rċivew 150 mg ta' maraviroc bi frekwenza ta' doża differenti (voluntiera b'saħħithom - kull 12-il siegħa; indeboliment tal-kliewi ħafif - kull 24 siegħa; indeboliment tal-kliewi moderat - kull 48 siegħa).
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 dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2. tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Maraviroc is the major circulating component (approximately 42% radioactivity) following a single oral dose of 300 mg.
Maltese: Maraviroc hu l-akbar komponent li jiċċirkola (madwar 42% radjuattività) wara doża orali waħda ta' 300 mg.
English: Blue, biconvex, oval film-coated tablets, approximate dimensions 10.5 mm x 19.0 mm and debossed with “MVC 300”.
Maltese: 5 mm x 19.0 mm miksijin b'rita mnaqqxa b' “MVC 300”.
English: Many medicines have profound effects on maraviroc exposure due to drug-drug interactions.
Maltese: Ħafna mediċini għandhom effett profond fuq l-esponiment ta' maraviroc minħabba interazzjonijiet mediċinali.
English: Based on the in vitro and clinical data, the potential for maraviroc to affect the pharmacokinetics of co-administered medicinal products is low.
Maltese: Abbażi ta' dejta in vitro u klinika, il-potenzjal għal maraviroc biex jaffettwa l-farmakokinetika ta' prodotti mediċinali mogħtija flimkien huwa baxx.
English: Dose adjustment of maraviroc is recommended when maraviroc is co-administered with potent CYP3A4 inhibitors and/or inducers.
Maltese: Huwa rakkomandat aġġustament fid-doża ta' maraviroc meta maraviroc jiġi amministrat ma' inibituri u/jew indutturi potenti ta' CYP3A4.
English: CD4+ cell count Mean change from baseline (cells/µL) 1 p-values < 0.0001 2 For all efficacy endpoints the confidence intervals were 95%, except for HIV-1 RNA Change from baseline, which was 97.5%
Maltese: 2 Għat-tragwardi finali kollha tal-effikaċja l-intervalli ta' kunfidenza kienu 95%, ħlief għall-Bidla flHIV-1 RNA mil-linja bażi, li kienet 97.5%
English: This analysis indicated that CXCR4-using virus emerged from a pre-existing CXCR4-using reservoir not detected at baseline, rather than from mutation of CCR5-tropic virus present at baseline.
Maltese: Din l-analiżi wriet li l-virus li juża CXCR4 ħareġ minn depożitu tal-virus li juża CXCR4 pre-eżistenti, li ma kienx instab fil-linja bażi iktar milli minħabba mutazzjoni ta' virus tropiku CCR5 li kien preżenti fil-linja bażi.
English: Luxembourg/Luxemburg
Maltese: Belgique/Belgien
English: Clinical status and relevant blood chemistry should be monitored and appropriate symptomatic therapy initiated.
Maltese: L-istat kliniku u l-kimika rilevanti tad-demm għandhom jiġu mmonitorjati u għandha tinbeda terapija sintomatika xierqa.
English:  lung infection  fungal infection of the gullet (oesophagus)  fits (seizures)
Maltese: • infezzjoni fil-pulmun • infezzjoni ta' fungus fil-kanal tal-ikel (esofagu)
English: Significant reductions in amprenavir Cmin observed may result in virological failure in patients
Maltese: Tnaqqis sinifikanti osservat f'Cmin ta' amprenavir jista' jwassal għal falliment viroloġiku fil-pazjenti
English: T. Narbuto 5,
Maltese: Narbuto 5,
English: Probability
Maltese: Probabilità
English: See also section 4 “Possible side effects”.
Maltese: Ara wkoll sezzjoni 4 "Effetti sekondarji possibbli".
English: Cometriq (n=219) Placebo (n=111)
Maltese: Cometriq (n=219) Plaċebo (n=111)
English: Cometriq (n=81) Placebo (n=45)
Maltese: Cometriq (n=81) Plaċebo (n=45)
English: Cabozantinib was metabolized in vivo.
Maltese: Cabozantinib kien metabolizzat in vivo.
English: MedDRA System Organ Class
Maltese: MedDRA Is-Sistema tal-Klassifika tal-Organi
English: 65 quai Georges Gorse 92100 Boulogne-Billancourt France
Maltese: 65 quai Georges Gorse 92100 Boulogne-Billancourt Franza
English: Catalent Germany Schorndorf GmbH Steinbeisstr.
Maltese: Catalent Germany Schorndorf GmbH Steinbeisstr. 1 und 2
English: 21.1 months HR: 0.85 (0.64, 1.12) p = 0.2409
Maltese: 21.1 xahar HR: 0.85 (0.64, 1.12) p = 0.2409
English: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, n° 16A-1°B
Maltese: Alameda Fernão Lopes, n° 16A-1°B
English: Cabozantinib is highly protein bound in vitro in human plasma (≥ 99.7%).
Maltese: Cabozantinib għandu affinità kbira mal-proteini in vitro fil-plażma umana (≥ 99.7%).
English: P-glycoprotein substrates
Maltese: Sottostrati ta' P-glycoprotein
English: Not Known (unknown frequency)
Maltese: Mhux magħruf (frekwenza mhux magħrufa)
English: INFORMATION IN BRAILLE COMETRIQ 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE COMETRIQ 20 mg
English: Adverse reactions are listed in Table 1 according to MedDRA system organ class and frequency categories.
Maltese: Reazzjonijiet avversi huma elenkati f'Tabella 1 skont il-klassifikazzjoni tas-sistema tal-organi (MedDRA) u kategoriji ta' frekwenza.
English: • Anxiety, depression, confusion
Maltese: • Ansjetà, depressjoni, stat konfuż
English: Based on the populationpharmacokinetic (PK) model, the volume of distribution (V/F) is approximately 349 L (SE: ± 2.73%).
Maltese: Abbażi talmudell popolazzjoni-farmakokinetiku (FK), il-volum ta' distribuzzjoni (V/F) hu madwar 349 L (SE: ± 2.73%).
English: Table 1: Adverse reactions reported with cabozantinib
Maltese: Tabella 1: Reazzjonijiet avversi rapportati b'cabozantinib
English: Date of first authorisation: 21 March 2014 Date of latest renewal: 28 March 2019
Maltese: Data tal-aħħar tiġdid: 28 ta' Marzu, 2019
English: Prolongation of QT interval
Maltese: Titwil tal-intervall QT
English: 20 mg and 80 mg
Maltese: 20 mg u 80 mg
English: Cardiac disorders atrial fibrillation angina pectoris, supraventricular tachycardia myocardial infarction
Maltese: Disturbi fil-qalb fibrilazzjoni atrijali anġina pektoris, takikardja supraventrikulari infart mijokardijaku
English: Capsule content Microcrystalline cellulose Croscarmellose sodium Sodium starch glycolate Silica colloidal anhydrous Stearic acid
Maltese: Kontenut tal-kapsula Microcrystalline cellulose Croscarmellose sodium Sodium starch glycoloate Silica colloidal anhydrous Stearic acid
English: The active substance is cabozantinib (S)-malate.
Maltese: Is-sustanza attiva hi cabozantinib (S)-malate.
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Maltese: Is-sindromu ta' eritrodisestesija palmar-plantar (PPES) ġie osservat b'cabozantinib.
English: Duration of Response; Median (95% CI)
Maltese: Tul ta' Żmien ta' Rispons, Medjan (95% CI)