FrancophonIA/ELRC3.0 huggingface dataset:
English: The geometric mean AUCinf (CV%) for maraviroc was as follows: healthy volunteers (normal renal function) 1348.4 ng·h/mL (61%); severe renal impairment 4367.7 ng·h/mL (52%); ESRD (dosing after dialysis) 2677.4 ng·h/mL (40%); and ESRD (dosing before dialysis) 2805.5 ng·h/mL (45%).
Maltese: L-AUCinf (CV%) ġeometrika medja ta' maraviroc kienet kif ġej: voluntiera b'saħħithom (funzjoni renali normali) 1348.4 ng siegħa/mL (61%); indeboliment renali sever 4367.7 ng siegħa/mL (52%); ESRD (doża mogħtija wara d-dijalisi) 2677.4 ng siegħa/mL (40%); u ESRD (doża mogħtija qabel id-dijalisi) 2805.5 ng siegħa/mL (45%).
English: Primary pharmacological activity (CCR5 receptor affinity) was limited in the species studied (see section 5.3).
Maltese: L-attività farmakoloġika primarja (affinità għar-riċettur CCR5) kienet limitata fl-ispeċi li ġew studjati (ara sezzjoni 5.3).
English: OBT: Optimised Background Therapy * Percentages based on total patients evaluated for each laboratory parameter
Maltese: OBT: L-Aħjar Terapija fl-Isfond * Perċentwali bbażati fuq il-pazjenti totali evalwati għal kull parametru tal-laboratorju
English: Placebo + OBT N =207*
Maltese: OBT waħedha N =207*
English: After 48 weeks of treatment, maraviroc did not reach non-inferiority to efavirenz for the endpoint of HIV-1 RNA < 50 copies/mL (65.3 vs. 69.3 % respectively, lower confidence bound -11.9%).
Maltese: Wara 48 ġimgħa ta' kura, maraviroc ma laħaqx non-inferjorità ma' efavirenz għat-tragward finali ta' HIV-1 RNA < 50 kopja/mL (65.3 vs. 69.3 % rispettivament, limitu ta' kunfidenza l-aktar baxx ta' -11.9%).
English: CELSENTRI has only been taken by limited numbers of people 65 years or older.
Maltese: CELSENTRI ttieħed biss f'numru limitat ta' persuni ta' 65 sena jew aktar.
English: HIV-1 variants with reduced susceptibility to maraviroc have been selected in vitro, following serial passage of two CCR5-tropic viruses (0 laboratory strains, 2 clinical isolates).
Maltese: Il-varjanti ta' HIV-1 b'suxxettibilità mnaqqsa għal maraviroc ġew magħżula in vitro, wara passaġġ konsekuttiv ta' żewġ virusis CCR5-tropiċi (0 razza tal-laboratorju, 2 iżolati kliniċi).
English: Excipient with known effect: each 300 mg film-coated tablet contains 1.68 mg of soya lecithin.
Maltese: Eċċipjent b'effett magħruf: kull pillola miksija b'rita ta' 300 mg fiha 1.68 mg ta' leċitina tas-sojja.
English: Antiretrovirals
Maltese: ANTIVIRALI
English: Table 2: Interactions and adulta dose recommendations with other medicinal products
Maltese: Tabella 2: Interazzjonijiet u rakkomandazzjonijiet dwar id-doża għall-adultia ma' prodotti mediċinali oħra
English: Placebo + OBT N = 209
Maltese: OBT waħdu N=209
English: The antiviral activity of maraviroc against HIV-2 has not been evaluated.
Maltese: L-attività antivirali ta' maraviroc kontra l-HIV-2 għadha ma ġietx evalwata.
English: ANTIBIOTICS Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (maraviroc 300 mg BID)
Maltese: ANTIBIJOTIĊI Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (maraviroc 300 mg BID)
English: Special patient populations:
Maltese: Popolazzjoni pedjatrika:
English: At 48 weeks, using a missing, switch or discontinuation equals failure analysis, 48% of subjects treated with maraviroc and OBT achieved plasma HIV-1 RNA less than 48 copies/mL and 65% of subjects achieved plasma HIV-1 RNA less than 400 copies per mL.
Maltese: Wara 48 ġimgħa, l-użu ta' analiżi nieqsa, ta' qlib jew ta' waqfien tfisser falliment, 48 % tal-individwi kkurati b'maraviroc u OBT kisbu HIV-RNA fil-plażma ta' inqas minn 48 kopja/mL u 65 % talindividwi kisbu HIV-1 RNA fil-plażma ta' inqas minn 400 kopja għal kull mL.
English: Polyvinyl chloride (PVC) blisters with child-resistant (CR) aluminium/polyethylene terephthalate (PET) lidding foil in a carton containing 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.
Maltese: Folji tal-polyvinyl chloride (PVC) b'fojl ta' l-aluminju/polyethylene terephthalate (PET) li ma jinfetħux faċilment mit-tfal (CR) ta' barra f'kaxxa li tesa' 30, 60, 90 pillola miksijin b'rita u pakketti multipli li fihom 180 (2 pakketti ta' 90) pillola miksijin b'rita.
English: Maraviroc belongs to a group of medicines called CCR5 antagonists.
Maltese: Maraviroc jagħmel parti minn grupp ta' mediċini msejħa antagonisti ta' CCR5.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) , or not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥ 1/10,000 sa < 1/1,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Maraviroc 300 mg twice daily + OBT N =421*
Maltese: Maraviroc 300 mg darbtejn kuljum + OBT N =421*
English: There are limited data in patients with hepatitis B and/or C virus co-infection (see section 5.1).
Maltese: Hemm dejta limitata ħafna f'pazjenti li jkollhom koinfezzjoni tal-virus tal-epatite B u/jew Ċ (ara sezzjoni 5.1).
English: At baseline, mean plasma HIV-1 RNA was 4.3 log10 copies/mL (range 2.4 to 6.2 log10
Maltese: Fil-linja bażi, il-medja tal-HIV‑1 RNA fil-plażma kienet ta 4.3 log10 kopji/mL (medda 2.4 sa 6.2 log10
English: There may be a risk of suboptimal levels with risk of loss of virologic response and resistance development.
Maltese: Jista' jkun hemm riskju ta' livelli anqas milli mixtieqa flimkien ma riskju ta' nuqqas ta' rispons viroloġiku u żvilupp ta' reżistenza.
English: Poly (vinyl alcohol) Titanium dioxide (E171) Macrogol 3350
Maltese: Titanium dioxide (E171)
English: This should be taken into consideration when treating infections such as active tuberculosis and invasive fungal infections.
Maltese: Dan għandu jiġi kkunsidrat meta jiġu kkurati infezzjonijiet bħal tuberkulożi attiva u infezzjonijiet fungali invażivi.
English: The average concentration (Cavg) of maraviroc over 24 hours was 445.1 ng/mL, 338.3 ng/mL, and 223.7 ng/mL for subjects with normal renal function, mild renal impairment, and moderate renal impairment, respectively.
Maltese: Il konċentrazzjoni medja (Cavg) ta' maraviroc fuq 24 siegħa kienet ta' 445.1 ng/mL, 338.3 ng/mL, u223.7 ng/mL għal individwi b'funzjoni renali normali, b'indeboliment tal-kliewi ħafif u b'indeboliment tal-kliewi moderat, rispettivament.
English: No relevant differences in pharmacokinetics have been observed.
Maltese: Ma ġew osservati l-ebda differenzi relevanti fil-farmakokinetika.
English: Adult dosage*
Maltese: Dożaġġ għall-adulti*
English: In paediatric patients with a successful tropism test, dual mixed/CXCR4-tropic virus was detected in around 40% of screening samples (8/27, 30% in 2-6 year-olds, 31/81, 38% in 6-12 year-olds and 41/90, 46% in 12-18 year-olds), underscoring the importance of tropism testing also in the paediatric population.
Maltese: F'pazjenti pedjatriċi b'test ta' tropiżmu li rnexxa, ġie identifikat virus imħallat doppju/CXCR4-tropiku f'madwar 40 % tal-kampjuni tal-iskrinjar (8/27, 30 % fi tfal ta' bejn sentejn u 6 snin, 31/81, 38 % f'dawk li għandhom bejn 6 u 12-il sena u 41/90, 46 % f'dawk li għandhom bejn 12 u 18-il sena), li jenfasizza l-importanza tal-ittestjar ta' tropiżmu anki fil-popolazzjoni pedjatrika.
English: Co-administration of a 300 mg tablet with a high fat breakfast reduced maraviroc Cmax and AUC by 33% and co-administration of 75 mg of oral solution with a high fat breakfast reduced maraviroc AUC by 73% in adult healthy volunteers.
Maltese: L-amministrazzjoni ta' pillola ta' 300 mg ma' kolazzjon b'kontenut għoli ta' xaħam naqqas is-Cmax u l-AUC ta' maraviroc bi 33% u l-amministrazzjoni ta' 75 mg ta' soluzzjoni orali ma' kolazzjoni b'kontenut għoli ta' xaħam naqqas maraviroc u AUC b'73 % f'voluntiera adulti b'saħħithom.
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX09
Maltese: Antivirali għal użu sistemiku, antivirali oħra, Kodiċi ATC:
English: CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 180 tablets or in blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) filmcoated tablets.
Maltese: Il- pilloli miksijin b'rita CELSENTRI ta' 150 mg u 300 mg jiġu fi fliexken ta' 180 pillola jew f'pakketti ta' folji ta' 30, 60, 90 pillola miksijin b'rita u pakketti multipli li fihom 180 (2 pakketti ta' 90) pillola miksija b'rita.
English: Hepatobiliary disorders Aspartate aminotransferase
Maltese: Disturbi fil-fwied u fil-marrara Aspartate aminotransferase
English: Effects on active substance levels Geometric mean change if not stated otherwise
Maltese: Effetti fuq livelli tas-sustanza attiva
English: Refer to section 4.5 for corresponding adult dosage.
Maltese: Irreferi għas-sezzjoni 4.5 għal dożaġġ għall-adulti korrispondenti.
English: How to store CELSENTRI Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: • The active substance in CELSENTRI oral solution is 20 mg of maraviroc in each ml of the solution.
Maltese: • Is-sustanza attiva fis-soluzzjoni orali CELSENTRI hija 20 mg ta' maraviroc f'kull ml tas soluzzjoni.
English: Blue, biconvex, oval film-coated tablets, approximate dimensions 8.56 mm x 15.5 mm and debossed with “MVC 150”.
Maltese: Pilloli blu konvessi miż-żewġ naħat b'forma ovali, b'dimensjonijiet ta' madwar 8.56 mm x 15.5 mm miksijin b'rita mnaqqxa b' “MVC 150”.
English: In treatment-naïve patients, the incidence of grade 3 and 4 laboratory abnormalities using ACTG criteria was similar among the maraviroc and efavirenz treatment groups.
Maltese: F'pazjenti li qatt ma' ħadu kura qabel, l-inċidenza ta' anormalitajiet tal-laboratorju ta' grad 3 u 4 blużu ta' kriterji ACTG, kienet simili fost il-gruppi ta' kura ta' maraviroc u efavirenz.
English: Failure with CXCR4-using virus
Maltese: Falliment ma' virus li juża CXCR4
English: (See also ‘Liver problems' in section 4).
Maltese: (Ara wkoll “Problemi fil-fwied” f'sezzjoni 4).
English: Studies in humans and in vitro studies using human liver microsomes and expressed enzymes have demonstrated that maraviroc is principally metabolized by the cytochrome P450 system to metabolites that are essentially inactive against HIV-1.
Maltese: Studji fil-bnedmin u studji in vitro li wżaw mikrosomi tal-fwied uman u enzimi espressi wrew li maraviroc jiġi metabolizzat prinċipalment mis-sistema taċ-ċitokromu P450 għal metaboliti li huma essenzjalment inattivi kontra l-HIV-1.
English: Table 5: Demographic and baseline characteristics of patients (pooled studies MOTIVATE 1 and MOTIVATE 2)
Maltese: Karatteristiċi demografiċi u tal-linja bażi tal-pazjenti (studji miġburin MOTIVATE 1 u MOTIVATE 2)
English: ULN: Upper Limit of Normal
Maltese: Limitu ta' Fuq tan-Normal
English: The Cavg of maraviroc from 24-48 hours for subjects with moderate renal impairment was low (Cavg: 32.8 ng/mL).
Maltese: Is-Cavg ta' maraviroc minn 24-48 siegħa għal pazjenti b'indeboliment tal-kliewi moderat, kien baxx (Cavg: 32.8 ng/mL).
English: A study compared the pharmacokinetics of a single 300 mg dose of maraviroc in patients with mild (Child-Pugh Class A, n=8), and moderate (Child-Pugh Class B, n=8) hepatic impairment compared to healthy subjects (n=8).
Maltese: Studju qabbel il-farmakokinetika ta' doża waħda ta' 300 mg ta' maraviroc f'pazjenti b'indeboliment tal-fwied ħafif (Child-Pugh Klassi A, n=8), u moderat (Child-Pugh Klassi B, n=8) meta mqabbla ma' individwi b'saħħithom (n=8).
English: ANTIARRHYTHMICS Digoxin 0.25 mg Single Dose (maraviroc 300 mg BID)
Maltese: ANTIARRITMIĊI Digoxin 0.25 mg Doża Waħda (maraviroc 300 mg BID)
English: Additionally, co-administration of maraviroc with tenofovir (substrate for renal elimination) and cotrimoxazole (contains trimethoprim, a renal cation transport inhibitor), showed no effect on the pharmacokinetics of maraviroc.
Maltese: Barra minn hekk, l-amministrazzjoni ta' maraviroc ma' tenofovir (sottostrat tal-eliminazzjoni mill-kliewi) u cotrimoxazole (fih trimethoprim, inibitur tat-trasport renali ta' katjoni), ma wriet l-ebda effett fuq il-farmakokinetika ta' maraviroc.
English: Fewer patients discontinued maraviroc due to adverse events (15 vs. 49).
Maltese: Inqas pazjenti waqqfu l-kura b'maraviroc minħabba reazzjonijiet avversi (15 vs.49).
English: copies per mL), mean CD4+ cell count was 551 cells/mm3 (range 1 to 1654 cells/mm3) and mean CD4+ % was 21% (range 0% to 42%).
Maltese: kopji għal kull mL),u l-medja tal-għadd ta' ċelloli CD4+ kienet ta' 551 ċellola/mm3 (medda 1 sa 1654 ċellola/mm3) u l-medja ta' CD4+ % kienet ta' 21 % (medda 0 % sa 42 %).
English: CELSENTRI with products that are CYP3A inducers (without a potent CYP3A inhibitor)
Maltese: CELSENTRI ma' prodotti li huma indutturi ta' CYP3A (mingħajr inibitur potenti ta' CYP3A)
English: Protease Inhibitors (PIs) Atazanavir 400 mg QD (maraviroc 300 mg BID)
Maltese: Inibituri tal-Protease (PIs) Atazanavir 400 mg QD (maraviroc 300 mg BID)
English: * Based on drug-drug interactions (refer to section 4.5)
Maltese: * Abbażi ta' interazzjonijiet mediċinali (irreferi għas-sezzjoni 4.5)
English: * Based on drug-drug Interactions (refer to section 4.5)
Maltese: * Abbażi ta' Interazzjonijiet mediċinali (irreferi għas-sezzjoni 4.5)
English: Table 6: Efficacy Outcomes at week 48 (pooled studies MOTIVATE 1 and MOTIVATE 2) Outcomes
Maltese: Tabella 6: Riżultati tal-Effikaċja f'ġimgħa 48 (studji miġbura MOTIVATE 1 u MOTIVATE 2) Riżultati
English: The recommended dose of CELSENTRI is 150 mg (with potent CYP3A inhibitor with or without a potent CYP3A inducer), 300 mg (without potent CYP3A inhibitors or inducers) or 600 mg twice daily (with potent CYP3A inducer without a potent CYP3A inhibitor) depending on interactions with concomitant antiretroviral therapy and other medicinal products (see section 4.5).
Maltese: Id-doża rakkomandata ta' CELSENTRI hi 150 mg (b'inibitur potenti ta' CYP3A bi jew mingħajr induttur potenti ta' CYP3A), 300 mg (mingħajr inibituri jew indutturi potenti ta' CYP3A) jew 600 mg darbtejn kuljum (b'induttur potenti ta' CYP3A mingħajr inibitur potenti ta' CYP3A) skont interazzjonijiet ma' terapija antiretrovirali konkomitanti u prodotti mediċinali oħra (ara sezzjoni 4.5).
English: Population analysis of the Phase 1/2a and Phase 3 studies (16-65 years of age) has been conducted and no effect of age have been observed (see section 4.2).
Maltese: L-analiżi tal-popolazzjoni tal-istudji ta' Fażi 1/2a u Fażi 3 (età ta' 16-65 sena) saret u ma ġie osservat l-ebda effett tal-età (ara sezzjoni 4.2).
English: Only a limited number of people with serious heart or circulatory problems have taken CELSENTRI.
Maltese: Numru limitat ta' persuni bi problemi filfwied biss ħadu CELSENTRI.
English: In the pivotal studies of treatment-experienced patients coronary heart disease events were more common in patients treated with maraviroc than with placebo (11 during 609 PY vs 0 during 111 PY of follow-up).
Maltese: Fl-istudji pivotali fuq pazjenti esperjenzati bil-kura, avvenimenti ta' mard koronarju tal-qalb kienu aktar komuni f'pazjenti ttrattati b'maraviroc milli bil-plaċebo (11 waqt 609 PY vs 0 waqt 111 PY ta' segwitu).
English: Residual activity in vivo for viruses with MPI-values <95% has not been determined.
Maltese: Attività residwa ta' virusis in vivo b'valuri MPI <95% ma ġietx stabbilita.
English: Nevirapine 200 mg BID (maraviroc 300 mg Single Dose)
Maltese: Nevirapine 200 mg BID (maraviroc 300 mg Doża Singola)
English: Pharmacokinetic Enhancers Cobicistat
Maltese: MEDIĊINI KONTRA L-INFEZZJONIJIET Mediċini Antiretrovirali Enhancers Farmakokinetiċi Cobicistat
English: The pharmacokinetics of maraviroc has not been studied in subjects with severe hepatic impairment (see sections 4.2 and 4.4).
Maltese: Il-farmakokinetika ta' maraviroc ma ġietx studjata f'suġġetti b'indeboliment tal-fwied sever (ara sezzjonijiet 4.2 u 4.4).
English: CXCR4-using virus was detected at failure in approximately 60% of subjects who failed treatment on maraviroc, as compared to 6% of subjects who experienced treatment failure in the placebo + OBT arm. To investigate the likely origin of the on-treatment CXCR4-using virus, a detailed clonal analysis was conducted on virus from 20 representative subjects (16 subjects from the maraviroc arms and 4 subjects from the placebo + OBT arm) in whom CXCR4-using virus was detected at treatment failure.
Maltese: Sabiex ikun investigat l-oriġini tal-virus li juża CXCR4 li ħareġ waqt it-trattament, analiżi klonali ddettaljata saret fuq virus minn 20 individwu rappreżentattiv (16-il individwu millgrupp tal-fergħa ta' maraviroc u 4 individwi mill-fergħa ta' kura b'OBT biss) li fihom il-virus li juża CXCR4 instab fil-punt meta t-terapija ma ħadmitx.
English: Excipient with known effect: each 25 mg film-coated tablet contains 0.14 mg of soya lecithin.
Maltese: Eċċipjent b'effett magħruf: kull pillola miksija b'rita ta' 25 mg fiha 0.14 mg ta' leċitina tas-sojja.
English: CELSENTRI could potentially increase your risk of developing infections.
Maltese: CELSENTRI jista' potenzjalment iżid ir-riskju tiegħek ta' żvilupp ta' infezzjonijiet.
English: CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets maraviroc
Maltese: CELSENTRI 25 mg pilloli miksijin b'rita CELSENTRI 75 mg pilloli miksijin b'rita CELSENTRI 150 mg pilloli miksijin b'rita CELSENTRI 300 mg pilloli miksijin b'rita maraviroc
English: Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous
Maltese: Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous Sodium starch glycolate Magnesium stearate
English: The primary objective assessed the incidence of Grade 3 and 4 ALT abnormalities (>5x upper limit of normal (ULN) if baseline ALT ≤ ULN; or >3.5x baseline if baseline ALT > ULN) at Week 48.
Maltese: L-objettiv ewlieni vvaluta l-inċidenza ta' anormalitajiet ALT ta' Grad 3 u 4 (>5x tal-aktar limitu tannormal (ULN) jekk il-linja bażi tkun ALT ≤ ULN; jew >3.5x tal-linja bażi jekk il-linja bażi tkun ALT > ULN) f'Ġimgħa 48.
English: Patients were randomised in a 2:2:1 ratio to maraviroc 300 mg (dose equivalence) once daily, twice daily or placebo in combination with an optimized background consisting of 3 to 6 antiretroviral medicinal products (excluding low-dose ritonavir).
Maltese: Il-pazjenti ġew magħżula fi proporzjon ta' 2:2:1 għal maraviroc 300 mg darba kuljum (ekwivalenza tad-doża) darba kuljum, darbtejn kuljum jew plaċebo f'kombinazzjoni ma' sfond ottimizzat magħmul minn 3 sa 6 prodotti mediċinali antiretrovirali (eskluża doża baxxa ta' ritonavir).
English: CELSENTRI with products that are not potent CYP3A inhibitors or potent CYP3A inducers
Maltese: CELSENTRI ma' prodotti li mhumiex inibituri potenti ta' CYP3A jew indutturi potenti ta' CYP3A
English: In a retrospective analysis of the MOTIVATE studies with a more sensitive assay for screening of tropism (Trofile ES), the response rates (<50 copies/mL at week 48) in patients with only CCR5tropic virus detected at baseline was 48.2% in those treated with maraviroc + OBT (n=328), and 16.3% in those treated with placebo + OBT (n=178).
Maltese: F'analiżi retrospettiva tal-istudji MOTIVATE b'assaġġ aktar sensittiv għall-iskrinjar ta' tropiżmu (Trofile ES), ir-rati ta' rispons (<50 kopja/mL fil-ġimgħa 48) f'pazjenti b'virus CCR5-tropiku biss mikxuf fil-linja bażi kienu 48.2% f'dawk ikkurati b'maraviroc + OBT (n=328), u 16.3% f'dawk ikkurati b'OBT waħdu (n=178).
English: The Monogram Trofile assay was used in the clinical studies of maraviroc.
Maltese: L-analiżi Monogram Trofile intużat fl-istudji kliniċi ta' maraviroc.
English: CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets
Maltese: CELSENTRI 25 mg pilloli miksijin b'rita CELSENTRI 75 mg pilloli miksijin b'rita CELSENTRI 150 mg pilloli miksijin b'rita CELSENTRI 300 mg pilloli miksijin b'rita
English: Approximately 20% of the radiolabel was recovered in the urine and 76% was recovered in the faeces over 168 hours.
Maltese: Madwar 20% tar-radjutikketta kien irkuprat fl-awrina u 76% kien irkuprat fl-ippurgar fuq perjodu ta' 168 siegħa.
English: Intensive pharmacokinetics of maraviroc were evaluated in 50 treatment-experienced, CCR5tropic, HIV-1 infected paediatric patients aged 2 to 18 years (weight 10.0 to 57.6 kg) in the dosefinding stage of clinical trial A4001031.
Maltese: Ġew evalwati farmakokinetiċi intensivi ta' maraviroc f'50 pazjent pedjatriku infettati bl-HIV-1, CCR5-tropiċi, esperjenzati bil-kura li kellhom bejn sentejn u 18-il sena (piż 10.
English: Phenotypic resistance
Maltese: Disturbi psikjatriċi
English: Medicinal product by therapeutic areas (dose of CELSENTRI used in study)
Maltese: Prodott mediċinali skont il-klassi terapewtika (doża ta' CELSENTRI użata flistudju)
English: In mice, no statistically significant increase in the incidence of tumours was reported at systemic exposures from 7 to 39-times the human exposure (unbound AUC 0-24h measurement) at a dose of 300 mg twice daily.
Maltese: Fil-ġrieden, ebda żieda statistikament sinjifikanti fl-inċidenza ta' xi tip ta' tumur ma ġiet irrapportata b'esponiment sistemiku fil-medda ta' 7 sa 39 darba l-esponiment uman (kejl talAUC 0-24 siegħa ta' mediċina mhux marbuta) bid-doża massima rakkomandata ta' 300 mg darbtejn kuljum.
English: When used with other antiretroviral medicinal products in cell culture, the combination of maraviroc was not antagonistic with a range of NRTIs, NNRTIs, PIs or the HIV fusion inhibitor enfuvirtide.
Maltese: Meta ntuża ma' prodotti mediċinali antiretrovirali oħra f'kultura ta' ċelluli t-taħlita ta' maraviroc ma kinetx antagonista għal medda ta' NRTIs, NNRTIs, PIs u l-inibitur tal-fużjoni tal-HIV enfuvirtide.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Maltese: Eżempji rilevanti huma cytomegalovirus retinitis, infezzjonijiet mikobatteriċi ġeneralizzati u/jew fokali, u pnewmonja kkawżata minn Pneumocystis jiroveci (preċedentament magħruf bħala Pneumocystis carinii).
English: The pack also includes a thermoplastic elastomeric press in bottle adapter, and a 10 ml oral applicator comprised of a polypropylene barrel (with mL graduations) and a polyethylene plunger.
Maltese: Il-pakkett jinkludi wkoll pressa elastomerika termoplastika fl-adapter tal-flixkun, u applikatur orali ta' 10 ml ta' bettija talpolypropylene (bi gradwazzjonijiet ta' mL) u planġer tal- polyethylene.
English: CELSENTRI contains a medicine called maraviroc.
Maltese: CELSENTRI fih mediċina msejħa maraviroc.
English: Delayed type hypersensitivity reactions, typically occurring within 2-6 weeks after start of therapy and including rash, fever, eosinophilia and liver reactions have been reported (see also section 4.4).
Maltese: Kienu rrappurtati reazzjonijiet ta' sensittività eċċessiva ttardjati, normalment fi żmien 2-6 ġimgħat wara l-bidu tat-terapija, inklużi raxx, deni, esinofilja u reazzjonijiet tal-fwied (ara wkoll sezzjoni 4.4).
English: Risk Management plan (RMP)
Maltese: Pjan tal-Immaniġġar tar-riskju (RMP)
English: Co-administration of maraviroc with medicinal products that induce CYP3A4 may decrease maraviroc concentrations and reduce its therapeutic effects.
Maltese: L-amministrazzjoni ta' maraviroc ma' prodotti mediċinali li jinduċu CYP3A4 tista' tnaqqas il-konċentrazzjonijiet ta' maraviroc u tnaqqas l-effetti terapewtiċi tiegħu.
English: Fluconazole is considered to be a moderate CYP3A4 inhibitor.
Maltese: Fluconazole, huwa kkunsidrat bħala inibitur moderat ta' CYP3A4.
English: The recommended dose of CELSENTRI differs depending on interactions with concomitant antiretroviral therapy and other medicinal products.
Maltese: Id-doża rakkomandata ta' CELSENTRI tvarja skont l-interazzjonijiet ma' terapija antiretrovirali konkomimtanti u prodotti mediċinali oħra.
English: In rats, there were no adverse effects on male or female fertility (see section 5.3).
Maltese: Fil-firien, ma kien hemm lebda effetti avversi fuq il-fertilità maskili jew femminili (ara sezzjoni 5.3).