FrancophonIA/ELRC3.0 huggingface dataset:
English: The difference in maraviroc exposure between CYP3A5 extensive and poor metabolisers was reduced when maraviroc was administered together with a strong CYP3A inhibitor: extensive CYP3A5 metabolisers (n=12) had a 17% lower maraviroc AUC compared with poor CYP3A5 metabolisers (n=11) when dosed with maraviroc 150 mg once daily in the presence of darunavir/cobicistat (800/150 mg).
Maltese: Id-differenza fl-esponiment ta' maraviroc bejn CYP3A5 estensiv u metabolizzaturi ħżiena tnaqqset meta maraviroc ingħata flimkien ma' inibitur qawwi ta' CYP3A5: metabolizzaturi estensivi ta' CYP3A5 (n=12) kellhom AUC ta' maraviroc 17 % aktar baxx meta mqabbel ma' metabolizzaturi ħżiena ta' CYP3A5 (n=11) meta ngħatat doża ta' maraviroc 150 mg darba kuljum fil-preżenza ta' darunavir/cobicistat (800/150 mg).
English: Maraviroc 300 mg twice daily + OBT N=426
Maltese: Maraviroc 300 mg darbtejn kuljum + OBT N = 426
English: Dose of CELSENTRI in children based on weight 10 to less than 20 kg
Maltese: Doża ta' CELSENTRI fi trfal abbażi tal-piż 10 sa inqas minn 20 kg
English: In vivo Treatment-Experienced Adult Patients
Maltese: In vivo Pazjenti Adulti Esperjenzati bil-Kura
English: Method of administration
Maltese: Reżistenza ġenotipika
English: Maraviroc-resistant viruses that emerged in vitro remained sensitive to the fusion inhibitor enfuvirtide and the PI, saquinavir.
Maltese: Virusis reżistenti għall-maraviroc li ħarġu in vitro baqgħu sensittivi għal inibitur tal-fużjoni enfuvirtide u għall-PI saquinavir.
English: In a Phase 1 study conducted in healthy subjects, Blacks with a CYP3A5 genotype conferring extensive maraviroc metabolism (2 CYP3A5*1 alleles; n=12) had a 37% and 26% lower AUC when dosed with maraviroc 300 mg twice daily compared with Black (n=11) and Caucasian (n=12) subjects with CYP3A5 genotype conferring poor maraviroc metabolism (no CYP3A5*1 allele), respectively.
Maltese: Fi studju ta' Fażi 1 li sar f'individwi b'saħħithom, Suwed b'ġenotip ta' CYP3A5 li jikkonferixxi metaboliżmu ta' maraviroc estensiv (2 alleli ta' CYP3A5*1; n=12) kellhom AUC 37 % u 26 % aktar baxx meta ngħataw doża ta' maraviroc ta' 300 mg darbtejn kuljum meta mqabbel ma' individwi Suwed (n=11) u Kawkasi (n=12) b'ġenotip ta' CYP3A5 li jikkonferixxi metaboliżmu ta' maraviroc ħażin (ebda allel ta' CYP3A5*1), rispettivament.
English: • liver problems, including chronic hepatitis B or C. Only a limited number of people with liver problems have taken CELSENTRI.
Maltese: • problemi fil-fwied, inkluż epatite B jew Ċ kronika.
English: How to take CELSENTRI
Maltese: X'fih CELSENTRI
English: Table 7: Proportion of patients achieving <50 copies/mL at Week 48 by subgroup (pooled Studies MOTIVATE 1 and MOTIVATE 2)
Maltese: Proporzjon ta' pazjenti li kisbu <50 kopja/mL f'Ġimgħa 48 skont is-sottogrupp (Studji miġbura MOTIVATE 1 u MOTIVATE 2)
English: In the pivotal studies (MOTIVATE 1 and MOTIVATE 2), 7.6% of patients had a change in tropism result from CCR5-tropic to CXCR4-tropic or dual/mixed-tropic between screening and baseline (a period of 4-6 weeks).
Maltese: Fl-istudji ewlenin (MOTIVATE 1 u MOTIVATE 2), 7.6% tal-pazjenti kellhom bidla fir-riżultat tattropiżmu minn CCR5-tropiku għal CXCR4-tropiku jew tropiku doppju/imħallat bejn meta sar l-eżami u l-linja bażi (perjodu ta' 4-6 ġimgħat).
English: GlaxoSmithKline s.r.o.
Maltese: Česká republika GlaxoSmithKline s.r.o.
English: The absolute bioavailability of a 100 mg dose is 23% and is predicted to be 33% at 300 mg. Maraviroc is a substrate for the efflux transporter Pglycoprotein.
Maltese: Ilbiodisponibilità assoluta ta' doża ta' 100 mg hi 23% u hija mistennija li tkun 33% bi 300 mg.
English: In vitro studies also indicate that polymorphic enzymes CYP2C9, CYP2D6 and CYP2C19 do not contribute significantly to the metabolism of maraviroc.
Maltese: L-istudji in vitro jindikaw ukoll li l-enzimi polimorfiċi CYP2C9, CYP2D6 u CYP2C19 ma jikkontribwixxux b'mod sinifikanti għall-metaboliżmu ta' maraviroc.
English: Blue, biconvex, oval film-coated tablets, approximate dimensions 6.74 mm x 12.2 mm and debossed with “MVC 75”.
Maltese: Pilloli blu konvessi miż-żewġ naħat b'forma ovali, b'dimensjonijiet ta' madwar 6.74 mm x 12 mm miksijin b'rita mnaqqxa b' “MVC 75”.
English: Assessment of treatment related adverse reactions is based on pooled data from two Phase 2b/3 studies in treatment-experienced adult patients (MOTIVATE 1 and MOTIVATE 2) and one study in treatment-naïve adult patients (MERIT) infected with CCR5-tropic HIV-1 (see sections 4.4 and
Maltese: L-evalwazzjoni tar-reazzjonijiet avversi b'rabta mal-kura hija bbażata fuq informazzjoni miġbura minn żewġ studji ta' Fażi 2b/3 f'pazjenti adulti b'esperjenza ta' kura (MOTIVATE 1 u MOTIVATE 2) u studju wieħed f'pazjenti li qatt ma' ħadu kura qabel (MERIT) infettati bl-HIV-1 CCR5-tropiku (ara sezzjonijiet 4.4 u 5.1).
English: Maraviroc was the major component present in urine (mean of 8% dose) and faeces (mean of 25% dose).
Maltese: Maraviroc kien il-komponent prinċipali preżenti fl-awrina (medja ta' 8 % tad-doża) u fl-ippurgar (medja ta' 25 % tad-doża).
English: Race (White/Black/Other) Mean Baseline HIV-1 RNA (log10 copies/mL) Median Baseline CD4+ Cell Count (cells/mm3) (range, cells/mm3)
Maltese: Razza (Bajda/Sewda/Oħra) Linja Bażi Medja ta' HIV-1 RNA (log10 kopji/mL)
English: Each ml of oral solution contains 20 mg maraviroc.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni orali fih 20 mg maraviroc.
English: Co-administration of maraviroc with St. John's Wort is expected to substantially decrease maraviroc concentrations and may result in suboptimal levels and lead to loss of virologic response and possible resistance to maraviroc.
Maltese: John's Wort u dan jista' jirriżulta f'livelli sub-ottimali ta' maraviroc, u hekk jwassal għal telf fir-rispons viroloġiku u possibilment reżistenza għal maraviroc.
English: The adverse reaction profile in paediatric patients is based on 48 Week safety data from study A4001031 in which 103 HIV-1 infected, treatment-experienced patients aged 2 to <18 years received maraviroc twice-daily with optimised background therapy (OBT).
Maltese: Il-profil ta' reazzjonijiet avversi f'pazjenti pedjatriċi huwa bbażat fuq dejta dwar is-sigurtà ta' 48 Ġimgħa minn studju A4001031 li fih 103 pazjenti esperjenzati bil-kura infettati bl-HIV-1 li kellhom bejn sentejn u <18-il sena rċivew maraviroc darbtejn kuljum bl-aħjar terapija fl-isfond (OBT, optimised background therapy).
English: Keep it safely 2.
Maltese: Żommu xi mkien sigur 2.
English: The incidence of AIDS-defining infections was similar between maraviroc and placebo arms in the pivotal studies.
Maltese: Il-frekwenza ta' infezzjonijiet relatati mal-AIDS kienet tixxiebah fil-ferghat ta' maraviroc u placebo fl-istudji pivotali.
English: Depression, insomnia common
Maltese: Depressjoni, nuqqas ta' rqad komuni
English: Table 4: Incidence ≥1% of grade 3-4 abnormalities (ACTG criteria) based on maximum shift in laboratory test values without regard to baseline studies MOTIVATE 1 and MOTIVATE 2 (pooled analysis, up to 48 weeks)
Maltese: Tabella 4: 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-istudji tal-linja bażi (MOTIVATE 1 u MOTIVATE 2 (analiżi miġbura, sa 48 ġimgħa)
English: The volume of distribution of maraviroc is approximately 194 L.
Maltese: Il-volum tad-distribuzzjoni ta' maraviroc hu madwar 194 L.
English: Number of active ARVs in OBT1:
Maltese: Numru ta' ARV attivi f'OBT
English: A study compared the pharmacokinetics of a single 300 mg dose of maraviroc in subjects with severe renal impairment (CLcr < 30 mL/min, n=6) and end stage renal disease (ESRD) to healthy volunteers (n=6).
Maltese: Il-farmakokinetika ta' doża waħda ta' 300 mg ta' maraviroc tqabblet fi studju li sar bejn individwi li għandhom indeboliment serju tal-kliewi (CLcr < 30 mL/min, n=6) u mard renali tal-aħħar stadju (ESRD), u voluntiera b'saħħithom (n=6).
English: CELSENTRI 75 mg film-coated tablets maraviroc
Maltese: CELSENTRI 75 mg pilloli miksijin b'rita maraviroc
English: Overall, the safety profile in paediatric patients was similar to that observed in adult clinical studies.
Maltese: B'mod ġenerali, il-profil tas-sigurtà f'pazjenti pedjatriċi kieen simili għal dak osservat fi studji kliniċi fl-adulti.
English: No relevant difference between Caucasian, Asian and Black subjects has been observed.
Maltese: Ma ġiet osservata l-ebda differenza relevanti bejn suġġetti Kawkasiċi, Asjatiċi u Suwed.
English: Concentration response curves for the maraviroc-resistant viruses were characterized phenotypically by curves that did not reach 100% inhibition in assays using serial dilutions of maraviroc (<100% maximal percentage inhibition (MPI)).
Maltese: Il-kurvi tar-rispons mal-konċentrazzjoni għall-virusis reżistenti għal maraviroc kienu kkaratterizzati fenotipikament minn kurvi li ma laħqux inibizzjoni 100% f'analiżi tal-mediċina fejn intużaw dilwizzjonijiet konsekuttivi ta' maraviroc (<100 % perċentwal massimu ta' inibizzjoni (MPI, maximal percentage inhibition)).
English: celsentri 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE celsentri 25 mg
English: Soya lecithin
Maltese: Leċitina tas-sojja
English: Concomitant Medications
Maltese: TAL-PRODOTT MEDIĊINALI
English: Benzodiazepines
Maltese: Il-Belġju
English: Ribavirin has not been studied, no interaction is expected.
Maltese: Ribavirin ma ġiex studjat, mhija mistennija l-ebda interazzjoni.
English: In addition, co-administration of maraviroc with lamivudine/zidovudine showed no effect of maraviroc on lamivudine (primarily renally cleared) or zidovudine (non-P450 metabolism and renal clearance) pharmacokinetics.
Maltese: Barra minn hekk, lamministrazzjoni ta' maraviroc ma' lamivudine/zidovudine ma wriet ebda effett ta' maraviroc fuq ilfarmakokinetika ta' lamivudine (imneħħi prinċipalment mill-kliewi) jew ta' zidovudine (metaboliżmu mhux P450 u tneħħija mill-kliewi).
English: Blue, biconvex, oval film-coated tablets, approximate dimensions 4.6 mm x 8.0 mm and debossed with “MVC 25”.
Maltese: Pilloli blu konvessi miż-żewġ naħat b'forma ovali, b'dimensjonijiet ta' madwar 4.6 mm x 8.0 mm miksijin b'rita mnaqqxa b' “MVC 25”.
English: In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti infettati bl-HIV li jkollhom defiċjenza immuni severa fiż-żmien li tinbeda terapija antiretrovirali kkombinata (CART), tista' tiżviluppa reazzjoni infjammatorja għal patoġeni opportunistiċi bla sintomi jew residwi u tikkawża kondizzjonijiet kliniċi serji, jew aggravament tassintomi.
English: Excipient with known effect: each 150 mg film-coated tablet contains 0.84 mg of soya lecithin.
Maltese: Eċċipjent b'effett magħruf: kull pillola miksija b'rita ta' 150 mg fiha 0.84 mg ta' leċitina tas-sojja.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, can have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Maltese: Pazjenti bi fwied li diġà ma jaħdimx normali, inklużi dawk b'epatite kronika attiva, jista' jkollhom frekwenza ogħla ta' anormalitajiet tal-funzjoni tal-fwied waqt terapija antiretrovirali kkombinata u għandhom jkunu mmonitorjati skont il-prattika standard.
English: Maraviroc AUC12: ↔ 1.11
Maltese: Maraviroc AUC12: ↔ 1.11 Maraviroc Cmax: ↔ 1.19
English: High density polyethylene bottles (HDPE) with polypropylene child resistant (CR) closures and an aluminium foil/polyethylene heat induction seal containing 120 film-coated tablets.
Maltese: Fliexken magħmulin minn polyethylene ta' densità għolja (HDPE - high density polyethylene) b'għatu tal-polypropylene reżistenti għat-tfal (CR - child resistant) u siġill ta' fojl tal-aluminju/ polyethylene b'induzzjoni termika li fih 120 pillola miksija b'rita.
English: The recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice per day depending on other medicines that you are taking at the same time.
Maltese: Id-doża rakkomandata ta' CELSENTRI li ssoltu tingħata hija 150 mg, 300 mg jew 600 mg darbtejn kuljum skont il-mediċini l-oħra li inti tkun qed tieħu fl-istess ħin.
English: Geometric mean ratios for Cmax and AUClast were 11% and 25% higher respectively for subjects with mild hepatic impairment, and 32% and 46% higher respectively for subjects with moderate hepatic impairment compared to subjects with normal hepatic function.
Maltese: Ilproporzjonijiet ġeometriċi medji għal Cmax u AUClast kienu 11% u 25% ogħla rispettivament għal individwi b'indeboliment tal-fwied ħafif, u 32% u 46% ogħla rispettivament għal individwi b'indeboliment tal-fwied moderat meta mqabbel ma' individwi b'funzjoni tal-fwied normali.
English: In addition, cholangiocarcinomas (2/60 males at 900 mg/kg) and cholangioma (1/60 females at 500 mg/kg) were reported in the rat study at a systemic exposure at least 15-times the expected free human exposure.
Maltese: Barra minn hekk, kolanġiokarċinomi (2/60 raġel b'900 mg/kg) u kolanġioma (1/60 mara b'500 mg/kg) kienu rappurtati fl-istudju tal-ġrieden b'esponiment sistemiku mill-anqas 15-il darba l-esponiment ħieles mistenni filbniedem.
English: At higher exposure of maraviroc a potential inhibition of CYP2D6 cannot be excluded.
Maltese: F'espożizzjoni ogħla ta' maraviroc, inibizzjoni potenzjali ta' CYP2D6 ma tistax tiġi eskluża.
English: You need to know about important signs and symptoms to look out for while you're taking CELSENTRI.
Maltese: Għandek tkun taf dwar sinjali u sintomi importanti li trid toqgħod attent għalihom waqt li tkun qed tieħu CELSENTRI.
English: Maraviroc was not mutagenic or genotoxic in a battery of in vitro and in vivo assays including bacterial reverse mutation, chromosome aberrations in human lymphocytes and mouse bone marrow micronucleus.
Maltese: Maraviroc ma kienx mutaġeniku jew ġenotossiku f'għadd ta' analiżi in vitro u in vivo li kienu jinkludu mutazzjoni batterika bil-kontra, aberrazzjoni ta' kromosomi f'limfoċiti umani u mikronukleju talmudullun tal-għadam tal-ġrieden.
English: Blister Strip of 10 tablets of 150 mg maraviroc film-coated tablets
Maltese: Strixxa tal-Folji ta' 10 pilloli ta' 150 mg maraviroc pilloli miksijin b'rita
English: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, In-Netherlands.
English: Pegylated interferon has not been studied, no interaction is expected.
Maltese: Pegylated interferon ma ġiex studjat, mhija mistennija l-ebda interazzjoni.
English: Study A4001029 was an exploratory study in patients infected with dual/mixed or CXCR4 tropic HIV-1 with a similar design as the studies MOTIVATE 1 and MOTIVATE 2.
Maltese: Studju A4001029 kien studju esploratorju magħmul f'pazjenti infettati b'CXCR4 HIV-1 doppju/mħallat jew tropiku b'disinn simili għall-istudji
English: In case of concomitant antiviral therapy for hepatitis B and/or C, please refer to the relevant product information for these medicinal products.
Maltese: F'każ ta' terapija antiretrovirali konkomitanti għall-epatite B u/jew Ċ, jekk jogħġbok irreferi għall-informazzjoni rilevanti tal-prodott ta' dawn il-prodotti mediċinali.
English: CELSENTRI 75 mg film-coated tablets
Maltese: CELSENTRI 75 mg pilloli miksijin b'rita
English: Elvitegravir/ritonavir 150/100mg QD (maraviroc 150 mg BID)
Maltese: Inibituri ta' Integrase Elvitegravir/ritonavir 150/100mg QD (maraviroc 150 mg BID)
English: HIV-1 clinical isolates resistant to NRTIs, NNRTIs, PIs and enfuvirtide were all susceptible to maraviroc in cell culture.
Maltese: Iżolati kliniċi tal-HIV-1 li kienu reżistenti għal NRTIs, għal NNRTIs, għal PIs u għal enfuvirtide kienu kollha suxxettibli għal maraviroc f'kulturi taċ-ċelluli.
English: boceprevir, telaprevir)  antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)  antifungal medicines (ketoconazole, itraconazole, fluconazole)  anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).
Maltese: • mediċini oħra għall-kura ta' infezzjoni tal-HIV jew tal-epatite Ċ (eż. atazanavir, cobicistat, darunavir, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir)
English: Outer wrapper label on multi packs of 180 (2 packs of 90 film-coated tablets) wrapped in transparent foil - including the blue box - 300 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 - inkluż il-kaxxa l-blu - pilloli miksijin b'rita ta' 300 mg
English: Common side effects
Maltese: Effetti sekondarji oħra
English: CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adults, adolescents and children of 2 years of age, and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable (see sections 4.2 and 5.1).
Maltese: CELSENTRI, flimkien ma' prodotti mediċinali oħra antiretrovirali, huwa indikat għal adulti b'esperjenza ta' kura, adolexxenti u tfal ta' sentejn, jew aktar u li jiżnu tal-inqas 10 kg infettati b'HIV1 CCR5-tropiku biss preżenti f'ammont li jista' jiġi osservat (ara sezzjonijiet 4.2 u 5.1).
English: In vitro studies indicate that CYP3A4 is the major enzyme responsible for maraviroc metabolism.
Maltese: L-istudji in vitro jindikaw li CYP3A4 hija l-enzima prinċipali responsabbli għall-metaboliżmu ta' maraviroc.
English: Co-administration of maraviroc with medicinal products that inhibit CYP3A4 may increase maraviroc plasma concentrations.
Maltese: L-amministrazzjoni ta' maraviroc ma' prodotti mediċinali li jimpedixxu CYP3A4 tista' żżid il-konċentrazzjonijiet ta' maraviroc fil-plasma.
English: Maraviroc selectively binds to the human chemokine receptor CCR5, preventing CCR5-tropic HIV-1 from entering cells.
Maltese: Maraviroc jeħel b'mod selettiv mar-riċettur tal-chemokine uman CCR5, u hekk jimpedixxi lill-HIV-1 CCR5-tropiku milli jidħol fiċ-ċelloli.
English: Exposures observed in subjects with severe renal impairment and ESRD were within the range observed in single maraviroc 300 mg dose studies in healthy volunteers with normal renal function.
Maltese: Esponimenti osservati f'individwi b'indeboliment renali sever u ESRD kienu fil-medda osservata fi studji ta' doża waħda ta' maraviroc 300 mg li saru fuq pazjenti b'saħħithom bil-funzjoni renali normali.
English: a Refer to Table 1 for maraviroc paediatric dosing recommendations when co-administered with antiretroviral therapy and other medicinal products.
Maltese: a Irreferi għal Tabella 1 għal rakkomandazzjonijiet tad-dożaġġ pedjatriku ta' maraviroc meta mogħtija flimkien ma' terapija antiretrovirali jew prodotti mediċinali oħra.
English: Close the bottle tightly with the cap, leaving the adaptor in place.
Maltese: Kindly correct the following SPC in line with the corrections made above where applicable.
English: In patients failing therapy with CCR5-tropic virus only, maraviroc might be considered still active if the MPI value is ≥95% (PhenoSense Entry assay).
Maltese: F'pazjenti li fallew il-kura b'virus CCR5 tropiku biss, maraviroc jista' xorta waħda jkun ikkunsidrat attiv jekk il-MPI huwa ≥95% (Analiżi PhenoSense Entry).
English: Subjects were required to have HIV-1 RNA greater than 1,000 copies per mL at Screening.
Maltese: L-individwi kienu meħtieġa li jkollhom HIV-1 RNA ikbar minn 1,000 kopja għal kull mL waqt l-Iskrinjar.
English: Use of weight (kg)-based doses in treatment-experienced HIV-1-infected paediatrics results in maraviroc exposures similar to those observed in treatmentexperienced adults receiving recommended doses with concomitant medications.
Maltese: L-użu ta' dożi bbażati fuq ilpiż (kg) fi tfal u adoloxxenti infettati bl-HIV-1 esperjenzati bil-kura rriżulta f'esponimenti ta' maraviroc simili għal dawk osservati fl-adulti esperjenzati bil-kura li rċivew dożi rakkomandati b'medikazzjonijiet konkomitanti.
English: Infomed@viivhealthcare.com
Maltese: • diffikultà biex tiċċaqlaq
English: An analysis of tropism following failure of maraviroc therapy with CXCR4using virus in patients with CCR5 virus at baseline, demonstrated that the virus population reverted back to CCR5 tropism in 33 of 36 patients with more than 35 days of follow-up.
Maltese: Analiżi ta' tropiżmu wara li terapija ta' maraviroc ma ħadmitx meta kien hemm virus li juża CXCR4 f'pazjenti bil-virus CCR5 fillinja bażi, uriet li l-popolazzjoni tal-virus marret lura għal tropiżmu CCR5 fi 33 minn 36 pazjent b'iktar minn 35 ġurnata ta' follow-up.
English: Itraconazole, is a potent CYP3A4 inhibitor and would be expected to increase the exposure of maraviroc.
Maltese: Itraconazole huwa inibitur qawwi ta' CYP3A4 u huwa mistenni li jżid l-esponiment ta' maraviroc.
English: Hepatitis toxic, hepatic failure, hepatic cirrhosis, blood alkaline phosphatase increased rare
Maltese: Epatite tossika, insuffiċjenza tal-fwied, ċirrożi tal-fwied, żieda fl-alkaline phosphatase tad-demm rari
English: The impact of potent CYP3A inhibitors and/or inducers on maraviroc pharmacokinetic parameters in paediatric patients was similar to that observed in adults.
Maltese: L-impatt ta' inibituri u/jew indutturi potenti ta' CYP3A fuq il-parametri farmakokinetiċi ta' maraviroc f'pazjenti pedjatriċi kien simili għal dak osservat fl-adulti.
English: Maraviroc AUC12: ↑ 2.86 (2.33-3.51) Maraviroc Cmax: ↑ 2.15 (1.71-2.69) Maraviroc C12: ↑ 4.23 (3.47-5.16) Elvitegravir AUC24: ↔ 1.07
Maltese: Lamivudine AUC12: ↔ 1.13 Lamivudine Cmax: ↔ 1.16 Il-konċentrazzjonijiet ta' maraviroc ma tkejlux, l-ebda effett mhu mistenni.
English: Lamivudine Cmax: ↔ 1.16
Maltese: Ritonavir Cmax: ↓ 0.61
English: Patients who were eligible for these studies had prior exposure to at least 3 antiretroviral medicinal product classes [≥1 NRTIs, ≥1 NNRTIs, ≥2 PIs, and/or enfurvirtide] or documented resistance to at least one member of each class.
Maltese: Il-pazjenti li kienu eleġibbli għal dawn l-istudji kellhom esponiment preċedenti għal mill-inqas 3 klassijiet ta' prodotti mediċinali antiretrovirali [≥1 NRTIs, ≥1 NNRTIs, ≥2 PIs, u/jew enfurvirtide] jew reżistenza dokumentata għal mill-anqas membru wieħed ta' kull klassi.
English: CELSENTRI 25 mg and 75 mg film-coated tablets are supplied in bottles of 120 tablets.
Maltese: Il-pilloli miksijin b'rita CELSENTRI ta' 25 mg u 75 mg jiġu fi fliexken ta' 120 pillola.
English: Therefore, dosing frequencies of longer than 24 hours in subjects with renal impairment may result in inadequate exposures between 24-48 hours.
Maltese: Għalhekk, frekwenzi ta' għoti tad-doża itwal minn 24 siegħa f'individwi b'indeboliment tal-kliewi, jista' jirriżulta f'esponimenti inadegwati bejn 24-48 siegħa.
English: Elvitegravir Cmax: ↔ 1.01 (0.89-1.15) Elvitegravir C24: ↔ 1.09 (0.95-1.26)
Maltese: Elvitegravir AUC24: ↔ 1.07 Elvitegravir Cmax: ↔ 1.01
English: In rabbit, 7 foetuses had external anomalies at maternally toxic doses and 1 foetus at the mid dose of 75 mg/kg.
Maltese: Fil-fenek, f'dożi tossiċi għall-omm, 7 feti kellhom anomaliji esterni u fetu wieħed b'doża tan-nofs ta' 75 mg/kg.
English: However, maraviroc does not significantly affect the pharmacokinetics of digoxin in vivo.
Maltese: Madankollu, maraviroc ma jaffettwax il-farmakokinetika ta' digoxin b'mod sinifikani in vivo.
English: Carton for blister pack containing 150 mg maraviroc film-coated tablets
Maltese: Kull pillola miksija b'rita fiha 150 mg ta' maraviroc.
English: Metabolism and nutrition disorders Anorexia common
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: CELSENTRI is used to treat Human Immunodeficiency Virus type-1 (HIV-1) in adults, adolescents and children of 2 years and older, and weighing at least 10 kg.
Maltese: CELSENTRI jintuża għall-kura tal-Virus tal-Immunodefiċjenza Uman tat-tip I (HIV-1) f'persuni adulti, fl-adoloxxenti u fi tfal ta' sentejn jew aktar, u li jiżnu tal-inqas 10 kg.