FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Convenia exceed the risks for the treatment of dogs and cats with certain specified skin, soft tissue and urinary tract infections and recommended that Convenia should be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Convenia jisboq ir-riskji għat-trattament tal-klieb u l-qtates li għandhom ċerti infezzjonijiet fil-ġilda, tessut artab jew fil-pajp ta' l-awrina u jirrakkomanda li Convenia jingħata awtorizzazzjoni għattqegħid fis-suq.
English: If any symptoms occur after accidental exposure to Convenia, for example a skin rash, then the advice of a doctor should be sought immediately.
Maltese: Jekk ikun hemm xi sintomi wara esponiment aċċidentali għal Convenia, eżempju raxx fil-ġilda, wieħed għandu jikkonsulta lil tabib minnufih.
English: It is generally given as a single injection, and the effect of the injection lasts for up to 14 days.
Maltese: Ġeneralment jingħata bħala injezzjoni waħda, u l-effett ta' l-injezzjoni jdum sa 14-il ġurnata.
English: Convenia is used in dogs to treat skin and soft tissue infections; these are infections on the skin and in the layers just below the skin, such as wounds, abscesses and pyoderma (a skin infection with a rash and pustules).
Maltese: Convenia jintuża fil-klieb biex jikkura infezzjonijiet tal-ġilda u tat-tessut artab; dawn huma infezzjonijiet fuq il-ġilda u fis-saffi li jinsabu eżattament taħt il-ġilda, bħal ġrieħi, axxessi u pijoderma (infezzjoni tal-ġilda li toħroġ bħala raxx u bżieżaq bil-materja).
English: The active substance in Convenia is cefovecin which belongs to a class of antibiotics called third generation cephalosporins.
Maltese: Is-sustanza attiva f'Convenia hija cefovecon li hija parti minn klassi ta' antibijotiċi li jissejħu cephalosporins tat-tielet ġenerazzjoni.
English: Convenia has also been studied in cats with skin and soft tissue infections (where it was compared to another antibiotic containing amoxicillin and clavulanic acid), and in a small study in cats with urinary tract infections, where it was compared with cefalexin.
Maltese: Antibijotiċi tat-tip cephalosporin u peniċillin jistgħu jikkawżaw allerġiji fin-nies, u xi kultant dawn lallerġiji jistgħu ikunu serji.
English: Swelling of the face, lips or eyes, or any difficulty breathing are more serious symptoms and require urgent medical attention.
Maltese: Nefħa fil-wiċċ, xofftejn jew għajnejn, jew diffikultajiet fin-nifs huma sintomi aktar serji u jeħtieġu attenzjoni medika urġenti.
English: All these cephalosporin antibiotics, including cefovecin, kill bacteria by disrupting the building of the bacterial cell walls, so the bacteria die and the infection is cured.
Maltese: Dawn l-antibijotiċi cephalopsorins kollha, inkluż cefovecin joqtlu 'l-batterji billi jfixklu l-bini tal-ħitan taċ-ċelluli batterjali, biex il-batterji jmutu u b'hekk tfieq linfezzjoni.
English: --1 ≥ 50x106 CD54+ cells/250mL
Maltese: --1 ≥ 50x106 ċelloli CD54+/250 mL
English: dispersion for infusion Intravenous use Bag
Maltese: Dispersjoni għal infużjoni Użu għal ġol-vini
English: Pack size
Maltese: Borża
English: Strength Pharmaceutical Form Route of Administration
Maltese: Prodott mediċinali li m'għadux awtorizzat
English: boceprevir, telaprevir)
Maltese: saquinavir, boceprevir, telaprevir)
English: • telaprevir and boceprevir.
Maltese: • telaprevir u boceprevir.
English: Total bilirubin
Maltese: Bilirubin Totali
English: Angina pectoris rare
Maltese: Anġina pectoris rari
English: Oral solution Pfizer Service Company Hoge Wei 10
Maltese: Soluzzjoni orali Pfizer Service Company Hoge Wei 10
English: HERBAL PRODUCTS St. John's Wort (Hypericum Perforatum)
Maltese: St John's Wort (Hypericum Perforatum)
English: Limit
Maltese: Limitu
English: ANTIVIRALS Anti-HBV Pegylated interferon
Maltese: Anti-HBV Pegylated interferon
English: Laboratory parameter
Maltese: Parametru tal-laboratorju
English: ViiV Healthcare sprl/bvba Belgique/Belgien Tél/Tel: + 32 (0) 10 85 65 00
Maltese: Luxembourg/Luxemburg ViiV Healthcare sprl/bvba Belgique/Belgien Tél/Tel: + 32 (0) 10 85 65 00
English: Citric acid (anhydrous) Sodium citrate dihydrate Sucralose
Maltese: Aċidu ċitriku (anhydrous) Sodium citrate dihydrate Sucralose
English: 22.5% Odds ratio: 4.76
Maltese: 56.1% 22.5% Proporzjon ta' probabbiltà: 4.76
English: Film-coat: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).
Maltese: Kisja tar-rita: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, leċitina tassojja, indigo carmine aluminium lake (E132).
English: Pfizer Service Company, Hoge Wei 10, B 1930 Zaventem, Belgium
Maltese: Pfizer Service Company, Hoge Wei 10, B 1930
English: • itraconazole, voriconazole, clarithromycin and telithromycin,
Maltese: • itraconazole, voriconazole, clarithromycin u telithromycin,
English: Age (years) (Range, years)
Maltese: Età (snin) (Medda, snin)
English: • antifungal medicines (ketoconazole, itraconazole, fluconazole)
Maltese: • mediċini antifungali (ketoconazole, itraconazole, fluconazole).
English: Store below 30 °C.
Maltese: Aħżen f'temperatura taħt 30 C.
English: • antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)
Maltese: • antibijotiċi (clarithromycin, telithromycin, rifampicin, rifabutin)
English: Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090
Maltese: Pfizer Manufacturing Deutschland GmbH, Betriebsstātte Freiburg, Mooswaldallee 1, 79090 Freiburg, Il-Ġermanja.
English: 30 to less than 40 kg at least 40 kg
Maltese: 30 sa inqas minn 40 kg tal-inqas 40 kg
English: efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir,
Maltese: darunavir, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir,
English: Failure with CCR5-tropic virus
Maltese: Falliment bil-virus tropiku CCR5
English: ANTICONVULSANTS Carbamezepine, Phenobarbital, Phenytoin
Maltese: Carbamezepine, Phenobarbital, Phenytoin
English: • headache, problems sleeping,depression
Maltese: • uġigħ ta' ras, problemi ta' rqad, depressjoni
English: CELSENTRI film-coated tablets are blue coloured with “MVC 25”, “MVC 75”, “MVC 150” or “MVC 300”.
Maltese: Il-pilloli miksijin b'rita CELSENTRI huma ta' lewn blu mnaqqxa b'“MVC 25”, “MVC 75”, “MVC 150” jew “MVC 300”.
English: ViiV Healthcare UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Maltese: United Kingdom ViiV Healthcare UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: 230 ml oral solution
Maltese: 230 ml soluzzjoni orali
English: Other possible side effects of combination therapy for HIV
Maltese: Effetti sekondarji possibbli oħra ta' terapija kombinata għall-HIV
English: Pancytopenia, granulocytopenia rare
Maltese: Panċitopenija, granuloċitopenija rari
English: Etravirine and lopinavir/ritonavir, saquinavir/ritonavir or atazanavir/ritonavir
Maltese: Etravirine u lopinavir/ritonavir, saquinavir/ritonavir jew atazanavir/ritonavir
English: Baseline CD4+ (cells/µL):
Maltese: Bażi ta' CD4+(ċelluli/uL):
English: Maraviroc inhibits P-glycoprotein in vitro (IC50 is 183 μM).
Maltese: Maraviroc jinibixxi l-glikoproteina P in vitro (IC50 huwa ta' 183 μM).
English: • The active ingredient in CELSENTRI is maraviroc.
Maltese: • Is-sustanza attiva f'CELSENTRI hi maraviroc.
English: DRUG ABUSE Methadone
Maltese: TA' DROGA Methadone
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjenti
English: Virologic Escape
Maltese: Evitar Viroloġiku
English: • anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).
Maltese: • mediċini antikonvulsanti (carbamazepine, phenytoin, phenobarbital).
English: Screening HIV-1 RNA (copies/mL):
Maltese: Skrinjar HIV-1 RNA (kopji/mL):
English: Anaemia common
Maltese: Anemija komuni
English: Efavirenz and atazanavir/ritonavir or darunavir/ritonavir
Maltese: Efavirenz u atazanavir/ritonivir jew darunavir/ritonavir
English: • drowsiness and confusion
Maltese: • ħedla u konfużjoni
English: Stevens-Johnson syndrome / Toxic epidermal necrolysis rare / not known
Maltese: Is-sindrome ta' Stevens-Johnson / Nekrolisi tossika tal-epidermide rari / mhux magħruf
English: ORAL CONTRACEPTIVES
Maltese: KONTRAĊETTIVI ORALI
English: GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
Maltese: Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300
English: Mooswaldallee 1 79090 Freiburg Germany
Maltese: 79090 Freiburg
English: Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Maltese: Qalba tal-pillola: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
English: Maraviroc is primarily metabolized and eliminated by the liver.
Maltese: Maraviroc huwa metabolizzat primarjament u eliminat mill-fwied.
English: CELSENTRI 300 mg film-coated tablets EU/1/07/418/006 (180 tablets) EU/1/07/418/007 (30 tablets) EU/1/07/418/008 (60 tablets) EU/1/07/418/009 (90 tablets) EU/1/07/418/010 (2 x 90 tablets - multipack)
Maltese: CELSENTRI 300 mg pilloli miksijin b'rita EU/1/07/418/006 (180 pillola) EU/1/07/418/007 (30 pillola) EU/1/07/418/008 (60 pillola) EU/1/07/418/009 (90 pillola) EU/1/07/418/010 (2 x 90 pillola - pakkett multiplu)
English: CELSENTRI 150 mg film-coated tablets EU/1/07/418/001 (180 tablets) EU/1/07/418/002 (30 tablets) EU/1/07/418/003 (60 tablets) EU/1/07/418/004 (90 tablets) EU/1/07/418/005 (2 x 90 tablets - multipack)
Maltese: CELSENTRI 150 mg pilloli miksijin b'rita EU/1/07/418/001 (180 pillola) EU/1/07/418/002 (30 pillola) EU/1/07/418/003 (60 pillola) EU/1/07/418/004 (90 pillola) EU/1/07/418/005 (2 x 90 pillola - pakkett multiplu)
English: Gastrointestinal disorders Amylase
Maltese: Disturbi gastro-intestinali Amylase
English: CELSENTRI 20 mg/ml oral solution maraviroc
Maltese: CELSENTRI 20 mg/ml soluzzjoni orali maraviroc
English: Multipack: 180 (2 packs of 90) film-coated tablets
Maltese: U KONTENUT Pakkett multiplu: 180 (2 pakketti ta' 90) pillola miksijin b'rita
English: It may not be excluded that maraviroc can increase the exposure to the P-glycoprotein substrate dabigatran etexilate.
Maltese: Ma jistax jiġi eskluż li maraviroc jista' jżid l-esponiment għas-sustrat tal-glikoproteina P dabigatran etexilate.
English: Maraviroc is bound (approximately 76%) to human plasma proteins, and shows moderate affinity for albumin and alpha-1 acid glycoprotein.
Maltese: Maraviroc jintrabat (madwar 76 %) mal-proteini tal-plasma umana, u juri affinità moderata għallalbumin u l-glikoproteina tal-aċidu alpha-1.
English: • tuberculosis (TB) or serious fungal infections.
Maltese: • tuberkulożi (TB) jew infezzjoni fungali serja .
English: Tropism
Maltese: Tropiżmu
English: ViiV Healthcare (logo)
Maltese: ViiV Healthcare BV
English: A randomised, double-blinded study (MERIT), explored maraviroc versus efavirenz, both in combination with zidovudine/lamivudine (n=721, 1:1).
Maltese: L-istudju randomised u double-blinded (MERIT), qabbel maraviroc ma' efavirenz, it-tnejn mgħotija flimkien ma' zidovudine/lamivudine (n=721, 1:1).
English: CELSENTRI 20 mg/ml oral solution
Maltese: CELSENTRI 20 mg/ml soluzzjoni orali
English: Table 3: Adverse reactions observed in clinical trials or post-marketing System Organ Class
Maltese: Tabella 3: Reazzjonijiet avversi osservati fi provi kliniċi u wara t-tqegħid fis-suq Sistema ta' Klassifika ta' l
English: Rare side effects These may affect up to 1 in 1,000 people:
Maltese: Effetti sekondarji rari Dawnjistgħu jaffettwaw sa persuna 1minn kull 1,000:
English: Sodium benzoate Strawberry flavouring Purified water
Maltese: Sodium benzoate Aromatizzant tal-frawli Ilma purifikat
English: Film-coat
Maltese: Sess maskil
English: The population was 52% female and 69% black, with mean age of 10 years (range: 2 years to 17 years).
Maltese: Il-popolazzjoni kienet 52 % nisa u 69 % suwed, b'età medja ta' 10 snin (medda: sentejn sa 17-il sena).
English: The C max (CV%) was 335.6 ng/mL (87%) in healthy volunteers (normal renal function); 801.2 ng/mL (56%) in severe renal impairment; 576.7 ng/mL (51%) in ESRD (dosing after dialysis) and 478.5 ng/mL (38%) in ESRD (dosing before dialysis).
Maltese: Is-C max (CV%) kienet 335.6 ng/mL (87%) fil-voluntiera b'saħħithom (funzjoni renali normali); 801.2 ng/mL (56%) f'dawk b'indeboliment renali sever; 576.7 ng/mL (51%) f'ESRD (doża mogħtija wara d-dijalisi) u 478.5 ng/mL (38%) f'ESRD (doża mogħtija qabel id-dijalisi).
English: For combination with etravirine + PI, see below.
Maltese: Għallkombinazzjoni ma' etravirine + PI, ara hawn taħt.
English: Table 1.
Maltese: Tabella 7:
English: celsentri 150 mg
Maltese: 150 mg darbtejn kuljum
English: • The other ingredients are: citric acid (anhydrous), sodium citrate dihydrate, sucralose, sodium benzoate, strawberry flavouring (501440T), purified water
Maltese: • Is-sustanzi l-oħra huma: aċidu ċitriku (anhydrous), sodium citrate dihydrate, sucralose, sodium benzoate, aromatizzant tal-frawli (501440T), ilma purifikat Kif jidher CELSENTRI u l-kontenut tal-pakkett
English: Maraviroc 300 mg twice daily + OBT was superior to placebo + OBT across all subgroups of patients analysed (see Table 7).
Maltese: Maraviroc 300 mg darbtejn kuljum + OBT kien aqwa minn OBT waħdu fis-sottogruppi ta' pazjenti kollha analizzati (ara Tabella 7).
English: The adverse reactions are listed by system organ class (SOC) and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi (SOC) u l-frekwenza.
English: Difference1 (Confidence Interval2)
Maltese: Differenza fil-Kura1 (Intervall ta' kunfidenza2)
English: The Long Term Safety/Selected Endpoints (LTS/SE) included death, AIDS-defining events, hepatic failure, Myocardial infarction/cardiac ischaemia, malignancies, rhabdomyolysis and other serious infectious events with maraviroc treatment.
Maltese: Is-Sigurtà Fit-Tul/ Punti ta' Tmiem Magħżula (LTS/SE) inkludew mewta, avvenimenti li jiddefinixxu l-AIDS, indeboliment tal-fwied, infart Mijokardijaku/iskemja kardijaka, malinni, rabdomijoliżi u avvenimenti infettużi serji oħrajn b'kura b'maraviroc.
English: HIV-1 RNA <50 copies/mL Maraviroc 300 mg twice daily + OBT N=426
Maltese: HIV-1 RNA <50 kopja/mL Maraviroc 300 mg darbtejn kuljum+ OBT N=426
English: Maraviroc is metabolised by cytochrome P450 CYP3A4 and CYP3A5.
Maltese: Maraviroc jiġi mmetabolizzat minn ċitokromu P450 CYP3A4 u CYP3A5.
English: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz 600 mg QD (maraviroc 100 mg BID)
Maltese: Inibituri ta' Non-Nucleoside Reverse Transcriptase (NNRTIs) Efavirenz 600 mg QD (maraviroc 100 mg BID)
English: The CYP3A5 allelic frequency depends on ethnicity: the majority of Caucasians (~90%) are poor metabolisers of CYP3A5 substrates (i.e., subjects with no copy of functional CYP3A5 alleles) while approximately 40% of African-Americans and 70% of Sub-Saharan Africans are extensive metabolisers (i.e., subjects with two copies of functional CYP3A5 alleles).
Maltese: Il-frekwenza allelika ta' CYP3A5 tiddependi fuq l-etniċità: il-maġġoranza tal-Kawkasi (~90%) huma metabolizzaturi ħżiena ta' sottostrati ta' CYP3A5 (jiġifieri, individwi bl-ebda kopja ta' alleli funzjonali ta' CYP3A5) filwaqt li madwar 40 % tal-Afrikani-Amerikani u 70 % tal-Afrikani Sub-Saħarjani huma metabolizzaturi estensivi (jiġifieri, individwi b'żewġ kopji ta' alleli funzjonali ta' CYP3A5).
English: Read the information ‘Other possible side effects of combination therapy for HIV' in Section 4 of this leaflet.
Maltese: Aqra l-informazzjoni “Effetti sekondarji possibbli oħra ta' terapija kombinata għall-HIV” f'Sezzjoni 4 ta' dan il-fuljett.
English: Insert the applicator (C) firmly into the adapter.
Maltese: Daħħal l-applikatur (C) sew fl-adapter.
English: celsentri 75 mg
Maltese: 75 mg darbtejn kuljum
English: Etravirine and darunavir/ritonavir (maraviroc 150 mg BID)
Maltese: Etravirine u darunavir/ritonavir (maraviroc 150 mg BID)
English: Percentage of patients with HIV-1 RNA <50 copies/mL
Maltese: Perċentwal ta' pazjenti b'HIV-1 RNA <50 kopja/mL
English: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) Lamivudine 150 mg BID (maraviroc 300 mg BID)
Maltese: Inibituri ta' Nucleoside/Nucleotide Reverse Transcriptase (NRTIs) Lamivudine 150 mg BID (maraviroc 300 mg BID)
English: Repeat steps 3 to 7 in the same way until the whole dose has been taken.
Maltese: Irrepeti l-passi 3 sa 7 bl-istess mod sakemm tkun ittieħdet id-doża kollha.
English: Bottle contents:
Maltese: U KONTENUT Kontenut tal-flixkun:
English: Other metabolites are products of mono-oxidation and are only minor components of plasma radioactivity.
Maltese: Metaboliti oħrajn huma prodotti ta' mono-ossidazzjoni u huma biss komponenti minuri tar-radjuattività fil-plasma.
English: Demographic and Baseline Characteristics
Maltese: Karatteristiċi Demografiċi u tal-linja Bażi
English: In the Week 48 analysis (N=103), non-CCR5 tropic-virus was detected in 5/23 (22%) subjects at virologic failure.
Maltese: Fl-analiżi ta' Ġimgħa 48 (N=103), ġie identifikat virus mhux CCR5 tropiku f'5/23 (22 %) individwi fil-falliment viroloġiku.
English: • kidney problems.
Maltese: • problemi fil-kliewi.
English: The clinical efficacy of maraviroc (in combination with other antiretroviral medicinal products) on plasma HIV RNA levels and CD4+ cell counts have been investigated in two pivotal randomized, double blind, multicentre studies (MOTIVATE 1 and MOTIVATE 2, n=1076) in patients infected with CCR5 tropic HIV-1 as determined by the Monogram Trofile Assay.
Maltese: L-effikaċja klinika ta' maraviroc (flimkien ma' prodotti mediċinali antiretrovirali oħra) fuq il-livelli ta' HIV RNA fil-plasma u l-għadd taċ-ċelloli CD4+ ġew investigati f'żewġ studji ewlenin, double blind, multicentriċi, randomized (MOTIVATE 1 u MOTIVATE 2, n=1076) f'pazjenti infettati bil-virus talHIV-1 CCR5 tropiku kif stabbilit bl-Analiżi Monogram Trofile.
English: Maraviroc had no clinically relevant effect on the pharmacokinetics of midazolam, the oral contraceptives ethinylestradiol and levonorgestrel, or urinary 6β-hydroxycortisol/cortisol ratio, suggesting no inhibition or induction of CYP3A4 in vivo.
Maltese: Maraviroc ma kellux effett kliniku rilevanti fuq il-farmakokinetika ta' midazolam, il-kontraċettivi orali ethinylestradiol u levonorgestrel, jew il-proporzjon 6β-hydroxycortisol/cortisol fl-awrina, li ma jissuġġerixxi l-ebda inibizzjoni jew induzzjoni ta' CYP3A4 in vivo.
English: • ritonavir-boosted protease inhibitors (with the exception of tipranavir/ritonavir),
Maltese: • inibituri tal-protease msaħħa b'ritonavir (għajr tipranavir/ritonavir),
English: Date of first authorisation: 18th September 2007 Date of latest renewal: 20 July 2012
Maltese: Data tal-aħħar tiġdid: 20 ta' Lulju 2012
English: The recommended dose of CELSENTRI is either 150 mg (7.5 ml), 300 mg (15 ml) or 600 mg (30 ml) twice daily, depending on other medicines that you are taking at the same time.
Maltese: Id-doża rakkomandata ta' CELSENTRI hija 150 mg (7.5 ml), 300 mg (15 ml) jew 600 mg (30 ml) darbtejn kuljum, skont il-mediċini l-oħra li inti tkun qed tieħu fl-istess ħin.
English: Etravirine is only approved for use with boosted protease inhibitors.
Maltese: Etravirine huwa approvat biss għall-użu ma' inibituri talprotease rinforzati.
English: The Monogram Trofile assay was used in the clinical studies of CELSENTRI (see sections 4.4 and 5.1).
Maltese: L-analiżi Monogram Trofile intużat fl-istudji kliniċi ta' CELSENTRI (ara sezzjonijiet 4.4 u 5.1).
English: CELSENTRI 75 mg film-coated tablets EU/1/07/418/012
Maltese: CELSENTRI 75 mg pilloli miksijin b'rita EU/1/07/418/012
English: Each film-coated tablet contains 25 mg, 75 mg, 150 mg or 300 mg of maraviroc.
Maltese: Kull pillola miksija b'rita fiha 25 mg, 75 mg, 150 mg jew 300 mg ta' maraviroc.
English: CCR5 antagonists could potentially impair the immune response to certain infections.
Maltese: Antagonisti ta' CCR5 jistgħu potenzjalment ifixklu r-reazzjoni ta' immunità għal ċerti infezzjonijiet.
English: CELSENTRI 25 mg film-coated tablets EU/1/07/418/011
Maltese: CELSENTRI 25 mg pilloli miksijin b'rita EU/1/07/418/011
English: Rash common
Maltese: Raxx komuni
English: Subjects with a functional CYP3A5 (CYP3A5*1 allele) have been shown to have a reduced exposure to maraviroc compared to subjects with defect CYP3A5 activity (e.g., CYP3A5*3, CYP3A5*6, and CYP3A5*7).
Maltese: Individwi b'CYP3A5 funzjonali (allel ta' CYP3A5*1) intwerew li għandhom esponiment imnaqqas għal maraviroc meta mqabbel ma' individwi b'difett flattività ta' CYP3A5 (eż., CYP3A5*3, CYP3A5*6, u CYP3A5*7).
English: In vitro studies have shown that maraviroc does not inhibit OATP1B1, MRP2 or any of the major P450 enzymes at clinically relevant concentrations (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4).
Maltese: Studji in vitro wrew li maraviroc ma jinibixxix OATP1B1, MRP2 jew xi wieħed mill-enzimi P450 prinċipali f'konċentrazzjonijiet kliniċi rilevanti (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 u CYP3A4).
English: Muscle atrophy rare
Maltese: Atrofija tal-muskoli rari
English: The pack contains an oral applicator and a bottle adapter.
Maltese: Il-pakkett fih applikatur orali u adapter tal-flixkun.
English: Pfizer Manufacturing Deutschland GmbH
Maltese: Pfizer Manufacturing Deutschland GmbH Betriebsstātte Freiburg Mooswaldallee 1
English: Darunavir Cmax: ↔ 0.96 Darunavir C12: ↓ 0.77
Maltese: Darunavir AUC12: ↓ 0.86 Darunavir Cmax: ↔ 0.96 Darunavir C12: ↓ 0.77
English: Studies in Adult Patients Co-infected with Hepatitis B and/or Hepatitis C virus
Maltese: Studji fuq Pazjenti Adulti Koinfettati bil-virus tal-Epatite B u/jew l-Epatite Ċ
English: celsentri 300 mg
Maltese: 300 mg darbtejn kuljum
English: The bottle contains 230 ml of maraviroc solution (20 mg/ml).
Maltese: Ilflixkun fih 230 ml ta' soluzzjoni maraviroc (20 mg/ml).
English: In addition, the study compared the pharmacokinetics of multiple dose maraviroc in combination with saquinavir/ritonavir 1000/100 mg BID (a potent CYP3A4 inhibitor) for 7 days in subjects with mild renal impairment (CLcr >50 and ≤80 mL/min, n=6) and moderate renal impairment (CLcr ≥30 and ≤50 mL/min, n=6) to healthy volunteers (n=6).
Maltese: Barra minn hekk, l-istudju qabbel il-farmakokinetika ta' doża multipla ta' maraviroc flimkien ma' saquinavir/ritonavir 1000/100 mg BID (inibitur potenti ta' CYP3A4) għal 7 ijiem bejn individwi li għandhom indeboliment tal-kliewi ħafif (CLcr >50 u 80 mL/min, n=6) u indeboliment tal-kliewi moderat (CLcr 30 u 50 mL/min, n=6), ma' voluntiera b'saħħithom (n=6).
English: The serum adjusted EC90 value in 43 primary HIV-1 clinical isolates was 0.57 (0.06 - 10.7) ng/mL without significant changes between different subtypes tested.
Maltese: Il-valur EC90 aġġustat skont is-serum, fi 43 isolat kliniku primarju, kien 0.57 (0.06 - 10.7) ng/mL mingħajr ebda bdil sinifikanti bejn is-sotto-tipi differenti studjati.
English: Immune reconstitution syndrome
Maltese: Sindrome tar-rikostituzzjoni immuni
English: In vitro studies have shown that maraviroc does not inhibit any of the major renal uptake transporters at clinically relevant concentrations (OAT1, OAT3, OCT2, OCTN1, and OCTN2).
Maltese: Studji in vitro wrew li maraviroc ma jinibixxi l-ebda wieħed mittrasportaturi tal-assorbiment mill-kliewi f'konċentrazzjonijiet klinikament rilevanti (OAT1, OAT3, OCT2, OCTN1, u OCTN2).
English: Study A4001031 is an open-label, multicenter trial in paediatric patients (aged 2 years to less than 18 years) infected with CCR5-tropic HIV-1, determined by the enhanced-sensitivity Trofile assay.
Maltese: Studju A4001031 huwa prova open-label multiċentrika f'pazjenti pedjatriċi (li għandhom sentejn sa inqas minn 18-il sena) infettati bl-HIV-1 CCR5-tropika, determinati mill-assaġġ Trofile ta' sensittività mtejba.
English: Maraviroc is a member of a therapeutic class called CCR5 antagonists.
Maltese: Maraviroc jifforma parti minn klassi terapewtika msejħa antagonisti ta' CCR5.
English: 16.7% Odds ratio: 4.49
Maltese: Proporzjon ta' probabbiltà: 4.49