FrancophonIA/ELRC3.0 huggingface dataset:
English: Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing atazanavir and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Maltese: Anormalitajiet oħrajn tal-laboratorju (Grad 3 jew 4) li ġew irrapportati f'≥ 2 % tal-pazjenti li jirċievu lkura b'atazanavir flimkien ma' NRTI wieħed jew iżjed inkludew: kreatina kinasi elevata (7 %), serum aminotransferasi/glutamikpiruvik transaminasi elevata (ALT/SGPT) (5 %), newtrofili baxxi (5 %), serum aspartate aminotransferasi/glutamic-oxaloacetic transaminasi (AST/SGOT) (3 %) u lipadosi elevati(3 %).
English: Atazanavir, dosed 1 hr after ddI+d4T (fasted) Atazanavir AUC ↔3% (↓36%
Maltese: Atazanavir, iddożat siegħa wara ddI+d4T (fi stat sajjem) AUC ta' Atazanavir ↔3 % (↓36 %
English: Atazanavir Cmin ↓72% (↓80%
Maltese: Cmin ta' Atazanavir ↓72% (↓80%
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Maltese: Eżempji rilevanti huma cytomegalovirus retinitis, infezzjonijiet ġeneralizzati u/jew mikobatteriċi ffukati, u pulmonite Pneumocystis jirovecii.
English: Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Not calculated
Maltese: Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Mhux ikkalkulat
English: Buprenorphine AUC ↑67% Buprenorphine Cmax ↑37% Buprenorphine Cmin ↑69%
Maltese: AUC ta' Buprenorphine ↑67 % Cmax ta' Buprenorphine ↑37 % Cmin ta' Buprenorphine ↑69 %
English: Following a single 400 mg dose of [14C]atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
Maltese: Wara doża waħda ta 400 mg ta' [14C]atazanavir, 79 % u 13 % tar-radjuattività totali kienu rkuprati fl ippurgar u fl-awrina, rispettivament.
English: Tablet core microcrystalline cellulose (E460(i)) croscarmellose sodium (E468) sodium starch glycolate crospovidone (E1202) stearic acid (E570) magnesium stearate (E470b) hydroxypropyl cellulose (E463) silicon dioxide (E551)
Maltese: Qalba tal-pillola microcrystalline cellulose (E460(i)) croscarmellose sodium (E468) sodium starch glycolate crospovidone (E1202) stearic acid (E570) magnesium stearate (E470b) hydroxypropyl cellulose (E463) silicon dioxide (E551)
English: The percentage of subjects with baseline viral loads >100,000 copies/ml was 39.7%.
Maltese: Il-perċentwali ta' individwi b'ammont virali fil-linja bażi ta' >100,000 kopja/ml kien ta' 39.7%.
English: Metabolites are then excreted in the bile as either free or glucuronidated metabolites.
Maltese: Ilmetaboliti joħorġu fil-bili kemm bħala metaboliti liberi kif ukoll bħala metaboliti glukuronidati.
English: Randomisation was stratified by screening HIV-1 RNA level (≤100,000 copies/ml or >100,000 copies/ml).
Maltese: Ir-randomizzazzjoni kienet stratifikata mil-livell ta' HIV-1 RNA taliskrinjar (≤100,000 kopja/ml jew >100,000 kopja/ml).
English: Film-coating hypromellose (hydroxypropyl methyl cellulose, E464) titanium dioxide (E171) talc (E553b) triacetin (E1518) red iron oxide (E172)
Maltese: Kisja tal-pillola hypromellose (hydroxypropyl methyl cellulose, E464) titanium dioxide (E171) talc (E553b) triacetin (E1518) red iron oxide (E172)
English: Rosuvastatin AUC: ↑ 242% Rosuvastatin Cmax: ↑ 958% Rosuvastatin Cmin: Not calculated
Maltese: AUC: ↑ 242% Rosuvastatin Cmax: ↑ 958% Rosuvastatin Cmin: Mhux ikkalkulat
English: Atazanavir has been studied in adult patients with severe renal impairment (n=20), including those on haemodialysis, at multiple doses of 400 mg once daily.
Maltese: Atazanavir kien studjat f'pazjenti adulti b'indeboliment renali sever (n=20), inkluż dawk fuq l-emodijalisi, f'dożi multipli ta' 400 mg darba kuljum.
English: During in vitro studies, cloned human cardiac potassium channel (hERG), was inhibited by 15% at a concentration (30 μM) of atazanavir corresponding to 30 fold the free drug concentration at Cmax in humans.
Maltese: Waqt studji in vitro , kanal tal-potassju kardijaku uman ikklonjat (hERG), kien impedut bi 15 % f'konċentrazzjoni (30 μM) ta' atazanavir li tikkorrispondi għal 30 darba l-konċentrazzjoni ta' mediċina libera Cmax fin-nies.
English: Atorvastatin 10 mg single dose
Maltese: Atorvastatin 10 mg doża waħdanija
English: Sofosbuvir 400 mg/velpatasvir, 100 mg/voxilaprevir 100 mg single dose* (atazanavir 300 mg with ritonavir 100 mg once daily)
Maltese: Sofosbuvir 400 mg/velpatasvir, 100 mg/voxilaprevir 100 mg doża unika* (atazanavir 300 mg ma' ritonavir 100 mg darba kuljum)
English: Atazanavir Cmin ↔3% (↓39%
Maltese: Cmin ta' Atazanavir ↔3 % (↓39 %
English: Atazanavir AUC ↓94% (↓95% Atazanavir Cmax ↓96% (↓96% Atazanavir Cmin ↓95% (↓97%
Maltese: Atazanavir AUC ↓94% (↓95% Cmax ta' Atazanavir ↓96% (↓96% Cmin ta' Atazanavir ↓95% (↓97%
English: The mechanism of this decrease is unknown (see sections 4.2 and 4.4.)
Maltese: Il-mekkaniżmu ta' dan it-tnaqqis mhuwiex magħruf (ara sezzjonijiet 4.2 u 4.4.)
English: Nevirapine Cmin ↑32% (↑22%
Maltese: Cmin ta' Nevirapine ↑32 % (↑22 %
English: Of these 692 patients, 613 (300 atazanavir with cobicistat and 313 atazanavir with ritonavir) and 496 (250 atazanavir with cobicistat and 246 atazanavir with ritonavir) received at least 48 and 144 weeks of treatment, respectively.
Maltese: Minn dawn is-692 pazjent, 613 (300 atazanavir ma' cobicistat u 313 atazanavir ma' ritonavir) u 496 (250 atazanavir ma' cobicistat u 246 atazanavir ma' ritonavir) irċevew tal-inqas 48 u 144 ġimgħa ta' kura, rispettivament.
English: Some examples include, but are not limited to etravirine, nevirapine, efavirenz, boceprevir, fluticasone and bosentan (see Table 1).
Maltese: Xi eżempji jinkludu, iżda mhumiex limitati għal etravirine, nevirapine, efavirenz, boceprevir, fluticasone u bosentan (ara Tabella 1).
English: Skin and subcutaneous tissue disorders common rash uncommon pruritus, erythema multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia rare
Maltese: Raxx mhux komuni prurite, eritema multiformea,b, eruzzjonijiet tossiċi tal-ġildaa,b, sindrome ta' raxx dovut għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS)a,b, anġjoedemaa, urtikarja, alopeċja rari
English: Belgique/België/Belgien N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Maltese: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: An alternate (non-hormonal) reliable method of contraception is recommended.
Maltese: Huwa rakkomandat metodu alternattiv (mhux ormonali) affidabbli ta' kontraċezzjoni.
English: Atazanavir Cmin ↓46% (↓59%
Maltese: Cmin ta' Atazanavir ↓46% (↓59%
English: AUC: ↔7% (↓11% ↓3%) Cmax: ↓13% (↓20% ↓6%) Cmin: Not determined
Maltese: ↔7 % (↓11 % ↓3 %) Cmax: ↓13 % (↓20 % ↓6 %) Cmin: Mhux determinati
English: The median baseline CD4+ cell count was 352 cells/mm3 (range: 1-1455) and 16.9% had CD4+ cell counts ≤200 cells/mm3.
Maltese: L-għadd taċċelluli ta' CD4+ tal-linja bażi medja kien 352 ċellula/mm3 (medda: 1-1455) u 16.9% kellhom għadd taċ-ċelluli CD4+ ≤200 ċellula/mm3.
English: Electrocardiogram monitoring is recommended.
Maltese: Mhuwiex rakkomandat monitoraġġ ta' elettrokardjogramma.
English: The other ingredients are:
Maltese: Inibituri ta' protease:
English: Some examples include, but are not limited to, itraconazole, ketoconazole and voriconazole (see Table 1).
Maltese: Xi eżempji jinkludu, iżda mhumiex limitati għal, itraconazole, ketoconazole u voriconazole (ara Tabella 1).
English: 14-OH clarithromycin 14-OH clarithromycin AUC ↓70%
Maltese: 14-OH clarithromycin AUC ta' 14-OH clarithromycin
English: Tenofovir disoproxil fumarate (tenofovir DF) 300 mg once daily (atazanavir 400 mg once daily)
Maltese: Tenofovir disoproxil fumarate (tenofovir DF) 300 mg darba kuljum (atazanavir 400 mg darba kuljum)
English: Atazanavir Cmin ↓84% (↓90%
Maltese: Cmin ta' Atazanavir ↓84 % (↓90 %
English: Atazanavir AUC ↓76% (↓78% Atazanavir Cmax ↓72% (↓76% Atazanavir Cmin ↓78% (↓81%
Maltese: AUC ta' atazanavir ↓76 % (↓78 % Cmax ta' Atazanavir ↓72% (↓76% Cmin ta' Atazanavir ↓78% (↓81%
English: Desacetyl-diltiazem AUC ↑165%
Maltese: AUC ta' Diltiazem ↑125 %
English: Nevirapine Cmax ↑17% (↑9%
Maltese: Cmax ta' Nevirapine ↑17 % (↑9 %
English: Raltegravir 400 mg twice daily (atazanavir 400 mg)
Maltese: Raltegravir 400 mg darbtejn kuljum (atazanavir 400 mg)
English: Food effect
Maltese: PRODOTTI
English: A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Maltese: Twettaq studju tal-farmakokinetika ta' cobicistat f'individwi mhux infettati bl-HIV-1 b'indeboliment epatiku moderat (Child-Pugh Klassi B).
English: ERGOT DERIVATES
Maltese: DERIVATTI
English: Cobicistat is primarily metabolised and eliminated by the liver.
Maltese: Cobicistat huwa metabolizzat primarjament u eliminat mill-fwied.
English: Paediatric population Interaction studies have only been performed in adults.
Maltese: Popolazzjoni pedjatrika Studji ta' interazzjoni twettqu biss fl-adulti.
English: CORTICOSTEROIDS
Maltese: KORTIKOSTEROJDI
English: Atazanavir Cmax ↓59% (↓77% Atazanavir Cmin ↓93% (↓95%
Maltese: Cmax ta' Atazanavir ↓59% (↓77% Cmin ta' Atazanavir ↓93% (↓95%
English: The combination of pimozide, quetiapine or lurasidone and EVOTAZ is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' pimozide, quetiapine jew lurasidone u EVOTAZ hija kontraindikata (ara sezzjoni 4.3).
English: Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the co-administered medicinal products (see section 4.4).
Maltese: L-għoti flimkien ta' EVOTAZ f'pazjenti li jingħataw prodotti mediċinali li huma sottostrati tat-trasportaturi ta' P-gp, BCRP, MATE1, OATP1B1 u OATP1B3 jista' jirriżulta f'żieda fil-konċentrazzjonijiet fil-plażma tal-prodotti mediċinali li jingħataw flimkien (ara sezzjoni 4.4).
English: Antihypertensives
Maltese: Anti-ipertensivi
English: Contrada Fontana del Ceraso 03012 Anagni (FR) Italy
Maltese: Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR) Italja
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li sopressjoni virali b'terapija antiretrovirali effettiva ngħatat prova li tnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: These medicinal products include alfuzosin, amiodarone, astemizole, bepridil, cisapride, colchicine, dronedarone, ergot deriviatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine), lovastatin, orally administered midazolam, pimozide, quetiapine, quinidine, lurasidone, simvastatin, sildenafil (when used to treat pulmonary arterial hypertension), avanafil, systemic lidocaine, ticagrelor, terfenadine and triazolam.
Maltese: Dawn il-prodotti mediċinali jinkludu alfuzosin, amiodarone, astemizole, bepridil, cisapride, colchicine, dronedarone, ergot deriviatives (eż. dihydroergotamine, ergometrine, ergotamine, methylergonovine), lovastatin, midazolam mogħti oralment, pimozide, quetiapine, quinidine, lurasidone, simvastatin, sildenafil (meta jintuża biex jikkura pressjoni għolja arterjali pulmonari), avanafil, systemic lidocaine, ticagrelor, terfenadine u triazolam.
English: 25-O-desacetyl-rifabutin: AUC: ↑525% Cmax: ↑384% Cmin: ↑394%
Maltese: ↑525% Cmax: ↑384% Cmin: ↑394%
English: Pink, oval, biconvex, film-coated tablet of approximate dimensions of 19 mm x 10.4 mm, debossed with "3641" on one side and plain on the other side.
Maltese: Pillola miksija b'rita, roża, ovali, bikonvessa b'dimensjonijiet ta' madwar 19 mm x 10.4 mm, imnaqqxa b'“3641” fuq naħa waħda u mingħajr marka n-naħa l-oħra.
English: Atazanavir Cmin ↓40% (↓48%
Maltese: Cmin ta' Atazanavir ↓40% (↓48%
English: Among the 21 subjects, 3 developed the emtricitabine-associated resistance substitution M184V.
Maltese: Fost il-21 individwu, 3 żviluppaw issostituzzjoni għal reżistenza assoċjata ma' emtricitabine M184V.
English: Atazanavir and cobicistat are metabolised by the hepatic system.
Maltese: Atazanavir u cobicistat huma metabolizzati mis-sistema epatika.
English: In a trial where HIV-infected subjects (n=22) were instructed to take atazanavir 300 mg with cobicistat 150 mg once daily with food, the steady-state atazanavir Cmax, AUCtau and Ctau (mean ± SD) values were 3.9 ± 1.9 μg/ml, 46.1 ± 26.2 μg•hr/ml and 0.80 ± 0.72 μg/ml, respectively.
Maltese: Fi prova fejn l-individwi infettati bl-HIV (n=22) ingħataw struzzjonijiet biex jieħdu atazanavir 300 mg ma' cobicistat 150 mg darba kuljum mal-ikel, il-valuri Cmax, AUCtau u Ctau ( ± SD medju) ta' atazanavir fi stat fiss kienu 3.9 ± 1.9 μg/ml, 46.1 ± 26.2 μg•siegħa/ml u 0.80 ± 0.
English: ANTIMYCOBACTERIALS
Maltese: ANTIMIKOBATTERIĊI
English: In the group receiving atazanavir 300 mg co-administered with ritonavir 100 mg, evaluable genotypic data was available for all 19 virologic failures (5%, 19/348).
Maltese: Fil-grupp li rċieva atazanavir 300 mg li ngħata flimkien ma' ritonavir 100 mg, kien hemm disponibbli dejta ġenotipika evalwabbli għad-19-il insuffiċjenza viroloġika kollha (5 %, 19/348).
English: Buprenorphine/naloxone in combination with cobicistat
Maltese: Buprenorphine/naloxone flimkien ma' cobicistat
English: QTc prolongationa, oedema, palpitation
Maltese: Titwil tal-QTca, edema, palpitazzjonijiet
English: Treatment outcomes at weeks 48 and 144 for study GS-US-216-0114 are presented in Table 3.
Maltese: L-eżiti tal-kura fil-ġimgħat 48 u 144 għallistudju GS-US-216-0114 huma ppreżentati fit-Tabella 3.
English: When co-administering tenofovir alafenamide/emtricitabine and EVOTAZ, the recommended dose of tenofovir alafenamide/emtricitabine is 10/200 mg once daily.
Maltese: Meta tenofovir alafenamide/emtricitabine jingħata flimkien ma' EVOTAZ, id-doża rakkomandata ta' tenofovir alafenamide/emtricitabine hija ta' 10/200 mg darba kuljum.
English: Amiodarone, dronedarone, quinidine and systemic lidocaine have a narrow therapeutic window and are contraindicated due to potential inhibition of CYP3A by EVOTAZ (see section 4.3).
Maltese: Amiodarone, dronedarone, quinidine u lidocaine sistemiku għandhom tieqa terapewtika dejqa u huma kontraindikati minħabba linibizzjoni potenzjali ta' CYP3A minn EVOTAZ (ara sezzjoni 4.3).
English: Cobicistat, a component of EVOTAZ, has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Maltese: Cobicistat, komponenti ta' EVOTAZ, intwera li jnaqqas l-eliminazzjoni stmata ta' kreatinina minħabba l-inibizzjoni ta' sekrezzjoni tubulari tal-kreatinina.
English: The median age of subjects was 36 years (range: 19-70).
Maltese: L-età medjana tal-individwi kienet ta' 36 sena (medda: 19-70).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 July 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' Lulju 2015
English: Integrase Inhibitors
Maltese: Inibituri tal-Integrase
English: The mechanism of interaction is inhibition of CYP3A4 and/or CYP2D6 by atazanavir and/or cobicistat.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l-inibizzjoni ta' CYP3A4 u/jew CYP2D6 minn atazanavir u/jew cobicistat.
English: EVOTAZ may be used by adults aged 18 years of age and older who are infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS).
Maltese: EVOTAZ jista' jintuża minn adulti li għandhom 18-il sena jew aktar li jkunu infettati bl-HIV, il-virus li jikkawża s-sindrome tal-immunodefiċjenza umana (AIDS).
English: An increase of > 3 x ULN in alanine aminotransferase or aspartate aminotransferase was recorded in 12.8% of subjects in the cobicistat-boosted group and 9.0% in the ritonavir-boosted group.
Maltese: Żieda ta' > 3 x ULN f'alanine aminotransferase jew aspartate aminotransferase kienet irreġistrata f'12.8 % ta' individwi fil-grupp imsaħħaħ minn cobicistat u 9.0 % fil-grupp imsaħħaħ minn ritonavir.
English: Telaprevir 750 mg three times daily (cobicistat 150 mg once daily in combination with elvitegravir)
Maltese: Telaprevir 750 mg tliet darbiet kuljum (cobicistat 150 mg darba kuljum f'kombinazzjoni ma' elvitegravir)
English: If available, 90% confidence intervals (CI) are shown in parentheses.
Maltese: Jekk ikunu disponibbli, intervalli ta' kunfidenza (CI - confidence interval) ta' 90 % jintwerew f'parentesi.
English: Serious skin rash, including Stevens-Johnson syndrome, may develop in patients taking EVOTAZ.
Maltese: Raxx serju tal-ġilda, inkluż is-Sindrome ta' Stevens-Johnson, jista' jiżviluppa f'pazjenti li jieħdu EVOTAZ.
English: Moderate to severe hepatic impairment.
Maltese: Indeboliment epatiku moderat sa sever.
English: Atazanavir AUC ↓18% (↓25% Atazanavir Cmax ↓20% (↓32% Atazanavir Cmin ↔1% (↓16%
Maltese: AUC ta' Atazanavir ↓18 % (↓25 % Cmax ta' Atazanavir ↓20% (↓32% Cmin ta' Atazanavir ↔1% (↓16%
English: In study GS-US-216-0114, through 144 weeks of treatment hyperbilirubinaemia (> 1 x ULN) was common: 97.7% in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir DF fixed-dose combination group, and 97.4% in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group.
Maltese: Fi studju GS-US-216-0114, wara 144 ġimgħa ta' kura, l-iperbilirubinemja (> 1 x ULN) kienet komuni: 97.7% fil-grupp ta' kombinazzjoni b'doża fissa ta' atazanavir imsaħħaħ b'cobicistat flimkien ma' emtricitabine u tenofovir DF u 97.4% fil-grupp ta' kombinazzjoni b'doża fissa ta' atazanavir imsaħħaħ b'ritonavir flimkien ma' emtricitabine u tenofovir DF.
English: Didanosine (buffered tablets) 200 mg/stavudine 40 mg, both single dose (atazanavir 400 mg single dose)
Maltese: Didanosine (pilloli buffered) 200 mg/stavudine 40 mg, it-tnejn doża waħda (atazanavir 400 mg doża waħda)
English: Rifabutin 150 mg every other day/elvitegravir 150 mg once daily/cobicistat 150 mg once daily
Maltese: Rifabutin 150 mg kull jumejn/elvitegravir 150 mg darba kuljum/cobicistat 150 mg darba kuljum
English: The safety and efficacy of atazanavir with cobicistat in HIV-1 infected patients were evaluated in the randomised, double-blind, active-controlled phase 3 study GS-US-216-0114 in HIV-1 infected patients with baseline estimated creatinine clearance above 70 ml/min who were treatment-naïve (n = 692).
Maltese: Is-sigurtà u l-effikaċja ta' atazanavir ma' cobicistat fil-pazjenti infettati bl-HIV-1 kienu evalwati flistudju GS-US-216-0114 tal-fażi 3 ikkontrollat b'mod attiv, double-blind, randomizzat f'pazjenti infettati bl-HIV-1 b'eliminazzjoni stmata tal-kreatinina fil-linja bażi ‘l fuq minn 70 ml/min li ma rċevewx kura qabel (n = 692).
English: A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 ml/min).
Maltese: Twettaq studju tal-farmakokinetika ta' cobicistat f'individwi li mhumiex infettati bl-HIV-1 b‘indeboliment renali sever (eliminazzjoni stmata tal-kreatinina taħt 30 ml/min).
English: In study GS-US-216-0114, decreases in estimated creatinine clearance occurred early in treatment with cobicistat, after which they stabilised.
Maltese: Fl-istudju GS-US-216-0114, kien hemm tnaqqis fit-tneħħija stmata fil-kreatinina fil-kura b'cobicistat, li wara stabbilizza.
English: The most frequently reported laboratory abnormality in patients receiving regimens containing atazanavir and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect [unconjugated] bilirubin (87% Grade 1, 2, 3, or 4).
Maltese: L-anormalità tal-laboratorju li l-aktar li ġiet irrapportata f'pazjenti b'kura b'atazanavir wieħed jew iżjed kienet żieda ta' bilirubin totali rrapportata predominantament bħala bilirubin għoli indirett [mhux konjugat] (87 % grad 1, 2, 3 jew 4).
English: Increased plasma concentrations of medicinal products that are metabolised by CYP3A (including atazanavir) are observed on co-administration with cobicistat.
Maltese: Huma osservati żidiet fil-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li huma metabolizzati minn CYP3A (inkluż atazanavir) bl-għoti flimkien ma' cobicistat.
English: Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Maltese: Cobicistat huwa inibitur selettiv ibbażat fuq il-mekkaniżmu taċ-ċitokromi P450 tas-sottofamilja CYP3A.
English: The active substances are atazanavir and cobicistat.
Maltese: Is-sustanzi attivi huma atazanavir u cobicistat.
English: Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported with the use of atazanavir (see section 4.4).
Maltese: Is-sindrome ta' Stevens-Johnson (SJS), eritema multiforme, eruzzjonijiet tossiċi tal-ġilda u s-sindrome ta' raxx dovut għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS) ġew irrapportati mal-użu ta' atazanavir (ara s-sezzjoni 4.4).
English: ERECTILE DYSFUNCTION
Maltese: DISFUNZJONI ERETTILI
English: Atazanavir is primarily hepatically metabolised and increased plasma concentrations were observed in patients with hepatic impairment (see sections 4.2 and 5.2).
Maltese: Atazanavir huwa primarjament metabolizzat mill-fwied u ġew osservati żidiet fil-konċentrazzjoni filplażma ta' pazjenti b'indeboliment epatiku (ara sezzjonijiet 4.2 u 5.2).
English: Cobicistat Cobicistat has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Cobicistat Cobicistat ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ).
English: Atazanavir concentrations were greatly decreased when co-administered with didanosine (buffered tablets) and stavudine.
Maltese: Il-konċentrazzjonijiet ta' atazanavir naqsu ħafna meta ngħata flimkien ma' didanosine (pilloli buffered) u stavudine.
English: It is important to tell your doctor if you are taking: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Maltese: Hu importanti li tgħid lit-tabib tiegħek jekk qed tieħu:: Kortikosterojdi inklużi betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
English: Similar concentrations of atazanavir increased by 13% the action potential duration (APD90) in rabbit Purkinje fibres study.
Maltese: Konċentrazzjonijiet simili ta' atazanavir żiedu bi 13 % iż-żmien li fih tista' ssir azzjoni (APD90) fi studju ta' fibri tal-fenek Purkinje.
English: Other medicines and EVOTAZ
Maltese: Mediċini oħra u EVOTAZ
English: The mechanism of interaction is CYP3A4 inhibition by atazanavir, cobicistat and ketoconazole or itraconazole.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l-inibizzjoni ta' CYP3A4 minn atazanavir, cobicistat u ketoconazole jew itraconazole.
English: Nervous system disorders common headache, dizziness, somnolence, dysgeusia uncommon peripheral neuropathy, syncope, amnesia
Maltese: Disturbi fis-sistema nervuża komuni uġigħ ta' ras, sturdament, ngħas, disgewżja mhux komuni newropatija periferali, sinkope, amnesija
English: Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving atazanavir (see section 4.8).
Maltese: Kien hemm livelli għoljin riversibbli fil-bilirubin indirett (mhux konjugat) assoċjati mal-inbizzjoni talUDP-glucuronosil transferasi (UGT) f'pazjenti li ħadu atazanavir (ara sezzjoni 4.8).
English: The mechanism of interaction is inhibition of CYP2D6 by cobicistat.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l-inibizzjoni ta' CYP2D6 minn cobicistat.
English: Telaprevir 750 mg three times daily (atazanavir/ritonavir 300/100 mg once daily)
Maltese: Telaprevir 750 mg tliet darbiet kuljum (atazanavir/ritonavir 300/100 mg darba kuljum)