FrancophonIA/ELRC3.0 huggingface dataset:
English: Age/gender
Maltese: Età/sess
English: John's wort is contraindicated.
Maltese: John's wort huwa kontraindikat.
English: Mylan S.A.S., 117 Allee des Parcs, Saint-Priest, 69800, France
Maltese: Mylan S.A.S., 117 Allee des Parcs, Saint-Priest, 69800, Franza
English: ANTI-RETROVIRALS
Maltese: ANTI-RETROVIRALI
English: Atazanavir is an azapeptide HIV-1 protease inhibitor (PI).
Maltese: Atazanavir huwa azapeptide HIV-1 protease inhibitor (PI).
English: Difference estimate [95% CI]
Maltese: Stima tad-differenzae [95 %CI]
English: Date of first authorisation: 22 August 2016
Maltese: Data ta' l-ewwel awtorizzazzjoni: 22 awissu, 2016
English: Desacetyl-diltiazem Cmax ↑172%
Maltese: Cmax ta' Desacetyl-diltiazem ↑172%
English: ANTIPSYCHOTICS Quetiapine
Maltese: ANTIPSIKOTIĊI Quetiapine
English: McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Maltese: McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, l-Irlanda
English: Generics [UK] Ltd Tel: +44 1707 853000
Maltese: United Kingdom Generics [UK] Ltd Tel: +44 1707 853000
English: Desacetyl-diltiazem Cmin ↑121%
Maltese: Cmin ta' Desacetyl-diltiazem ↑121%
English: Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900 Hungary
Maltese: Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900
English: Without tenofovir
Maltese: Mingħajr tenofovir
English: NA = not applicable.
Maltese: NA = ma japplikax.
English: An alternate reliable method of contraception is recommended.
Maltese: Huwa rakkomandat metodu alternattiv affidabbli ta' kontraċezzjoni.
English: Store below 25°C.
Maltese: Aħżen f'temperatura ta' inqas minn 25ºC.
English: Frequency de novo PI substitution (n=35)
Maltese: Frekwenza de novo PI sostituzzjoni (n=35)a,b
English: Pharmacokinetic Parameter
Maltese: Parametru Farmakokinetiku
English: Diltiazem Cmax ↑98% (↑78%
Maltese: Cmax ta' Diltiazem ↑98% (↑78%
English: ≥100,000 copies/ml
Maltese: ≥100,000 kopja/ml
English: Fluvastatin is partially metabolised by CYP2C9.
Maltese: Fluvastain hu parzjalment metabolizzat minn CYP2C9.
English: 300 mg tenofovir disoproxil fumarate is equivalent to 245 mg tenofovir disoproxil.
Maltese: 300 mg tenofovir disoproxil fumarate huwa ekwivalenti għal 245 mg tenofovir disoproxil.
English: • hypersensitivity (allergic reaction)
Maltese: • sensittività eċċessiva (reazzjoni allerġika)
English: Frequency is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Maltese: Il-frekwenza hija definita bl-użu ta' din ilkonvenzjoni: 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), rari ħafna (< 1/10,000).
English: The M184I/V substitution emerged in 5/26 Atazanavir /ritonavir and 7/26 lopinavir/ritonavir virologic failure patients, respectively.
Maltese: Is-sostituzzjoni ta' M184I/V ħarġet f'5/26 atazanavir/ritonavir u 7/26 pazjenti lopinavir/ritonavir/viroloġiċi li fallew, rispettivament.
English: HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Maltese: John's wort (Hypericum perforatum)
English: Frequency de novo PI substitution (n=26)
Maltese: Frekwenza de novo PI sostituzzjoni (n=26)a ħadd
English: HIV RNA <100,000 copies/ml
Maltese: HIV RNA <100,000 kopja/ml
English: Deutschland Mylan dura GmbH Tel: +49-(0) 6172 888 01
Maltese: Mylan dura GmbH Tel: : +49-(0) 6172 888 01
English: uncommon: hypersensitivity
Maltese: mhux komuni: sensittività eċċessiva
English: Grade 3 or 4 elevation of total bilirubin was noted in 37% (6% Grade 4).
Maltese: Żieda ta' bilirubin totali ta' grad 3 jew 4 ġiet innotata (37% (6 % Grad 4).
English: The proportion of patients with HIV RNA < 400 copies/ml were 53% and 43% for ATV/RTV and 54% and 46% for LPV/RTV at weeks 48 and 96 respectively.
Maltese: Il-proporzjon ta' pazjenti b'HIV RNA < 400 kopja/ml kienu 53% u 43% għal ATV/RTV u 54% u 46% għal LPV/RTV fil-ġimgħat 48 u 96 rispettivament.
English: There were no cases of lactic acidosis observed in the clinical trial AI424-182.
Maltese: Ma kien hemm l-ebda każ ta' aċidożi lattika fil-prova klinika AI424-182.
English: Consistent results were obtained with the last observation carried forward method of analysis (time-averaged difference of 0.11, 97.5% confidence interval [-0.15, 0.36]).
Maltese: Kien hemm riżultati konsistenti bilmetodu ta' analiżi fejn l-aħħar osservazzjoni ġiet mgħoddija ‘l quddiem (differenza fuq medja ta' żmien ta' 0.11, intervall ta' fiduċja 97.5% [-0.15, 0.36]).
English: Diltiazem Cmin ↑142% (↑114%
Maltese: Cmin ta' Diltiazem ↑142% (↑114%
English: The fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82%- 89%).
Maltese: Il-livelli ta' fluticasone propionate fil-plażma żdiedu b'mod sinifikanti, filwaqt li l-livelli intrinsiċi talcortisol naqsu b'madwar 86 % (90 % intervall ta' fiduċja 82-89 %).
English: Week 48: 1.7% [-3.8%, 7.1%] Week 96: 6.1% [0.3%, 12.0%]
Maltese: Ġimgħa 48: 1.7% [-3.8%, 7.1%] Ġimgħa 96: 6.1% [0.3%, 12.0%] Analiżi skont il-protokolle 86 (n=392f)
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Maltese: Eżempji relevanti huma cytomegalovirus retinitis, infezzjonijiet ġeneralizzati u/jew mikobatteriċi ffukati, u Pneumocystis jirovecii pneumonia.
English: Titanium dioxide (E171) Indigo Carmine (E132) Gelatin
Maltese: Titanium dioxide (E171) Indigo Carmine (E132) Ġelatina
English: Atazanavir Mylan is an antiviral (or antiretroviral) medicine.
Maltese: Atazanavir Mylan huwa mediċina antivirali (jew antiretrovirali).
English: Nevirapine AUC ↑26% (↑17%
Maltese: AUC ta' Nevirapine ↑26% (↑17%
English: ANTIMYCOBACTERIAL
Maltese: ANTIMIKOBATTERIĊI
English: Nevirapine Cmin ↑35% (↑25%
Maltese: Cmin ta' Nevirapine ↑35% (↑25%
English: 300 mg capsules
Maltese: 300 mg kapsuli
English: 50 to <100 cells/mm
Maltese: 50 sa <100 ċellula/mm3
English: Metabolites are then excreted in the bile as either free or glucuronidated metabolites.
Maltese: Ilmetaboliti joħorġu fil-bili kemm bħala metaboliti liberi jew bħala metaboliti glukuronidati.
English: Fluvastatin
Maltese: Pravastatin Fluvastatin
English: Norgestimate Cmax ↑68% (↑51%
Maltese: Cmax ta' Norgestimate ↑68% (↑51%
English: 100 mg at least 35
Maltese: 100 mgb mill-inqas 35
English: Atazanavir AUC ↓30% (↓43%
Maltese: AUC ta' Atazanavir ↓30% (↓43%
English: Combination of rifampicin (see section 4.5).
Maltese: Il-kombinazzjoni ta' rifampicin (ara sezzjoni 4.5).
English: - The other ingredients are lactose monohydrate (see section 2, ‘Atazanavir Mylan contains lactose'), crospovidone, magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate (ara sezzjoni 2, “Atazanavir Mylan fih il-lactose”), crospovidone, magnesium stearate.
English: The geometric mean (CV%) for atazanavir Cmin and AUC was 654 (76%) ng/ml and 44185 (51%) ng•h/ml, respectively.
Maltese: Il-medja ġeometrika (CV%) għal atazanavir Cmin u AUC kienet 654 (76%) ng/ml u 44,185 (51%) ng•h/ml, rispettivament.
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 oħra tal-laboratorju (Grad 3 jew 4) li ġew irrapportati f'≥ 2% tal-pazjenti li jirċievu lkura bi 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: Total rifabutin and 25-O-desacetylrifabutin AUC ↑119% (↑78%
Maltese: Total ta' rifabutin u AUC ta' 25-Odesacetyl-rifabutin ↑119% (↑78%
English: Didanosine Cmax ↓38% (↓48%
Maltese: Cmax ta' Didanosine ↓38% (↓48%
English: In clinical studies AI424-397 and AI424-451, paediatric patients 3 months to less than 11 years of age had a mean duration of treatment with atazanavir oral powder of 80 weeks.
Maltese: Fl-istudji kliniċi AI424-397 u AI424-451, il-pazjenti pedjatriċi li kellhom minn 3 xhur sa inqas minn 11-il xahar ta' età kellhom durata ta' kura medja b'atazanavir trab orali ta' 80 ġimgħa.
English: CD4 count <50 cells/mm
Maltese: Għadd CD4 <50 ċellula/mm3
English: Clarithromycin Cmin ↑160%
Maltese: Cmin ta' Clarithromycin ↑160%
English: Diltiazem AUC ↑125% (↑109%
Maltese: AUC ta' Diltiazem ↑125% (↑109%
English: Neither metabolite demonstrated in vitro antiviral activity.
Maltese: L-ebda metabolit in vitro ma wera attività antivirali.
English: ≥ 200 cells/mm
Maltese: ≥200 ċellula/mm3
English: Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristic d
Maltese: Ġimgħa 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 kopja/ml, % skont il-Karattteristika tal-Linjabażid
English: Geometric mean (CV%) AUC ng•h/mL
Maltese: Medja ġeometrika (CV%) AUC ng•h/mL Medja ġeometrika (CV%)
English: Nevirapine Cmax ↑21% (↑11%
Maltese: Cmax ta' Nevirapine ↑21% (↑11%
English: 14-OH clarithromycin
Maltese: Cmax ta' 14-OH clarithromycin
English: ERECTILE DYSFUNCTION PDE5 Inhibitors Sildenafil, tadalafil, vardenafil
Maltese: Sildenafil, tadalafil, vardenafil
English: - The other ingredients are lactose monohydrate, crospovidone, magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, crospovidone, magnesium stearate.
English: High doses of ketoconazole and itraconazole (>200 mg/day) are not recommended.
Maltese: Mhumiex rakkomandati dożi għoljin ta' ketoconazole u itraconazole (>200 mg/kuljum).
English: Elbasvir Cmin: ↑545% (↑451%
Maltese: ↑315% (↑246% Cmin ta' Elbasvir: ↑545% (↑451%
English: Each capsule contains 168 mg lactose monohydrate
Maltese: Kull kapsula fiha 168 mg ta' lactose monohydrate.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily
Maltese: Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
English: Patients co-infected with hepatitis B and/or hepatitis C virus
Maltese: Pazjenti infettati bil-virus ta' l-epatite B u/jew tal-epatite Ċ
English: Atazanavir Cmin ↔3% (↓39%
Maltese: Cmin ta' Atazanavir ↔3% (↓39%
English: Each capsule contains 112 mg lactose monohydrate
Maltese: Kull kapsula fiha 112 mg ta' lactose monohydrate.
English: Atazanavir (am): 2 hr after omeprazole
Maltese: Atazanavir (am): siegħa wara omeprazole
English: • pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores), dysgeusia (impairment of the sense of taste), flatulence
Maltese: • pankreatite (infjammazzjoni tal-pancreas), gastrite (infjammazzjoni ta' l-istonku), stomatitis aphtous (ulċeri tal-ħalq u ponot tad-deni), disgweżja (indeboliment tas-sens tat-togħma), gass ,
English: • interstitial nephritis (kidney inflammation), haematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination)
Maltese: • nefrite interstizjali (infjammazzjoni tal-kliewi), ematurja (demm fl-awrina), proteinurja (eċċess ta' proteina fl-awrina), pollakjurja (żieda fil-frekwenza ta' tibwil)
English: Atazanavir Cmin ↑91% (↑66%
Maltese: Cmin ta' Atazanavir ↑91% (↑66%
English: Norethindrone Cmax ↑67% (↑42%
Maltese: Cmax ta' Norethindrone ↑67 % (↑42
English: 150 mg
Maltese: TA' 150 MG
English: Each capsule contains 84 mg lactose monohydrate
Maltese: Kull kapsula fiha 84 mg ta' lactose monohydrate.
English: 90 hard capsules.
Maltese: 90 kapsula iebsa.
English: Patients should be closely monitored for tenofovir disoproxil fumarate-associated adverse reactions, including renal disorders.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal reazzjonijiet avversi assoċjati ma' tenofovir disoproxil fumarate, inkluż disturbi renali.
English: Didanosine Cmin ↑25% (↓8% ↑69%)
Maltese: Cmin ta' Didanosine ↑25% (↓8%
English: Analyses of data through 96 weeks of treatment demonstrated durability of antiviral activity (Table 5).
Maltese: Analiżi tad-dejta matul is-96 ġimgħa ta' trattament wrew id-durabilità tal-attività antivirali (Tabella 5).
English: Atazanavir binds to both alpha-1-acid glycoprotein (AAG) and albumin to a similar extent (89% and 86%, respectively, at 1,000 ng/ml).
Maltese: Atazanavir jingħaqad kemm mal-glikoproteina alpha-1-acid (AAG) kif ukoll ma' l-albumina bl-istess ammont (rispettivament 89% u 86% f'1,000 ng/ml).
English: For dosing recommendations see section 4.2 and for pharmacokinetic data see section 5.2.
Maltese: Għal rakkomandazzjonijiet tad-dożaġġ, ara sezzjoni 4.2 u għal dejta farmakokinetika ara ssezzjoni 5
English: In clinical trial AI424-182 atazanavir/ritonavir (300/100 mg or 400/100 mg) in combination with zidovudine/lamivudine was administered to 41 pregnant women during the second or third trimester.
Maltese: Fi prova klinika AI424-182, atazanavir/ritonavir (300/100 mg jew 400/100 mg) f'kombinazzjoni ma' zidovudine/lamivudine ngħata lil 41 mara tqila matul it-tieni u t-tielet trimestru.
English: Atazanavir Cmin ↓84% (↓90%
Maltese: Cmin ta' Atazanavir ↓84% (↓90%
English: A dose reduction of clarithromycin may result in subtherapeutic concentrations of 14-OH clarithromycin.
Maltese: Tnaqqis fid-doża ta' clarithromycin jista' jirriżulta f'konċentrazzjonijiet subterapewtiċi ta' 14-OH clarithromycin.
English: Ethinyloestradiol AUC ↓19%
Maltese: AUC ta' Ethinyloestradiol↓19%
English: Atazanavir (without ritonavir) has been studied in adult subjects with moderate-to-severe hepatic impairment (14 Child-Pugh Class B and 2 ChildPugh Class C subjects) after a single 400 mg dose.
Maltese: Atazanavir (mingħajr ritonavir) ġie studjat fuq individwi adulti b'indeboliment epatiku ta' natura moderata sa severa (14-il individwu b'Child-Pugh tal-Klassi B u żewġ individwi b'Child-Pugh tal-Klassi C) wara doża unika ta' 400 mg.
English: 60 hard capsules.
Maltese: 60 kapsula iebsa.
English: (responder/evaluable)
Maltese: (indiġestjoni)
English: Laboratory abnormalities
Maltese: Anormalitajiet tal-laboratorju
English: Manufacturer
Maltese: PRODOTTI
English: Ethinyloestradiol 35 µg + norethindrone
Maltese: Ethinyloestradiol 35 µg + norethindrone (atazanavir 400 mg darba kuljum)
English: * In a combined analysis from several clinical studies, atazanavir/ritonavir 300/100 mg coadministered with tenofovir disoproxil fumarate 300 mg (n=39) was compared to atazanavir/ritonavir 300/100 mg (n=33).
Maltese: * F'analiżi kombinata minn bosta studji kliniċi, atazanavir/ritonavir 300/100 mg mogħti fl-istess ħin ma' tenofovir disoproxil fumarate 300 mg (n=39) tqabbel ma' atazanavir/ritonavir 300/100 mg (n=33).
English: (See sections 4.2 and 4.4.)
Maltese: ‘(ara sezzjoni 4.3)
English: Atazanavir exhibits anti- HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture.
Maltese: Atazanavir jesibixxi anti-HIV-1 (inkluż l-gruppi kollha ta' organiżmi li evolvew minn antenat wieħed li ġew ittestjati) u anti-HIV 2 attività f'kultura ta' ċelloli.
English: Lovastatin
Maltese: Bepridil
English: The mean AUC(0-∞) was 42% greater in subjects with impaired hepatic function than in healthy subjects.
Maltese: L-AUC(0-∞) medja kienet 42% aktar f'individwi b'indeboliment tal-funzjoni epatika milli f'individwi b'saħħithom.
English: Ritonavir Dose* once daily (mg)
Maltese: Ritonavir Doża* darba kuljum (mg)
English: 2nd Trimester (n=9)
Maltese: 2 trimestru (n=9)
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, materjal kardijaku uman ikklonjat tal-potassju (hERG), kien impedut bi 15% f'konċentrazzjoni (30 μM) ta' atazanavir li tikkorrispondi għal 30 darba l-konċentrazzjoni ta' droga libera Cmax fin-nies.
English: The N88S substitution has been rarely observed in patients with virologic failure on atazanavir (with or without ritonavir).
Maltese: Is-sostituzzjoni ta' N88S rari ġiet osservata f'pazjenti b'indeboliment viroloġiku fuq atazanavir (bil- jew mingħajr ritonavir).
English: Study 138 is an international randomised, open-label, multicenter, prospective trial of treatment naïve patients comparing atazanavir/ritonavir (300 mg/100 mg once daily) to lopinavir/ritonavir (400 mg/100 mg twice daily), each in combination with fixed dose tenofovir disoproxil fumarate/emtricitabine (300 mg/200 mg tablets once daily).
Maltese: Studju 138 huwa prova prospettiva, multiċentri, open-label, randomizzata, internazzjonali ta' pazjent li ma ħadux kura, li tqabbel atazanavir/ritonavir (300 mg/100 mg darba kuljum) ma' lopinavir/ritonavir (400 mg/100 mg darbtejn kuljum), kull waħda flimkien ma' doża fissa ta' tenofovir/disoproxil fumarate/emtricitabine (pilloli ta' 300 mg/200 mg darba kuljum).
English: Sildenafil, tadalafil, and vardenafil are metabolised by CYP3A4.
Maltese: Sildenafil, tadalafil u vardenafil huma metabolizzati minn CYP3A4.
English: Atazanavir AUC ↑7% (↓2% ↑17%) Atazanavir Cmax ↑2% (↓4% ↑8%) Atazanavir Cmin ↑15% (↑2% ↑29%)
Maltese: AUC ta' Atazanavir ↑7% (↓2% Cmax ta' Atazanavir ↑2% (↓4% ↑8%) Cmin ta' Atazanavir ↑15% (↑2% AUC ta' Elbasvir:
English: 30 x 1 hard capsules.
Maltese: 30 x 1 kapsula iebsa.
English: Atazanavir Cmin ↓59% (↓73%
Maltese: Cmin ta' Atazanavir ↓59% (↓73%
English: Cholelithiasis
Maltese: Kolelitjażi
English: The combination of rifampicin and atazanavir is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' rifampicin u atazanavir hija kontraindikata (ara sezzjoni 4.3).
English: PI major L24I, D30N, V32I, L33F, M46IL, I47AV, G48V, I50LV, F53LY,I54ALMSTV, L76V, V82AFLST, I84V, N88DS, L90M; PI minor: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
Maltese: V82AFLST, I84V, N88DS, L90M; PI minuri: L10CFIRV, V11I, E35G, K43T, Q58E, A71ILTV, G73ACST, T74P, N83D, L89V.
English: Antacids and medicinal products containing buffers
Maltese: Antaċidi u prodotti mediċinali li fihom buffers
English: 60 x 1 hard capsules.
Maltese: 60 x 1 kapsula iebsa.
English: • muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles)
Maltese: • muskolotrofija (tnaqqis fil-volum tal-muskoli), artralġja (uġigħ fil-ġogi), mijalġja (uġigħ fil muskoli)
English: Omeprazole 20 mg once daily
Maltese: Famotidine 20 mg darbtejn kuljum
English: Co-administration with products containing St. John's wort (Hypericum perforatum) (see section 4.5).
Maltese: John's wort (Hypericum perforatum) (ara sezzjoni 4.5).
English: Atazanavir Cmin ↔1.3% (↓10%
Maltese: Cmin ta' Atazanavir1.3 % (↓10%
English: Atazanavir AUC ↓22% (↓35%
Maltese: AUC ta' Atazanavir ↓22% (↓35%
English: Atazanavir + saquinavir was shown to be inferior to lopinavir + ritonavir.
Maltese: Atazanavir + saquinavir jidher li hu inferjuri għal lopinavir + ritonavir.
English: common: headache; uncommon: peripheral neuropathy, syncope, amnesia, dizziness, somnolence, dysgeusia
Maltese: komuni: uġigħ ta' ras; mhux komuni: newropatija periferali, sinkope, amnesija, sturdament, ħedla, disgwesja
English: Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Maltese: Fost l-1,151 pazjent li ħadu atazanavir 400 mg darba kuljum, 177 pazjent kienu infettati wkoll b'epatite kronika B jew Ċ, u fost 655 pazjent li ħadu atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum, 97 pazjent ġew infettati wkoll b'epatite kronika B jew Ċ.
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-sindromu ta' Stevens-Johnson (SJS), eritema multiforme, eruzzjonijiet tossiċi tal-ġilda u s-sindromu ta' raxx dovut għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms) ġew irrapportati mal-użu ta' atazanavir (ara s-sezzjoni 4.4).
English: Combination of the PDE5 inhibitor sildenafil when used for the treatment of pulmonary arterial hypertension (PAH) only (see section 4.5).
Maltese: Il-kombinazzjoni tal-inibitur PDE5 sildenafil meta użat għall-kura ta' pressjoni għolja arterjali pulmonari (PAH - pulmonary arterial hypertension) biss (ara sezzjoni 4.5).
English: In an open-label, randomised, comparative study following a 26- to 30-week induction phase with atazanavir 300 mg + ritonavir 100 mg once daily and two NRTIs, unboosted atazanavir 400 mg once daily and two NRTIs administered during a 48-week maintenance phase (n=87) had similar antiviral efficacy compared with atazanavir + ritonavir and two NRTIs (n=85) in HIV infected subjects with fully suppressed HIV replication, as assessed by the proportion of subjects with HIV RNA < 50 copies/ml: 78% of subjects on unboosted atazanavir and two NRTIs compared with 75% on atazanavir + ritonavir and two NRTIs.
Maltese: Fi studju randomizzat, komparattiv u b'tikketta mikxufa li sar wara fażi ta' induzzjoni ta' 26 sa 30 ġimgħa b'atazanavir 300 mg + ritonavir 100 mg darba kuljum u żewġ NRTIs, atazanavir mhux imsaħħaħ 400 mg darba kuljum u żewġ NRTIs li ngħataw matul fażi ta' manutenzjoni ta' 48 ġimgħa (n=87) kellhom effikaċja antivirali simili meta mqabbla ma' atazanavir + ritonavir u żewġ NRTIs (n=85) f'individwi infettati bl-HIV b'replikazzjoni tal-HIV kompletament mrażżna, kif ġie vvalutat mill-proporzjon ta' individwi b'HIV RNA < 50 kopja/ml: 78% tal-individwi fuq atazanavir mhux imsaħħaħ u żewġ NRTIs meta mqabbla ma' 75% fuq atazanavir + ritonavir u żewġ NRTIs.
English: Atazanavir Cmax ↑12% (↑1% ↑24%) Atazanavir Cmin ↑23% (↑13%
Maltese: AUC ta' Atazanavir ↑43% (↑30% Cmax ta' Atazanavir ↑12% (↑1% Cmin ta' Atazanavir ↑23% (↑13% AUC ta' Grazoprevir:
English: (n=90
Maltese: (n=90 e)
English: Interaction studies have only been performed in adults.
Maltese: Studji ta' interazzjoni twettqu biss f‘adulti.
English: Atazanavir (am): 1 hr after omeprazole
Maltese: Atazanavir (am): sagħtejn wara omeprazole
English: , angioedema a, urticaria, alopecia, pruritus; rare: Stevens-Johnson syndrome a,b
Maltese: urtikarja, alopeċja, ħakk; rari: is-sindromu ta' Stevens-Johnsona,b, raxx bl-infafet,
English: The most frequently reported laboratory abnormalities in paediatric patients receiving atazanavir oral powder was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4; 16%) and increased amylase (Grade 3-4; 33%), generally of non-pancreatic origin.
Maltese: L-anormalitajiet tal-laboratorju rrapportati liktar ta' spiss fil-pazjenti pedjatriċi li kienu qegħdin jirċievu atazanavir trab orali kienu żieda filbilirubina totali (≥2.6 darbiet ULN, Grad 3-4; 16%) u żieda fl-amylase (Grad 3-4; 33%), ġeneralment ta' oriġini mhux pankreatika.
English: Week 48
Maltese: Ġimgħa 48
English: Weight and metabolic parameters
Maltese: Parametri metaboliċi
English: (range: 2 to 800 cells/ mm 3) and mean baseline plasma HIV 1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml).
Maltese: sa 800 ċellula/mm3) u linja bażi medja tal-HIV 1 RNA fil-plażma ta' 4.67 log10 kopji/ml (medda 3.70 sa 5.00 log10 kopji/ml).