FrancophonIA/ELRC3.0 huggingface dataset:
English: Each capsule of REYATAZ 300 mg contains 300 mg atazanavir.
Maltese: Kull kapsula ta' REYATAZ 300 mg fiha 300 mg atazanavir.
English: uncommon: nephrolithiasisa, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea; rare: kidney pain
Maltese: mhux komuni: nefrolitjażia, ematurja, proteinurja, pollakurja; nefrite interstizjali, mard tal-kliewi kronikua; rari: uġigħ fil-kliewi
English: Fifteen of 120 (13%) patients in the REYATAZ + ritonavir treatment arm and 17 of 123 (14%) patients in the lopinavir + ritonavir arm had four or more of the PI substitutions L10, M46, I54, V82, I84, and L90.
Maltese: Ħmistax mill-120 (13 %) pazjent li ħadu REYATAZ + fergħa ta' trattament ta' ritonavir u 17 mill-123 (14 %) pazjent li ħadu fergħa ta' lopinavir + ritonavir kellhom erba' sostituzzjonijiet ta' L10, M46, I54, V82, I84, u L90 jew iżjed.
English: Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir Cmax : ↑29% (↑15% ↑45%) Pibrentasvir Cmin: ↑129% (↑95%
Maltese: ↑64% (↑48% Cmax ta' pibrentasvir: ↑29% (↑15% Cmin ta' pibrentasvir:
English: CORTICOSTEROIDS Fluticasone propionate intranasal 50 µg 4 times daily for 7 days (ritonavir 100 mg capsules twice daily)
Maltese: KORTIKOSTEROJDI Fluticasone propionate li jingħata minn ġol-imnieħer 50 µg 4 darbiet kuljum għal 7 ijiem (ritonavir 100 mg kapsuli darbtejn kuljum)
English: Additional minor metabolic pathways consist of N-dealkylation and hydrolysis.
Maltese: Passaġġi metaboliċi oħra huma N-dealkilazzjoni u idrolisi.
English: , drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia, pruritus;
Maltese: , eruzzjonijiet tossiċi tal-ġildaa,b, sindromu ta' raxx dovut għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms)a,b, anġjoedemaa, urtikarja, alopeċja, ħakk;
English: Assessment of the pharmacokinetics, safety, tolerability, and efficacy of REYATAZ is based on data from the open-label, multicenter clinical trial AI424-020 conducted in patients from 3 months to 21 years of age.
Maltese: Evalwazzjoni tal-farmakokinetika, is-sigurtà, it-tollerabilità u l-effikaċja ta' REYATAZ huma bbażati fuq tagħrif miġbur mill-prova klinika, open-label, multiċentrika AI424-020, li saret fuq pazjenti bejn letajiet ta' 3 xhur sa 21 sena.
English: Study 138 is an international randomised, open-label, multicenter, prospective trial of 883 antiretroviral treatment naive patients comparing REYATAZ/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: F'pazjenti adulti li ma jkunux ħadu kura antiretrovirali qabel Studju 138 huwa prova prospettiva, multiċentri, open-label, randomizzata, internazzjonali ta' 883 pazjent li ma ħadux kura antiretrovirali, li tqabbel REYATAZ/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: The most frequently reported laboratory abnormalities in paediatric patients receiving REYATAZ 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' spissfil-pazjenti pedjatriċi li kienu qegħdin jirċievu REYATAZ 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: common: rash; uncommon: erythemia multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia, pruritus; rare: Stevens-Johnson syndromea,b, vesiculobullous rash, eczema, vasodilatation
Maltese: mhux komuni: eritema multiformea,b, eruzzjonijiet tossiċi tal-ġildaa,b, sindromu ta' raxx dovut għall-mediċina b'esinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms)
English: HIV RNA <50 copies/ml, % All patientsd
Maltese: HIV RNA <50 kopji/ml, % a Il-pazjenti kollha
English: Risk Management plan (RMP)
Maltese: Pjan tal-ġestjoni tar-riskju (RMP)
English: Ritonavir Dose once daily (mg)
Maltese: Ritonavir Doża darba kuljum (mg)
English: uncommon: nephrolithiasis a, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea; rare: kidney pain
Maltese: mhux komuni: nefrolitjażia, ematurja, proteinurja, pollakurja; nefrite interstizjali, mard tal-kliewi kroniku a;
English: 250 mg (5 sachetsb)
Maltese: 250 mg (5 qratasa)
English: HIV RNA <400 copies/ml, % a All patients
Maltese: HIV RNA <400 kopji/ml, % a Il-pazjenti kollha
English: Atazanavir AUC ↔6% (↓10% ↑26%)
Maltese: AUC ta' Atazanavir ↔6 % (↓10 %
English: Each sachet of REYATAZ 50 mg oral powder contains 50 mg atazanavir.
Maltese: Kull qartas ta' REYATAZ 50 mg trab orali fih 50 mg atazanavir.
English: Sofosbuvir 400 mg / velpatasvir 100 mg / voxilaprevir 100 mg single dose* (atazanavir 300 mg / ritonavir 100 mg once daily)
Maltese: Sofosbuvir 400 mg / velpatasvir 100 mg / voxilaprevir 100 mg doża waħda* (atazanavir 300 mg / ritonavir 100 mg darba kuljum)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of 1.5 g oral powder contains 50 mg of atazanavir (as sulphate).
Maltese: Kull qartas ta' 1.5 g trab orali fih 50 mg ta' atazanavir (bħala sulphate).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REYATAZ 50 mg ORAL POWDER - FOIL SACHET 1.
Maltese: Ż-ŻGĦAR EWLENIN REYATAZ 50 mg TRAB ORALI - QARTAS TA' FOLJA 1.
English: Capsule contents: crospovidone, lactose monohydrate and magnesium stearate Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171) Blue ink containing: shellac, propylene glycol, ammonium hydroxide and indigocarmin (E132) White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Maltese: Kontenut tal-kapsula: crospovidone, lactose monohydrate u magnesium stearate Qoxra tal-kapsula: gelatine, indigocarmin (E132) u titanium dioxide (E171) Linka blu li fiha: shellac, propylene glycol, ammonium hydroxide u indigocarmin (E132) Linka bajda li fiha: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol u simethicone
English: The combination of rifampicin and REYATAZ is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' rifampicin u REYATAZ hija kontraindikata (ara sezzjoni 4.3).
English: 250 mg (5 sachets a)
Maltese: 200 mg (4 qratas a)
English: REYATAZ 150 mg hard capsules
Maltese: REYATAZ 150 mg kapsuli ibsin
English: The most frequently reported laboratory abnormality in patients receiving regimens containing REYATAZ 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 bi REYATAZ u NRTI wieħed jew iżjed kienet żieda ta' bilirubin totali rrapportata predominantament bħala bilirubin għoli indirett [mhux konjugat] (87 % grad 1, 2, 3 jew 4).
English: Musculoskeletal and connective tissue disorders:
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi:
English: REYATAZ is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Maltese: REYATAZ huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: The geometric mean (CV%) for atazanavir Cmin and AUC were 120 (109) ng/ml and 14874 (91) ng•h/ml, respectively.
Maltese: Il-medja ġeometrika (CV %) għas-Cmin u lAUC ta' atazanavir kienu ta' 120 (109) ng/ml u ta' 14,874
English: PHARMACEUTICAL FORM AND CONTENTS Carton and label bottle pack (1 bottle): 60 hard capsules Blister pack: 60 hard capsules
Maltese: U KONTENUT Kartuna u tikketta tal-pakkett tal-fliexken (1 flixkun): 60 kapsuli ibsin Pakkett tal-folji: 60 kapsuli ibsin
English: Paediatric trials with REYATAZ oral powder
Maltese: Provi kliniċi b'REYATAZ trab orali
English: Atazanavir Cmax ↔9% (↓5% ↑26%)
Maltese: Cmax ta' Atazanavir ↔9 % (↓5 %
English: REYATAZ (without ritonavir) 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: REYATAZ (mingħajr ritonavir) kien studjat f'pazjenti adulti b'indeboliment sever tal-kliewi (n=20), li jinkludu dawk fuq l-emodijalisi, f'dożi multipli ta' 400 mg darba kuljum.
English: common: vomiting, diarrhoea, abdominal pain, nausea, dyspepsia; uncommon: pancreatitis, gastritis, abdominal distension, stomatitis aphthous, flatulence, dry mouth
Maltese: komuni: rimettar, dijarea, uġigħ addominali, dardir, dispepsja; mhux komuni: pankreatite, gastrite, distensjoni addominali, stomatite aphthous, gass fl-istonku, ħalq xott
English: Norethindrone AUC ↑110% (↑68% Norethindrone Cmax ↑67% (↑42% Norethindrone Cmin ↑262% (↑157%
Maltese: AUC ta' Norethindrone ↑110 % Cmax ta' Norethindrone ↑67 % (↑42 % Cmin ta' Norethindrone ↑262 %
English: Six of 20 (30%) women on REYATAZ/ritonavir 300/100 mg and 13 of 21 (62%) women on REYATAZ/ritonavir 400/100 mg experienced grades 3 to 4 hyperbilirubinaemia.
Maltese: Sitta mill-20 (30 %) mara li kienu fuq REYATAZ/ritonavir 300/100 mg u 13 mill-21 (62 %) mara li kienu fuq REYATAZ/ritonavir 400/100 mg esperjenzaw iperbilirubinemija ta' skala 3 sa 4.
English: Reversible elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase (UGT) have occurred in patients receiving REYATAZ (see section 4.8).
Maltese: Kien hemm livelli għolja riversibbli fil-bilirubin indirett (mhux konjugat) assoċjati ma' l-inibizzjoni tal-UDP-glucuronosil transferasi (UGT) f'pazjenti li ħadu REYATAZ (ara sezzjoni 4.8).
English: Consult the dosing table for the specific formulation (see Summary of Product Characteristics for REYATAZ oral powder).
Maltese: Ikkonsulta t-tabella taddożaġġ għall-formulazzjoni speċifika (ara s-Sommarju tal-Karatteristiċi tal-Prodott għal REYATAZ trab orali).
English: When co-administered with tenofovir disoproxil fumarate, it is recommended that REYATAZ 300 mg be given with ritonavir 100 mg and tenofovir disoproxil fumarate 300 mg (all as a single dose with food).
Maltese: Meta jingħata flimkien ma' tenofovir disoproxil fumarate, huwa rakkomandat li REYATAZ 300 mg jingħata ma' ritonavir 100 mg u tenofovir disoproxil fumarate 300 mg (kollha bħala doża unika malikel).
English: Capsule contents: crospovidone, lactose monohydrate and magnesium stearate Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171) White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Maltese: Kontenut tal-kapsula: crospovidone, lactose monohydrate u magnesium stearate Qoxra tal-kapsula: gelatine, indigocarmin (E132) u titanium dioxide (E171) Linka bajda li fiha: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol u simethicone
English: Glecaprevir 300 mg / pibrentasvir 120 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily*)
Maltese: Glecaprevir 300 mg / pibrentasvir 120 mg darba kuljum (atazanavir 300 mg / ritonavir 100 mg darba kuljum*)
English: Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with REYATAZ/ritonavir (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu mwissija dwar dawn l-effetti sekondarji li jista' jkun hemm meta jintużaw inibituri PDE5 għal disfunzjoni erettili b'REYATAZ/ritonavir (ara sezzjoni 4.4).
English: Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose, malassorbiment ta' glucose galactose jew isomaltase sucrase ma għandhomx jieħdu din il-mediċina.
English: The decrease in AUC, Cmax, and Cmin was not mitigated when an increased dose of REYATAZ/ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours.
Maltese: It-tnaqqis fl-AUC, fis-Cmax, u fis-Cmin ma ttaffiex meta doża akbar ta' REYATAZ/ritonavir (400/100 mg darba kuljum) ġiet separata temporalment minn omeprazole bi 12il siegħa.
English: 3) and mean baseline plasma HIV-1 RNA was 4.09 log10 copies/ml (range: 3.28 to 5.00 log10 copies/ml).
Maltese: 3) 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).
English: (range: 84 to 5703 cells/mm 3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 2.0 to 5.9 log10 copies/ml).
Maltese: (medda: 2 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).
English: Atazanavir AUC ↑28% (↑16% ↑43%) Atazanavir Cmax ↔6% (↓7% ↑20%) Atazanavir Cmin ↑91% (↑66% ↑121%)
Maltese: AUC ta' Atazanavir ↑28 % (↑16 % Cmax ta' Atazanavir ↔6 % (↓7 % Cmin ta' Atazanavir ↑91 % (↑66 %
English: 3 x 30 hard capsules: EU/1/03/267/010
Maltese: 3 x 30 kapsuli ibsin: EU/1/03/267/010
English: ANTIFUNGALS Ketoconazole 200 mg once daily (atazanavir 400 mg once daily)
Maltese: ANTIFUNGALI Ketoconazole 200 mg darba kuljum (atazanavir 400 mg darba kuljum)
English: In an open-label, randomised, comparative study following a 26- to 30-week induction phase with REYATAZ 300 mg + ritonavir 100 mg once daily and two NRTIs, unboosted REYATAZ 400 mg once daily and two NRTIs administered during a 48-week maintenance phase (n=87) had similar antiviral efficacy compared with REYATAZ + 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 REYATAZ and two NRTIs compared with 75% on REYATAZ + 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'REYATAZ 300 mg + ritonavir 100 mg darba kuljum u żewġ NRTIs, REYATAZ 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' REYATAZ + 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 REYATAZ mhux imsaħħaħ u żewġ NRTIs meta mqabbla ma' 75 % fuq REYATAZ + ritonavir u żewġ NRTIs.
English: Co-administration with glecaprevir/pibrentasvir fixed dose combination (see section 4.5).
Maltese: L-għoti flimkien ma' doża fissa kombinata ta' glecaprevir/pibrentasvir (ara sezzjoni 4.5).
English: Renal and urinary disorders:
Maltese: Indeboliment renali:
English: REYATAZ 150 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Maltese: REYATAZ 150 mg kapsuli ibsin jiġu f'folji f'pakketti ta' 60 kapsuli.
English: Among patients who received REYATAZ 400 mg once daily or REYATAZ 300 mg with ritonavir 100 mg once daily, the only adverse reactions of any severity reported very commonly with at least a possible relationship to regimens containing REYATAZ and one or more NRTIs were nausea (20%), diarrhoea (10%), and jaundice (13%).
Maltese: Fost il-pazjenti li ħadu REYATAZ 400 mg darba kuljum jew REYATAZ 300 mg ma' ritonavir 100 mg darba kuljum, l-uniċi reazzjonijiet avversi ta' xi severità li ġew irrappurtati b'mod komuni ħafna li għall-inqas kien possibbli li kellhom x'jaqsmu mat-terapija li kienet tinkludi REYATAZ u wieħed jew iktar NRTIs kienu nawsja (20 %), dijarrea (10 %) u suffejra (13 %).
English: Atazanavir AUC: ↑250% (↑144% Atazanavir Cmax: ↑120% (↑56% Atazanavir Cmin: ↑713% (↑359%
Maltese: ↑120% (↑56% Cmin ta' Atazanavir: ↑713 % (↑359 %
English: Atazanavir AUC ↓12% (↓18% ↓5%) Atazanavir Cmax ↓13% (↓20% ↓4%) Atazanavir Cmin ↓ 20 % (↓28 % ↓10%)
Maltese: AUC ta' Atazanavir ↓12% (↓18% Cmax ta' Atazanavir ↓13% (↓20% ↓4%) Cmin ta' Atazanavir ↓20 % (↓28 %
English: Table 1: Dose for paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) for REYATAZ capsules with ritonavir Body Weight (kg)
Maltese: Tabella 1: Doża għal pazjenti pedjatriċi (minn 6 snin sa inqas minn 18-il sena u jiżnu millinqas 15 kg) għal kapsuli REYATAZ ma' ritonavir
English: Study 138 is an international randomised, open-label, multicenter, prospective trial of treatment naïve patients comparing REYATAZ/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: F'pazjenti adulti li ma jkunux ħadu kura antiretrovirali qabel Studju 138 huwa prova prospettiva, multiċentri, open-label, randomizzata, internazzjonali ta' pazjent li ma ħadux kura, li tqabbel REYATAZ/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: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway, e.g., budesonide.
Maltese: Effetti ta' kortikosterojdi sistemiċi fosthom is-sindrome ta' Cushing u suppressjoni adrenali ġew irrappurtati f'pazjenti li rċivew ritonavir u ħadu fluticasone propionate man-nifs jew mill-imnieħer; dan jista' jseħħ ukoll b'kortikosterojdi oħrajn metabolizzati permezz tal-passaġġ ta' P450 3A, eż. budesonide.
English: Through 48 weeks of treatment, the mean changes from baseline in HIV RNA levels for REYATAZ + ritonavir and lopinavir + ritonavir were similar (non-inferior).
Maltese: HIV RNA għal REYATAZ + ritonavir u lopinavir + ritonavir kienu l-simili (mhux inferjuri).
English: Ritonavir AUC ↓11% (↓20% ↓1%) Ritonavir Cmax ↓11% (↓24% ↑4%) Ritonavir Cmin ↓19% (↓35% ↑1%)
Maltese: AUC ta' Ritonavir ↓11% (↓20% ↓1%) Cmax ta' Ritonavir ↓11 % (↓24 %
English: ≥ 200 cells/mm3
Maltese: ≥ 200 ċellula/mm
English: Capsule shells: gelatine, red iron oxide, black iron oxide, yellow iron oxide, indigocarmin (E132) and titanium dioxide (E171)
Maltese: Kontenut tal-kapsula: crospovidone, lactose monohydrate u magnesium stearate Qxur tal-kapsula: gelatine, red iron oxide, black iron oxide, yellow iron oxide, indigocarmin (E132) u titanium dioxide (E171)
English: REYATAZ/ritonavir should not be used in combination with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index.
Maltese: REYATAZ/ritonavir m'għandux jintuża f'kombinazzjoni ma' prodotti mediċinali li huma substrati ta' CYP3A4 u li għandhom indiċi terapewtiku dejjaq.
English: REYATAZ oral powder contains :
Maltese: REYATAZ trab orali fih:
English: Atazanavir AUC ↓20% (↓35% ↓3%) Atazanavir Cmax ↓19% (↓34% ↔0.2%) Atazanavir Cmin ↓ 31 % (↓46 % ↓13%)
Maltese: AUC ta' Atazanavir ↓20% (↓35% Cmax ta' Atazanavir ↓19 % (↓34 % Cmin ta' Atazanavir ↓31 % (↓46 %
English: Tenofovir disoproxil fumarate 300 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Maltese: Tenofovir disoproxil fumarate 300 mg darba kuljum (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: The REYATAZ/ritonavir arm has similar (non-inferior) antiviral efficacy compared to the lopinavir/ritonavir arm, as assessed by the proportion of patients with HIV RNA < 50 copies/ml at week 48: 78% of patients on REYATAZ/ritonavir compared to 76% on lopinavir/ritonavir (difference estimate of ATV/RTV-LPV/RTV: 1.7% [95% CI, -3.8%, 7.1%] according to the Confirmed Virologic Response (CVR) Non-Completer = Failure (NC = F) definition of response.
Maltese: Il-fergħa ta' REYATAZ/ritonavir għandha effikaċja antivirali (mhux inferjuri) simili meta mqabbel mal-fergħa ta' lopinavir/ritonavir, kif ivvalutat mill-proporzjon ta' pazjenti b'HIV RNA <50 kopja/ml fil-ġimgħa 48: 78 % tal-pazjenti fuq REYATAZ/ritonavir meta mqabbel ma' 76 % fuq lopinavir/ritonavir (differenza fl-istima ta' ATV/RTV-LPV/RTV:
English: Store in the original package
Maltese: Aħżen fil-pakkett oriġinali
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jingħataw dan il-prodott mediċinali.
English: Three of 20 infants (15%) born to women treated with REYATAZ/ritonavir 300/100 mg and four of 20 infants (20%) born to women treated with REYATAZ/ritonavir 400/100 mg experienced grade 3-4 bilirubin.
Maltese: Tlieta mill-20 tarbija (15 %) imwielda minn nisa kkurati b'REYATAZ/ritonavir 300/100 mg u erbgħa minn 20 tarbija (20 %) twieldu lil nisa kkurati bi REYATAZ/ritonavir 400/100 mg esperjenzaw bilirubin ta' skala 3-4.
English: Table 9: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg Pharmacokinetic Parameter 2nd Trimester (n=9)
Maltese: Tabella 9: Farmakokinetika fl-Istat Fiss ta' Atazanavir ma' ritonavir f'Nisa Tqal Infettati blHIV fi Stat Mhux Sajjem atazanavir 300 mg ma' ritonavir 100 mg
English: HCV Protease Inhibitors Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Maltese: Inibituri tal-Protease HCV Boceprevir 800 mg tliet darbiet kuljum (atazanavir 300 mg/ritonavir 100 mg darba kuljum)
English: LIST OF EXCIPIENTS Excipients: contains lactose (see leaflet for further information).
Maltese: TA' EĊĊIPJENTI Eċċipjenti: fih lactose (ara l-fuljett għal aktar informazzjoni).
English: Co-administration of simvastatin or lovastatin with REYATAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Maltese: L-għoti flimkien ta' simvastatin jew lovastatin ma' REYATAZ hu kontraindikat minħabba riskju miżjud ta' mijopatija inkluż rabdomijoliżi (ara sezzjoni 4.3).
English: Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations).
Maltese: Skont tagħrif viroloġiku u kliniku minn pazjenti adulti, m'hu mistenni ebda benefiċċju f'pazjenti b'razez reżistenti għall-inibituri ta' protease multipliċi (≥ 4 mutazzjonijet PI).
English: REYATAZ 300 mg hard capsules are also supplied in blister strips in packs of 30 capsules.
Maltese: REYATAZ 300 mg kapsuli ibsin jiġu f'folji f'pakketti ta' 30 kapsuli.
English: Distribution: atazanavir was approximately 86% bound to human serum proteins over a concentration range of 100 to 10,000 ng/ml.
Maltese: Distribuzzjoni: atazanavir jeħel b'rata ta' bejn wieħed u ieħor 86 % mal-proteini tad-demm uman f'konċentrazzjoni li tvarja minn 100 sa 10,000 ng/ml.
English: The mechanism of nevirapine/atazanavir interaction is CYP3A4 induction.
Maltese: Ilmekkaniżmu ta' interazzjoni ta' nevirapine/atazanavir huwa linduzzjoni ta' CYP3A4.
English: Metabolism: studies in humans and in vitro studies using human liver microsomes have demonstrated that atazanavir is principally metabolised by CYP3A4 isozyme to oxygenated metabolites.
Maltese: Bijotrasformazzjoni: minn studji fil-bniedem u minn studji in vitro fejn intużaw mikrosomi epatiċi umani sar magħruf li atazanavir ġie metabolizzat prinċipalment bl-iżożimu ta' CYP3A4 għal metaboliti ossiġenati.
English: Treatment-Naive REYATAZ Capsules/ritonavir (300 mg/100 mg once daily) n=16
Maltese: Pazjenti li Qatt Ma Kienu Kkurati filPassat b'kapsuli REYATAZ/ritonavir (300 mg/100 mg darba kuljum) n=16
English: Atazanavir (pm): all administered with food
Maltese: Atazanavir (am): sagħtejn wara omeprazole
English: Co-administration of REYATAZ with products containing St. John's wort is contraindicated.
Maltese: John's wort huwa kontraindikat.