FrancophonIA/ELRC3.0 huggingface dataset:
English: HIV RNA <50 copies/ml by select baseline PI substitutions,f, g % (responder/evaluable) NA
Maltese: HIV RNA <50 kopji/ml skont is-sostituzzjonijiet PI tal-linja bażi magħżula,f, g % (responditur/evalwabbli)
English: 300 mg (6 sachetsb)
Maltese: 300 mg (6 qratasb)
English: Carton Bottle pack (1 bottle): 60 hard capsules Carton Bottle pack: (3 bottles): 3 x 60 hard capsules (3 bottles of 60 hard capsules) Label Bottle pack: 60 hard capsules
Maltese: Pakkett tal-Kartun tal-Flixkun (flixkun 1): 60 kapsula iebsa Pakkett tal-Kartun tal-flixkun: (3 fliexken): 3 x 60 kapsula iebsa (3 fliexken ta' 60 kapsula iebsa) Tikketta tal-Pakkett tal-fliexken: 60 kapsula iebsa
English: Norgestimate AUC ↑85% (↑67% Norgestimate Cmax ↑68% (↑51% Norgestimate Cmin ↑102% (↑77%
Maltese: AUC ta' Norgestimate ↑85 % (↑67 % Cmax ta' Norgestimate ↑68 % (↑51 % Cmin ta' Norgestimate ↑102 % (↑77 %
English: Co-administration with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (see section 4.5).
Maltese: L-għoti flimkien ma' prodotti li fihom grazoprevir, inkluż doża fissa kombinata ta' elbasvir/grazoprevir (ara sezzjoni 4.5).
English: REYATAZ (without ritonavir) has been studied in adult subjects with moderate-to-severe hepatic impairment (14 Child-Pugh Class B and 2 Child-Pugh Class C subjects) after a single 400 mg dose.
Maltese: REYATAZ (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: Table 8: Efficacy Outcomes for oral powder (paediatric patients at least 3 months of age and weighing at least 5 kg) at Week 48 (Studies AI424-397 and AI424-451) Parameter
Maltese: Tabella 8: Eżiti ta' Effikaċja għal trab orali (pazjenti pedjatriċi li għandhom tal-inqas 3 xhur u li jiżnu tal-inqas 5 kg) fil-Ġimgħa 48 (Studji AI424-397 u AI424-451)
English: Diltiazem AUC ↑125% (↑109% Diltiazem Cmax ↑98% (↑78% ↑119%) Diltiazem Cmin ↑142% (↑114%
Maltese: AUC ta' Diltiazem ↑125 % (↑109 % Cmax ta' Diltiazem ↑98 % (↑78 % Cmin ta' Diltiazem ↑142 % (↑114 %
English: LIPID LOWERING AGENTS HMG-CoA reductase inhibitors Simvastatin
Maltese: Inibituri ta' HMG-CoA reductase Simvastatin
English: Metabolism and nutrition disorders:
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni:
English: ERECTILE DYSFUNCTION PDE5 Inhibitors
Maltese: DISFUNZJONI TAL-EREZZJONI Inibituri tal-PDE5
English: Methadone, stable maintenance dose (atazanavir 400 mg once daily)
Maltese: Methadone, doża ta' manteniment stabbli (atazanavir 400 mg darba kuljum)
English: ATV/RTVb (300 mg/ 100 mg once daily) n=120
Maltese: ATV/RTVb (300 mg/ 100 mg darba kuljum) n=120
English: Each carton contains 30 x 1 capsules; 5 blister cards of 6 x 1 capsules each in Alu/Alu perforated unit dose blisters.
Maltese: Kull kartuna fiha 30 x 1 kapsula; 5 folji ta' 6 x 1 kapsula kull waħda f'folji ta' Alu/Alu ipperforat f'doża ta' unità waħda.
English: Age/Gender: a study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
Maltese: Età/Sess: sar studju fuq il-farmakokinetika ta' atazanavir fuq 59 persuna f'saħħithom, nisa u rġiel (29 żgħażagħ, 30 anzjani).
English: White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone
Maltese: Linka bajda li fiha: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol u simethicone
English: AI424-451 (PRINCE II): In paediatric patients from 3 months to less than 11 years of age In these studies, 155 patients (59 antiretroviral-naive and 96 antiretroviral-experienced) received once daily REYATAZ oral powder and ritonavir, in combination with two NRTIs.
Maltese: AI424-451 (PRINCE II): F'pazjenti pedjatriċi li għandhom bejn 3 xhur u inqas minn 11 snin F'dawn l-istudji, 155 pazjent (59 li qatt ma saritilhom kura antiretrovirali qabel u 96 li kellhom kura antiretrovirali) irċevew REYATAZ trab orali darba kuljum u ritonavir, fimkien ma' żewġ NRTIs.
English: Frequency de novo PI substitution (n=26)a none none a Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Maltese: Frekwenza de novo PI sostituzzjoni (n=26)a ħadd ħadd a Numru ta' pazjenti b'ġenotipi ffurmati bħala pari kklasifikati bħala fallimenti virloġikali (HIV RNA ≥400 kopji/ml).
English: The mechanism of interaction between REYATAZ/ritonavir and sofosbuvir/velpatasvir/voxilaprevir is inhibition of OATP1B, Pgp, and CYP3A.
Maltese: Il-mekkaniżmu ta' interazzjoni bejn REYATAZ/ritonavir u sofosbuvir/velpatasvir/voxilaprevir huwa l-inibizzjoni ta' OATP1B, Pgp, u CYP3A.
English: LPV/RTVc (400 mg/ 100 mg twice daily) n=123
Maltese: LPV/RTVc (400 mg/ 100 mg darbtejn kuljum) n=123
English: 300 mg (6 sachetsa)
Maltese: 300 mg (6 qratasa)
English: Ritonavir may decrease plasma levels of phenytoin and/or phenobarbital due to CYP2C9 and CYP2C19 induction.
Maltese: Ritonavir jista' jnaqqas il-livelli ta' phenytoin u/jew ta' phenobarbital minħabba induzzjoni ta' CYP2C9 u ta' CYP2C19.
English: Blister pack: 60 hard capsules
Maltese: Pakkett tal-folji: 60 kapsuli ibsin
English: Antiretroviral treatment experienced adult patients In antiretroviral treatment experienced patients from Studies 009, 043, and 045, 100 isolates from patients designated as virological failures on therapy that included either atazanavir, atazanavir + ritonavir, or atazanavir + saquinavir were determined to have developed resistance to atazanavir.
Maltese: F'pazjenti li kienu għaddew minn kura antiretrovirali minn Studji 009, 043, u 045, ġew stabbiliti 100 iżolati minn pazjenti nnominati bħala fallimenti viroloġiċi fuq kura li kienet tinkludi jew atazanavir, atazanavir + ritonavir, jew atazanavir + saquinavir li żviluppaw reżistenza għal atazanavir.
English: Patients co-infected with hepatitis B and/or hepatitis C virus 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: Pazjenti infettati flimkien bil-virus ta' l-epatite B u/jew tal-epatite Ċ 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: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: a Intent-to-treat analysis, with missing values considered as failures.
Maltese: a Analiżi intent-to-treat, b'valuri nieqsa kkunsidrati bħala falliment.
English: *Lack of pharmacokinetics interaction bounds 70-143%
Maltese: *Nuqqas ta' interazzjoni talfarmakokinetika jammonta għal 70
English: * In a combined analysis from several clinical studies, atazanavir/ritonavir 300/100 mg co-administered 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: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg twice daily + zidovudine 300 mg twice daily (atazanavir 400 mg once daily)
Maltese: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Lamivudine 150 mg darbtejn kuljum + zidovudine 300 mg darbtejn kuljum (atazanavir 400 mg darba kuljum)
English: Ethinyloestradiol AUC ↑48% (↑31% Ethinyloestradiol Cmax ↑15% (↓1% Ethinyloestradiol Cmin ↑91% (↑57%
Maltese: AUC ta' Ethinyloestradiol ↑48 % Cmax ta' Ethinyloestradiol ↑15 % (↓1 % Cmin ta' Ethinyloestradiol ↑91 %
English: Serious skin rash, including Stevens-Johnson syndrome, has been reported in patients taking REYATAZ.
Maltese: Raxx serju tal-ġilda, inkluż is-Sindromu ta' Stevens-Johnson, ġie rrapportat f'pazjenti li kienu qegħdin jieħdu REYATAZ.
English: Hepatic impairment: atazanavir is metabolised and eliminated primarily by the liver.
Maltese: Indeboliment epatiku: atazanavir jiġi metabolizzat u eliminat prinċipalment mill-fwied.
English: Didanosine (with food) Didanosine AUC ↓34% (↓41% ↓27%) Didanosine Cmax ↓38% (↓48% ↓26%) Didanosine Cmin ↑25% (↓8% ↑69%)
Maltese: Didanosine (mal-ikel) AUC ta' Didanosine ↓34 % (↓41 % Cmax ta' Didanosine ↓38 % (↓48 % Cmin ta' Didanosine ↑25 % (↓8 %
English: Atazanavir, simultaneous administration with ddI+d4T (fasted) Atazanavir AUC ↓87% (↓92% ↓79%) Atazanavir Cmax ↓89% (↓94% ↓82%) Atazanavir Cmin ↓84% (↓90% ↓73%)
Maltese: Atazanavir, għoti fl-istess ħin ma' ddI+d4T (fi stat sajjem) AUC ta' Atazanavir ↓87 % (↓92 % Cmax ta' Atazanavir ↓89 % (↓94 % Cmin ta' Atazanavir ↓84 % (↓90 %
English: Voriconazole AUC ↓33% (↓42% Voriconazole Cmax ↓10% (↓22% ↓4%) Voriconazole Cmin ↓39% (↓49% ↓28%)
Maltese: AUC ta' Voriconazole ↓33 % (↓42 % Cmax ta' Voriconazole ↓10 % (↓22 % Cmin ta' Voriconazole ↓39 % (↓49 %
English: HORMONAL CONTRACEPTIVES Ethinyloestradiol 25 μg + norgestimate (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Maltese: KONTRAĊETTIVI ORMONALI Ethinyloestradiol 25 μg + norgestimate (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: Linearity/non-linearity: the pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV infected patients; significant differences were observed between the two groups.
Maltese: Linearità/nuqqas ta' linearità: il-farmakokinetika ta' atazanavir ġiet evalwata f'voluntiera adulti b'saħħithom u f'pazjenti infettati bl-HIV; ma dehru ebda differenzi sinjifikanti bejn iż-żewġ gruppi.
English: Unchanged drug accounted for approximately 20% and 7% of the administered dose in the faeces and urine, respectively.
Maltese: Mill-mediċina mogħtija, madwar 20 % u 7 % talmediċina mhux mibdula ġiet irkuprata rispettivament fil-purgar u fl-urina.
English: HIV RNA <50 copies/ml, %a at least 5 to < 10 kg (REYATAZ 150 and 200 mg) at least 10 to < 15 kg at least 15 to < 25 kg at least 25 to < 35 kg
Maltese: HIV RNA <50 kopja/ml, %a mill-inqas 5 sa <10 kg (REYATAZ 150 u 200 mg) mill-inqas 10 sa <15 kg mill-inqas 15 sa <25 kg mill-inqas 25 sa <35 kg
English: Instructions for REYATAZ oral powder:
Maltese: Struzzjonijiet għal REYATAZ trab orali:
English: Tenofovir disoproxil fumarate AUC Tenofovir disoproxil fumarate Cmax Tenofovir disoproxil fumarate Cmin
Maltese: AUC ta' Tenofovir disoproxil fumarate ↑37 % (↑30 % ↑45 %) Cmax ta' Tenofovir disoproxil fumarate Cmin ta' Tenofovir disoproxil fumarate
English: a Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Maltese: a Numru ta' pazjenti b'ġenotipi ffurmati bħala pari kklasifikati bħala fallimenti virloġikali (HIV RNA ≥400 kopji/ml).
English: For the recommended paediatric dosage, REYATAZ oral powder contains 3915.45 mg sucrose per 150 mg atazanavir, 5220.60 mg sucrose per 200 mg atazanavir, 6525.75 mg sucrose per 250 mg atazanavir, and 7830.90 mg sucrose per 300 mg atazanavir.
Maltese: Għad-dożaġġ pedjatriku rakkomandat, REYATAZ trab orali fih 3,915.45 mg sucrose għal kull 150 mg atazanavir, 5,220.
English: Eleven subjects (13%) in the unboosted REYATAZ group and 6 (7%) in the REYATAZ + ritonavir group, had virologic rebound.
Maltese: Ħdax-il individwu (13 %) fil-grupp ta' REYATAZ mhux imsaħħaħ u 6 (7 %) fil-grupp ta' REYATAZ + ritonavir, kellhom rikaduta viroloġika.
English: Raltegravir AUC ↑41% Raltegravir Cmax ↑24% Raltegravir C12hr ↑77% The mechanism is UGT1A1 inhibition.
Maltese: AUC ta' Raltegravir ↑41 % Cmax ta' Raltegravir ↑24 % C12hr ta' Raltegravir ↑77 %
English: g Select substitutions include any change at positions L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71, G73, V82, I84, and L90 (0-2, 3, 4 or more) at baseline.
Maltese: g Sostituzzjonijiet magħżula nklużi kwalunkwe tibdil fil-pożizzjonijiet L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71, G73, V82, I84, u L90 (0-2, 3, 4 jew aktar) fil-linja bażi.
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: The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2blockers.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa tnaqqis fis-solubilità ta' atazanavir hekk kif il-pH intragastriku jiżdied blimblokkaturi ta' H2.
English: common: fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance a These adverse reactions were identified through post-marketing surveillance, however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to REYATAZ in randomised controlled and other available clinical trials (n = 2321).
Maltese: komuni: għeja; mhux komuni: uġigħ fis-sider, telqa, deni, astenja; rari: disturbi fil-mixi a Dawn ir-reazzjonijiet avversi ġew identifikati permezz ta' sorveljanza ta' wara t-tqegħid fis-suq, madankollu l-frekwenzi ġew stmati minn kalkolazzjoni statistika bbażata fuq in-numru totali ta' pazjenti esposti għal REYATAZ fi provi kliniċi randomizzati u kkontrollati u fi provi kliniċi disponibbli oħrajn (n=2,321).
English: HIV RNA <400 copies/ml, %a at least 5 to < 10 kg (REYATAZ 150 and 200 mg) at least 10 to < 15 kg at least 15 to < 25 kg at least 25 to < 35 kg
Maltese: HIV RNA <400 kopja/ml, %a mill-inqas 5 sa <10 kg (REYATAZ 150 u 200 mg) mill-inqas 10 sa <15 kg mill-inqas 15 sa <25 kg mill-inqas 25 sa <35 kg
English: Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with REYATAZ/ritonavir.
Maltese: Il-konċentrazzjonijiet imnaqqsa ta' atazanavir fil-plażma jistgħu jkunu lkonsegwenza ta' żieda fil-pH gastriku jekk antaċidi, inklużi prodotti mediċinali buffered jingħataw ma' REYATAZ/ritonavir.
English: uncommon: torsades de pointesa rare: QTc prolongationa, oedema, palpitation
Maltese: mhux komuni: torsades de pointesa rari: titwil tal-QTca, edema, palpitazzjonijiet
English: In a per protocol analysis which excluded non-completers (i.e. patients who discontinued before the week 48 HIV RNA assessment) and patients with major protocol deviations, the proportion of patients with HIV RNA < 50 copies/ml at week 48 was 86% (338/392) for REYATAZ/ritonavir and 89% (332/372) for lopinavir/ritonavir (difference estimate of ATV/RTV-LPV/RTV: -3% [95% CI, -7.6%,
Maltese: F'analiżi permezz tal-protokoll li eskludiet pazjenti li ma komplewx il-kura (jiġifieri pazjenti li waqfu qabel il-ġimgħa 48 tal-valutazzjoni ta' HIV RNA) u pazjenti b'devjazzjonijiet maġġuri mill-protokoll, il-proporzjon ta' pazjenti b'HIV RNA <50 kopja/ml fil-ġimgħa 48 kienet ta' 86 % (338/392) għal REYATAZ/ritonavir u 89 % (332/372) għal lopinavir/ritonavir (differenza fl-istima ta' ATV/RTVLPV/RTV: -3 % [95 % CI, -7.6 %, 1.5 %].
English: By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA <400 copies/ml (<50 copies/ml) for REYATAZ + ritonavir were 84% (72%) and for lopinavir + ritonavir were 82% (72%).
Maltese: Skond l-analiżi hekk kif trattati, meta teskludi l-valuri nieqsa, il-proporzjon ta' pazjenti blHIV RNA <400 kopji/ml (<50 kopji/ml) għal REYATAZ + ritonavir kien ta' 84 % (72 %) u għal lopinavir + ritonavir kien ta' 82 % (72 %).
English: * In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to atazanavir 400 mg without ritonavir (n=28).
Maltese: * F'analiżi kombinata, atazanavir 300 mg u ritonavir 100 mg (n=33) tqabbel ma' atazanavir 400 mg mingħajr ritonavir (n=28).
English: CD4 Mean Change from Baseline, cells/mm3 All patients 110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60)
Maltese: 110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60)
English: De novo substitutions in treatment naive patients failing therapy with atazanavir + ritonavir (Study 138, 96 weeks)
Maltese: Tabella 3. Sostituzzjonijiet De novo fit-trattament ta' pazjenti li qatt qabel ma ħadu kura li fallew it-terapija b'atazanavir + ritonavir (Studju 138, 96 ġimgħa)
English: (range: 100 to
Maltese: (medda: 2
English: If tenofovir disoproxil or an H2-receptor antagonist is needed, a dose increase to REYATAZ 400 mg with ritonavir 100 mg with TDM may be considered (see sections 4.6 and 5.2).
Maltese: Jekk ikun meħtieġ tenofovir disoproxil jew antagonista ta' riċettur ta' H2, tista' tiġi kkunsidrata żieda fid-doża ta' REYATAZ 400 mg ma' ritonavir 100 mg b'TDM (ara sezzjonijiet 4.6 u 5.2).
English: The mechanism of amiodarone or systemic lidocaine/atazanavir interaction is CYP3A inhibition.
Maltese: Il-mekkaniżmu ta' amiodarone jew interazzjoni sistemika ta' lidocaine/atazanavir hija linibizzjoni ta' CYP3A.
English: 80 mgc at least 35
Maltese: 80 mgc tal-inqas 35
English: There was less hyperbilirubinaemia and jaundice in the unboosted REYATAZ group compared with the REYATAZ + ritonavir group (18 and 28 subjects, respectively).
Maltese: Kien hemm inqas iperbilirubinemija u suffejra fil-grupp ta' REYATAZ mhux imsaħħaħ meta mqabbla mal-grupp ta' REYATAZ + ritonavir (18 u 28 individwu, rispettivament).
English: No dose adjustment is needed for REYATAZ/ritonavir.
Maltese: REYATAZ/ritonavir.
English: Time-averaged difference ATV/RTV-LPV/RTV [97.5% CId] Week 48 Week 96 Week 48 Week 96 Week 48 Week 96 HIV RNA Mean Change from Baseline, log10 copies/ml
Maltese: Differenza skont il-Medja tal-Ħin ATV/RTVLPV/RTV [97.5 % CId] Ġimgħa 48 Ġimgħa 96 Ġimgħa 48 Ġimgħa 96 Ġimgħa 48 Ġimgħa 96 Bidla Medja fl-HIV RNA mil-Linja Bażi, log10 kopji/ml Il-pazjenti kollha
English: Atazanavir AUC ↑7% (↓2% ↑17%) Atazanavir Cmax ↑2% (↓4% ↑8%) Atazanavir Cmin ↑15% (↑2% ↑29%)
Maltese: AUC ta' Atazanavir ↑7% (↓2% ↑17%) Cmax ta' Atazanavir ↑2% (↓4% ↑8%) Cmin ta' Atazanavir ↑15% (↑2% ↑29%)
English: Similar concentrations of atazanavir increased by 13% the action potential duration (APD90) in rabbit Purkinje fibres study.
Maltese: Konċentrazzjnijiet simili ta' atazanavir żiedu bi 13 % iż-żmien li fih tista' ssir azzjoni (APD90) fi studju ta' fibri tal-fenek Purkinje.
English: Lopinavir/ritonavirc (400 mg/100 mg twice daily) n=443
Maltese: Lopinavir/ritonavirc (400 mg/100 mg darbtejn kuljum) n=443
English: Absorption: in HIV-infected patients (n=33, combined studies), multiple dosing of REYATAZ 300 mg once daily with ritonavir 100 mg once daily with food produced a geometric mean (CV%) for atazanavir, Cmax of 4466 (42%) ng/ml, with time to Cmax of approximately 2.5 hours.
Maltese: Assorbiment: f'pazjenti infettati bl-HIV, (n=33 studji kombinati), wara li ngħataw ħafna dożi ta' REYATAZ 300 mg darba kuljum b'ritonavir 100 mg darba kuljum ma' l-ikel, il-medja ġeometrika (CV %) għal atazanavir, Cmax ta' 4,466 (42 %) ng/ml, b'ħin għal Cmax ta' madwar 2.5 sigħat.
English: Ketoconazole and itraconazole should be used cautiously with REYATAZ/ritonavir, high doses of ketoconazole and itraconazole (>200 mg/day) are not recommended.
Maltese: Ketoconazole u itraconazole għandhom jintużaw b'kawtela ma' REYATAZ/ritonavir, mhumiex rakkomandati dożi għoljin ta' ketoconazole u itraconazole (>200 mg/kuljum).
English: Blister pack :
Maltese: Cmax ta' Elbasvir:
English: 15 to less than 35 at least 35
Maltese: minn 15 sa inqas minn 35 tal-inqas 35
English: Ritonavir AUC ↓12% (↓17% ↓7%) Ritonavir Cmax ↓9% (↓17% ↔0%) Ritonavir Cmin ↓25% (↓35% ↓14%)
Maltese: AUC ta' Ritonavir ↓12 % (↓17 % Cmax ta' Ritonavir ↓9 % (↓17 % Cmin ta' Ritonavir ↓25 % (↓35 %
English: Phenobarbital and phenytoin should be used with caution in combination with REYATAZ/ritonavir.
Maltese: Phenobarbital u phenytoin għandhom jintużaw b'attenzjoni f'kombinazzjoni ma' REYATAZ/ritonavir.
English: The efficacy of REYATAZ/ritonavir in combination with tenofovir disoproxil fumarate in treatmentexperienced patients has been demonstrated in clinical study 045 and in treatment naive patients in clinical study 138 (see sections 4.8 and 5.1).
Maltese: L-effikaċja ta' REYATAZ/ritonavir f'kombinazzjoni ma' tenofovir disoproxil fumarate f'pazjenti li kienu diġà ħadu l-kura qabel, ġiet osservata fl-istudju kliniku 045 u f'pazjenti li qatt ma ħadu l-kura qabel fi studju kliniku 138 (ara sezzjonijiet 4.8 u 5.1).
English: REYATAZ/ritonavirb (300 mg/100 mg once daily) n=440
Maltese: REYATAZ/ritonavirb (300 mg/100 mg darba kuljum) n=440
English: Hepatobiliary disorders:
Maltese: Indeboliment epatiku:
English: Diltiazem 180 mg once daily (atazanavir 400 mg once daily)
Maltese: Diltiazem 180 mg darba kuljum (atazanavir 400 mg darba kuljum)
English: If available, 90% confidence intervals (CI) are shown in parentheses.
Maltese: Jekk ikunu disponibbli, intervalli ta' kunfidenza ta' 90 % (CI) jiġu murija f'parentesi.
English: common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitisa
Maltese: komuni: suffejra; mhux komuni: epatite, kolelitjażia, kolestażia; rari: epatosplenomegalija, koleċistitea
English: By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA < 400 copies/ml (< 50 copies/ml) in the REYATAZ + ritonavir arm and the lopinavir + ritonavir arm were 55% (40%) and 56% (46%), respectively.
Maltese: Skond l-analiżi hekk kif ikkurati, meta teskludi l-valuri nieqsa, il-proporzjon ta' pazjenti bl-HIV RNA <400 kopji/ml (<50 kopji/ml) li ħadu REYATAZ + ritonavir u fergħa ta' lopinavir + ritonavir kien ta' 55 % (40 %) u 56 % (46 %) rispettivament.
English: Table 6: Efficacy Outcomes at Week 48a and at Week 96 (Study 045)
Maltese: Tabella 6: Riżultati ta' Effikaċja f'Ġimgħa 48a u f'Ġimgħa 96 (Studju 045)
English: 15 to less than 35
Maltese: Tal-inqas 15 sa inqas minn 35
English: De novo substitutions in treatment experienced patients failing therapy with atazanavir + ritonavir (Study 045, 48 weeks) Frequency de novo PI substitution (n=35)a,b M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
Maltese: Frekwenza de novo PI sostituzzjoni (n=35)a,b M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
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 REYATAZ (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' REYATAZ (ara s-sezzjoni 4.4).
English: REYATAZ has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving REYATAZ 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or REYATAZ 300 mg with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration).
Maltese: REYATAZ ġie evalwat għas-sigurtà bħala terapija mogħtija flimkien ma' prodotti mediċinali antiretrovirali oħra fi provi kliniċi kkontrollati f'1,806 pazjenti adulti li ħadu REYATAZ 400 mg darba kuljum (1,151 pazjent, b'tul ta' żmien medjan ta' 52 ġimgħa u b'tul ta' żmien massimu ta' 152 ġimgħa) jew REYATAZ 300 mg b'ritonavir 100 mg darba kuljum (655 pazjent, tul ta' żmien medjan ta' 96 ġimgħa u b'tul ta' żmien medjan ta' 108 ġimgħa).
English: Atazanavir Cmin ↔12% (↓16% ↑49%)
Maltese: Cmin ta' Atazanavir ↔12 % (↓16 %
English: ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
Maltese: ANTIBIJOTIĊI Clarithromycin 500 mg darbtejn kuljum (atazanavir 400 mg darba kuljum)
English: REYATAZ 50 mg oral powder atazanavir
Maltese: REYATAZ 50 mg trab orali atazanavir