FrancophonIA/ELRC3.0 huggingface dataset:
English: Atazanavir has been evaluated for safety in combination therapy with other antiretroviral medicinal products in controlled clinical trials in 1,806 adult patients receiving atazanavir 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or atazanavir 300 mg with ritonavir 100 mg once daily (655 patients, 96°weeks median duration and 108 weeks maximum duration).
Maltese: Atazanavir ġie evalwat għas-sigurtà bħala terapija mogħtija flimkien ma' prodotti mediċinali antiretrovirali oħra fi provi kliniċi kkontrollati f'1,806 pazjenti adulti li ħadu atazanavir 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 atazanavir 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: Therefore, Atazanavir Mylan is contraindicated with medicinal products that are substrates of CYP3A4 and have a narrow therapeutic index: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, orally administered midazolam, and ergot alkaloids, particularly ergotamine and dihydroergotamine (see section 4.3).
Maltese: Għalhekk, Atazanavir Mylan huwa kontra-indikat ma' prodotti mediċinali li huma sottosratti ta' CYP3A4 u għandhom indiċi terapewtiku limitat: quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam mogħti mill-ħalq, u alkalojdi ergot, partikolarment ergotamine u dihydroergotamine (ara sezzjoni 4.3).
English: There was less hyperbilirubinaemia and jaundice in the unboosted atazanavir group compared with the atazanavir + ritonavir group (18 and 28 subjects, respectively).
Maltese: Kien hemm inqas iperbilirubinemija u suffejra fil-grupp ta' atazanavir mhux imsaħħaħ meta mqabbla mal-grupp ta' atazanavir + ritonavir (18 u 28 individwu, rispettivament).
English: Co-administration with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection) (see section 4.5).
Maltese: Għoti flimkien ma' prodotti li fihom grazoprevir, inkluż elbasvir/grazoprevir f'doża fissa kombinata (jintużaw biex jikkuraw infezzjoni tal-epatite Ċ kronika) (ara sezzjoni 4.5).
English: Atazanavir Mylan contains lactose
Maltese: Atazanavir Mylan fih lactose
English: Titanium dioxide (E171) Patent blue V (E131) Gelatin
Maltese: Titanium dioxide (E171) Patent blue V (E131) Ġelatina
English: (atazanavir 300 mg/ritonavir 100 mg once daily)
Maltese: (atazanavir 300 mg / ritonavir 100 mg darba kuljum)
English: Serious skin rash, including Stevens-Johnson syndrome, has been reported in patients taking atazanavir.
Maltese: Raxx serju tal-ġilda, inkluż is-Sindromu ta' Stevens-Johnson, ġie rrapportat f'pazjenti li kienu qegħdin jieħdu atazanavir.
English: 15 to less than 35 At least 35 * Ritonavir capsules, tablets or oral solution may be used.
Maltese: minn 15 sa inqas minn 35 Mill-inqas 35 *Kapsuli, pilloli jew s-soluzzjoni orali ta' ritonavir jistgħu jintużaw.
English: 150 mg capsules
Maltese: U KWANTITATTIVA 150 mg kapsuli
English: Two minor metabolites of atazanavir in plasma have been characterised.
Maltese: Ġew ikkaratterizzati żewġ metaboliti minuri ta' atazanavir fil-plażma.
English: There were no clinically important pharmacokinetic differences based on age or gender.
Maltese: Ma kienx hemm differenzi klinikament importanti fil-farmakokinetika minħabba l-età jew is-sess.
English: The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2-blockers.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa tnaqqis fis-solubilità ta' atazanavir hekk kif il-pH intragastriku jiżdied blimblokkaturi ta' H2.
English: Atazanavir Cmin ↔12% (↓16%
Maltese: Cmin ta' Atazanavir ↔12% (↓16%
English: Fifteen of 120 (13%) patients in the atazanavir + 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 atazanavir + 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: By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA <400 copies/ml (<50 copies/ml) for atazanavir + 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 atazanavir + ritonavir kien ta' 84% (72%) u għal lopinavir + ritonavir kien ta' 82% (72%).
English: The pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV-infected patients; significant differences were observed between the two groups.
Maltese: Il-farmakokinetika ta' atazanavir ġiet evalwata f'voluntiera adulti b'saħħithom u f'pazjenti infettati blHIV; ma dehru ebda differenzi sinjifikanti bejn iż-żewġ gruppi.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza totali ta' lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jingħataw dan il-prodott mediċinali.
English: 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: Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Maltese: L-għoti flimkien ma' prodotti mediċinali li huma sottostrati ta' isoform CYP3A4 ta' cytochrome P450 u li għandhom meded terapewtiċi dojoq (eż., quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam mogħtija mill-ħalq (għal midazolam parenterali, ara sezzjoni 4.5), u ergot alkaloids, b'mod partikolari ergotamine, dihydroergotamine, ergonovine, methylergonovine) (ara sezzjoni 4.5).
English: Atazanavir AUC ↓19% (↓35%
Maltese: AUC ta' Atazanavir ↓19% (↓35%
English: Rifampicin is a strong CYP3A4 inducer and has been shown to cause a 72% decrease in atazanavir AUC which can result in virological failure and resistance development.
Maltese: Rifampicin huwa induttur qawwi ta' CYP3A4 u ntwera li jikkawża tnaqqis ta' 72 % fl-AUC ta' atazanavir li jista' jirriżulta f'indeboliment viroloġiku u żvilupp ta' reżistenza.
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: Interaction
Maltese: Interazzjoni
English: Pravastatin
Maltese: Antaċidi
English: Single doses up to 1,200 mg have been taken by healthy volunteers without symptomatic untoward effects.
Maltese: Voluntieri f'saħħithom ħadu doża waħda sa 1,200 mg mingħajr ma kellhom effetti sintomatiċi mhux mixtieqa.
English: Table 7: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020) Parameter
Maltese: Riżultati tal-Effikaċja (pazjenti pedjatriċi minn 6 snin sa inqas minn 18-il sena) f'Ġimgħa 48 (Studju AI424-020)
English: Atazanavir AUC ↔6% (↓10%
Maltese: AUC ta' Atazanavir ↔6% (↓10%
English: Ethinyloestradiol AUC ↑48%
Maltese: AUC ta' Ethinyloestradiol ↑48 %
English: Atazanavir was negative in an Ames reverse-mutation assay but did induce chromosomal aberrations in vitro in both the absence and presence of metabolic activation.
Maltese: Atazanavir ħareġ negattiv f'analiżi ta' mutazzjoni-riversa ta' Ames iżda kkaġuna aberazzjonijiet kromosomali in vitro fl-assenza u fil-preżenza t'attivazzjoni metabolika.
English: uncommon: muscle atrophy, arthralgia, myalgia; rare: myopathy
Maltese: mhux komuni: atrofija tal-muskoli, artralġja, uġigħ filmuskoli; rari: mijopatija
English: The efficacy of atazanavir/ritonavir in combination with tenofovir disoproxil fumarate in treatment-experienced 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' atazanavir/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: Atazanavir Cmin ↓31% (↓46%
Maltese: Cmin ta' Atazanavir ↓31% (↓46%
English: A study of the pharmacokinetics of atazanavir was performed in 59 healthy male and female subjects (29 young, 30 elderly).
Maltese: Sar studju fuq il-farmakokinetika ta' atazanavir fuq 59 persuna f'saħħithom, nisa u rġiel (29 żgħażagħ, 30 anzjani).
English: Immunosuppressants Cyclosporin
Maltese: U IMMUNOSUPPRESSANTI
English: Week 96
Maltese: Ġimgħa 96
English: Atazanavir Mylan 150 mg hard capsules Atazanavir Mylan 200 mg hard capsules Atazanavir Mylan 300 mg hard capsules atazanavir
Maltese: Atazanavir Mylan 150 mg kapsuli ibsin Atazanavir Mylan 200 mg kapsuli ibsin Atazanavir Mylan 300 mg kapsuli ibsin
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: Atazanavir Mylan is contraindicated in patients with severe hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Maltese: Atazanavir Mylan huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Subjects without a functional CYP2C19 allele.
Maltese: Individwi mingħajr allele CYP2C19 funzjonali.
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: Atazanavir Cmax ↓16% (↓30%
Maltese: Cmax ta' Atazanavir ↓16% (↓30%
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 bi atazanavir 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: Didanosine AUC ↓34% (↓41%
Maltese: Didanosine (mal-ikel) AUC ta' Didanosine ↓34% (↓41%
English: Capsule shell cap 200 mg
Maltese: Kapsuli ta' 200 mg
English: Reporting of suspected adverse reactions
Maltese: Rapportar ta' effetti sekondarji suspettati
English: This association was observed independently of exposure to tenofovir disoproxil.
Maltese: Din l-assoċjazzjoni ġiet osservata b'mod indipendenti mill-esponiment għal tenofovir disoproxil.
English: Stevens-Johnson syndrome (SJS), erythema multiforme, toxic skin eruptions and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported in patients receiving atazanavir.
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 f'pazjenti li kienu qegħdin jirċievu atazanavir.
English: It inhibits CYP3A4.
Maltese: Jinibixxi l-CYP3A4.
English: Intent-to-treat analysis, with missing values considered as failures.
Maltese: NA NA NA a Analiżi intent-to-treat, b'valuri nieqsa kkunsidrati bħala falliment.
English: For randomised patients, the mean time of prior antiretroviral exposure was 138 weeks for PIs, 281 weeks for NRTIs, and 85 weeks for NNRTIs.
Maltese: F'pazjenti fuq bażi każwali l-ħin medju ta' l-espożizzjoni preċedenti antiretrovirali kien ta' 138 ġimgħa għal PIs, 281 ġimgħa għal NRTIs, u 85 ġimgħa għal NNRTIs.
English: INHALED BETA AGONISTS Salmeterol
Maltese: BETA LI JITTIEĦDU MAN-NIFS Salmeterol
English: Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitors, ATC code: J05AE08
Maltese: Antivirali għal użu sistemiku, inibitur tal-proteasi, kodiċi ATC:
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% tal-mediċina mhux mibdula ġiet irkuprata rispettivament fil-purgar u fl-urina.
English: Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities.
Maltese: Atazanavir jimpedixxi l-UGT u jista' jinterferixxi mal-metaboliżmu ta' irinotecan, li jirriżulta f'effetti tossiċi miżjuda ta' irinotecan.
English: Capsule shell cap 150 mg
Maltese: Kapsuli ta' 150 mg
English: The capsule shell and printing ink contain titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172), patent blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide.
Maltese: Il-qoxra tal-kapsula u l-linka tal-istampar fihom titanium dioxide (E171), indigo carmine (E132), iron oxide red (E172), patent blue V (E131), gelatin, shellac, propylene glycol, soluzzjoni ta 'ammonja kkonċentrata, iron oxide black (E172), potassium hydroxide.
English: Calcium channel blockers Bepridil
Maltese: Imblokkaturi tal-kanali tal-kalċju
English: The decrease in AUC, Cmax, and Cmin was not mitigated when an increased dose of atazanavir /ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours.
Maltese: It-tnaqqis fl-AUC, fis-Cmax, u fisCmin ma ttaffiex meta doża akbar ta' atazanavir/ritonavir (400/100 mg darba kuljum) ġiet separata temporalment minn omeprazole bi 12-il siegħa.
English: Clarithromycin Cmax ↑50% (↑32%
Maltese: Cmax ta' Clarithromycin ↑50%
English: Eleven subjects (13%) in the unboosted atazanavir group and 6 (7%) in the atazanavir + ritonavir group, had virologic rebound.
Maltese: Ħdax-il individwu (13%) fil-grupp ta' atazanavir mhux imsaħħaħ u 6 (7%) fil-grupp ta' atazanavir + ritonavir, kellhom rikaduta viroloġika.
English: Atazanavir Cmax ↓89% (↓94%
Maltese: Cmax ta' Atazanavir ↓89% (↓94%
English: Table 8: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg
Maltese: Tabella 8: 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: Cardiac monitoring is recommended based on the presence of clinical findings (e.g., bradycardia).
Maltese: Huwa rrakkomandat monitoraġġ kardijaku skont il-preżenza tar-riżultati kliniċi (eż. bradikardija).
English: Co-administration of atazanavir with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection) is contraindicated because of the increase in grazoprevir and elbasvir plasma concentrations and potential for the increase in risk of ALT elevations associated with increased grazoprevir concentrations (see section 4.3).
Maltese: L-għoti flimkien ta' atazanavir ma' prodotti li fihom grazoprevir, inkluż elbasvir/grazoprevir f'doża fissa kombinata (jintuża biex jikkura infezzjoni tal-epatite Ċ kronika) huwa kontraindikat minħabba żżieda fil-konċentrazzjonijiet fil-plażma ta' grazoprevir u elbasvir u l-potenzjal għal żieda fir-riskju ta' żieda fl-ALT assoċjati ma' konċentrazzjonijiet miżjuda ta' grazoprevir (ara sezzjoni 4.3).
English: The capsule shell and printing ink contain iron oxide red (E172), titanium dioxide (E171), patent blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide.
Maltese: Il-qoxra tal-kapsula u l-linka tal-istampar fiha iron oxide red (E172), titanium dioxide (E171), patent blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide.
English: Atazanavir Cmax ↔2% (↓15%
Maltese: Cmax ta' Atazanavir ↔2% (↓15%
English: Treatment-Naive Atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=16
Maltese: Pazjenti li Qatt Ma Kienu Kkurati filPassat b'kapsuli Atazanavir /ritonavir (300 mg/100 mg darba kuljum) n=16
English: HIV RNA <50 copies/ml, % All patients d
Maltese: HIV RNA <50 kopji/ml, % a Il-pazjenti kollha
English: common: ocular icterus
Maltese: komuni: icterus fl-għajnejn
English: uncommon: torsades de pointes a rare: QTc prolongation a, oedema, palpitation
Maltese: mhux komuni: torsades de pointesa rari: titwil tal-QTca, edema, palpitazzjonijiet
English: Capsule contents
Maltese: Il-kontenut tal-kapsula
English: Triazolam
Maltese: Midazolam Triazolam
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 issindrome ta' Cushing u suppressjoni adrenali ġew irrappurtati f'pazjenti li rċivew ritonavir u ħadu fluticasone propionate man-nifs jew millimnieħer; dan jista' jseħħ ukoll b'kortikosterojdi oħrajn metabolizzati permezz tal-passaġġ ta' P450 3A, eż. budesonide.
English: HIV-1 RNA was 4.94 log10 copies/ml (range 2.6 to 5.88 log10 copies/ml)
Maltese: ċellula/mm3) u l-plażma medja tal-linja bażi HIV-1 RNA kien 4.94 log10 kopji /ml) (firxa minn 2.6 sa 5.88 log10 kopja/ml).
English: Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4.
Maltese: Bħal ketoconazole, itraconazole huwa inibitur qawwi kif ukoll substrat ta' CYP3A4.
English: Hard capsule
Maltese: Kapsuli ibsin
English: Iron oxide yellow (E172) Titanium dioxide (E171) Patent blue V (E131) Gelatin
Maltese: Iron oxide yellow (E172) Titanium dioxide (E171) Patent blue V (E131) Ġelatina
English: By as-treated analysis, excluding missing values, the proportions of patients with HIV RNA < 400 copies/ml (< 50 copies/ml) in the atazanavir + ritonavir arm and the lopinavir + ritonavir arm were 55% (40%) and 56% (46%), respectively.
Maltese: Skont 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 atazanavir + ritonavir u fergħa ta' lopinavir + ritonavir kien ta' 55% (40%) u 56% (46%) rispettivament.
English: Iron oxide red (E172) Titanium dioxide (E171) Patent blue V (E131) Gelatin
Maltese: Iron oxide red (E172) Titanium dioxide (E171) Patent blue V (E131) Ġelatina
English: Per protocol analysis e
Maltese: e Analiżi skont il-protokoll:
English: • syncope (fainting), hypertension (high blood pressure)
Maltese: • sinkope (ħass ħażin), ipertensjoni (pressjoni tad-demm għolja)
English: The mechanism of interaction is CYP3A4 and UGT1A1 inhibition.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l-inibizzjoni ta' CYP3A4 u UGT1A1.
English: 2D barcode carrying the unique identifier included
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Didanosine (buffered tablets) 200 mg/stavudine 40 mg, both single dose
Maltese: Didanosine (pilloli buffered) 200 mg/stavudine 40 mg, it-tnejn doża waħda (atazanavir 400 mg doża waħda)
English: Assessment of the pharmacokinetics, safety, tolerability, and efficacy of atazanavir 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' atazanavir huma bbażati fuq tagħrif miġbur mill-prova klinika, open-label, multiċentrika AI424-020, li saret fuq pazjenti bejn l-etajiet ta' 3 xhur sa 21 sena.
English: In HIV-infected patients (n=33, combined studies), multiple dosing of atazanavir 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: F'pazjenti infettati bl-HIV, (n=33 studji kombinati), wara li ngħataw ħafna dożi ta' atazanavir 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: The primary endpoint was the time-averaged difference in change from baseline in HIV RNA through 48 weeks (Table 6).
Maltese: Il-punt finali primarju kien id-differenza fuq medja ta' żmien mill-bidla mil-linja bażi tal-HIV RNA matul 48 ġimgħa (Tabella 6).
English: Six of 20 (30%) women on atazanavir/ritonavir 300/100 mg and 13 of 21 (62%) women on atazanavir /ritonavir 400/100 mg experienced grades 3 to 4 hyperbilirubinaemia.
Maltese: Sitta mill-20 (30%) mara li kienu fuq atazanavir/ritonavir 300/100 mg u 13 mill-21 (62%) mara li kienu fuq atazanavir/ritonavir 400/100 mg esperjenzaw iperbilirubinemija ta' skala 3 sa 4.
English: 3rd Trimester (n=20)
Maltese: 3 trimestru (n=20)
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni HIV fi stat avvanzat (AIDS) u passat ta' infezzjoni opportunistika, jista' jkun hemm sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet ta' qabel, ftit wara li tibda l-kura kontra l-HIV.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Ipersensittività għas-sustanza attiva jew għal kwalunkwe eċċipjent elenkat fit-taqsima 6.1.
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: Ethinyloestradiol Cmin ↑91% (↑57%
Maltese: Cmin ta' Ethinyloestradiol ↑91 %
English: Clarithromycin AUC ↑94% (↑75%
Maltese: AUC ta' Clarithromycin ↑94%
English: Atazanavir Mylan dose once daily (mg)
Maltese: Atazanavir Mylan Doża darba kuljum (mg)
English: HDPE bottle with polypropylene screw cap containing 30, 90 capsules.
Maltese: Flixkun tal-HDPE b'għatu bil-kamin tal-polypropylene li jkun fih 30, 90 kapsula.
English: M36, M46, I54, A71, V82 L10, I15, K20, V32, E35, S37, F53, I62, G73, I84, L90
Maltese: M36, M46, G48, I50, I54, L63, A71, G73, V82, I84, u L90 (0-2, 3, 4 jew aktar) fil-linja bażi.
English: A change in dose may occur when switching between other formulations and capsules.
Maltese: Jista' jkun hemm tibdil fid-doża meta taqleb bejn formulazzjonijiet alternattivi u l-kapsuli.
English: PHARMACEUTICAL FORM AND CONTENTS
Maltese:  GĦAMLA FARMAĊEWTIKA U KONTENUT