FrancophonIA/ELRC3.0 huggingface dataset:
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: SEDATIVES Benzodiazepines Midazolam Triazolam
Maltese: Midazolam Triazolam
English: De novo substitutions in treatment experienced patients failing therapy with atazanavir + ritonavir (Study 045, 48 weeks)
Maltese: Sostituzzjonijiet De novo f'pazjenti li kienu għaddew minn kura li fallew it-terapija b'atazanavir + ritonavir (Studji 045, 48 ġimgħa)
English: Voriconazole AUC ↓33% (↓42% Voriconazole cmax ↓10% (↓22% Voriconazole cmin ↓39% (↓49%
Maltese: AUC ta' Voriconazole ↓33 % (↓42 % cmax ta' Voriconazole ↓10 % (↓22 % cmin ta' Voriconazole ↓39 % (↓49 %
English: Atazanavir AUC: ↑250% (↑144%
Maltese: AUC ta' Atazanavir: ↑250 % (↑144 % cmax ta' Atazanavir:
English: (indigestion) - fatigue (extreme tiredness)
Maltese: (indiġestjoni) - għeja (għeja tremenda)
English: Geometric mean (CV%)
Maltese: (CV %)
English: Atazanavir cmin: ↑713% (↑359%
Maltese: ↑120% (↑56% cmin ta' Atazanavir: ↑713 % (↑359 %
English: 15 to less than 35 At least 35
Maltese: minn 15 sa inqas minn 35 Tal-inqas 35
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 s sezzjoni 5
English: HDPE tablet container with child-resistant tamper evident PP with desiccant closure: 30 hard capsules and 90 (3 x 30) hard capsules, in a box.
Maltese: Kontenitur tal-pilloli HDPE b'għatu PP reżistenti għall-ftuħ mit-tfal b'dessikant: 30 kapsula iebsa u 90 (3 x 30) kapsula iebsa f'kaxxa.
English: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020)
Maltese: Riżultati tal-Effikaċja (pazjenti pedjatriċi minn 6 snin sa inqas minn 18-il sena) f'Ġimgħa 48 (Studju AI424-020)
English: 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: Atazanavir Krka 150 mg hard capsules Atazanavir Krka 200 mg hard capsules Atazanavir Krka 300 mg hard capsules atazanavir
Maltese: Krka 200 mg kapsuli ibsin Atazanavir Krka 300 mg kapsuli ibsin atazanavir
English: 300 mg tenofovir disoproxil fumarate is equivalent to 245 mg tenofovir disoproxil
Maltese: B'Tenofovir disoproxil fumarate 300 mg darba kuljum (ekwivalenti għal 245 mg tenofovir disoproxil)
English: Other formulations of this medicine may be available for paediatric patients at least 3 months of age and weighing at least 5 kg (see relevant Summary of Product Characteristics for alternative forms).
Maltese: Formulazzjonijiet oħra ta' din il-mediċina huwa disponibbli għal pazjenti pedjatriċi li għandhom talinqas 3 xhur u li jiżnu tal-inqas 5 kg (ara s-Sommarju tal-Karatteristiċi tal-Prodott għal formulazzjonijiet alternattivi).
English: 30 hard capsules
Maltese: 30 kapsula iebsa:
English: uncommon: torsades de pointes a rare: QTc prolongationa, oedema, palpitation
Maltese: mhux komuni: torsades de pointesa rari: titwil tal-QTca, edema, palpitazzjonijiet
English: 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: Atazanavir AUC ↑28% (↑16% Atazanavir cmax ↔6% (↓7% Atazanavir cmin ↑91% (↑66%
Maltese: AUC ta' Atazanavir ↑28 % (↑16 % cmax ta' Atazanavir ↔6 % (↓7 % cmin ta' Atazanavir ↑91 % (↑66 %
English: Difference estimatee [95% CI]
Maltese: [95 %CI]
English: Atazanavir + saquinavir was shown to be inferior to lopinavir + ritonavir.
Maltese: Atazanavir+ saquinavir jidher li hu inferjuri għal lopinavir + ritonavir.
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 % ↑4 %) cmin ta' Ritonavir ↓19 % (↓35 % ↑1 %)
English: common: fatigue; uncommon: chest pain, malaise, pyrexia, asthenia; rare: gait disturbance aThese 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 atazanavir in randomised controlled and other available clinical trials (n = 2321).
Maltese: 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 atazanavir fi provi kliniċi randomizzati u kkontrollati u fi provi kliniċi disponibbli oħrajn (n=2,321).
English: INFORMATION IN BRAILLE Atazanavir Krka 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Atazanavir Krka 300 mg
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: 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: 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. Coinfected 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: It inhibits CYP3A4.
Maltese: CYP3A4.
English: 300 mg tenofovir disoproxil fumarate is equivalent to 245 mg tenofovir disoproxil.
Maltese: 245 mg tenofovir disoproxil.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE08.
Maltese: .1 Proprjetajiet farmakodinamiċi Kategorija farmakoterapewtika: antivirali għal użu sistemiku, inibituri tal-proteasi, kodiċi ATC:
English: 90 (3 x 30) hard capsules
Maltese: Kapsula iebsa 30 kapsula iebsa 90 (3 x 30) kapsula iebsa
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: Reproductive system and breast disorders:
Maltese: Disturbi fis-sistema riproduttiva u fissider:
English: RNA level was 4.4 log10 copies/ml (range: 2.6 to 5.88 log10 copies/ml).
Maltese: HIV-1 RNA fil-plażma kienet ta' 4.94 log10 kopja/ml (medda: bejn 2.6 u 5.88 log10 kopja/ml)
English: Atazanavir Krka Dose once daily (mg)
Maltese: Atazanavir Krka Doża darba kuljum (mg)
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 % ↔0 %) cmin ta' Ritonavir ↓25 % (↓35 %
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: 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 %
English: (atazanavir 300 mg / ritonavir 100 mg once daily)
Maltese: (atazanavir 300 mg / ritonavir 100 mg darba kuljum)
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: potassium hydroxide
Maltese: SEDATTIVI Benzodiazepines
English: Driving and using machines
Maltese: ekżema, vażodilazzjoni
English: The geometric mean (CV%) for atazanavir cmin and AUC were 120 (109) ng/ml and 14874 (91) ng•h/ml, respectively.
Maltese: AUC ta' atazanavir kienu ta' 120 (109) ng/ml u ta' 14,874
English: Atazanavir AUC ↑7% (↓2% Atazanavir cmax ↑2% (↓4% ↑8%) Atazanavir cmin ↑15% (↑2% ↑29%) Elbasvir AUC: ↑376% (↑307% Elbasvir cmax: ↑315% (↑246% Elbasvir cmin: ↑545% (↑451%
Maltese: AUC ta' Atazanavir ↑7% (↓2% ↑17%) cmax ta' Atazanavir ↑2% (↓4% ↑8%) cmin ta' Atazanavir ↑15% (↑2% ↑29%) AUC ta' Elbasvir: ↑376% (↑307% cmax ta' Elbasvir:
English: Efficacy Outcomes at Week 48a and at Week 96 (Study 045)
Maltese: Riżultati ta' Effikaċja f'Ġimgħa 48a u f'Ġimgħa 96 (Studju 045)
English: The most frequently reported laboratory abnormality in patients receiving regimens containing atazanavir and one or more NRTIs was elevated total bilirubin reported predominantly as elevated indirect [unconjugated] bilirubin (87% Grade 1, 2, 3, or 4).
Maltese: L-anormalità tal-laboratorju li l-aktar li ġiet irrapportata f'pazjenti b'kura b'atazanavir 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: Atazanavir Krka 300 mg hard capsules
Maltese: Atanzanavir Krka 300 mg kapsuli ibsin
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: 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: common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitis a
Maltese: mhux komuni: epatite, kolelitjażia, kolestażia; rari: epatosplenomegalija, koleċistitea
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 letajiet ta' 3 xhur sa 21 sena.
English: Didanosine (with food) Didanosine AUC ↓34% (↓41% ↓27%) Didanosine cmax ↓38% (↓48% ↓26%) Didanosine cmin
Maltese: AUC ta' Didanosine ↓34 % (↓41 % cmax ta' Didanosine ↓38 % (↓48 % cmin ta' Didanosine ↑25 % (↓8 %
English: Norethindrone cmax ↑67% (↑42% Norethindrone cmin ↑262%
Maltese: AUC ta' Norethindrone ↑110 % cmax ta' Norethindrone ↑67 % (↑42 % cmin ta' Norethindrone ↑262 %
English: PULMONARY ARTERIAL HYPERTENSION PDE5 Inhibitors
Maltese: Inibituri PDE5 Sildenafil
English: 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: The capsule cap is imprinted with black mark A150.
Maltese: L-għatu tal-kapsula huwa stampat bil-marka sewda A150.
English: Hard gelatine capsule (capsule), size no. 1.
Maltese: Kapsula tal-ġelatina iebsa (kapsula), ta' daqs nru, 1.
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: 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
English: Musculoskeletal and connective tissue disorders uncommon: muscle atrophy, arthralgia, myalgia; rare: myopathy
Maltese: mhux komuni: atrofija tal-muskoli, artralġja, uġigħ fil muskoli; rari: mijopatija
English: - interstitial nephritis (kidney inflammation), haematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination) - gynaecomastia (breast enlargement in men) - chest pain, malaise (generally feeling unwell), fever - insomnia (difficulty sleeping)
Maltese: - nefrite interstizjali (infjammazzjoni tal-kliewi), ħematurja (demm fl-awrina), proteinurja (eċċess ta' proteina fl-awrina), pollakjurja (żieda fil-frekwenza ta' tibwil) - ginektomastja (tkabbir tas-sider fl-irġiel)
English: (atazanavir 400 mg once daily)
Maltese: (atazanavir 400 mg doża waħda)
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: Atazanavir Krka capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products (see section 4.2).
Maltese: Il-kapsuli Atazanavir Krka, li jingħataw flimkien ma' doża baxxa ta' ritonavir, huma indikati bħala kura lil pazjenti adulti u pedjatriċi li għandhom 6 snin jew aktar infettati b'HIV-1 flimkien ma' prodotti mediċinali antiretrovirali oħra (ara sezzjoni 4.2).
English: 14-OH clarithromycin 14-OH clarithromycin AUC ↓70%
Maltese: 14-OH clarithromycin
English: HORMONAL CONTRACEPTIVES Ethinyloestradiol 25 μg + norgestimate (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Maltese: Ethinyloestradiol 25 μg + norgestimate (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: Methadone, stable maintenance dose
Maltese: Methadone, doża ta'
English: Atazanavir AUC ↓19% (↓35% Atazanavir cmax ↔2% (↓15% Atazanavir cmin ↓59% (↓73%
Maltese: AUC ta' Atazanavir ↓19 % (↓35 % cmax ta' Atazanavir ↔2 % (↓15 % cmin ta' Atazanavir ↓59 % (↓73 %
English: Tenofovir disoproxil fumarate Cmin
Maltese: Mingħajr Tenofovir disoproxil
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: 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 atazanavir + ritonavir u fergħa ta' lopinavir + ritonavir kien ta' 55 % (40 %) u 56 % (46 %)
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, %f (responder/evaluable) All patients
Maltese: HIV RNA <50 kopja/ml, %f (min rrisponda/evalwabbli) Il-pazjenti kollha
English: Table 1: Dose for paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) for Atazanavir Krka capsules with ritonavir Body Weight (kg)
Maltese: Tabella 1: Doża għal pazjenti pedjatriċi (minn 6 snin sa inqas minn 18-il sena u jiżnu mill inqas 15 kg) għal kapsuli Atazanavir Krka ma' ritonavir
English: The capsule cap is imprinted with white mark A300.
Maltese: L-għatu tal-kapsula huwa stampat bil-marka sewda A300.
English: Phenobarbital and phenytoin should be used with caution in combination with atazanavir /ritonavir.
Maltese: Phenobarbital u phenytoin għandhom jintużaw b'attenzjoni f'kombinazzjoni ma' atazanavir/ritonavir.
English: Cmax ng/mL Geometric mean (CV%) AUC ng•h/mL Geometric mean (CV%)
Maltese: (CV %) AUC ng•h/mL
English: The atazanavir /ritonavir arm showed 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 (Table 5).
Maltese: Il-fergħa ta' atazanavir/ritonavir auriet effikaċja antivirali simili (mhux inferjuri) meta mqabbla mal-fergħa ta' lopinavir/ritonavir, kif evalwat mill-proporzjon ta' pazjenti b'HIV RNA <50 kopji/ml f'ġimgħa 48 (Tabella 5).
English: Week 48 Week 96 Week 48 Week 96 Week 48 Week 96
Maltese: Ġimgħa 48 Ġimgħa 96 Ġimgħa 48 Ġimgħa 96 Ġimgħa 48 Ġimgħa 96
English: administered with atazanavir.
Maltese: reżistenza firmatarja għal atazanavir.
English: Ritonavir 100 mg once daily is used as a booster of atazanavir pharmacokinetics.
Maltese: Ritonavir 100 mg darba kuljum jintuża bħala booster tal farmakokinetika ta' atazanavir.
English: Atazanavir AUC ↓20% (↓35% Atazanavir cmax ↓19% (↓34% Atazanavir cmin ↓ 31 % (↓46 %
Maltese: AUC ta' Atazanavir ↓20% (↓35% cmax ta' Atazanavir ↓19 % (↓34 % cmin ta' Atazanavir ↓31 % (↓46 %
English: Hard gelatine capsule (capsule), size no. 0.
Maltese: Kapsula tal-ġelatina iebsa (kapsula), ta' daqs nru. 0.
English: The capsule cap is imprinted with black mark A200.
Maltese: L-għatu tal-kapsula huwa stampat bil-marka sewda A200.
English: g Select substitutions include any change at positions L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63, A71,
Maltese: g Sostituzzjonijiet magħżula nklużi kwalunkwe tibdil fil-pożizzjonijiet L10, K20, L24, V32, L33, M36, M46, G48, I50, I54,
English: Atazanavir AUC ↓22% (↓35% Atazanavir cmax ↓16% (↓30% Atazanavir cmin ↓23% (↓43% ↑2%)
Maltese: AUC ta' Atazanavir ↓22 % (↓35 % cmax ta' Atazanavir ↓16 % (↓30 % cmin ta' Atazanavir ↓23 % (↓43 %
English: Subjects without a functional CYP2C19 allele.
Maltese: CYP2C19 funzjonali.
English: atazanavir (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: Atazanavir (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: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/002
Maltese: EU/1/19/1353/002
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Lactose Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza totali għal-lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jingħataw din il-mediċina. 4.5
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: 300 mg u ritonavir 100 mg (n=33) tqabbel ma' atazanavir 400 mg mingħajr ritonavir (n=28).
English: Hard gelatine capsule (capsule), size no. 00.
Maltese: Kapsula tal-ġelatina iebsa (kapsula), ta' daqs nru 00.
English: ANTIBIOTICS Clarithromycin 500 mg twice daily (atazanavir 400 mg once daily)
Maltese: Clarithromycin 500 mg darbtejn kuljum (atazanavir 400 mg darba kuljum)
English: Concentrations of atazanavir with or without ritonavir are expected to be increased in patients with moderately or severely impaired hepatic function (see sections 4.2, 4.3, and 4.4).
Maltese: Atazanavir Krka ma' ritonavir huwa kontraindikat f'pazjenti b'indeboliment epatiku moderat (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: MARKETING AUTHORISATION HOLDER KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja Manifatturi
English: Hard gelatine capsule, size no. 0.
Maltese: Kapsula tal-ġelatina iebsa, ta' daqs nru. 0.
English: b Cmin is concentration 24 hours post-dose
Maltese: b Cmin hija konċentrazzjoni 24 siegħa wara d-doża.
English: Co-administration of atazanavir with grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination 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 doża fissa kombinata ta' elbasvir/grazoprevir huwa kontraindikat minħabba ż-żieda fil-konċentrazzjonijiet fil-plażma ta' grazoprevir u elbasvir u l-potenzjal għaż-żieda fir-riskju ta' żidiet fl-ALT assoċjati ma' konċentrazzjonijiet miżjuda ta' grazoprevir (ara sezzjoni 4.3).
English: See section 2 "Atazanavir Krka contains lactose monohydrate".
Maltese: Fih ukoll lactose monohydrate.
English: Atazanavir AUC ↓30% (↓43% Atazanavir cmax ↓31% (↓42% Atazanavir cmin ↓31% (↓46%
Maltese: AUC ta' Atazanavir ↓30% (↓43% cmax ta' Atazanavir ↓31% (↓42% ↓17%) cmin ta' Atazanavir ↓31% (↓46% ↓12%)
English: The mechanism of nevirapine/atazanavir interaction is CYP3A4 induction.
Maltese: nevirapine/atazanavir huwa linduzzjoni ta' CYP3A4.
English: ANTIFUNGALS Ketoconazole 200 mg once daily (atazanavir 400 mg once daily)
Maltese: Ketoconazole 200 mg darba kuljum (atazanavir 400 mg darba kuljum)
English: The mean
Maltese: Total ta'
English: 300 mg hard capsules:
Maltese: Krka 200 mg kapsuli ibsin: