FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5 inhibitor-associated adverse events.
Maltese: L-għoti flimkien ta' EVOTAZ jista' jirriżulta f'konċentrazzjonijiet akbar talinibitur ta' PDE5 u żieda flavvenimenti avversi assoċjati malinibitur PDE5.
English: ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Maltese: Grazoprevir 200 mg darba kuljum (atazanavir 300 mg / ritonavir 100 mg darba kuljum)
English: Efavirenz 600 mg once daily (atazanavir 400 mg once daily)
Maltese: Efavirenz 600 mg darba kuljum (atazanavir 400 mg darba kuljum)
English: In these pharmacokinetic trials, the exposure of atazanavir 300 mg with cobicistat 150 mg was consistent with that observed when boosted with ritonavir 100 mg. EVOTAZ is bioequivalent to atazanavir 300 mg once daily in combination with cobicistat 150 mg once daily coadministered as single agents (see section 5.2).
Maltese: F'dawn il-provi farmakokinetiċi, l-esponiment għal atazanavir 300 mg ma' cobicistat 150 mg kien konsistenti ma' dak osservat meta msaħħaħ b'ritonavir 100 mg.
English: Co-administration warrants clinical monitoring for sedation and cognitive effects.
Maltese: L-għoti flimkien jitlob monitoraġġ kliniku għal effetti ta' sedazzjoni u konoxxittivi.
English: Telaprevir AUC ↓20% (↓24% Telaprevir Cmax ↓21% (↓26% Telaprevir Cmin ↓15% (↓25% ↓2%) Atazanavir AUC ↑17% (↓3% Atazanavir Cmax ↓15% (↓27% Atazanavir Cmin ↑85% (↑40%
Maltese: AUC ta' Atazanavir ↑17 % (↓3 % Cmax ta' Atazanavir ↓15% (↓27% Cmin ta' Atazanavir ↑85 % (↑40 %
English: ANTINEOPLASTICS AND IMMUNOSUPRESSANTS
Maltese: U IMMUNOSUPPRESSANTI
English: EVOTAZ should be used with caution in patients with mild hepatic impairment (see sections 4.2, 4.3 and 5.2).
Maltese: EVOTAZ għandu jintuża b'kawtela f'pazjenti b‘indeboliment epatiku ħafif (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: The mechanism of interaction is CYP3A4 induction by etravirine.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l-inibizzjoni ta' CYP3A4 minn etravirine.
English: How to store EVOTAZ 6.
Maltese: Kif taħżen EVOTAZ 6.
English: In clinical trials of antiretroviral treatment naive patients treated with unboosted atazanavir, the I50L substitution, sometimes in combination with an A71V change, is the signature resistance substitution for atazanavir.
Maltese: F'esperimenti kliniċi ta' pazjenti li qatt qabel ma ħadu kura antiretrovirali li ġew ikkurati b'atazanavir mhux ibbustjat, is-sostituzzjoni I50L, kultant flimkien ma' bidla fl-A71V, hija sostituzzjoni ta' reżistenza ewlenija għal atazanavir.
English: Subsequent 9 month oral toxicity studies in dogs showed no drug-related electrocardiographic changes.
Maltese: Studji susseggwenti ta' tossiċità orali fil-klieb li damu 9 xhur ma wrew ebda bidla elettrokardjografika relatata mal-mediċini.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets.
Maltese: FARMAĊEWTIKA U KONTENUT 30 pillola miksijin b'rita.
English: Adverse Reactions uncommon myalgia, muscle atrophy, arthralgia rare myopathy
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi mhux komuni mijalġja, atrofija tal-muskoli, artralġja rari
English: Endothelin Receptor Antagonists
Maltese: IL-PRODOTT MEDIĊINALI
English: Rifampicin 600 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Maltese: Rifampicin 600 mg darba kuljum (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: Concentrations of atazanavir given with cobicistat are expected to be increased in patients with impaired hepatic function (see sections 4.2 and 4.4).
Maltese: Il-konċentrazzjonijiet ta' atazanavir mogħtija ma‘ cobicistat huma mistennija li jiżdiedu f'pazjenti b'indeboliment filfunzjoni epatika (ara sezzjonijiet 4.2 u 4.4).
English: Concomitant use of EVOTAZ and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Maltese: L-użu f'daqqa ta' EVOTAZ u fluticasone jew glukokortikojdi oħrajn li huma metabolizzati b'CYP3A4 mhuwiex rakkomandat sakemm il-benefiċċju mistenni ma jkunx akbar mir-riskju ta' leffetti sistematiċi ta' kortikosterojdi, inkluż is-sindrome ta' Cushing u t-trażżin adrenali (ara sezzjoni 4.5).
English: Co-administration of EVOTAZ with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3).
Maltese: Kontraindikat minħabba ż-żieda potenzjali fir-riskju ta' żidiet flALT minħabba żieda sinifikanti filkonċentrazzjonijiet ta' glecaprevir u ta' pibrentasvir fil-plażma (ara sezzjoni 4.3).
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and is a CYP3A substrate.
Maltese: Cobicistat huwa inibitur ta' CYP3A bbażat fuq mekkaniżmu b'saħħtu u huwa sottostrat ta' CYP3A.
English: Co-administration of EVOTAZ and medicinal products that induce CYP3A4 is contraindicated or not recommended (see sections 4.3 and 4.5) because, in addition to decreased plasma concentrations of atazanavir due to induction of CYP3A4, decreased plasma concentrations of cobicistat could result in cobicistat plasma levels that are insufficient to achieve adequate pharmacoenhancement of atazanavir.
Maltese: L-għoti flimkien ta' EVOTAZ u prodotti mediċinali li jinduċu CYP3A4 huwa kontraindikat jew mhux irrakkomandat (ara sezzjonijiet 4.3 u 4.5) għaliex, minbarra tnaqqis fil-konċentrazzjonijiet fil-plażma ta' atazanavir minħabba l-induzzjoni ta' CYP3A4, tnaqqis fil-konċentrazzjonijiet fil-plażma ta' cobicistat jista' jirriżulta f'livelli fil-plażma ta' cobicistat li huma biżżejjed biex jintlaħaq titjib farmakoloġiku adegwat ta' atazanavir.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of cobicistat has not been studied.
Maltese: L-effett ta' indeboliment epatiku sever (Child-Pugh Klassi C) fuq il-farmakokinetika ta' cobicistat ma ġiex studjat.
English: Dose related asymptomatic prolongations in PR interval with atazanavir, a component of EVOTAZ have been observed in clinical studies.
Maltese: Fi studji kliniċi ġie osservat titwil mingħajr sintomi relatat mad-dożi f'intervall ta' PR b'atazanavir, komponent ta' EVOTAZ.
English: Effect of cobicistat on atazanavir pharmacokinetics
Maltese: Prodotti mediċinali skont ilqasam terapewtiku
English: Patients with chronic hepatitis B or hepatitis C virus co-infection:
Maltese: Pazjenti b'koinfezzjoni bil-virus tal-epatite B jew tal-epatite Ċ kronika:
English: With Tenofovir DF 300 mg once daily Famotidine 20 mg twice daily (atazanavir 300 mg/ritonavir 100 mg/tenofovir DF 300 mg once daily, simultaneous administration)
Maltese: 300 mg/ritonavir 100 mg/tenofovir DF 300 mg darba kuljum, għoti f'daqqa)
English: Telaprevir AUC ↔ Telaprevir Cmax ↔ Telaprevir Cmin ↔
Maltese: AUC ta' Telaprevir ↔ Cmax ta' Telaprevir ↔ Cmin ta' Telaprevir ↔
English: Avoid concomitant use of EVOTAZ and rivaroxaban.
Maltese: Evita l-użu f'daqqa ta' EVOTAZ u rivaroxaban.
English: Co-administration of EVOTAZ with alfuzosin is contraindicated (see section 4.3)
Maltese: L-għoti flimkien ta' EVOTAZ ma' alfuzosin huwa kontraindikat (ara sezzjoni 4.3).
English: Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-associated adverse events, including hypotension, visual changes, and priapism.
Maltese: L-għoti flimkien ma' EVOTAZ jista' jirriżulta f'konċentrazzjonijiet akbar talinibitur PDE5 u żieda flavvenimenti avversi relatati ma' inibitur PDE5, fosthom pressjoni baxxa, bidliet viżwali, u prijapiżmu.
English: Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with EVOTAZ.
Maltese: Il-konċentrazzjonijiet imnaqqsa ta' atazanavir fil-plażma jistgħu jkunu l-konsegwenza ta' żieda fil-pH gastriku jekk antaċidi, inklużi prodotti mediċinali buffered jingħataw ma' EVOTAZ.
English: The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa solubilità mnaqqsa ta' atazanavir hekk kif il-pH intragastriku jiżdied b'inibituri talproton pump.
English: Omeprazole 40 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily, 2 hours after omeprazole)
Maltese: Omeprazole 40 mg darba kuljum (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum, sagħtejn wara omeprazole)
English: Subjects with significant liver function test abnormalities generally had abnormal baseline transaminases (AST or ALT), underlying chronic or acute hepatitis B or C co-infection, concomitant hepatotoxic medications (e.g., isoniazid), or a medical history of alcoholism or alcohol abuse.
Maltese: Individwi b'anormalitajiet sinifikanti tat-test talfunzjoni tal-fwied ġeneralment kellhom transaminażi tal-linja bażi abnormali (AST jew ALT), ko-infezzjoni kronika jew akuta tal-epatite B jew Ċ bażi, medikazzjonijiet epatotossiċi konkomitanti (eż. isoniazid), jew storja medika ta' alkoħoliżmu jew abbuż mill-alkoħol.
English: Co-administration with antiretroviral medicinal products EVOTAZ is indicated for use with other antiretrovirals for the treatment of HIV-1 infection.
Maltese: L-għoti flimkien ma' prodotti mediċinali antiretrovirali EVOTAZ huwa indikat għall-użu ma' antiretrovirali oħra għall-kura ta' infezzjoni ta' HIV-1.
English: In rats, ossification changes in the spinal column and sternebra of foetuses occurred at a dose that produced significant maternal toxicity.
Maltese: Fil-firien, kien hemm bidliet fl-ossifikazzjoni tal-kolonna vertebrali u listernebra tal-feti f'doża li pproduċiet tossiċità materna sinifikanti.
English: Atazanavir Cmax ↑2% (↓4% ↑8%) Atazanavir Cmin ↑15% (↑2%
Maltese: AUC ta' Atazanavir ↑7% (↓2% Cmax ta' Atazanavir ↑2% (↓4% Cmin ta' Atazanavir ↑15% (↑2% AUC ta' Elbasvir:
English: Nevirapine 200 mg twice daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Maltese: Nevirapine 200 mg darbtejn kuljum (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Maltese: Tnejn fil-mija tal-pazjenti kkurati b'atazanavir kellhom flimkien ALT/AST Grad 3-4 u bilirubin totali ta' Grad 3-4 elevati.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains atazanavir sulphate corresponding to 300 mg atazanavir and 150 mg of cobicistat.
Maltese: Kull pillola miksija b'rita fiha atazanavir sulphate li jikkorrispondi għal 300 mg ta' atazanavir u 150 mg ta' cobicistat.
English: If EVOTAZ is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Maltese: Jekk EVOTAZ jingħata flimkien ma' midazolam parenterali, dan għandu jsir f'taqsima tal-kura intensiva (ICUintensive care unit) jew f'ambjent simili li jiżgura monitoraġġ kliniku mill-qrib u mmaniġġjar mediku xieraq f'każ ta' qtugħ ta' nifs u/jew sedazzjoni mtawla.
English: Rifabutin 150 mg twice weekly (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Maltese: Rifabutin 150 mg darbtejn filġimgħa (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum)
English: More frequent therapeutic concentration monitoring is recommended for immunosuppressant agents when co-administered with EVOTAZ.
Maltese: Huwa rrakkomandat monitoraġġ ta' konċentrazzjoni terapewtika aktar frekwenti għal sustanzi immunosuppressanti meta jingħataw ma' EVOTAZ.
English: Both asymptomatic first-degree (23%) and second-degree (1%) atrioventricular block were reported in paediatric patients.
Maltese: Ġew irrappurtati kemm imblokk atrijoventrikulari tal-ewwel grad (23 %) kif ukoll tat-tieni grad (1 %) f'pazjenti pedjatriċi.
English: There are currently inadequate data to determine whether co-administration of tenofovir disoproxil and cobicistat is associated with a greater risk of renal adverse reactions compared with regimens that include tenofovir disoproxil without cobicistat.
Maltese: Bħalissa hemm dejta inadegwata biex jiġi ddeterminat jekk l-għoti flimkien ta‘ tenofovir disoproxil u cobicistat huwiex assoċjat ma' riskju akbar ta' reazzjonijiet avversi fil-kliewi meta mqabbel ma‘ reġimi li jinkludu tenofovir disoproxil mingħajr cobicistat.
English: An initial dose reduction of diltiazem by 50% should be considered, and electrocardiogram monitoring is recommended.
Maltese: Għandu jiġi kkunsidrat tnaqqis fid-doża inizjali ta' diltiazem b'50 %, u huwa rakkomandat monitoraġġ b'elettrokardjogramma.
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at mean concentrations at least 10-fold higher than the human exposure at the recommended 150 mg daily dose.
Maltese: Studji fuq il-fniek ex vivo u studji fuq il-klieb in vivo jindikaw li cobicistat għandu potenzjal baxx għal titwil tal-QT, u jaf itawwal bi ftit l-intervall tal-PR u jnaqqas il-funzjoni ventrikulari tax-xellug f'konċentrazzjonijiet medji għallinqas 10 darbiet aktar l-espożizzjoni tal-bniedem fid-doża rakkomandata ta' kuljum ta' 150 mg.
English: Plasma concentrations of drospirenone are increased following co-administration of drospirenone/ethinyloestradiol with atazanavir/cobicistat.
Maltese: Il-konċentrazzjonijiet ta' drospirenone fil-plażma jiżdiedu wara l-għoti ta' drospirenone/ethinyloestradiol ma' atazanavir/cobicistat.
English: Metabolism and nutrition disorders common increased appetite uncommon weight decreased, weight gain, anorexia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni żieda fl-aptit mhux komuni tnaqqis fil-piż, żieda fil-piż, anoreksja
English: Atazanavir has been shown in vivo not to induce its own metabolism, nor to increase the biotransformation of some medicinal products metabolised by CYP3A4.
Maltese: Atazanavir intwera in vivo li ma jinduċix il-metaboliżmu tiegħu stess, u lanqas iżid ilbijotrasformazzjoni ta' xi prodotti mediċinali metabolizzati minn CYP3A4.
English: Exposure to diltiazem and a metabolite, desacetyl-diltiazem, is increased when diltiazem is co-administered with atazanavir, a component of EVOTAZ.
Maltese: L-esponiment għal diltiazem u metabolit, desacetyl-diltiazem, jiżdied meta diltiazem jingħata flimkien ma' atazanavir, komponent ta' EVOTAZ.
English: For medicinal products metabolised by CYP3A these higher plasma concentrations may potentially lead to severe, life-threatening or fatal events (see sections 4.3 and 4.5).
Maltese: Għal prodotti mediċinali metabolizzati minn CYP3A, dawn ilkonċentrazzjonijiet fil-plażma ogħla jistgħu potenzjalment iwasslu għal avvenimenti serji, ta' theddida għall-ħajja jew fatali (ara sezzjonijiet 4.3 u 4.5).
English: Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Tel: + 372 6827 400
Maltese: Slovenská republika Bristol-Myers Squibb spol. s r.o. Tel: + 421 2 59298411
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Maltese: Cobicistat ġie osservat li jnaqqas l-eliminazzjoni stmata tal-kreatinina minħabba l-inibizzjoni ta' sekrezzjoni tubulari tal-kreatinina.
English: One EVOTAZ tablet is bioequivalent to one atazanavir capsule (300 mg) plus one cobicistat tablet (150 mg) following single oral dose administration with a light meal in healthy subjects (n=62).
Maltese: Pillola waħda ta' EVOTAZ hija bijoekwivalenti għal kapsula waħda ta' atazanavir (300 mg) flimkien ma' pillola waħda ta' cobicistat (150 mg) wara l-għoti ta' doża orali waħda ma' ikla ħafifa f'individwi b'saħħithom (n=62).
English: Co-administration of simvastatin or lovastatin with EVOTAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Maltese: L-għoti flimkien ta' simvastatin jew lovastatin ma' EVOTAZ hu kontraindikat minħabba riskju akbar ta' mijopatija li tinkludi rabdomijoliżi (ara sezzjoni 4.3).
English: Atazanavir should be used with caution in patients with mild (Child-Pugh Class A) hepatic impairment.
Maltese: Atazanavir għandu jintuża b'kawtela f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh Klassi A).
English: However, a higher percentage of subjects in the atazanavir boosted with cobicistat group had increases in total bilirubin > 2 x ULN than those in the atazanavir boosted with ritonavir group (88.0% versus 80.9%).
Maltese: Madankollu, perċentwal ogħla ta' individwi filgrupp ta' atazanavir imsaħħaħ b'cobicistat kellhom żidiet fil-bilirubin totali > 2 x ULN minn dawk filgrupp ta' atazanavir imsaħħaħ b'ritonavir (88.0 % meta mqabbel ma' 80.
English: Atazanavir with cobicistatf
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: It is one of a group called protease inhibitors.
Maltese: Huwa wieħed mill-grupp magħruf bħala inibituri ta' protease.
English: Atazanavir Cmax ↓9% (↓16% ↓1%) Atazanavir Cmin ↓19% (↓31%
Maltese: Cmin ta' Atazanavir ↓19% (↓31%
English: NAME OF THE MEDICINAL PRODUCT EVOTAZ 300 mg/150 mg film-coated tablets
Maltese: EVOTAZ 300 mg/150 mg pilloli miksijin b'rita
English: Among experienced patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
Maltese: Fost il-pazjenti li kienu rċevew il-kura, ikkurati b'atazanavir 300 mg darba kuljum ma' 100 mg ritonavir darba kuljum għal żmien medju ta' 95 ġimgħa, 53 % kellhom żidiet totali ta' bilirubin ta' Grad 3-4.
English: Cobicistat does not select any HIV resistance mutations, due to its lack of antiviral activity.
Maltese: Cobicistat ma jagħżel ebda mutazzjoni għar-reżistenza tal-HIV, minħabba n-nuqqas ta' attività antivirali tiegħu.
English: In an analysis of treatment-failure subjects who received atazanavir 300 mg co-administered with cobicistat 150 mg in study GS-US-216-0114 through Week 144, evaluable genotypic data from paired baseline and treatment-failure isolates were available for all 21 virologic failures in this group (6%, 21/344).
Maltese: F'analiżi tal-individwi li l-kura fuqhom ma rnexxietx, li rċevew atazanavir 300 mg li ngħata flimkien ma' cobicistat 150 mg fl-istudju GS-US-216-0114 sal-Ġimgħa 144, kien hemm disponibbli dejta ġenotipika evalwabbli minn iżolati fil-linja bażi mqabbla u li ma rnexxietilhomx il-kura għall
English: In a 3-month combination oral toxicity study of atazanavir and cobicistat in rats, there were no toxicologic interactions apparent as no additive or synergistic toxicities were observed.
Maltese: Fi studju ta' tossiċità orali ta' kombinazzjoni ta' 3 xhur ta' atazanavir u cobicistat fil-firien, ma kien hemm ebda interazzjoni tossikoloġika peress li ma ġiet osservata ebda tossiċità addittiva jew sinerġistika.
English: EVOTAZ must not be used in patients with moderate to severe hepatic impairment (see section 4.3).
Maltese: EVOTAZ ma għandux jintuża f'pazjenti b'indeboliment epatiku moderat sa sever (ara sezzjoni 4.3).
English: The mechanism of interaction between atazanavir and tenofovir DF is unknown.
Maltese: Il-mekkaniżmu ta' interazzjoni bejn atazanavir u tenofovir DF mhuwiex magħruf.
English: ANTIPSYCHOTICS Pimozide
Maltese: KONTRAĊETTIVI ORMONALI
English: Clinical monitoring is recommended upon co-administration with EVOTAZ.
Maltese: Monitoraġġ kliniku huwa rakkomandat mal-għoti f'daqqa ma' EVOTAZ.
English: Co-administration of EVOTAZ and these ergot derivates is contraindicated (see section 4.3).
Maltese: L-għoti f'daqqa ta' EVOTAZ u dawn id-derivattivi ta' ergot huwa kontraindikat (ara sezzjoni 4.3).
English: Rifabutin AUC ↑48% (↑19% Rifabutin Cmax ↑149% (↑103% Rifabutin Cmin ↑40% (↑5% 25-O-desacetyl-rifabutin AUC 25-O-desacetyl-rifabutin Cmax 25-O-desacetyl-rifabutin Cmin *When compared to rifabutin 150 mg once daily alone.
Maltese: Jekk tkun meħtieġa lkombinazzjoni, id-doża rakkomandata ta' rifabutin hija ta' 150 mg 3 darbiet fil-ġimgħa fi ġranet fissi (pereżempju, it-Tnejn-lErbgħa-il-Ġimgħa).
English: Respiratory, thoracic and mediastinal disorders uncommon dyspnoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali mhux komuni dispnea
English: EVOTAZ should not be initiated in patients with creatinine clearance less than 70 ml/min if any co-administered agent (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir) requires dose adjustment based on creatinine clearance (see sections 4.4, 4.8 and 5.2).
Maltese: EVOTAZ ma għandux jinbeda f'pazjenti bi tneħħija tal-kreatinina ta' inqas minn 70 ml/min jekk kwalunkwe sustanza li tingħata b'mod konkomitanti (eż. emtricitabine, lamivudine, tenofovir disoproxil jew adefovir) tkun teħtieġ aġġustament fid-doża abbażi tat-tneħħija tal-kreatinina (ara sezzjonijiet 4.4, 4.8 u 5.2).
English: PHARMACEUTICAL PARTICULARS
Maltese: 5. PROPRJETAJIET FARMAKOLOĠIĊI
English: In repeat-dose toxicity studies, conducted in mice, rats, and dogs, atazanavir-related findings were generally confined to the liver and included generally minimal to mild increases in serum bilirubin and liver enzymes, hepatocellular vacuolation and hypertrophy, and, in female mice only, hepatic single-cell necrosis.
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti fi ġrieden, firien u klieb, l-effetti relatati ma' atazanavir li nstabu kienu l-iktar limitati għall-fwied u kienu jinkludu ġeneralment żidiet minimali għal moderati fil-livelli tas-serum bilirubin u tal-enzimi tal-fwied, vakwolazzjoni u ipertrofija epatoċellulari, u, fil-ġrieden nisa biss, nekrosi epatika ta' ċellula waħda.
English: Co-administration of EVOTAZ and tenofovir alafenamide 25 mg for treatment of HBV infection is not recommended
Maltese: L-għoti flimkien ta' EVOTAZ u tenofovir alafenamide 25 mg għallkura ta' infezzjoni
English: Atazanavir with ritonavirf
Maltese: Indeboliment tal-fwied Atazanavir
English: The mechanism of interaction is CYP3A inhibition.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l-inibizzjoni ta' CYP3A.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Pregnancy
Maltese: ANTIDIPRESSANTI
English: The median terminal plasma half-life of cobicistat following administration of cobicistat is approximately 3-4 hours.
Maltese: Il-half-life fil-plażma terminali medjana ta' cobicistat wara l-għoti ta' cobicistat hija madwar 3-4 sigħat.
English: The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l-inibizzjoni ta' CYP3A4 minn atazanavir u cobicistat.
English: Clinical monitoring is recommended when dabigatran is co-administered with P-gp inhibitors.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Osteonecrosis
Maltese: Ostjonekrosi
English: If signs or symptoms of nephrolithiasis occurs, temporary interruption or discontinuation of treatment may be considered.
Maltese: Jekk iseħħu sinjali jew sintomi ta' kolelitijasi, għandha tiġi kkunsidrata interruzzjoni temporanja jew inkella waqfien tal-kura.
English: Low levels of metabolites are observed in urine and faeces and do not contribute to the CYP3A inhibitory activity of cobicistat.
Maltese: Livelli baxxi ta' metaboliti huma osservati flawrina u l-ippurgar u ma jikkontribwixxux għall-attività inibitorja ta' CYP3A ta' cobicistat.
English: As atazanavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see sections 4.2 and 5.2).
Maltese: Peress li atazanavir u cobicistat jingħaqdu b'mod qawwi ma' proteini fil-plażma, huwa improbabbli li dawn jitneħħew b'mod sinifikanti permezz ta' emodijalisi jew dijaliżi peritoneali (ara ssezzjonijiet 4.2 u 5.2).