FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinued study drug due to other reasons and last available HIV-1 RNA <50 copies/mle
Maltese: Mediċina ta' studju mwaqqfa minħabba raġunijiet oħra u l-aħħar HIV-1 RNA disponibbli <50 kopja/mle
English: Missing data during window but on study drug a Week 48 window is between day 309 and 378 (inclusive)
Maltese: Dejta nieqsa matul il-perjodu iżda dwar il-mediċina ta' studju a Il-perjodu ta' Ġimgħa 48 bejn il-jum 309 u 378 (it-tnejn inklużi)
English: Each film-coated tablet contains 300 mg of atazanavir (as sulphate), and 150 mg cobicistat.
Maltese: Kull pillola miksija b'rita fiha 300 mg ta' atazanavir (bħala sulphate), u 150 mg ta' cobicistat.
English: ANTIDEPRESSANTS Other antidepressants:
Maltese: Antidipressanti oħra:
English: Cobicistat is a CYP3A substrate and is metabolised to a minor extent by CYP2D6.
Maltese: Cobicistat huwa sottostrat ta' CYP3A dgħajjef u huwa metabolizzat sa ċertu punt minn CYP2D6.
English: The mechanism of interaction is CYP3A4 induction by nevirapine and CYP3A4 inhibition by atazanavir and cobicistat.
Maltese: Il-mekkaniżmu ta' interazzjoni hija l-induzzjoni ta' CYP3A4 minn nevirapine u l-inibizzjoni ta' CYP3A4 minn atazanavir u cobicistat.
English: Atazanavir Cmax ↓28% (↓40%
Maltese: Cmax ta' Atazanavir ↓28% (↓40%
English: The pharmacokinetics of atazanavir and cobicistat, alone or in combination, have not been evaluated in an elderly population (65 years of age and older).
Maltese: Il-farmakokinetika ta' atazanavir u cobicistat, waħedhom jew flimkien, ma ġietx evalwata f'popolazzjoni tal-anzjani (li għandhom 65 sena u aktar).
English: Omeprazole 20 mg once daily am (atazanavir 300 mg once daily with ritonavir 100 mg once daily pm, 12 hours after omeprazole)
Maltese: Omeprazole 20 mg darba kuljum am (atazanavir 300 mg darba kuljum ma' ritonavir 100 mg darba kuljum, 12-il siegħa wara omeprazole)
English: The mean (± SD) change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was -15.1 ± 16.5 ml/min in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir DF fixed-dose combination group and -8.0 ± 16.8 ml/min in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group.
Maltese: 1 ± 16.5 ml/min fil-grupp ta' kombinazzjoni b'doża fissa ta' atazanavir imsaħħaħ b'cobicistat flimkien ma' emtricitabine u tenofovir DF u -8.0 ± 16.8 ml/min fil-grupp ta' kombinazzjoni b'doża fissa ta' atazanavir imsaħħaħ b'ritonavir flimkien ma' emtricitabine u tenofovir DF.
English: Atazanavir demonstrates nonlinear pharmacokinetics with greater than dose-proportional increases in AUC and Cmax values over the dose range of 200 mg to 800 mg once daily.
Maltese: Atazanavir juri farmakokinetika mhux lineari b'żidiet aktar minn proporzjonali mad-doża fil-valuri AUC u Cmax fuq il-medda tad-doża ta‘ 200 mg sa 800 mg darba kuljum.
English: Omeprazole 40 mg once daily (atazanavir 400 mg once daily, 2 hours after omeprazole)
Maltese: Omeprazole 40 mg darba kuljum (atazanavir 400 mg darba kuljum,sagħtejn wara omeprazole)
English: Clarithromycin AUC ↑94% (↑75%
Maltese: AUC ta' Clarithromycin ↑94 %
English: Resistance levels to atazanavir ranged from 3.5- to 29-fold without evidence of phenotypic cross resistance to other PIs.
Maltese: Il-livelli ta' reżistenza għal atazanavir varjaw minn 3.5 għal 29 darba mingħajr evidenza ta' reżistenza fenotipika inkroċjata għal PIs oħra.
English: The safety and efficacy of EVOTAZ in children less than 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' EVOTAZ fit-tfal taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Tenofovir alafenamide 10 mg once daily (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Maltese: Tenofovir alafenamide 10 mg darba kuljum (atazanavir 300 mg darba kuljum b'cobicistat 150 mg darba kuljum)
English: Buprenorphine AUC: ↑35% Buprenorphine Cmax: ↑66% Buprenorphine Cmin: ↑12%
Maltese: ↑66% Cmin ta' Buprenorphine: ↑12%
English: Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Maltese: L-għoti flimkien ma' EVOTAZ jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li huma metabolizzati minn CYP3A, CYP2C8, CYP2D6 u/jew UGT1A1.
English: Exposure to clarithromycin is expected to increase if co-administered with EVOTAZ.
Maltese: Clarithromycin jista' jżid ilkonċentrazzjonijiet ta' atazanavir u cobicistat.
English: An increase from baseline in serum creatinine solely due to cobicistat's inhibitory effect generally does not exceed 0.4 mg/dl.
Maltese: Żieda mil-linja bażi fil-kreatinina fisserum, unikament minħabba effett inibitorju ta' cobicistat, ġeneralment ma taqbiżx 0.4 mg/dl.
English: Clinical monitoring is recommended when co-administered with EVOTAZ and a dose reduction of the beta-blocker may be necessary.
Maltese: Huwa rrakkomandat monitoraġġ kliniku meta jingħata flimkien ma' EVOTAZ u jaf ikun meħtieġ tnaqqis fid-doża tal-imblokkatur beta.
English: Reproductive system and breast disorders uncommon gynaecomastia
Maltese: Disturbi fis-sistema riproduttiva u fis-sider mhux komuni
English: f Plus background regimen of emtricitabine 200 mg and tenofovir DF 300 mg fixed-dose combination.
Maltese: f Flimkien ma' reġim ta' sfond ta' kombinazzjoni ta' doża fissa ta' emtricitabine 200 mg u tenofovir DF 300 mg.
English: Rosuvastatin (10 mg single dose) (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Maltese: Rosuvastatin (10 mg doża waħdanija) (atazanavir 300 mg darba kuljum b'cobicistat 150 mg darba kuljum)
English: Viruses were known to be susceptible to atazanavir, emtricitabine and tenofovir DF at baseline.
Maltese: Kien magħruf li l-virusijiet huma suxxettibbli għal atazanavir, emtricitabine u tenofovir DF fil-linja bażi.
English: Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3).
Maltese: Għandha tingħata attenzjoni partikolari meta EVOTAZ jingħata b'riċetta flimkien ma' prodotti mediċinali li jistgħu jżidu l-intervall QT u/jew f'pazjenti li diġà għandhom fatturi ta' riskju (bradikardja, QT konġenitali twila, żbilanċi ta' elettroliti (ara sezzjonijiet 4.8 u 5.3).
English: For further details, consult the Summary of Product Characteristics for maraviroc.
Maltese: Għal aktar dettalji, ikkonsulta s-Sommarju talKaretteristiċi tal-Prodott għal maraviroc.
English: The most frequently reported laboratory abnormality in paediatric patients receiving atazanavir was elevation of total bilirubin (≥ 2.6 times ULN, Grade 3-4) which occurred in 45% of patients.
Maltese: L-aktar anormalità fil-laboratorju frekwenti rrappurtata f'pazjenti pedjatriċi li kienu qed jirċievu atazanavir kienet livelli ogħla ta' bilirubina totali (≥ 2.6 darbiet aktar mil-livelli normali ta' fuq (ULN), Grad 3-4) li seħħet f'45 % talpazjenti.
English: Cobicistat is not expected to induce CYP3A4 or P-gp.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l-inibizzjoni ta' CYP3A4 u P-gp.
English: Co-administration of EVOTAZ with astemizole and terfenadine is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' EVOTAZ ma' astemizole u terfenadine huwa kontraindikat (ara sezzjoni 4.3).
English: The resistance profile of EVOTAZ is driven by atazanavir.
Maltese: Il-profil ta' reżistenza ta' EVOTAZ huwa xprunat minn atazanavir.
English: The rates of study drug discontinuation due to bilirubin-related adverse events were low and similar in both groups (4.9% in the cobicistat-boosted group and 4.0% in the ritonavir-boosted group).
Maltese: Ir-rati ta' twaqqif talmediċina tal-istudju minħabba l-avvenimenti avversi relatati ma' bilirubin kienu baxxi u simili fiżżewġ gruppi (4.9 % fil-grupp imsaħħaħ b'cobicistat u 4.0 % fil-grupp imsaħħaħ b'ritonavir).
English: Psychiatric disorders common insomnia, abnormal dreams uncommon depression, sleep disorder, disorientation, anxiety
Maltese: Disturbi psikjatriċi komuni insomnja, ħolm stramb mhux komuni depressjoni, disturb fl-irqad, diżorjentament, ansjetà
English: Concomitant administration of EVOTAZ with ticagrelor is contraindicated.
Maltese: L-għoti f'daqqa ta' EVOTAZ ma' ticagrelor huwa kontraindikat.
English: The activity of cobicistat as a pharmacokinetic enhancer to atazanavir has been demonstrated in pharmacokinetic trials.
Maltese: L-attività ta' cobicistat bħala stimulant farmakokinetiku għal atazanavir ġiet osservata fil-provi farmakokinetiċi.
English: No clinically relevant pharmacokinetic differences due to ethnicity have been identified for atazanavir or cobicistat.
Maltese: Ma ġiet identifikata l-ebda differenza farmakokinetika minħabba l-etniċità għal atazanavir jew cobicistat.
English: Medicinal products that affect atazanavir/cobicistat exposure Atazanavir is metabolised in the liver through CYP3A4.
Maltese: Prodotti mediċinali li jaffettwaw l-esponiment ta' atazanavir/cobicistat Atazanavir jiġi metabolizzat fil-fwied permezz ta' CYP3A4.
English: Administration of a single dose of EVOTAZ with a high fat meal (1,038 kcal, 59 g fat, 37 g protein) resulted in a 14% reduction in atazanavir Cmax with no change in atazanavir AUC or cobicistat exposures (Cmax, AUC) relative to the fasting state.
Maltese: L-għoti ta' doża waħda ta' EVOTAZ ma' ikla b'ħafna xaħam (1,038 kcal, 59 g ta' xaħam, 37 g ta' proteini) irriżulta fi tnaqqis ta' 14 % fis-Cmax bl-ebda bidla fl-AUC ta' atazanavir jew l-esponimenti għal cobicistat (Cmax, AUC) fir-rigward tal-istat ta' sawn.
English: Electrocardiographic changes (sinus bradycardia, prolongation of PR interval, prolongation of QT interval, and prolongation of QRS complex) were observed only in an initial 2 week oral toxicity study performed in dogs.
Maltese: Bidliet elettrokardjografiċi (sinus bradycardia, titwil tal-intervall PR, titwil tal-intervall QR u titwil tal-kumpless QRS) ġew osservati biss fi studju inizjali tat-tossiċità orali ta' ġimagħtejn, li sar fil-klieb.
English: Potential cardiac effects of this product in humans cannot be ruled out (see sections 4.4 and 4.8).
Maltese: Il-potenzjal tal-effetti kardijaċi ta' dan il-prodott filbniedem mhux eskluż (ara sezzjonijiet 4.4 u 4.8).
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that atazanavir is principally metabolised by CYP3A4 isozyme to oxygenated metabolites.
Maltese: Studji fil-bniedem u minn studji in vitro fejn intużaw mikrosomi epatiċi umani sar magħruf li atazanavir ġie metabolizzat prinċipalment bl-isożim ta' CYP3A4 għal metaboliti ossiġenati.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions (see section 4.8).
Maltese: Pazjenti li jbatu minn epatite kronika B jew Ċ u kkurati b'taħlita ta' terapija antiretrovirali għandhom iktar riskju ta' reazzjonijiet avversi, epatiċi severi u potenzjalment fatali(ara sezzjoni 4.8).
English: Efavirenz 600 mg single dose (cobicistat 150 mg once daily)
Maltese: (Efavirenz 600 mg doża waħda) (cobicistat 150 mg darba kuljum)
English: Among naïve patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 96 weeks, 48% had Grade 3-4 total bilirubin elevations (see section 4.4).
Maltese: Fost il-pazjenti li ma rċevewx kura qabel, ikkurati b'atazanavir 300 mg darba kuljum ma' 100 mg ritonavir darba kuljum għal żmien medju ta' 96 ġimgħa, 48 % kellhom żidiet totali ta' bilirubin ta' Grad 3-4 (ara sezzjoni 4.4).
English: When co-administration is necessary, do not exceed 10 mg rosuvastatin daily, and clinical monitoring for safety (e.g. myopathy) is recommended.
Maltese: F'każ li l-għoti flimkien ikun neċessarju, taqbiżx l-10 mg ta' rosuvastatin kuljum, u huwa rakkomandat li jsir monitoraġġ kliniku tas-sigurtà (eż. mijopatija).
English: The effects of hepatic impairment on the pharmacokinetics of atazanavir given with cobicistat have not been studied.
Maltese: L-effetti ta‘ indeboliment epatiku fuq il-farmakokinetika ta‘ atazanavir mogħtija ma‘ cobicistat ma ġewx studjati.
English: Virologic success
Maltese: Insuffiċjenza viroloġikac
English: Nevirapine AUC ↑25% (↑17%
Maltese: AUC ta' Nevirapine ↑25 %
English: It is especially important to mention these: medicines containing ritonavir or cobicistat (booster agents) other medicines to treat HIV infection (e.g. indinavir, didanosine, tenofovir disoproxil, tenofovir alafenamide, efavirenz, etravirine, nevirapine and maraviroc) boceprevir, simeprevir and sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C) sildenafil, vardenafil and tadalafil (used by men to treat impotence [erectile dysfunction]) if you are taking an oral contraceptive ("the Pill") any medicines used to treat diseases related to the acid in the stomach (e.g. antacids, H2-blockers like famotidine and proton pump inhibitors like omeprazole) disopyramide, flecainide, mexiletine, propafenone, digoxin, bosentan, amlodipine, felodipine, nicardipine, nifedipine, verapamil, diltiazem, metoprolol and timolol (medicines to lower blood pressure, to slow heart rate or to correct heart rhythm) atorvastatin, pravastatin, fluvastatin, pitavastatin and rosuvastatin (used to lower blood cholesterol) salmeterol (used to treat asthma) ciclosporin, tacrolimus and sirolimus (medicines to decrease the effects of body's immune system) certain antibiotics (rifabutin, clarithromycin) ketoconazole, itraconazole, voriconazole and fluconazole (antifungals) metformin (used to treat type 2 diabetes) warfarin, rivaroxaban and dabigatran (anticoagulants, used to reduce blood clots) irinotecan, dasatinib, nilotinib, vinblastine and vincristine (used to treat cancer) trazodone (used to treat depression)
Maltese: Huwa ferm importanti li dawn li ġejjin jissemmgħu: mediċini li fihom ritonavir jew cobicistat (sustanzi ta' tisħiħ) mediċini oħrajn għall-kura tal-infezzjoni tal-HIV (eż. indinavir, didanosine, tenofovir disoproxil, tenofovir alafenamide, efavirenz, etravirine, nevirapine u maraviroc) boceprevir, simeprevir u sofosbuvir/velpatasvir/voxilaprevir (jintużaw għall-kura tal-epatite Ċ) sildenafil, vardenafil u tadalafil (użati mill-irġiel kontra l-impotenza [disfunzjoni erettili]) jekk qed tieħu kontraċettiv mill-ħalq (“il-Pill”) kull mediċina użata biex tikkura mard relatat mal-aċidu fl-istonku (eż. antaċidi, imblokkaturi ta' H2 bħal famotidine u inibituri ta' proton pump bħal omeprazole) disopyramide, flecainide, mexiletine, propafenone, digoxin, bosentan, amlodipine, felodipine, nicardipine, nifedipine, verapamil, diltiazem, metoprolol u timolol (mediċini biex ibaxxu lpressjoni, ir-rata tat-taħbit tal-qalb, jew biex jikkoreġu r-ritmu tat-taħbit tal-qalb) atorvastatin, pravastatin, fluvastatin, pitavastatin u rosuvastatin (użati biex ibaxxu l-livell talkolesterol fid-demm) salmeterol (użat għall-kura tal-ażżma)
English: Co-administration with the following medicinal products due to the potential for serious and/or lifethreatening adverse reactions (see section 4.5): colchicine, when used in patients with renal and/or hepatic impairment (antigout) (see section 4.5) sildenafil - when used for the treatment of pulmonary arterial hypertension (see sections 4.4 and 4.5 for co-administration for the treatment of erectile dysfunction), avanafil (PDE5 inhibitors) simvastatin and lovastatin (HMG-CoA reductase inhibitors) (see section 4.5) grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection) (see section 4.5) glecaprevir/pibrentasvir fixed dose combination (see section 4.5)
Maltese: L-għoti flimkien mal-prodotti mediċinali li ġejjin minħabba l-potenzjal għal reazzjonijiet avversi serji u/jew ta' periklu għall-ħajja (ara sezzjoni 4.5): colchicine, meta jintuża f'pazjenti b'indeboliment renali u/jew epatiku (kontra l-gotta) (ara sezzjoni 4.5) sildenafil meta jintuża għall-kura ta' pressjoni arterjali pulmonari (ara s-sezzjonijiet 4.4 u 4.5 għall-għoti flimkien għall-kura ta' disfunzjoni erettili), avanafil (inibituri ta' PDE5) simvastatin u lovastatin (inibituri ta' reducatase HMG-CoA) (ara sezzjoni 4.5)
English: EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).
Maltese: EVOTAZ huwa indikat flimkien ma' prodotti mediċinali antiretrovirali oħrajn għall-kura ta' adulti infettati bl-HIV-1 mingħajr mutazzjonijiet assoċjati magħrufa b'reżistenza għal atazanavir (ara sezzjonijiet 4.4 u 5.1).
English: The 24-hour atazanavir concentration following a high-fat meal was increased approximately 23% due to delayed absorption; the median Tmax increased from 2.0 to 3.5 hours.
Maltese: Il-konċentrazzjoni ta' 24 siegħa ta' atazanavir wara ikla b'ħafna xaħam żdiedet b'madwar 23 % minħabba assorbiment imdewwem; it-Tmax medjan żdied minn 2.0 għal 3.5 sigħat.
English: There is a risk of loss of therapeutic effect and development of resistance to atazanavir (see section 4.3).
Maltese: Hemm riskju ta' telf tal-effett terapewtiku u ta' żvilupp ta' reżistenzagħal atazanavir (ara sezzjoni 4.3).
English: Renal impairment Atazanavir
Maltese: Atazanavir ma' ritonavirf
English: Uncommon (may affect up to 1 in 100 people) torsade de pointes (life threatening irregular heart beat) hypersensitivity (allergic reaction) anorexia (loss of appetite), weight loss, weight gain depression, anxiety, sleep disorder disorientation, amnesia (loss of memory) peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) syncope (fainting), hypertension (high blood pressure) dyspnoea (shortness of breath) pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores) hepatitis (inflammation of the liver) angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) urticaria (itchy rash), alopecia (unusual hair loss or thinning), pruritus (itching) muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles) nephrolithiasis (formation of kidney stones), interstitial nephritis (kidney inflammation), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination), chronic kidney disease (how well your kidneys work) gynaecomastia (breast enlargement in men) chest pain, malaise (generally feeling unwell), fever asthenia (unusual tiredness or weakness) serious skin rashes (allergic reactions including rash, a high temperature, increased levels of liver enzymes seen in blood tests, an increase in a type of white blood cell [esosinophilia] and/or enlarged lymph nodes) (see section 2) gallbladder disorders (gallstones and gallbladder inflammation)
Maltese: urtikarja (raxx bil-ħakk), alopeċja (waqa' tax-xagħar mhux normali jew tħaffif tax-xagħar), prurite (ħakk) muskolotrofija (tnaqqis fil-volum tal-muskoli), artralġja (uġigħ fil-ġogi), mijalġja (uġigħ filmuskoli) nefrolitjażi (formazzjoni ta' ġebel fil-kliewi), nefrite interstizjali (infjammazzjoni tal-kliewi), ħematurja (demm fl-awrina), proteinurja (eċċess ta' proteina fl-awrina), pollakjurja (żieda filfrekwenza ta' tibwil), mard tal-kliewi kroniku (kemm jaħdmu tajjeb il-kliewi tiegħek) ginektomastja (tkabbir tas-sider fl-irġiel) uġigħ fis-sider, malaise (kundizzjoni ġenerali ħażina), deni astenja (għeja jew dgħjufija mhux normali) raxxijiet serji tal-ġilda (reazzjonijiet allerġiċi inkluż raxx, temperatura għolja, żieda fil-livelli ta' enzimi tal-fwied li jidhru f'testijiet tad-demm, żieda f'tip ta' ċelloli tad-demm bojod [esosinofilja], u/jew nefħa tan-nodi tal-limfa) (ara sezzjoni 2) disturbi fil-bużżieqa tal-marrara (ġebel fil-marrara u infjammazzjoni tal-bużżieqa tal-marrara)
English: Medicinal products that may be affected by atazanavir/cobicistat Atazanavir is an inhibitor of CYP3A4 and UGT1A1.
Maltese: Prodotti mediċinali li ma jaqblux ma' din il-mediċina Atazanavir huwa prinċipalment metabolizzat minn CYP3A4.
English: Atazanavir AUC ↑28% (↑16%
Maltese: AUC ta' Atazanavir ↑28 % (↑16 %
English: Drospirenone/ethinyloestradiol 3 mg/0.02 mg single dose (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Maltese: 02 mg doża unika (atazanavir 300 mg darba kuljum ma' cobicistat 150 mg darba kuljum)
English: Concentrations of beta-blockers may be increased when co-administered with EVOTAZ.
Maltese: Il-konċentrazzjonijiet ta' imblokkaturi beta jistgħu jiżdiedu meta jingħataw flimkien ma' EVOTAZ.
English: Co-administration of EVOTAZ with medicinal products that inhibit CYP3A may decrease the clearance of atazanavir and cobicistat, resulting in increased atazanavir and cobicistat plasma concentrations (see section 4.5).
Maltese: L-għoti flimkien ta' EVOTAZ ma' prodotti mediċinali li jinibixxu CYP3A jista' jnaqqas leliminazzjoni ta' atazanavir u cobicistat, li jirriżulta fi naqqis fil-konċentrazzjonijiet fil-plażma ta' atazanavir u cobicistat (ara sezzjoni 4.5).
English: There are no pharmacokinetic data regarding the use of EVOTAZ in patients with hepatic impairment.
Maltese: M‘hemm ebda dejta farmakokinetika dwar l-użu ta‘ EVOTAZ f‘pazjenti b‘indeboliment epatiku.
English: Nephrolithiasis has been reported in patients receiving atazanavir (see section 4.8).
Maltese: Nefrolitjasi ġiet irrapportata f'pazjenti li kienu qed jirċievu atazanavir (ara sezzjoni 4.8).
English: If drospirenone/ethinyloestradiol is co-administered with atazanavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Maltese: F'każ tal-għoti ta' drospirenone/ethinyloestradiol flimkien ma' atazanavir/cobicistat, huwa rrakkomandat li jsir monitoraġġ kliniku minħabba l-potenzjal għal iperkalimja.
English: H2-Receptor antagonists
Maltese: Antagonisti tar-riċettur H2
English: Co-administration of EVOTAZ with proton pump inhibitors (PPIs) is not recommended due to the decreased solubility of atazanavir as intra-gastric pH increase with PPIs (see section 4.5).
Maltese: L-għoti flimkien ta' EVOTAZ ma' inibituri ta' proton pump (PPIs) mhuwiex rakkomandat minħabba t-tnaqqis fis-solubbiltà ta' atazanavir biż-żieda fil-pH intra-gastriku bil-PPIs (ara sezzjoni 4.5).
English: Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Maltese: Maraviroc huwa sottostrat ta' CYP3A u l-konċentrazzjoni filplażma tiegħu tiżdied meta jingħata flimkien ma' inibituri ta' CYP3A qawwija.
English: In an ex vivo rabbit pharmacology study, isolated hearts were exposed to atazanavir, cobicistat, or atazanavir and cobicistat in combination.
Maltese: Fi studju farmakoloġiku ex vivo tal-fniek, il-qlub iżolati kienu esposti għal atazanavir, cobicistat, jew atazanavir u cobicistat f'daqqa.
English: Desacetyl-diltiazem Cmin ↑121%
Maltese: Cmin ta' Diltiazem ↑142 %
English: Clinical and laboratory monitoring for hyperbilirubinaemia is recommended.
Maltese: Huwa rrakkomandat monitoraġġ kliniku u fil-laboratorju għal iperbilirubinimja.
English: Co-administration of EVOTAZ with products containing St. John's wort is contraindicated (see section 4.3).
Maltese: John's wort huwa kontrindikat (ara sezzjoni 4.3).
English: Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when co-administered with protease inhibitors.
Maltese: Għalkemm ma ġiex studjat, hemm potenzjal għal żieda fl-esponiment għal pravastatin or fluvastatin meta jingħataw flimkien ma' inibituri ta' protease.
English: Because atazanavir is a component of EVOTAZ, the combination of EVOTAZ with atorvastatin is not recommended (see section 4.5).
Maltese: Peress li atazanavir huwa komponent ta' EVOTAZ, il-kombinazzjoni ta' EVOTAZ ma' atorvastatin mhijiex rakkomandata (ara sezzjoni 4.5).