FrancophonIA/ELRC3.0 huggingface dataset:
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Maltese: B'differenza minn ritonavir, cobicistat mhuwiex inibitur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 jew UGT1A1.
English: Atazanavir was approximately 86% bound to human serum proteins over a concentration range of 100 to 10,000 ng/ml.
Maltese: Atazanavir kien madwar 86 % imwaħħal mal-proteini fis-serum tal-bniedem fuq medda ta' konċentrazzjonijiet ta' 100 sa 10,000 ng/ml.
English: Atazanavir is a weak to moderate inhibitor of CYP2C8.
Maltese: Atazanavir huwa inibitur moderat ta' CYP2C8.
English: Cobicistat is not expected to inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2C19.
Maltese: Cobicistat mhuwiex mistenni li jinibixxi CYP1A2, CYP2B6, CYP2C8, CYP2C9 jew CYP2C19.
English: Co-administration with the following medicinal products that are strong inducers of the CYP3A4 isoform of cytochrome P450 due to the potential for loss of therapeutic effect (see section 4.5): carbamazepine, phenobarbital, phenytoin (antiepileptics) St John's wort (Hypericum perforatum) (herbal product) rifampicin (antimycobacterial)
Maltese: L-għoti flimkien mal-prodotti mediċinali li ġejjin li huma inibituri b'saħħithom tal-isoform CYP3A4 ta' cytochrome P450 minħabba l-potenzjal għal telf tal-effett terapewtiku (ara sezzjoni 4.5): carbamazepine, phenobarbital, phenytoin (antiepilettiċi) St John's wort (Hypericum perforatum) (prodott mill-ħxejjex) rifampicin (antimikobatterjali)
English: Midazolam and triazolam are extensively metabolized by CYP3A4.
Maltese: Midazolam u triazolam jiġu metabolizzati b'mod estensiv minn CYP3A4.
English: Atazanavir Cmax ↔6% (↓7%
Maltese: Cmax ta' Atazanavir ↔6 % (↓7 %
English: In 2 controlled clinical studies for combination therapy with other antiretroviral medicinal products 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 boosted with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration), the most frequently reported adverse reactions were nausea, diarrhoea and jaundice.
Maltese: F'2 studji kliniċi kkontrollati għal terapija ta' kombinazzjoni ma' prodotti mediċinali antiretrovirali oħra, 1,806 pazjenti adulti li rċievew atazanavir 400 mg darba kuljum (1,151 pazjent, perjodu medjan ta' 52 ġimgħa, perjodu massimu ta' 152 ġimgħat) jew atazanavir 300 mg imsaħħaħ b'ritonavir 100 mg darba kuljum (655 pazjent, perjodu medjan ta' 96 ġimgħa u perjodu massimu ta' 108 ġimgħat), ir reazzjonijiet avversi rrapportati l-aktar ta' spiss kienu dardir, dijarea u suffejra.
English: Following oral administration of [14C]cobicistat, 86% and 8.2% of the dose were recovered in faeces and urine, respectively.
Maltese: Wara li [14C]cobicistat jingħata mill-ħalq, 86 % u 8.2 % tad-doża kienu rkuprati fl-ippurgar u flawrina, rispettivament.
English: Cobicistat is a weak CYP2D6 inhibitor and is metabolised to a minor extent by CYP2D6.
Maltese: Cobicistat huwa inibitur CYP2D6 dgħajjef u huwa metabolizzat sa ċertu punt minn CYP2D6.
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 Cmax ↓21% (↓27%
Maltese: Cmax ta' Atazanavir ↓21% (↓27%
English: The mechanism of interaction is CYP3A4 induction by rifampicin.
Maltese: Il-mekkaniżmu ta' interazzjoni huwa l-induzzjoni ta' CYP3A4 minn rifampicin.
English: Renal and urinary disorders uncommon nephrolithiasisa, haematuria, proteinuria, pollakiuria, interstitial nephritis, chronic kidney diseasea rare kidney pain
Maltese: Disturbi fil-kliewi u fis-sistema urinarja mhux komuni nefrolitjażia, ematurja, proteinurja, pollakurja; nefrite interstizjali, mard talkliewi kronikua rari uġigħ fil-kliewi
English: EVOTAZ is a fixed-dose combination of the antiviral drug atazanavir boosted by the pharmacokinetic enhancer cobicistat.
Maltese: EVOTAZ huwa kombinazzjoni b'doża fissa tal-mediċina antivirali atazanavir imsaħħa bl-istimulant farmakokinetiku cobicistat.
English: Co-administration with EVOTAZ can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.5).
Maltese: L-għoti flimkien ma' EVOTAZ jista' jżid il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li huma metabolizzati minn CYP2D6 (ara sezzjonijiet 4.3 u 4.5).
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 malmetaboliżmu ta' irinotecan, li jirriżulta f'effetti tossiċi miżjuda ta' irinotecan.
English: Cobicistat is 97-98% bound to human plasma proteins and the mean plasma to blood drug concentration ratio was 2.
Maltese: Cobicistat huwa 97-98 % imwaħħal mal-proteini fil-plażma tal-bniedem u l-proporzjon medju ta' konċentrazzjoni tal-plażma mad-demm kien 2.
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Maltese: Cobicistat huwa metabolizzat minn ossidazzjoni permezz ta' CYP3A (maġġuri) u CYP2D6 (minuri) u ma jgħaddix minn glukuronidazzjoni.
English: Famotidine 20 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily) in HIV-infected patients
Maltese: Famotidine 20 mg darbtejn kuljum (atazanavir 300 mg/ritonavir 100 mg darba kuljum) f'pazjenti infettati bl-HIV
English: In study GS-US-216-0114, the mean increase from baseline in CD4+ cell count at weeks 48 and 144 were 213 and 310 cells/mm3 in patients receiving atazanavir boosted with cobicistat and 219 and 332 cells/mm3 in patients receiving atazanavir boosted with ritonavir, respectively.
Maltese: Fl-istudju GS-US-216-0114, iż-żieda medja mil-linja bażi fl-għadd ta' ċelloli CD4+ fil-ġimgħat 48 u 144 kienu 213 u 310 ċelloli/mm3 f'pazjenti li rċevew atazanavir imsaħħaħ b'cobicistat u 219 u 332 ċellola/mm3 f'pazjenti li rċevew atazanavir imsaħħaħ b'ritonavir, rispettivament.
English: Tablet core - microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), sodium starch glycolate, crospovidone (E1202), stearic acid (E570), magnesium stearate (E470b), hydroxypropyl cellulose (E463), silicon dioxide (E551) Film-coating - hypromellose (hydroxypropyl methyl cellulose, E464), titanium dioxide (E171), talc (E553b), triacetin (E1518), red iron oxide (E172)
Maltese: Qalba tal-pillola - microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), sodium starch glycolate, crospovidone (E1202), stearic acid (E570), magnesium stearate (E470b), hydroxypropyl cellulose (E463), silicon dioxide (E551)
English: Administration of a single dose of EVOTAZ with a light meal (336 kcal, 5.1 g fat, 9.3 g protein) resulted in a 42% increase in atazanavir Cmax, a 28% increase in atazanavir AUC, a 31% increase in cobicistat Cmax, and a 24% increase in cobicistat AUC relative to the fasting state.
Maltese: L-għoti ta' doża waħda ta' EVOTAZ ma' ikla ħafifa (336 kcal, 5.1 g ta' xaħam, 9.3 g ta' proteini) irriżulta f'żieda ta' 42 % fis-Cmax ta' atazanavir, żieda ta' 28 % fl-AUC ta' atazanavir, żieda ta' 31 % fis-Cmax ta' cobicistat, u żieda ta' 24 % fl-AUC ta' cobicistat fir-rigward tal-istat ta' sawm.
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-sindrome ta' Stevens-Johnson (SJS), eritema multiforme, eruzzjonijiet tossiċi tal-ġilda u s-sindromu ta' raxx dovut għall-mediċina b'esinofilja u sintomi sistemiċi (drug rash with eosinophilia and systemic symptoms, DRESS) ġew irrapportati f'pazjenti li kienu qegħdin jirċievu atazanavir.
English: Atazanavir Cmax ↓89% (↓94%
Maltese: Cmax ta' Atazanavir ↓89 % (↓94 %
English: Immune reactivation syndrome and autoimmune disorders
Maltese: Sindrome ta' riattivazzjoni tal-immunità u disturbi awtoimmuni
English: The mechanism of interaction is CYP3A induction by the antiepileptic.
Maltese: Il-mekkaniżmu ta' interazzjoni hija l-induzzjoni ta' CYP3A millantiepilettiku.
English: The combination of rifampicin and EVOTAZ is contraindicated (see section 4.3).
Maltese: Ilkombinazzjoni ta' rifampicin u EVOTAZ hija kontraindikata (ara sezzjoni 4.3).
English: Voriconazole should not be co-administered with EVOTAZ unless the benefit/risk assessment justifies the use of voriconazole (see section 4.4).
Maltese: Voriconazole ma għandux jingħata flimkien ma' EVOTAZ sakemm ilvalutazzjoni tal-benefiċċju/riskju tiġġustifika l-użu ta' voriconazole (ara sezzjoni 4.4).
English: Clarithromycin Cmax ↑50% (↑32%
Maltese: Cmax ta' Clarithromycin ↑50 %
English: Didanosine (with food) Didanosine AUC ↓34% (↓40%
Maltese: Didanosine (mal-ikel) AUC ta' Didanosine ↓34 %
English: Elbasvir 50 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily
Maltese: Elbasvir 50 mg darba kuljum (atazanavir 300 mg / ritonavir 100 mg darba kuljum
English: Glecaprevir 300 mg/pibrentasvir 120 mg once daily (atazanavir 300 mg with ritonavir 100 mg once daily*)
Maltese: Glecaprevir 300 mg/pibrentasvir 120 mg darba kuljum (atazanavir 300 mg ma' ritonavir 100 mg darba kuljum*)
English: Higher concentrations could potentiate tenofovir-associated adverse reactions, including renal disorders.
Maltese: Konċentrazzjonijiet ogħla jistgħu jsaħħu r-reazzjonijiet avversi assoċjati ma' tenofovir, inkluż disturbi renali.
English: EVOTAZ should not be used in combination with ritonavir or medicinal products containing ritonavir due to similar pharmacological effects of cobicistat and ritonavir on CYP3A (see section 4.5).
Maltese: EVOTAZ ma għandux jintuża flimkien ma' ritonavir jew ma' prodotti mediċinali li fihom ritonavir minħabba l-effetti farmakoloġiċi ta' cobicistat u ritonavir fuq CYP3A (ara sezzjoni 4.5).
English: The mechanism of interaction between atazanavir/ritonavir and sofosbuvir/velpatasvir/voxilaprevir is inhibition of OATP1B, Pgp, and CYP3A.
Maltese: Il-mekkaniżmu ta' interazzjoni bejn atazanavir/ritonavir u sofosbuvir/velpatasvir/voxilaprevir huwa inibizzjoni ta' OATP1B, Pgp, u CYP3A.
English: substrates of CYP3A4 or the UGT1A1 isoform of UDP-glucuronyltransferase and have narrow therapeutic windows: alfuzosin (alpha-1-adrenoreceptor antagonist) amiodarone, bepridil, dronedarone, quinidine, systemic lidocaine (antiarrhythmics/antianginals) astemizole, terfenadine (antihistamines) cisapride (gastrointestinal motility agent) ergot derivatives (e.g. dihydroergotamine, ergometrine, ergotamine, methylergonovine) pimozide, quetiapine, lurasidone (antipsychotics/neuroleptics) (see section 4.5) ticagrelor (platelet aggregation inhibitor) triazolam, midazolam administered orally (sedatives/hypnotics) (for caution on parenterally administered midazolam, see section 4.5).
Maltese: prodotti li fihom grazoprevir, inkluż elbasvir/grazoprevir f'doża fissa kombinata (jintużaw biex jikkuraw infezzjoni tal-epatite Ċ kronika) (ara sezzjoni 4.5) kombinazzjoni ta' doża fissa ta' glecaprevir/pibrentasvir (ara sezzjoni 4.5) sottostrati ta' isoform ta' CYP3A4 jew UGT1A1 ta' UDP-glucuronyltransferase u għandhom twieqi terapewtiċi dojoq: alfuzosin (antagonista alpha-1-adrenoreceptor) amiodarone, bepridil, dronedarone, quinidine, lidocaine sistemiku (anti-arritmiċi/kontra lanġina) astemizole, terfenadine (antistamini) cisapride (sustanza tal-motilità gastrointestinali) derivattivi ta' ergot (eż. dihydroergotamine, ergometrine, ergotamine, methylergonovine) pimozide, quetiapine, lurasidone (antipsikotiċi/newrolettiċi) (ara sezzjoni 4.5) ticagrelor (inibitur tal-aggregazzjoni tal-plejtlits) triazolam, midazolam li jingħata mill-ħalq (sedattivi/ipnotiċi) (għal kawtela fuq midazolam mogħti b'mod parenterali, ara sezzjoni 4.5).
English: EVOTAZ should not be used in combination with products containing the same active components including atazanavir, cobicistat or with fixed-dose products that contain cobicistat.
Maltese: EVOTAZ ma għandux jintuża flimkien ma' prodotti li fihom l-istess komponenti attivi inkluż atazanavir, cobicistat jew ma' prodotti b'doża fissa li fihom cobicistat.
English: Clinically significant interactions between EVOTAZ and substrates of CYP1A2, CYP2B6, CYP2C9 or CYP2C19 are not expected.
Maltese: Interazzjonijiet klinikament sinifikanti bejn EVOTAZ u s-sottostrati ta' CYP1A2, CYP2B6, CYP2C9 jew CYP2C19 mhumiex mistennija.
English: Tenofovir alafenamide 10 mg once daily/emtricitabine 200 mg once daily (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Maltese: Tenofovir alafenamide 10 mg darba kuljum/emtricitabine 200 mg darba kuljum (atazanavir 300 mg darba kuljum b'cobicistat 150 mg darba kuljum)
English: The mechanism of interaction is inhibition of metabolism by atazanavir.
Maltese: Ilmekkaniżmu ta' interazzjoni huwa l-inibizzjoni tal-metaboliżmu minn atazanavir.
English: Cholelithiasis has been reported in patients receiving atazanavir (see section 4.8).
Maltese: Kolelitijasi ġiet irrapportata f'pazjenti li kienu qed jirċievu atazanavir (ara sezzjoni 4.8).
English: Immune reactivation syndrome
Maltese: Sindrome ta' riattivazzjoni tal-immunità
English: Pharmacotherapeutic group: Antivirals for systemic use; antivirals for treatment of HIV infections, combinations.
Maltese: Antivirali għal użu sistemiku; antivirali għall-kura ta' infezzjonijiet bl-HIV, kombinazzjonijiet.
English: (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Maltese: (atazanavir 300 mg darba kuljum b'cobicistat 150 mg darba kuljum)
English: Atazanavir Cmax ↓39% (↓64%
Maltese: Cmax ta' Atazanavir ↓39% (↓64%
English: Cobicistat exposures are non-linear and greater than dose-proportional over the range of 50 mg to 400 mg, consistent with a mechanism-based CYP3A inhibitor.
Maltese: L-esponimenti għal Cobicistat mhumiex lineari u huma aktar minn proporzjonali mad-doża fuq ilmedda ta' 50 mg sa 400 mg, b'mod konsistenti ma' inibitur ta' CYP3A bbażat fuq il-mekkaniżmu.
English: In clinical study GS-US-216-0114, a phase 3 randomised, active-controlled clinical study, in which 692 treatment-naïve patients received at least one dose of atazanavir boosted with cobicistat (n = 344) or atazanavir boosted with ritonavir (n = 348) administered with other antiretroviral medicinal products, the most frequently reported adverse reactions in the atazanavir boosted with cobicistat group during 144 weeks were associated with elevated bilirubin levels (see Table 2).
Maltese: Fi studju kliniku GS-US-216-0114, studju kliniku kkontrollat b'mod attiv, randomizzat, tal-fażi 3, fejn 692 pazjent li ma rċevewx kura qabel ingħataw tal-inqas doża waħda ta' atazanavir imsaħħaħ b'cobicistat (n = 344) jew atazanavir imsaħħaħ b'ritonavir (n = 348) mogħti ma' prodotti mediċinali antiretrovirali oħra, ir-reazzjonijiet avversi rrapportati l-aktar ta' spiss fil-grupp ta' atazanavir imsaħħaħ b'cobicistat matul 144 ġimgħa kienu assoċjati ma' livelli ta' bilirubin għoljin (ara Tabella 2).
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 fl-ippurgar u fl-awrina.
English: The combination of avanafil and EVOTAZ is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ta' avanafil u EVOTAZ hija kontraindikata (ara sezzjoni 4.3).
English: However, atazanavir must not be used in patients with moderate (Child-Pugh Class B) to severe (Child-Pugh Class C) hepatic impairment.
Maltese: Madankollu, atazanavir ma għandux jintuża f'pazjenti b'indeboliment epatiku moderat (Child-Pugh Klassi B) sa sever (Child-Pugh Klassi C).
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 b'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: Co-administration of tenofovir alafenamide with cobicistat is expected to increase tenofovir alafenamide and tenofovir plasma concentrations.
Maltese: L-għoti flimkien ta' tenofovir alafenamide ma' cobicistat huwa mistenni li jżid ilkonċentrazzjonijiet fil-plażma ta' tenofovir alafenamide u ta' tenofovir.
English: No subject developed the tenofovir-associated resistance substitution K65R or K70E or any primary resistance substitution associated with protease inhibitors.
Maltese: L-ebda individwu ma żviluppa sostituzzjoni għal reżistenza assoċjata ma' tenofovir K65R jew K70E jew sostituzzjoni għal kwalunkwe reżistenza primarja assoċjata ma' inibituri ta' protease.
English: Animal studies do not indicate direct or indirect harmful effects of cobicistat with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma jurux effetti ħżiena diretti jew indiretti ta' cobicistat fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Patients were randomised in a 1:1 ratio to receive either atazanavir 300 mg with cobicistat 150 mg once daily or atazanavir 300 mg with ritonavir 100 mg once daily, each administered with a fixed background regimen containing tenofovir DF 300 mg and emtricitabine 200 mg administered as a fixed-dose combination tablet.
Maltese: Il-pazjenti ġew randomizzati fi proporzjon 1:1 biex jirċievu atazanavir 300 mg ma' cobicistat 150 mg darba kuljum jew atazanavir 300 mg ma' ritonavir 100 mg darba kuljum, kull wieħed minnhom mogħti b'kors ta' sfond fiss li fih tenofovir DF 300 mg u emtricitabine 200 mg mogħtija bħala pillola ta' kombinazzjoni b'doża fissa.
English: In treatment-naïve HIV-1 infected patients
Maltese: F'pazjenti infettati bl-HIV-1 li ma rċevewx kura qabel
English: No clinically relevant differences in cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Maltese: Ma ġiet osservata l-ebda differenza klinika rilevanti fil-farmakokinetika ta' cobicistat bejn lindividwi b'indeboliment moderat u l-individwi b'saħħithom.
English: Atazanavir with cobicistat and emtricitabine and tenofovir DF fixed-dose combination was non-inferior in achieving HIV-1 RNA <50 copies/ml when compared to atazanavir with ritonavir and emtricitabine and tenofovir DF fixed-dose combination.
Maltese: Atazanavir ma' kombinazzjoni ta' doża fissa ta' cobicistat u emtricitabine u tenofovir DF ma kienx inferjuri fl-ilħuq ta' HIV-1 RNA <50 kopja/ml meta mqabbel ma' kombinazzjoni ta' doża fissa ta' atazanavir ma' ritonavir u emtricitabine u tenofovir DF.
English: Among the 19 patients, 1 developed the emtricitabine-associated resistance substitution M184V with no tenofovir or protease inhibitor associated resistance substitutions.
Maltese: Fost id-19-il pazjent, 1 żviluppa ssostitutuzzjoni għal reżistenza assoċjata ma' emtricitabine M184V mingħajr sostituzzjonijiet għal reżistenza assoċjati mal-inibitur ta' protease jew tenofovir.
English: Atazanavir Cmax ↑12% (↓33%
Maltese: Cmax ta' Atazanavir ↑12 % (↓33 %
English: In particular, atazanavir boosted with cobicistat is more sensitive for CYP3A induction (see section 4.3 and the interaction table).
Maltese: B'mod partikolari, atazanavir imsaħħaħ b'cobicistat huwa aktar sensittiv għal induzzjoni ta' CYP3A (ara sezzjoni 4.3 u t-tabella ta' interazzjoni).
English: ANTIGOUT Colchicine
Maltese: KONTRA L-GOTTA Colchicine
English: Gastrointestinal disorders very common nausea common vomiting, diarrhoea, dyspepsia, abdominal pain, abdominal distension, flatulence, dry mouth uncommon pancreatitis, gastritis, stomatitis aphthous
Maltese: Disturbi gastro-intestinali komuni ħafna dardir komuni rimettar, dijarea, dispepsja, uġigħ fl-addome, nefħa addominali, gass, ħalq xott mhux komuni pankreatite, gastrite, stomatite bl-afte
English: Atazanavir AUC: ↔ Atazanavir Cmax:↔ Atazanavir Cmin: ↑ 6%
Maltese: ↔ Atazanavir Cmax:↔ Atazanavir Cmin: ↑ 6%
English: Didanosine (enteric coated capsules) 400 mg single dose (atazanavir 400 mg once daily)
Maltese: Didanosine (kapsuli miksijin b'mod enteriku) 400 mg doża waħda (atazanavir 400 mg darba kuljum)
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as atazanavir, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism.
Maltese: L-inibizzjoni tal-metaboliżmu permezz ta' CYP3A minn cobicistat issaħħaħ l-esponiment sistemiku tas-sottostrati ta' CYP3A, bħal atazanavir, fejn il-bijodisponibbiltà hija limitata u l-half-life titqassar minn metaboliżmu li jiddependi fuq CYP3A.
English: EVOTAZ should not be initiated in patients with creatinine clearance less than 70 ml/min if one or more co-administered agent requires dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir; see sections 4.2, 4.8 and 5.2).
Maltese: EVOTAZ ma għandux jinbeda f'pazjenti bi tneħħija tal-kreatinina ta' inqas minn 70 ml/min jekk waħda jew aktar mis-sustanzi li jingħataw flimkien tkun teħtieġ aġġustament fid-doża abbażi taleliminazzjoni tal-kreatinina (eż. emtricitabine, lamivudine, tenofovir disoproxil jew adefovir; ara sezzjonijiet 4.2, 4.8 u 5.2).
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Maltese: Huma disponibbli d-daqsijiet tal-pakkett li ġejjin: kartuniet ta' barra li fihom 1 flixkun ta' 30 pillola miksija b'rita u kartuniet ta' barra li fihom 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: Co-administration of EVOTAZ 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 the increase in grazoprevir concentrations (see section 4.3 and Table 1).
Maltese: L-għoti flimkien ta' EVOTAZ 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 u Tabella 1).
English: General disorders and administration site conditions common fatigue uncommon pyrexia, asthenia, chest pain, malaise rare gait disturbance a These adverse reactions were identified through post-marketing surveillance; however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to atazanavir (with and without ritonavir) in randomised controlled and other available clinical trials (n = 2321).
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata komuni għeja mhux komuni deni, astenja, uġigħ fis-sider, telqa 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 (bi jew mingħajr ritonavir) fi provi kliniċi randomizzati u kkontrollati u fi provi kliniċi disponibbli oħrajn (n = 2321).
English: Lamivudine 150 mg twice daily + zidovudine 300 mg twice daily (atazanavir 400 mg once daily)
Maltese: Lamivudine 150 mg darbtejn kuljum + zidovudine 300 mg darbtejn kuljum (atazanavir 400 mg darba kuljum)
English: Film-coated tablet
Maltese: Differenza fil-kura
English: PULMONARY ARTERIAL HYPERTENSION
Maltese: PRESSJONI GĦOLJA ARTERJALI PULMONARI
English: Atazanavir increases tenofovir concentrations.
Maltese: Atazanavir iżid il-konċetrazzjonijiet ta' tenofovir.
English: When co-administering maraviroc and EVOTAZ, patients should receive maraviroc 150 mg twice daily.
Maltese: Meta maraviroc u EVOTAZ jingħataw flimkien, il-pazjenti għandhom jirċievu maraviroc 150 mg darbtejn kuljum.