FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies.
Maltese: Sintomi li jinkludu, iżda mhumiex limitati għal, sturdament, insomnja, somnolenza, konċentrazzjoni mfixkla u ħolm anormali huma effetti mhux mixtieqa rrappurtati b'mod frekwenti f'pazjenti li ngħataw efavirenz 600 mg kuljum fi studji kliniċi.
English: Psychiatric disorders: Common depression (severe in 1.6%)3, anxiety3, abnormal dreams3, insomnia3
Maltese: Komuni depressjoni (severa f'1.6%)3, ansjetà3, ħolm anormali3, nuqqas ta' rqad3
English: Emtricitabine displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, and G. Tenofovir displayed antiviral activity against HIV-1 clades A, B, C, D, E, F, G, and O. Both emtricitabine and tenofovir showed strain specific activity against HIV-2 and antiviral activity against HBV.
Maltese: Emtricitabine wera attività antivirali kontra HIV-1 clades A, B, C, D, E, F, u G.
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected patients with varying degrees of hepatic impairment defined according to CPT classification.
Maltese: Doża singola ta' 245 mg ta' tenofovir disoproxil ingħatat lil pazjenti mhux infettati bl-HIV bi gradi varji ta' indeboliment tal-fwied definiti skont il-klassifikazzjoni tas-CPT.
English: This loss is due to significant decreases in elbasvir/grazoprevir plasma concentrations caused by CYP3A4 or P gp induction.
Maltese: Dan it-telf huwa minħabba ttnaqqis sinifikanti filkonċentrazzjonijiet ta' elbasvir/grazoprevir fil-plażma ikkawżat mill-induzzjoni ta' CYP3A4 jew P gp.
English: Seizures
Maltese: Osteonekrożi
English: In patients with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 µg•h/ml (19%) of emtricitabine, and over 48 hours to 42,857 ng•h/ml (29%) of tenofovir.
Maltese: F'pazjenti b'mard renali tal-aħħar fażi (ESRD) li jeħtieġu emodijaliżi, l-espożizzjonijiet tal-mediċina bejn id-dijaliżi żdiedu tul 72 siegħa għal 53 µg•h/ml (19%) ta' emtricitabine, u aktar minn 48 siegħa għal 42,857 ng•h/ml (29%) ta' tenofovir.
English: TAMs2
Maltese: Treddigħ
English: Uncommon rhabdomyolysis2, muscular weakness2
Maltese: Mhux komuni rabdomijoliżi2, dgħufija fil-muskoli2
English: Table 4: 48-week efficacy data from study AI266073 in which efavirenz/emtricitabine/tenofovir disoproxil was administered to virologically suppressed patients on combination antiretroviral therapy
Maltese: Tabella 4: Dejta tal-effikaċja fuq 48 ġimgħa mill-istudju AI266073 li fih efavirenz/emtricitabine/tenofovir disoproxil Mylan ingħata lil pazjenti mrażżna viroloġikament fuq terapija antiretrovirali ta' kombinazzjoni
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan hi kombinazzjoni ta' doża fissa ta' efavirenz, emtricitabine u tenofovir disoproxil.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets efavirenz/emtricitabine/tenofovir disoproxil
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg pilloli miksija b'rita efavirenz/emtricitabine/tenofovir disoproxil
English: Cmax: ↑ 38% (competitive inhibition of oxidative metabolism) Co-administration of standard doses of efavirenz and voriconazole is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess ħin ta' dożi standard ta' efavirenz u voriconazole huwa kontraindikat (ara sezzjoni 4.3).
English: AUC: ↔ 20%
Maltese: AUC: ↓ 27% (↓ 20 sa
English: Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Maltese: Kemm emtricitabine triphosphate u tenofovir diphosphate huma inibituri dgħajfa ta' polymerases tadDNA tal-mammali u ma kien hemm ebda evidenza ta' tossiċità għal mitokondrija in vitro uin vivo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1222/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1222/002
English: Based on the concentration-QTc relationship, the mean QTc prolongation and its upper bound 90% confidence interval are 8.7 ms and 11.3 ms in subjects with CYP2B6*6/*6 genotype following the administration of 600 mg daily dose for 14 days (see section 4.5).
Maltese: Abbażi tar-relazzjoni bejn ilkonċentrazzjoni u QTc, it-titwil medju ta' QTc u l-għola livell tal-interval ta' kunfidenza ta' 90% tiegħu huma ta' 8.7 ms u 11.3 ms f'individwi bil-ġenotip CYP2B6 *6/*6 wara l-għoti ta' doża ta' 600 mg kuljum għal 14-il ġurnata (ara sezzjoni 4.5).
English: If concomitant use of efavirenz/emtricitabine/tenofovir disoproxil and nephrotoxic agents (e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir, interleukin-2) is unavoidable, renal function must be monitored weekly (see section 4.5).
Maltese: Jekk l-użu konkomitanti ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan u mediċini nefrotossiċi (eż. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir, interleukin-2) ma jistax jiġi evitat, il-funzjoni renali għandha tkun sorveljata kull ġimgħa (ara sezzjoni 4.5).
English: In combination studies evaluating the in vitro antiviral activity of efavirenz and emtricitabine together, efavirenz and tenofovir together, and emtricitabine and tenofovir together, additive to synergistic antiviral effects were observed.
Maltese: Fi studji ta' kombinazzjoni li jevalwaw l-attività antivirali in vitrota' efavirenz u emtricitabine flimkien, efavirenz u tenofovir flimkien, u emtricitabine u tenofovir flimkien, ġew osservati effetti antivirali addittivi ma' dawk sinerġistiċi.
English: Lopinavir/ritonavir soft capsules or oral solution/Efavirenz
Maltese: Kapsuli rotob/Lopinavir/ritonavir jew soluzzjoni orali/Efavirenz
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosinerelated adverse reactions.
Maltese: L-għoti flimkien ta' tenofovir disoproxil u didanosine jirriżulta f'żieda ta' 40 - 60% flespożizzjoni sistemika għal didanosine, li tista' żżid ir-riskju għal avvenimenti avversi assoċjati ma' didanosine.
English: Refer to the Summary of Product Characteristics for elbasvir/grazoprevir for more information.
Maltese: Irreferi għas-Sommarju talKaratteristiċi tal-Prodott ta' elbasvir/grazoprevir għal aktar informazzjoni.
English: Norepinephrine and dopamine reuptake inhibitor Bupropion/Efavirenz [150 mg single dose (sustained release)/600 mg q.d.]
Maltese: Inibitur tal-assorbiment mill-ġdid ta' norepinephrine u dopamine Bupropion/Efavirenz [150 mg doża waħda (mediċina li tintreħa b'mod sostnut)/600 mg q.d.]
English: Prior efavirenz/emtricitabine/tenofovir disoproxil components (N=299)
Maltese: Komponenti ta' qabel ta' efavirenz/emtricitabine/tenofovir disoproxil (N = 299)
English: CARDIOVASCULAR AGENTS Calcium Channel Blockers Diltiazem/Efavirenz (240 mg q.d./600 mg q.d.)
Maltese: Imblokkaturi tal-Kanal tal-Kalċju Diltiazem/Efavirenz (240 mg q.d./ 600 mg q.d.)
English: AUC: ↔* (↓ 9% to ↑ 10%) Cmax: ↑ 17%* (↑ 8 to ↑ 27) Cmin: ↓ 42%* (↓ 31 to ↓ 51)
Maltese: Cmax: ↑ 17%* (↑ 8 sa Cmin: ↓ 42%* (↓ 31 sa
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pilloli miksija b'rita
English: Malformations have been observed in foetuses from efavirenz-treated monkeys (see section 5.3).
Maltese: Formazzjoni difettuża ġiet osservata f'feti ta' xadini kkurati b'efavirenz (ara sezzjoni 5.3).
English: Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Maltese: Disturbi newroloġiċi li dehru iktar tard ġew irrappurtati b'mod rari (ipertonja, konvulżjoni, imġiba mhux normali).
English: Sufficient data on the tolerability of efavirenz with low-dose ritonavir (100 mg, once or twice daily) are not available.
Maltese: M'hemmx dejta suffiċjenti disponibbli dwar it-tollerabilità ta' efavirenz ma' doża baxxa ta' ritonavir (100 mg, darba jew darbtejn kuljum).
English: Resistance analysis by week 144 On-therapy genotypes Efavirenz resistance1
Maltese: Ġenotipi fuq it-terapija Reżistenza għal efavirenz1
English: AUC: ↓ 43% (↓ 34 to ↓ 50) Cmax: ↓ 12% (↓ 1 to ↓ 26) 2-hydroxy atorvastatin:
Maltese: Cmax: ↓ 12% (↓ 1 sa ↓ 26) 2-hydroxy atorvastatin:
English: It contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: There were no clinically significant pharmacokinetic interactions when efavirenz was administered with azithromycin, cetirizine, fosamprenavir/ritonavir, lorazepam, nelfinavir, zidovudine,
Maltese: Ma kien hemm ebda interazzjoni farmakokinetika klinikament sinifikanti meta efavirenz ingħata ma' azithromycin, cetirizine, fosamprenavir/ritonavir, lorazepam, nelfinavir, zidovudine, aluminium/magnesium hydroxide antacids, famotidine jew fluconazole.
English: AUC: ↓ 13% Cmin: ↓ 31% Cmax: ↓ 15% (CYP3A4 induction) Efavirenz:
Maltese: Cmax: ↓ 15% (Induzzjoni ta' CYP3A4) Efavirenz:
English: Exacerbations of hepatitis after discontinuation of treatment: In HIV infected patients co-infected with HBV, clinical and laboratory evidence of hepatitis may occur after discontinuation of treatment (see section 4.4).
Maltese: F'pazjenti infettati bl-HIV ko-infettati bl-HBV, evidenza ta' epatite klinika u tal-laboratorju tista' sseħħ wara twaqqif tat-trattament (ara sezzjoni 4.4).
English: Artemether/Lumefantrine/Emtricitabine Interaction not studied.
Maltese: Artemether/Lumefantrine/Emtricitabine
English: Dose adjustment: If Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is co-administered with rifampicin to patients weighing 50 kg or more, an additional 200 mg/day (800 mg total) of efavirenz may be considered (see section 4.5).
Maltese: Jekk Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan jingħata flimkien ma' rifampicin lil pazjenti li jiżnu 50 kg jew aktar, jistgħu jiġu kkunsidrati 200 mg/kuljum (total ta' 800 mg ) ta' efavirenz addizzjonali (ara sezzjoni 4.5).
English: Paroxetine: AUC: ↔ Cmax: ↔ Cmin: ↔ Efavirenz: AUC: ↔ Cmax: ↔ Cmin: ↔
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↔ Efavirenz:
English: Sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir: Co-administration of efavirenz/emtricitabine/tenofovir disoproxil and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended (see section 4.4 and Table 1).
Maltese: L-għoti flimkien ta' efavirenz/emtricitabine/tenofovir disoproxil u sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 1).
English: Efavirenz, one of the active components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, may remain in your blood for a time after therapy is stopped.
Maltese: Efavirenz, wieħed mill-komponenti attivi ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, jista' jibqa' f'demmek għal xi żmien wara li titwaqqaf it-terapija.
English: - Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Maltese: - Sertraline,mediċina użata biex tittratta d-depressjoni, għax it-tabib tiegħek jista' jkun jeħtieġ li jbiddillek id-doża ta' sertraline.
English: In vivo resistance (antiretroviral-naïve patients): In a 144-week open-label randomised clinical study (GS-01-934) in antiretroviral-naïve patients, where efavirenz, emtricitabine and tenofovir disoproxil were used as individual formulations (or as efavirenz and the fixed combination of emtricitabine and tenofovir disoproxil from week 96 to 144), genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA > 400 copies/ml at week 144 or early study drug discontinuation (see section on Clinical experience).
Maltese: Reżistenza in vivo (pazjenti li qatt ma jkunu ħadu trattament antiretrovirali qabel): Fi studju kliniku każwali bit-tikketta mikxufa ta' 144 ġimgħa (GS-01-934) f'pazjenti li qatt ma jkunu ħadu trattament antiretrovirali qabel, fejn efavirenz, emtricitabine u tenofovir disoproxil intużaw bħala formulazzjonijiet individwali (jew bħala efavirenz u l-kombinazzjoni fissa ta' emtricitabine u tenofovir disoproxil minn ġimgħa 96 sa 144), il-genotyping sar fuq iżolati ta' HIV-1 fil-plażma mill-pazjenti kollha b'HIV RNA kkonfermat ta' > 400 kopja/ml f'ġimgħa 144 jew twaqqif kmieni tal-mediċina studjata (ara sezzjoni dwar l-Esperjenza Klinika).
English: Cmax: ↓ 87% (CYP3A4 or P gp inductioneffect on grazoprevir)
Maltese: AUC: ↓ 83% Cmax: ↓ 87% (Induzzjoni ta' CYP3A4 jew ta' P gp -effett fuq grazoprevir)
English: Clinically significant interactions are not expected as simeprevir and emtricitabine are eliminated via different pathways.
Maltese: Interazzjonijiet klinikament sinifikanti mhumiex mistennija billi simeprevir u emtricitabine huma eliminati permezz ta' passaġġi differenti.
English: Animal studies on emtricitabine and tenofovir disoproxil do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali b'emtricitabine u tenofovir disoproxil ma jurux effetti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: AUC: ↓ 10% C12h: ↓ 13%
Maltese: AUC: ↓ 10% C12h: ↓ 13% Cmax: ↓ 23%
English: Adverse reactions associated with the use of efavirenz/emtricitabine/tenofovir disoproxil: Treatmentemergent adverse reactions considered possibly or probably related to efavirenz/emtricitabine/tenofovir disoproxil reported in study AI266073 (over 48 weeks; n = 203), which have not been associated with one of the individual components of efavirenz/emtricitabine/tenofovir disoproxil, include:
Maltese: Reazzjonijiet avversi assoċjati mal-użu ta' efavirenz/emtricitabine/tenofovir disoproxil Ir-reazzjonijiet avversi li żviluppaw mill-kura li huma kkunsidrati bħala possibbilment jew probabbilment marbuta ma' efavirenz/emtricitabine/tenofovir disoproxil Mylan rrappurtati fi studju AI266073 (fuq perjodu ta' 48 ġimgħa; n=203), li ma ġewx assoċjati ma' wieħed mill-komponenti individwali ta' efavirenz/emtricitabine/tenofovir disoproxil Mylan, jinkludu:
English: Didanosine: Co-administration of efavirenz/emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1).
Maltese: L-għoti flimkien ta' efavirenz/emtricitabine/tenofovir disoproxil u didanosine mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 1).
English: Data are available from 286 patients who switched to efavirenz/emtricitabine/tenofovir disoproxil: 160 had previously received efavirenz, emtricitabine and tenofovir disoproxil, and 126 had previously received lamivudine/zidovudine and efavirenz.
Maltese: Tagħrif huwa disponibbli minn 286 pazjent li qalbu għal efavirenz/emtricitabine/tenofovir disoproxil: 160 kienu rċevew efavirenz, emtricitabine u tenofovir disoproxil qabel, u 126 kienu rċevew lamivudine/zidovudine u efavirenz qabel.
English: Resistance to emtricitabine or tenofovir disoproxil has been seen in vitro and in some HIV-1 infected patients due to the development of an M184V or M184I substitution in RT with emtricitabine or a K65R substitution in RT with tenofovir disoproxil.
Maltese: Reżistenza għal emtricitabine jew tenofovir intweriet in vitrou f'xi pazjenti infettati bl-HIV-1 minħabba l-iżvilupp ta' sostituzzjoni ta' M184V jew M184I f'RT b'sostituzzjoni ta' emtricitabine jew ta' K65R f'RT b'tenofovir disoproxil.
English: A similar reduction in indinavir exposures was observed when indinavir 1,000 mg q8h was given with efavirenz 600 mg q.d.
Maltese: Tnaqqis simili flesponimenti ta' indinavir ġie osservat meta indinavir 1,000 mg q8h ingħata ma' efavirenz 600 mg q.d. (Induzzjoni ta' CYP3A4).
English: 0.5% (-7.0% to 9.3%)
Maltese: 85/97 (87.6%) 0.5% (-7.0% sa 9.3%)
English: 1.2% (-2.3% to 6.7%)
Maltese: 85/87 (97.7%) 1.2% (-2.3% sa 6.7%)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is not recommended for patients with moderate or severe renal impairment (creatinine clearance (CrCl) < 50 ml/min).
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan mhux rakkomandat għal pazjenti b'indeboliment renali moderat jew sever (tneħħija tal-kreatinina (CrCl) ta' < 50 mL/min).
English: - if you are taking other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Maltese: - jekk qed tieħu mediċini oħra li fihom efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine jew adefovir dipivoxil.
English: Hepatobiliary disorders:
Maltese: Parametri metaboliċi:
English: However, it was negative in an in vivo mouse bone marrow micronucleus assay.
Maltese: Madankollu kienu negattivi f'analiżi in vivo mikronuklejari talmudullun tal-ġurdien.
English: When the two strata were analysed separately, response rates in the stratum with prior PI-treatment were numerically lower for patients switched to efavirenz/emtricitabine/tenofovir disoproxil [92.4% versus 94.0% for the PVR (sensitivity analysis) for efavirenz/emtricitabine/tenofovir disoproxil and SBR patients respectively; a difference (95%CI) of -1.6% (-10.0%, 6.7%).
Maltese: Meta ż-żewġ strata kienu analizzati separatament, ir-rati tar-rispons fl-istratum b'kura bil-PI fil-passat kienu numerikament iktar baxxi għal pazjenti li qalbu għal efavirenz/emtricitabine/tenofovir disoproxil [92.4% kontra 94.0% għall-PVR (analiżi tas-sensittività) għal efavirenz/emtricitabine/tenofovir disoproxil Mylan u pazjenti SBR (stayed on their baseline regimen) rispettivament; differenza (95%CI) ta' -1.6% (-10.0%, 6.7%)].
English: Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives, see section 4.5) while on therapy with efavirenz/emtricitabine/tenofovir disoproxil.
Maltese: Kontraċezzjoni barriera għandha dejjem tintuża flimkien ma' metodi oħra ta' kontraċezzjoni (pereżempju, kontraċettivi orali jew ormonali, ara sezzjoni 4.5) waqt it-terapija b'efavirenz/emtricitabine/tenofovir disoproxil Mylan.
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the CYP system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Maltese: Studji fl-umani u studji in vitroli jużaw mikrosomi tal-fwied uman urew li efavirenz huwa metabolizzat b'mod ewlieni mis-sistema ta' CYP għal metaboliti idrossillati b'glukuronidazzjoni sussegwenti tal-metaboliti idrossilati.
English: In the open-label extended phase of study GS-01-934, where patients received efavirenz/emtricitabine/tenofovir disoproxil on an empty stomach, 3 additional cases of resistance were seen.
Maltese: Fil-fażi estiża b'tikketta mikxufa ta' studju GS-01-934, fejn il-pazjenti rċivew efavirenz/emtricitabine/tenofovir disoproxil fuq stonku vojt, 3 każijiet addizzjonali ta' reżistenza ġew osservati.
English: Although in vitro data suggest that efavirenz inhibits CYP2C9 and CYP2C19, there have been contradictory reports of both increased and decreased exposures to substrates of these enzymes when coadministered with efavirenz in vivo.
Maltese: Għalkemm dejta in vitro tissuġġerixxi li efavirenz jinibixxi CYP2C9 u CYP2C19, kien hemm rapporti kontradittorji kemm ta' żidiet kif ukoll ta' tnaqqis fl-esponimenti għas-substrati ta' dawn l-enzimi meta jingħataw flimkien ma' efavirenz in vivo.
English: The inducing effect of St. John's wort may persist for at least 2 weeks after cessation of treatment (see section 4.3).
Maltese: John's wort jista' jippersisti għal mill-inqas ġimagħtejn wara l-waqfien tat-trattament (ara sezzjoni 4.3).
English: Prior PI-based regimen (N=34)
Maltese: Kors ibbażat fuq PI fil-passat (N = 34)
English: Tenofovir disoproxil and emtricitabine, two of the active substances in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, show some activity against hepatitis B virus although emtricitabine is not approved for the treatment of hepatitis B infection.
Maltese: Tenofovir disoproxil u emtricitabine, tnejn mis-sustanzi attivi f'Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan juru xi attività kontra l-virus talepatite B għalkemm emtricitabine mhuwiex approvat għat-trattament tal-infezzjoni blepatite B.
English: The adverse reaction profile of efavirenz, emtricitabine and tenofovir disoproxil in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection.
Maltese: Il-profil tar-reazzjonijiet avversi ta' efavirenz, emtricitabine u tenofovir disoproxil Mylan f'pazjenti ko-infettati bl-HIV/HBV jew bl-HIV/HCV kien jixbah lil dak osservat f'pazjenti infettati bl-HIV mingħajr ko-infezzjoni.
English: Interaction with didanosine: Co-administration of efavirenz/emtricitabine/tenofovir disoproxil and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Maltese: L-għoti ta' efavirenz/emtricitabine/tenofovir disoproxil Mylan flimkien ma' didanosine mhuwiex rakkomandat għax jista' jirriżulta f'żieda ta' 40 - 60% fl-esponiment sistemiku għal didanosine li jista' jżid ir-riskju ta' reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: The separate pharmaceutical forms of efavirenz, emtricitabine and tenofovir disoproxil were used to determine the pharmacokinetics of efavirenz, emtricitabine and tenofovir disoproxil, administered separately in HIV infected patients.
Maltese: Il-forom farmaċewtiċi separati ta' efavirenz, emtricitabine u tenofovir disoproxil intużaw biex tiġi stabbilita l-farmakokinetika ta' efavirenz, emtricitabine u tenofovir disoproxil, mogħtija separatament f'pazjenti infettati bl-HIV.
English: Cmax: ↑ 38% (↑ 14 to ↑ 67)
Maltese: ↑ 38% (↑ 14 sa
English: Patients either changed to efavirenz/emtricitabine/tenofovir disoproxil (N=203) or continued on their original antiretroviral treatment regimen (N=97).
Maltese: Ilpazjenti jew qalbu għal efavirenz/emtricitabine/tenofovir disoproxil Mylan (N= 203) jew komplew fuq ir-reġim ta' trattament antiretrovirali oriġinali tagħhom (N= 97).
English: - if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Maltese: - jekk għandek storja ta' mard mentali, inkluża depressjoni, jew abbuż ta' sustanzi jew alkoħol.
English: See ritonavir row below.
Maltese: Ara r-ringiela ta' ritonavir hawn taħt.
English: The adverse reactions from clinical study and post-marketing experience with efavirenz/emtricitabine/tenofovir disoproxil and the individual components of efavirenz/emtricitabine/tenofovir disoproxil in antiretroviral combination therapy are listed in Table 2 below by body system organ class, frequency and the component(s) of efavirenz/emtricitabine/tenofovir disoproxil to which the adverse reactions are attributable.
Maltese: Ir-reazzjonijiet avversi minn studju kliniku u l-esperjenza ta' wara t-tqegħid fis-suq b'efavirenz/emtricitabine/tenofovir disoproxil Mylan u l-komponenti individwali ta' efavirenz/emtricitabine/tenofovir disoproxil Mylan f'terapija antiretrovirali kombinata huma elenkati f'Tabella 2 hawn taħt bis-sistema tal-klassifika tal-organi tal-ġisem, frekwenza u l-komponent(i) ta' efavirenz/emtricitabine/tenofovir disoproxil Mylan li għalihom ir-reazzjonijiet avversi huma attribwibbli.
English: Your doctor may consider giving you an alternative medicine or changing the dose of the protease inhibitors.
Maltese: Ittabib tiegħek jista' jikkunsidra li jagħtik mediċina alternattiva jew ibiddel id-doża tal-inibituri protease.