FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz to patients with mild hepatic impairment.
Maltese: Minħabba l-metaboliżmu estensiv ta' efavirenz li hu medjat minn cytochrome P450, u minħabba lesperjenza klinika limitata f'pazjenti b'mard kroniku fil-fwied, għandu jkun hemm kawtela meta wieħed jagħti efavirenz lil pazjenti b'indeboliment ħafif tal-fwied.
English: Hepatitis C antivirals Boceprevir/efavirenz (800 mg 3 times daily/600 mg
Maltese: Antivirali tal-Epatite Ċ Boceprevir/efavirenz (800 mg 3 darbiet kuljum/600 mg darba kuljum)
English: CARDIOVASCULAR AGENTS Calcium Channel Blockers Diltiazem/efavirenz (240 mg once daily/600 mg once daily)
Maltese: Imblokkaturi tal-Kanali tal-Kalċju Diltiazem/Efavirenz (240 mg darba kuljum/600 mg darba kuljum)
English: Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine and tenofovir disoproxil.
Maltese: Ma sarux studji speċifiċi talinterazzjoni b'efavirenz u NRTIs oħra apparti minn lamivudine, zidovudine, u tenofovir disoproxil.
English: At baseline, median plasma HIV-1 RNA was 4.8 log10 copies/mL, median CD4+ cell count was 367 cells/mm3, and median CD4+ percentage was 18%.
Maltese: 4.8 log10 kopja/mL, il-medjan tal-għadd ta' ċelluli CD4+ kien 367 ċellula/mm3, u l-medjan tal perċentwali ta' CD4+ kien 18%.
English: AUC: ↓ 55% (↓ 48 to ↓ 62) Cmax: ↓ 34% (↓ 21 to ↓ 47)
Maltese: AUC: ↓ 55% (↓ 48 sa ↓ 62) Cmax: ↓ 34% (↓ 21 sa ↓ 47)
English: It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood.
Maltese: Hija mediċina antiretrovirali li tissielet infezzjoni bil-virus talimmunodefiċjenza umana (HIV-1) billi tnaqqas l-ammont ta' virus fiddemm.
English: Cmax: ↑ 11% (↑ 6 to ↑ 16)
Maltese: Cmax: ↑ 11% (↑ 6 għal ↑ 16) Cmin: ↔
English: Film-coated tablet Yellow, capsule-shaped, film-coated tablet debossed with “Teva” on one side and “7541” on the other
Maltese: Pillola miksija b'rita ta' lewn isfar forma ta' kapsula bil-kelma “Teva” mnaqqxa fuq naħa waħda u “7541” fuq in-naħa l-oħra
English: Indinavir/efavirenz (800 mg q8h/200 mg once daily)
Maltese: Indinavir/Efavirenz (800 mg q8h/200 mg darba kuljum)
English: AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78)
Maltese: AUC: ↓ 60% (↓ 52 għal ↓ 68) Cmax: ↓ 62% (↓ 55 għal ↓ 78)
English: AUC: ↓ 75% (↓ 62 to ↓ 84) Cmax: ↓ 44% (↓ 20 to ↓ 61)
Maltese: AUC: ↓ 75% (↓ 62 sa ↓ 84) Cmax: ↓ 44% (↓ 20 sa ↓ 61)
English: Elevations of GGT to greater than five times ULN were observed in 4% of all patients treated with 600 mg of efavirenz and 1.5-2% of patients treated with control regimens (7% of efavirenz-treated patients and 3% of control-treated patients after long-term treatment).
Maltese: Ġew osservati elevazzjonijiet simili f'pazjenti kkurati b'GGT għal iktar minn ħames darbiet ULN f'4% mill-pazjenti kollha kkurati b'600 mg ta' efavirenz u 1.5 - 2% tal-pazjenti f'kuri ta' kontroll (7% ta' tal-pazjenti kkurati b'efavirenz u 3% ta' pazjenti f'kuri ta' kontroll wara kura fit-tul).
English: Study AI266922 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of efavirenz in combination with didanosine and emtricitabine in antiretroviral-naive and -experienced paediatric patients.
Maltese: Studju AI266922 kien studju open-label għall-evalwazzjoni tal-farmakokinetika, is-sigurtà, ittollerabbiltà, u l-attività antivirali ta' efavirenz flimkien ma' didanosine u emtricitabine f'pazjenti pedjatriċi li qatt ma ħadu t-terapija antiretrovirali qabel u oħrajn b'esperjenza għal terapija antiretrovirali.
English: This mutation was observed in 90% of patients receiving efavirenz with virological failure.
Maltese: Din il-mutazzjoni kienet osservata f'90% mill-pazjenti li kienu qed jingħataw efavirenz b'falliment viroloġiku.
English: Using an ITT analysis, the overall proportions of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 57% (21/37) and 46% (17/37), respectively.
Maltese: <50 kopja/mL tal-RNA tal-HIV fil-Ġimgħa 48 kienu 57% (21/37) u 46% (17/37), rispettivament.
English: Nelfinavir/efavirenz (750 mg q8h/600 mg once daily)
Maltese: Nelfinavir/Efavirenz (750 mg q8h/600 mg darba kuljum)
English: Limited data suggest there is no clinically significant effect on valproic acid pharmacokinetics.
Maltese: Dejta limitata tissuġġerixxi li ma hemm ebda effett klinikament sinifikanti fuq il-farmakokinetiċi tal aċidu valprojku.
English: AUC: ↓ 36% C12: ↓ 21% Cmax: ↓ 36%
Maltese: ↓ 36% C12: ↓ 21% Cmax: ↓ 36%
English: White opaque PVC/PVdC-aluminium or aluminium-aluminium blisters in a carton containing 30 or 90 film-coated tablets.
Maltese: Folji bojod opaki PVC/PVdC-aluminju jew aluminju-aluminju f'kartuna li fiha 30 jew 90 pillola miksija b'rita.
English: Responder rates (NC = F
Maltese: Rati tar-rispons (NC = F a)
English: Using an ITT analysis, the overall proportion of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 57% (58/102) and 43% (44/102), respectively.
Maltese: ITT, il-proporzjonijiet ġenerali ta' pazjenti b'<400 kopja/mL u <50 kopja/mL tal-RNA tal-HIV fil-Ġimgħa 48 kienu 57% (58/102) u 43%
English: Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Maltese: Ħafna minn Rosuvastatin huwa eliminat mhux mibdul permezz tal eskreta, għalhekk mhijiex mistennija interazzjoni ma' efavirenz.
English: - Medicines used to treat malaria:
Maltese: - ċerti mediċini kontra l-malarja,
English: Posaconazole/efavirenz (--/400 mg once daily)
Maltese: Posaconazole/Efavirenz --/400 mg darba kuljum
English: Table 3: Efficacy results for studies ACTG 364 and 020 Responder rates (NC = Fa) Plasma HIV-RNA
Maltese: Tabella 3: Riżultati tal-effikaċja għall-istudji ACTG 364 u 020
English: Pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) elbasvir or grazoprevir (used to treat hepatitis C) St John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) flecainide, metoprolol (used to treat irregular heart beat) certain antibiotics (macrolides, fluoroquinolones, imidazole)
Maltese: John's wort (Hypericum perforatum) (rimedju erbali użat biex jikkura dipressjoni u ansjetà flecainide, metoprolol (użati biex jikkuraw taħbit tal-qalb irregolari) ċerti antibijotiċi (makrolidi, fluoroquinolones, imidazole)
English: Efavirenz induced foetal resorptions in rats.
Maltese: simeprevir ma' efavirenz mhux rakkomandat.
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenz-containing antiretroviral therapy and subjects receiving no antiretroviral therapy.
Maltese: Fi studju ta' interazzjoni talmediċina ta' 3 xhur, ma nstabet ebda differenza sinifikanti filparametri farmakokinetiċi tal-MPA bejn suġġetti li kienu qegħdin jirċievu terapija antiretrovirali li fiha efavirenz u suġġetti li ma kienu qegħdin jirċievu ebda terapija.
English: The steady-state AUC, Cmax and Cmin of the active carbamazepine epoxide metabolite remained unchanged.
Maltese: L-AUC stabbli, il-Cmax u l-Cmin talmetabolit epossidu attiv ta' carbamazepine baqa' mhux mibdul.
English: With efavirenz, an increase of the lopinavir/ritonavir soft capsule or oral solution doses by 33% should be considered (4 capsules/ ~6.5 ml twice daily instead of 3 capsules/5 ml twice daily).
Maltese: Ma' efavirenz, għandha tiġi kkunsidrata żieda ta' 33% fiddożi ta' lopinavir/ritonavir kapsula ratba jew soluzzjoni orali (4 kapsuli/~6.5 ml darbtejn
English: No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/l) when given with ritonavir and efavirenz was higher than the mean historical Cmin (0.15 mg/l) when indinavir was given alone at 800 mg q8h.
Maltese: Ebda interazzjoni farmakokinetika klinikament sinifikanti Il-Cmin ġeometrika medja għal indinavir (0.33 mg/l) meta ngħata ma' ritonavir u efavirenz kienet ogħla mill-Cmin storika medja (0.15 mg/l) meta indinavir ingħata waħdu f'doża ta'
English: While effective viral suppression with antiretroviral therapy, has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li soppressjoni virali b'terapija antiretrovirali effikaċi ġiet ippruvata li tnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: Common Abnormal dreams, anxiety, depression, insomnia* Uncommon Affect lability, aggression, confusional state, euphoric mood, hallucination, mania,
Maltese: mhux komuni bidla kontinwa fil-burdata, aggressjoni, stat konfużjonali, burdata ewforika, alluċinazzjoni, manija, paranoja, psikożi†, attentat ta' suwiċidju, ideat dwar suwiċidju*, katatonja*
English: AUC: ↓ 26% (↓ 15 to ↓ 36) Cmax: ↓ 20% (↓ 11 to ↓ 28) Cmin: ↓ 32% (↓ 15 to ↓ 46)
Maltese: AUC: ↓ 26% (↓ 15 għal ↓ 36) Cmax: ↓ 20% (↓ 11 għal ↓ 28) Cmin: ↓ 32% (↓ 15 għal ↓ 46)
English: At baseline, median plasma HIV-1 RNA was 4.57 log10 copies/mL, median CD4+ cell count was 755 cells/mm3, and median CD4+ percentage was 30%.
Maltese: 4.57 log10 kopji/mL, il-medjan tal-għadd ta' ċelluli CD4+ kien 755 ċellula/mm3, il-medjan tal perċenwatal ta' CD4+ kien 30%.
English: LIPID-LOWERING MEDICINAL PRODUCTS HMG CoA Reductase Inhibitors Atorvastatin/efavirenz (10 mg once daily/600 mg once daily)
Maltese: HMG Co-A Reductase Atorvastatin/Efavirenz (10 mg darba kuljum/600 mg darba kuljum)
English: AUC: ↓ 75% (↓ 59 to ↓ 84) Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
Maltese: AUC: ↓ 75% (↓ 59 għal ↓ 84) Cmax: ↓ 64% (↓ 57 għal ↓ 69) Cmin: ↓ 62% (↓ 44 għal ↓ 75)
English: Liver enzymes: Elevations of AST and ALT to greater than five times the upper limit of the normal range (ULN) were seen in 3% of 1,008 patients treated with 600 mg of efavirenz (5-8% after long-term treatment in study 006).
Maltese: Enzimi tal-fwied: fi 3% ta' 1,008 pazjenti li ngħataw 600 mg ta' efavirenz (5-8% wara kura fit-tul fi studju 006) dehru livelli ta' AST u ALT li għolew għal iktar minn ħames darbiet il-livell ta' fuq tal medda normali (ULN).
English: It is used by adults, adolescents and children 3 years of age and older.
Maltese: Jintuża minn adulti, adolexxenti u tfal minn 3 snin 'il fuq.
English: Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.4).
Maltese: estratti ta' Ginkgo biloba mhuwiex rakkomandat (ara sezzjoni 4.4).
English: The single substitutions which led to the highest resistance to efavirenz in cell culture correspond to a leucine-to-isoleucine change at position 100 (L100I, 17 to 22-fold resistance) and a lysine-to-asparagine at position 103 (K103N, 18 to 33-fold resistance).
Maltese: Is-sostituzzjonijiet singoli li wasslu għall-ogħla reżistenza lil efavirenz fil-kulturi taċ-ċelluli jikkorrispondu għall-bidla minnleucine-għalisoleucine f'pożizzjoni 100 (L100I, reżistenza minn 17 sa 22 darba iktar) u bidla minnlysine-għalasparagine fil-pożizzjoni 103 (K103N, reżistenza minn 18 sa 33 darba iktar).
English: EU/1/11/742/005 (carton multi-pack - blister PVC/PVDC/alu) EU/1/11/742/010 (carton multi-pack - blister alu/alu)
Maltese: EU/1/11/742/005 (mazz ta' pakketti b'ħafna - folja PVC/PVDC/alu) EU/1/11/742/010 (mazz ta' pakketti b'ħafna - folja alu/alu)
English: 90 x 1 film-coated tablet in white opaque PVC/PVdC-aluminium perforated unit-dose blisters.
Maltese: 90 x 1 pillola miksija b'rita f'folji bojod opaki PVC/PVdC-aluminju pperforati b'dożi uniċi.
English: ↔efavirenz
Maltese: Efavirenz Teva.
English: Saquinavir/ritonavir/efavirenz
Maltese: Darunavir/ritonavir/Efavirenz
English: Fosamprenavir/nelfinavir/
Maltese: Fosamprenavir/Nelfinavir/Efavire nz
English: Cmin: ↓ 44% Efavirenz:
Maltese: Cmin: ↓ 91% (↓ 88 sa ↓ 92) Efavirenz:
English: Fosamprenavir/saquinavir/ efavirenz
Maltese: Fosamprenavir/Saquinavir/Efavir enz
English: There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP450 isoenzymes when co-administered with efavirenz.
Maltese: Hemm potenzjal għal tnaqqis jew żieda fil-konċentrazzjonijiet filplażma ta' phenytoin, phenobarbital u antikonvulsivi oħra li huma substrati ta' isoenzimi CYP450 meta jingħataw fl-istess ħin ma' efavirenz.
English: ANTICONVULSANTS Carbamazepine/efavirenz (400 mg once daily/600 mg once daily)
Maltese: ANTIKONVULSIVI Carbamazepine/Efavirenz (400 mg darba kuljum/600 mg darba kuljum)
English: Immune system disorders Uncommon Hypersensitivity Metabolism and nutrition disorders common hypertriglyceridaemia* uncommon hypercholesterolaemia*
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni ipertrigliċeridemija*
English: Multipack (bundle) containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablet) in white opaque PVC/PVdC-aluminium or aluminium-aluminium perforated unit-dose blisters.
Maltese: Pakkett b'ħafna (mazz) li fih 90 pillola miksija b'rita (3 pakketti ta' 30 x 1 pillola miksija b'rita) f'folji bojod opaki PVC/PVdC-aluminju jew aluminju-aluminju b'dożi uniċi.
English: - Film-coated tablet: yellow, capsule-shaped, film-coated tablet debossed with “Teva” on one side and “7541” on the other - Efavirenz Teva is available in pack sizes of 30, 90 film-coated tablets or 30 x 1 / 90 x 1 film-coated tablets (in perforated unit dose blisters) or a multi-pack bundle or carton containing 90 film-coated tablets (3 packs of 30 x 1 film-coated tablet).
Maltese: - Efavirenz Teva jinsab f'pakketti tad-daqs 30, 90 pillola miksija b'rita jew 30 x 1 / 90 x 1 pilloli miksija b'rita (f'folji mtaqqbin ta' dożi uniċi) jew f'mazz li fih pakkett b'ħafna jew kartuna li fiha 90 pillola miksija b'rita (3 pakketti ta' 30 x 1 pillola miksija b'rita).
English: Lopinavir concentrations: similar to lopinavir/ritonavir 400/100 mg twice daily without efavirenz
Maltese: jixbhu lil lopinavir/ritonavir 400/100 mg darbtejn kuljum mingħajr efavirenz
English: A similar reduction in indinavir exposures was observed when indinavir 1000 mg q8h was given with efavirenz 600 mg daily.
Maltese: Tnaqqis simili fl-espożizzjonijiet għal indinavir ġew osservati meta indinavir 1.000 mg q8h ingħata flimkien ma' efavirenz 600 mg kuljum
English: Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.
Maltese: ritonavir) jew ikel (per eżempju, meraq tal-grejpfrut), li jinibixxu l-attività ta' CYP3A4 jew CYP2B6.
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: kunfidenza ta' 90% tiegħu huma 8.7 ms u 11.3 ms f'individwi b'ġenotip CYP2B6*6/*6 wara l-għoti ta' doża ta' kuljum ta' 600 mg għal 14-il jum (ara s-sezzjoni 4.5).
English: AUC: ↓ 18% (↓ 8 to ↓ 27) Cmax: ↓ 14% (↓ 3 to ↓ 24) Cmin: ↓ 25% (↓ 14 to ↓ 34)% Efavirenz:
Maltese: AUC: ↓ 18% (↓ 8 sa ↓ 27) Cmax: ↓ 14% (↓ 3 sa ↓ 24) Cmin: ↓ 25% (↓ 14 sa ↓ 34)%
English: (S.E.M.d)
Maltese: I.c) Ċelluli/mm3 (S.E.M.d)
English: N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 to ↓ 52) Cmax: ↓ 28% (↓ 7 to ↓ 44) Cmin: ↓ 37% (↓ 17 to ↓ 52)
Maltese: ↓ 37% (↓ 17 għal ↓ 52) Cmax: ↓ 28% (↓ 7 għal ↓ 44) Cmin: ↓ 37% (↓ 17 għal ↓ 52)
English: If therapy with efavirenz is discontinued, consideration should also be given to interrupting therapy with other antiretroviral agents to avoid development of resistant virus (see section 4.8).
Maltese: Jekk titwaqqaf it-terapija b'efavirenz, għandha titqies il-possibilita` li tiġi interrotta t-terapija b'aġenti antiretrovirali oħra biex ma jiżviluppax virus reżistenti (ara sezzjoni 4.8).
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: KARTUNA GĦALL-PAKKETTI
English: Buprenorphine/naloxone/ efavirenz
Maltese: Buprenorphine/naloxone/Efaviren z
English: Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme, psychiatric adverse reactions including severe depression, death by suicide, and psychosis-like behaviour, and seizures have been reported in patients treated with efavirenz.
Maltese: Reazzjonijiet qawwija fil-ġilda bħas-sindrome ta' Stevens-Johnson u eritema multiforme; reazzjonijiet avversi psikjatriċi li jinkludu dipressjoni qawwija, mewt minħabba suwiċidju, u mġieba li qisha psikotika; u aċċessjonijiet kienu rrappurtati f'pazjenti kkurati b'efavirenz.
English: 30 x 1 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 x 1 pillola miksija b'rita.
English: • Risk Management Plan (RMP)
Maltese: Pjan tal-Immaniġġar tar-Riskju (RMP)
English: EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir.
Maltese: IDV, indinavir; NRTI, inibitur nukleosid reverse transcriptase;
English: - Efavirenz Teva is for oral use.
Maltese: - Efavirenz Teva huwa għal użu orali.
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 40-55 hours after multiple doses.
Maltese: Efavirenz għandu half-life terminali relattivament twila ta' mill-anqas 52 siegħa wara dożi waħedhom u minn 40 sa 55 siegħa wara dożi multipli.
English: The dose of lopinavir/ritonavir tablets should be increased to 500/125 mg twice daily when co-administered with efavirenz 600 mg once daily.
Maltese: Id-dożaġġ ta' pilloli ta' lopinavir/ritonavir għandu jiżdied għal 500/125 mg darbtejn kuljum meta mogħti flimkien ma' efavirenz 600 mg kuljum.
English: Reported rates of recurrent rash following a switch from nevirapine to efavirenz therapy, primarily based on retrospective cohort data from published literature, range from 13 to 18%, comparable to the rate observed in patients treated with efavirenz in clinical studies (see section 4.4).
Maltese: Ir-rati rrappurtati ta' raxx rikorrenti wara bidla minn terapija b'nevirapine għal terapija b'efavirenz, ibbażati primarjament fuq dejta retrospettiva ta' gruppi minn letteratura medika ppubblikata, kienu fuq medda bejn 13 u 18 %, kumparabbli mar-rata osservata f'pazjenti kkurati b'efavirenz fi studji kliniċi.
English: Efavirenz may be an inducer of CYP2C19 and CYP2C9; however inhibition has also been observed in vitro and the net effect of co-administration with substrates of these enzymes is not clear (see section 5.2).
Maltese: CYP2C9; madankollu in vitro ġiet ukoll osservata inibizzjoni u l-effett finali ta' għoti flimkien ma' sustrati ta' dawn l-enzimi mhuwiex ċar (ara sezzjoni 5.2).
English: d S.E.M., standard error of the mean.
Maltese: d S.E.M., żball standardizzat mill-medja
English: (induction of metabolism)
Maltese: (inibizzjoni ta' metaboliżmu ossidattiv medjat minn CYP)
English: 30 x 1 film-coated tablet in white opaque PVC/PVdC-aluminium or aluminium-aluminium perforated unit-dose blisters.
Maltese: 30 x 1 pillola miksija b'rita f'folji bojod opaki PVC/PVdC-aluminju jew aluminju-aluminju b'dożi uniċi.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: At baseline, median plasma HIV-1 RNA was 5.88 log10 copies/mL, median CD4+ cell count was 1144 cells/mm3, and median CD4+ percentage was 25%.
Maltese: Fil-linja bażi, il-medjan tal-RNA tal-HIV-1 fil-plażma kien 5.88 log10 kopja/mL, il medjan tal-għadd ta' ċelluli CD4+ kien 1144 ċellula/mm3, u l-medjan tal-perċentwali ta' CD4+ kien
English: - Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): you must also use a reliable barrier method of contraception (see Pregnancy, breast-feeding and fertility).
Maltese: - Kontraċettiv ormonali, bħal pilloli ta' kontroll tat-twelid, kontraċettiv injettat (per eżempju, Depo-Provera), jew kontraċettiv impjantat (per eżempju, Implanon): għandek tuża wkoll metodu barriera ta' kontraċezzjoni affidabbli (ara Tqala, treddigħ u fertilità). Efavirenz Teva jista' jagħmel lill-kontraċettivi ormonali inqas probabbli li jaħdmu.
English: Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, table 1).
Maltese: Esponimenti għal raltegravir (sustrat ta' UGT1A1) jitnaqqsu fil-preżenza ta'
English: ↓elbasvir ↓grazoprevir
Maltese: ↓elbasvir ↓grazoprevir ↔efavirenz
English: Study PACTG 382 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of efavirenz in combination with nelfinavir and an NRTI in antiretroviral-naive and NRTI-experienced paediatric patients.
Maltese: Studju PACTG 382 kien studju open-label biex jevalwa l-farmakokinetika, is-sigurtà, it-tollerabbiltà, u l-attività antivirali ta' efavirenz flimkien ma' nelfinavir u NRTI f'pazjenti pedjatriċi li qatt ma ħadu tterapija antiretrovirali qabel u oħrajn b'esperjenza għal NRTI. Mija u żewġ pazjenti minn 3 xhur sa 16-il sena (medjan ta' 5.7 snin) kienu kkurati b'efavirenz.
English: A multiple-dose study showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh Class A) compared with controls.
Maltese: Studju b'dożi multipli ma wera l-ebda effett sinifikanti fuq il-farmakokinetika ta' efavirenz f'pazjenti b'indeboliment ħafif tal-fwied (Child-Pugh Klassi A) meta mqabbel ma' kontrolli.
English: Voriconazole/efavirenz (400 mg twice daily/300 mg once daily)
Maltese: Voriconazole/Efavirenz (400 mg darbtejn kuljum/ 300 mg darba kuljum)
English: Each film-coated tablet contains 600 mg efavirenz.
Maltese: Kull pillola miksija b'rita fiha 600 mg efavirenz.
English: If efavirenz and telaprevir are coadministered, telaprevir 1,125 mg every 8 hours should be used.
Maltese: Jekk efavirenz u telaprevir huma jingħataw flimkien, għandu jintuża telaprevir 1,125 mg kull 8 sigħat.
English: Adverse reactions of moderate or greater severity with at least possible relationship to treatment regimen (based on investigator attribution) reported in clinical trials of efavirenz at the recommended dose in combination therapy (n = 1,008) are listed below.
Maltese: Lista ta' reazzjonijiet avversi miġburin f'tabella Reazzjonijiet avversi ta' severità moderata jew akbar b'għallinqas relazzjoni possibbli għar-reġimen tat-trattament (abbażi tal-attribuzzjoni tal-investigatur) irrapportati fi provi kliniċi ta' efavirenz fiddoża rakkomandata f'terapija ta' kombinazzjoni (n = 1,008) huma elenkati hawn taħt.
English: Nervous system symptoms of moderate-to-severe intensity were experienced by 19% (severe 2%) of patients compared to 9% (severe 1%) of patients receiving control regimens.
Maltese: 19 % (2.0 % qawwija) tal-pazjenti meta mqabbla ma' 9 % (1 % qawwija) mill-pazjenti li kienu qed jirċievu skedi ta' kura ta' kontroll.
English: Refer to the prescribing information for glecaprevir/pibrentasvir for more information.
Maltese: glecaprevir/pibrentasvir għal aktar informazzjoni.
English: The mechanism of the effect on velpatasvir is induction of CYP3A and CYP2B6 by efavirenz.
Maltese: Il-mekkaniżmu tal-effett fuq velpatasvir huwa induzzjoni ta' CYP3A u CYP2B6 minn efavirenz.
English: If available, 90% or 95% confidence intervals are shown in parentheses.
Maltese: Jekk ikunu disponibbli, l-intervalli ta' kunfidenza ta' 90% jew 95% jiġu murija fil-parentesi.
English: Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with the fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate.
Maltese: Ġew irrapportati żewġ każijiet addizzjonali (1 prospettiv u 1 retrospettiv) inkluż avvenimenti konsistenti ma' difetti fit-tubu newrali bil-pillola ta' kombinazzjoni ta' doża fissa li fiha efavirenz, emtricitabine, u tenofovir disoproxil fumarate.Ma setax jiġi stabbilit jekk dawn il-każijiet kinux ikkawżati bl-użu ta' efavirenz, u d-denominatur mhux magħruf.