FrancophonIA/ELRC3.0 huggingface dataset:
English: (UDP-G induction)
Maltese: (induzzjoni ta' UDP-G)
English: HIV antivirals Protease inhibitors (PI)
Maltese: Antivirali tal-HIV Inibituri protease (PI)
English: Plasma HIV-RNA
Maltese: Plażma HIV-RNA
English: Verapamil, felodipine, nifedipine and nicardipine
Maltese: Verapamil, Felodipine, Nifedipine u Nicardipine
English: EXP {MM/YYYY}
Maltese: EXP{XX/SSSS}
English: (PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
Maltese: PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, 10000
English: Efavirenz Teva contains lactose
Maltese: Efavirenz Teva fih lactose
English: 10000 Zagreb, Croatia
Maltese: Zagreb, Kroazja
English: Efavirenz is highly bound (approximately 99.5-99.75%) to human plasma proteins, predominantly albumin.
Maltese: Efavirenz jintabat ħafna (bejn wieħed u ieħor 99.5 - 99.75%) mal-proteini tal-plażma umana, speċjalment albumin.
English: Cellulose, microcrystalline Hydroxypropylcellulose Sodium laurilsulfate Sodium starch glycolate (Type A) Poloxamer 407
Maltese: Cellulose, microcrystalline Hydroxpropylocellulose Sodium laurilsulfate Sodium starch glycolate (Tip A) Poloxamer 407
English: Study ACTG 364 48 weeks
Maltese: Studju ACTG 364
English: EFV + NRTIs NFV + NRTIs Study 020
Maltese: EFV + NRTIs NFV + NRTIs Studju 020
English: Phenytoin, phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
Maltese: Phenytoin, Phenobarbital, u antikonvulsivi oħra li huma substrati ta' isoenzimi CYP450
English: IDV + NRTIs a NC = F, noncompleter = failure.
Maltese: IDV + NRTIs a NC = F, mhux komplut = falliment.
English: Antiviral activity
Maltese: Attivita` antivirali
English: < 400 copies/ml (95% C.I.b)
Maltese: < 400 kopja/ml (95% C.I.b)
English: <50 copies/ml (95% C.I.b)
Maltese: <50 kopja/ml (95% C.I.b)
English: An alternative anticonvulsant should be considered.
Maltese: antikonvulsiv alternattiv.
English: Efavirenz Teva contains sodium
Maltese: Efavirenz Teva fih sodium
English: (UGT1A1 induction)
Maltese: (Induzzjoni ta' UGT1A1)
English: EU/1/11/742/001 (30 x 1 - blister PVC/PVDC/alu) EU/1/11/742/002 (30 - blister PVC/PVDC/alu) EU/1/11/742/003 (90 - blister PVC/PVDC/alu) EU/1/11/742/006 (30 x 1 - blister alu/alu) EU/1/11/742/007 (30 - blister alu/alu) EU/1/11/742/008 (90 - blister alu/alu) EU/1/11/742/011 (90 x 1 - blister PVC/PVDC/alu)
Maltese: EU/1/11/742/001 (30 x 1 - folja PVC/PVDC/alu) EU/1/11/742/002 (30 - folja PVC/PVDC/alu) EU/1/11/742/003 (90 - folja PVC/PVDC/alu) EU/1/11/742/006 (30 x 1 - folja alu/alu) EU/1/11/742/007 (30 - folja alu/alu) EU/1/11/742/008 (90 - folja alu/alu) EU/1/11/742/011 (90 x 1 - folja PVC/PVDC/alu)
English: The film-coating agent contains hypromellose, lactose monohydrate, titanium dioxide, macrogol/PEG 3350, triacetin and iron oxide yellow.
Maltese: Laġent tar-rita fih hypromellose, lactose monohydrate, titanium dioxide, macrogol/PEG 3350, triacetin u iron oxide isfar.
English: protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir-boosted atazanavir, saquinavir or fosamprenavir/saquinavir.
Maltese: - inibituri tal-protease: darunavir, indinavir, lopinavir/ritonavir, ritonavir, atazanavir,
English: The potency of efavirenz in cell culture against viral variants with amino acid substitutions at positions 48, 108, 179, 181 or 236 in RT or variants with amino acid substitutions in the protease was similar to that observed against wild-type viral strains.
Maltese: Il-qawwa ta' efavirenz fil-kulturi taċ-ċelluli kontra varjanti virali bis-sostituzzjonijiet ta' amino acid fil-pożizzjonijiet 48, 108, 179, 181 or 236 fl-RT jew varjanti bis-sostituzzjonijiet ta' amino acid fi protease kien simili għal dak osservat kontra razez virali wild type.
English: 95% confidence intervals.
Maltese: b intervalli ta' kunfidenza ta' 95%.
English: d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
Maltese: ZDV, zidovudine; 3TC, lamivudine;
English: - Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir,
Maltese: - Mediċini użati biex jikkuraw infezzjoni bil-virus tal-epatite Ċ: boceprevir, telaprevir,
English: AUC: ↔ Cmax: ↑ 50% (↑ 20 to ↑ 80)
Maltese: AUC: ↔ Cmax: ↑ 50% (↑ 20 sa ↑ 80)
English: ZDV + 3TC a NC = F, noncompleter = failure.
Maltese: IDV + ZDV + 3TC a NC = F, mhux komplut = falliment.
English: Telaprevir (relative to 750 mg q8h):
Maltese: Telaprevir (fir-rigward ta' 750 mg q8h):
English: imidazole and triazole antifungal agents, - certain non-sedating antihistamines (terfenadine, astemizole), - cisapride, - flecainide, - certain antimalarials, - methadone.
Maltese: imidazole u aġenti antifungali triazole, - ċerti antistamini mhux sedattivi (terfenadine, astemizole), - cisapride, - flecainide,
English: phenobarbital.
Maltese: phenytoin, phenobarbital.
English: In 35 patients receiving efavirenz 600 mg once daily, steady-state Cmax was 12.9 ± 3.7 microM (29%) [mean ± S.D. (% C.V.)], steady-state Cmin was 5.6 ± 3.2 microM (57%), and AUC was 184 ± 73 microM·h (40%).
Maltese: F'35 pazjent li kienu qed jirċievu 600 mg ta' efavirenz darba kuljum, Cmax fiss kien 12.9 ± 3.7 mikroM (29%) [medja ± S.D. (% C.V.)], Cmin fiss kien 5.6 ± 3.2 mikroM (57%), u AUC kien 184 ± 73 mikroM·h (40%).
English: Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).
Maltese: Efavirenz huwa impeditur mhux kompetittiv ta' HIV-1 reverse transcriptase (RT) u ma jimpedix b'mod sinifikanti HIV-2 RT jew polymerases (α, β, γ or δ) tad-DNA
English: - Medicines used to treat bacterial infections including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
Maltese: - Mediċini użati biex jikkuraw infezzjonijiet batterjali, inkluż tuberkolożi u kumpless ta' avju mijobatterjum: clarithromycin, rifabutin, rifampicin.
English: - Ginkgo biloba extracts (a herbal preparation)
Maltese: - Estratti ta' Ginkgo biloba (preparazzjoni erbali)
English: Ethinyloestradiol + norgestimate / efavirenz (0.035 mg + 0.25 mg once daily/600 mg once daily)
Maltese: Ethinyloestradiol+Norgestimate/E favirenz (0.035 mg + 0.25 mg darba kuljum/600 mg darba kuljum)
English: Study number/ Treatment regimensb n % (95% C.I.c) % (95% C.I.c) cells/mm3
Maltese: Numru talistudju/ Tipi ta' Kurab n % (95% C.I.c) % (95% C.
English: AUC: ↔*/** (↓ 10 to ↑ 26) Cmax: ↔*/** (↓ 5 to ↑ 26) Cmin: ↑ 12%*/** (↓ 16 to ↑ 49)
Maltese: AUC: ↔*/** (↓ 10 sa ↑ 26) Cmax: ↔*/** (↓ 5 sa ↑ 26) Cmin: ↑ 12%*/** (↓ 16 sa ↑ 49)
English: In HIV infected patients at steady-state, mean Cmax, mean Cmin, and mean AUC were linear with 200 mg, 400 mg, and 600 mg daily doses.
Maltese: F'pazjenti nfettati bl-HIV fi stat fiss, Cmax medju, Cmin medju, and AUC medju kienu lineari b'dożi ta' kuljum ta' 200 mg, 400 mg u 600 mg.
English: The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
Maltese: L-inċidenza ta' eritema multiforme jew is sindrome ta' Stevens-Johnson kienet madwar 0.1 %.
English: (CYP3A4 induction) Efavirenz:
Maltese: (induzzjoni ta' CYP3A4) Efavirenz:
English: AUC: ↓ 7% (↓ 23 to ↑ 13) * Cmax: ↑ 23% (↓ 1 to ↑ 53) *
Maltese: AUC: ↓ 7% (↓ 23 għal ↑ 13)* Cmax: ↑ 23% (↓ 1 għal ↑ 53)*
English: Efavirenz Teva, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Maltese: Efavirenz Teva, li fih is-sustanza attiva efavirenz, jagħmel parti minn klassi ta' mediċini antiretrovirali li jissejħu inibituri non-nukleosidi ta' reverse transcriptase (NNTRIs).
English: Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Maltese: Kienu osservati wkoll sostituzzjonjiet fil-pożizzjonijiet RT 98, 100, 101, 108, 138, 188, 190 jew 225, imma fil-frekwenzi iktar baxxi u ħafna drabi biss flimkien ma' K103N.
English: < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); or very rare (< 1/10,000).
Maltese: Il-frekwenza hija definita permezz tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); jew rari ħafna (< 1/10,000).
English: - The other ingredients are cellulose microcrystalline, hydroxypropylcellulose, sodium laurilsulfate, sodium starch glycolate (Type A), poloxamer 407 and magnesium stearate in the core.
Maltese: - Is-sustanzi l-oħra huma cellulose microcrystalline, hydroxpypropylcellulose, sodium laurilsulfate, sodium starch glycolate (Tip A), poloxamer 407 u magnesium stearate fil-qalba.
English: (500/125 mg twice daily/ 600 mg once daily)
Maltese: (500/125 mg darbtejn kuljum/ 600 mg darba kuljum)
English: For a summary of clinical and pharmacodynamic information, see section 5.1.
Maltese: Għal taqsira tal-informazzjoni klinika u farmakodinamika, ara sezzjoni 5
English: Cmin: ↓ 12% (↓ 24% to ↑ 1%)
Maltese: Cmin: ↓ 12% (↓ 24 għal ↑ 1)
English: Amylase: In the clinical trial subset of 1,008 patients, asymptomatic increases in serum amylase levels greater than 1.5 times the upper limit of normal were seen in 10% of patients treated with efavirenz and 6% of patients treated with control regimens.
Maltese: Amylase: fis-sottogrupp ta' 1,008 pazjenti fil-prova klinika, ġew osservati żidiet asintomatiċi fil-livelli ta' serum amylase iktar minn 1.5 darbiet il-livell ta' fuq tan-normal f'10% tal-pazjenti kkurati b'efavirenz u f'6% tal-pazjenti f'kuri ta' kontroll.
English: ANTICOAGULANTS Warfarin/efavirenz Acenocoumarol/efavirenz
Maltese: Warfarin/Efavirenz Acenocoumarol/efavirenz
English: The AUC and Cmax of a single 600 mg dose of efavirenz film-coated tablets in uninfected volunteers was increased by 28% (90% CI: 22-33%) and 79% (90% CI: 58-102%), respectively, when given with a high-fat meal, relative to when given under fasted conditions (see section 4.4).
Maltese: AUC u Cmax ta' doża waħda ta' 600 mg ta' pilloli miksija b'rita ta' efavirenz f'voluntiera mhux infettati żdiedu bi 28% (90% CI: 22 - 33%) u 79% (90% CI:58 - 102%), rispettivament, meta ngħataw ikla b'ħafna xaħam meta mqabble ma' meta kienu f'kondizzjonijiet ta' sawm (ara sezzjoni
English: Each film-coated tablet contains 9.98 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 9.98 mg lactose (b lactmonohydrate).
English: AUC: ↓ 43% (↓ 7 to ↓ 65) Cmax: ↔
Maltese: AUC: ↓ 43% (↓ 7 sa ↓ 65) Cmax: ↔
English: Close monitoring of immunosuppressant
Maltese: IMMUNOSUPPRESSANTI
English: EU/1/11/742/001 (30 x 1 - blister PVC/PVDC/alu) EU/1/11/742/006 (30 x 1 - blister alu/alu)
Maltese: EU/1/11/742/001 (30 x 1 - folja PVC/PVDC/alu) EU/1/11/742/006 (30 x 1 - folja alu/alu)
English: The in vitro studies suggest that CYP3A4 and CYP2B6 are the major isozymes responsible for efavirenz metabolism and that it inhibited P450 isozymes 2C9, 2C19, and 3A4.
Maltese: Studji in vitro jissuġġerixxu li CYP3A4 u CYP2B6 huma l-iżozimi li l-iktar huma responsabbli għallmetaboliżmu ta' efavirenz u li hu impedixxa iżozimi P450 2C9, 2C19, and 3A4.
English: Peak efavirenz plasma concentrations of 1.6-9.1 microM were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers.
Maltese: L-ogħla konċentrazzjonijiet ta' efavirenz fil-plażma ta' 1.6 - 9.1 mikroM intlaħqu 5 sigħat wara dożi orali waħedhom ta' 100 mg sa 1,600 mg mogħti lil voluntiera mhux infettati.
English: AUC: ↓ 31% (↓ 8 to ↓47) Cmin: ↓ 40%
Maltese: AUC : ↓ 31% (↓ 8 għal ↓ 47) Cmin : ↓ 40%
English: - Medicines used to treat convulsions/seizures (anticonvulsants): carbamazepine, phenytoin,
Maltese: - Mediċini użati biex jikkuraw konvulżjonijiet/attakki (antikonvulżjonijiet): carbamazepine,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK CONTAINING OF <30><30x1><90><90 x 1> EFAVIRENZ TEVA 600 mg FILM-COATED TABLETS
Maltese: B'FOLJI LI FIHOM <30><30x1><90><90 x 1> EFAVIRENZ TEVA 600 mg PILLOLA MIKSIJA B'RITA
English: AUC: ↔ Cmax: ↑ 11% (↑ 3 to ↑19)
Maltese: AUC: ↔ Cmax: ↑ 11% (↑ 3 għal ↑ 19)
English: c S.E.M., standard error of the mean.
Maltese: c S.E.M., żball standardizzat mill-medja.
English: (PLIVA Croatia Ltd.)
Maltese: PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
English: Other macrolide antibiotics (e.g. erythromycin)/efavirenz
Maltese: Antibijotiċi makrolidi oħrajn (e.ż.,erythromycin)/Efavirenz
English: Methadone/efavirenz (stable maintenance, 35-100 mg once daily/600 mg once daily)
Maltese: Methadone/Efavirenz (manteniment stabbli, 35-100 mg darba kuljum/600 mg darba kuljum)
English: This medicine contains 9.98 mg lactose (as monohydrate) per tablet.
Maltese: Din il-mediċina fiha 9.98 mg lactose (bħala monohydrate) f'kull pillola.
English: AUC: ↔* (↓ 9 to ↑ 10) Cmax: ↑ 17%* (↑ 8 to ↑ 27) Cmin: ↓ 42%* (↓ 31 to ↓ 51)
Maltese: ↔* (↓ 9 sa ↑ 10) Cmax: ↑ 17%* (↑ 8 sa ↑ 27) Cmin: ↓ 42%* (↓ 31 sa ↓ 51)
English: Implant: Etonogestrel/efavirenz Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
Maltese: Etonogestrel/Efavirenz Tista' tkun mistennija espożizzjoni mnaqqsa ta' etonogestrel (induzzjoni ta' CYP3A4).
English: QTc prolongation has been observed with the use of efavirenz (see sections 4.5 and 5.1).
Maltese: Bl-użu ta' efavirenz, ġie osservat titwil tal-QTc (ara s-sezzjonijiet 4.5 u 5.1).
English: In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/or NRTIs in controlled clinical studies, the most frequently reported adverse reactions of at least moderate severity reported in at least 5% of patients were rash (11.6%), dizziness (8.5%), nausea (8.0%), headache (5.7%) and fatigue (5.5%).
Maltese: Fi grupp ta' 1,008 minn dawn li ngħataw 600 mg ta' efavirenz kuljum flimkien ma' PIs u/jew NRTIs fi studji kliniċi kkontrollati, l-iktar reazzjonijiet avversi ta' severita` moderata jew agħar f'minimu ta' 5 % li kienu rrapurtati kienu raxx (11.6 %), sturdament (8.5 %), dardir (8.0 %), uġigħ ta' ras (5.7 %) u għeja (5.5 %).
English: Do not take Efavirenz Teva).
Maltese: Efavirenz Teva”):
English: Interactions between efavirenz and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, and once every 8 or 12 hours as “q8h” or “q12h”).
Maltese: L-interazzjonijiet bejn efavirenz u l-inibituri protease, sustanzi antiretrovirali li mhumiex inibituri protease u prodotti mediċinali oħra li mhumiex anti-retrovirali huma elenkati f'Tabella 1 hawn isfel (żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, ebda bidla bħala “↔”, u darba kull 8 jew 12-il siegħa bħala “q8h” jew “q12h”).
English: Delusion ‡, neurosis ‡, completed suicide‡,* Nervous system disorders Common Cerebellar co-ordination and balance disturbances†, disturbance in attention (3.6%), dizziness (8.5%), headache (5.7%), somnolence (2.0%)* Uncommon Agitation, amnesia, ataxia, co-ordination abnormal, convulsions, thinking abnormal*, tremor†
Maltese: sturdament (8.5 %), uġigħ ta' ras (5.7 %), ngħas (2.0 %)* mhux komuni aġitazzjoni, amneżija, ataksja, ko-ordinament anormali, konvulżjonijiet, ħsieb anormali*, tregħid†
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Cmax: ↓ 17% (↓ 6 to ↓ 26) b Cmin: ↓ 50% (↓ 40 to ↓ 59)
Maltese: Cmax: ↓ 17% (↓ 6 għal ↓ 26)b Cmin: ↓ 50% (↓ 40 għal ↓ 59)
English: Depomedroxyprogesterone acetate (DMPA)/efavirenz (150 mg IM single dose DMPA)
Maltese: Depomedroxyprogesterone acetate (DMPA)/Efavirenz
English: (CYP3A induction by efavirenz)
Maltese: (induzzjoni tas-CYP3A b'efavirenz)
English: AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46)
Maltese: AUC: ↑ 21% (↑ 10 għal ↑ 34) Cmax: ↑ 14% (↑ 4 għal ↑ 26) Cmin: ↑ 25% (↑ 7 għal ↑ 46)b
English: Multipack: 90 (3 packs of 30 x 1) film-coated tablets
Maltese: TA' 90 (3 PAKKETTI TA' 30 x 1 PILLOLA
English: Symptoms including, but not limited to dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported adverse reactions in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).
Maltese: Sintomi li jinkludu, imma mhux limitati għal, sturdament, nuqqas ta' rqad, ngħas, diffikultà ta' konċentrazzjoni u ħolm mhux normali huma reazzjonijiet avversi irrapportati b'mod frekwenti f'pazjenti li kienu qed jieħdu 600 mg ta' efavirenz kuljum fi studji kliniċi (ara sezzjoni 4.8).
English: Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV+IDV, 196 patients with EFV+ZDV+3TC and 127 patients with IDV+ZDV+3TC, respectively), suggest durability of response in terms of proportions of patients with HIV-RNA < 400 copies/ml, HIV-RNA < 50 copies/ml and in terms of mean change from baseline CD4 cell count.
Maltese: Riżultati fit-tul mal-168 ġimgħa tal-istudju 006 (160 pazjent spiċċaw l-istudju bil-kura b'EFV +IDV, 196 pazjent b'EFV + ZDV + 3TC u 127 pazjent b'IDV + ZDV + 3TC, rispettivament), jissuġġerixxu li r-rispons ma jisfaxxax fix-xejn, fis-sens tal-proporzjoni ta' pazenti b'HIV RNA < 400 kopji/ml, HIV RNA < 50 kopji/ml u fis-sens tal-bidla medja mil-linja bażi CD4 tal-għadd taċ-ċelluli.
English: Reproductive system and breast disorders Uncommon Gynaecomastia
Maltese: Disturbi fis-sistema riproduttiva u fis-sider mhux komuni ginekomastja
English: 30 film-coated tablets 30 x 1 film-coated-tablets 90 x 1 film-coated tablets 90 film-coated tablets
Maltese: 30 pillola miksija b'rita 30 x 1 pilloli miksija b'rita 90 x 1 pilloli miksija b'rita 90 pillola miksija b'rita
English: AUC: ↓ 83% (↓ 79 to ↓ 87) Cmax: ↓ 80% (↓ 77 to ↓ 83) Cmin: ↓ 86% (↓ 80 to ↓ 90)
Maltese: AUC: ↓ 83% (↓ 79 għal ↓ 87) Cmax: ↓ 80% (↓ 77 għal ↓ 83) Cmin: ↓ 86% (↓ 80 għal ↓ 90)
English: Table 4: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients
Maltese: Tabella 4: Farmakokinetika mbassra fi stat fiss ta' efavirenz (kapsuli/traxxix tal-kapsuli)
English: Co-administration with elbasvir (EBR) and grazoprevir (GZR) due to the potential for significant decreases in plasma concentrations of EBR and GZR (see section 4.5).
Maltese: L-għoti flimkien ma' elbasvir (EBR) u grazoprevir (GZR) minħabba l-potenzjal għal tnaqqis sinifikanti fil-konċentrazzjonijiet ta' EBR u GZR fil-plażma (ara sezzjoni 4.5).
English: Dose
Maltese: PROVVISTA
English: - certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones,
Maltese: - Antibijotiċi, inkluż it-tipi li ġejjin: makrolidi, fluoroquinolones jew imidazole.
English: The mean Cmax of efavirenz in subjects with CYP2B6 *6/*6 genotype following the administration of 600 mg daily dose for 14 days was 2.25-fold the mean Cmax observed in subjects with CYP2B6 *1/*1 genotype.
Maltese: Is-Cmax medja ta' efavirenz f'individwi b'ġenotip CYP2B6 *6/*6 wara l-għoti ta' doża ta' kuljum ta' 600 mg għal 14-il ġurnata kienet 2.25 drabi ogħla mis-Cmax medja osservata f'individwi b'ġenotip CYP2B6 *1/*1.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Maltese: Lactose Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes) such as: antiarrhythmics of classes IA and III, neuroleptics and antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride, flecainide, certain antimalarials and methadone (see section 4.3).
Maltese: Efavirenz huwa kontraindikat mal-użu konkomitanti ta' mediċini (dawn jistgħu jikkawżaw intervall tal-QTc imtawwal u Torsade de Pointes) bħal: antiarritmiċi ta' klassijiet IA u IIA, newrolettiċi u aġenti antidepressanti, ċerti antibijotiċi li jinkludu xi aġentii tal-klassijiet li ġejjin: makrolidi, fluoroquinolones, imidazole, u aġenti antifungali triazole, ċerti antistamini mhux sedattivi (terfenadine, astemizole), cisapride, flecainide, ċerti mediċini kontra l-malarja u methadone (ara sezzjoni 4.3).
English: (CYP3A4 and CYP2B6 induction)
Maltese: (induzzjoni ta' CYP3A4 u ta' CYP2B6)
English: Approximately 14-34% of a radiolabelled dose of efavirenz was recovered in the urine and less than 1% of the dose was excreted in urine as unchanged efavirenz.
Maltese: Bejn wieħed u ieħor 14 - 34 % tad-doża radjutikkettata ta' efavirenz instabet fl-urina u inqas minn 1 % tad-doża tneħħiet fl-urina bħala efavirenz mhux mibdul.
English: Telaprevir/efavirenz (1,125 mg q8h/600 mg once daily)
Maltese: Telaprevir/efavirenz (1,125 mg q8h/600 mg darba kuljum)
English: Using an ITT analysis, the overall proportions of patients with HIV RNA <400 copies/mL and <50 copies/mL at Week 48 were 77% (33/43) and 70% (30/43), respectively.
Maltese: ITT, il-proporzjonijiet ġenerali ta' pazjenti b'<400 kopja/mL u <50 kopja/mL tal-RNA tal-HIV fil-Ġimgħa 48 kienu 77% (33/43) u 70% (30/43),
English: Clarithromycin/efavirenz (500 mg q12h/400 mg once daily)
Maltese: Clarithromycin/Efavirenz (500 mg q12h/400 mg darba kuljum)
English: The free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Maltese: Il-konċentrazzjoni ħielsa ta' efavirenz li kien hemm bżonn għall-inibizzjoni ta' bejn id-90 u l-95% ta' iżolati wild type jew iżolati tal-laboratorju reżistenti għal zidovudine u iżolati kliniċi in vitro kienet minn 0.46 sa 6.8 nM f'razez ta' ċelluli limfoblastojdi, ċelluli periferali mononukleari tad-demm (PBMCs) u kolturi makrofaġi monoċistiċi.
English: AUC: ↓ 25% (↓ 16 to ↓32)
Maltese: AUC: ↓ 25% (↓ 16 għal ↓ 32)
English: - if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
Maltese: - jekk għandek disturb fil-qalb, bħal sinjal elettriku anormali li jissejjaħ titwil tal intervall QT.
English: Itraconazole/efavirenz (200 mg q12h/600 mg once daily)
Maltese: Itraconazole/Efavirenz (200 mg q12h/600 mg darba kuljum)
English: (400/100 mg twice daily/ 600 mg once daily)
Maltese: (400/100 mg darbtejn kuljum/ 600 mg darba kuljum)
English: - Each Efavirenz Teva film-coated tablet contains 600 mg of the active substance efavirenz.
Maltese: - Kull pillola miksija b'rita Efavirenz Teva fiha 600 mg tas-sustanza attiva efavirenz.
English: Table 2: Efficacy results for study 006 Treatment regimen d n
Maltese: Tabella 2: Riżultati tal-effikaċja għall-istudju 006
English: Plasma levels of efavirenz can be reduced by concomitant use of St. John's wort due to induction of drug-metabolising enzymes and/or transport proteins by St. John's wort.
Maltese: John's wort minħabba l-induzzjoni ta' enzimi li jimmetabolizzaw il-mediċini u/jew jittrasportaw il-proteini permezz ta' St.
English: Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction).
Maltese: Espożizzjoni mnaqqsa tal-immunosuppressant (CYP3A4 induction).
English: Tel: +353 19630330
Maltese: L-Irlanda Tel: +353 19630330
English: Concomitant administration of velpatasvir/sofosbuvir/voxilaprevir with efavirenz is not recommended (see section 4.5).
Maltese: L-għoti konkomitanti ta' velpatasvir/sofosbuvir/voxilaprevir ma' efavirenz mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches) Midazolam or triazolam (used to help you sleep)
Maltese: ergot alkaloids (eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) (użati biex jikkuraw l-emikranji u uġigħ ta' ras regolari)