FrancophonIA/ELRC3.0 huggingface dataset:
English: In in vitro studies efavirenz did not inhibit CYP2E1 and inhibited CYP2D6 and CYP1A2 only at concentrations well above those achieved clinically.
Maltese: Fi studji in vitro efavirenz ma impedixxiex CUP2E1 u impedixxa CYP2D6 u CYP1A2 biss f'konċentrazzjonijiet ogħla sew minn dawk li setgħu jintlaħqu klinikament.
English: Cmin: ↓ 12% (↓ 24 to ↑ 1) (CYP3A4 induction)
Maltese: Cmax: ↑ 11% (↑ 6 għal ↑ Cmin: ↔ (induzzjoni ta' CYP3A4)
English: Dose
Maltese: ISEM
English: Osteonecrosis
Maltese: Antibijotiċi
English: Serious psychiatric adverse reactions have been reported in patients treated with efavirenz.
Maltese: Ġew irrapportati reazzjonijiet psikjatriċi avversi serji f'pazjenti kkurati b'efavirenz.
English: 3, or after failure of protease inhibitor (PI) containing regimens.
Maltese: 3, jew wara li jkunu fallew kuri li jkun fihom l-impeditur ta' protease (PI).
English: Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.4).
Maltese: L-użu konkomitanti ta' estratti ta' Ginkgo biloba mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Cmax: ↓ 62% (↓ 55 to ↓ 78)
Maltese: Cmax: ↓ 62% (↓ 55 għal
English: When using efavirenz with lowdose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Maltese: Meta efavirenz jintuża ma' ritonavir, wieħed għandu jikkunsidra l-possibilità ta' żieda fl-inċidenza ta' episodji avversi assoċjati ma' efavirenz, minħabba interazzjoni farmakodinamika possibbli.
English: Cmax: ↓ 45% (↓ 25 to ↓ 59)
Maltese: Cmax: ↓ 45% (↓ 25 għal
English: Convulsions have been observed in adult and paediatric patients receiving efavirenz, generally in the presence of known medical history of seizures.
Maltese: Ġew osservati konvulżjonijiet f'pazjenti adulti u pedjatriċi li kienu qed jieħdu efavirenz, ġeneralment meta diġà kien hemm storja medika ta' aċċessjonijiet.
English: Cmax: ↓ 51% (↓ 32 to ↓ 58)
Maltese: Cmax: ↓ 51% (↓ 32 għal
English: 10 Mix the capsule contents and food together (illustration e).
Maltese: Ħawwad il-kontenut tal-kapsula u l-ikel flimkien (illustrazzjoni e).
English: Concomitant administration with efavirenz should be avoided due to the risk for QTc prolongation (see section 4.3).
Maltese: L-użu konkomitanti ma' efavirenz għandu jiġi evitat minħabba rriskju għal titwil tal-QTc (ara sezzjoni 4.3).
English: If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the efavirenz dose must be reduced by 50%, i.e., to 300 mg once daily.
Maltese: Jekk efavirenz jingħata flimkien ma' voriconazole, id-doża ta' manteniment ta' voriconazole għandha tiżidied għal 400 mg kull 12-il siegħa u d-doża ta' efavirenz għandha titnaqqas b'50 %, i.e., għal 300 mg darba kuljum.
English: Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.5).
Maltese: L-użu konkomitanti ta' estratti ta' Ginkgo biloba mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Theoretically, efavirenz may therefore initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index (see section 4.3).
Maltese: Għalhekk, teoretikament, efavirenz jista' inizjalment jżid l-espożizzjoni għas-sottostrati ta' CYP3A4 u hija meħtieġa kawtela għassottostrati ta' CYP3A4 b'indiċi terapewtiku dejjaq (ara sezzjoni 4.3).
English: Carbamazepine: AUC: ↓ 27% (↓ 20 to ↓ 33)
Maltese: AUC: ↓ 27% (↓ 20 għal ↓
English: Each carton contains 1 bottle of 30 hard capsules.
Maltese: Kull kartuna fiha flixkun wieħed ta' 30 kapsula iebsa.
English: No clinically significant pharmacokinetic change.
Maltese: Ebda bidla farmakokinetika klinikament sinifikanti.
English: If efavirenz is coadministered with rifampicin to patients weighing 50 kg or more, an increase in the dose of efavirenz to 800 mg/day may be considered (see section 4.5).
Maltese: Jekk efavirenz jingħata flimkien ma' rifampicin lill-pazjenti li jiżnu 50 kg jew aktar, żieda fid-doża ta' efavirenz għal 800 mg/kuljum tista' tiġi kkunsidrata (ara sezzjoni 4.5).
English: In uninfected volunteers, multiple doses of 200 - 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 - 42% lower) and a shorter terminal half-life compared with single dose administration (see below).
Maltese: F'voluntiera mhux infettati, dożi multipli ta' 200400 mg kuljum għal 10 ijiem irriżulta f'akkumulu li kien iktar baxx minn dak imbassar (22 - 42 % iktar baxx) u half-life terminali iqsar meta mqabbel ma' l-għoti ta' doża waħda (ara taħt).
English: Treatment Regimend n
Maltese: Tul tal-Kurad N
English: Cmax: ↓ 20% (↓ 15 to ↓ 24)
Maltese: Cmax: ↓ 20% (↓ 15 għal ↓
English: Study ACTG 364 enrolled 196 patients who had been treated with NRTIs but not with PIs or NNRTIs.
Maltese: Studju ACTG 364 kellu 196 pazjent li kienu ġew ikkurati b'NRTIs imma mhux b'PIs jew NNRTIs.
English: Table 2: Interactions between efavirenz and other medicinal products in adults
Maltese: Tabella 2: Interazzjonijiet fl-adulti bejn efavirenz u prodotti mediċinali oħra Prodott mediċinali skond l-oqsma terapewtiċi (doża)
English: See also ritonavir row below.
Maltese: Ara wkoll irringiela dwar ritonavir hawn isfel.
English: Concomitant administration of efavirenz with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir.
Maltese: L-għoti konkomitanti ta' efavirenz ma' elbasvir/grazoprevir huwa kontraindikat għax jista' jwassal għal telf tar-rispons viroloġiku għal elbasvir/grazoprevir.
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: 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: Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin.
Maltese: Mediċini użati biex ibaxxu l-ammont ta' xaħam fid-demm (magħrufin ukoll bħala statini): atorvastatin, pravastatin, simvastatin.
English: When taken with rifampicin in patients weighing 50 kg or greater, increasing efavirenz daily dose to 800 mg may provide exposure similar to a daily dose of 600 mg when taken without rifampicin.
Maltese: Meta jittieħed ma' rifampicin f'pazjenti li jiżnu 50 kg jew aktar, iż-żieda fid-doża ta' kuljum ta' efavirenz għal 800 mg tista' tipprovdi esponiment simili għal doża ta' 600 mg, meta jittieħed mingħajr rifampicin.
English: (CYP3A4 induction) In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal.
Maltese: Fi studju fuq utenti infettati bl-HIV li kienu jieħdu d-droga mill-vina, l-għoti flimkien ta' efavirenz u l-methadone rriżulta f'livelli aktar baxxi ta' methadone filplażma u sinjali ta' opiate withdrawal.
English: Protease inhibitors (PI) Atazanavir/ ritonavir/Efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
Maltese: ANTI-INFETTIVI Antivirali tal-HIV Inibituri protease (PI) Atazanavir/ritonavir/Efavirenz (400 mg darba kuljum/100 mg darba kuljum/600 mg darba kuljum, kollha mogħtija mal-ikel)
English: This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection.
Maltese: Dan se jsaħħaħlek issistema immuni u jnaqqas ir-riskju li tiżviluppa mard assoċjat mal-infezzjoni tal-HIV.
English: Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc.
Maltese: Irreferi għas-Sommarju talKaratteristiċi tal-Prodott għallprodott mediċinali li fih maraviroc.
English: AUC: ↓71% (↓67 to ↓74) Cmax: ↓51% (↓46 to ↓56) Cmin: ↓91% (↓88 to ↓92) Efavirenz:
Maltese: AUC: ↓ 75% (↓ 59 għal ↓ Cmax: ↓ 64% (↓ 57 għal ↓ Cmin: ↓ 62% (↓ 44 għal ↓ N-monodesmethyl diltiazem:
English: Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine), since inhibition of their metabolism may lead to serious, lifethreatening events (see section 4.3).
Maltese: Efavirenz m'għandux jingħata flimkien ma' terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, jew ergot alkaloids (ngħidu aħna, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) billi l-inibizzjoni tal-metaboliżmu tagħhom tista' twassal għal avvenimenti serji u ta' riskju għall-ħajja (ara sezzjoni 4.3).
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-doża ta' pilloli ta' lopinavir/ritonavir għandu jiżdied għal 500/125 mg darbtejn kuljum meta mogħti flimkien ma' efavirenz 600 mg kuljum.
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 effettiva ġiet ippruvata li tnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: If you could get pregnant while receiving SUSTIVA, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection).
Maltese: Jekk tista' tinqabad tqila waqt li tkun qed tieħu SUSTIVA, inti trid tuża forma affidabbli ta' kontraċezzjoni barriera (per eżempju, kondom) ma' metodi oħra ta' kontraċezzjoni fosthom kontraċettivi orali (pillola) jew kontraċettivi oħra ormonali, (per eżempju impjanti, injezzjoni).
English: Capsule shell: Gelatine, Sodium laurilsulfate, Yellow iron oxide (E172), Silicon dioxide (E551)
Maltese: Il-qoxra tal-kapsula: Ġelatina, Sodium laurilsulfate, Iron oxide isfar (E172), Silicon dioxide (E551)
English: The dose of nelfinavir was 750 mg given three times a day.
Maltese: Id-doża ta' nelfinavir kienet ta' 750 mg tliet darbiet kuljum.
English: AUC: ↓ 37% (↓ 14 to ↓ 55)
Maltese: AUC: ↓ 71% (↓ 67 sa ↓
English: Common (affects 1 to 10 users in 100) abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness, problems with coordination or balance stomach pain, diarrhoea, feeling sick (nausea), vomiting itching tiredness feeling anxious, feeling depressed
Maltese: Komuni (jaffettwaw utent wieħed sa 10 minn kull 100) ħolm mhux normali, diffikultà fil-konċentrazzjoni, sturdament, uġigħ ta' ras, diffikultà fl-irqad, ħedla, problemi bil-koordinazzjoni jew bil-bilanċ uġigħ ta' stonku, dijarea, tħossok ma tiflaħx (nawsja), rimettar ħakk għeja tħossok anzjuż/a, tħossok imdejjaq/imdejqa
English: The most notable adverse reactions associated with efavirenz are rash and nervous system symptoms.
Maltese: Ir-reazzjonijiet avversi marbuta ma' efavirenz li kienu l-iktar prominenti kienu raxx u sintomi tas-sistema nervuża.
English: Malformations have been observed in foetuses from efavirenz-treated monkeys (see section 5.3).
Maltese: Malformazzjonijiet dehru f'feti ta' xadini ikkurati b'efavirenz (ara sezzjoni 5.3).
English: Methadone: AUC: ↓ 52% (↓ 33 to ↓ 66)
Maltese: AUC: ↓ 52% (↓ 33 għal ↓
English: What SUSTIVA looks like and contents of the pack SUSTIVA 50 mg hard capsules are supplied in bottles of 30 capsules.
Maltese: Id-Dehra tal-prodott u d-daqs tal-pakkett Il-kapsuli ibsin SUSTIVA tal-50 mg jiġu fi fliexken ta' 30 kapsula.
English: Cmax: ↓ 26% (↓ 15 to ↓ 35)
Maltese: Cmax: ↓ 26% (↓ 15 għal ↓
English: Indinavir: AUC: ↓ 25% (↓ 16 to ↓ 32)
Maltese: AUC: ↓ 25% (↓ 16 għal ↓ 32) b
English: CD4+ percentage was 13%.
Maltese: 3, u l-medjan talperċentwali ta' CD4+ kien 18%.
English: SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg. SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm
Maltese: SUSTIVA huwa indikat għall-kura kombinata antiretrovirali tal-adulti, l-adoloxxenti u t-tfal ta' tliet xhur jew ikbar u li jiżnu tal-inqas 3.5 kg li huma nfettati bil-virus tal-immunodefiċjenza umana-1 (HIV-1).
English: Fosamprenavir/ritonavir/Efavirenz (700 mg twice daily/100 mg twice daily/600 mg once daily)
Maltese: Fosamprenavir/Ritonavir/Efavirenz (700 mg darbtejn kuljum/100 mg darbtejn kuljum/600 mg darba kuljum)
English: Merck Sharp & Dohme d.o.o.
Maltese: Merck Sharp & Dohme OÜ Tel.:
English: Vascular disorders uncommon flushing†
Maltese: Disturbi vaskulari mhux komuni fwawar
English: - a history of symptomatic cardiac arrythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
Maltese: - storja ta' arritmiji kardijaċi sintomatiċi jew bi bradikardija klinikament relevanti jew b'insuffiċjenza kardijaka konġestiva akkumpanjata minn frazzjoni mnaqqsa tal-ħruġ tal-ventriklu tax-xellug.
English: Non-sustained convulsions were observed in some monkeys receiving efavirenz for ≥ 1 year, at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose (see sections 4.4 and 4.8).
Maltese: Kienu osservati konvulżjonijiet mhux sostnuti f'xi xadini li kienu qed jingħataw efavirenz għal ≥ sena, b'dożi li kienu jwasslu għal valuri ta' AUC fil-plażma bejn 4 u 13-il darba ikbar minn dawk fil-bnedmin li ngħataw id-doża rakkomandata (ara sezzjonijiet 4.4 u 4.8).
English: Refer to the prescribing information for glecaprevir/pibrentasvir for more information.
Maltese: Irreferi għall-informazzjoni dwar il-preskrizzjoni ta' glecaprevir/pibrentasvir għal aktar informazzjoni.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV li kellhom defiċjenza immunitarja qawwija meta bdew jieħdu t-terapija antiretrovirali kombinata (CART), jista' jkun hemm reazzjoni infjammatorja għal reazzjonijiet asintomatiċi jew residwali opportunistiċi.
English: Cmax: ↓ 21% (↓ 15 to ↓ 26)
Maltese: Cmax: ↓ 21% (↓ 15 għal ↓
English: Capsule shell: Gelatine, Sodium laurilsulfate, Yellow iron oxide (E172), Titanium dioxide (E171), Silicon dioxide (E551)
Maltese: Il-qoxra tal-kapsula: Ġelatina, Sodium laurilsulfate, Iron oxide isfar (E172), Titanium dioxide (E171), Silicon dioxide (E551)
English: Concomitant administration of sofosbuvir/velpatasvir with efavirenz resulted in a reduction (approximately 50%) in the systemic exposure of velpatasvir.
Maltese: L-għoti konkomitanti ta' sofosbuvir/velpatasvir ma' efavirenz irriżulta fi tnaqqis (ta' madwar 50%) fl-esponiment sistemiku ta' velpatasvir.
English: Rifampicin/Efavirenz (600 mg once daily/600 mg once daily)
Maltese: Rifampicin/Efavirenz (600 mg darba kuljum/600 mg darba kuljum)
English: The increased efavirenz concentrations observed following administration of efavirenz with food may lead to an increase in frequency of adverse reactions (see sections 4.4. and 5.2).
Maltese: Il-konċentrazzjonijiet miżjudin ta' efavirenz osservati matul għoti ta' efavirenz mal-ikel wasslu għal żieda fil-frekwenza ta' reazzjonijiet avversi (ara sezzjonijiet 4.4 u 5.2).
English: Ear and labyrinth disorders uncommon tinnitus†, vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika mhux komuni tinnitus ‡, vertigo
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: Cmin: ↓ 82% (↓ 79 to ↓ 85) Levonorgestrel (active metabolite): AUC: ↓ 83% (↓ 79 to ↓ 87)
Maltese: AUC: ↓ 64 % (↓ 62 għal Cmax: ↓ 46 % (↓ 39 għal Cmin: ↓ 82 % (↓ 79 għal Levonorgestrel (metabolit attiv):
English: Study PACTG 382 was an open-label study to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of SUSTIVA 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' SUSTIVA 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'SUSTIVA.
English: Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/mm3, or in PI or NNRTI experienced patients.
Maltese: Efavirenz ma ġiex studjat fi studji kkontrollati f'pazjenti b'mard avvanzat tal-HIV, speċifikament b'għadd ta' CD4 < 50 ċelluli/ mm3, jew f'pazjenti li kienu ħadu PI jew NNRTI.
English: Cmin: ↓42%* (↓31 to ↓51)
Maltese: Cmin: ↓ 45% (↓ 31 għal ↓
English: SUSTIVA is for oral use.
Maltese: SUSTIVA huwa għal użu orali.
English: one 200 mg capsule + one 50 mg capsule
Maltese: kapsula waħda ta' 200 mg + kapsula waħda ta' 50 mg
English: Indinavir/ritonavir/Efavirenz (800 mg twice daily/100 mg twice daily/600 mg once daily)
Maltese: Indinavir/Ritonavir/Efavirenz (800 mg darbtejn kuljum/100 mg darbtejn kuljum/600 mg darba kuljum)
English: Cmin: ↓ 86% (↓ 80 to ↓ 90) (induction of metabolism) Efavirenz: no clinically significant interaction.
Maltese: AUC: ↓ 83 % (↓ 79 għal Cmax: ↓ 80 % (↓ 77 għal Cmin: ↓ 86 % (↓ 80 għal (induzzjoni tal metaboliżmu) Efavirenz: ebda interazzjoni klinika sinifikanti.
English: Your doctor has prescribed SUSTIVA for you because you have HIV infection.
Maltese: kwalunkwe sinjal ta' infjammazzjoni jew infezzjoni.
English: Valproic acid/Efavirenz (250 mg twice daily/600 mg once daily)
Maltese: Aċidu valprojku/Efavirenz (250 mg darbtejn kuljum/600 mg darba kuljum)
English: AUC: ↑ 11% (↑ 5 to ↑ 18)
Maltese: AUC: ↑ 17% (↑ 6 għal ↑
English: Voriconazole/Efavirenz (200 mg twice daily/400 mg once daily)
Maltese: Voriconazole/Efavirenz (200 mg darbtejn kuljum/400 mg darba kuljum)
English: White, printed with "SUSTIVA" on the body and "100 mg" on the cap. SUSTIVA 200 mg hard capsules
Maltese: SUSTIVA 100 mg kapsuli ibsin Bajda, b'”SUSTIVA” stampata fuqha u "100 mg” fuq il-kappa.
English: What SUSTIVA looks like and contents of the pack SUSTIVA 100 mg hard capsules are supplied in bottles of 30 capsules.
Maltese: Id-Dehra tal-prodott u d-daqs tal-pakkett Il-kapsuli ibsin SUSTIVA tal-100 mg jiġu fi fliexken ta' 30 kapsula.
English: The administration of efavirenz with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in the frequency of adverse reactions (see section 4.8).
Maltese: L-għoti ta' efavirenz ma' l-ikel jista' jkabbar l-esponiment għal efavirenz (ara sezzjoni 5.2) u jista' jwassal għal żieda fil-frekwenza tar-reazzjonijiet avversi (ara sezzjoni 4.8).
English: The capsule shell contains: gelatine, sodium laurilsulfate, titanium dioxide (E171) and silicon dioxide.
Maltese: Il-qoxra tal-kapsula fiha: gelatine, sodium laurilsulfate, titanium dioxide (E171) u silicon dioxide.
English: Mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Maltese: Ġie rrappurtat raxx minn ħafif sa moderat fi studju kliniċi b'efavirenz, u s-soltu jgħaddi mat-tkomplija tat-terapija.
English: b EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir.
Maltese: IDV, indinavir; NRTI, inibitur nukleosid reverse transcriptase;
English: Psychiatric disorders common abnormal dreams, anxiety, depression, insomnia*
Maltese: Disturbi psikjatriċi komuni ħolm anormali, ansjetà, dipressjoni, nuqqas ta' rqad*
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 episodji 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.
English: Morning Cmin: ↑ 42% (↑ 9 to ↑ 86) b Evening Cmin: ↑ 24% (↑ 3 to ↑ 50) b Efavirenz:
Maltese: AUC filgħaxija: ↔ Cmax filgħodu: ↑ 24% (↑ 12 għal ↑ 38) Cmax filgħaxija: ↔ Cmin filgħodu: ↑ 42% (↑ 9
English: Raltegravir/Efavirenz (400 mg single dose/ -)
Maltese: Inibitur ta' trasferiment ta' faxxa ta' integrase Raltegravir/Efavirenz (400 mg doża waħda/ - )
English: This proportion is approximately 3-fold higher than the nonprotein-bound (free) fraction of efavirenz in plasma.
Maltese: Dan il-proporzjon huwa bejn wieħed u ieħor 3 darbiet ogħla mill-frazzjoni mhux marbuta mal-proteina (ħielsa) ta' efavirenz fil-plażma.
English: In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
Maltese: Fi studju dwar interazzjoni bejn il-mediċini, il-konċentrazzjonijiet ta' carbamazepine fil-plażma tnaqqsu meta carbamazepine ingħata flimkien ma' efavirenz (ara sezzjoni 4.5).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION SUSTIVA 50 mg hard capsules
Maltese: U KWANTITATTIVA SUSTIVA 50 mg kapsuli ibsin
English: The median increase from baseline in CD4+ count at 48 weeks of therapy was 128 cells/mm3 and the median increase in CD4+ percentage was 5%.
Maltese: Iż-żieda medjana mil-linja bażi fl-għadd ta' CD4+ fil-Ġimgħa 48 ta' terapija kienet 128 ċelluli/mm3 u ż-żieda medjana fil-perċentwali ta' CD4+ kienet ta' 5%.
English: Eighty-seven percent of patients had received prior antiretroviral therapy.
Maltese: Sebgħa u tmenin fil-mija tal-pazjenti kienu rċevew terapija antiretrovirali qabel.
English: one 100 mg capsule
Maltese: tliet kapsuli ta' 100 mg
English: if you have a history of liver disease, including active chronic hepatitis.
Maltese: -jekk għandek storja medika ta' mard fil-fwied inkluż epatite kronika attiva.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains: efavirenz 50 mg.
Maltese: Kull kapsula iebsa fiha: efavirenz 50 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains: efavirenz 100 mg.
Maltese: Kull kapsula iebsa fiha: efavirenz 100 mg
English: Patients with a history of psychiatric disorders appear to be at greater risk of these serious psychiatric adverse reactions with frequencies ranging from 0.3% for manic reactions to 2.0% for both severe depression and suicidal ideation.
Maltese: Pazjenti bi storja medika ta' mard psikjatriku jidher li għandhom riskju ikbar għal dawn irreazzjonijiet psikjatriċi avversi serji bi frekwenzi ta' kull waħda minn dawn il-każijiet t'hawn fuq f'medda bejn 0.3 % għal reazzjonijiet manijaċi sa 2.0 % kemm għal dipressjoni severa kif ukoll għal ideat suwiċidali.
English: Ritonavir/Efavirenz (500 mg twice daily/600 mg once daily)
Maltese: Ritonavir/Efavirenz (500 mg darbtejn kuljum/600 mg darba kuljum)
English: The mean baseline CD4 cell count was 341 cells/mm3 and the mean baseline HIV-RNA level was 60,250 copies/ml.
Maltese: Il-medja tal-linja bażi CD4 tal-għadd taċ-ċelluli kienet ta' 341 ċelloli/mm3 u l-medja tal-linja bażi tal-livell HIV-RNA kienet ta' 60,250 kopji/ml.
English: Cmin: ↓ 25% (↓ 14 to ↓ 34)%
Maltese: Cmin: ↓ 44% (↓ 27 għal ↓
English: Bottle: EU/1/99/110/008
Maltese: EU/1/99/110/008