FrancophonIA/ELRC3.0 huggingface dataset:
English: AUC: ↓ 36% (↓ 32 to ↓ 40) Cmax: ↓ 21% (↓ 15 to ↓ 26) Cmin: ↓ 47% (↓ 41 to ↓ 53) (decrease in carbamazepine concentrations: CYP3A4 induction; decrease in efavirenz concentrations: CYP3A4 and CYP2B6 induction)
Maltese: ↓ 36% (↓ 32 għal ↓ 40) Cmax: ↓ 21% (↓ 15 għal ↓ 26) Cmin: ↓ 47% (↓ 41 għal ↓ 53) (tnaqqis fil-konċentrazzjonijiet ta'
English: Mean change from baseline-CD4 cell count Cells/mm3 (S.E.M.
Maltese: ċelluli/mm3 (S.E.M.
English: Simeprevir/efavirenz (150 mg once daily /600 mg once daily)
Maltese: Simeprevir/efavirenz (150 mg darba kuljum /600 mg darba kuljum)
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'numru ta' CD4 < 50 ċelluli/ mm3, jew f'pazjenti li kienu ħadu PI jew NNRTI.
English: Seizures
Maltese: Inibituri
English: ACID-REDUCING AGENTS Aluminium hydroxidemagnesium hydroxidesimethicone antacid/efavirenz (30 ml single dose/400 mg single dose)
Maltese: SUSTANZI LI JNAQQSU L-AĊIDU Aluminium hydroxidemagnesium hydroxidesimethicone antacid/Efavirenz
English: Refer to the prescribing information for elbasvir/grazoprevir for more information.
Maltese: elbasvir/grazoprevir għal aktar informazzjoni.
English: Study 006, a randomized, open-label trial, compared efavirenz + zidovudine + lamivudine or efavirenz + indinavir with indinavir + zidovudine + lamivudine in 1,266 patients who were required to be efavirenz-, lamivudine-, NNRTI-, and PI-naive at study entry.
Maltese: lamivudine jew efavirenz + indinavir ma' indinavir + zidovudine + lamivudine f'1,266 pazjent li ma setgħux kienu ħadu efavirenz, lamivudine, NNRTI, jew PI meta daħlu fl-istudju.
English: The pattern of amino acid substitutions in RT associated with resistance to efavirenz was independent of the other antiviral medicines used in combination with efavirenz.
Maltese: Il mudell ta' sostituzzjonijiet amino acid fl-RT li kienu assoċjati mar-reżistenza lil efavirenz kien indipendenti minn mediċini antivirali oħra li jintużaw flimkien ma' efavirenz.
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: 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, life-threatening events (see section 4.3).
Maltese: pimozide, bepridil, jew ergot alkaloids (ngħidu aħna, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) billi l-inibizzjoni tal-metaboliżmu tagħhom jista' jwassal għal avvenimenti serji u ta' riskju għall-ħajja (ara sezzjoni 4.3).
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: AUC: ↓ 39% (↓ 21 to ↓ 53) Cmax: ↓ 37% (↓ 20 to ↓ 51) Cmin: ↓ 44% (↓ 27 to ↓ 58)
Maltese: ↓ 39% (↓ 21 għal ↓ 53) Cmax: ↓ 37% (↓ 20 għal ↓ 51) Cmin: ↓ 44% (↓ 27 għal ↓ 58) (tnaqqis fil-konċentrazzjonijiet ta'
English: AUC: ↓ 52% (↓ 33 to ↓ 66) Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction)
Maltese: AUC: ↓ 52% (↓ 33 għal ↓ 66) Cmax: ↓ 45% (↓ 25 għal ↓ 59)
English: Package leaflet: information for the user Efavirenz Teva 600 mg film-coated tablets efavirenz
Maltese: Studju 006, prova randomized bil-mediċina meħuda magħrufa, qabbel efavirenz + zidovudine +
English: Efavirenz Teva 600 mg film-coated tablets
Maltese: Efavirenz Teva 600 mg pilloli miksija b'rita
English: Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Maltese: Għal pazjenti li qed jirċievu fl-istess ħin prodotti mediċinali antikonvulżivi li jiġu metabolizzati primarjament fil-fwied, bħal phenytoin, carbamazepine u phenobarbital, jista' jkun hemm bżonn li l-livelli tagħhom fil-plażma jkun monitorjat.
English: If you could get pregnant while receiving Efavirenz Teva, 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 Efavirenz Teva, 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: Recommendation concerning co-administration with efavirenz gabapentin are exclusively eliminated unchanged in the urine and are unlikely to compete for the same metabolic enzymes and elimination pathways as efavirenz.
Maltese: Mhumiex mistennija interazzjonijiet klinikament sinifikanti billi vigabatrin u gabapentin jitneħħew esklussivament mhux mibdula flawrina u mhumiex probabbli li jikkompetu għall-istess enzimi metaboliċi u passaġġi ta' eliminazzjoni bħal efavirenz.
English: One patient experienced involuntary muscle contractions.
Maltese: Pazjent wieħed kellu kontrazzjonijiet involvontarji tal-muskoli.
English: Biliary hyperplasia was observed in cynomolgus monkeys given efavirenz for ≥ 1 year at a dose resulting in mean AUC values approximately 2-fold greater than those in humans given the recommended dose.
Maltese: Ġiet osservata iperplażja biljarja f'xadini cynomolgus li kienu mogħtija efavirenz għal ≥ sena b'doża li wasslet għal valuri medji ta' AUC bejn wieħed u ieħor darbtejn ikbar minn dawk tal-bnedmin li ngħataw id-doza rakkomandata.
English: - The dose for adults is 600 mg once daily.
Maltese: - Id-doża għall-adulti, hija ta' 600 mg kuljum.
English: Voriconazole: AUC: ↓ 77% Cmax: ↓ 61%
Maltese: AUC: ↓ 77% Cmax: ↓ 61%
English: Two of three delavirdine-resistant clinical isolates examined were cross-resistant to efavirenz and contained the K103N substitution.
Maltese: Tnejn minn tliet iżolati kliniċi reżistenti għal delavirdine li ġew eżaminati kienu cross-resistant għal efavirenz u kellhom issostituzzjoni K103N.
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: 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: (Decrease in itraconazole concentrations: CYP3A4 induction)
Maltese: (induzzjoni tal-enzima ta' CYP3A4)
English: Immune Reactivation Syndrome
Maltese: Sindromu tar-Rijattivazzjoni Immunitarja
English: Liver enzymes in hepatitis B or C co-infected patients In the long-term data set from study 006, 137 patients treated with efavirenz-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/or C (hepatitis C antibody positive).
Maltese: Fis-sett ta' dejta miġbura fuq perjodu ta' żmien twil minn studju numru 006, 137 pazjent li kienu fuq skedi ta' kura li kien fihom efavirenz (tul medjan tal-kura ta' 68 ġimgħa) u 84 li kienu kkurati bi skeda ta' kura ta' kontroll (tul medjan ta' 56 ġimgħa) kienu seropożittivi meta ġew ittestjati għall-epatite B (pożitivi għall-antiġen tal-wiċċ) u/jew Ċ (pożittivi għall-antikorpi tal-epatite Ċ).
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolized by CYP3A4 (e.g. cyclosporine, tacrolimus, sirolimus)/efavirenz
Maltese: Immunosuppressanti metabolizzati minn CYP3A4 (eż.,
English: ‡These adverse reactions were identified through post-marketing surveillance but not reported as drug-related events for efavirenz-treated patients in 16 clinical trials.
Maltese: Dawn ir-reazzjonijiet avversi kienu identifikati permezz ta' sorveljanza ta' wara t-tqegħid fis suq iżda ma kinux irrappurtati bħala każijiet marbuta mal-mediċina fil-pazjenti kkurati b'efavirenz f'16-il prova klinika.
English: This loss is due to significant decreases in elbasvir and grazoprevir plasma concentrations caused by CYP3A4 induction.
Maltese: Dan it telf jiġri minħabba tnaqqis sinifikanti fil konċentrazzjonijiet ta' elbasvir u grazoprevir fil-plażma kkawżat minn induzzjoni ta' CYP3A4.
English: In these studies the dose of efavirenz was 600 mg once daily; the dose of indinavir was 1,000 mg every 8 hours when used with efavirenz and 800 mg every 8 hours when used without efavirenz.
Maltese: F'dawn l-istudji d-doża ta' efavirenz kienet ta' 600 mg darba kuljum; id-doża ta' indinavir kienet ta' 1,000 mg kull 8 sigħat meta użat ma' efavirenz u 800 mg kull 8 sigħat meta wżat mingħajr efavirenz.
English: If efavirenz is co-administered 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: EU/1/11/742/004 (bundle multi-pack - blister PVC/PVDC/alu) EU/1/11/742/009 (bundle multi-pack - blister alu/alu)
Maltese: EU/1/11/742/009 (mazz ta' pakketti b'ħafna - folja alu/alu)
English: Table 1: Interactions between efavirenz and other medicinal products in adults
Maltese: Tabella 1: Interazzjonijiet fl-adulti bejn efavirenz u prodotti mediċinali oħra Prodott mediċinali skond loqsma terapewtiċi (doża)
English: Thirty-seven patients 3 months to 6 years of age (median 0.7 years) were treated with efavirenz.
Maltese: Sebgħa u tletin pazjent minn 3 xhur sa 6 snin (medjan ta' 0.7 snin) kienu kkurati b'efavirenz.
English: Efavirenz: no clinically significant interaction.
Maltese: (induzzjoni tal-metaboliżmu) Efavirenz: ebda interazzjoni klinika sinifikanti.
English: AUC: ↑ 20% (↑ 8 to ↑ 34) Cmax: ↑ 21% (↑ 10 to ↑ 33)
Maltese: AUC: ↑ 7% (↑ 1 għal ↑ 14) Cmax: ↑ 16% (↑ 2 għal ↑ 32)
English: Convulsions have been observed in adult and paediatric patients receiving efavirenz, generally in the presence of known medical history of seizures.
Maltese: Gew osservati konvulżjonijiet f'pazjenti adulti u pedjatriċi li kienu qed jieħdu efavirenz, ġeneralment meta diġà kien hemm storja medika ta' aċċessjonijiet.
English: Efavirenz Teva", at the start of Section 2.
Maltese: efavirenz (ara sezzjoni 4.5, tabella 1).
English: Skin rash was considered treatment-related in 18% of patients treated with efavirenz.
Maltese: Ir-raxx fil-ġilda tqies li kien marbut malkura fi 18 % tal-pazjenti kkurati b'efavirenz.
English: In HIV-1 infected patients (n = 9) who received efavirenz 200 to 600 mg once daily for at least one month, cerebrospinal fluid concentrations ranged from 0.26 to 1.19% (mean 0.69%) of the corresponding plasma concentration.
Maltese: 0.26 sa 1.19% (medja 0.69%) tal-konċentrazzjoni korrospondenti tal-plażma.
English: Treatment of overdose with efavirenz should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status.
Maltese: Il-kura ta' doża eċċessiva ta' efavirenz għandha tikkonsisti f'miżuri ġenerali ta' sapport, inkluż l monitoraġġ tas-sinjali vitali u l-osservazzjoni tal-qagħda klinika tal-pazjent.
English: AUC: ↓ 64% (↓ 62 to ↓ 67) Cmax: ↓ 46% (↓ 39 to ↓ 52) Cmin: ↓ 82% (↓ 79 to ↓ 85)
Maltese: Cmax: ↓ 46% (↓ 39 għal ↓ 52) Cmin: ↓ 82% (↓ 79 għal ↓ 85)
English: If efavirenz is co-administered 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
English: Two controlled studies (006 and ACTG 364) of approximately one-year duration with efavirenz in combination with NRTIs and/or PIs, have demonstrated reduction of viral load below the limit of quantification of the assay and increased CD4 lymphocytes in antiretroviral therapy-naïve and NRTI-experienced HIV infected patients.
Maltese: Żewġ studji kkontrollati (006 u ACTG 364) li damu bejn wieħed u ieħor sena b'efavirenz flimkien ma' NRTIs u/jew PIs, urew li n-numru tal-virus naqas taħt il-livell tal-kwantifikazzjoni tal-assay u
English: Component of a multipack, can't be sold separately.
Maltese: Komponent tal-pakkett b'ħafna ma jistax jinbiegħ separatament.
English: Among co-infected patients in study 006, elevations in AST to greater than five times ULN developed in 13% of efavirenz-treated patients and in 7% of control, and elevations in ALT to greater than five times ULN developed in 20% and 7%, respectively.
Maltese: tal-pazjenti kkurati b'efavirenz, u f'7% tal-kontrolli u livelli elevati ta'ALT għal iktar minn ħames darbiet l-ULN żviluppaw f'20 % u 7 % rispettivament.
English: The pharmacokinetic parameters for efavirenz at steady state in paediatric patients were predicted by a population pharmacokinetic model and are summarized in Table 4 by weight ranges that correspond to the recommended doses of the capsules.
Maltese: Il-parametri farmakokinetiċi għal efavirenz fi stat fiss f'pazjenti pedjatriċi kienu mbassra b'mudell farmakokinetiku tal-popolazzjoni u huma miġbura fil-qosor fit-Tabella 4 b'meded ta' piżijiet li jikkorrispondu għad-dożi rakkomandati tal-kapsuli.
English: Efavirenz Teva 600 mg film-coated tablets Efavirenz
Maltese: ** meta mqabbel ma' 600 mg darba kuljum waħdu
English: Voriconazole/efavirenz (200 mg twice daily/400 mg once daily)
Maltese: Voriconazole/Efavirenz (200 mg darbtejn kuljum/400 mg darba kuljum)
English: Rifampicin/efavirenz (600 mg once daily/600 mg once daily)
Maltese: Rifampicin/Efavirenz (600 mg darba kuljum/600 mg darba kuljum)
English: Your doctor has prescribed Efavirenz Teva for you because you have HIV infection.
Maltese: kwalunkwe sinjal ta' infjammazzjoni jew infezzjoni.
English: Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening adverse reactions [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Maltese: L-għoti flimkien ma' terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, jew ergot alkaloids (ngħidu aħna, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) billi l kompetizzjoni għal CYP3A4 minn efavirenz jista' jwassal biex jimpedixxi lmetaboliżmu u joħloq ilpotenzjal għal reazzjonijiet avversi serji u/jew ta' theddida għall-ħajja.
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: This proportion is approximately 3-fold higher than the non-protein-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 HIV-1 infected patients (n=6), the pharmacokinetics of indinavir and efavirenz were generally comparable to these uninfected volunteer data.
Maltese: HIV-1 (n = 6), il-farmakokinetiċi ta'
English: Atazanavir/ritonavir/efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
Maltese: Atazanavir/ritonavir/Efavirenz (400 mg darba kuljum/100 mg darba kuljum/600 mg darba kuljum, kollha mogħtija mal-ikel)
English: Eighty-seven percent of patients had received prior antiretroviral therapy.
Maltese: Sebgħa u tmenin fil-mija tal-pazjenti kienu ċevew terapija antiretrovirali qabel.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BUNDLE LABEL FOR MULTIPACKS OF 90 (3 PACKS OF 30 x 1 FILM-COATED TABLET) - WITH THE BLUE BOX
Maltese: U KONTENUT Pakkett b'ħafna: 90 (3 pakketti ta' 30 x 1) pillola miksija b'rita
English: Fosamprenavir/ritonavir/ efavirenz (700 mg twice daily/100 mg twice daily/600 mg once daily)
Maltese: Fosamprenavir/Ritonavir/Efavire nz (700 mg darbtejn kuljum/ 100 mg darbtejn kuljum/ 600 mg darba kuljum)
English: Cross-resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Maltese: Il-profili ta' reżistenza msallba għal efavirenz, nevirapine u delavirdine fil-koltura taċ-ċelluli urew li ssostituzzjoni K103N tagħti nuqqas ta' suxxettibilita` lit-tliet NNRTIs li huma.
English: artemether/lumefantrine: Efavirenz Teva may reduce the amount of artemether/lumefantrine in your blood atovaquone/proguanil: Efavirenz Teva may reduce the amount of atovaquone/proguanil in your blood.
Maltese: atovaquone/proguanil: Efavirenz Teva jista' jnaqqas l-ammont ta' atovaquone/proguanil fid-demm tiegħek.
English: - unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly - suicide
Maltese: - sentimenti inspjegabbli ta' dwejjaq mhux assoċjati ma' alluċinazzjonijiet, iżda jista' jkun diffiċli li taħseb b'mod ċar jew b'mod sensibbli - suwiċidju
English: (Inhibition of CYP-mediated oxidative metabolism) When efavirenz was given with ritonavir 500 mg or 600 mg twice daily, the combination was not well tolerated (for example, dizziness, nausea, paraesthesia and elevated liver enzymes occurred).
Maltese: (300 mg darbtejn kuljum*/100 mg darbtejn kuljum/600 mg darba kuljum) *dożi inqas minn dawk rakkomandati, sejbiet simili huma mistennija b'dożi rakkomandati
English: In a single-dose study, half-life was doubled in the single patient with severe hepatic impairment (Child Pugh Class C), indicating a potential for a much greater degree of accumulation.
Maltese: Fi studju ta' doża singola, il-half-life irduppjat f'pazjent wieħed b'indeboliment qawwi tal-fwied (Child-Pugh Klassi Ċ), li jindika possibbiltà ta' akkumulazzjoni sa grad ferm ogħla.
English: Concomitant administration with efavirenz should be avoided due to the risk for QTc prolongation (see section 4.3).
Maltese: L-għoti konkomitanti ma' efavirenz għandu jiġi evitat minħabba r-riskju ta' titwil talQTc (ara sezzjoni 4.3).
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism which may be clinically relevant in some patients.
Maltese: Efavirenz wera li jinduċi CYP3A4 u CYP2B6, bir-riżultat li induċa l-metaboliżmu tiegħu stess u dan jista' jkun rilevanti b'mod kliniku f'xi pazjenti.
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the cytochrome P450 system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Maltese: Biotrasformazzjoni Studji fil-bnedmin u studji in vitro bil-mikrosomi tal-fwied uman urew li efavirenz l-iktar li jkun metabolizzat bis-sistema cytochrome P450 f'metaboliti idrossilati li wara jgħaddu minn proċess ta'
English: - Medicines used to treat fungal infections (antifungals):
Maltese: - Mediċini użati biex jikkuraw infezzjonijiet fungali (antifungali):
English: Ritonavir/efavirenz (500 mg twice daily/600 mg once daily)
Maltese: Ritonavir/Efavirenz (500 mg darbtejn kuljum/ 600 mg darba kuljum)
English: Five of these NNRTI-resistant isolates were found to have K103N or a valine-to-isoleucine substitution at position 108 (V108I) in RT. Three of the efavirenz treatment failure isolates tested remained sensitive to efavirenz in cell culture and were also sensitive to nevirapine and delavirdine.
Maltese: Tlieta mill-iżolati tal-falliment tal-kura b'efavirenz li ġew ittestjati baqgħu sensittivi għal efavirenz fil-kulturi taċ-ċelluli u kienu sensittivi wkoll għal nevirapine u delavirdine.
English: Hepatobiliary disorders common aspartate aminotransferase (AST) increased*, alanine aminotransferase (ALT) increased*, gamma-glutamyltransferase (GGT) increased*
Maltese: - astemizole jew terfenadine (użat biex jikkura sintomi allerġiċi) - bepridil (użat biex jikkura ħruq fl-istonku) - cisapride (użat biex jikkura ħruq fl-istonku)
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: 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: - Immunosuppressants such as cyclosporine, sirolimus, or tacrolimus (medicines used to prevent organ transplant rejection): when you start or stop taking Efavirenz Teva, your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
Maltese: - Immunosuppressanti bħal cyclosporine, sirolimus, jew tacrolimus (mediċini użati biex jimpedixxu rifjut ta' trapjant ta' organu): meta tibda jew tieqaf tieħu Efavirenz Teva, it-tabib tiegħek jimmonitorja l-livelli tal-immunosuppressant fil-plasma tiegħek mill-qrib u jista' jkollu bżonn jaġġusta d-doża tiegħu.
English: AUC: ↑ 11% (↑ 5 to ↑ 18) Cmax: ↑ 16% (↑ 6 to ↑ 26) Cmin: ↑ 13% (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Maltese: AUC: ↑ 11% (↑ 5 għal ↑ 18) Cmax: ↑ 16% (↑ 6 għal ↑ 26) Cmin: ↑ 13% (↑ 1 għal ↑ 26)
English: Body Weight
Maltese: - dipressjoni severa
English: See also ritonavir row below.
Maltese: Ara wkoll ir ringiela dwar ritonavir hawn isfel.
English: Pravastatin/efavirenz (40 mg once daily/600 mg once daily)
Maltese: Pravastatin/Efavirenz (40 mg darba kuljum/600 mg darba kuljum)
English: Malformations have been observed in foetuses from efavirenz-treated monkeys (see section 5.3).
Maltese: Malformazzjonijiet dehru f'feti ta' xadini kkurati b'efavirenz (ara sezzjoni 5.3).
English: Fluconazole/efavirenz (200 mg once daily/400 mg once daily)
Maltese: Fluconazole/Efavirenz (200 mg darba kuljum/400 mg darba kuljum)
English: AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
Maltese: AUC: ↓ 18% (↓ 10 sa ↓ 26) Cmax: ↓ 24% (↓ 15 sa ↓ 32) Cmin: ↓ 10% (↑ 1 sa ↓ 19)%
English: Paroxetine/efavirenz (20 mg once daily/600 mg once daily)
Maltese: Paroxetine/Efavirenz (20 mg darba kuljum/600 mg darba kuljum)
English: If efavirenz is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Maltese: għandu jintuża l-kors ta' dożaġġ ta' darunavir/ritonavir 600/100 mg darbtejn kuljum.
English: The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev. 2, Sept. 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of patients treated with efavirenz in these clinical trials (n=3,969).
Maltese: fuq il-bażi ta' stima talupper bound tal-inervall ta' kunfidenza ta' 95 % għal każijiet 0 meta jitqiesu n-numru ta' individwi kkurati b'efavirenz f'dawn il-provi kliniċi (n=3,969).
English: Simvastatin/efavirenz (40 mg once daily/600 mg once daily)
Maltese: Simvastatin/Efavirenz (40 mg darba kuljum/600 mg darba kuljum)