FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3: Development of resistance in study GS-01-934 through week 144
Maltese: Tabella 3: Żvilupp tar-reżistenza fl-istudju GS-01-934 sa ġimgħa 144
English: Phenytoin, Phenobarbital, and other anticonvulsants that are substrates of CYP isozymes
Maltese: Phenytoin, Phenobarbital, u antikonvulsivi oħra li huma sottostrati ta' isozimi CYP
English: Uncommon anaemia1
Maltese: Mhux komuni anemija1
English: 2 Thymidine analogue associated mutations included D67N (n=1) and K70R (n=1).
Maltese: 2 Mutazzjonijiet assoċjati ma' analogi ta' thymidine kienu jinkludu D67N (n=1) u K70R (n=1).
English: Refer to section 2 “Atripla contains sodium”.
Maltese: Irreferi għal sezzjoni 2 “Atripla fih sodium”.
English: Efavirenz non-competitively inhibits HIV-1 reverse transcriptase (RT) and does not significantly inhibit human immunodeficiency virus-2 (HIV-2) RT or cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, and δ).
Maltese: Efavirenz jinibixxi b'mod mhux kompetittiv HIV-1 reverse transcriptase (RT) u ma jinibixxix b'mod sinifikanti human immunodeficiency virus-2 (HIV-2) RT jew cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, u δ).
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: Sostituzzjonijiet fil-pożizzjonijiet RT 98, 100, 101, 108, 138, 188, 190 jew 225 ġew osservati wkoll, madankollu fi frekwenzi aktar baxxi, u spiss biss f'kombinazzjoni ma' K103N.
English: 1.2% (-2.3% to 6.7%)
Maltese: 1.2% (-2.3% sa 6.7%)
English: Date of first authorisation: 13 December 2007 Date of latest renewal: 17 September 2012
Maltese: Data tal-aħħar tiġdid: 17 ta' Settembru 2012
English: Hepatic events
Maltese: Avvenimenti epatiċi
English: - Ginkgo biloba extracts (herbal preparation).
Maltese: - Estratti ta' Ginkgo biloba (preparazzjoni tal-ħxejjex).
English: Dihydroartemisinin (active metabolite):
Maltese: Dihydroartemisinin (metabolit attiv):
English: Levonorgestrel (active metabolite):
Maltese: Levonorgestrel (metabolit attiv):
English: 0% (-2.4% to 4.2%)
Maltese: 0% (-2.4% sa 4.2%)
English: - The other ingredients in the tablet are croscarmellose sodium, hyprolose, magnesium stearate, microcrystalline cellulose, sodium laurilsulfate.
Maltese: - Is-sustanzi l-oħra fil-pillola huma croscarmellose sodium, hyprolose, magnesium stearate, microcrystalline cellulose, sodium laurilsulfate.
English: 1 The predominant circulating metabolite of sofosbuvir.
Maltese: 1 Il-metabolit predominanti ta' sofosbuvir fiċ-ċirkolazzjoni.
English: Treatment group
Maltese: Grupp ta' trattament
English: Osteonecrosis
Maltese: Osteonekrosi
English: In uninfected volunteers, multiple doses of 200 to 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 to 42% lower) and a shorter terminal half-life of 40 to 55 hours (single dose half-life 52 to 76 hours).
Maltese: F'voluntiera mhux infettati, dożi multipli ta' 200 sa 400 mg kuljum għal 10 t-ijiem irriżultaw f'firxa ta' akkumulazzjoni inqas milli mistenni (22 sa 42% inqas) u half-life terminali inqas ta' 40 sa 55 siegħa (half-life ta' doża waħda ta' 52 sa 76 siegħa).
English: Rare lactic acidosis
Maltese: Rari aċidożi lattika
English: Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Maltese: Emtricitabine u tenofovir individwalment u f'kumbinazzjoni wrew attività kontra l-HBV fi studji farmakodinamiċi (ara sezzjoni 5.1).
English: [outer packaging only]
Maltese: [pakkett ta' barra biss]
English: Concomitant use of St. John's wort is contraindicated (see section 4.3).
Maltese: John's Wort huwa kontra-indikat (ara sezzjoni 4.3).
English: In vitro binding of tenofovir to human plasma or serum protein is < 0.7% and 7.2%, respectively over the tenofovir concentration range 0.01 to 25 µg/ml.
Maltese: It-twaħħil in vitro ta' tenofovir mal-plażma umana jew mal-proteina tas-serum hija < 0.7% u 7.2%, rispettivament fuq il-medda 0.01 sa 25 µg/ml tal-konċentrazzjoni ta' tenofovir.
English: There were no clinically significant pharmacokinetic interactions when efavirenz was administered with azithromycin, cetirizine, fosamprenavir/ritonavir, lorazepam, nelfinavir, zidovudine, aluminium/magnesium hydroxide antacids, famotidine or fluconazole.
Maltese: Ma kien hemm ebda interazzjoni farmakokinetika klinikament sinifikanti meta efavirenz ingħata ma' azithromycin, cetirizine, fosamprenavir/ritonavir, lorazepam, nelfinavir, zidovudine, aluminium/magnesium hydroxide antacids, famotidine jew fluconazole.
English: Since fluoxetine shares a similar metabolic profile with paroxetine, i.e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
Maltese: Billi fluoxetine jaqsam profil metaboliku simili ma' paroxetine, jiġifieri effett inibitorju qawwi ta' CYP2D6, huwa mistenni nuqqas simili ta' interazzjoni għal fluoxetine.
English: (CYP3A4 induction) Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
Maltese: Żviluppa raxx f'46% tal-voluntiera mhux infettati li rċevew efavirenz u clarithromycin.
English: - if you have a history of liver disease, including chronic active hepatitis.
Maltese: jekk għandek storja ta' mard tal-fwied, inkluża epatite attiva kronika.
English: Biliary fibrosis has been observed in rats.
Maltese: Fibrożi biljari ġiet osservata fil-firien.
English: Rare hepatic failure3,4
Maltese: Rari insuffiċjenza tal fwied3,4
English: Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.
Maltese: Bristol-Myers Squibb Gyógyszerkereskedelmi
English: Stayed on original treatment regimen (N=97) n/N (%)
Maltese: Baqgħu fuq ir-reġim ta' trattament oriġinali (N=97) n/N (%)
English: Norgestimate/Ethinyloestradiol/ Emtricitabine
Maltese: Norgestimate/Ethinyloestradiol/
English: Table 6: Summary of pharmacokinetic data from study GS-US-177-0105
Maltese: Tabella 6: Sommarju tat-tagħrif farmakokinetiku mill-istudju GS-US-177-0105 Efavirenz (n=45)
English: Poly(vinyl alcohol) Talc
Maltese: poly(vinyl alcohol), talc, titanium dioxide.
English: HIV/HBV or HCV co-infected patients: Only a limited number of patients were co-infected with HBV (n = 13) or HCV (n = 26) in study GS-01-934.
Maltese: Numru limitat biss ta' pazjenti kienu ko-infettati bl-HBV (n=13) jew bl-HCV (n=26) fi studju GS-01-934.
English: Table 1: Interactions between Atripla or its individual components and other medicinal products
Maltese: Tabella 1: Interazzjonijiet bejn Atripla jew il-komponenti individwali tiegħu u prodotti mediċinali oħra
English: - Medicines used to treat convulsions/seizures (anticonvulsants): Carbamazepine, phenytoin,
Maltese: - Mediċini użati biex jittrattaw aċċessjonijiet (antikonvulsanti): Carbamazepine, phenytoin, phenobarbital.
English: Atovaquone and proguanil hydrochloride/Emtricitabine
Maltese: Atovaquone u proguanil hydrochloride/Emtricitabine
English: 0.5% (-7.0% to 9.3%)
Maltese: 0.5% (-7.0% sa 9.3%)
English: • Genotypic resistance to efavirenz, predominantly the K103N mutation, developed in virus from 13/19 (68%) patients in the efavirenz + emtricitabine + tenofovir disoproxil group and in virus from 21/29 (72%) patients in the efavirenz + lamivudine/zidovudine group.
Maltese: • Reżistenza ġenotipika għal efavirenz, fil-biċċa l-kbira l-bidla ta' K103N, żviluppat f'virus f'13/19 (68%) tal-pazjenti fil-grupp ta' efavirenz + emtricitabine + tenofovir disoproxil u f'virus f'21/29 (72%) tal-pazjenti fil-grupp efavirenz + lamivudine/zidovudine.
English: -0.5% (-7.6% to 7.9%)
Maltese: -0.5% (-7.6% sa 7.9%)
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil in clinical practice (see section 4.8).
Maltese: Insuffiċjenza renali, indeboliment renali, livell għoli ta' krejatinina, ipofosfatimja u tubulopatija prossimali (inkluż is-sindromu ta' Fanconi) ġew irrapportati bl-użu ta' tenofovir disoproxil fil-prattika klinika (ara sezzjoni 4.8).
English: AUC: ↔ Cmax: ↑ 38% (↑ 14 to ↑ 67)
Maltese: AUC: ↔ Cmax: ↑ 38% (↑ 14 sa ↑ 67)
English: In virologically suppressed patients, the clinical relevance of this reduction can be expected to be limited (see section 5.1).
Maltese: F'pazjenti viroloġikament soppressi, ir-rilevanza klinika ta' dan it-tnaqqis tista' tkun mistennija li tkun limitata (ara sezzjoni 5.1).
English: Cmax: ↑ 15% (CYP3A4 inhibition)
Maltese: Cmax: ↑ 15% (Inibizzjoni ta' CYP3A4)
English: Following oral administration, the elimination half-life of tenofovir is approximately 12 to 18 hours.
Maltese: Wara amministrazzjoni orali, il-half-life tal-eliminazzjoni ta' tenofovir hija madwar 12 sa 18-il siegħa.
English: Cmin: ↓ 8% (↑ 14 to ↓ 25)
Maltese: Cmin: ↓ 8% (↑ 14 għal ↓ 25)
English: Alternatives to clarithromycin (e.g. azithromycin) may be considered.
Maltese: Jistgħu jiġu kkunsidrati alternattivi għal clarithromycin (eż. azithromycin).
English: -0.5% (-3.2% to 2.2%)
Maltese: -0.5% (-3.2% sa 2.2%)
English: Gilead Sciences, Lda.
Maltese: Portugal Gilead Sciences, Lda.
English: Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, Table 1).
Maltese: Esponimenti ta' raltegravir (substrat ta' UGT1A1) jonqsu fil-preżenza ta' efavirenz (ara sezzjoni 4.5, Tabella 1).
English: *lower than recommended doses; similar findings are expected with recommended doses.
Maltese: *dożi inqas minn dawk rakkomandati; sejbiet simili huma mistennija bid-dożi rakkomandati.
English: Emtricitabine and tenofovir are phosphorylated by cellular enzymes to form emtricitabine triphosphate and tenofovir diphosphate, respectively.
Maltese: Emtricitabine u tenofovir huma fosforilati minn enzimi ċellulari sabiex jifformaw emtricitabine triphosphate u tenofovir diphosphate, rispettivament.
English: Following multiple dose oral administration of emtricitabine to 20 HIV infected patients, steady-state Cmax was 1.8 ± 0.7 µg/ml (mean ± S.D.) (39%CV), steady-state Cmin was 0.09 ± 0.07 µg/ml (80%) and the AUC was 10.0 ± 3.1 µg•h/ml (31%) over a 24 hour dosing interval.
Maltese: Wara għoti orali ta' aktar minn doża waħda ta' emtricitabine lil 20 pazjent infettat blHIV, Cmax ta' stat fiss kien 1.8 ± 0.7 µg/ml (medju ± S.D.) (39%CV), Cmin ta' stat fiss kien 0.09 ± 0.07 µg/ml (80%) u l-AUC kien 10.0 ± 3.1 µg•h/ml (31%) fuq intervall ta' dożaġġ ta' 24 siegħa.
English: Gilead Sciences S.r.l.
Maltese: Italia Gilead Sciences S.r.l.
English: 8.9% (-7.7% to 25.6%)
Maltese: 8.9% (-7.7% sa 25.
English: Most frequent side effects
Maltese: L-iktar effetti sekondarji frekwenti
English: Atripla 600 mg/200 mg/245 mg film-coated tablets Efavirenz/emtricitabine/tenofovir disoproxil
Maltese: Atripla 600 mg/200 mg/245 mg pilloli miksijin b'rita Efavirenz/emtricitabine/tenofovir disoproxil
English: Stevens-Johnson syndrome, erythema multiforme3, severe rash angioedema4
Maltese: Mhux komuni sindromu StevensJohnson, eritema multiforme3, raxx sever (< 1%)
English: The most frequently reported adverse reactions considered possibly or probably related to Atripla among patients treated up to 48 weeks in study AI266073 were psychiatric disorders (16%), nervous system disorders (13%), and gastrointestinal disorders (7%).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti u li kienu kkunsidrati bħala possibbilment jew probabbilment relatati ma' Atripla fost pazjenti li kienu ttrattati għal sa 48 ġimgħa fi studju AI266073 kienu disturbi psikjatriċi (16%), disturbi fis-sistema nervuża (13%), u disturbi gastro-intestinali (7%).
English: 1 Other efavirenz resistance mutations included A98G (n=1), K103E (n=1), V179D (n=1), and M230L (n=1).
Maltese: 1 Mutazzjonijiet oħra tar-reżistenza għal efavirenz kienu jinkludu A98G (n=1), K103E (n=1), V179D (n=1),
English: Efavirenz is highly bound (> 99%) to human plasma proteins, predominantly albumin.
Maltese: Distribuzzjoni Efavirenz jeħel tajjeb ħafna (> 99%) ma' proteini tal-plażma umana, il-biċċa l-kbira albumina.
English: Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Maltese: Emtricitabine triphosphate u tenofovir diphosphate jinibixxu HIV-1 reverse transcriptase b'mod kompetittiv, u dan jirriżulta f'terminazzjoni tal-katina tad-DNA.
English: The mean (%CV) tenofovir exposure increased from 2,185 ng•h/ml (12%) in patients with normal renal function, to 3,064 ng•h/ml (30%), 6,009 ng•h/ml (42%) and 15,985 ng•h/ml (45%) in patients with mild, moderate and severe renal impairment, respectively.
Maltese: L-espożizzjoni medja (%CV) ta' tenofovir żdiedet minn 2,185 ng•h/ml (12%) f'pazjenti b'funzjoni renali normali, għal 3,064 ng•h/ml (30%), 6,009 ng•h/ml (42%) u 15,985 ng•h/ml (45%) f'pazjenti b'indeboliment renali, ħafif, moderat u sever, rispettivament.
English: Cross-resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Maltese: Profili ta' kross-reżistenza għal efavirenz, nevirapine u delavirdine in vitro urew li s-sostituzzjoni K103N tagħti nuqqas ta' suxxettibbiltà għat-tliet NNRTIs kollha.
English: In clinical controlled studies of efavirenz, nervous system symptoms of moderate to severe intensity were experienced by 19% (severe 2%) of patients, and 2% of patients discontinued therapy due to such symptoms.
Maltese: Fi studji kliniċi kkontrollati ta' efavirenz, sintomi fis-sistema nervuża ta' intensità minn moderata sa severa affettwaw lil 19% (severi 2%) tal-pazjenti, u 2% tal-pazjenti waqqfu t-terapija minħabba dawn is-sintomi.
English: One patient experienced involuntary muscle contractions.
Maltese: Pazjent esperjenza kontrazzjonijiet involontarji tal-muskoli.
English: In 35 patients receiving efavirenz 600 mg once daily, steady-state peak concentration (Cmax) was 12.9 ± 3.7 µM (29%) [mean ± standard deviation (S.D.) (coefficient of variation (%CV))], steady-state Cmin was 5.6 ± 3.2 µM (57%), and AUC was 184 ± 73 µM•h (40%).
Maltese: F'35 pazjent li kienu qed jirċievu efavirenz 600 mg darba kuljum, il-konċentrazzjoni massima fi stat fiss (Cmax) kienet 12.9 ± 3.7 µM (29%) [medja ± devjazzjoni standard (S.D.) (koeffiċjent ta' varjazzjoni (%CV))], Cmin stat fiss kien 5.6 ± 3.2 µM (57%), u AUC kien 184 ± 73 µM•h (40%).
English: Uncommon hepatitis acute
Maltese: Mhux komuni epatite akuta
English: Efavirenz demonstrated antiviral activity against most non-clade B isolates (subtypes A, AE, AG, C, D, F, G, J, and N) but had reduced antiviral activity against group O viruses.
Maltese: Efavirenz wera attività antivirali kontra ħafna mill-iżolati non-clade B (subtipi A, AE, AG, C, D, F, G, J, u N) iżda ma naqqasx l-attività antivirali kontra l-virusijiet ta' grupp O.
English: 3 See section 4.8 Description of selected adverse reactions for more details.
Maltese: 3 Ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula għal aktar dettalji.
English: The frequency category was estimated from a statistical calculation based on the total number of patients treated with efavirenz in clinical trials (n = 3,969) or exposed to emtricitabine in randomised controlled clinical trials (n = 1,563) or exposed to tenofovir disoproxil in randomised controlled clinical trials and the expanded access programme (n = 7,319).
Maltese: Il-kategorija ta' frekwenza kienet stmata mill-kalkulazzjoni statistika bbażata fuq in-numru totali ta' pazjenti ttrattati b'efavirenz fl-istudji kliniċi (n=3,969) jew esposti għal emtricitabine fi studji kliniċi kkontrollati randomised (n=1,563) jew esposti għal tenofovir disoproxil fi studji kliniċi kkontrollati randomised u l-programm ta' aċċess imkabbar (n=7,319).
English: Rare completed suicide3,4, delusion3,4, neurosis3,4 Nervous system disorders: Very common headache dizziness
Maltese: Rari suwiċidju komplut3,4, delużjoni3,4, nevrożi3,4
English: Limited clinical experience in patients co-infected with HIV and HBV suggests that treatment with emtricitabine or tenofovir disoproxil in antiretroviral combination therapy to control HIV infection also results in a reduction in HBV DNA (3 log10 reduction or 4 to 5 log10 reduction, respectively) (see section 4.4).
Maltese: Esperjenza klinika limitata f'pazjenti ko-infettati b'HIV u b'HBV tissuġġerixxi li trattament b'emtricitabine jew b'tenofovir disoproxil f'terapija ta' kombinazzjoni antiretrovirali biex jikkontrolla infezzjoni tal-HIV jirriżulta wkoll fi tnaqqis f'HBV DNA (tnaqqis ta' 3 log10 jew tnaqqis 4 sa 5 log10, rispettivament) (ara sezzjoni 4.4).
English: Cannabinoid test interaction
Maltese: Interazzjoni tat-test kannabinojde
English: AUC: ↓ 43% (↓ 7 to ↓ 65) Cmax: ↔
Maltese: AUC: ↓ 43% (↓ 7għal ↓ 65) Cmax: ↔
English: (CYP3A4 induction).
Maltese: CYP3A4).
English: Headache has been reported in clinical studies with emtricitabine (see section 4.8).
Maltese: L-uġigħ ta' ras ġie rrapportat fi studji kliniċi b'emtricitabine (ara sezzjoni 4.8).
English: AUC: ↔* (↓ 9% to ↑ 10%) Cmax: ↑ 17%* (↑ 8 to ↑ 27) Cmin: ↓ 42%* (↓ 31 to ↓ 51)
Maltese: AUC: ↔* (↓ 9% għal ↑ 10%) Cmax: ↑ 17%* (↑ 8 għal ↑ 27) Cmin: ↓ 42%* (↓ 31 għal ↓ 51)
English: Resistance to efavirenz can be selected in vitro and resulted in single or multiple amino acid substitutions in HIV-1 RT, including L100I, V108I, V179D, and Y181C.
Maltese: Ir-reżistenza għal efavirenz tista' tkun in vitro magħżula u rriżultat f'sostituzzjoni waħda jew aktar ta' aċidu amminiku f'HIV-1 RT, inkluż L100I, V108I, V179D, u Y181C.
English: A similar trend was observed in a sub-group analysis of treatment-experienced patients with baseline HIV-1 RNA < 75 copies/ml from a retrospective cohort study (data collected over 20 months, see Table 5).
Maltese: Tendenza simili kienet osservata f'analiżi ta' sotto-grupp ta' pazjenti li kienu kkurati fil-passat, b'HIV-1 RNA < 75 kopji/ml fil-linja bażi minn studju retrospettiv dwar koorti (dejta miġbura fuq perjodu ta' 20 xahar, ara t-Tabella 5).
English: Patients with mild liver disease (Child-Pugh-Turcotte (CPT), Class A) may be treated with the normal recommended dose of Atripla (see sections 4.3, 4.4 and 5.2).
Maltese: Pazjenti b'mard talfwied ħafif (Child-Pugh-Turcotte (CPT), Klassi A) jistgħu jiġu ttrattati bid-doża normali rrikkmandata ta' Atripla (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: The mean (%CV) emtricitabine exposure increased from 12 µg•h/ml (25%) in subjects with normal renal function to 20 µg•h/ml (6%), 25 µg•h/ml (23%) and 34 µg•h/ml (6%) in patients with mild, moderate and severe renal impairment, respectively.
Maltese: L-espożizzjoni medja (%CV) ta' emtricitabine żdiedet minn 12 µg•h/ml (25%) f'suġġetti b'funzjoni renali normali għal 20 µg•h/ml (6%), 25 µg•h/ml (23%) u 34 µg•h/ml (6%) f'pazjenti b'indeboliment renali, ħafif, moderat u sever, rispettivament.
English: No clinically significant pharmacokinetic interaction.
Maltese: L-ebda interazzjoni farmakokinetika klinikament sinifikanti.
English: Pink, capsule-shaped, film-coated tablet, of dimensions 20 mm x 10.4 mm, debossed with “123” on one side, plain on the other side.
Maltese: Pillola roża miksija b'rita, forma ta' kapsula, b'daqs ta' 20 mm x 10.4 mm, b' “123” inċiż fuq naħa waħda, sempliċi fuq in-naħa l-oħra.
English: In the prior-NNRTI stratum, response rates were 98.9% vs 97.4% for Atripla and SBR patients respectively; a difference (95%CI) of 1.4% (-4.0%, 6.9%)].
Maltese: Fl-istratum ta' qabel NNRTI, ir-rati tar-rispons kienu 98.9% vs 97.4% għal Atripla u għal pazjenti SBR rispettivament; differenza (95%CI) ta' 1.4% (-4.0%,
English: In vitro binding of emtricitabine to human plasma proteins is < 4% and independent of concentrations over the range of 0.02 to 200 µg/ml.
Maltese: It-twaħħil in vitro ta' emtricitabine mal-proteini tal-plażma umana huwa < 4% u indipendenti minn konċentrazzjonijiet fuq il-medda ta' 0.02 sa 200 µg/ml.
English: Skin and subcutaneous tissue disorders: Very common rash (moderate-severe, 11.6%, all grades, 18%)3
Maltese: Komuni ħafna raxx (moderat-sever, 11.6%, il-gradi kollha,
English: The in vitro studies suggest that CYP3A4 and CYP2B6 are the major isozymes responsible for efavirenz metabolism and that it inhibits CYP isozymes 2C9, 2C19, and 3A4.
Maltese: L-istudji in vitro jissuġġerixxu li CYP3A4 u CYP2B6 huma l-isozimi maġġuri responsabbli għallmetaboliżmu ta' efavirenz u li jinibixxi l-isozimi CYP, 2C9, 2C19, u 3A4.
English: Atripla in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Maltese: Atripla flimkien ma' darunavir/ritonavir 800/100 mg darba kuljum jista' jirriżulta f'darunavir Cmin subottimali.
English: If a patient is already taking St. John's wort, stop St. John's wort, check viral levels and if possible efavirenz levels.
Maltese: John's wort, iċċekkja l-livelli virali u jekk ikun possibbli l livelli ta' efavirenz.
English: Patients coinfected with HIV and HBV
Maltese: Pazjenti ko-infettati b'HIV u b'HBV
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available (mechanism)
Maltese: Effetti fuq il-livelli tal-mediċina Bidla perċentwali medja fl-AUC, Cmax, Cmin b'intervalli ta' kunfidenza ta' 90% jekk disponibbli (mekkaniżmu)
English: If therapy with Atripla is discontinued, consideration should be given to the long half-life of efavirenz (see section 5.2) and long intracellular half-lives of emtricitabine and tenofovir.
Maltese: Jekk titwaqqaf t-terapija b'Atripla, għandha tingħata konsiderazzjoni għall-half-life twila ta' efavirenz (ara sezzjoni 5.2) u l-half-lives intraċellulari twal ta' tenofovir u emtricitabine.
English: The combination of efavirenz, emtricitabine and tenofovir disoproxil has been studied in 460 patients either as the fixed-dose combination tablet Atripla (study AI266073) or as the component products (study GS-01-934).
Maltese: Il-kumbinazzjoni ta' efavirenz, emtricitabine u tenofovir disoproxil ġiet studjata f'460 pazjent jew bħala l-pillola ta' kombinazzjoni ta' doża fissa waħda ta' Atripla (studju AI266073) jew bħala lprodotti tal-komponenti (studju GS-01-934).
English: Co-administration with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine).
Maltese: L-għoti flimkien ma' terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, jew alkalojdi ergotina (per eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine).
English: Atovaquone and proguanil hydrochloride/Tenofovir disoproxil
Maltese: Atovaquone u proguanil hydrochloride/Tenofovir disoproxil
English: AUC: ↔*/** (↓ 10% to ↑ 26%) Cmax: ↔*/** (↓ 5% to ↑ 26%) Cmin: ↑ 12%*/** (↓ 16 to ↑ 49)
Maltese: AUC: ↔*/** (↓ 10% għal ↑ 26%) Cmax: ↔*/** (↓ 5% għal ↑ 26%) Cmin: ↑ 12%*/** (↓ 16 għal ↑ 49) (Induzzjoni ta' CYP3A4).
English: 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Maltese: 30 pillola miksija b'rita 90 (3 fliexken ta' 30) pillola miksija b'rita
English: Emtricitabine-resistant viruses with the M184V/I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir and zidovudine.
Maltese: Virusijiet reżistenti għal emtricitabine bil-mutazzjoni M184V/I kienu kross-reżistenti għal lamivudine, madankollu żammew is-sensittività għal didanosine, stavudine, tenofovir u zidovudine.
English: Psychiatric disorders: Common depression (severe in 1.6%)3, anxiety3, abnormal dreams3, insomnia3
Maltese: 1.6%)3, ansjetà3, ħolm anormali3, insomnja3
English: Voriconazole: Co-administration of standard doses of efavirenz and voriconazole is contraindicated.
Maltese: L-għoti fl-istess ħin ta' dożi standard ta' efavirenz u voriconazole huwa kontra-indikat.
English: When used in combination with efavirenz and two NRTIs, 533/133 mg lopinavir/ritonavir (soft capsules) twice daily yielded similar lopinavir plasma concentrations as compared to lopinavir/ritonavir (soft capsules) 400/100 mg twice daily without efavirenz (historical data).
Maltese: 533/133 mg lopinavir/ritonavir (kapsuli rotob) darbtejn kuljum taw konċentrazzjonijiet simili ta' lopinavir filplażma meta mqabbel ma' lopinavir/ritonavir (kapsuli rotob) 400/100 mg darbtejn kuljum mingħajr efavirenz (dejta storika).