FrancophonIA/ELRC3.0 huggingface dataset:
English: Azopt must not be used in people who are hypersensitive (allergic) to brinzolamide or any of the other ingredients, or to other medicines called sulphonamides (such as some antibiotics).
Maltese: Azopt ma għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għal brinżolamur jew kwalunkwe wieħed mill-ingredjenti l-oħra, jew għall-mediċini msejħa sulfonamidi (bħal xi antibijotiċi).
English: When used on its own, Azopt was less effective than timolol.
Maltese: Meta użat waħdu, Azopt kien inqas effettiv minn timolol.
English: The medicine can only be obtained with a prescription.
Maltese: Azopt huwa mediċina li fih is-sustanza attiva brinżolamur.
English: It is used in patients with ocular hypertension (when the pressure in the eye is higher than normal) or open-angle glaucoma (a disease in which the pressure inside the eye rises because fluid cannot drain out of the eye).
Maltese: Jintuża f'pazjenti li jbatu minn ipertensjoni okulari (meta l-pressjoni fl-għajn tkun ogħla min-normal) jew glawkoma b'angolu miftuħ (marda li tgħolli lpressjoni fl-għajn minħabba li l-fluwidi ma jkunux jistgħu joħorġu).
English: When used as an add-on to travoprost, Azopt had a similar effect to timolol in reducing eye pressure.
Maltese: Kollox ma' kollox, Azopt wera effett simili meta intuża darbtejn jew tliet darbiet kuljum.
English: In all of the studies, the main measure of effectiveness was the change in pressure inside the eye, measured in units called ‘millimetres of mercury' (mmHg).
Maltese: Fl-istudji kollha, il-kejl ewlieni tal-effikaċja kien il-bidla fil-pressjoni fl-għajn imkejla b'unitajiet imsejħa ”millilitri ta' merkurju” (mmHg).
English: For the full list of all side effects reported with Azopt, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Azopt, ara l-fuljett ta' tagħrif.
English: Expected: Voxilaprevir:↓
Maltese: Mistenni: Voxilaprevir:↓
English: 117 Allée Des Parcs, 69 800 Saint-Priest, France
Maltese: 117 Allée Des Parcs, 69 800 Saint-Priest, Franza
English: 117 Allée des Parcs 69800 Saint-Priest France
Maltese: 117 Allée des Parcs 69800 Saint-Priest Franza
English: As of week 144:
Maltese: F'ġimgħa 144:
English: hypokalaemia2
Maltese: ipokalemija2
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolised by CYP3A4 (e.g. cyclosporine, tacrolimus, sirolimus)/Efavirenz
Maltese: Immunosuppressanti metabolizzati minn CYP3A4 (eż., cyclosporine, tacrolimus, sirolimus)/Efavirenz
English: Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate.
Maltese: Tenofovir disoproxil jinbidel in vivo għal tenofovir, analogue ta' nucleoside monophosphate (nucleotide) ta' adenosine monophosphate.
English: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin 35/36 Baldoyle Industrial Estate, Baldoyle, Dublin 13 Ireland
Maltese: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin 35/36 Baldoyle Industrial Estate, Baldoyle, Dublin 13 Irlanda
English: Severe hepatic impairment (CPT, Class C) (see section 5.2).
Maltese: Indeboliment epatiku sever (CPT, Klassi Ċ) (ara sezzjoni 5.2).
English: Mylan Hungary Kft Mylan utca 1, Komárom 2900, Hungary
Maltese: Mylan Hungary Kft Mylan utca 1, Komárom 2900, L-Ungerija
English: Stevens-Johnson syndrome, erythema multiforme3, severe rash angioedema4
Maltese: Mhux komuni sindrome ta' Stevens-Johnson, eritema multiforme3, raxx sever anġjoedema4
English: abnormal dreams, insomnia
Maltese: ħolm anormali, insomnja
English: Common elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gammaglutamyltransferase (GGT)
Maltese: Komuni żieda f'aspartate aminotransferase (AST), żieda f'alanine aminotransferase (ALT), żieda f'gamma-glutamyltransferase (GGT)
English: ANTIDEPRESSANTS
Maltese: ANTIDEPRESSIVI
English: - Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) - Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) - Tenofovir disoproxil is a nucleotide reverse transcriptase inhibitor (NtRTI)
Maltese: - Efavirenz huwa inibitur non-nucleoside reverse transcriptase (NNRTI) - Emtricitabine huwa inibitur nucleoside reverse transcriptase (NRTI) - Tenofovir disoproxil huwa inibitur nucleotide reverse transcriptase (NtRTI)
English: Latvija Mylan Healthcare SIATel: +371 676 055 80
Maltese: Latvija Mylan Healthcare SIA Tel: +371 676 055 80
English: - Medicines used to treat convulsions/seizures (anticonvulsants): Carbamazepine, phenytoin, phenobarbital.
Maltese: - Mediċini użati biex jittrattaw aċċessjonijiet (antikonvulsanti): Carbamazepine, phenytoin, phenobarbital.
English: Rare hepatic failure3,4
Maltese: Rari insuffiċjenza epatika3,4
English: Cmax: ↓ 23% (↓ 30 to ↑ 16) Efavirenz:
Maltese: Cmax: ↓ 23% (↓ 30 sa ↑ 16) Efavirenz:
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: 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), u M230L (n = 1).
English: patients with HIV-1 RNA < 50 copies/ml
Maltese: pazjenti b'HIV‑1 RNA < 50 kopja/mL
English: Norbuprenorphine:
Maltese: Buprenorphine:
English: Iron oxide yellow (E172) Iron oxide red (E172) Macrogol
Maltese: Iron oxide yellow (E172)
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: Depomedroxyprogesterone acetate (DMPA)/Efavirenz (150 mg IM single dose DMPA)
Maltese: Depomedroxyprogesterone acetate (DMPA)/Efavirenz (Doża waħda DMPA IM ta' 150 mg)
English: (CYP3A4 induction).
Maltese: (Induzzjoni ta' CYP3A4).
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 filpożizzjonijiet 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: • allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
Maltese: • reazzjoni allerġika (sensittività eċċessiva) li tista' tikkawża reazzjonijiet serji tal-ġilda (sindromu ta' Stevens-Johnson, eritema multiformi, ara sezzjoni 2)
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, 18%)3
English: Common cerebellar coordination and balance disturbances3, somnolence (2.0%)3, headache (5.7%)3, disturbance in attention (3.6%)3, dizziness dizziness headache
Maltese: Komuni disturbi ċerebrali talkoordinazzjoni u tal-bilanċ 3 sonnolenza (2.0%)3, uġigħ ta' ras (5.7%)3, disturb fl-attenzjoni (3.6%)3, sturdament (8.5%)3
English: Uncommon suicide attempt3, suicide ideation3, psychosis3, mania3, paranoia3, hallucination3, euphoric mood3, affect lability3, confusional state3, aggression3, catatonia3
Maltese: Mhux komuni attentat ta' suwiċidju3, ideat dwar suwiċidju3, psikożi3, manija3, paranojja3, alluċinazzjoni3, burdata ewforika3, labilità tal- affett3, stat konfużjonali3, aggressjoni3, katatonja3
English: Multipack: 90 (3 packs of 30) film-coated tablets.
Maltese: Pakkett multiplu: 90 (3 pakketti ta' 30) pilloli miksija b'rita.
English: AUC: ↓ 50% Cmax: ↓ 45% (UDP-G induction)
Maltese: AUC: ↓ 50% Cmax: ↓ 45% (Induzzjoni ta' UDP-G)
English: Phenytoin, Phenobarbital, and other anticonvulsants that are substrates of CYP isozymes
Maltese: Phenytoin, Phenobarbital, u antikonvulsivi oħra li huma substrati ta' isoenzimi ta' CYP450
English: AUC: ↓ 4% (↓ 0 to ↓ 31) Cmax: ↓ 47% (↓ 9 to ↓ 51) Total active HMG Co-A reductase inhibitors:
Maltese: AUC: ↓ 4% (↓ 0 sa ↓ 31) Cmax: ↓ 47% (↓ 9 sa ↓ 51) Inibituri ta' HMG Co-A reductase totali attivi:
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Maltese: Ilfrekwenzi huma deskritti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) jew rari (≥ 1/10,000 sa < 1/1,000).
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 huwa < 0.7% u 7.2%, rispettivament fuq il-medda 0.01 sa 25 µg/ml tal-konċentrazzjoni ta' tenofovir.
English: Stayed on original treatment regimen (N=97) n/N (%)
Maltese: Baqgħu fuq ittrattament oriġinali (N = 97) n/N (%)
English: Efavirenz/emtricitabine/tenofovir disoproxil (N=203) n/N (%)
Maltese: Efavirenz/ emtricitabine/ tenofovir disoproxil Mylan (N = 203) n/N (%)
English: 1 The predominant circulating metabolite of sofosbuvir.
Maltese: 1 Il -metabolit predominanti ta' sofosbuvir fiċ-ċirkolazzjoni.
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 mhuwiex affettwati, dożi multipli ta' 200 sa 400 mg kuljum għal 10 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: Hepatitis C antivirals Elbasvir/Grazoprevir + Efavirenz
Maltese: Antivirali tal-epatite Ċ Elbasvir/Grazoprevir + Efavirenz
English: Croscarmellose sodium Hydroxypropylcellulose Low-substituted hydroxypropylcellulose Magnesium stearate
Maltese: Low-substituted hydroxypropylcellulose
English: - The other ingredients in the tablet are croscarmellose sodium, hydroxypropylcellulose, lowsubstituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, silica colloidal anhydrous, sodium metabisulfite, lactose monohydrate and iron oxide red (E171).
Maltese: - Is-sustanzi mhux attivi l-oħra fil-pillola huma croscarmellose sodium, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, silica colloidal anhydrous, sodium metabisulfite, lactose monohydrate u iron oxide red (E171).
English: (mechanism)
Maltese: (mekkaniżmu)
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: NNRTIs/Efavirenz
Maltese: NRTIs/Efavirenz
English: Pack size: 30 tablets
Maltese: Daqs tal-pakkett: 30 pillola
English: Rare completed suicide3,4, delusion3,4, neurosis3,4
Maltese: Rari suwiċidju komplut3,4, delużjoni3,4, newrożi3,4
English: Concomitant use of St. John's wort is contraindicated (see section 4.3).
Maltese: John's Wort huwa kontraindikat (ara sezzjoni 4.3).
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: The systemic clearance of emtricitabine averaged 307 ml/min.
Maltese: It-tneħħija sistematika ta' emtricitabine kellha medja ta' 307 mL/min.
English: The degree of renal impairment was defined according to baseline creatinine clearance (normal renal function when creatinine clearance > 80 ml/min; mild impairment with creatinine clearance=50 to 79 ml/min; moderate impairment with creatinine clearance=30 to 49 ml/min and severe impairment with creatinine clearance=10 to 29 ml/min).
Maltese: Il-grad ta' indeboliment renali ġie definit skont l-eliminazzjoni ta' kreatinina tal-linja bażi (funzjoni renali normali meta l-eliminazzjoni tal-kreatinina > 80 mL/min; indeboliment ħafif b'eliminazzjoni tal-kreatinina =50 sa 79 mL/min; indeboliment moderat b'eliminazzjoni tal-kreatinina =30 sa 49 mL/min u indeboliment sever b'eliminazzjoni tal-kreatinina =10 sa 29 mL/min).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 September 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 05 ta' Settembru 2017
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: • Ir-reżistenza ġenotipika għal efavirenz, l-aktar il-mutazzjoni K103N, żviluppat f'virus fi 13/19 (68%) tal-pazjenti fil-grupp ta' efavirenz + emtricitabine + tenofovir disoproxil, u f'virus f'21/29 (72%) tal-pazjenti fil-grupp ta' efavirenz + lamivudine/zidovudine.
English: Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available
Maltese: Bidla medja perċentwali fl-AUC, Cmax, Cmin b'intervalli ta' kunfidenza ta' 90% jekk disponibbli
English: Efavirenz is highly bound (> 99%) to human plasma proteins, predominantly albumin.
Maltese: Efavirenz jeħel tajjeb ħafna (> 99%) ma' proteini tal-plażma umana, il-biċċa l-kbira albumina.
English: - Medicines used to treat infection with the hepatitis C virus: boceprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
Maltese: - Mediċini użati biex jittrattaw infezzjoni bil-virus tal-epatite Ċ: boceprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir.
English: In the prior-NNRTI stratum, response rates were 98.9% vs 97.4% for efavirenz/emtricitabine/tenofovir disoproxil 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 efavirenz/emtricitabine/tenofovir disoproxil Mylan u għal pazjenti SBR rispettivament; differenza (95%CI) ta' 1.4% (-4.0%, 6.9%).
English: - The other ingredients in the tablet film coating are iron oxide yellow (E172), iron oxide red (E172), macrogol, poly(vinyl alcohol), talc, titanium dioxide (E171).
Maltese: - Is-sustanzi mhux attivi l-oħra fil-kisja tar-rita tal-pillola huma iron oxide yellow (E172), iron oxide red (E172), macrogol, poly(vinyl alcohol), talc, titanium dioxide (E171).
English: hepatic steatosis, hepatitis
Maltese: steatożi epatika, epatite
English: Rare renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)4, nephrogenic diabetes insipidus
Maltese: Rari insuffiċjenza talkliewi (akuta u kronika), nekrożi tubulari akuta, nefrite (li tinkludi nefrite akuta interstizjali)4, dijabete insipidus nefroġenika
English: - This medicine contains sodium metabisulfite and lactose.
Maltese: - Din il-mediċina fiha sodium metabisulfite u lactose.
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' kreatinina, ipofosfatemija u tubulopatija prossimali (inkluż is-sindromu ta' Fanconi) ġew irrappurtati bl-użu ta' tenofovir disoproxil fil-prattika klinika (ara sezzjoni 4.8).
English: Component of a multipack cannot be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: CARTON AND LABEL (BOTTLE)
Maltese: KARTUNA U TIKKETTA (FLIXKUN)
English: AUC: ↓ 26% (↓ 15 to ↓ 36) Cmax: ↓ 20% (↓ 11 to ↓ 28) Cmin: ↓ 32% (↓ 15 to ↓ 46) (CYP3A4 and CYP2B6 induction)
Maltese: AUC: ↓ 26% (↓ 15 sa Cmax: ↓ 20% (↓ 11 sa Cmin: ↓ 32% (↓ 15 sa (Induzzjoni ta' CYP3A4 u CYP2B6)
English: (CYP3A4 induction) Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
Maltese: Ir-raxx żviluppa f'46% tal-voluntiera mhux infettati li kienu qed jirċievu efavirenz u clarithromycin.
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 bl-HIV, Cmaxfl-istat fiss kien 1.8 ± 0.7 µg/ml (medja ± S.D.) (39%CV), Cminfl-istat 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: BGP Products Switzerland GmbH Eesti filiaal
Maltese: BGP Products UAB
English: Efavirenz/emtricitabine/tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R, M184V/I or K103N mutation (see sections 4.1 and 5.1).
Maltese: Efavirenz/emtricitabine/tenofovir disoproxil għandu jiġi evitat f'pazjenti b'HIV-1 li jkun qed jaħbi mutazzjonijiet K65R, M184V/I jew K103N (ara sezzjoni 4.1 u 5.1).
English: Cmax: ↑ 64% (mechanism of interaction unknown)
Maltese: Cmax: ↑ 64% (mekkaniżmu talinterazzjoni mhuwiex magħruf)
English: Common pruritus vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)1
Maltese: Komuni ħakk raxx vesikulobolluż, raxx pustulari, raxx makulopapulari, raxx, ħakk, urtikarja, telf tal-kulur tal-ġilda (żieda filpigmentazzjoni)1
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 vitrowrew li s-sostituzzjoni K103N tagħti nuqqas ta' suxxettibbiltà għat-tliet NNRTIs kollha.
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 (pereżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine).
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 fl-istat fiss kien 5.6 ± 3.2 µM (57%), u AUC kien 184 ± 73 µM•h (40%).
English: Cmin: ↓ 12% (↓ 24 to ↑ 1) (CYP3A4 induction)
Maltese: Cmin: ↓ 12% (↓ 24 sa ↑ 1) (Induzzjoni ta' CYP3A4)
English: -0.5% (-3.2% to 2.2%)
Maltese: 98.9% -0.5% (-3.2% sa 2.2%)
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: 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'HIV1 RNA < 75 kopja/ml fil-linja bażi minn studju retrospettiv dwar koorti (dejta miġbura fuq perjodu ta' 20 xahar, ara t-Tabella 5).
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: Listudji 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: 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: Meta użati flimkien ma' efavirenz u żewġ NRTIs, 533/133 mg lopinavir/ritonavir (kapsuli rotob) darbtejn kuljum taw konċentrazzjonijiet simili ta' lopinavir fil-plażma meta mqabbel ma' lopinavir/ritonavir (kapsuli rotob) 400/100 mg darbtejn kuljum mingħajr efavirenz (dejta storika).
English: AUC: ↓ 43% (↓ 7 to ↓ 65) Cmax: ↔
Maltese: AUC: ↓ 43% (↓ 7 sa Cmax: ↔
English: AUC: ↓ 75% (↓ 62 to ↓ 84) Cmax: ↓ 44% (↓ 20 to ↓ 61) Proguanil:
Maltese: AUC: ↓ 75% (↓ 62 sa Cmax: ↓ 44% (↓ 20 sa Proguanil:
English: 0% (-2.4% to 4.2%)
Maltese: 87/87 (100%) 0% (-2.4% sa 4.2%)
English: Also contains: sodium metabisulfite and lactose monohydrate.
Maltese: Fih ukoll: sodium metabisulfite u lactose monohydrate.
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 magħżula in vitrou rriżultat f'sostituzzjonijiet ta' aċidu amminiku singolu jew aktar minn wieħed f'HIV-1 RT, inkluż L100I, V108I, V179D, u Y181C.
English: The most frequently reported adverse reactions considered possibly or probably related to efavirenz/emtricitabine/tenofovir disoproxil 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' efavirenz/emtricitabine/tenofovir disoproxil Mylan fost pazjenti li kienu ttrattati għal sa 48 ġimgħa fi studju AI266073 kienu disturbi psikjatriċi (16%), disturbi fis-sistema nervuża (13%), u disturbi gastrointestinali (7%).
English: Also, emtricitabine did not inhibit uridine 5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Maltese: Emtricitabine, ukoll, ma impedixxietx lill-enżima uridine 5' diphosphoglucuronyl transferase responsabbli għall-glukoronidazzjoni.
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 jiffurmaw emtricitabine triphosphate u tenofovir diphosphate, rispettivament.
English: Cmax: ↑ 11% (↑ 6 to ↑ 16) Cmin: ↔ (CYP3A4 induction)
Maltese: Cmax: ↑ 11% (↑ 6 sa ↑ 16) Cmin: ↔ (Induzzjoni ta' CYP3A4)
English: - Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): You must also use a reliable barrier method of contraception (see Pregnancy and breast-feeding).
Maltese: - Kontraċettiv ormonali, bħal pilloli kontraċettivi, kontraċettiv injettat (pereżempju, DepoProvera), jew impjant kontraċettiv (pereżempju, Implanon): Trid tuża wkoll metodu affidabbli ta' kontraċezzjoni tat-tip barriera (ara Tqala u treddigħ).