FrancophonIA/ELRC3.0 huggingface dataset:
English: AUC: ↓ 64% (↓ 62 to ↓ 67) Cmax: ↓ 46% (↓ 39 to ↓ 52) Cmin: ↓ 82% (↓ 79 to ↓ 85)
Maltese: AUC: ↓ 64% (↓ 62 għal ↓ 67) Cmax: ↓ 46% (↓ 39 għal ↓ 52) Cmin: ↓ 82% (↓ 79 għal ↓ 85)
English: A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Maltese: kontraċezzjoni tat-tip barriera flimkien mal kontraċettivi ormonali (ara sezzjoni 4.6).
English: - Medicines used to treat infection with the hepatitis C virus: boceprevir, elbasvir/grazoprevir,
Maltese: - Mediċini użati biex jikkuraw infezzjoni bil-virus tal-epatite Ċ: boceprevir,
English: (CYP3A4 or P-gp induction - effect on elbasvir)
Maltese: (induzzjoni ta' CYP3A4 jew P-gp - effett fuq elbasvir)
English: Patients either changed to Atripla (N=203) or continued on their original antiretroviral treatment regimen (N=97).
Maltese: Il-pazjenti jew qalbu għal Atripla (N= 203) jew komplew fuq ir-reġimen ta' trattament antiretrovirali oriġinali tagħhom (N= 97).
English: After 96 weeks of Atripla treatment, HIV-1 RNA plasma concentrations remained < 50 copies/ml in 82% of patients and < 400 copies/ml in 85% of patients (intention to treat analysis (ITT), missing=failure).
Maltese: Wara 96 ġimgħa ta' trattament b'Atripla, konċentrazzjonijiet ta' HIV-1 RNA fil-plażma baqgħu < 50 kopji/ml fi 82% tal-pazjenti u < 400 kopja/ml f'85% tal-pazjenti (analiżi b'intenzjoni li tiġi ttrattata (ITT), nieqsa=ma ħadimx).
English: AUC: ↓ 69% (↓ 55 to ↓ 79) Cmax: ↓ 60% (↓ 50 to ↓ 68) Cmin: ↓ 63% (↓ 44 to ↓ 75)
Maltese: AUC: ↓ 69% (↓ 55 għal ↓ 79) Cmax: ↓ 60% (↓ 50 għal ↓ 68) Cmin: ↓ 63% (↓ 44 għal ↓ 75)
English: The potential for interactions with efavirenz and other azole antifungals, such as ketoconazole, has not been studied.
Maltese: Il-potenzjal għal interazzjonijiet ma' efavirenz u antifungali azole oħrajn, bħal ketoconazole, ma ġiex studjat.
English: Renal and urinary disorders: Uncommon increased creatinine, proteinuria, proximal renal tubulopathy including Fanconi syndrome
Maltese: proteinurja, tubulopatija renali prossimali li tinkludi s sindromu ta' Fanconi.
English: Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz (see section 4.8).
Maltese: Raxx sever assoċjat ma' nfafet, deskwamazzjoni niedja jew ulċerazzjoni ġew irrapportati f'anqas minn 1% tal-pazjenti ttrattati b'efavirenz (ara sezzjoni 4.8).
English: AUC: ↑ 11% (↑ 5 to ↑ 18) Cmax: ↑ 16% (↑ 6 to ↑ 26) Cmin: ↑ 13% (↑ 1 to ↑ 26)
Maltese: AUC: ↑ 11% (↑ 5 għal ↑ 18) Cmax: ↑ 16% (↑ 6 għal ↑ 26) Cmin: ↑ 13% (↑ 1 għal ↑ 26) (Induzzjoni ta' CYP3A4)
English: In patients with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 µg•h/ml (19%) of emtricitabine, and over 48 hours to 42,857 ng•h/ml (29%) of tenofovir.
Maltese: F'pazjenti b'mard renali tal-aħħar fażi (ESRD) li jeħtieġu emodijaliżi, l-espożizzjonijiet tal-mediċina bejn id-dijaliżi żdiedu sostanzjalment tul 72 siegħa għal 53 µg•h/ml (19%) ta' emtricitabine, u aktar minn 48 siegħa għal 42,857 ng•h/ml (29%) ta' tenofovir.
English: • back pain caused by kidney problems, including kidney failure.
Maltese: • uġigħ fid-dahar ikkaġunat minn problemi tal-kliewi, inkluż insuffiċjenza tal-kliewi.
English: Severe skin reactions such as Stevens-Johnson syndrome and erythema multiforme; neuropsychiatric adverse reactions (including severe depression, death by suicide, psychosis-like behaviour, seizures); severe hepatic events; pancreatitis and lactic acidosis (sometimes fatal) have been reported.
Maltese: Reazzjonijiet severi tal-ġilda bħas-sindromu ta' Stevens-Johnson u eritema multiforme; reazzjonijiet avversi newropsikjatriċi (li jinkludu dipressjoni severa, mewt permezz ta' suwiċidju, imġiba qisha ta' persuna bi psikożi, aċċessjonijiet); avvenimenti epatiċi severi; pankreatite u aċidożi lattika (li kultant kienu fatali) ġew irrappurtati.
English: AUC: ↓ 55% (↓ 48 to ↓ 62) Cmax: ↓ 34% (↓ 21 to ↓ 47)
Maltese: AUC: ↓ 55% (↓ 48 għal ↓ 62) Cmax: ↓ 34% (↓ 21 għal ↓ 47)
English: Common diarrhoea, vomiting, abdominal pain, nausea elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia abdominal pain, abdominal distension, flatulence
Maltese: Komuni dijarea, rimettar, uġigħ addominali, dardir amylase għolja inkluża amylase pankreatika għolja, lipase fis-serum għoli, rimettar, uġigħ addominali, dispepsja uġigħ addominali,
English: Adverse reactions associated with the use of Atripla: Treatment-emergent adverse reactions considered possibly or probably related to Atripla reported in study AI266073 (over 48 weeks; n = 203), which have not been associated with one of the individual components of Atripla, include:
Maltese: Ir-reazzjonijiet avversi li żviluppaw mill-kura li huma kkunsidrati bħala possibbilment jew probabbilment marbuta ma' Atripla rrappurtati fi studju AI266073 (fuq perjodu ta' 48 ġimgħa; n=203), li ma ġewx assoċjati ma' wieħed mill-komponenti individwali ta' Atripla, jinkludu:
English: Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies.
Maltese: Sintomi li jinkludu, iżda mhumiex limitati għal, sturdament, insomnja, somnolenza, konċentrazzjoni mfixkla u ħolm anormali huma effetti mhux mixtieqa rrapportati b'mod frekwenti f'pazjenti li ngħataw efavirenz 600 mg kuljum fi studji kliniċi.
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 intwera li jinduċi CYP3A4 u CYP2B6, li jirriżulta fl-induzzjoni tal-metaboliżmu tiegħu stess li jista' jkun klinikament rilevanti f'xi pazjenti.
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse reactions.
Maltese: L-għoti fl-istess ħin ta' tenofovir disoproxil u didanosine jirriżulta f'żieda ta' 40-60% fl-esponiment sistemiku għal didanosine li jista' jżid ir-riskju ta'
English: EXP
Maltese: Talc
English: Antimalarials
Maltese: Antivirali
English: AUC: ↓ 43% (↓ 34 to ↓ 50) Cmax: ↓ 12% (↓ 1 to ↓ 26)
Maltese: AUC: ↓ 43% (↓ 34 għal ↓ 50) Cmax: ↓ 12% (↓ 1 għal ↓ 26)
English: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill
Maltese: Gilead Sciences Ireland UC
English: Tenofovir disoproxil and emtricitabine, two of the active substances in Atripla, show some activity against hepatitis B virus although emtricitabine is not approved for the treatment of hepatitis B infection.
Maltese: Tenofovir disoproxil u emtricitabine, tnejn mis-sustanzi attivi f'Atripla juru xi attività kontra l-virus tal-epatite B għalkemm emtricitabine mhuwiex approvat għat-trattament tal-infezzjoni bl-epatite B.
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected patients with varying degrees of hepatic impairment defined according to CPT classification.
Maltese: Doża singola ta' 245 mg ta' tenofovir disoproxil ingħata lil pazjenti mhux infettati bl-HIV bi gradi varji ta' indeboliment tal-fwied definiti skont il-klassifikazzjoni tas-CPT.
English: This medicinal product contains 23.6 mg sodium per dose, equivalent to 1.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 23.6 mg sodium f'kull doża, ekwivalenti għal 1.2% tal-ammont massimu rakkomandat mill-WHO ta' 2 g sodium li għandu jittieħed kuljum minn adult.
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the CYP system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Maltese: Bijotrasformazzjoni Studji fl-umani u studji in vitro li jużaw mikrosomi tal-fwied uman urew li efavirenz huwa metabolizzat b'mod ewlieni mis-sistema ta' CYP għal metaboliti idrossillati b'glukuronidazzjoni sussegwenti tal-metaboliti idrossilati.
English: Nervous system symptoms: Nervous system symptoms are common with efavirenz, one of the components of Atripla.
Maltese: Sintomi tas-sistema nervuża huma komuni b'efavirenz, wieħed millkomponenti ta' Atripla.
English: Efavirenz exposure may be increased when given with medicinal products (for example ritonavir) or food (for example, grapefruit juice) which inhibit CYP3A4 or CYP2B6 activity.
Maltese: L-esponiment għal efavirenz jista' jiżdied meta jingħata ma' prodotti mediċinali (eżempju ritonavir) jew ikel (eżempju, meraq tal-grejpfrut) li jimpedixxu attività ta' CYP3A4 jew CYP2B6.
English: Package leaflet: Information for the patient Atripla 600 mg/200 mg/245 mg film-coated tablets
Maltese: Informazzjoni għall-pazjent Atripla 600 mg/200 mg/245 mg pilloli miksija b'rita
English: AUC: ↓ 35% (↓ 13 to ↓ 40) Cmax: ↓ 13% (↓ 0 to ↓ 23)
Maltese: ↓ 35% (↓ 13 għal ↓ 40) Cmax: ↓ 13% (↓ 0 għal ↓ 23)
English: How to take Atripla
Maltese: Mediċini oħra u Atripla
English: There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh-Turcotte Class B or C) affects efavirenz pharmacokinetics.
Maltese: Kien hemm dejta insuffiċjenti biex jiġi stabbilit jekk indeboliment tal-fwied moderat jew sever (Child-Pugh-Turcotte Klassi B jew Ċ) jaffettwax il-farmakokinetika ta' efavirenz.
English: AUC: ↓ 39% (↓ 27 to ↓ 50) Cmax: ↓ 29% (↓ 15 to ↓ 40) Cmin: ↓ 46% (↓ 31 to ↓ 58)
Maltese: ↓ 39% (↓ 27 għal ↓ 50) Cmax: ↓ 29% (↓ 15 għal ↓ 40) Cmin: ↓ 46% (↓ 31 għal ↓ 58)
English: Titanium dioxide (E171)
Maltese: Titanium dioxide (E171) 6.2 Inkompatibbiltajiet Mhux applikabbli.
English: The frequency of this is unknown (see section 4.4).
Maltese: Ilfrekwenza ta' dan mhix magħrufa (ara sezzjoni 4.4).
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: L-effetti avversi ewlenin li kienu rrappurtati huma disturbi ematoloġiċi (anemija, newtropenja), u disturbi fil-metaboliżmu (iperlaktejtimja, iperlajpejżimja).
English: It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months.
Maltese: Hija indikata għat-trattament ta' infezzjoni bil-virus-1 tal-immunodefiċjenza tal-bniedem (HIV-1) fl adulti minn età ta' 18-il sena u aktar b'soppressjoni viroloġika għal livelli HIV-1 RNA ta' < 50 kopja/ml fuq it-terapija antiretrovirali tagħhom ta' kombinazzjoni għal aktar minn tliet xhur.
English: Uncommon rhabdomyolysis2, muscular weakness2
Maltese: dgħjufija fil-muskoli2
English: Monitoring of renal function is recommended for patients receiving Atripla (see section 4.4).
Maltese: Sorveljanza tal-funzjoni renali hi rakkomandata għal pazjenti li jkunu qed jirċievu Atripla (ara sezzjoni 4.4).
English: Elbasvir/grazoprevir: Co-administration of Atripla with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir (see section 4.3 and Table 1).
Maltese: L-għoti ta' Atripla flimkien ma' elbasvir/grazoprevir huwa kontraindikat għaliex dan jista' jwassal għal telf tar-rispons viroloġiku għal elbasvir/grazoprevir (ara sezzjoni 4.3 u
English: AUC: ↓ 37% (↓ 14 to ↓ 55) Cmax: ↓ 35% (↓ 12 to ↓ 52) Cmin: ↓ 43% (↓ 18 to ↓ 60)
Maltese: ↓ 37% (↓ 14 għal ↓ 55) Cmax: ↓ 35% (↓ 12 għal ↓ 52) Cmin: ↓ 43% (↓ 18 għal ↓ 60)
English: Darunavir/ritonavir/Efavirenz (300 mg b.i.d.
Maltese: Darunavir/ritonavir/Efavirenz (300 mg b.i.d.*/100 mg b.i.d./
English: ↓ exposure of the immunosuppressant may be expected (CYP3A4 induction).
Maltese: Tnaqqis fl-esponiment ta' etonogestrel jista' jkun mistenni (induzzjoni ta' CYP3A4).
English: The safety and efficacy of Atripla in children under the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Atripla fit-tfal taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Uncommon suicide attempt3, suicide ideation3, psychosis3, mania3, paranoia3, hallucination3, euphoric mood3, affect lability3, confusional state3, aggression3, catatonia3
Maltese: alluċinazzjoni3, burdata ewforika3, labilità talaffett3, stat konfużjonali3,
English: Each film-coated tablet contains 1 mmol (23.6 mg) of sodium.
Maltese: Kull pillola miksija b'rita fiha 1 mmol (23.6 mg) ta' sodju.
English: Musculoskeletal and connective tissue disorders: Very common elevated creatine kinase
Maltese: Komuni ħafna creatine kinase elevat
English: - The other ingredients in the tablet film coating are iron oxide black, iron oxide red, macrogol 3350, poly(vinyl alcohol), talc, titanium dioxide.
Maltese: - Is-sustanzi l-oħra fil-kisja-rita tal-pillola huma iron oxide black, iron oxide red, macrogol 3350,
English: AUC: ↓ 38% (↓ 28 to ↓ 47) Cmax: ↓ 32% (↓ 15 to ↓ 46) Cmin: ↓ 45% (↓ 31 to ↓ 56)
Maltese: ↓ 38% (↓ 28 għal ↓ 47) Cmax: ↓ 32% (↓ 15 għal ↓ 46) Cmin: ↓ 45% (↓ 31 għal ↓ 56)
English: The safety and efficacy of Atripla have not been studied for the treatment of chronic HBV infection.
Maltese: Is-sigurtà u l-effikaċja ta' Atripla ma ġewx studjati għat-trattament ta' infezzjoni HBV kronika.
English: Malformations have been observed in foetuses from efavirenz-treated monkeys (see section 5.3).
Maltese: Formazzjoni difettużi ġiet osservata f'feti ta' xadini kkurati b'efavirenz (ara sezzjoni 5.3).
English: Resistance to emtricitabine or tenofovir has been seen in vitro and in some HIV-1 infected patients due to the development of an M184V or M184I substitution in RT with emtricitabine or a K65R substitution in RT with tenofovir.
Maltese: Reżistenza għal emtricitabine jew tenofovir intweriet in vitro u f'xi pazjenti infettati blHIV-1 minħabba l-iżvilupp ta' sostituzzjoni ta' M184V jew M184I f'RT b'sostituzzjoni ta' emtricitabine jew ta' K65R f'RT b'tenofovir.
English: It is important not to miss a dose of Atripla.
Maltese: Huwa importanti li ma taqbiżx doża ta' Atripla.
English: Gilead Sciences Poland Sp. z o.o.
Maltese: Gilead Sciences Belgium SPRL-BVBA
English: AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46)
Maltese: AUC: ↑ 21% (↑ 10 għal ↑ 34) Cmax: ↑ 14% (↑ 4 għal ↑ 26) Cmin: ↑ 25% (↑ 7 għal ↑ 46) (inibizzjoni ta' metaboliżmu ossidattiv medjat minn CYP)
English: The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla (see section 5.1).
Maltese: Il-wiri tal-benefiċċju ta' Atripla huwa bbażat primarjament fuq dejta ta' 48 ġimgħa minn studju kliniku li fih il-pazjenti b'soppressjoni viroloġika stabbli fuq terapija antiretrovirali ta' kombinazzjoni bidlu għal Atripla (ara sezzjoni 5.1).
English: Interaction with didanosine: Co-administration of Atripla and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Maltese: L-għoti ta' Atripla flimkien ma' didanosine mhuwiex rakkomandat għax jista' jirriżulta f'żieda ta' 40-60% fl-esponiment sistemiku għal didanosine li jista' jżid ir-riskju ta' reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 24 01 35 50
Maltese: Tél/Tel: + 32 (0) 24 01 35 50
English: fluoroquinolones, imidazole and triazole antifungal agents, - certain non-sedating antihistamines (terfenadine, astemizole), - cisapride, - flecainide, - certain antimalarials, - methadone (see sections 4.4, 4.5 and 5.1).
Maltese: - ċerti sustanzi kontra l-malarja, - methadone (ara sezzjonijiet 4.4, 4.5 u 5.1).
English: - Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Maltese: - Sertraline, mediċina użata biex tittratta d-depressjoni, għax it-tabib tiegħek jista' jkun jeħtieġ li jbiddillek id-doża ta' sertraline.
English: hyperglycaemia, hypertriglyceridaemia
Maltese: ipergliċemija, ipertrigliċeridimja
English: If concomitant use of Atripla and nephrotoxic agents (e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir, interleukin-2) is unavoidable, renal function must be monitored weekly (see section 4.5).
Maltese: Jekk l-użu konkomitanti ta' Atripla u mediċini nefrotossiċi (eż. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir, interleukin-2) ma jistax jiġi evitat, il-funzjoni renali għandha tkun sorveljata kull ġimgħa (ara sezzjoni 4.5).
English: • angry behaviour, suicidal thoughts, strange thoughts, paranoia, unable to think clearly, mood being affected, seeing or hearing things that are not really there (hallucinations), suicide attempts, personality change (psychosis), catatonia (a condition in which the patient is rendered motionless and speechless for a period).
Maltese: • imġiba rrabjata, ideat suwiċidali, ħsibijiet strambi, paranojja, ma tistax taħseb sewwa, burdata li tkun affettwata, tara jew tisma' affarijiet li ma jkunux veru hemm (alluċinazzjonijiet), attentati ta' suwiċidju, tibdil fil-personalità (psikożi), katatonja (kundizzjoni fejn il-pazjent ma jkunx jista' jiċċaqlaq jew jitkellem għal perjodu ta' żmien).
English: Lopinavir concentrations: similar to lopinavir/ritonavir 400/100 mg twice daily without efavirenz.
Maltese: Konċentrazzjonijiet ta' lopinavir: simili għal lopinavir/ritonavir 400/100 mg darbtejn kuljum mingħajr efavirenz.
English: Lopinavir/ritonavir soft capsules or oral solution/Efavirenz
Maltese: Lopinavir/ritonavir kapsuli rotob jew soluzzjoni orali/Efavirenz
English: When the two strata were analysed separately, response rates in the stratum with prior PI-treatment were numerically lower for patients switched to Atripla [92.4% versus 94.0% for the PVR (sensitivity analysis) for Atripla and SBR patients respectively; a difference (95%CI) of -1.6% (-10.0%, 6.7%).
Maltese: Meta ż-żewġ strata kienu analizzati separatament, ir-rati tar-rispons fl-istratum b'kura bil-PI fil-passat kienu numerikament iktar baxxi għal pazjenti li qalbu għal Atripla [92.4% kontra 94.0% għall-PVR (analiżi tas-sensittività) għal Atripla u pazjenti SBR (stayed on their baseline regimen) rispettivament; differenza (95%CI) ta' -1.6% (-10.0%, 6.7%)].
English: When efavirenz is co-administered with a calcium channel blocker that is a substrate of the CYP3A4 enzyme, there is a potential for reduction in the plasma concentrations of the calcium channel blocker.
Maltese: Meta efavirenz jingħata flistess ħin ma' imblokkatur tal-kanali talkalċju li jkun sottostrat ta' enzima CYP3A4, hemm potenzjal għal tnaqqis filkonċentrazzjonijiet tal-plażma tal imblokkatur tal-kanali tal-kalċju.
English: AUC: ↓ 39% (↓ 30 to ↓ 46) Cmax: ↓ 26% (↓ 15 to ↓ 35)
Maltese: ↓ 39% (↓ 30 għal ↓ 46) Cmax: ↓ 26% (↓ 15 għal ↓ 35)
English: Rare renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)4, nephrogenic diabetes insipidus
Maltese: nefrite (inkluż nefrite interstizjali akuta)4,
English: Morning Cmin: ↑ 42% (↑ 9 to ↑ 86) Evening Cmin: ↑ 24% (↑ 3 to ↑ 50)
Maltese: Cmin fil-għodu: ↑ 42% (↑ 9 għal ↑ 86) Cmin fil-għaxija: ↑ 24% (↑ 3 għal ↑ 50)
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli: kartun ta' barra li fihom 1 flixkun ta' 30 pillola miksija b'rita u kartun ta' barra li fihom 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: Lopinavir/ritonavir/Tenofovir disoproxil (400 mg b.i.d./100 mg b.i.d./245 mg q.d.)
Maltese: Darunavir/ritonavir/Tenofovir disoproxil (300 mg b.i.d.*/100 mg b.i.d./ 245 mg q.d.)
English: The adverse reaction profile of efavirenz, emtricitabine and tenofovir disoproxil in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection.
Maltese: emtricitabine u tenofovir disoproxil f'pazjenti ko-infettati bl-HIV/HBV jew bl-HIV/HCV kien jixbah lil dak osservat f'pazjenti infettati bl-HIV mingħajr ko-infezzjoni.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni tal-HIV avvanzata (AIDS) u bi storja ta' infezzjoni opportunistika, sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet ta' qabel jistgħu jseħħu wara li jinbeda trattament kontra l-HIV.
English: The safety and efficacy of Atripla in children under the age of 18 years have not been established (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' Atripla fit-tfal taħt l-età ta' 18-il sena ma ġewx determinati s'issa (ara sezzjoni 5.2).
English: Co-administration of Atripla with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir.
Maltese: Atripla ma' elbasvir/grazoprevir huwa kontraindikat għaliex dan jista' jwassal għal telf tarrispons viroloġiku għal elbasvir/grazoprevir.
English: Patients with HIV-1 harbouring mutations
Maltese: Pazjenti b'HIV-1 b'mutazzjonijiet moħbija
English: Atripla may make hormonal contraceptives less likely to work.
Maltese: Atripla jista' jagħmel kontraċettivi ormonali inqas possibbli li jaħdmu.
English: Recommendation concerning co-administration with Atripla (efavirenz 600 mg, emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Maltese: Rakkomandazzjoni dwar l-għoti flimkien ma' Atripla (efavirenz 600 mg, emtricitabine 200 mg, tenofovir disoproxil 245 mg)
English: St. John's wort (Hypericum perforatum): Co-administration of Atripla and St. John's wort or herbal preparations containing St. John's wort is contraindicated.
Maltese: John's wort (Hypericum perforatum) (preparazzjoni tal-ħxejjex użat għad depressjoni u l-ansjetà)
English: Animal studies on emtricitabine and tenofovir disoproxil do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali b'emtricitabine u tenofovir disoproxil ma jurwx effetti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Artemether/Lumefantrine/Emtricitabine Interaction not studied.
Maltese: Artemether/Lumefantrine/ Emtricitabine
English: genotype following the administration of 600 mg daily dose for 14 days was 2.25-fold the mean Cmax observed in subjects with CYP2B6 *1/*1 genotype.
Maltese: Is-Cmax medja ta' efavirenz f'individwi bil-ġenotip CYP2B6 *6/*6 wara l-għoti ta' doża ta' 600 mg kuljum għal 14-il ġurnata kienet 2.25 darba s-Cmax medja osservata f'individwi bil-ġenotip CYP2B6 *1/*1.
English: Mechanism of action and pharmacodynamic effects Efavirenz is an NNRTI of HIV-1.
Maltese: Mekkaniżmu ta' azzjoni u effetti farmakodinamiċi Efavirenz huwa NNRTI ta' HIV-1.
English: (UGT1A1 induction)
Maltese: ↓ 36% (Induzzjoni ta' UGT1A1)
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Maltese: It-tossiċità fl-għadam kienet dijanjostikata bħala osteomalaċja (fix-xadini) u tnaqqis fid-densità minerali tal-għadam (BMD) (fil-firien u l-klieb).
English: Anencephaly and unilateral anophthalmia with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus and cleft palate was observed in a third foetus.
Maltese: Anenċefalija u anoftalmija unilaterali bi tkabbir sekondarju tal-ilsien kienu osservati f'fetu wieħed, mikro-oftalmija kienet osservata f'fetu ieħor, u palat mixquq kien osservat fit-tielet fetu.
English: Efavirenz may be an inducer of CYP2C19 and CYP2C9; however, inhibition has also been observed in vitro and the net effect of co-administration with substrates of these enzymes is not clear (see section 5.2).
Maltese: Efavirenz jista' jkun induttur ta' CYP2C19 u CYP2C9; madankollu, inibizzjoni ġiet osservata wkoll in vitro u l-effett nett tal-għoti fl-istess ħin ma' substrati ta' dawn l-enzimi mhuwiex ċar (ara sezzjoni 5.2).