FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Maltese: jekk għandek storja ta' mard mentali, inkluża depressjoni, jew abbuż ta' sustanzi jew alkoħol.
English: Modified LOCF 190/203 (93.6%)
Maltese: M=Ma rnexxewx 181/203 (89.2%)
English: Pharmacokinetic studies have not been performed with Atripla in infants and children under 18 years of age (see section 4.2).
Maltese: Popolazzjoni pedjatrika Għadhom ma sarux studji farmakokinetiċi b'Atripla fuq trabi u tfal taħt l-età ta' 18-il sena (ara sezzjoni 4.2).
English: (induction of metabolism)
Maltese: (mekkaniżmu tal-interazzjoni mhux magħruf)
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density of the hip and spine were observed in both treatment groups.
Maltese: Fi studju kliniku kkontrollat ta' 144 ġimgħa li qabbel tenofovir disoproxil ma' stavudine mogħti flimkien ma' lamivudine u efavirenz f'pazjenti li qatt ma kienu ngħataw mediċinali antiretrovirali qabel, kien osservat tnaqqis żgħir fid-densità tal-minerali tal-għadam tal-ġenbejn u tas-sinsla tad-dahar fiż-żewġ gruppi ta' trattament.
English: Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with the fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil.
Maltese: Ġew irrapportati żewġ każijiet addizzjonali (1 prospettiv u 1 retrospettiv) inkluż episodji konsistenti ma' difetti fit-tubu newrali bil-pillola ta' kombinazzjoni ta' doża fissa li fiha efavirenz, emtricitabine, u tenofovir disoproxil.Ma setax jiġi stabbilit jekk dawn il-każijiet kinux ikkawżati bl-użu ta' efavirenz, u d-denominatur mhux magħruf.
English: However, malformations were observed in 3 of 20 foetuses/newborns from efavirenz-treated cynomolgus monkeys given doses resulting in plasma efavirenz concentrations similar to those seen in humans.
Maltese: Madankollu, kienu osservati malformazzjonijiet fi 3 minn 20 fetu/wild ġdid minn xadini cynomolgus ittrattati b'efivirenz li ngħataw dożi li rriżultaw f'konċentrazzjonijiet ta' efivirenz fil-plażma simili għal dawk li dehru fil-bnedmin.
English: AUC: ↓ 27% (↓ 20 to ↓ 33) Cmax: ↓ 20% (↓ 15 to ↓ 24) Cmin: ↓ 35% (↓ 24 to ↓ 44)
Maltese: AUC: ↓ 27% (↓ 20 għal ↓ 33) Cmax: ↓ 20% (↓ 15 għal ↓ 24)
English: Also, emtricitabine did not inhibit uridine 5'-diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Maltese: Barra minn hekk, emtricitabine ma inibixxix uridine 5'-diphosphoglucuronyl transferase, l-enzim responsabbli għall-glukuronidazzjoni.
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Maltese: Fi tfal li ommhom ħadet NRTIs waqt it-tqala, il-benefiċċju mill-protezzjoni kontra l-HIV kien ikbar mir-riskju tal-effetti sekondarji.
English: Test: single fixed-dose combination tablet taken under fasted conditions.
Maltese: Test: pillola ta' kombinazzjoni ta' doża fissa waħda taħt kundizzjonijiet ta' sawm.
English: Fosamprenavir/ritonavir/Tenofovir disoproxil
Maltese: Lopinavir/ritonavir/Tenofovir disoproxil
English: Since Atripla is a combination product and the dosing interval of the individual components cannot be altered, treatment with Atripla must be interrupted in patients with confirmed creatinine clearance < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Maltese: Peress li Atripla hija prodott ikkumbinat u l-intervall tad-dożaġġ tal-komponenti individwali ma jistax jinbidel, it trattament b'Atripla għandu jiġi interrott f'pazjenti b'rata tat-tneħħija tal-krejatinina < 50 ml/min ikkonfermata jew tnaqqis fil-fosfat fis-serum għal < 1.0 mg/dl (0.
English: Clinically significant interactions have not been found and would not be expected since the NRTIs are metabolised via a different route than efavirenz and would be unlikely to compete for the same metabolic enzymes and elimination pathways.
Maltese: Ma nstabux u m'għandhomx ikunu mistennija interazzjonijiet kliniċi sinifikanti billi l-NRTIs jiġu metabolizzati permezz ta' rotta differenti minn efavirenz u mhumiex probabbli li jikkompetu għall istess enzimi metaboliċi u mogħdijiet ta' tneħħija.
English: Patients with renal impairment: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any patient with mild renal impairment treated with Atripla (see sections 4.2, 4.4 and 5.2).
Maltese: Billi tenofovir disoproxil jista' jikkawża tossiċità renali, sorveljanza mill-qrib tal-funzjoni renali hi rakkomandata fi kwalunkwe pazjent b'indeboliment renali ħafif ittrattat b'Atripla (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Maltese: Irriżultat kliniku ta' dan ittnaqqas osservat tal-inqas konċentrazzjonijiet ta' boceprevir ma ġiex evalwat direttament.
English: Indinavir/Emtricitabine (800 mg q8h/200 mg q.d.)
Maltese: (800 mg q8h/200 mg q.d.)
English: Two subjects with confirmed virologic rebound developed NNRTI resistance-associated substitutions to efavirenz including K103N, V106V/I/M and Y188Y/C reverse transcriptase substitutions at week 240 (96 weeks on Atripla) and week 204 (60 weeks on Atripla).
Maltese: u Y188Y/C reverse transcriptase f'ġimgħa 240 (96 ġimgħa fuq Atripla) u ġimgħa 204 (60 ġimgħa fuq Atripla).
English: GMR=geometric least-squares mean ratio, CI=confidence interval
Maltese: Il-valuri għat-Test u Referenza huma medji (% koeffiċjent ta' varjazzjoni) GMR: proporzjon medju tal-inqas kwadri ġeometriku, CI=intervall ta' kunfidenza
English: Atripla was administered on an empty stomach (see section 4.2).
Maltese: Atripla ngħatat fuq stonku vojt (ara sezzjoni 4.2).
English: Co-administration of Atripla with sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/ voxilaprevir is not recommended (see section 4.4).
Maltese: sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir (ara sezzjoni 4.5).
English: In a drug interaction study, carbamazepine plasma concentrations were decreased when carbamazepine was co-administered with efavirenz (see section 4.5).
Maltese: Fi studju tal-interazzjoni tal-mediċina, il-konċentrazzjonijiet fil-plażma ta' carbamazepine kienu mnaqqsa meta carbamazepine ngħata flimkien ma' efavirenz (ara sezzjoni 4.5).
English: In in vitro studies efavirenz did not inhibit CYP2E1 and inhibited CYP2D6 and CYP1A2 only at concentrations well above those achieved clinically.
Maltese: Fi studji in vitro, efavirenz ma inibixxix CYP2E1 iżda inibixxa CYP2D6 u CYP1A2 biss f'konċentrazzjonijiet 'l fuq sewwa minn dawn miksuba klinikament.
English: The pharmacokinetics, safety and efficacy of Atripla have not been established in patients with significant underlying liver disorders (see section 5.2).
Maltese: Il-farmakokinetika, is-sigurtà u l-effikaċja ta' Atripla ma ġewx stabbiliti f'pazjenti b'disturbi sinifikanti diġà eżistenti tal-fwied (ara sezzjoni 5.2).
English: Co-administration with drugs that are known to prolong the QTc interval (proarrhythmic).
Maltese: Dejta dwar l-impatt kliniku li jista' jkollu t-tnaqqis fl-esponiment farmakokinetiku mhijiex disponibbli.
English: Tenofovir is primarily excreted by the kidneys by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration.
Maltese: Tenofovir jinħareġ primarjament mill-kilwa kemm mill-filtrazzjoni kif ukoll mis-sistema ta' trasport tubulari attiva b'bejn wieħed u ieħor 70 sa 80% tad-doża eliminata mhux mibdula fl-awrina wara għoti ġol-vini.
English: Where discontinuation of therapy with one of the components of Atripla is indicated or where dose modification is necessary, separate preparations of efavirenz, emtricitabine and tenofovir disoproxil are available.
Maltese: Fejn jiġi indikat it-twaqqif tat-terapija b'wieħed mill-komponenti ta' Atripla jew fejn tkun meħtieġa modifikazzjoni tad-doża, hemm disponibbli preparazzjonijiet separati ta' efavirenz, emtricitabine u tenofovir disoproxil.
English: Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Maltese: potassju fid-demm u glukows fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: Due to similarities with emtricitabine, Atripla should not be administered concomitantly with other cytidine analogues, such as lamivudine (see section 4.5).
Maltese: Minħabba xebh ma' emtricitabine, Atripla m'għandhiex tingħata fl-istess ħin ma' analogi cytidine oħra, bħal lamivudine (ara sezzjoni 4.5).
English: AUC: ↑ 44% Cmax: ↑ 38%
Maltese: AUC: ↑ 49% C12h: ↑ 3% Cmax: ↑ 64%
English: Atripla may affect your kidneys.
Maltese: Dawn l-avvenimenti ta' spiss kienu transitorji.
English: As of July 2013, the Antiretroviral Pregnancy Registry (APR) has received prospective reports of 904 pregnancies with first trimester exposure to efavirenz-containing regimens, resulting in 766 live births.
Maltese: Minn Lulju 2013, ir-Reġistru tat-Tqala Antiretrovirali (APR, Antiretroviral Pregnancy Registry) irċieva rapporti prospettivi ta' 904 tqaliet b'espożizzjoni tal-ewwel trimestru għal korsijiet li fihom efavirenz, li rriżultaw f'766 twelid ħaj.
English: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with emtricitabine, nelfinavir or ribavirin.
Maltese: Ma kien hemm ebda interazzjoni farmakokinetika klinikament sinifikanti meta tenofovir disoproxil ingħata fl-istess ħin ma' emtricitabine, nelfinavir jew ribavirin.
English: Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg q.d.)
Maltese: Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg q.d.) + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
English: Some patients accidentally taking 600 mg efavirenz twice daily have reported increased nervous system symptoms.
Maltese: Xi pazjenti li aċċidentalment ħadu 600 mg efavirenz darbtejn kuljum irrapportaw żidiet fis-sintomi tas-sistema nervuża.
English: - Medicines used to treat fungal infections (antifungals): Itraconazole or posaconazole.
Maltese: - Mediċini użati biex jittrattaw infezzjonijiet fungali (antifungali):
English: • dizziness, headache, diarrhoea, feeling sick (nausea), being sick (vomiting)
Maltese: • sturdament, uġigħ ta' ras, dijarea, dardir (nawsja), rimettar
English: The pharmacokinetics of Atripla have not been studied in HIV infected patients with hepatic impairment.
Maltese: Il-farmakokinetiċi ta' Atripla ma ġewx studjati f'pazjenti infettati bl-HIV b'indeboliment epatiku.
English: - Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin.
Maltese: - Mediċini użati biex jittrattaw infezzjonijiet batteriċi, inklużi tuberkolożi u l-kumpless relatat mal-AIDS u mycobacterium avium:
English: AUC: ↓ 36% C12h: ↓ 21% Cmax: ↓ 36%
Maltese: ↓ 36% C12h: ↓ 21%
English: Immune Reactivation Syndrome
Maltese: Sindromu tal-Attivazzjoni Immunitarja mill-Ġdid
English: Atripla has not been studied in patients over the age of 65.
Maltese: Atripla ma ġiex studjat f'pazjenti li jkollhom iktar minn 65 sena.
English: AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78)
Maltese: AUC: ↓ 60% (↓ 52 għal ↓ 68) Cmax: ↓ 62% (↓ 55 għal ↓ 78) (Induzzjoni ta' CYP3A4)
English: • difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
Maltese: • diffikultà fl-irqad, holm anormali, diffikultà fil-konċentrazzjoni, ħedla
English: Gilead Sciences Sweden AB Sími: + 46 (0) 8 5057 1849
Maltese: Sími: + 46 (0) 8 5057 1849
English: simvastatin.
Maltese: rispettivament.
English: Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1849
Maltese: Tel: + 46 (0) 8 5057 1849
English: Based on the different elimination pathways, no interaction is expected.
Maltese: Ibbażata fuq il-mogħdijiet ta' tneħħija differenti, lebda interazzjoni mhi mistennija.
English: Adverse reactions were generally consistent with those seen in previous studies of the individual components.
Maltese: Ir-reazzjonijiet avversi kienu ġeneralment konsistenti ma' dawk li ġew osservati fl-istudji ta' qabel tal-komponenti individwali.
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' itraconazole: induzzjoni ta' CYP3A4)
English: AUC: ↓ 52% (↓ 33 to ↓ 66) Cmax: ↓ 45% (↓ 25 to ↓ 59)
Maltese: AUC: ↓ 52% (↓ 33 għal ↓ 66) Cmax: ↓ 45% (↓ 25 għal ↓ 59) (Induzzjoni ta' CYP3A4)
English: Following oral administration of a single 300 mg dose of tenofovir disoproxil to HIV-1 infected patients in the fasted state, maximum tenofovir concentrations were achieved within one hour and the Cmax and AUC (mean ± S.D.) (%CV) values were 296 ± 90 ng/ml (30%) and 2,287 ± 685 ng•h/ml (30%), respectively.
Maltese: Il-valuri (%CV) kienu 296 ± 90 ng/ml (30%) u 2,287 ± 685 ng•h/ml (30%),
English: Atripla film-coated tablets are pink, capsule shaped tablets, engraved on one side with the number “123” and plain on the other side.
Maltese: Il-pilloli Atripla miksijin b'rita huma pilloli roża, f'għamla ta' kapsula, migrufa fuq naħa waħda binnumru “123” u sempliċi fuq in-naħa l-oħra.
English: Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited.
Maltese: L-esperjenza b'efavirenz f'pazjenti li waqqfu sustanzi antiretrovirali oħra tal-klassi NNRTI hija limitata.
English: The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
Maltese: Johnson kienet madwar 0.1%.
English: - if you are taking other medicines that contain efavirenz, emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or lamivudine or adefovir dipivoxil.
Maltese: tenofovir alafenamide, lamivudine jew adefovir dipivoxil.
English: • a feeling of spinning or tilting (vertigo), whistling, ringing or other persistent noise in the ears
Maltese: • sensazzjoni ta' tidwir jew tmejjil (vertiġni), tisfir, żanżin jew ħoss persistenti ieħor fil-widnejn
English: • decreases in phosphate levels in the blood
Maltese: • tnaqqis fil-livelli tal-fosfat fid-demm
English: Resistance analysis by week 144 On-therapy genotypes Efavirenz resistance1 K103N K101E G190A/S Y188C/H V108I P225H M184V/I K65R K70E TAMs2
Maltese: Pazjenti b' HIV-1 li jesprimu tliet mutazzjonijiet analogue assoċjati ta' thymidine (TAMs) jew aktar inkluż jew sostituzzjoni M41L jew L210W f'RT urew suxxettibbiltà mnaqqsa għal tenofovir disoproxil.
English: Table 2: Adverse reactions associated with Atripla listed by the component(s) of Atripla to which the adverse reactions are attributable
Maltese: Tabella 2: Reazzjonijiet avversi assoċjati ma' Atripla elenkati skont il-komponent(i) ta' Atripla li għalihom ir-reazzjonijiet avversi huma attribwibbli
English: Psychiatric symptoms: Patients with a history of psychiatric disorders appear to be at greater risk of serious psychiatric adverse reactions listed in the efavirenz column of Table 2.
Maltese: Pazjenti bi storja ta' disturbi psikjatriċi jidhru li huma f'riskju akbar ta' reazzjonijiet avversi psikjatriċi serji elenkati fil-kolonna ta' efavirenz f'Tabella 2.
English: If you accidentally take too many Atripla tablets you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Maltese: Jekk aċċidentalment tieħu pilloli żejda ta' Atripla, tista' tkun f'riskju miżjud li jkollok effetti sekondarji possibbli b'din il-mediċina (ara sezzjoni 4, Effetti sekondarji possibbli).
English: Atazanavir/ritonavir/Emtricitabine
Maltese: Atazanavir/ritonavir:
English: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Maltese: Għalkemm l-etjoloġija hija kkunsidrata li hija multifattorja (inkluż l-użu ta' kortikosterojdi, konsum ta' alkoħol, immunosoppressjoni severa, indiċi aktar għoli tal-massa tal-ġisem), każijiet ta' osteonekrosi ġew irrapportati partikolarment f'pazjenti b'mard tal-HIV avanzat u/jew esponiment fuq tul ta' żmien għal CART.
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: (5.7%)3, disturb tal attenzjoni (3.6%)3, sturdament (8.5%)3
English: K103N was the most frequently observed RT substitution in viral isolates from patients who experienced rebound in viral load during clinical studies of efavirenz.
Maltese: K103N kienet l-aktar sostituzzjoni RT osservata b'mod frekwenti f'iżolati virali minn pazjenti li esperjenzaw rikaduta flgħadd virali matul l-istudji kliniċi ta' efavirenz.
English: Atripla is not recommended for patients with moderate or severe renal impairment (creatinine clearance (CrCl) < 50 ml/min).
Maltese: Atripla mhix irrikkmandata għal pazjenti b'indeboliment renali moderat jew sever (rata tat-tneħħija tal-krejatinina (CrCl) < 50 ml/min).
English: If your doctor decides to stop one of the components of Atripla, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil separately or with other medicines for the treatment of your HIV infection.
Maltese: Jekk it-tabib tiegħek jiddeċiedi li jwaqqaf wieħed mill-komponenti ta' Atripla, tista' tingħata efavirenz, emtricitabine u/jew tenofovir disoproxil separatament jew ma' mediċini oħra għat trattament tal-infezzjoni tal-HIV tiegħek.
English: In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza immunitarja severa fiż-żmien tal-bidu ta' CART, tista' tqum reazzjoni infjammatorja għal patoġeni opportunisti asintomatiċi jew residwi u tikkaġuna kundizzjonijiet kliniċi serji, jew aggravament tas-sintomi.
English: Atripla is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
Maltese: Atripla mhuwiex rakkomandat għal pazjenti b'indeboliment renali moderat jew sever (eliminazzjoni tal-kreatinina < 50 ml/min).
English: Saquinavir/ritonavir/Tenofovir disoproxil There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with ritonavir boosted saquinavir.
Maltese: Valproic acid/Tenofovir disoproxil L-interazzjoni ma ġietx studjata.
English: Contraception in males and females
Maltese: Mediċini kontra l-malarja
English: If serum phosphate is < 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to < 50 ml/min in any patient receiving Atripla, renal function must be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk il-fosfat fis-serum ikun < 1.5 mg/dl (0.48 mmol/l) jew ir-rata tat-tneħħija tal-krejatinina titnaqqas għal < 50 ml/min fi kwalunkwe pazjent li jkun qed jirċievi Atripla, il-funzjoni renali jeħtieġ li tiġi evalwata mill-ġdid fi żmien ġimgħa, fosthom kejl tal-konċentrazzjonijiet ta' glukows fid-demm,
English: Insufficient data are available to make a dosing recommendation for lopinavir/ritonavir when dosed with Atripla.
Maltese: M'hemmx biżżejjed informazzjoni disponibbli biex issir rakkomandazzjoni tad doża għal lopinavir/ritonavir meta jingħata ma' Atripla.
English: Patients co-infected with HIV and HBV who discontinue Atripla must be closely monitored with both clinical and laboratory follow-up for at least four months after stopping treatment with Atripla.
Maltese: HBV li jwaqqfu Atripla jeħtieġ li jkunu sorveljati mill-qrib b'follow-up kemm kliniku kif ukoll tal laboratorju għal mill-anqas erba' xhur wara t-twaqqif tat-trattament b'Atripla.
English: Cmax: ↓ 64% (↓ 57 to ↓ 69) Cmin: ↓ 62% (↓ 44 to ↓ 75)
Maltese: AUC: ↓ 75% (↓ 59 għal ↓ 84) Cmax: ↓ 64% (↓ 57 għal ↓ 69) Cmin: ↓ 62% (↓ 44 għal ↓ 75)
English: Co-administration of Atripla and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended since plasma concentrations of velpatasvir and voxilaprevir are expected to decrease following co-administration with efavirenz leading to reduced therapeutic effect of sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 4.5).
Maltese: L-għoti flimkien ta' Atripla ma' sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir mhux rakkomandat peress li l-konċentrazzjonijiet fil-plażma ta' velpatasvir u voxilaprevir huma mistennija li jonqsu wara għoti flimkien ma' efavirenz li jwasslu għal effett terapewtiku mnaqqas ta'
English: - You must remain under the care of your doctor while taking Atripla.
Maltese: M'għandekx tieħu Atripla ma' ċerti mediċini.
English: Efavirenz, emtricitabine and tenofovir have been shown to be excreted in human milk.
Maltese: Intwera li efavirenz, emtricitabine u tenofovir huma eliminati fil-ћalib tas-sider tal-bniedem.
English: Description of selected adverse reactions
Maltese: Komuni ħafna astenja
English: • forgetfulness, confusion, fitting (seizures), incoherent speech, tremor (shaking)
Maltese: • tinsa, konfużjoni, aċċessjonijiet, diskors li ma jiftiehemx, rogħda (tertir)
English: These problems tend to occur more often in those who have a history of mental illness.
Maltese: Dawn il-problemi għandhom tendenza li jseħħu aktar spiss f'dawk li għandhom storja ta' mard mentali.
English: Pregnancy
Maltese: Adulti
English: Manufacturer:
Maltese: Impjant:
English: Administration of efavirenz capsules with a high fat meal increased the mean AUC and Cmax of efavirenz by 28% and 79%, respectively, compared to administration in a fasted state.
Maltese: Għoti ta' pilloli ta' efavirenz ma' ikla b'ħafna xaħam żied l-AUC medju u Cmax ta' efavirenz bi 28% u b'79%, rispettivament, meta mqabbla mal-għoti fi stat ta' sawm.
English: QTc prolongation has been observed with the use of efavirenz (see sections 4.5 and 5.1).
Maltese: Titwil ta' QTc Ġie osservat titwil ta' QTc bl-użu ta' efavirenz (ara sezzjonijiet 4.5 u 5.1).
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: Pazjenti li qed jirċievu prodotti mediċinali konkomitanti kontra l-aċċessjonijiet metabolizzati primarjament permezz tal-fwied, bħal ma huma phenytoin, carbamazepine u phenobarbital, jistgħu jeħtieġu sorveljanza perjodika tal-livelli fil-plażma.
English: Severe hepatic impairment (CPT, Class C) (see section 5.2).
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1. Indeboliment epatiku sever (CPT, Klassi Ċ) (ara sezzjoni 5.2).
English: Inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported rarely when medicines containing tenofovir disoproxil and didanosine were taken together.
Maltese: Infjammazzjoni tal-frixa u aċidożi lattika (eċċess ta' aċidu lattiku fid-demm), li tista' xi kultant tikkaġuna l-mewt, ġew irrapportati rarament meta mediċini li fihom tenofovir disoproxil u didanosine ttieħdu flimkien.
English: There is no specific antidote for overdose with efavirenz.
Maltese: Ma hemm lebda antidotu speċifiku għal doża eċċessiva b'efavirenz.
English: IMMUNOSUPPRESSANTS Ciclosporing
Maltese: IMMUNOSUPPRESSANTI Ciclosporing
English: Moderate RI
Maltese: RI Moderat
English: EU/1/14/958/001 EU/1/14/958/002
Maltese: EU/1/14/958/002
English: Study 1119
Maltese: Studju 1119
English: Genotype 2b 16-530b
Maltese: Ġenotip 2b 16-530b
English: Observed:
Maltese: Osservata:
English: County Cork, T45 DP77 Ireland
Maltese: County Cork, T45 DP77
English: > or = 75
Maltese: > jew = 75