FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR06.
Maltese: Antivirali għal użu sistemiku, antivirali għat-trattament ta' infezzjonijiet tal-HIV, kombinazzjonijiet, Kodiċi ATC:
English: The combination of efavirenz, emtricitabine and tenofovir disoproxil has been studied in 460 patients either as the fixed-dose combination tablet efavirenz/emtricitabine/tenofovir disoproxil (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' efavirenz/emtricitabine/tenofovir disoproxil (studju AI266073) jew bħala l-prodotti tal-komponenti (studju GS-01-934).
English: Valproic acid/Tenofovir disoproxil Interaction not studied.
Maltese: Valproic acid/Tenofovir disoproxil L-interazzjoni ma ġietx studjata.
English: AUC: ↑ 21% (↑ 10 to ↑ 34) Cmax: ↑ 14% (↑ 4 to ↑ 26) Cmin: ↑ 25% (↑ 7 to ↑ 46) (inhibition of CYP-mediated oxidative metabolism)
Maltese: AUC: ↑ 21% (↑ 10 għal ↑ 34) Cmax: ↑ 14% (↑ 4 għal ↑ 26) Cmin: ↑ 25% (↑ 7 għal ↑ 46) (inibizzjoni ta' metaboliżmu ossidattiv medjat minn CYP)
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 llivelli ta' efavirenz.
English: Tacrolimus/Emtricitabine/Tenofovi r disoproxil (0.1 mg/kg q.d./200 mg/245 mg q.d.)
Maltese: Tacrolimus/Emtricitabine/Tenofovir disoproxil (0.1 mg/kg q.d./200 mg/ 245 mg q.d.)
English: Insufficient numbers of patients over 65 years of age have been studied.
Maltese: Ġew studjati numri insuffiċjenti ta' pazjenti li għandhom 'l fuq minn 65 sena.
English: AUC: ↓ 53% (↓ 61 to ↓ 43) Cmax: ↓ 47% (↓ 57 to ↓ 36) Cmin: ↓ 57% (↓ 64 to ↓ 48)
Maltese: AUC: ↓ 53% (↓ 61 għal ↓ 43) Cmax: ↓ 47% (↓ 57 għal ↓ 36) Cmin: ↓ 57% (↓ 64 għal ↓ 48)
English: Cmax: ↑ 11% (↑ 3 to ↑ 19) (CYP3A4 induction)
Maltese: Cmax: ↑ 11% (↑ 3 għal ↑ 19) (Induzzjoni ta' CYP3A4)
English: In addition, a K70E substitution in HIV-1 RT has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, lamivudine and tenofovir.
Maltese: Barra minn hekk, sostituzzjoni K70E f'HIV-1 RT intgħażlet minn tenofovir u tirriżulta f'suxxetibilita mnaqqsa ta' livell baxx għal abacavir, emtricitabine, lamivudine u tenofovir.
English: AUC: ↓ 26% (↓ 15 to ↓ 36) Cmax: ↓ 20% (↓ 11 to ↓ 28) Cmin: ↓ 32% (↓ 15 to ↓ 46) (CYP3A4 and CYP2B6 induction)
Maltese: AUC: ↓ 26% (↓ 15 għal ↓ 36) Cmax: ↓ 20% (↓ 11 għal ↓ 28) Cmin: ↓ 32% (↓ 15 għal ↓ 46) (Induzzjoni ta' CYP3A4 u CYP2B6)
English: If therapy with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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'Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, għandha tingħata konsiderazzjoni għall-half-life twila ta' efavirenz (ara sezzjoni 5.2) u l-half-lives intraċellulari twal ta' tenofovir u emtricitabine.
English: Concomitant use of St. John's wort is contraindicated (see section 4.3).
Maltese: L-użu konkomitanti ta' St John's Wort huwa kontraindikat (ara sezzjoni 4.3).
English: *lower than recommended doses; similar findings are expected with recommended doses.
Maltese: *dożi inqas minn dawk rakkomandati; riżultati simili huma mistennija bid-dożi rakkomandati.
English: Cmax: ↑ 11% (↑ 6 to ↑ 16) Cmin: ↔ (CYP3A4 induction)
Maltese: Cmax: ↑ 11% (↑ 6 għal ↑ 16) Cmin: ↔ (Induzzjoni ta' CYP3A4)
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, distensjoni addominali, gass fl-istonku
English: Atovaquone and proguanil hydrochloride/Efavirenz (250/100 mg single dose/600 mg q.d.)
Maltese: Atovaquone u proguanil hydrochloride/Efavirenz (250/100 mg doża waħda/600 mg q.d.)
English: Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Maltese: Kemm emtricitabine triphosphate u tenofovir diphosphate huma impedituri dgħajfa ta' polymerases tad-DNA tal-mammali u ma kien hemm ebda evidenza ta' tossiċità għal mitokondrija in vitro u in vivo.
English: Rare renal failure (acute and chronic), acute tubular necrosis,
Maltese: Rari insuffiċjenza renali (akuta u kronika), nekrosi tubulari akuta, nefrite (inkluż nefrite interstizjali akuta) dijabete insipidus nefroġenika
English: AUC: ↓ 71% (↓ 67 to ↓ 74) Cmax: ↓ 51% (↓ 46 to ↓ 56) Cmin: ↓ 91% (↓ 88 to ↓ 92)
Maltese: AUC: ↓ 71% (↓ 67 għal 74) Cmax: ↓ 51% (↓ 46 għal ↓ 56) Cmin: ↓ 91% (↓ 88 għal ↓ 92)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka fih sodium Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Some examples include: aminoglycosides, vancomycin (medicines for bacterial infections) foscarnet, ganciclovir, cidofovir (medicines for viral infections) amphotericin B, pentamidine (medicines for fungal infections) interleukin-2 (to treat cancer) non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Maltese: Xi eżempji jinkludu: aminoglycosides, vancomycin (mediċini għal infezzjonijiet batteriċi) foscarnet, ganciclovir, cidofovir (mediċini għal infezzjonijiet virali) amphotericin B, pentamidine (mediċini għal infezzjonijiet fungali) interleukin-2 (biex jittratta l-kanċer)
English: Efavirenz plasma exposure may be increased in patients with homozygous G516T genetic variant of the CYP2B6 isozyme.
Maltese: L-esponiment ta' efavirenz fil-plażma jista' jiżdied f'pazjenti b'varjant ġenetiku G516T omozigotiku tal-isoezim CYP2B6.
English: Compared to fasted administration, dosing of tenofovir disoproxil and emtricitabine in combination with either a high fat meal or a light meal increased the mean AUC of tenofovir by 43.6% and 40.5%, and Cmax by 16% and 13.5%, respectively without affecting emtricitabine exposures.
Maltese: Meta mqabbel tal-għoti fi stat ta' sawm, id-doża ta' tenofovir disoproxil u emtricitabine f'kombinazzjoni jew ma' ikla b'ħafna xaħam jew ma' ikla ħafifa żiedet l-AUC u Cmax medju ta' tenofovir b'43.6% u 40.5%, u Cmax b'16% u 13.5%, rispettivament mingħajr ma ġew affettwati l-esponimenti ta' emtricitabine.
English: Patients with mild liver disease (Child-Pugh-Turcotte (CPT), Class A) may be treated with the normal recommended dose of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (see sections 4.3, 4.4 and 5.2).
Maltese: Pazjenti b'mard tal-fwied ħafif (Child-Pugh-Turcotte (CPT), Klassi A) jistgħu jiġu ttrattati bid-doża normali rrikkmandata ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Reproductive system and breast disorders: Uncommon gynaecomastia
Maltese: Disturbi fis-sistema immuni: Komuni reazzjoni allerġika
English: AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78) (CYP3A4 induction)
Maltese: AUC: ↓ 60% (↓ 52 għal ↓ 68) Cmax: ↓ 62% (↓ 55 għal ↓ 78) (Induzzjoni ta' CYP3A4)
English: Co-administration of standard doses of efavirenz and voriconazole is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess ħin ta' dożi standard ta' efavirenz u voriconazole huwa kontraindikat (ara sezzjoni 4.3).
English: Table 5: Maintenance of pure virologic response (Kaplan Meier % (Standard Error) [95%CI]) at week 48 for treatment-experienced patients with baseline HIV-1 RNA < 75 copies/ml who had therapy switched to efavirenz/emtricitabine/tenofovir disoproxil according to the type of prior antiretroviral regimen (Kaiser Permanente patient database)
Maltese: Manteniment ta' rispons viroloġiku pur (Kaplan Meier % (Errur Standard) [95%CI]) f'ġimgħa 48 għal pazjenti li kienu kkurati fil-passat b'HIV-1 RNA < 75 kopji/ml fil-linja bażi li kellhom it-terapija maqluba għal Efavirenz/Emtricitabine/Tenofovir disoproxil.
English: No virus analysed contained the K65R or K70E mutation.
Maltese: L-ebda virus li kien analizzat ma kien fih il-mutazzjoni K65R jew K70E.
English: The bioequivalence of one efavirenz/emtricitabine/tenofovir disoproxil film-coated tablet with one efavirenz 600 mg film-coated tablet plus one emtricitabine 200 mg hard capsule plus one tenofovir disoproxil 245 mg film-coated tablet administered together, was established following single dose administration to fasting healthy subjects in study GS-US 1770105 (see Table 6).
Maltese: Il-bijoekwivalenza ta' pillola waħda miksija b'rita ta' efavirenz/emtricitabine/tenofovir disoproxil ma' pillola waħda miksija b'rita ta' efavirenz 600 mg flimkien ma' kapsula iebsa waħda ta' emtricitabine 200 mg u pillola miksija b'rita ta' tenofovir disoproxil 245 mg mogħtija flimkien, ġiet stabbilita wara għoti ta' doża waħda lil suġġetti b'saħħithom sajmin fl-istudju GS-US-177-0105 (ara Tabella 6).
English: erythema multiforme 3, severe rash angioedema
Maltese: 3, raxx sever anġjoedema
English: Date of first authorisation: 8 February 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 8 ta' Frar 2018
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 (per eżempju, DepoProvera), jew impjant kontraċettiv (per eżempju, Implanon): Trid tuża wkoll metodu affidabbli ta' kontraċezzjoni tat-tip barriera (ara Tqala u treddigħ).
English: Levonorgestrel (active metabolite): AUC: ↓ 83% (↓ 79 to ↓ 87) Cmax: ↓ 80% (↓ 77 to ↓ 83) Cmin: ↓ 86% (↓ 80 to ↓ 90) (induction of metabolism)
Maltese: AUC: ↓ 83% (↓ 79 għal ↓ 87) Cmax: ↓ 80% (↓ 77 għal ↓ 83) Cmin: ↓ 86% (↓ 80 għal ↓ 90) (induzzjoni ta' metaboliżmu)
English: Selective Serotonin Reuptake Inhibitors (SSRIs) Sertraline/Efavirenz (50 mg q.d./600 mg q.d.)
Maltese: Impedituri Selettivi tal-Assorbiment mill-ġdid ta' Serotonin (SSRIs) Sertraline/Efavirenz (50 mg q.d./600 mg q.d.)
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-isoenzimi maġġuri responsabbli għallmetaboliżmu ta' efavirenz u li jimpedixxi l-isoenzimi CYP 2C9, 2C19, u 3A4.
English: Protease inhibitors Atazanavir/ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Maltese: ANTI-INFETTIVI Antiretrovirali Impedituri tal-protease Atazanavir/ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./ 245 mg q.d.)
English: Cmax: ↓ 45% (CYP3A4 or P-gp induction - effect on elbasvir)
Maltese: Cmax: ↓ 45% (induzzjoni ta' CYP3A4 jew P-gp - effett fuq elbasvir)
English: A third subject had pre-existing NNRTI resistanceassociated substitutions to efavirenz and the M184V reverse transcriptase resistance-associated substitution to emtricitabine at entry into the efavirenz/emtricitabine/tenofovir disoproxil extension phase and experienced a suboptimal virologic response, and developed K65K/R, S68N and K70K/E NRTI resistance-associated substitutions at week 180 (36 weeks on efavirenz/emtricitabine/tenofovir disoproxil).
Maltese: It-tielet pazjent kellu sostituzzjonijiet assoċjati ma' reżistenza għal efavirenz (NNRTI) li kienu jeżistu minn qabel u s-sostituzzjoni assoċjata ma' reżistenza M184V reverse transcriptase assoċjati ma' reżistenza għal emtricitabine meta daħal fil-fażi ta' estensjoni ta' efavirenz/emtricitabine/tenofovir disoproxil u kellu rispons viroloġiku subottimali, u żviluppa sostituzzjonijiet assoċjati ma' reżistenza (NRTI) K65K/R, S68N u K70K/E f'ġimgħa 180 (36 ġimgħa fuq efavirenz/emtricitabine/tenofovir disoproxil).
English: Study AI266073 was a 48-week open-label randomised clinical study in HIV infected patients comparing the efficacy of efavirenz/emtricitabine/tenofovir disoproxil to antiretroviral therapy consisting of at least two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs) with a protease inhibitor or non-nucleoside reverse transcriptase inhibitor; however not a regimen containing all efavirenz/emtricitabine/tenofovir disoproxil components (efavirenz, emtricitabine and tenofovir disoproxil).
Maltese: L-istudju AI266073 kien studju kliniku każwali bit-tikketta mikxufa mifrux fuq 48 ġimgħa fuq pazjenti infettati b'HIV li qabbel l-effikaċja ta' efavirenz/emtricitabine/tenofovir disoproxil ma' terapija antiretrovirali magħmula minn mill-inqas żewġ nucleoside jew nucleotide reverse transcriptase inhibitors (NRTIs) b'impeditur tal-protease jew b'non-nucleoside reverse transcriptase inhibitor; madankollu mhux reġim li fih il-komponenti kollha ta' efavirenz/emtricitabine/tenofovir disoproxil (efavirenz, emtricitabine u tenofovir disoproxil).
English: Psychiatric disorders: Common depression (severe in 3, anxiety 3, abnormal dreams 3, insomnia abnormal dreams, insomnia
Maltese: Komuni depressjoni (severa f' 3, ansjetà 3, ħolm anormali
English: Norepinephrine and dopamine reuptake inhibitor Bupropion/Efavirenz [150 mg single dose (sustained release)/600 mg q.d.]
Maltese: Impeditur tal-Assorbiment mill-ġdid ta' Norepinephrine u dopamine Bupropion/Efavirenz [150 mg doża waħda (tnixxija sostnuta)/600 mg q.d.]
English: AUC: ↓ 36% (↓ 32 to ↓ 40) Cmax: ↓ 21% (↓ 15 to ↓ 26) Cmin: ↓ 47% (↓ 41 to ↓ 53) (decrease in carbamazepine concentrations: CYP3A4 induction; decrease in efavirenz concentrations: CYP3A4 and CYP2B6 induction)
Maltese: ↓ 36% (↓ 32 għal ↓ 40) Cmax: ↓ 21% (↓ 15 għal ↓ 26) Cmin: ↓ 47% (↓ 41 għal ↓ 53) (tnaqqis fil-konċentrazzjonijiet ta' carbamazepine: induzzjoni ta' CYP3A4; tnaqqis fil-konċentrazzjonijiet ta' efavirenz: induzzjoni ta' CYP3A4 u CYP2B6)
English: ANTICONVULSANTS Carbamazepine/Efavirenz (400 mg q.d./600 mg q.d.)
Maltese: ANTIKONVULSIVI Carbamazepine/Efavirenz (400 mg q.d./600 mg q.d.)
English: M184V/I K65R K70E TAMs
Maltese: M184V/I
English: AUC: ↓ 75% (↓ 62 to ↓ 84) Cmax: ↓ 44% (↓ 20 to ↓ 61)
Maltese: AUC: ↓ 75% (↓ 62 għal↓ 84) Cmax: ↓ 44% (↓ 20 għal ↓ 61)
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Maltese: Il-bijotrasformazzjoni ta' emtricitabine tinkludi l-ossidazzjoni tal-moiety tat-thiol sabiex jiġu ffurmati 3'-sulphoxide diastereomers (madwar 9% tad-doża) u flimkien ma' aċidu glukuroniku biex jifforma 2'-O-glucuronide (madwar 4% tad-doża).
English: Exacerbations of hepatitis after discontinuation of treatment In HIV infected patients co-infected with HBV, clinical and laboratory evidence of hepatitis may occur after discontinuation of treatment (see section 4.4).
Maltese: F'pazjenti infettati b'HIV ko-infettati b'HBV, evidenza ta' epatite klinika u tal-laboratorju tista' sseħħ wara twaqqif tat-trattament (ara sezzjoni 4.4).
English: Prior efavirenz/emtricitabine/tenofovir disoproxil components (N=299)
Maltese: Komponenti ta' efavirenz/emtricitabine/tenofovir disoproxil fil-passat (N=299)
English: Cmax: ↓ 87% (CYP3A4 or P-gp induction - effect on grazoprevir)
Maltese: Cmax: ↓ 87% (induzzjoni ta' CYP3A4 jew P-gp - effett fuq grazoprevir)
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' reazzjonijiet avversi relatati ma' didanosine.
English: Table 4: 48-week efficacy data from study AI266073 in which efavirenz/emtricitabine/tenofovir disoproxil was administered to virologically suppressed patients on combination antiretroviral therapy
Maltese: Tabella 4: Dejta tal-effikaċja fuq 48 ġimgħa mill-istudju AI266073 li fih efavirenz/emtricitabine/tenofovir disoproxil ingħata lil pazjenti mrażżna viroloġikament fuq terapija antiretrovirali ta' kombinazzjoni
English: If concomitant use of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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: 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-esponimenti 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: After 96 weeks of efavirenz/emtricitabine/tenofovir disoproxil 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'efavirenz/emtricitabine/tenofovir disoproxil, konċentrazzjonijiet ta' HIV-1 RNA fil-plażma baqgħu < 50 kopja/ml fi 82% tal-pazjenti u < 400 kopji/ml f'85% tal-pazjenti (analiżi b'intenzjoni li tiġi ttrattata (ITT), nieqsa=ma ħadimx).
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: Huwa indikat għat-trattament ta' infezzjoni bil-virus-1 talimmunodefiċjenza tal-bniedem (HIV-1) f'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: Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays.
Maltese: Efivarenz ma kienx mutaġeniku jew klastoġeniku f'analiżi ġenotossiċi konvenzjonali.
English: Limited clinical experience suggests that emtricitabine and tenofovir disoproxil have an anti-HBV activity when used in antiretroviral combination therapy to control HIV infection.
Maltese: Esperjenza klinika limitata tissuġġerixxi li emtricitabine u tenofovir disoproxil għandhom attività kontra l-HBV meta jintużaw f'terapija antiretrovirali kkumbinata biex tikkontrolla infezzjoni tal-HIV.
English: 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: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses (see also data from bioequivalence study described above) and 40 to 55 hours after multiple doses.
Maltese: Efavirenz għandu half-life terminali relattivament twila ta' mill-anqas 52 siegħa wara dożi uniċi (ara wkoll id-dejta mill-istudju ta' bijoekwivalenza deskritt fuq) u 40 sa 55 siegħa wara dożi multipli.
English: Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives, see section 4.5) while on therapy with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Maltese: Kontraċezzjoni barriera għandha dejjem tintuża ma' metodi oħra ta' kontraċezzjoni (per eżempju, kontraċettivi orali jew ormonali, ara sezzjoni 4.5) waqt terapija b'Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
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: Studji fl-umani u studji in vitro li jużaw mikrosomi tal-fwied uman urew li efavirenz huwa prinċipalment metabolizzat mis-sistema CYP għal metaboliti idrossillati b'glukuronidazzjoni sussegwenti tal-metaboliti idrossilati.
English: Cmax: ↑ 38% (↑ 14 to ↑ 67)
Maltese: ↑ 38% (↑ 14 għal 67)
English: A similar reduction in indinavir exposures was observed when indinavir 1,000 mg q8h was given with efavirenz 600 mg q.d.
Maltese: Tnaqqis simili fl-espożizzjonijiet għal indinavir ġew osservati meta indinavir 1,000 mg q8h ingħata flimkien ma' efavirenz 600 mg q.d. (Induzzjoni ta' CYP3A4)
English: That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil-containing products such as Efavirenz/Emtricitabine /Tenofovir disoproxil Krka Efavirenz/Emtricitabine /Tenofovir disoproxil Krka is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min) That use of Efavirenz/Emtricitabine /Tenofovir disoproxil Krka should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Maltese: Li hemm żieda fir-riskju ta' mard renali f'pazjenti infettati b'HIVassoċjata ma' prodotti li jkun fihom tenofovir disoproxil bħal Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Efavirenz/Emtricitabine/Tenofovir disoproxil mhux rakkomandat għal pazjenti b'indeboliment renali moderat jew sever (tneħħija tal-kreatinina < 50 ml/min) Li l-użu ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka għandu jiġi evitat bl-użu konkomitanti jew riċenti ta' prodotti mediċinali nefrotossiċi.
English: GMR=geometric least-squares mean ratio, CI=confidence interval
Maltese: Il-valuri għat-Test u Referenza huma medji (% koeffiċjent ta' varjazzjoni) GMR = (geometric least sqaures mean ratio) proporzjon medju tal-inqas kwadri ġeometriku, CI=(confidence interval)
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia).
Maltese: L-effetti avversi ewlenin li kienu rrappurtati huma disturbi ematoloġiċi (anemija, newtropenja) u disturbi fil-metaboliżmu (iperlaktejtimja, iperlipażimja).
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 unika 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: Pharmacokinetic parameters were determined following administration of single doses of the individual preparations of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected patients with varying degrees of renal impairment.
Maltese: Il-parametri farmakokinetiċi ġew stabbiliti wara għoti ta' dożi uniċi tal-preparazzjonijiet individwali ta' emtricitabine 200 mg jew tenofovir disoproxil 245 mg lil pazjenti mhux infettati bl-HIV bi gradi varji ta' indeboliment renali.