FrancophonIA/ELRC3.0 huggingface dataset:
English: Reported rates of recurrent rash following a switch from nevirapine to efavirenz therapy, primarily based on retrospective cohort data from published literature, range from 13 to 18 %, comparable to the rate observed in patients treated with efavirenz in clinical studies.
Maltese: Ir-rati rrapportati ta' raxx rikorrenti wara bidla minn terapija b'nevirapine għal terapija b'efavirenz, ibbażati primarjament fuq dejta retrospettiva ta' gruppi minn letteratura medika ppubblikata, kienu fuq medda bejn 13 u 18 %, kumparabbli mar-rata osservata f'pazjenti kkurati b'efavirenz fi studji kliniċi.
English: Ritonavir: Morning AUC: ↑ 18 % (↑ 6 to
Maltese: AUC filgħodu: ↑ 18% (↑ 6 għal
English: AUC: ↓ 35 % (↓ 13 to ↓ 40) Cmax: ↓ 13 % (↓ 0 to ↓ 23) 4-hydroxy atorvastatin:
Maltese: ↓ 35% (↓ 13 għal ↓ 40) Cmax: ↓ 13% (↓ 0 għal ↓ 23) 4-hydroxy atorvastatin:
English: ACID REDUCING AGENTS Aluminium hydroxide-magnesium hydroxide-simethicone antacid/Efavirenz (30 mL single dose/400 mg single dose)
Maltese: Aluminium hydroxide-magnesium hydroxide-simethicone antacid/Efavirenz
English: In HIV-1 infected patients (n = 9) who received efavirenz 200 to 600 mg once daily for at least one month, cerebrospinal fluid concentrations ranged from 0.26 to 1.19 % (mean 0.69 %) of the corresponding plasma concentration.
Maltese: F'pazjenti infettati bl-HIV-1 (N = 9) li rċevew efavirenz 200 sa 600 mg darba kuljum għall-inqas għal xahar, il-konċentrazzjonijiet tal-fluwidu ċerebrospinali kienu jvarjaw minn 0.26 sa 1.19 % (medja 0.69 %) tal-konċentrazzjoni korrospondenti tal-plażma.
English: The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev. 2, Sept 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of patients treated with efavirenz in these clinical trials (n=3,969).
Maltese: Il-kategorija ta' frekwenza "rari" ġiet definita skont il-gwida Linja Gwida dwar is-Sommarju tal-Karateristiċi tal-Prodott (SmPC) (rev. 2, Sett 2009) fuq il-bażi ta' stima tal-upper bound tal-intervall ta' kunfidenza ta' 95 % għal każijiet 0 meta jitqiesu n-numru ta' individwi kkurati b'efavirenz f'dawn il-provi kliniċi (n=3,969).
English: STOCRIN 30 mg/ml oral solution
Maltese: STOCRIN 30 mg/ml soluzzjoni orali
English: AUC: ↓ 69 % (↓ 55 to ↓ 79) Cmax: ↓ 60 % (↓ 50 to ↓ 68) Cmin: ↓ 63 % (↓ 44 to ↓ 75) Desacetyl diltiazem:
Maltese: AUC: ↓ 69% (↓ 55 għal ↓ 79) Cmax: ↓ 60% (↓ 50 għal ↓ 68) Cmin: ↓ 63% (↓ 44 għal ↓ 75) Desacetyl diltiazem:
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: STOCRIN 200 mg film-coated tablets Yellow, round, debossed with “223” on one side.
Maltese: STOCRIN 200 mg pilloli miksija b'rita Safra, tonda, imnaqqxa b'“223” fuq naħa waħda.
English: Stocrin, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Maltese: X'inhu Stocrin u gћalxiex jintuża Stocrin, li fih is-sustanza attiva efavirenz, jagħmel parti minn klassi ta' mediċini antiretrovirali li jissejħu inibituri non-nukleosidi ta' reverse transcriptase (NNTRIs).
English: Evening Cmax: ↔ Morning Cmin: ↑ 42 % (↑ 9 to b
Maltese: Cmax filgħaxija: ↔ Cmin filgħodu: ↑ 42% (↑ 9 għal ↑ 86) b
English: Limited data suggest there is no clinically significant effect on valproic acid pharmacokinetics.
Maltese: Dejta limitata tissuġġerixxi li ma hemm ebda effett klinikament sinifikanti fuq il-farmakokinetiċi tal-aċidu valprojku.
English: • The other ingredients are: medium chain triglycerides, benzoic acid (E210) and strawberry/mint flavour.
Maltese: • Is-sustanzi l-oħra huma: medium chain triglycerides, benzoic acid (E210) u togħma ta'
English: Ginkgo bilobaextracts(herbal preparation)
Maltese: Estratti ta' Ginkgo biloba (preparazzjoni erbali)
English: Evening AUC: ↔ Morning Cmax: ↑ 24 % (↑ 12 to
Maltese: AUC filgħaxija: ↔ Cmax filgħodu: ↑ 24% (↑ 12 għal
English: (CYP3A4 enzyme induction)
Maltese: CYP3A4)
English: EFV + NFV + NRTIs EFV + NRTIs NFV + NRTIs
Maltese: EFV + NFV + NRTIs 65 70 (59, 82) EFV + NRTIs
English: Stocrin 30 mg/ml oral solution is supplied in bottles of 180 ml.
Maltese: Stocrin 30 mg/ml soluzzjoni orali tiġi fi fliexken ta' 180 ml.
English: • The dose for adults is 24 ml once daily.
Maltese: • Id-doża għall-adulti hija ta' 24 ml kuljum.
English: AUC: ↑ 17 % (↑ 6 to ↑ 29) ** Cmax: ↔** *compared to 200 mg twice daily alone ** compared to 600 mg once daily alone (competitive inhibition of oxidative metabolism)
Maltese: AUC: ↑ 17% (↑ 6 għal ↑ 29) ** Cmax: ↔** *meta mqabbel ma' 200 mg darbtejn kuljum waħdu ** meta mqabbel ma' 600 mg darba kuljum waħdu (inibizzjoni kompetittiva talmetaboliżmu kompetittiv)
English: Paediatric population: ACTG 382 is an ongoing uncontrolled study of 57 NRTI-experienced paediatric patients (3 - 16 years) which characterises the pharmacokinetics, antiviral activity and safety of efavirenz in combination with nelfinavir (20 - 30 mg/kg given three times a day) and one or more NRTIs.
Maltese: ACTG 382 huwa studju bla miżuri ta' kontroll li għadu għaddej fuq 57 tifel u tifla pazjent (3 - 16-il sena) li kienu ħadu NRTI li jidentifika l-karatteristiċi farmakokinetiċi, l-attività antivirali u s-sigurtà ta' efavirenz meta tintuża flimkien ma' nelfinavir (20 - 30 mg/kg tliet darbiet kuljum) u NRTI wieħed jew iktar.
English: Lopinavir concentrations:
Maltese: Popolazzjoni pedjatrika:
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, breast-feeding and fertility).
Maltese: Kontraċettiv ormonali, bħal pilloli ta' kontroll tat-twelid, kontraċettiv injettat (per eżempju, Depo-Provera), jew kontraċettiv impjantat (per eżempju, Implanon): għandek tuża wkoll metodu ta' kontraċezzjoni barriera affidabbli (ara Tqala, treddigħ u fertilità).
English: AUC: ↓54% Cmax: ↓45%
Maltese: ↓54% Cmax: ↓45%
English: When using efavirenz with low-dose ritonavir, the possibility of an increase in the incidence of efavirenz-associated adverse events should be considered, due to possible pharmacodynamic interaction.
Maltese: Meta efavirenz jintuża ma' ritonavir, wieħed għandu jikkunsidra l-possibilità ta' żieda fl-inċidenza ta' episodji avversi assoċjati ma' efavirenz, minħabba interazzjoni farmakodinamika possibbli.
English: AUC: ↓ 34 % (↓ 21 to ↓ 41) Cmax: ↓ 20 % (↓ 2 to ↓ 26)
Maltese: ↓ 34% (↓ 21 għal ↓ 41) Cmax: ↓ 20% (↓ 2 għal ↓ 26)
English: Other medicines and Stocrin
Maltese: Mediċini oħra u Stocrin
English: AUC : ↓ 13 % Cmin : ↓ 31 % Cmax: ↓ 15% (CYP3A4 induction) Efavirenz:
Maltese: Cmax: ↓ 15% (induzzjoni ta' CYP3A4) Efavirenz:
English: Elevations of GGT to greater than five times ULN were observed in 4 % of all patients treated with 600 mg of efavirenz and 1.5 - 2 % of patients treated with control regimens (7 % of efavirenz-treated patients and 3 % of control-treated patients after long-term treatment).
Maltese: Ġew osservati elevazzjonijiet simili f'pazjenti kkurati b'GGT għal iktar minn ħames darbiet l-ULN f'4% mill-pazjenti kollha kkurati b'600 mg ta' efavirenz u 1.5 - 2 % tal-pazjenti f'kuri ta' kontroll (7% ta' tal-pazjenti kkurati b'efavirenz u 3% ta' pazjenti f'kuri ta' kontroll wara kura fit-tul).
English: In 17 paediatric patients receiving an investigational oral solution similar to the commercial formulation adjusted on the basis of body size to be equivalent to an adult 600 mg capsule dose, the steady-state Cmax was 11.8 M, steady state Cmin was 5.2 M, and AUC was 188 M·h.
Maltese: Fi 17-il pazjent tifel u tifla li kienu qed jirċievu soluzzjoni orali li kienet qed tiġi studjata u li tixbah ilformulazzjoni kummerċjali, aġġustata skont id-daqs tal-ġisem biex tkun ekwivalenti għal doża adulta ta' kapsula ta'600 mg, Cmax fl-istat fiss kien ta' 11.8 µM, Cmin fl-istat fiss kien ta' 5.2 µM, u l-AUC kienet ta' 188 µM·siegħa.
English: Date of first authorisation: 28 May 1999 Date of latest renewal: 23 April 2014
Maltese: Data tal-aħħar tiġdid: 23 ta' April 2014
English: AUC: ↓ 69 % (↓ 62 to ↓ 73) Cmax: ↓ 76 % (↓ 63 to ↓ 79) Simvastatin acid:
Maltese: AUC: ↓ 69% (↓ 62 għal ↓ 73) Cmax: ↓ 76% (↓ 63 għal ↓ 79) Aċidu ta' simvastatin:
English: EFV + IDV + NRTIs IDV + NRTIs
Maltese: NFV + NRTIs
English: Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz to patients with mild hepatic impairment.
Maltese: efavirenz li hu medjat minn cytochrome P450, u minħabba l-esperjenza klinika limitata f'pazjenti b'mard kroniku fil-fwied, għandu jkun hemm kawtela meta wieħed jagħti efavirenz lil pazjenti b'indeboliment ħafif tal-fwied.
English: Evening Cmin: ↑ 24 % (↑ 3 to
Maltese: Cmin filgħaxija ↑ 24% (↑ 3 għal ↑ 50)
English: • Risk Management plan (RMP)
Maltese: • Pjan tal-immaniġġar tar-riskju (RMP)
English: This mutation was observed in 90 % of patients receiving efavirenz with virological failure.
Maltese: Din il-mutazzjoni kienet osservata f'90 % mill-pazjenti li kienu qed jingħataw efavirenz b'falliment viroloġiku.
English: Medium chain triglycerides Benzoic acid (E210) Strawberry/mint flavour
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Medium chain triglycerides Benzoic acid (E210)
English: - any signs of inflammation or infection.
Maltese: - kwalunkwe sinjal ta' infjammazzjoni jew infezzjoni.
English: There have been seven retrospective reports of findings consistent with neural tube defects, including meningomyelocele, all in mothers exposed to efavirenz-containing regimens (excluding any efavirenz-containing fixed-dose combination tablets) in the first trimester.
Maltese: Kien hemm seba' rapporti retrospettivi ta' sejbiet konsistenti ma' difetti fit-tubu tan-nervituri, inkluż meningomajelosil, kollha f'ommijiet esposti għal korsijiet li kien fihom efavirenz (eskluż kwalunkwe pillola ta' kombinazzjoni ta' doża fissa li fiha efavirenz) fl-ewwel trimestru.
English: Each film-coated tablet contains: efavirenz 600 mg
Maltese: Kull pillola miksija b'rita fiha: efavirenz 600 mg
English: AUC: ↓ 39 % (↓ 27 to ↓ 50) Cmax: ↓ 29 % (↓ 15 to ↓ 40) Cmin: ↓ 46 % (↓ 31 to ↓ 58) Efavirenz:
Maltese: ↓ 39% (↓ 27 għal ↓ 50) Cmax: ↓ 29% (↓ 15 għal ↓ 40) Cmin: ↓ 46% (↓ 31 għal ↓ 58) Efavirenz:
English: AUC: ↓ 64 % (↓ 62 to ↓ 67) Cmax: ↓ 46 % (↓ 39 to ↓ 52) Cmin: ↓ 82 % (↓ 79 to ↓ 85) Levonorgestrel
Maltese: AUC: ↓ 64 % (↓ 62 għal ↓ 67) Cmax: ↓ 46 % (↓ 39 għal ↓ 52) Cmin: ↓ 82 % (↓ 79 għal ↓ 85) Levonorgestrel (metabolit attiv):
English: In clinical studies, 26 % of patients treated with 600 mg of efavirenz experienced skin rash compared with 17 % of patients treated in control groups.
Maltese: Fi studji kliniċi, 26 % tal-pazjenti kkurati b'600 mg ta' efavirenz kellhom raxx fil-ġilda meta mqabbla ma' 17 % ta' pazjenti kkurati fil-gruppi ta' kontroll.
English: • Stocrin is for oral use.
Maltese: • Stocrin huwa għal użu orali.
English: Two controlled studies (006 and ACTG 364) of approximately one year duration with efavirenz in combination with NRTIs and/or PIs, have demonstrated reduction of viral load below the limit of quantification of the assay and increased CD4 lymphocytes in antiretroviral therapy-naïve and NRTI-experienced HIV-infected patients.
Maltese: Żewġ studji kkontrollati (006 u ACTG 364) li damu bejn wieħed u ieħor sena b'efavirenz flimkien ma' NRTIs u/jew PIs, urew li n-numru tal-virus naqas taħt il-livell tal-kwantifikazzjoni tal-assay u CD4 limfoċiti f'pazjenti infettati bl-HIV li ma kinux ħadu terapija antiretrovirali u li kienu ħadu NRTI.
English: AUC12: ↓ 45 % (↓ 38 to ↓ 51) Cmax: ↓ 51 % (↓ 37 to ↓ 62) Efavirenz concentrations not measured, no effect is expected.
Maltese: AUC12: ↓ 45% (↓ 38 sa ↓ 51) Cmax: ↓ 51% (↓ 37 sa ↓ 62) Konċentrazzjonijiet ta' Efavirenz mhux imkejla, ebda effett ma huwa mistenni.
English: AUC: ↓ 38 % (↓ 28 to ↓ 47) Cmax: ↓ 32 % (↓ 15 to ↓ 46) Cmin: ↓ 45 % (↓ 31 to ↓ 56) Efavirenz:
Maltese: ↓ 38% (↓ 28 għal ↓ 47) Cmax: ↓ 32% (↓ 15 għal ↓ 46) Cmin: ↓ 45% (↓ 31 għal ↓ 56) Efavirenz:
English: 180 ml oral solution Oral syringe with a pushin bottleneck adapter.
Maltese: Siringa orali b'adapter tal-għonq tal-flixkun tat-tip push-in.
English: Cmax: ↑ 11 % (↑ 3 to ↑ 19) (CYP3A4 induction) Rash developed in 46 % of uninfected volunteers receiving efavirenz and clarithromycin.
Maltese: Żviluppa raxx f'46% tal voluntiera mhux infettati li rċevew efavirenz u clarithromycin.
English: AUC: ↓ 39 % (↓ 21 to ↓ 53) Cmax: ↓ 37 % (↓ 20 to ↓ 51) Cmin: ↓ 44 % (↓ 27 to ↓ 58) (decrease in itraconazole concentrations: CYP3A4 induction)
Maltese: ↓ 39% (↓ 21 għal ↓ 53) Cmax: ↓ 37% (↓ 20 għal ↓ 51) Cmin: ↓ 44% (↓ 27 għal ↓ 58) (tnaqqis fil-konċentrazzjonijiet ta' itraconazole: induzzjoni ta' CYP3A4)
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 40 - 55 hours after multiple doses.
Maltese: Efavirenz għandu half-life terminali relattivament twila ta' mill-anqas 52 siegħa wara dożi waħedhom u minn 40 sa 55 siegħa wara dożi multipli.
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenzcontaining antiretroviral therapy and subjects receiving no antiretroviral therapy.
Maltese: Fi studju ta' interazzjoni tal mediċina ta' 3 xhur, ma nstabet ebda differenza sinifikanti filparametri farmakokinetiċi talMPA bejn suġġetti li kienu qegħdin jirċievu terapija antiretrovirali li fiha efavirenz u suġġetti li ma kienu qegħdin jirċievu ebda terapija.
English: There is a potential for reduction or increase in the plasma concentrations of phenytoin, phenobarbital and other anticonvulsants that are substrates of CYP450 isoenzymes when co-administered with efavirenz.
Maltese: Hemm potenzjal għal tnaqqis jew żieda fil-konċentrazzjonijiet fil-plażma ta' phenytoin, phenobarbital u antikonvulsivi oħra li huma substrati ta' isoenzimi CYP450 meta jingħataw fl-istess ħin ma'
English: Protease inhibitors (PI) Atazanavir/ ritonavir/Efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
Maltese: Antivirali tal-HIV Inibituri protease (PI) Atazanavir/ritonavir/Efavirenz (400 mg darba kuljum/100 mg darba kuljum/600 mg darba kuljum, kollha mogħtija mal-ikel)
English: Among co-infected patients in study 006, elevations in AST to greater than five times ULN developed in 13 % of efavirenz treated patients and in 7 % of controls, and elevations in ALT to greater than five times ULN developed in 20 % and 7 % respectively.
Maltese: Fost pazjenti koinfettati fl-istudju 006, livelli elevati ta' AST għal iktar minn ħames darbiet l-ULN żviluppaw fi 13% tal-pazjenti kkurati b'efavirenz, u f'7% tal-kontrolli u livelli elevati ta'ALT għal iktar minn ħames darbiet l-ULN żviluppaw f'20 % u 7 % rispettivament.
English: Your doctor may give you a different anticonvulsant.
Maltese: jagħtik antikonvulsant differenti.
English: - if you have a history of liver disease, including active chronic hepatitis.
Maltese: - jekk għandek storja medika ta' mard fil-fwied inkluż epatite kronika attiva.
English: Although not studied, a similar decrease in voxilaprevir exposure is anticipated.
Maltese: Għalkemm ma ġiex studjat, huwa antiċipat tnaqqis simili flesponiment għal voxilaprevir.
English: It may harm them,
Maltese: Dihydroartemisinin:
English: Diarrhoea occurred in children who took Stocrin oral solution and nelfinavir in combination with other antiretroviral medicines.
Maltese: It-tfal li ħadu Stocrin soluzzjoni orali u nelfinavir flimkien ma' mediċini antiretrovirali oħra kellhom dijarrea.
English: AUC: ↓ 25 % (↓ 16 to ↓ 32) Cmax: ↓ 17 % (↓ 6 to ↓ 26) Cmin: ↓ 50 % (↓ 40 to ↓ 59) Efavirenz:
Maltese: AUC: ↓ 25% (↓ 16 għal ↓ 32) b Cmax: ↓ 17% (↓ 6 għal ↓ 26)b Cmin: ↓ 50% (↓ 40 għal ↓ 59)b Efavirenz:
English: Efavirenz must not be administered with elbasvir/grazoprevir due to the expected significant decreases in elbasvir and grazoprevir plasma concentrations caused by induction of drug metabolising enzymes and/or transport proteins and which are expected to result in the loss of virologic response of elbasvir/grazoprevir (see section 4.5).
Maltese: Efavirenz m'għandux jingħata ma' elbasvir/grazoprevir minħabba t-tnaqqis sinifikanti mistenni filkonċentrazzjonijiet fil-plażma ta' elbasvir u grazoprevir ikkawżat mill-induzzjoni ta' enzimi li jimmetabolizzaw il-mediċina u/jew proteini tat-trasport u li huma mistennija li jirriżultaw fit-telf tarrispons viroloġiku ta' elbasvir/grazoprevir (ara sezzjoni 4.5).
English: AUC: ↑ 11 % (↑ 5 to ↑ 18) Cmax: ↑ 16 % (↑ 6 to ↑ 26) Cmin: ↑ 13 % (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Maltese: AUC: ↑ 11% (↑ 5 għal ↑ 18) Cmax: ↑ 16% (↑ 6 għal ↑ 26) Cmin: ↑ 13% (↑ 1 għal ↑ 26) (induzzjoni ta' CYP3A4)
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 fl-istess ħin ma' imblokkatur tal-kanali tal-kalċju li jkun substrat talenzima CYP3A4, hemm potenzjal għal tnaqqis filkonċentrazzjonijiet talimblokkatur tal-kanali tal-kalċju fil-plażma.
English: Each ml contains: efavirenz 30 mg
Maltese: Kull ml fih: 30 mg ta' efavirenz
English: Clinically significant interactions are not 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: Mhumiex mistennija interazzjonijiet klinikament sinifikanti billi nNRTIs huma metabolizzati permezz ta' rotta differenti minn efavirenz u mhumiex probabbli li jikkompetu għall-istess enzimi metaboliċi u passaġġi tattneħħija.
English: Efavirenz in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Maltese: darunavir/ritonavir 800/100 mg darba kuljum jista' jwassal għal Cmin ta' darunavir subottimali.
English: The response rate, based on the NC = F analysis of the percentage of patients with plasma HIV-RNA < 400 copies/ml at 48 weeks was 60 % (95 %, C.I.
Maltese: Ir-rata ta' rispons, ibbażat fuq l-analiżi NC = F tal-perċentwal ta' pazjenti bi plażma HIV-RNA < 400 copji/ml fit-48 ġimgħa kienet 60 % (95 %, C.I. 47, 72), u 53 % (C.I. 40, 66).
English: Study Number/ Treatment Regimens n % (95 % C.I.
Maltese: Numru tal-istudju/ Tipi ta' Kurab n % (95 % C.I.c) % (95 % C.I.) Ċelluli/mm3 (S.E.M.d)
English: In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/or NRTIs in controlled clinical studies, the most frequently reported adverse reactions of at least moderate severity reported in at least 5 % of patients were rash (11.6 %), dizziness (8.5 %), nausea (8.0 %), headache (5.7 %) and fatigue (5.5 %).
Maltese: Fi grupp ta' 1,008 minn dawn li ngħataw 600 mg ta' efavirenz kuljum flimkien ma' PIs u/jew NRTIs fi studji kliniċi kkontrollati, l-iktar reazzjonijiet avversi ta' severità moderata jew agħar f'minimu ta' 5 % li kienu rrapportati kienu raxx (11.6 %),
English: • The dose for adults is 600 mg once daily.
Maltese: • Id-doża għall-adulti hija ta' 600 mg kuljum.
English: Cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Maltese: Il-profili ta' reżistenza msallba għal efavirenz, nevirapine u delavirdine fil-kultura taċ-ċelluli urew li s sostituzzjoni K103N tagħti nuqqas ta' suxxettibilità lit-tliet NNRTIs li huma.
English: AUC: ↓ 37 % (↓ 14 to ↓ 55) Cmax: ↓ 35 % (↓ 12 to ↓ 52) Cmin: ↓ 43 % (↓ 18 to ↓ 60) Efavirenz:
Maltese: ↓ 37% (↓ 14 għal ↓ 55) Cmax: ↓ 35% (↓ 12 għal ↓ 52) Cmin: ↓ 43% (↓ 18 għal ↓ 60) Efavirenz:
English: • The dose for children weighing 40 kg or more is 24 ml once daily.
Maltese: • Id-doża għat-tfal li jiżnu 40 kg jew aktar hija ta' 24 ml darba kuljum.
English: AUC: ↑ 7 % (↑ 1 to ↑ 14) Cmax: ↑ 16 % (↑ 2 to ↑ 32) These changes are not considered clinically significant.
Maltese: AUC: ↑ 7% (↑ 1 għal ↑ 14) Cmax: ↑ 16% (↑ 2 għal ↑ 32) Dawn il-bidliet mhumiex meqjusa bħala klinikament sinifikanti.
English: Liver enzymes: elevations of AST and ALT to greater than five times the upper limit of the normal range (ULN) were seen in 3 % of 1,008 patients treated with 600 mg of efavirenz (5-8 % after longterm treatment in study 006).
Maltese: Enzimi tal-fwied: fi 3% ta' 1,008 pazjenti li ngħataw 600 mg ta' efavirenz (5-8% wara kura fit-tul fi studju 006) dehru livelli ta' AST u ALT li għolew għal iktar minn ħames darbiet il-livell ta' fuq talmedda normali (ULN).
English: • The other ingredients of the tablet core are: croscarmellose sodium, microcrystalline cellulose,
Maltese: Qalba tal-pillola: Croscarmellose sodium, Microcrystalline cellulose, Sodium laurilsulfate,
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: CYP2C19 u CYP2C9; madankollu in vitro ġiet ukoll osservata inibizzjoni u l-effett finali ta' għoti flimkien ma' sustrati ta' dawn l-enzimi mhuwiex ċar (ara sezzjoni 5.2).
English: Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms.
Maltese: Xi pazjenti li bi żball ħadu 600 mg darbtejn kuljum irrapportaw żieda fis-sintomi tas-sistema nervuża.
English: Approximately 14 - 34 % of a radiolabelled dose of efavirenz was recovered in the urine and less than 1 % of the dose was excreted in urine as unchanged efavirenz.
Maltese: Bejn wieħed u ieħor 14 - 34 % tad-doża radjutikkettata ta' efavirenz instabet fl-awrina u inqas minn 1 % tad-doża tneħħiet fl-awrina bħala efavirenz mhux mibdul.
English: (UDP-G induction)
Maltese: Prodott għall-atorvastatin).
English: The pattern of amino acid substitutions in RT associated with resistance to efavirenz was independent of the other antiviral medicinal products used in combination with efavirenz.
Maltese: Il-mudell ta' sostituzzjonijiet ta' amino acid fl-RT li kienu assoċjati mar-reżistenza għal efavirenz kien indipendenti minn prodotti mediċinali antivirali oħra li jintużaw flimkien ma' efavirenz.
English:  Efavirenz 50 mg, 200 mg and 600 mg film-coated tablets are available.
Maltese: ∗ Efavirenz 50 mg, 200 mg u 600 mg pilloli miksijin b'rita huma disponibbli.
English: Liver enzymes in hepatitis B or C co-infected patients In the long-term data set from study 006, 137 patients treated with efavirenz-containing regimens (median duration of therapy, 68 weeks) and 84 treated with a control regimen (median duration, 56 weeks) were seropositive at screening for hepatitis B (surface antigen positive) and/or C (hepatitis C antibody positive).
Maltese: Enzimi tal-fwied f'pazjenti koinfettati bl-epatite B jew Ċ Fis-sett ta' dejta miġbura fuq perjodu ta' żmien twil minn studju numru 006, 137 pazjent li kienu fuq skedi ta' kura li kien fihom efavirenz (tul medjan tal-kura ta' 68 ġimgħa) u 84 li kienu kkurati bi skeda ta' kura ta' kontroll (tul medjan ta' 56 ġimgħa) kienu seropożittivi meta ġew ittestjati għall-epatite B (pożitivi għall-antiġen tal-wiċċ) u/jew Ċ (pożittivi għall-antikorpi tal-epatite Ċ).
English: Rash was reported in 26 of 57 children (46 %) treated with efavirenz during a 48-week period and was severe in three patients.
Maltese: Ġie rrapportat raxx f'26 minn 57 tifel u tifla (46 %) li ġew ikkurati b'efavirenz waqt perjodu ta' 48 ġimgħa, u kien qawwi fi tliet pazjenti.
English: - if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
Maltese: - jekk għandek disturb fil-qalb, bħal sinjal elettriku anormali li jissejjaħ titwil tal-intervall QT.