FrancophonIA/ELRC3.0 huggingface dataset:
English: One patient experienced involuntary muscle contractions.
Maltese: Pazjent wieħed kellu kontrazzjonijiet involontarji tal-muskoli.
English: Efavirenz induced foetal resorptions in rats.
Maltese: Studji ta' interazzjoni twettqu biss fl-adulti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: efavirenz 600 mg.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha: efavirenz 600 mg.
English: Instructions for capsule sprinkle method:
Maltese: Istruzzjonijiet għall-metodu ta' traxxix tal-kapsula:
English: AUC: ↓ 13% Cmin: ↓ 31% Cmax: ↓ 15% (CYP3A4 induction) Efavirenz:
Maltese: Cmax: ↓ 15% (induzzjoni ta' CYP3A4) Efavirenz:
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 NRTIexperienced 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: Efficacy results for studies ACTG 364 and 020 are found in Table 4.
Maltese: Studji dwar l-effikaċja għall-istudji ACTG 364 u 020 jinstabu f'Tabella 4.
English: NOREPINEPHRINE AND DOPAMINE REUPTAKE INHIBITOR Bupropion/Efavirenz [150 mg single dose (sustained release)/600 mg once daily]
Maltese: Inibitur tat-teħid mill-ġdid ta' norepinephrine u ta' dopamine Bupropion/Efavirenz [doża waħda ta' 150 mg (li terħi lmediċina bil-mod)/600 mg darba kuljum]
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 tal-enzima CYP3A4, hemm potenzjal għal tnaqqis filkonċentrazzjonijiet talimblokkatur tal-kanali tal-kalċju fil-plażma.
English: ANTICONVULSANTS Carbamazepine/Efavirenz (400 mg once daily/600 mg once daily)
Maltese: ANTIKONVULSIVI Carbamazepine/Efavirenz (400 mg darba kuljum/600 mg darba kuljum)
English: Although in vitro data suggest that efavirenz inhibits CYP2C9 and CYP2C19, there have been contradictory reports of both increased and decreased exposures to substrates of these enzymes when coadministered with efavirenz in vivo.
Maltese: Għalkemm dejta in vitro tissuġġerixxi li efavirenz jinibixxi CYP2C9 u CYP2C19, kien hemm rapporti kontradittorji kemm ta' żieda kif ukoll ta' tnaqqis fl-esponimenti għal sustrati ta' dawn l-enzimi meta ngħataw flimkien ma' efavirenz in vivo.
English: Each SUSTIVA hard capsule contains 50 mg of the active substance efavirenz.
Maltese: • Kull kapsula SUSTIVA fiha 50 mg tas-sostanza attiva efavirenz.
English: Study 006, a randomized, open-label trial, compared efavirenz + zidovudine + lamivudine or efavirenz + indinavir with indinavir + zidovudine + lamivudine in 1,266 patients who were required to be efavirenz-, lamivudine-, NNRTI-, and PI-naive at study entry.
Maltese: Studju 006, prova li fiha l-parteċipanti ntgħażlu b'mod każwali bil-mediċina meħuda magħrufa, qabbel efavirenz + zidovudine + lamivudine jew efavirenz + indinavir ma' indinavir + zidovudine + lamivudine f'1,266 pazjent li ma setgħux kienu ħadu efavirenz, lamivudine, NNRTI, jew PI meta daħlu fl-istudju.
English: It is used by adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg.
Maltese: Jintuża minn adulti, adoloxxenti, adolexxenti u tfal minn 3 xhur 'il fuq u li jiżnu tal-inqas 3.5 kg.
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenz-containing 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 tal-MPA bejn suġġetti li kienu qegħdin jirċievu terapija antiretrovirali li fiha efavirenz u suġġetti li ma kienu qegħdin jirċievu ebda terapija.
English: one 100 mg capsule + one 50 mg capsule
Maltese: tliet kapsuli ta' 100 mg + kapsula waħda ta' 50 mg
English: Cmax: ↓ 17% (↓ 6 to ↓ 26)b
Maltese: Cmax: ↓ 17% (↓ 6 għal ↓
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 4055 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: Cmax: ↓ 20% (↓ 11 to ↓ 28)
Maltese: Cmax: ↓ 20% (↓ 11 għal ↓
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/110/001-004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/110/001-004
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 coadministered with efavirenz.
Maltese: Hemm potenzjal għal tnaqqis jew żieda filkonċentrazzjonijiet filplażma ta' phenytoin, phenobarbital u antikonvulsivi oħra li huma substrati ta' isoenzimi CYP450 meta jingħataw fl-istess ħin ma' efavirenz.
English: Use in children and adolescents
Maltese: Tfal u adolexxenti
English: Each carton contains 1 bottle of 90 hard capsules.
Maltese: Kull kartuna fiha flixkun wieħed ta' 90 kapsula iebsa.
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) irċieva rapporti prospettivi ta' 904 tqaliet b'espożizzjoni tal-ewwel trimestru għal korsijiet li fihom efavirenz, li rriżultaw f'766 twelid ħaj.
English: Cmax: ↑ 14% (↑ 4 to ↑ 26)
Maltese: Cmax: ↑ 14% (↑ 4 għal ↑
English: Steps 11-14 must be completed within 30 minutes of mixing: 11 Give the mixture of food and capsule contents to the child, making sure he or she eats the full amount (illustration f).
Maltese: Passi 11-14 għandhom iridu fi żmien 30 minuta mit-taħlit: 11 Agħti t-taħlita ta' ikel u l-kontenut tal-kapsula lit-tifel/tifla, filwaqt li tiżgura li jiekol/tiekol l-ammont kollu (illustrazzjoni f).
English: Tabulated list of adverse reactions
Maltese: Lista ta' reazzjonijiet avversi miġburin f'tabella
English: SUSTIVA 100 mg hard capsules efavirenz
Maltese: SUSTIVA 100 mg kapsuli ibsin efavirenz
English: Maraviroc: AUC12: ↓ 45% (↓ 38 to ↓ 51)
Maltese: AUC12: ↓ 45% (↓ 38 sa
English: Efavirenz is contraindicated with concomitant use of drugs (they may cause prolonged QTc interval and Torsade de Pointes) such as: antiarrhythmics of classes IA and III, neuroleptics and antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride, flecainide, certain antimalarials and methadone (see section 4.3).
Maltese: Efavirenz huwa kontraindikat mal-użu konkomitanti tal-mediċini (dawn jistgħu jikkawżaw intervall tal-QTc imtawwal u Torsade de Pointes) bħal: antiarrmitiċi ta' klassijiet IA u IIA, newrolettiċi u aġenti antidipressanti, ċerti antibijotiċi li jinkludu xi aġenti tal-klassijiet li ġejjin: makrolidi, fluworokinoloni, imidazole, u aġenti antifungali ta' triazole, ċerti antistaminiċi mhux sedattivi (terfenadine, astemizole), cisapride, flecainide, ċerti mediċini kontra l-malarja u methadone (ara sezzjoni 4.3).
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 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: The recommended dose of efavirenz in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg orally, once daily.
Maltese: Id-doża rakkomandata ta' efavirenz flimkien ma' nucleoside analogue reverse transcriptase inhibitors (NRTIs) flimkien ma' PIs jew mingħajrhom (ara sezzjoni 4.5) hija ta' 600 mg kuljum, darba kuljum.
English: Cmax: ↓ 24% (↓ 18 to ↓ 30)
Maltese: Cmax: ↓ 24% (↓ 18 għal ↓
English: Each hard capsule contains 114.0 mg of lactose (as monohydrate).
Maltese: Kull kapsula iebsa fiha 114 mg ta' lactose (bħala monohydrate).
English: Each SUSTIVA hard capsule contains 100 mg of the active substance efavirenz.
Maltese: Kull kapsula SUSTIVA fiha 100 mg tas-sostanza attiva efavirenz.
English: The tablets are printed with inks containing hypromellose (E464), propylene glycol, cochineal carminic acid (E120), indigo carmine (E132) and titanium dioxide (E171).
Maltese: Linka għall-istampar Hypromellose (E464) Propylene glycol Cochineal carminic acid (E120) Indigo carmine (E132) Titanium dioxide (E171)
English: SUSTIVA 200 mg hard capsules efavirenz
Maltese: SUSTIVA 200 mg kapsuli ibsin efavirenz
English: Antimycobacterials Rifabutin/Efavirenz (300 mg once daily/600 mg once daily)
Maltese: Antimikobatteriċi Rifabutin/Efavirenz (300 mg darba kuljum/600 mg darba kuljum)
English: K103N was the most frequently observed RT substitution in viral isolates from patients who experienced a significant rebound in viral load during clinical studies of efavirenz in combination with indinavir or zidovudine + lamivudine.
Maltese: K103N kienet l-iktar sostituzzjoni RT osservata fl-iżolati virali minn pazjenti li rkadew b'mod sinifikanti fin-numru ta' virus waqt studji kliniċi b'efavirenz flimkien ta' indinavir jew zidovudine + lamivudinee.
English: Simvastatin: AUC: ↓ 69% (↓ 62 to ↓ 73)
Maltese: AUC: ↓ 69% (↓ 62 għal ↓
English: Darunavir/ritonavir/Efavirenz (300 mg twice daily*/100 mg twice daily/600 mg once daily)
Maltese: Darunavir/ritonavir/Efavirenz (300 mg darbtejn kuljum*/100 mg darbtejn kuljum/600 mg darba kuljum)
English: SUSTIVA 50 mg hard capsules
Maltese: SUSTIVA 50 mg kapsuli ibsin
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 n-NRTIs huma metabolizzati permezz ta' rotta differenti minn efavirenz u mhumiex probabbli li jikkompetu għall-istess enzimi metaboliċi u passaġġi tattneħħija.
English: Medicines used to treat malaria: artemether/lumefantrine: SUSTIVA may reduce the amount of artemether/lumefantrine in your blood.
Maltese: Mediċini użati biex jikkuraw il-malarja: artemether/lumefantrine:
English: Efavirenz must be given in combination with other antiretroviral medicines (see section 4.5).
Maltese: Efavirenz irid jingħata flimkien ma' mediċini antiretrovirali oħra (ara sezzjoni 4.5).
English: A positive relationship between efavirenz concentration and QTc prolongation was observed.
Maltese: Ġiet osservata relazzjoni pożittiva bejn il-konċentrazzjoni ta' efavirenz u t-titwil tal-QTc.
English: Packs of 42 x 1 hard capsules in aluminium/PVC perforated unit dose blisters.
Maltese: Pakki bil-folji tal-aluminjum bi 42 kapsula iebsa.
English: If efavirenz and telaprevir are co-administered, telaprevir 1,125 mg every 8 hours should be used.
Maltese: Jekk efavirenz u telaprevir huma jingħataw flimkien, għandu jintuża telaprevir 1,125 mg kull 8 sigħat.
English: Cmax: ↓ 51% (↓ 37 to ↓ 62)
Maltese: Cmax: ↓ 51% (↓ 37 sa
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 ssostituzzjoni K103N tagħti nuqqas ta' suxxettibilità lit-tliet NNRTIs li huma.
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: Injection:
Maltese: Impjant:
English: Tell your doctor:
Maltese: Aċidu ta' simvastatin:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains: efavirenz 200 mg
Maltese: Kull kapsula iebsa fiha: efavirenz 200 mg
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 control, 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: Voriconazole/Efavirenz (400 mg twice daily/300 mg once daily)
Maltese: Voriconazole/Efavirenz (400 mg darbtejn kuljum/300 mg darba kuljum)
English: Efavirenz: AUC: ↓ 26% (↓ 15 to ↓ 36)
Maltese: AUC: ↓ 26% (↓ 15 għal ↓
English: SUSTIVA 200 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules.
Maltese: SUSTIVA 200 mg kapsuli ibsin jistgħu jittieħdu minn tfal u adolexxenti ta' 3 xhur u aktar u li jiżnu għallinqas 3.5 kg li kapaċi jibilgħu l-kapsuli.
English: FURTHER INFORMATION
Maltese: 3. LISTA
English: Cmax: ↓ 76% (↓ 63 to ↓ 79)
Maltese: Cmax: ↓ 76% (↓ 63 għal
English: Azithromycin/Efavirenz (600 mg single dose/400 mg once daily)
Maltese: Azithromycin/Efavirenz (600 mg doża waħda/400 mg darba kuljum)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/110/008 - bottle
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/110/008 - flixkun
English: AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
Maltese: AUC: ↓ 75% (↓ 62 sa Cmax: ↓ 44% (↓ 20 sa
English: two 200 mg capsules one 600 mg tablet OR three 200 mg capsules
Maltese: żewġ kapsuli ta' 200 mg pillola waħda ta' 600 mg JEW tliet kapsuli ta' 200 mg
English: SUSTIVA 200 mg hard capsules
Maltese: SUSTIVA 200 mg kapsuli ibsin
English: Simeprevir/Efavirenz (150 mg once daily /600 mg once daily)
Maltese: Simeprevir/Efavirenz (150 mg darba kuljum /600 mg darba kuljum)
English: Simvastatin acid: AUC: ↓ 58% (↓ 39 to ↓ 68)
Maltese: AUC: ↓ 58% (↓ 39 għal ↓
English: If available, 90% or 95% confidence intervals are shown in parentheses.
Maltese: Jekk ikunu disponibbli, l-intervalli ta' kunfidenza ta' 90% jew 95% jintwerew fil-parentesi.
English: ANTIANXIETY AGENTS Lorazepam/Efavirenz (2 mg single dose/600 mg once daily)
Maltese: SUSTANZI KONTRA L-ANSJETÀ Lorazepam/Efavirenz (2 mg doża waħda/600 mg darba kuljum)
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Maltese: Eżempji relevanti huma retinite tas-sitomegalovirus, infezzjonijiet mikobatteriċi ġeneralizzati u/jew fokali, u pulmonite kkawżata minn Pneumocystis jiroveci (li qabel kien magħruf bħala Pneumocystis carinii).
English: Study 020 enrolled 327 patients who had been treated with NRTIs but not with PIs or NNRTIs.
Maltese: Studju 020 kellu 327 pazjent li kienu ġew ikkurati b'NRTIs imma mhux b'PIs jew NNRTIs.
English: SUSTIVA 100 mg hard capsules
Maltese: SUSTIVA 100 mg kapsuli ibsin
English: If therapy with efavirenz is discontinued, consideration should also be given to interrupting therapy with other antiretroviral agents to avoid development of resistant virus (see section 4.8).
Maltese: Jekk titwaqqaf it-terapija b'efavirenz, għandha titqies il-possibbiltà li tiġi interrotta t-terapija b'aġenti antiretrovirali oħra biex ma jiżviluppax virus reżistenti (ara sezzjoni 4.8).
English: The effect of efavirenz on the QTc interval was evaluated in an open-label, positive and placebo controlled, fixed single sequence 3-period, 3-treatment crossover QT study in 58 healthy subjects enriched for CYP2B6 polymorphisms.
Maltese: L-effett ta' efivarenz fuq l-intervall tal-QTc kien evalwat fi studju QT crossover ta' kura bi 3, ta' 3 perjodi ta' sekwenza waħdanija fissa, pożittiv u kkontrollat bi plaċebo, bit-tikketta mikxufa fi 58 individwu b'saħħtu arrikkit għal poliformiżmi CYP2B6.
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: bepridil (used to treat heart disease) cisapride (used to treat heartburn) ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches) midazolam or triazolam (used to help you sleep) pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions) elbasvir or grazoprevir (used to treat hepatitis C) St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety) flecainide, metoprolol (used to treat irregular heart beat) certain antibiotics (macrolides, fluoroquinolones, imidazole) triazole antifungal agents certain antimalarial treatments methadone (used to treat opiate addiction)
Maltese: - cisapride (użata biex tikkura ħruq fl-istonku) - ergot alkaloids (eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) (użati biex jikkuraw l-emikranji u uġigħ ta' ras regolari) - midazolam jew triazolam (użati biex jgħinuk torqod) - pimozide, imipramine, amitriptyline jew clomipramine (użati biex jikkuraw ċerti kundizzjonijiet mentali) - elbasvir jew grazoprevir (użati biex jikkuraw epatite Ċ) - St.
English: SUSTIVA 100 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules.
Maltese: SUSTIVA 100 mg kapsuli ibsin jistgħu jittieħdu minn tfal u adolexxenti ta' 3 xhur u aktar u li jiżnu għallinqas 3.5 kg li kapaċi jibilgħu l-kapsuli.
English: Seizures
Maltese: UŻU
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the cytochrome P450 system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Maltese: Studji fil-bnedmin u studji in vitro bil-mikrosomi tal-fwied uman urew li efavirenz l-iktar li jkun metabolizzat bis-sistema cytochrome P450 f'metaboliti idrossilati li wara jgħaddu minn proċess ta' glukuronidazzjoni.
English: Coadministration of sofosbuvir/velpatasvir with efavirenz is not recommended (see section 4.5).
Maltese: L-għoti flimkien ta' sofosbuvir/velpatasvir ma' efavirenz mhuwiex rakkomandat (ara sezzjoni 4.5).
English: AUC : ↓ 31% (↓ 8 to ↓ 47) Cmin : ↓ 40%
Maltese: AUC : ↓ 31% (↓ 8 għal ↓
English: In these studies the dose of efavirenz was 600 mg once daily; the dose of indinavir was 1,000 mg every 8 hours when used with efavirenz and 800 mg every 8 hours when used without efavirenz.
Maltese: F'dawn l-istudji d-doża ta' efavirenz kienet ta' 600 mg darba kuljum; id-doża ta' indinavir kienet ta' 1,000 mg kull 8 sigħat meta użat ma' efavirenz u 800 mg kull 8 sigħat meta użat mingħajr efavirenz.
English: Experience with efavirenz in patients who discontinued other antiretroviral agents of the NNRTI class is limited (see section 4.8).
Maltese: Esperjenza b'efavirenz f'pazjenti li ma komplewx jieħdu sustanzi antiretovirali oħra mill-klassi ta' NNRTI hija limitata (ara sezzjoni 4.8).
English: * When compared to atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
Maltese: 300 mg/ritonavir 100 mg darba kuljum filgħaxija mingħajr efavirenz.
English: Capsule shell: Gelatine, Sodium laurilsulfate, Titanium dioxide (E171), Silicon dioxide (E551)
Maltese: Il-qoxra tal-kapsula: Ġelatina, Sodium laurilsulfate, Titanium dioxide (E171), Silicon dioxide (E551)
English: The mixture should be administered as soon as possible, but no more than 30 minutes after mixing.
Maltese: It-taħlita għandha tingħata kemm jista' jkun malajr, iżda mhux aktar tard minn 30 minuta wara li ssir it-taħlita.
English: The pattern of amino acid substitutions in RT associated with resistance to efavirenz was independent of the other antiviral medicines 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 mediċini antivirali oħra li jintużaw flimkien ma' efavirenz.
English: ANTIHISTAMINES Cetirizine/Efavirenz (10 mg single dose/600 mg once daily)
Maltese: Cetirizine/Efavirenz (10 mg doża waħda/600 mg darba kuljum)
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti b'epatite kronika B jew C u kkurati b'terapija antiretrovirali kombinata għandhom riskju ikbar ta' reazzjonijiet avversi severi jew potenzjalment fatali tal-fwied.
English: The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172) and silicon dioxide.
Maltese: Il-qoxra tal-kapsula fiha: gelatine, sodium laurilsulfate, yellow iron oxide (E172) u silicon dioxide.
English: Nelfinavir: AUC: ↑ 20% (↑ 8 to ↑ 34)
Maltese: AUC filgħodu: ↑ 18% (↑ 6 għal ↑ 33)
English: A multipledose study showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh Class A) compared with controls.
Maltese: Studju b'dożi multipli ma wera l-ebda effett sinifikanti fuq il-farmakokinetika ta' efavirenz f'pazjenti b'indeboliment ħafif tal-fwied (Child-Pugh Klassi A) meta mqabbel ma' kontrolli.
English: Coadministration of glecaprevir/pibrentasvir with efavirenz is not recommended (see section 4.5).
Maltese: L-għoti flimkien ta' glecaprevir/pibrentasvir ma' efavirenz mhuwiex rakkomandat (ara sezzjoni 4.5).
English: SUSTIVA 50 mg hard capsules can be taken by children and adolescents 3 months of age and older and weighing at least 3.5 kg who are able to swallow the capsules.
Maltese: SUSTIVA 50 mg kapsuli ibsin jistgħu jittieħdu minn tfal u adolexxenti ta' 3 xhuru aktar u li jiżnu għallinqas 3.5 kg li kapaċi jibilgħu l-kapsuli.
English: In healthy adult subjects, the efavirenz AUC when administered as the contents of three 200 mg hard capsules mixed with 2 teaspoons of certain food vehicles (applesauce, grape jelly, yogurt or infant formula) met bioequivalency criteria for the AUC of the intact capsule formulation administered under fasted conditions.
Maltese: F'suġġetti adulti b'saħħithom, l-AUC ta' efavirenz meta mogħti bħala l-kontent ta' tliet kapsuli iebsin ta' 200 mg imħalltin ma' 2 kuċċarini ta' ċerti sustanzi li fihom l-ikel (meraq tat-tuffieħ, jelly talgħeneb, jogurt jew ħalib tat-trabi) issodisfa l-kriterji ta' bijoekwivalenza għall-AUC tal-formula talkapsula intatta mogħtija taħt kundizzjonijiet ta' sawm.