FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatobiliary disorders common aspartate aminotransferase (AST) increased*, alanine aminotransferase (ALT) increased*, gamma-glutamyltransferase (GGT) increased*
Maltese: Disturbi fil-fwied u fil-marrara komuni żieda fil-livelli ta' aspartate aminotransferase (AST)*, żieda fil-livelli ta' alanine aminotransferase (ALT)*, żieda fil-livelli ta' gamma-glutamyltransferase (GGT)*
English: a 90% confidence intervals unless otherwise noted.
Maltese: a intervalli ta' kunfidenza ta' 90% sakemm mhux indikat mod ieħor.
English: Cmin: ↑ 25% (↑ 7 to ↑ 46) b
Maltese: Cmin: ↑ 25% (↑ 7 għal ↑ 46) b
English: Adults and adolescents over 40 kg
Maltese: Adulti u adoloxxenti 'l fuq minn 40 kg
English: Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).
Maltese: Efavirenz huwa impeditur mhux kompetittiv ta' HIV-1 reverse transcriptase (RT) u ma jimpedix b'mod sinifikanti HIV-2 RT jew polymerases (α, β, γ or δ) tad-DNA ċellulari.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 May 1999
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 28 ta' Mejju 1999
English: MSD Α.Φ.Β.Ε.Ε Τηλ: + 30-210 98 97 300 dpoc_greece@merck.com
Maltese: Τηλ: + 30-210 98 97 300 dpoc_greece@merck.com
English: PHARMACEUTICAL FORM AND CONTENTS 90 hard capsules: bottle
Maltese: FARMAĊEWTIKA U KONTENUT 90 kapsula iebsa: flixkun
English: Ethinyloestradiol: AUC: ↔
Maltese: Ethinyloestradiol:
English: Patients with severe hepatic impairment (Child Pugh Class C) (see section 5.2).
Maltese: Pazjenti b'indeboliment sever tal-fwied (Child Pugh Klassi Ċ) (ara sezzjoni 5.2).
English: Mean Cmax µg/mL
Maltese: Medja tas-Cmax µg/mL
English: Nervous system symptoms
Maltese: Sintomi tas-sistema nervuża
English: Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors.
Maltese: Antivirali għal użu sistemiku, inibituri non-nukleosidi ta' reverse transcriptase.
English: C.
Maltese: D.
English: Gender, race, elderly
Maltese: Sess, razza, anzjani
English: - severe depression - suicidal ideation - non-fatal suicide attempts - aggressive behaviour - paranoid reactions - manic reactions
Maltese: - dipressjoni severa - ideat suwiċidali - attentati mhux fatali ta' suwiċidju - mġiba aggressiva - reazzjonijiet paranojdi - reazzjonijiet manijaċi
English: Concomitant use of St. John's wort is contraindicated (see section 4.3).
Maltese: John's wort huwa kontraindikat (ara sezzjoni 4.3).
English: The long-term safety profile of efavirenz-containing regimens was evaluated in a controlled trial (006) in which patients received efavirenz + zidovudine + lamivudine (n = 412, median duration 180 weeks), efavirenz + indinavir (n = 415, median duration 102 weeks), or indinavir + zidovudine + lamivudine (n = 401, median duration 76 weeks).
Maltese: Il-profil ta' sigurtà fit-tul ta' kuri li fihom efavirenz ġie evalwat fi prova kkontrollata (006) li fiha pazjenti ngħataw efavirenz + zidovudine + lamivudine (n = 412, tul medju ta' 180 ġimgħa), efavirenz + indinavir (n = 415, tul medju ta' 102 ġimgħa), jew indinavir + zidovudine + lamivudine (n = 401, tul medju ta' 76 ġimgħa).
English: LIST OF EXCIPIENTS It contains: lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Fiha: lactose monohydrate.
English: cells/mm3 (S.E.M.d)
Maltese: ċelluli /mm3 (S.E.
English: In 35 patients receiving efavirenz 600 mg once daily, steady state Cmax was 12.9 ± 3.7 μM (29%) [mean ± S.D. (% C.V.)], steady state Cmin was 5.6 ± 3.2 μM (57%), and AUC was 184 ± 73 μM·h (40%).
Maltese: F'35 pazjent li kienu qed jirċievu 600 mg ta' efavirenz darba kuljum, Cmax fiss kien 12.9 ± 3.7 µM (29 %) [medja ± S.D. ( % C.V.)], Cmin fiss kien 5.6 ± 3.2 µM (57 %), u AUC kien 184 ± 73 µM·h (40 %).
English: ATC code: J05AG03
Maltese: J05A G03
English: Since fluoxetine shares a similar metabolic profile with paroxetine, i.e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
Maltese: Billi fluoxetine għandu profil metaboliku simili għal paroxetine, jiġifieri effett inibitorju qawwi fuq CYP2D6, huwa mistenni nuqqas simili ta' interazzjoni għal fluoxetine.
English: Contrada Fontana del Ceraso 03012 Anagni (FR) Italy
Maltese: Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR) L-Italja
English: 7.5 to < 15
Maltese: 7.5 sa < 15
English: Clinical experience in controlled studies with combinations including didanosine or zalcitabine is limited.
Maltese: L-esperjenza klinika fi studji kkontrollati b'kombinazzjonijiet inkluż didanosine jew zalcitabine hija limitata.
English: uncommon affect lability, aggression, confusional state, euphoric mood, hallucination, mania, paranoia, psychosis†, suicide attempt, suicide ideation, catatonia*
Maltese: mhux komuni bidla kontinwa fil-burdata, aggressjoni, stat konfużjonali, burdata ewforika, alluċinazzjoni, manija, paranoja, psikożi‡, attentat ta' suwiċidju, ideat dwar suwiċidju, katatonja*
English: uncommon hypercholesterolaemia*
Maltese: mhux komuni iperkolesterolimja*
English: Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
Maltese: Mediċini użati biex jikkuraw infezzjonijiet batterjali, inkluż tuberkolożi u kumpless ta' avju mijobatterjum: clarithromycin, rifabutin, rifampicin.
English: Cmax: ↑ 50% (↑ 20 to ↑ 80)
Maltese: Cmax: ↑ 50% (↑ 20 sa
English: SUSTIVA, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Maltese: SUSTIVA, li fih is-sustanza attiva efavirenz, jagħmel parti minn klassi ta' mediċini antiretrovirali li jissejħu inibituri non-nukleosidi ta' reverse transcriptase (NNTRIs).
English: Immune system disorders uncommon hypersensitivity
Maltese: Disturbi fis-sistema immuni mhux komuni sensittività eċċessiva
English: Croscarmellose sodium Microcrystalline cellulose Sodium laurilsulfate Hydroxypropylcellulose Lactose monohydrate Magnesium stearate
Maltese: Qalba tal-pillola Croscarmellose sodium Microcrystalline cellulose Sodium laurilsulfate Hydroxypropylcellulose Lactose monohydrate Magnesium stearate.
English: Responder rates (NC = Fa) Plasma HIV-RNA
Maltese: Rati tar-rispons (NC = Fa) Plażma HIV-RNA
English: In HIV infected patients at steady state, mean Cmax, mean Cmin, and mean AUC were linear with 200 mg, 400 mg, and 600 mg daily doses.
Maltese: F'pazjenti infettati bl-HIV fi stat fiss, Cmax medju, Cmin medju, and AUC medju kienu lineari b'dożi ta' kuljum ta' 200 mg, 400 mg u 600 mg.
English: Ethinyloestradiol + Norgestimate/ Efavirenz (0.035 mg + 0.25 mg once daily/600 mg once daily)
Maltese: Ethinyloestradiol+Norgestimate/ Efavirenz (0.035 mg+0.25 mg darba kuljum/600 mg darba kuljum)
English: Cmin: ↓ 50% (↓ 40 to ↓ 59)b
Maltese: Cmin: ↓ 50% (↓ 40 għal ↓ 59)b
English: Other medicines used for HIV infection: protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/saquinavir.
Maltese: Mediċini oħrajn użati għal infezzjoni tal-HIV: inibituri tal-protease: darunavir, indinavir, lopinavir/ritonavir, ritonavir, atazanavir, saquinavir jew fosamprenavir/saquinavir imsaħħin b'ritonavir.
English: Ginkgo biloba extracts (a herbal preparation)
Maltese: Estratti ta' Ginkgo biloba (preparazzjoni erbali)
English: ANTIDEPRESSANTS
Maltese: ANTIDIPRESSANTI
English: ANTICOAGULANTS Warfarin/Efavirenz Acenocoumarol/Efavirenz
Maltese: Warfarin/Efavirenz Acenocoumarol/Efavirenz
English: 3.5 to < 5
Maltese: 3.5 sa < 5
English: Biliary fibrosis has been observed in rats.
Maltese: Fil-firien ġiet osservata fibrosi biljarja.
English: AUC: ↓ 17% Cmax: ↔ (CYP3A4 induction)
Maltese: AUC: ↓ 17% Cmax: ↔ (induzzjoni ta' CYP3A4)
English: ACID REDUCING AGENTS Aluminium hydroxide-magnesium hydroxide-simethicone antacid/Efavirenz (30 ml single dose/400 mg single dose)
Maltese: SUSTANZI LI JNAQQSU L-AĊIDU Aluminium hydroxide-magnesium hydroxide-simethicone antacid/Efavirenz (30 mL doża waħda/400 mg doża waħda)
English: < 400 copies/ml
Maltese: < 400 kopja/ml
English: (CYP3A4 induction) Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
Maltese: Żviluppa raxx f'46% talvoluntiera mhux infettati li rċevew efavirenz u clarithromycin.
English: < 400 copies/ml (95% C.I.
Maltese: < 400 kopja/ml (95% C.I.
English: SUSTIVA 50 mg hard capsules SUSTIVA 100 mg hard capsules 3 years.
Maltese: SUSTIVA 50 mg kapsuli ibsin SUSTIVA 100 mg kapsuli ibsin 3 snin.
English: Amylase: in the clinical trial subset of 1,008 patients, asymptomatic increases in serum amylase levels greater than 1.5 times the upper limit of normal were seen in 10% of patients treated with efavirenz and 6% of patients treated with control regimens.
Maltese: Amylase: fis-sottogrupp ta' 1,008 pazjenti fil-prova klinika, ġew osservati żidiet asintomatiċi fil-livelli ta' serum amylase iktar minn 1.5 darbiet il-livell ta' fuq tan-normal f'10% tal-pazjenti kkurati b'efavirenz u f'6% tal-pazjenti f'kuri ta' kontroll.
English: < 50 copies/ml (95% C.I.
Maltese: < 50 kopja/ml (95% C.I.
English: Other macrolide antibiotics (e.g.,erythromycin)/Efavirenz
Maltese: Antibijotiċi makrolidi oħrajn (e.ż.,erythromycin)/Efavirenz
English: < 500 copies/ml
Maltese: < 500 kopja/ml
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30 x 1) film-coated tablets
Maltese: U KONTENUT Pakkett multiplu: 90 (3 pakketti ta' 30 x 1) pilloli miksijin b'rita
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: Herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
Maltese: John's wort (Hypericum perforatum) minħabba li joktor irriskju ta' konċentrazzjonijiet imnaqqsa fil-plażma u ta' effetti kliniċi mnaqqsa ta' efavirenz (ara sezzjoni 4.5).
English: Table 4: Efficacy results for studies ACTG 364 and 020
Maltese: Tabella 4: Riżultati tal-effikaċja għall-istudji ACTG 364 u 020
English: < 50 copies/ml
Maltese: < 50 kopja/ml
English: % (95% C.I.)
Maltese: % (95% C.I.) Celluli/m
English: Nervous system symptoms of moderate-to-severe intensity were experienced by 19% (severe 2%) of patients compared to 9% (severe 1%) of patients receiving control regimens.
Maltese: Sintomi tas-sistema nervuża li kienu minn moderati sa qawwija nħassu minn 19 % (2.0 % qawwija) tal-pazjenti meta mqabbla ma' 9 % (1 % qawwija) mill-pazjenti li kienu qed jirċievu skedi ta' kura ta' kontroll.
English: Study ACTG 364 48 weeks
Maltese: Studju ACTG 364 48 ġimgħa Studju ACTG 364 48 ġimgħa
English: The in vitro studies suggest that CYP3A4 and CYP2B6 are the major isozymes responsible for efavirenz metabolism and that it inhibited P450 isozymes 2C9, 2C19, and 3A4.
Maltese: Studji in vitro jissuġġerixxu li CYP3A4 u CYP2B6 huma l-iżozimi li l-iktar huma responsabbli għall-metaboliżmu ta' efavirenz u li hu impedixxa iżozimi P450 2C9, 2C19, and 3A4.
English: 4 Place 1-2 teaspoons of the food in a small container (illustration a).
Maltese: Poġġi 1-2 kuċċarini tal-ikel f'kontenitur żgħir (illustrazzjoni a).
English: MSD Polska Sp. z o.o.
Maltese: MSD Α.Φ.Β.Ε.Ε
English: Packs of 30 x 1 or multipacks of 90 (3 packs of 30 x 1) film-coated tablets in aluminium/PVC perforated unit dose blisters.
Maltese: Pakketti ta' 30 x 1 jew pakketti multipli ta' 90 (3 pakketti x 30 x 1) pillola miksija b'rita f'folji talaluminju/PVC perforati għal dożi singoli.
English: Methadone/Efavirenz (stable maintenance, 35-100 mg once daily/600 mg once daily)
Maltese: Methadone/Efavirenz (manteniment stabbli, 35-100 mg darba kuljum/600 mg darba kuljum)
English: (CYP3A4 enzyme induction)
Maltese: (CYP3A4 induction).
English: Table 4: Predicted steady-state pharmacokinetics of efavirenz (capsules/capsule sprinkles) in HIV-infected paediatric patients Body Weight
Maltese: Tabella 4: Farmakokinetika mbassra fi stat fiss ta' efavirenz (kapsuli/traxxix tal-kapsuli) f'pazjenti pedjatriċi infettati bl-HIV
English: astemizole or terfenadine (used to treat allergy symptoms)
Maltese: -astemizole jew terfenadine (użata biex tikkura sintomi allerġiċi)
English: Velpatasvir/ sofosbuvir/ voxilaprevir
Maltese: Velpatasvir/sofosbuvir/voxilaprevir ↓velpatasvir ↓voxilaprevir
English: Peak efavirenz plasma concentrations of 1.6 - 9.1 μM were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers.
Maltese: L-ogħla konċentrazzjonijiet ta' efavirenz fil-plażma ta' 1.6 - 9.1 µM intlaħqu 5 sigħat wara dożi orali waħedhom ta' 100 mg sa 1,600 mg mogħti lil voluntiera mhux infettati.
English: No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/l) when given with ritonavir and efavirenz was higher than the mean historical Cmin (0.15 mg/l) when indinavir was given alone at 800 mg q8h.
Maltese: Ebda interazzjoni farmakokinetika klinikament sinifikanti Il-Cmin ġeometrika medja għal indinavir (0.33 mg/l) meta ngħata ma' ritonavir u efavirenz kienet ogħla mill-Cmin storika medja (0.15 mg/l) meta indinavir ingħata waħdu f'doża ta' 800 mg q8h.
English: Antibiotics, including the following types: macrolides, fluoroquinolones or imidazole.
Maltese: - Antibijotiċi, inkluż it-tipi li ġejjin: makrolidi, fluworokinoloni jew imidazole.
English: Alternatives to clarithromycin (e.g. azithromycin) may be considered.
Maltese: Jistgħu jiġu kkunsidrati alternattivi għallclarithromycin (eż. azithromycin).
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 %), sturdament (8.5 %), dardir (8.0 %), uġigħ ta' ras (5.7 %) u għeja (5.5 %).
English: AUC: ↓ 36% C12: ↓ 21%
Maltese: ↓ 36% C12: ↓ 21%
English: Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, table 2).
Maltese: Esponimenti għal raltegravir (sustrat ta' UGT1A1) jitnaqqsu filpreżenza ta' efavirenz (ara sezzjoni 4.5, tabella 2).
English: Mean AUC(0-24) µM·h
Maltese: Medja tal-AUC(0µM·h
English: An alternative anticonvulsant should be considered.
Maltese: Għandu jiġi kkunsidrat antikonvulsiv alternattiv.
English: No dose adjustment is necessary for rifampicin, including 600 mg.
Maltese: M'hemmx bżonn ta' aġġustament fid-doża għal rifampicin, inkluż 600 mg.
English: The free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudineresistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Maltese: Il-konċentrazzjoni ħielsa ta' efavirenz li kien hemm bżonn għall-inibizzjoni ta' bejn id-90 u l-95 % ta' iżolati wild type jew iżolati tal-laboratorju reżistenti għal zidovudine u iżolati kliniċi in vitro kienet minn 0.46 sa 6.8 nM f'razez ta' ċelluli limfoblastojdi, ċelluli periferali mononukleari tad-demm (PBMCs) u kulturi makrofaġi monoċistiċi.
English: 8 Sprinkle the contents of the capsule on the food (illustration d).
Maltese: 8 Xerred il-kontenut tal-kapsula fuq l-ikel (illustrazzjoni d).
English: Cmax: ↔*/** (↓5 to ↑26)
Maltese: Cmax: ↔*/** (↓ 5 sa ↑ 26) Cmin: ↑ 12%*/** (↓ 16 sa
English: 30 x 1 TABLETS
Maltese: 30 x 1 pillola miksija b'rita
English: Efavirenz is a NNRTI of HIV-1.
Maltese: Efavirenz huwa NNRTI tal-HIV-1.
English: The AUC and Cmax of a single 600 mg dose of efavirenz film-coated tablets in uninfected volunteers was increased by 28% (90% CI: 22-33%) and 79% (90% CI: 58-102%), respectively, when given with a high fat meal, relative to when given under fasted conditions (see section 4.4).
Maltese: L-AUC u s-Cmax ta' doża waħda ta' 600 mg ta' pilloli miksija b'rita ta' efavirenz f'voluntiera mhux infettati żdiedu bi 28 % (90 % CI: 22 - 33 %) u 79 % (90 % CI:58 - 102 %), rispettivament, meta ngħataw ikla b'ħafna xaħam meta mqabbel ma' meta kienu f'kondizzjonijiet ta' sawm (ara sezzjoni 4.4).
English: Because of the limited information available, a reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Maltese: Minħabba l-informazzjoni limitata disponibbli, għandu jintuża metodu affidabbli ta' kontraċezzjoni barriera flimkien mal-kontraċettivi ormonali (ara sezzjoni 4.6).
English: - severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
Maltese: - disturbi severi tal-bilanċ tal-elettroliti eż. ipokalemija jew ipomanjeżemija.
English: Laboratory test abnormalities
Maltese: Anormalitajiet f'testijiet tal-laboratorju
English: AUC: ↑ 21% (↑ 10 to ↑ 34)
Maltese: AUC: ↑ 21% (↑ 10 għal ↑
English: Reproductive system and breast disorders uncommon gynaecomastia
Maltese: Disturbi fis-sistema riproduttiva u fis-sider mhux komuni ginekomastja
English: In vitro efavirenz is also an inhibitor of CYP3A4.
Maltese: In vitro efavirenz huwa wkoll inibitur ta' CYP3A4.
English: Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported adverse reactions in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).
Maltese: Sintomi li jinkludu, imma mhux limitati għal, sturdament, nuqqas ta' rqad, ngħas, diffikultà ta' konċentrazzjoni u ħolm mhux normali huma reazzjonijiet avversi irrapportati b'mod frekwenti f'pazjenti li kienu qed jieħdu 600 mg ta' efavirenz kuljum fi studji kliniċi (ara sezzjoni 4.8).
English: Other medicines and SUSTIVA
Maltese: Mediċini oħra u SUSTIVA
English: The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
Maltese: L-inċidenza ta' eritema multiforme jew issindrome ta' Stevens-Johnson kienet madwar 0.1 %.
English: LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A Reductase Inhibitors Atorvastatin/Efavirenz (10 mg once daily/600 mg once daily)
Maltese: PRODOTTI MEDIĊINALI LI JBAXXU L-LIPIDI Inibituri HMG Co-A Reductase Atorvastatin/Efavirenz (10 mg darba kuljum/600 mg darba kuljum)
English: Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction).
Maltese: Espożizzjoni mnaqqsa talimmunosuppressant (CYP3A4 induction).
English: QTc prolongation has been observed with the use of efavirenz (see sections 4.5 and 5.1).
Maltese: Bl-użu ta' efavirenz, ġie osservat it-titwil tal-QTc (ara s-sezzjonijiet 4.5 u 5.1).
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, mhux biex jinbiegħ separatament.
English: Atovaquone and proguanil hydrochloride/Efavirenz (250/100 mg single dose/600 mg once daily)
Maltese: Atovaquone u proguanil hydrochloride/Efavirenz (doża waħda ta' 250/100 mg/600 mg darba kuljum)
English: †These adverse reactions were identified through post-marketing surveillance; however, the frequencies were determined using data from 16 clinical trials (n=3,969).
Maltese: Dawn ir-reazzjonijiet avversi kienu identifikati permezz ta' sorveljanza wara t-tqegħid fis-suq; madankollu l-frekwenzi kienu stabbiliti bl-użu ta' dejta minn 16-il prova klinika (n=3,969).
English: Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV+IDV, 196 patients with EFV+ZDV+3TC and 127 patients with IDV+ZDV+3TC, respectively), suggest durability of response in terms of proportions of patients with HIV RNA < 400 copies/ml, HIV RNA < 50 copies/ml and in terms of mean change from baseline CD4 cell count.
Maltese: Riżultati fit-tul mal-168 ġimgħa tal-istudju 006 (160 pazjent spiċċaw l-istudju bil-kura b'EFV +IDV, 196 pazjent b'EFV + ZDV + 3TC u 127 pazjent b'IDV + ZDV + 3TC, rispettivament), jissuġġerixxu li r-rispons ma' jisfaxxax fix-xejn, fis-sens tal-proporzjoni ta' pazenti b'HIV RNA < 400 kopji/ml, HIV RNA < 50 kopji/ml u fis-sens tal-bidla medja mil-linja bażi CD4 tal-għadd taċ-ċelluli.
English: OTHER
Maltese: com
English: Artemether/lumefantrine/ Efavirenz (20/120 mg tablet, 6 doses of 4 tablets each over 3 days/600mg once daily)
Maltese: SUSTANZI KONTRA L-MALARJA Artemether/lumefantrine/ Efavirenz (20/120 mg pillola, 6 dożi ta' 4 pilloli kull waħda fuq 3 ijiem/600 mg darba kuljum)
English: Efavirenz has been studied in over 9,000 patients.
Maltese: Efavirenz ġie studjat f'iktar minn 9,000 pazjent.
English: Specific interaction studies have not been performed with efavirenz and NRTIs other than lamivudine, zidovudine, and tenofovir disoproxil.
Maltese: Ma sarux studji speċifiċi tal-interazzjoni b'efavirenz u NRTIs oħra apparti minn lamivudine, zidovudine, u tenofovir disoproxil.
English: Psychiatric symptoms
Maltese: Sintomi psikjatriċi
English: Clarithromycin/Efavirenz (500 mg q12h/400 mg once daily)
Maltese: Clarithromycin/Efavirenz (500 mg q12h/400 mg darba kuljum)
English: The mean Cmax of efavirenz in subjects with CYP2B6 *6/*6 genotype following the administration of 600 mg daily dose for 14 days was 2.25-fold the mean Cmax observed in subjects with CYP2B6 *1/*1 genotype.
Maltese: Is-Cmax medja ta' efavirenz f'individwi b'ġenotip CYP2B6 *6/*6 wara l-għoti ta' doża ta' kuljum ta' 600 mg għal 14-il ġurnata kienet 2.25 drabi ogħla mis-Cmax medja f'individwi b'ġenotip CYP2B6 *1/*1.
English: Each hard capsule contains 57.0 mg of lactose (as monohydrate).
Maltese: Kull kapsula iebsa fiha 57.0 mg ta' lactose (bħala monohydrate).
English: uncommon agitation, amnesia, ataxia, coordination abnormal, convulsions, thinking abnormal,* tremor†
Maltese: mhux komuni aġitazzjoni, amneżija, ataksja, ko-ordinament anormali, konvulżjonijiet, ħsieb anormali, tregħid‡
English: With efavirenz, an increase of the lopinavir/ritonavir soft capsule or oral solution doses by 33% should be considered (4 capsules/~6.5 ml twice daily instead of 3 capsules/5 ml twice daily).
Maltese: Ma' efavirenz, għandha tiġi kkunsidrata żieda ta' 33% fid-dożi ta' lopinavir/ritonavir kapsula ratba jew soluzzjoni orali (4 kapsuli/~6.5 ml darbtejn kuljum minflok 3 kapsuli/5 ml darbtejn kuljum).
English: Children and adolescents (3 months to 17 years)
Maltese: Tfal u adolexxenti (3 xhur sa 17-il sena)
English: Posaconazole/Efavirenz --/400 mg once daily
Maltese: Posaconazole/Efavirenz --/400 mg darba kuljum
English: Itraconazole/Efavirenz (200 mg q12h/600 mg once daily)
Maltese: Itraconazole/Efavirenz (200 mg q12h/600 mg darba kuljum)
English: No clinically significant pharmacokinetic interaction
Maltese: Ebda interazzjoni farmakokinetika klinikament sinifikanti
English: SUSTIVA 600 mg film-coated tablets efavirenz
Maltese: SUSTIVA 600 mg pilloli miksija efavirenz
English: Telaprevir/Efavirenz (1,125 mg q8h/600 mg once daily)
Maltese: Telaprevir/Efavirenz (1,125 mg q8h/600 mg darba kuljum)
English: How to take SUSTIVA
Maltese: X'fih SUSTIVA
English: Concomitant administration of velpatasvir/sofosbuvir/ voxilaprevir with efavirenz is not recommended (see section 4.5).
Maltese: L-għoti konkomitanti ta' velpatasvir/sofosbuvir/voxilaprevir ma' efavirenz mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Contraindications of concomitant use
Maltese: Kontraindikazzjonijiet tal-użu simultanju
English: Cmax: ↑ 23% (↓ 1 to ↑ 53) *
Maltese: Cmax: ↑ 23% (↓ 1 għal ↑