FrancophonIA/ELRC3.0 huggingface dataset:
English: Interactions between efavirenz/emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products are listed in Table 1 below (increase is indicated as ‘↑', decrease as ‘↓', no change as ‘↔', twice daily as ‘b.i.d.
Maltese: Interazzjonijiet bejn efavirenz/emtricitabine/tenofovir disoproxil Mylan jew il-komponent(i) individwali tiegħu u prodotti mediċinali oħra huma elenkati fit-Tabella 1 hawn taħt (żieda hija indikata b'“↑”, tnaqqis b'“↓”, ebda bidla b'“↔”, darbtejn kuljum b'“b.i.d.”, darba kuljum bi “q.d.” u darba kull 8 sigħat bi “q8h”).
English: AUC: ↓ 71%
Maltese: AUC: ↓ 71% (↓ 67 sa
English: Efavirenz/emtricitabine/tenofovir disoproxil in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Maltese: Efavirenz/emtricitabine/tenofovir disoproxil Mylan flimkien ma' darunavir/ritonavir 800/100 mg darba kuljum jistgħu jirriżultaw f'darunavir Cminsubottimali.
English: If serum phosphate is < 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to < 50 ml/min in any patient receiving efavirenz/emtricitabine/tenofovir disoproxil, renal function must be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk il-fosfat fis-serum ikun < 1.5 mg/dl (0.48 mmol/l) jew ir-rata tat-tneħħija tal-kreatinina titnaqqas għal < 50 mL/min fi kwalunkwe pazjent li jkun qed jirċievi efavirenz/emtricitabine/tenofovir disoproxil, il-funzjoni renali jeħtieġ li tiġi evalwata mill-ġdid fi żmien ġimgħa, fosthom kejl talkonċentrazzjonijiet tal-glukożju fid-demm, potassju fid-demm u glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
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 ta' żaqq, dardir amylase għoli li jinkludi amylase pankreatika, lipase fis-serum għoli, rimettar, uġigħ addominali, dispepsja uġigħ addominali, distensjoni addominali, gass
English: Cmax: ↓ 45% (CYP3A4 or P gp inductioneffect on elbasvir)
Maltese: AUC: ↓ 54% Cmax: ↓ 45% (Induzzjoni ta' CYP3A4 jew ta' P gp -effett fuq elbasvir)
English: Lopinavir/ritonavir tablets/Efavirenz (400/100 mg b.i.d./600 mg q.d.)
Maltese: Lopinavir/ritonavir pilloli/Efavirenz (400/100 mg b.i.d./ 600 mg q.d.)
English: When efavirenz/emtricitabine/tenofovir disoproxil is taken with rifampicin in patients weighing 50 kg or greater, an additional 200 mg/day (800 mg total) of efavirenz may provide exposure similar to a daily efavirenz dose of 600 mg when taken without rifampicin.
Maltese: Meta efavirenz/emtricitabine/tenofovir disoproxil Mylan jittieħed ma' rifampicin f'pazjenti li jiżnu 50 kg jew iktar, 200 mg/jum (total ta' 800 mg) addizzjonali ta' efavirenz jistgħu jipprovdu esponiment simili għal doża ta' kuljum ta' efavirenz ta' 600 mg meta jittieħrd mingħajr rifampicin.
English: • angry behaviour, suicidal thoughts, strange thoughts, paranoia, unable to think clearly, mood being affected, seeing or hearing things that are not really there (hallucinations), suicide attempts, personality change (psychosis), catatonia (a condition in which the patient is rendered motionless and speechless for a period)
Maltese: • imġiba rrabjata, ideat suwiċidali, ħsibijiet strambi, paranojja, ma tistax taħseb sewwa, burdata li tkun affettwata, tara jew tisma' affarijiet li ma jkunux veru hemm (alluċinazzjonijiet), attentati ta' suwiċidju, tibdil fil-personalità (psikożi), katatonja (kundizzjoni fejn il-pazjent ma jkunx jista' jiċċaqlaq jew jitkellem għal perjodu ta' żmien).
English: Efavirenz/emtricitabine/tenofovir disoproxil is contraindicated in patients with severe hepatic impairment (see section 4.3) and not recommended in patients with moderate hepatic impairment.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan hu kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3) u mhuwiex rakkomandat f'pazjenti b'indeboliment epatiku moderat.
English: Following intravenous administration the volume of distribution of tenofovir was approximately 800 ml/kg.
Maltese: Wara għoti ġol-vini, ilvolum ta' distribuzzjoni ta' tenofovir kien madwar 800 mL/kg.
English: The pharmacokinetics, safety and efficacy of efavirenz/emtricitabine/tenofovir disoproxil have not been established in patients with significant underlying liver disorders (see section 5.2).
Maltese: Il-farmakokinetika, is-sigurtà u l-effikaċja ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan għadhom ma ġewx determinati s'issa f'pazjenti b'disturbi sinifikanti diġà eżistenti tal-fwied (ara sezzjoni 5.2).
English: Values for Test and Reference are mean (% coefficient of variation).
Maltese: Il-valuri għat-Test u Referenza huma medji (% koeffiċjent ta' varjazzjoni).
English: Interaction only studied with sofosbuvir/velpatasvir.
Maltese: Sofosbuvir/velpatasvir u and sofosbuvir/velpatasvir/voxilaprevir:
English: AUC: ↔ Cmax: ↔ Emtricitabine: AUC: ↔ Cmax: ↔
Maltese: AUC: ↔ Cmax: ↔ Emtricitabine:
English: Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.4).
Maltese: L-użu konkomitanti ta' estratti ta' Ginkgo biloba mhux irrikkmandat (ara sezzjoni 4.4).
English: What Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan looks like and contents of the pack Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan film-coated tablets are pink capsule-shaped tablets, engraved with ‘M' on one side and ‘TME' on the other side.
Maltese: Kif jidher Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan u l-kontenut tal-pakkett Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan pilloli miksijin b'rita huma pillola roża b'forma ta' kapsula, imnaqqxa b' 'M' fuq naħa waħda u "TME" fuq in-naħa l-oħra.
English: {DD month YYYY}
Maltese: • fwied li jkun fih ix-xaħam
English: QTc prolongation has been observed with the use of efavirenz (see sections 4.5 and 5.1).
Maltese: Ġie osservat titwil ta' QTc bl-użu ta' efavirenz (ara sezzjonijiet 4.5 u 5.1).
English: Cmax: ↑ 11% (↑ 3 to ↑ 19)
Maltese: Cmax: ↑ 49% (↑ 32 sa
English: Table 1: Interactions between efavirenz/emtricitabine/tenofovir disoproxil or its individual components and other medicinal products
Maltese: Tabella 1: Interazzjonijiet bejn efavirenz/emtricitabine/tenofovir disoproxil Mylan jew ilkomponenti individwali tiegħu u prodotti mediċinali oħra
English: Elbasvir/grazoprevir: Co administration of efavirenz/emtricitabine/tenofovir disoproxil with elbasvir/grazoprevir is contraindicated because it may lead to loss of virologic response to elbasvir/grazoprevir (see section 4.3 and Table 1).
Maltese: L-għoti flimkien ta' efavirenz/emtricitabine/tenofovir disoproxil ma' elbasvir/grazoprevir huwa kontraindikat għaliex dan jista' jwassal għal telf tar-rispons viroloġiku għal elbasvir/grazoprevir (ara sezzjoni 4.3 u Tabella 1).
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
Maltese: It-tielet pazjent kellu sostituzzjonijiet assoċjati ma' reżistenza għal efavirenz (NNRTI) li kienu jeżistu minn qabel u s-sostituzzjoni ta' M184V reverse transcriptase assoċjati ma' reżistenza għal emtricitabine meta daħal fil-fażi ta' estensjoni ta' efavirenz/emtricitabine/tenofovir disoproxil Mylan u kellu rispons viroloġiku subottimali, u żviluppa sostituzzjonijiet K65K/R, S68N u K70K/E assoċjati ma' reżistenza għal NRTI f'ġimgħa 180 (36 ġimgħa fuq efavirenz/emtricitabine/tenofovir disoproxil Mylan).
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: However, there was no increased risk of fractures or evidence for clinically relevant bone abnormalities over 144 weeks.
Maltese: Madankollu, ma kien hemm l-ebda riskju miżjud ta' ksur jew evidenza ta' anormalitajiet fl-għadam klinikament rilevanti matul 144 ġimgħa.
English: In a 144-week open-label randomised clinical study (GS-01-934) antiretroviral treatment-naïve HIV-1 infected patients received either a once-daily regimen of efavirenz, emtricitabine and tenofovir disoproxil or a fixed combination of lamivudine and zidovudine administered twice daily and efavirenz once daily (please refer to the Summary of Product Characteristics for this medicine).
Maltese: Fi studju kliniku każwali bit-tikketta mikxufa ta' 144 ġimgħa (GS-01-934) li fih, pazjenti infettati blHIV-1 li qatt ma kienu ħadu trattament antiretrovirali qabel irċevew jew kors ta' darba kuljum ta' efavirenz, emtricitabine u tenofovir disoproxil jew kombinazzjoni fissa ta' lamivudine u zidovudine mogħti darbtejn kuljum u efavirenz darba kuljum (jekk jogħġbok irreferi għas-Sommarju tal
English: AUC: ↔ 19%*
Maltese: AUC: ↔ 19%* Cmax: ↔ 8%
English: Renal and urinary disorders: Uncommon increased creatinine, proteinuria, proximal renal tubulopathy including Fanconi syndrome
Maltese: Mhux komuni żieda fil-kreatinina, proteinurja, tubulopatija renali prossimali li tinkludi s-sindromu ta' Fanconi
English: This medicinal product contains 7.5 mg of sodium metabisulfite per dose, which may rarely cause severe hypersensitivity reactions and bronchospasm.
Maltese: Dan il-prodott mediċinali fih 7.5 mg ta' sodium metabisulfite f'kull pillola, u dan jista, b'mod rari, jikkawża reazzjonijiet ta' sensittività eċċessiva u bronkospażmu.
English: AUC: ↓ 83%
Maltese: AUC: ↓ 83% (↓ 79 sa
English: It is anticipated that tenofovir exposure (AUC) will be approximately 30% lower following administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan on an empty stomach as compared to the individual component tenofovir disoproxil when taken with food (see section 5.2).
Maltese: Huwa mistenni li l-esponiment ta' tenofovir (AUC) ikun madwar 30% aktar baxx wara l-għoti ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan fuq stonku vojt meta mqabbel mal-komponent individwali tenofovir disoproxil meta mogħti mal-ikel (ara sezzjoni 5.2).
English: - Diltiazem or similar medicines (called calcium channel blockers): When you start taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, your doctor may need to adjust your dose of the calcium channel blocker.
Maltese: - Diltiazem jew mediċini simili (imsejħa imblokkaturi tal-kanal tal-kalċju): Meta tibda tieħu Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, it-tabib tiegħek jista' jkun jeħtieġ li jbiddillek id-doża tal-imblokkatur tal-kanal tal-kalċju.
English: Two subjects with confirmed virologic rebound developed NNRTI resistance-associated substitutions to efavirenz including K103N, V106V/I/M and Y188Y/C reverse transcriptase substitutions at week 240 (96 weeks on efavirenz/emtricitabine/tenofovir disoproxil) and week 204 (60 weeks on efavirenz/emtricitabine/tenofovir disoproxil).
Maltese: u Y188Y/C reverse transcriptase f'ġimgħa 240 (96 ġimgħa fuq efavirenz/emtricitabine/tenofovir disoproxil) u ġimgħa 204 (60 ġimgħa fuq efavirenz/emtricitabine/tenofovir disoproxil Mylan).
English: Antimycobacterials Rifabutin/Efavirenz (300 mg q.d./600 mg q.d.)
Maltese: Antimikobatterjali Rifabutin/Efavirenz (300 mg q.d./ 600 mg q.d.)
English: Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
Maltese: Tnaqqis fl-espożizzjoni ta' etonogestrel jista' jkun mistenni (induzzjoni ta' CYP3A4).
English: A multiple-dose study of efavirenz showed no significant effect on efavirenz pharmacokinetics in patients with mild hepatic impairment (Child-Pugh-Turcotte Class A) compared with controls.
Maltese: Studju dwar dożi multipli ta' efavirenz ma wera l-ebda effett sinifikanti fuq il-farmakokinetika ta' efavirenz f'pazjenti b'indeboliment tal-fwied ħafif (Child-Pugh-Turcotte Klassi A) meta mqabbel malkontrolli.
English: V108I
Maltese: M = Ma rnexxiex
English: NAME OF THE MEDICINAL PRODUCT Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg pilloli miksija b'rita
English: Cmax: ↓ 38%
Maltese: AUC: ↓ 46% Cmax: ↓ 38%
English: *lower than recommended doses; similar findings are expected with recommended doses.
Maltese: * aktar baxx mid-dożi rakkomandati; sejbiet simili huma mistennija bid-dożi rakkomandati.
English: If you take more Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan than you should If you accidentally take too many Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan tablets you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Maltese: Jekk tieħu Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, tista' tkun f'riskju miżjud li jkollok effetti sekondarji possibbli b'din il-mediċina (ara sezzjoni 4, Effetti sekondarji possibbli).
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, inibizzjoni ġiet osservata wkoll in vitrou l-effett nett tal-għoti fl-istess ħin ma' substrati ta' dawn l-enzimi mhuwiex ċar (ara sezzjoni 5.2).
English: For patients at increased risk of Torsade de Pointes or who are receiving drugs with a known risk for Torsade de Pointes, consider alternatives to efavirenz/emtricitabine/tenofovir disoproxil.
Maltese: Għall-pazjenti f'riskju akbar ta' Torsade de Pointes jew li qed jirċievu mediċini b'riskju magħruf għal Torsade de Pointes, ikkunsidra alternattivi għal efavirenz/emtricitabine/tenofovir disoproxil.
English: Recommendation concerning coadministration with efavirenz/emtricitabine/tenofovir disoproxil (efavirenz 600 mg, emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Maltese: Rakkomandazzjoni dwar l-għoti flimkien ma' efavirenz/emtricitabine/tenofovir disoproxil Mylan (efavirenz 600 mg, emtricitabine 200 mg, tenofovir disoproxil 245 mg)
English: Also, Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan should not be taken with any other medicines that contain efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Maltese: Barra minn hekk, Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan m'għandux jittieħed ma' kwalunkwe mediċini oħra li fihom efavirenz (ħlief jekk rakkomandati mit-tabib tiegħek), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, lamivudine jew adefovir dipivoxil.
English: Efavirenz/emtricitabine/tenofovir disoproxil must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine), since inhibition of their metabolism may lead to serious, life-threatening events (see section 4.3).
Maltese: Efavirenz/emtricitabine/tenofovir disoproxil Mylan m'għandux jingħata fl-istess ħin ma' terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, jew ergot alkaloids (eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine), minħabba li l-inibizzjoni talmetaboliżmu tagħhom tista' twassal għal episodji ta' perikli serji għall-ħajja (ara sezzjoni 4.3).
English: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of efavirenz/emtricitabine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Maltese: Prodotti mediċinali eliminati mill-kliewi: Minħabba li emtricitabine u tenofovir huma eliminati b'mod ewlieni mill-kliewi, l-għoti fl-istess ħin ta' efavirenz/emtricitabine/tenofovir disoproxil Mylan ma' prodotti mediċinali li jnaqqsu l-funzjoni renali jew li jikkompetu għal sekrezzjoni tubulari attiva (eż. cidofovir) jistgħu iżidu l-konċentrazzjonijiet fis-serum ta' emtricitabine, tenofovir u/jew il-prodotti mediċinali amministrati fl-istess ħin.
English: If efavirenz/emtricitabine/tenofovir disoproxil is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Maltese: Jekk efavirenz/emtricitabine/tenofovir disoproxil ikunu se jintużaw flimkien ma' darunavir/ritonavir, il-kors ta' darbtejn kuljum ta' darunavir/ritonavir 600/100 mg għandu jintuża.
English: Currently available data indicate a trend that in patients on a PI-based antiretroviral regimen the switch to efavirenz/emtricitabine/tenofovir disoproxil may lead to a reduction of the response to the therapy (see section 5.1).
Maltese: Dejta li hemm disponibbli bħalissa tindika tendenza li f'pazjenti fuq reġim ta' trattament antiretrovirali bbażat fuq il-PI, il-bidla għal efavirenz/emtricitabine/tenofovir disoproxil tista' twassal għal tnaqqis fir-rispons għat-terapija (ara sezzjoni 5.1).
English: Pharmacokinetic studies have not been performed with efavirenz, emtricitabine or tenofovir in elderly patients (over 65 years of age).
Maltese: Għadhom ma sarux studji farmakokinetiċi b'efavirenz, emtricitabine jew tenofovir fuq pazjenti anzjani (aktar minn 65 sena).
English: Each Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as maleate).
Maltese: Kull pillola miksija b'rita ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan fiha 600 mg ta' efavirenz, 200 mg ta' emtricitabine u 245 mg ta' tenofovir disoproxil (bħala maleate).
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan contains three active substances that are used to treat human immunodeficiency virus (HIV) infection:
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan fih tliet sustanzi attivi li jintużaw biex jittrattaw infezzjoni bil-virus ta' l-immunodefiċjenza (HIV) tal-bniedem:
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 sottostrat ta' enzima ta' CYP3A4, hemm potenzjal għal tnaqqis fil-konċentrazzjonijiet tal-plażma talimblokkatur tal-kanali tal- kalċju.
English: Anencephaly and unilateral anophthalmia with secondary enlargement of the tongue were observed in one foetus, microophthalmia was observed in another foetus and cleft palate was observed in a third foetus.
Maltese: Anenċefalija u anoftalmija unilaterali bi tkabbir sekondarju tal-ilsien kienu osservati f'fetu wieħed, mikro-oftalmija kienet osservata f'fetu ieħor, u palat mixquq kien osservat fittielet fetu.
English: There have also been post-marketing reports of severe depression, death by suicide, delusions, psychosis-like behaviour, and catatonia.
Maltese: Kien hemm ukoll rapporti wara t-tqegħid fis-suq tal-prodott ta' depressjoni severa, mewt permezz ta' suwiċidju, delużjonijiet, imġiba tixbah il-psikożi, u katatonja.
English: Nervous system symptoms: Nervous system symptoms are common with efavirenz, one of the components of efavirenz/emtricitabine/tenofovir disoproxil.
Maltese: Sintomi tas-sistema nervuża huma komuni b'efavirenz, wieħed millkomponenti ta' efavirenz/emtricitabine/tenofovir disoproxil Mylan.
English: PC:
Maltese: AUC:
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni talHIV avvanzata (AIDS) u bi storja ta' infezzjoni opportunistika, sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet ta' qabel jistgħu jseħħu dritt wara li jinbeda trattament kontra l-HIV.
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Maltese: Każijiet ta' kollass tal-kliewi akut wara l-bidu ta' doża għolja jew mediċini multipli anti-infjammatorji mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs) ġew irrappurtati f'pazjenti kkurati b'tenofovir disoproxil, u b'fatturi ta' riskju għal funzjoni renali ħażina.
English: K65R
Maltese: J05AR06.
English: LIPID LOWERING MEDICINAL PRODUCTS HMG Co-A Reductase Inhibitors
Maltese: L-għoti flimkien ma' prodotti mediċinali oħra
English: AUC: ↑ 81% (↑ 68 to ↑ 94) Cmax: ↑ 77% (↑ 53 to ↑ 104) Cmin: ↑ 121% (↑ 100 to ↑ 143)
Maltese: Cmax: ↑ 16% (↑ 6 sa ↑ 26) Cmin: ↑ 13% (↑ 1 sa ↑ 26) (Induzzjoni ta' CYP3A4)
English: Dose adjustments of calcium channel blockers when co-administered with efavirenz/emtricitabine/tenofovir disoproxil should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
Maltese: Aġġustamenti fid-doża talimblokkaturi tal-kanali tal-kalċju meta jingħataw fl-istess ħin ma' efavirenz/emtricitabine/tenofovir disoproxil Mylan għandhom ikunu ggwidati mir-rispons kliniku (irreferi għas-Sommarju talKaratteristiċi tal-Prodott għallimblokkatur tal-kanali tal-kalċju).
English: Patients with renal impairment: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any patient with mild renal impairment treated with efavirenz/emtricitabine/tenofovir disoproxil (see sections 4.2, 4.4 and 5.2).
Maltese: Billi tenofovir disoproxil jista' jikkawża tossiċità renali, sorveljanza mill-qrib tal-funzjoni renali hi rakkomandata fi kwalunkwe pazjent b'indeboliment renali ħafif ittrattat b'efavirenz/emtricitabine/tenofovir disoproxil (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as maleate).
Maltese: Kull pillola miksija b'rita fiha 600 mg ta' efavirenz, 200 mg ta' emtricitabine u 245 mg ta' tenofovir disoproxil (bħala maleate).
English: AUC: ↑ 34% (↑ 18 to ↑ 53) Cmax: ↑ 49% (↑ 32 to ↑ 69) Efavirenz:
Maltese: AUC filgħodu: ↑ 18% (↑ 6 sa ↑ 33) AUC filgħaxija: ↔ Cmaxfilgħodu: ↑ 24% (↑ 12 sa ↑ 38) Cmaxfilgħaxija:
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Maltese: Pazjenti b'funzjoni ħażina diġà eżistenti tal-fwied, fosthom epatite kronika attiva, għandhom frekwenza miżjuda ta' anormalitajiet tal-funzjoni tal-fwied waqt terapija antiretrovirali kombinata (CART) u għandhom jiġu sorveljati skont il-prattika standard.
English: These patients should be carefully monitored for efavirenz adverse reactions, especially nervous system symptoms.
Maltese: Dawn il-pazjenti għandhom jiġu sorveljati bir-reqqa għal reazzjonijiet avversi ta' efavirenz, speċjalment sintomi tas-sistema nervuża.
English: Efavirenz: 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 newrali, inkluż meningomyelocele, kollha f'ommijiet esposti għal korsijiet li kien fihom efavirenz (eskluż kwalunkwe pillola ta' kombinazzjoni ta' doża fissa li fiha efavirenz) fl-ewwel trimestru.