FrancophonIA/ELRC3.0 huggingface dataset:
English: If your doctor decides to stop one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil separately or with other medicines for the treatment of your HIV infection.
Maltese: Jekk it-tabib tiegħek jiddeċiedi li jwaqqaf wieħed mill-komponenti ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, tista' tingħata efavirenz, emtricitabine u/jew tenofovir disoproxil separatament jew ma' mediċini oħra għat-trattament tal-infezzjoni tal-HIV tiegħek.
English: AUC: ↑ 21% Cmin: ↑ 17% Cmax: ↑ 15% (CYP3A4 inhibition)
Maltese: AUC: ↓ 17% Cmax: ↔ (Induzzjoni ta' CYP3A4)
English: A decreased dosage of 250 mg didanosine coadministered with tenofovir disoproxil therapy has been associated with reports of high rates of virologic failure within several tested combinations.
Maltese: Doża mnaqqsa ta' 250 mg ta' didanosine mogħtija fl-istess ħin ma' terapija b'tenofovir disoproxil ġiet assoċjata ma' rapporti ta' rati għoljin ta'' falliment viroloġiku f'diversi kombinazzjonijiet ittestjati.
English: adverse events should be considered, due to possible pharmacodynamic interaction.
Maltese: Mekkaniżmu ta' azzjoni u effetti farmakodinamiċi
English: - signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming.
Maltese: - sinjali ta' sturdament, diffikultà fl-irqad, ħedla, diffikultà fil-konċentrazzjoni jew ħolm anormali.
English: These drugs include: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides,
Maltese: Dawn il-mediċini jinkludu: - antiarritmiċi tal-klassijiet IA u III, - newrolettiċi, sustanzi antidepressivi, - ċerti antibijotiċi li jinkludu xi sustanzi mill-klassijiet li ġejjin: macrolides, fluoroquinolones,
English: False-positive urine cannabinoid test results have been reported with some screening assays in uninfected and HIV infected subjects receiving efavirenz.
Maltese: Riżultati pożittivi foloz ta' testijiet kannabinojde talawrina ġew irrappurtati b'xi assaġġi ta' screening f'suġġetti mhux infettati u f'pazjenti infettati bl-HIV li rċevew efavirenz.
English: Common hypertriglyceridaemia3 hyperglycaemia, hypertriglyceridaemia
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA U L-PAKKETT LI JMISS MAL-PRODOTT
English: Administration of efavirenz capsules with a high fat meal increased the mean AUC and Cmax of efavirenz by 28% and 79%, respectively, compared to administration in a fasted state.
Maltese: Għoti ta' pilloli ta' efavirenz ma' ikla b'ħafna xaħam żied l-AUC medju u Cmaxta' efavirenz bi 28% u b'79%, rispettivament, meta mqabbel mal-għoti fi stat ta' sawm.
English: - Medicines used to prevent organ transplant rejection (also called immunosuppressants), such as cyclosporine, sirolimus or tacrolimus.
Maltese: - Mediċini użati għall-prevenzjoni tar-rifjut tat-trapjant ta' organu (imsejħa wkoll immunosoppressanti),bħal cyclosporine, sirolimus jew tacrolimus.
English: - Do not give Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan to children and adolescents under 18 years of age.
Maltese: - Tagħtix Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan lil tfal u adolexxenti taħt it18-il sena.
English: Co-administration of efavirenz/emtricitabine/tenofovir disoproxil and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended since plasma concentrations of velpatasvir and voxilaprevir are expected to decrease following co-administration with efavirenz leading to reduced therapeutic effect of sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir (see section
Maltese: L-għoti flimkien ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan ma' sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir mhux rakkomandat peress li l-konċentrazzjonijiet fil-plażma ta' velpatasvir u voxilaprevir huma mistennija li jonqsu wara għoti flimkien ma' efavirenz li jwasslu għal effett terapewtiku mnaqqas ta' sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir (ara sezzjoni 4.5).
English: K70E
Maltese: • ħakk
English: Methadone: AUC: ↔ Cmax: ↔ Cmin: ↔ Tenofovir: AUC: ↔ Cmax: ↔ Cmin: ↔
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↔ Tenofovir:
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' efavirenz fuq l-intervall QTc ġie evalwat fi studju crossover dwar QT bit-tikketta mikxufa, ikkontrollat b'mod pożittiv u bi plaċebo, b'sekwenza waħda fissa ta' 3 perjodi, bi 3 trattamenti fi 58 individwu f'saħħtu imtejba għal polimorfiżmi ta' CYP2B6.
English: The demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1).
Maltese: Il-wiri tal-benefiċċju ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan huwa bbażat primarjament fuq dejta ta' 48 ġimgħa minn studju kliniku li fih il-pazjenti b'soppressjoni viroloġika stabbli fuq terapija antiretrovirali ta' kombinazzjoni bidlu għal Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (ara sezzjoni 5.1).
English: Reproductive system and breast disorders: Uncommon gynaecomastia
Maltese: Disturbi fis-sistema riproduttiva u fis-sider: Mhux komuni ġinekomastija
English: - dry mouth - incoherent speech - increased appetite - libido decreased - myalgia
Maltese: Mhux komuni: - ħalq xott - diskors ma jiftiehemx - żieda fl-aptit - tnaqqis fil-libido - majalġja
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR(I) RESPONSABBLI GĦALL-ĦRUĠ TAL-LOTT B.
English: If there is evidence of worsening liver disease or persistent elevations of serum transaminases to greater than 5 times the upper limit of the normal range, the benefit of continued therapy with efavirenz/emtricitabine/tenofovir disoproxil needs to be weighed against the potential risks of significant liver toxicity.
Maltese: Jekk ikun hemm evidenza ta' deterjorament tal-mard tal-fwied jew żidiet persistenti ta' transaminases fis-serum għal akbar minn 5 darbiet il-limitu ta' fuq tal-medda normali, il-benefiċċju ta' terapija li tkompli b'efavirenz/emtricitabine/tenofovir disoproxil jeħtieġ li jiġi evalwat kontra r-riskji potenzjali ta' tossiċità sinifikattiva tal-fwied.
English: Other macrolide antibiotics, such as erythromycin, have not been studied in combination with efavirenz/emtricitabine/tenofovir disoproxil.
Maltese: Antibijotiċi makrolidi oħra, bħal erythromycin, ma ġewx studjati f'kombinazzjoni ma' efavirenz/emtricitabine/tenofovir disoproxil Mylan.
English: Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1).
Maltese: Il-pazjenti ma jridux ikunu esperjenzaw falliment viroloġiku fuq xi terapija antiretrovirali preċedenti u jrid ikun magħruf li ma kellhomx forom tal-virus b'mutazzjonijiet li jagħtu reżistenza sinifikanti għal xi wieħed mit-tliet komponenti kontenuti f'Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan qabel ma jinbeda l-ewwel reġim ta' trattament antiretrovirali tagħhom (ara sezzjoni 4.4 u 5.1).
English: M184V/I
Maltese: 32 mmol/l).
English: Evening Cmax: ↔ Morning Cmin: ↑ 42% (↑ 9 to
Maltese: ↔ Cminfilgħodu: ↑ 42% (↑ 9 sa ↑ 86)
English: In a 3-month drug interaction study, no significant differences in MPA pharmacokinetic parameters were found between subjects receiving efavirenzcontaining antiretroviral therapy
Maltese: Fi studju li dam 3 xhur dwar l-interazzjoni talmediċina, ma nstabu lebda differenzi sinifikanti fil-parametri farmakokinetiċi ta' MPA bejn pazjenti li kienu qed jirċievu terapija antiretrovirali li fiha efavirenz u pazjenti li ma jirċievu l-ebda terapija antiretrovirali.
English: The pharmacokinetics of emtricitabine and tenofovir are similar in male and female patients.
Maltese: Il-farmakokinetika ta' emtricitabine u tenofovir huma simili f'pazjenti nisa u rġiel.
English: Atazanavir (pm):
Maltese: Atazanavir/ritonavir:
English: It is recommended that efavirenz/emtricitabine/tenofovir disoproxil be taken on an empty stomach, preferably at bedtime.
Maltese: Huwa rrikkmandat li efavirenz/emtricitabine/tenofovir disoproxil jittieħed fuq stonku vojt, preferibbilment fil-ħin tal-irqad.
English: AUC: ↓ 34% (↓ 21 to ↓ 41) Cmax: ↓ 20% (↓ 2 to ↓ 26)
Maltese: Cmax: ↓ 20% (↓ 2 sa ↓ 26)
English: In in vitro studies efavirenz did not inhibit CYP2E1 and inhibited CYP2D6 and CYP1A2 only at concentrations well above those achieved clinically.
Maltese: Fi studji in vitro, efavirenz ma inibixxix CYP2E1 iżda inibixxa CYP2D6 u CYP1A2 biss f'konċentrazzjonijiet 'il fuq sewwa minn dawn miksuba klinikament.
English: How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Maltese: X'fih Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
English: It is recommended that Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan be taken on an empty stomach since food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see sections 4.4 and 4.8).
Maltese: Huwa rrikkmandat li Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan jittieħed fuq stonku vojt peress li l-ikel jista' jżid l-esponiment ta' efavirenz u jwassal għal żieda fil-frekwenza tar-reazzjonijiet avversi (ara sezzjonijiet 4.4 u 4.8).
English: CCR5 antagonist Maraviroc/Efavirenz (100 mg b.i.d./600 mg q.d.)
Maltese: Maraviroc/Efavirenz (100 mg b.i.d./ 600 mg q.d.)
English: K103N was the most frequently observed RT substitution in viral isolates from patients who experienced rebound in viral load during clinical studies of efavirenz.
Maltese: K103N kienet l-aktar sostituzzjoni RT osservata b'mod frekwenti f'iżolati virali minn pazjenti li esperjenzaw rikaduta fl-għadd virali matul l-istudji kliniċi ta' efavirenz.
English: Atazanavir/ritonavir/Efavirenz (400 mg q.d./200 mg q.d./600 mg q.d., all administered with food)
Maltese: Atazanavir/ritonavir/Efavirenz (400 mg q.d./ 200 mg q.d./ 600 mg q.d., kollha mogħtija mal-ikel)
English: AUC: ↓ 60% (↓ 52 to ↓ 68) Cmax: ↓ 62% (↓ 55 to ↓ 78) (CYP3A4 induction) Co-administration of efavirenz with atorvastatin, pravastatin, or simvastatin did not affect efavirenz AUC or Cmax values.
Maltese: AUC: ↔ 20% Cmax: ↔ 11% (Induzzjoni ta' CYP3Aeffett fuq boceprevir) *0 - 8 sigħat L-ebda effett (↔) hu ugwali għal tnaqqis flistima tal-proporzjon medju ta ' ≤ 20% jew żieda fl-istima talproporzjon medju ta ' ≤
English: The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Maltese: Konċentrazzjonijiet ogħla ta' tenofovir jistgħu jżidu lavvenimenti avversi assoċjati ma' tenofovir, li jinkludu disturbi renali.
English: Efavirenz/emtricitabine/tenofovir disoproxil was administered on an empty stomach (see section 4.2).
Maltese: Efavirenz/emtricitabine/tenofovir disoproxil Mylan ingħata fuq stonku vojt (ara sezzjoni 4.2).
English: Renal impairment: As efavirenz/emtricitabine/tenofovir disoproxil may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Maltese: Billi efavirenz/emtricitabine/tenofovir disoproxil Mylan jista' jikkawża ħsara renali, is-sorveljanza tal-funzjoni renali hi rakkomandata (ara sezzjonijiet 4.4 u 4.8 Sommarju tal-profil tas-sigurtà).
English: Darunavir/ritonavir/Tenofovir disoproxil (300 mg b.i.d.
Maltese: Darunavir/ritonavir/Tenofovir disoproxil (300 mg b.i.d.*/ 100 mg b.i.d./ 245 mg q.d.)
English: Substantial decrease in lopinavir exposure, necessitating dosage adjustment of lopinavir/ritonavir.
Maltese: Tnaqqis sostanzjali flesponiment għal lopinavir, li kien jeħtieġ aġġustament fid-doża ta' lopinavir/ritonavir.
English: Pharmacokinetic studies have not been performed with efavirenz/emtricitabine/tenofovir disoproxil in infants and children under 18 years of age (see section 4.2).
Maltese: Għadhom ma sarux studji farmakokinetiċi b'efavirenz/emtricitabine/tenofovir disoproxil Mylan fuq trabi u tfal taħt l-età ta' 18-il sena (ara sezzjoni 4.2).
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may make hormonal contraceptives less likely to work.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan jista' jagħmel kontraċettivi ormonali inqas possibbli li jaħdmu.
English: Emtricitabine and tenofovir individually and in combination have shown activity against HBV in pharmacodynamic studies (see section 5.1).
Maltese: HBV fi studji farmakokinetiċi (ara sezzjoni 5.1).
English: (200 mg b.i.d./600 mg q.d.)
Maltese: (250/100 mg doża waħda/600 mg q.d.)
English: If Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is stopped, speak to your doctor before you restart taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan tablets.
Maltese: Jekk jitwaqqaf Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is stopped, kellem lit-tabib tiegħek qabel terġa' tibda tieħu l-pilloli Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan.
English: Swallow Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan whole with water.
Maltese: Ibla' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan sħiħ mal-ilma.
English: Since efavirenz/emtricitabine/tenofovir disoproxil is a combination product and the dosing interval of the individual components cannot be altered, treatment with efavirenz/emtricitabine/tenofovir disoproxil must be interrupted in patients with confirmed creatinine clearance < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Maltese: Peress li efavirenz/emtricitabine/tenofovir disoproxil huwa prodott kombinat u l-intervall tad-dożaġġ tal-komponenti individwali ma jistax jinbidel, it-trattament b' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan għandu jiġi interrott b'rata tat-tneħħija talkreatinina < 50 mL/min ikkonfermata jew tnaqqis fil-fosfat fis-serum għal < 1.0 mg/dl (0.
English: There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Maltese: Kien hemm rapporti ta' disfunzjoni mitokondrijali fi trabi li kienu negattivi għal HIV li kienu esposti in utero u/jew wara t-twelid għal analogi tan-nukleosidi; dawn kienu kkonċernati b'mod predominanti b'kura b'korsijiet li kien fihom zidovudine.
English: - Medicines containing didanosine (for HIV infection): Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Maltese: It-teħid ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan ma' mediċini antivirali oħra li fihom didanosine jistgħu jgħollu l-livelli ta' didanosine fid-demm tiegħek u jistgħu jnaqqsu l-għadd taċ-ċelloli CD4.
English: Following oral administration of a single 245 mg dose of tenofovir disoproxil to HIV-1 infected patients in the fasted state, maximum tenofovir concentrations were achieved within one hour and the Cmax and AUC (mean ± S.D.) (%CV) values were 296 ± 90 ng/ml (30%) and 2,287 ± 685 ng•h/ml (30%), respectively.
Maltese: Il-valuri (%CV) kienu 296 ± 90 ng/ml (30%) u 2,287 ± 685 ng•h/ml (30%), rispettivament.
English: Since efavirenz/emtricitabine/tenofovir disoproxil is a fixed-dose combination product, the dose of efavirenz cannot be altered; therefore, voriconazole and efavirenz/emtricitabine/tenofovir disoproxil must not be co-administered (see section 4.3 and Table 1).
Maltese: Billi efavirenz/emtricitabine/tenofovir disoproxil huwa prodott ta' kombinazzjoni ta' doża fissa, iddoża ta' efavirenz ma tistax tinbidel; għaldaqstant, voriconazole u efavirenz/emtricitabine/tenofovir disoproxil Mylan ma għandhomx jingħataw flimkien (ara sezzjoni 4.3 u t-Tabella 1).
English: Tenofovir is primarily excreted by the kidneys by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration.
Maltese: Tenofovir jinħareġ primarjament mill-kliewi kemm mill-filtrazzjoni kif ukoll mis-sistema ta' trasport tubulari attiva b'bejn wieħed u ieħor 70 sa 80% tad-doża eliminata mhux mibdula fl-awrina wara għoti ġol-vini.
English: Co-administration with drugs that are known to prolong the QTc interval (proarryhthmic).
Maltese: Dejta dwar l-impatt kliniku li jista' jkollu t-tnaqqis fl-esponiment farmakokinetiku mhijiex disponibbli.
English: ** based on historical comparison.
Maltese: ** ibbażat fuq paragun storiku.
English: Discontinuation of efavirenz/emtricitabine/tenofovir disoproxil therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
Maltese: Jekk Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan jitwaqqaf f'pazjenti ko-infettati bl-HIV u lHBV, dawn il-pazjenti għandhom jiġu sorveljati mill-qrib għal taħrix tal-epatite (ara sezzjoni 4.4).
English: In a single-dose study of efavirenz, half-life was doubled in the single patient with severe hepatic impairment (Child-Pugh-Turcotte Class C), indicating a potential for a much greater degree of accumulation.
Maltese: Fi studju dwar doża singola ta' efavirenz, il-half-life irduppjat fl-uniku pazjent b'indeboliment tal-fwied sever (Child-Pugh-Turcotte Klassi Ċ), li jindika potenzjal għal grad ferm akbar ta' akkumulazzjoni.
English: Inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported rarely when medicines containing tenofovir disoproxil and didanosine were taken together.
Maltese: Infjammazzjoni tal-frixa u aċidożi lattika (eċċess ta' aċidu lattiku fid-demm), li tista' xi kultant tikkaġuna l-mewt, ġew irrappurtati rarament meta mediċini li fihom tenofovir disoproxil u didanosine ttieħdu flimkien.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan jista' jaħdem fuq mediċini oħra, li jinkludu preparazzjonijiet tal-ħxejjex bħal estratti ta' Ginkgo biloba.
English: In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza immunitarja severa fiż-żmien tal-bidu ta' CART, tista' tiżviluppa reazzjoni infjammatorja għal patoġeni opportunisti asintomatiċi jew residwi u tikkaġuna kundizzjonijiet kliniċi serji, jew aggravament tas-sintomi.
English: Co-administration of efavirenz/emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' efavirenz/emtricitabine/tenofovir disoproxil Mylan u didanosine mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Atazanavir/ritonavir/Efavirenz (400 mg q.d./100 mg q.d./600 mg q.d., all administered with food)
Maltese: Atazanavir/ritonavir/Efavirenz (400 mg q.d./ 100 mg q.d./ 600 mg q.d., kollha mogħtija mal-ikel)
English: QTc Prolongation
Maltese: LOCF modifikat
English: - Medicines used to lower blood fats (also called statins): Atorvastatin, pravastatin, simvastatin.
Maltese: Atorvastatin, pravastatin, simvastatin.
English: Cmax: ↔ (CYP3A4 induction)
Maltese: Cmax: ↑ 15% (Inibizzjoni ta' CYP3A4)
English: Metabolic parameters: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Maltese: Il-piż u l-livelli ta' lipidi u glucose fid-demm jistgħu jiżdiedu matul it-terapija antiretrovirali (ara sezzjoni 4.4).
English: AUC: ↓ 38% (↓ 28 to ↓ 47) Cmax: ↓ 32% (↓ 15 to ↓ 46) Cmin: ↓ 45% (↓ 31 to ↓ 56) Efavirenz:
Maltese: Cmax: ↓ 28% (↓ 50 sa ↑ 5) Cmin: ↓ 26% (↓ 46 sa
English: Contraindications of concomitant use
Maltese: Kontraindikazzjonijiet ta' użu konkomitanti
English: Endpoint
Maltese: Macrogol
English: Antifungals Itraconazole/Efavirenz
Maltese: Acenocoumarol/Efavirenz
English: Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite tenofovir disoproxil discontinuation (see section 4.4).
Maltese: Pazjenti f'riskju ta' indeboliment renali (bħal pazjenti b'fatturi ta' riskju renali fil-linja bażi, mard tal-HIV li jkun fi stadju avvanzat, jew pazjenti li jkunu qed jirċievu prodotti mediċinali nefrotossiċi fl-istess ħin) għandhom riskju akbar li jkollhom irkupru mhux komplet tal-funzjoni renali minkejja t-twaqqif ta' tenofovir disoproxil (ara sezzjoni 4.4).
English: Both the K65R and M184V/I mutation remain fully susceptible to efavirenz.
Maltese: Fil-biċċa l-kbira tal-pazjenti r-raxx irrisolva fi żmien xahar bi tkomplija tat-terapija b'efavirenz.
English: AUC: ↓ 31% (↓ 8 to ↓ 47) Cmin: ↓ 40%
Maltese: Cmax: ↓ 28% (↓ 7 sa ↓ 44) Cmin: ↓ 37% (↓ 17 sa
English: The pharmacokinetics of efavirenz/emtricitabine/tenofovir disoproxil have not been studied in HIV infected patients with hepatic impairment.
Maltese: Il-farmakokinetika ta' efavirenz/emtricitabine/tenofovir disoproxil Mylan ma ġewx studjati f'pazjenti infettati bl-HOV b'indeboliment epatiku.
English: Monitoring of renal function is recommended for patients receiving efavirenz/emtricitabine/tenofovir disoproxil (see section 4.4).
Maltese: Monitoraġġ tal-funzjoni tal-kliewi hu rakkomandat għal pazjenti li jkunu qed jirċievu efavirenz/emtricitabine/tenofovir disoproxil (ara sezzjoni 4.4).
English: AUC: ↓ 46%
Maltese: AUC: ↓ 43% (↓ 34 sa
English: 10 ml (30 mg/ml) 2 vials
Maltese: Kunjett (ħġieġ) 10 ml (30 mg/ml) 2 kunjetti
English: 10 ml (30 mg/ml) 1 vial
Maltese: Kunjett (ħġieġ) 10 ml (30 mg/ml) 1 kunjett
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: The active substance is entecavir.
Maltese: Is-sustanza attiva hi entecavir.
English: Placebo*
Maltese: Plaċebo*
English: ATC code: J05AF10
Maltese: J05AF10
English: b Albumin (≥1 X LLN)
Maltese: b Albumina (≥1 X LLN)
English: ULN=upper limit of normal, LLN=lower limit of normal.
Maltese: ULN=limitu ta' fuq tan-normal, LLN=limitu ta' isfel tan-normal.
English: Age/gender:
Maltese: Età/ġeneru:
English: Immune system disorders: rare
Maltese: Disturbi fis-sistema immuni: rari
English: Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors
Maltese: Kategorija farmakoterapewtika: antivirali għal użu sistemiku, nucleoside u nucleotide reverse transcriptase inhibitors
English: Iron oxide red (E172)
Maltese: Macrogol Iron oxide red (E172)
English: Cumulative probability of:
Maltese: Probabbiltà kumuluttiva ta':
English: c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
Maltese: c Roche Cobas Amplicor PCR assay (LLOQ = 300 kopja/ml)
English: Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park Paola, PLA 3000
Maltese: KW20A Kordin Industrial Park Paola, PLA 3000
English: Year 5 a
Maltese: Sena 5 a