FrancophonIA/ELRC3.0 huggingface dataset:
English: Also, Efavirenz/Emtricitabine/Tenofovir disoproxil Krka should not be taken with any other medicines that contain efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or lamivudine or adefovir dipivoxil.
Maltese: Barra minn hekk, Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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: Patients either changed to efavirenz/emtricitabine/tenofovir disoproxil (N=203) or continued on their original antiretroviral treatment regimen (N=97).
Maltese: Il-pazjenti jew qalbu għal efavirenz/emtricitabine/tenofovir disoproxil Krka (N= 203) jew komplew fuq irreġimen ta' trattament antiretrovirali oriġinali tagħhom (N= 97).
English: Since
Maltese: I
English: 3, psychosis mania
Maltese: 3, labilità tal affett
English: Renal clearance has been estimated to be approximately 210 ml/min, which is in excess of the glomerular filtration rate.
Maltese: L-eliminazzjoni mill-kliewi kienet stmata bħala bejn wieħed u ieħor 210 ml/min, li hija aktar mir-rata ta' filtrazzjoni glomerulari.
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka, Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka should not be administered concomitantly with lamivudine (see section 4.4).
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka mhuwiex rakkomandat f'din il-popolazzjoni (ara sezzjoni 4.2).
English: Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Maltese: - Sertraline, mediċina użata biex tittratta d-depressjoni, għax it-tabib tiegħek jista' jkun jeħtieġ li jbiddillek id-doża ta' sertraline.
English: Concomitant use of Ginkgo biloba extracts is not recommended (see section 4.4).
Maltese: L-użu konkomitanti ta' estratti ta' Gingko biloba mhux irrikkmandat (ara sezzjoni 4.4).
English: Data are available from 286 patients who switched to efavirenz/emtricitabine/tenofovir disoproxil: 160 had previously received efavirenz, emtricitabine and tenofovir disoproxil, and 126 had previously received lamivudine/zidovudine and efavirenz.
Maltese: Tagħrif huwa disponibbli minn 286 pazjent li qalbu għal efavirenz/emtricitabine/tenofovir disoproxil: 160 kienu rċievew efavirenz, emtricitabine u tenofovir disoproxil qabel, u 126 kienu rċievew lamivudine/zidovudine u efavirenz qabel.
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: Rare completed suicide delusion
Maltese: Rari suwiċidju komplut delużjoni
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 ma ġewx stabbiliti f'pazjenti b'disturbi sinifikanti diġà eżistenti tal-fwied (ara sezzjoni 5.2).
English: Nervous system symptoms are common with efavirenz, one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Maltese: Sintomi tas-sistema nervuża huma komuni b'efavirenz, wieħed mill-komponenti ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Other macrolide antibiotics, such as erythromycin, have not been
Maltese: Antibijotiċi makrolidi oħra, bħal erythromycin, ma ġewx studjati f'kombinazzjoni ma'
English: Cmax: ↑ 49% (↑ 32 to ↑ 69)
Maltese: ↑ 34% (↑ 18 għal ↑ 53) Cmax: ↑ 49% (↑ 32 għal ↑ 69)
English: maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)
Maltese: Komuni ħakk raxx vesikulobulluż, raxx pustulari, raxx makulopapulari, raxx, ħakk, urtikarja, telf talkulur tal-ġilda (żieda filpigmentazzjoni)
English: Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka 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: Efavirenz/Emtricitabine/Te nofovir disoproxil Krka tittieħed ma' rifampicin f'pazjenti li jiżnu 50 kg jew aktar, doża addizzjonali ta' 200 mg/ġurnata (800 mg total) ta' efavirenz tista' tipprovdi esponiment simili għal doża ta' 600 mg efavirenz kuljum, meta tittieħed mingħajr rifampicin.
English: Norelgestromin (active metabolite): AUC: ↓ 64% (↓ 62 to ↓ 67) Cmax: ↓ 46% (↓ 39 to ↓ 52) Cmin: ↓ 82% (↓ 79 to ↓ 85)
Maltese: AUC: ↓ 64% (↓ 62 għal ↓ 67) Cmax: ↓ 46% (↓ 39 għal ↓ 52) Cmin: ↓ 82% (↓ 79 għal ↓ 85)
English: It is anticipated that tenofovir exposure (AUC) will be approximately 30% lower following administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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 Krka fuq stonku vojt meta mqabbel mal-komponent individwali tenofovir disoproxil meta mogħti mal-ikel (ara sezzjoni 5.2).
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 Krka needs to be weighed against the potential risks of significant liver toxicity.
Maltese: Jekk ikun hemm evidenza ta' deterjorament tal-mard talfwied jew żidiet persistenti ta' transaminases fis-serum għal akbar minn 5 darbiet il-limitu ta' fuq talmedda normali, il-benefiċċju ta' terapija li tkompli b'Efavirenz/Emtricitabine/Tenofovir disoproxil Krka jeħtieġ li jiġi evalwat kontra r-riskji potenzjali ta' tossiċità tal-fwied sinifikattiva.
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 akuta wara l-bidu ta' doża għolja jew mediċini multipli antiinfjammatorji mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs) ġew irrappurtati f'pazjenti trattati b'pazjenti trattati b'tenofovir disoproxil u b'fatturi ta' riskju għal funzjoni renali ħażina.
English: Rare hepatic failure hepatic steatosis, hepatitis
Maltese: Rari insuffiċjenza tal-fwied stejatożi epatika, epatite
English: This loss is due to significant decreases in elbasvir/grazoprevir plasma concentrations caused by CYP3A4 or P-gp induction.
Maltese: Dan it-telf huwa minħabba ttnaqqis sinifikanti filkonċentrazzjonijiet ta' elbasvir/grazoprevir filplażma ikkawżat millinduzzjoni ta' CYP3A4 jew P-gp.
English: In a 144-week open-label randomised clinical study (GS 01-934) in antiretroviral-naïve patients, where efavirenz, emtricitabine and tenofovir disoproxil were used as individual formulations (or as efavirenz and the fixed combination of emtricitabine and tenofovir disoproxil from week 96 to 144), genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA > 400 copies/ml at week 144 or early study drug discontinuation (see section on Clinical experience).
Maltese: Reżistenza in vivo (pazjenti li qatt ma jkunu ħadu trattament antiretrovirali qabel): Fi studju kliniku każwali bittikketta mikxufa ta' 144 ġimgħa (GS-01-934) f'pazjenti li qatt ma jkunu ħadu trattament antiretrovirali qabel, fejn efavirenz, emtricitabine u tenofovir disoproxil ntużaw bħala formulazzjonijiet individwali (jew bħala efavirenz u l-kombinazzjoni fissa ta' emtricitabine u tenofovir disoproxil minn ġimgħa 96 sa 144), il-genotyping sar fuq iżolati ta' HIV-1 fil-plażma mill-pazjenti kollha b'HIV RNA kkonfermat ta' > 400 kopja/ml f'ġimgħa 144 jew twaqqif kmieni tal-mediċina studjata (ara sezzjoni dwar l-Esperjenza Klinika).
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka contains three active substances that are used to treat human immunodeficiency virus (HIV) infection:
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka fih tliet sustanzi attivi li jintużaw biex jittrattaw infezzjoni bil-virus tal-immunodefiċjenza (HIV) tal-bniedem:
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 Krka, renal function must be reevaluated 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 Krka, il-funzjoni renali jeħtieġ li tiġi evalwata mill-ġdid fi żmien ġimgħa, fosthom kejl talkonċentrazzjonijiet ta' glukows fid-demm, potassju fid-demm u glukows fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: Tenofovir: AUC: ↔ Cmax: ↔ Cmin: ↔
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↔ Tenofovir:
English: Compounds or herbal preparations (for example Ginkgo biloba extracts and St. John's wort) which induce these enzymes may give rise to decreased plasma concentrations of efavirenz.
Maltese: Komposti jew preparazzjonijiet tal-ħxejjex (pereżempju estratti ta' Ginkgo biloba u St John's Wort) li jinduċu dawn l-enzimi jistgħu jikkawżaw tnaqqis tal-konċentrazzjonijiet fil-plażma ta' efavirenz.
English: That patients should have their baseline renal function assessed prior to initiating Efavirenz/Emtricitabine /Tenofovir disoproxil Krka therapy The importance of regular monitoring of renal function during Efavirenz/Emtricitabine /Tenofovir disoproxil Krka therapy
Maltese: L-importanza ta' monitoraġġ regolari tal-funzjoni renali matul it-terapija b'Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Interaction only studied with sofosbuvir/velpatasvir.
Maltese: L-interazzjoni ġiet studjata biss ma' sofosbuvir/velpatasvir.
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 irrapportati f'xi assaġġi ta' screening f'suġġetti mhux infettati u f'pazjenti infettati bl-HIV li rċevew efavirenz.
English: 3, coordination abnormal 3, agitation tremor
Maltese: 3, manija paranojja alluċinazzjoni 3, burdata ewforika
English: In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal.
Maltese: Fi studju ta' utilizzaturi tal-mediċina millvina infettati bl-HIV, l-għoti fl-istess ħin ta' efavirenz mal-methadone rriżulta fi tnaqqis fil-livelli tal-methadone fil-plażma u sinjali ta' opiate withdrawal.
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is not recommended for patients with moderate or severe renal impairment (creatinine clearance (CrCl) < 50 ml/min).
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka mhux rikkmandat għal pazjenti b'indeboliment renali moderat jew sever (rata tat-tneħħija tal-kreatinina (CrCl) < 50 ml/min).
English: 3, suicide ideation
Maltese: 3, aġitazzjoni rogħda
English: + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Maltese: Sofosbuvir (400 mg q.d.) + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
English: Age
Maltese: Meta
English: Treatment-emergent adverse reactions considered possibly or probably related to efavirenz/emtricitabine/tenofovir disoproxil reported in study AI266073 (over 48 weeks; n = 203), which have not been associated with one of the individual components of efavirenz/emtricitabine/tenofovir disoproxil, include:
Maltese: Reazzjonijiet avversi assoċjati tal-użu ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Ir-reazzjonijiet avversi li żviluppaw mill-kura li huma kkunsidrati bħala possibbilment jew probabbilment marbuta ma' efavirenz/emtricitabine/tenofovir disoproxil rrappurtati fi studju AI266073 (fuq perjodu ta' 48 ġimgħa; n=203), li ma ġewx assoċjati ma' wieħed mill-komponenti individwali ta' efavirenz/emtricitabine/tenofovir disoproxil, jinkludu:
English: Since Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is a combination product and the dosing interval of the individual components cannot be altered, treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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 Krka huwa prodott ikkumbinat u l-intervall tad-dożaġġ tal-komponenti individwali ma jistax jinbidel, it-trattament b'Efavirenz/Emtricitabine/Tenofovir disoproxil Krka għandu jiġi interrott f'pazjenti b'rata tat-tneħħija tal-kreatinina < 50 ml/min ikkonfermata jew tnaqqis fil-fosfat fis-serum għal < 1.0 mg/dl (0.
English: Medicines containing didanosine (for HIV infection): Taking Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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 Krka 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: Co-administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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 ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka flimkien 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: It is anticipated that tenofovir exposure (AUC) will be approximately 30% lower following administration of efavirenz/emtricitabine/tenofovir disoproxil on an empty stomach as compared to the individual component tenofovir disoproxil when taken with food (see section 5.1).
Maltese: Huwa mistenni li l-esponiment ta' tenofovir (AUC) tkun bejn wieħed u ieħor 30% inqas wara għoti ta' efavirenz/emtricitabine/tenofovir disoproxil fuq stonku vojt meta mqabbel mal-komponenti individwali ta' tenofovir disoproxil meta meħud mal-ikel (ara sezzjoni 5.1).
English: The methadone dose was increased by a mean of 22% to alleviate withdrawal symptoms.
Maltese: Id-doża talmethadone ġiet miżjuda b'medja ta' 22% biex jittaffew is-sintomi tal-withdrawal.
English: Animal studies on emtricitabine and tenofovir disoproxil do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali b'emtricitabine u tenofovir disoproxil ma urewx effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
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 fil-linja bażi għall-kliewi, mard tal-HIV li jkun fi stadju avvanzat, jew pazjenti li jkunu qed jirċievu mediċini nefrotossiċi fl-istess waqt) huma f'riskju akbar li jkollhom irkupru mhux komplut tal-funzjoni renali minkejja t-twaqqif ta' tenofovir disoproxil (ara sezzjoni 4.4).
English: Immune Reactivation Syndrome
Maltese: Sindromu ta' Riattivazzjoni Immunitarja mill-Ġdid
English: The following pack sizes are available: cartons containing 1 bottle of 30 film-coated tablets or 90 (3 bottles of 30) film-coated tablets.
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli: kartun li fihom flixkun 1 ta' 30 pillola miksija b'rita jew 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: If you accidentally take too many Efavirenz/Emtricitabine/Tenofovir disoproxil Krka tablets you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Maltese: Jekk aċċidentalment tieħu pilloli żejda ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, tista' tkun f'riskju ogħla li jkollok effetti sekondarji possibbli b'din il-mediċina (ara sezzjoni 4, Effetti sekondarji possibbli).
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, Antiretroviral Pregnancy Registry) irċieva rapporti prospettivi ta' 904 tqaliet b'espożizzjoni fl-ewwel trimestru għal korsijiet li fihom efavirenz, li rriżultaw f'766 twelid ħaj.
English: Lopinavir/ritonavir/Emtricitabine Interaction not studied.
Maltese: Lopinavir/ritonavir/Emtricitabine L-interazzjoni ma ġietx studjata.
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).
English: If
Maltese: ISEM
English: Emtricitabine is primarily excreted by the kidneys with complete recovery of the dose achieved in urine (approximately 86%) and faeces (approximately 14%).
Maltese: Emtricitabine jiġi eliminat prinċipalment mill-kliewi b'irkupru sħiħ tad-doża miksub fl-awrina (bejn wieħed u ieħor 86%) u ippurgar (bejn wieħed u ieħor 14%).
English: No clinically significant effect on efavirenz pharmacokinetics.
Maltese: Mekkaniżmu ta' azzjoni u effetti farmakodinamiċi
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.”, once daily as “q.d.” and once every 8 hours as “q8h”).
Maltese: Interazzjonijiet bejn Efavirenz/Emtricitabine/Tenofovir disoproxil Krka jew il-komponent(i) individwali tiegħu u prodotti mediċinali oħra huma elenkati fit-Tabella 1 taħt (żieda hija indikata b'“↑”, tnaqqis b'“↓”, ebda bidla b'“↔”, darbtejn kuljum b'“b.i.d.”, darba kuljum b'“q.d.” u darba kull
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is not recommended for patients with moderate or severe renal impairment (creatinine clearance < 50 ml/min).
Maltese: Efavirenz/emtricitabine/tenofovir disoproxil mhuwiex rakkomandat għal pazjenti b'indeboliment renali moderat jew sever (eliminazzjoni tal-kreatinina < 50 ml/min).
English: Pharmacokinetic studies have not been performed with efavirenz, emtricitabine or tenofovir in elderly patients (over 65 years of age).
Maltese: Età Għadhom ma sarux studji farmakokinetiċi b'efavirenz, emtricitabine jew tenofovir fuq l-anzjani (aktar minn 65 sena).
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 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 (ara sezzjoni 5.1).
English: 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 Krka (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 Krka (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Dose adjustments of calcium channel blockers when coadministered with Efavirenz/Emtricitabine/Tenofovi r disoproxil Krka should be guided by clinical response (refer to the Summary of Product Characteristics for the calcium channel blocker).
Maltese: L-aġġustamenti fid-doża tal-imblokkaturi tal-kanali tal-kalċju meta jingħataw fl-istess ħin ma' Efavirenz/Emtricitabine/Te nofovir disoproxil Krka għandhom ikunu ggwidati mir-rispons kliniku (irreferi għas-Sommarju tal-Karatteristiċi talProdott għall-imblokkatur tal-kanali tal-kalċju).
English: Diltiazem or similar medicines (called calcium channel blockers): When you start taking Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, 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 Krka, it-tabib tiegħek jista' jkun jeħtieġ li jbiddillek id-doża tal-imblokkatur tal-kanal tal-kalċju.
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25)
Maltese: ↓ 34% (↓ 41 għal ↓ 25) Cmax: ↓ 34% (↓ 41 għal ↑ 25) Cmin: ↓ 34% (↓ 43 għal ↑ 24)
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil ma ġietx evalwat fil-preżenza tal-ikel.
English: Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc.
Maltese: Irreferi għas-Sommarju talKaratteristiċi tal-Prodott għall-prodott mediċinali li fih maraviroc.
English: As Efavirenz/Emtricitabine/Tenofovir disoproxil Krka contains efavirenz, emtricitabine and tenofovir disoproxil, any interactions that have been identified with these agents individually may occur with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Maltese: Minħabba li Efavirenz/Emtricitabine/Tenofovir disoproxil Krka fih efavirenz, emtricitabine u tenofovir disoproxil, kull interazzjoni li ġiet identifikata ma' dawn is-sustanzi individwalment tista' sseħħ b'Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: Co administration with drugs that are known to prolong the QTc interval (proarrhythmic).
Maltese: Dejta dwar l-impatt kliniku li jista' jkollu t-tnaqqis fl-esponiment farmakokinetiku mhijiex disponibbli.
English: Pointes, consider alternatives to efavirenz/emtricitabine/tenofovir disoproxil.
Maltese: - Is-sustanzi attivi huma efavirenz, emtricitabine u tenofovir disoproxil.
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 ibbażat fuq il-PI, il-bidla għal Efavirenz/Emtricitabine/Tenofovir disoproxil tista' twassal għal tnaqqis fir-rispons għat-terapija (ara sezzjoni 5.1).
English: Uncommon rhabdomyolysis muscular weakness
Maltese: 2, dgħufija fil-muskoli