FrancophonIA/ELRC3.0 huggingface dataset:
English: HIV/HBV or HCV co-infected patients: The adverse reaction profile of emtricitabine and tenofovir disoproxil in a limited number of HIV-infected patients in study GS-01-934 who were co-infected with HBV (n = 13) or HCV (n = 26) was similar to that observed in patients infected with HIV without co-infection.
Maltese: Il-profil tar-reazzjoni avversa ta' emtricitabine u tenofovir disoproxil f'numru limitat ta' pazjenti infettati bl-HIV fl-istudju GS-01-934 li kienu infetti kemm bl-HBV (n=13) jew bl-HCV (n=26) kien jixbah lil dak osservat f'pazjenti infettati bl-HIV biss.
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24)
Maltese: ↓ 34% (↓ 41 sa ↓ 25) Cmax: ↓ 34% (↓ 41 sa ↑ 25) Cmin: ↓ 34% (↓ 43 sa ↑ 24)
English: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0) Cmin: NC
Maltese: AUC: ↓ 11% (↓ 14 sa ↓ 7) Cmax: ↓ 7% (↓ 13 sa ↓ 0) Cmin: NC
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9) Cmin: NC
Maltese: AUC: ↑ 4% (↓ 3 sa ↑ 11) Cmax: ↑ 3% (↓ 3 sa ↑ 9) Cmin: NC
English: In clinical studies of HIV-1 uninfected individuals, small decreases in BMD were observed.
Maltese: Fi studji kliniċi ta' individwi mhux infettati bl-HIV-1, kien osservat tnaqqis żgħir fil-BMD.
English: Maximum emtricitabine and tenofovir concentrations are observed in serum within 0.5 to 3.0 h of dosing in the fasted state.
Maltese: Konċentrazzjonijiet massimi ta' emtricitabine u tenofovir jidhru fis-serum fi żmien 0.5 sa 3.0 sigħat minn mindu tkun ingħatat id-doża fl-istat sajjem.
English: However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.
Maltese: Madankollu, it-tnejn huma ġeneralment magħrufin bħala NRTIs u jaħdmu billi jinterferixxu mal-ħidma normali ta' enzima (reverse transcriptase) li hi essenzjali biex il-virus jirriproduċi.
English: In the Partners PrEP clinical study, no HIV-1 variants expressing K65R, K70E, M184V, or M184I were detected at the time of seroconversion among subjects who became infected with HIV-1 during the study.
Maltese: Fl-istudju kliniku Partners PrEP, l-ebda varjant tal-HIV-1 li jesprimu K65R, K70E, M184V, jew M184I ma kienu skoperti fiż-żmien tas-serokonverżjoni fost individwi li ġew infettati bl-HIV-1 waqt listudju.
English: PrEP Checklist for prescribers:
Maltese: Lista ta' Kontroll għall-PrEP għal dawk li jiktbu r-riċetti:
English: AUC: ↑ 40% (↑ 34 to ↑ 46) Cmax: ↑ 44% (↑ 33 to ↑ 55) Cmin: ↑ 84% (↑ 76 to ↑ 92)
Maltese: AUC: ↑ 40% (↑ 34 sa ↑ 46) Cmax: ↑ 44% (↑ 33 sa ↑ 55) Cmin: ↑ 84% (↑ 76 sa ↑ 92)
English: Additive to synergistic effects were observed in combination studies with protease inhibitors, and with nucleoside and non-nucleoside analogue inhibitors of HIV reverse transcriptase.
Maltese: Żidiet ma' l-effetti sinerġistiċi dehru fi studji kombinati ta' emtricitabine flimkien ma' impedituri tal-protease, u ma' impedituri tal-analogi tan-nukleosidi u mhux nukleosidi tar-reverse transcriptase ta' l-HIV.
English: Limited data from clinical studies support once daily dosing (see section 4.4).
Maltese: Dejta limitata minn studji kliniċi tappoġġja doża ta' darba kuljum (ara sezzjoni 4.4).
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24) Cmin: NC
Maltese: AUC: ↓ 4% (↓ 32 sa ↑ 34) Cmax: ↓ 5% (↓ 27 sa ↑ 24) Cmin: NC
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14) Cmin: NC
Maltese: AUC: ↑ 5% (↓ 2 sa ↑ 13) Cmax: ↑ 5% (↓ 3 sa ↑ 14) Cmin: NC
English: rash
Maltese: raxx
English: Renal impairment: Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and tenofovir increases in individuals with renal dysfunction (see sections 4.4 and 5.2).
Maltese: Indeboliment renali: Emtricitabine u tenofovir huma eliminati permezz ta' tneħħija renali u lesponiment għal emtricitabine u tenofovir tiżdied f'individwi b'disfunzjoni renali (ara sezzjonijiet 4.4 u 5.2).
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse reactions.
Maltese: L-għoti ta' tenofovir disoproxil flimkien ma' didanosine jirriżulta f'żieda ta' 40-60% flesponiment sistemiku għaddidanosine, li jista' jżid ir-riskju għal reazzjonijiet avversi relatati ma' didanosine.
English: Do not take Emtricitabine/Tenofovir disoproxil Mylan if you are already taking other medicines that contain the components of this medicine (which are emtricitabine and tenofovir disoproxil), or any other antiviral medicines that contain tenofovir, alafenamide, lamivudine or adefovir dipivoxil.
Maltese: Tiħux Emtricitabine/Tenofovir disoproxil Mylan jekk diġà qed tieħu mediċini oħra li fihom il-komponenti ta' din il-mediċina (li huma emtricitabine u tenofovir disoproxil), jew kwalunkwe mediċina antivirali oħra li fihom tenofovir alafenamide, lamivudine jew adefovir dipivoxil.
English: allergic reaction
Maltese: reazzjoni allergika
English: 4.6 Fertility, pregnancy and lactation Pregnancy
Maltese: .6 Fertilità, tqala u treddigħ
English: Mean change from baseline in CD4 cell count (cells/mm3) p-value
Maltese: Bidla medja millinja bażi fl-għadd taċ-ċelluli CD4 (ċelluli/mm3) Valur p
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Maltese: L-għoti flimkien ta' tenofovir disoproxil ma' ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir intwera li jżid il-konċentrazzjonijiet ta' tenofovir fil-plażma, b'mod speċjali meta jintuża flimkien ma' kors kontra l HIV li jinkludi tenofovir disoproxil u aġent li jżid l-effett farmakokinetiku (ritonavir jew cobicistat).
English: Consideration should be given to interrupting treatment with emtricitabine/tenofovir disoproxil in patients with creatinine clearance decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Maltese: Għandha titqies l-interruzzjoni tat-trattament bi emtricitabine/tenofovir disoproxil f'pazjenti bi tneħħija tal-kreatinina mnaqqsa għal < 50 mL/min jew tnaqqis fil-phosphate fis-serum għal < 1.0 mg/dL (0.
English: HDPE bottle with white opaque polypropylene screw cap or white opaque polypropylene child resistant closure with wad containing aluminium induction sealing liner and dessicant labelled ‘DO NOT EAT'pack containing 30 film-coated tablets and mutlipacks containing 90 (3 packs of 30) film-coated tablets Cold form blister laminated with embedded desiccant layer on one side and hard tampered aluminium foil on the other pack containing 30 film-coated tablets
Maltese: Flixkun tal-HDPE b'tapp bil-kamin tal-polypropylene abjad opak jew tapp tal-polypropylene abjad opak li ma jinfetaħx mit-tfal b'tajjara li fiha siġillant tal-induzzjoni tal-aluminju u pakkett taddessikant ittikkettat “TIKOLX” li fih 30 pillola miksija b'rita u pakketti multipli li fihom 90 (3 pakketti ta' 30) pillola miksija b'rita
English: Emtricitabine/Tenofovir disoproxil Mylan contains two active substances, emtricitabine and tenofovir disoproxil.
Maltese: Emtricitabine/Tenofovir disoproxil Mylan fiha żewġ sustanzi attivi, emtricitabine u tenofovir disoproxil.
English: EXP:
Maltese: PC:
English: AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5) Cmin: NC
Maltese: AUC: ↓ 5% (↓ 9 sa ↓ 1) Cmax: ↓ 11% (↓ 17 sa ↓ 5) Cmin: NC
English: Neither emtricitabine nor tenofovir inhibited in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation.
Maltese: La emtricitabine u lanqas tenofovir ma inibixxew in vitro l-metaboliżmu tal-mediċina medjat minn xi wieħed mill-iżoformi umani maġġuri ta' CYP450 involuti fil-bijotrasformazzjoni tal-mediċina.
English: Table 5: Study population from study CO-US-104-0288 (iPrEx)
Maltese: Popolazzjoni tal-istudju mill-istudju CO-US-104-0288 (iPrEx)
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li s-soppressjoni virali effettiva b'terapija antiretrovirali ġiet ippruvata li tnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, ma jistax jiġi eskluż riskju residwu.
English: At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as > 4% loss).
Maltese: 48, sitt adolexxenti fil-grupp ta' tenofovir disoproxil u adolexxent wieħed fil-grupp tal-plaċebo kellhom telf tal-BMD sinifikanti fl-ispina lumbari (imfisser bħala telf ta' > 4%).
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in HIV-1 infected patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Maltese: Każijiet ta' falliment akut tal-kliewi wara l-bidu ta' doża għolja jew diversi mediċini kontra linfjammazzjoni mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs) kienu rrappurtati f'pazjenti infettati bl-HIV-1 ittrattati b'tenofovir disoproxil u b'fatturi ta' riskju għal disfunzjoni talkliewi.
English: AUC: ↑ 40% (↑ 34 to ↑ 45) Cmax: ↑ 46% (↑ 39 to ↑ 54) Cmin: ↑ 70% (↑ 61 to ↑ 79)
Maltese: AUC: ↑ 40% (↑ 34 sa ↑ 45) Cmax: ↑ 46% (↑ 39 sa ↑ 54) Cmin: ↑ 70% (↑ 61 sa ↑ 79)
English: In vitro: Resistance has been seen in vitro and in some HIV-1 infected patients due to the development of the M184V/I mutation with emtricitabine or the K65R mutation with tenofovir.
Maltese: Ir-reżistenza ntweriet in vitro u f'xi pazjenti infettati bl-HIV-1 minħabba l-iżvilupp talmutazzjoni M184V/I b'emtricitabine jew il-mutazzjoni K65R b'tenofovir.
English: This indicates that active tubular secretion is an important part of the elimination of tenofovir.
Maltese: Dan jindika li s-sekrezzjoni tubulari attiva hija parti importanti milleliminazzjoni ta' tenofovir.
English: • changes to your urine Rare side effects
Maltese: Effetti sekondarji rari
English: Darunavir/Ritonavir/Emtricitabine Interaction not studied.
Maltese: Darunavir/Ritonavir/Emtricitabine L-interazzjoni ma ġietx studjata.
English: AUC: ↑ 39% (↑ 33 to ↑ 44) Cmax: ↑ 55% (↑ 45 to ↑ 66) Cmin: ↑ 52% (↑ 45 to ↑ 59)
Maltese: ↑ 39% (↑ 33 sa ↑ 44) Cmax: ↑ 55% (↑ 45 sa ↑ 66) Cmin: ↑ 52% (↑ 45 sa ↑ 59)
English: Tenofovir disoproxil is indicated for the treatment of HBV and emtricitabine has shown activity against HBV in pharmacodynamic studies but the safety and efficacy of emtricitabine/tenofovir disoproxil have not been specifically established in patients with chronic HBV infection.
Maltese: Tenofovir (disoproxil) huwa indikat għat-trattament tal-HBV u emtricitabine wera attività kontra lHBV fi studji farmakodinamiċi iżda s-sigurtà u l-effikaċja ta' emtricitabine/tenofovir disoproxil ma ġewx stabbiliti speċifikament f'pazjenti b'infezzjoni kronika tal-HBV.
English: In vitro and clinical pharmacokinetic interaction studies have shown the potential for CYP450 mediated interactions involving emtricitabine and tenofovir disoproxil with other medicinal products is low.
Maltese: Studji in vitro u kliniċi dwar interazzjonijiet farmakokinetiċi wrew li l-potenzjal għall-interazzjonijiet medjati minn CYP450 li jinvolvu emtricitabine u tenofovir disoproxil ma' prodotti mediċinali oħrajn hija baxxa.
English: a Relative risk reduction calculated on incident (post-baseline) seroconversion from the double-blind treatment period and through the 8-week follow-up period.
Maltese: It-tnaqqis fir-riskju relattiv ikkalkulat fuq l-inċidenza ta' serokonverżjoni (wara l-linja bażi) minn perjodu ta' trattament double-blind u matul il-perjodu ta' segwitu ta' 8 ġimgħat.
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22) Cmin: NC
Maltese: AUC: ↓ 1% (↓ 8 sa ↑ 6) Cmax: ↑ 7% (↓ 6 sa ↑ 22) Cmin: NC
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV-1 infected patients when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Maltese: Kien hemm rapporti ta' rata għolja ta' falliment viroloġiku u tal-iżvilupp ta' reżistenza fi stadju bikri f'pazjenti infettati bl-HIV-1 meta tenofovir disoproxil kien mogħti flimkien ma' lamivudine u abacavir kif ukoll ma' lamivudine u didanosine bħala kors ta' darba kuljum.
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in both treatment groups.
Maltese: Fi studju kliniku kkontrollat ta' 144 ġimgħa li qabbel tenofovir disoproxil ma' stavudine mogħti flimkien ma' lamivudine u efavirenz f'pazjenti li qatt ma ngħataw antiretrovirali qabel, tnaqqis żgħir fid-densità tal-minerali tal-għadam (BMD, bone mineral density) tal-ġenbejn u tas-sinsla tad-dahar kien osservat fiż-żewġ gruppi ta' trattament.
English: The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil meta jingħata flimkien ma' ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir u aġent li jżid l-effett farmakokinetiku għadha ma ġietx stabbilita.
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1) Cmin: NC
Maltese: AUC: ↓ 7% (↓ 13 sa ↓ 1) Cmax: ↓ 11% (↓ 20 sa ↑ 1) Cmin: NC
English: headache dizziness
Maltese: Bijotrasformazzjoni
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
Maltese: Kull pillola miksija b'rita fiha 200 mg ta' emtricitabine u 245 mg ta' tenofovir disoproxil (ekwivalenti għal 300 mg ta' tenofovir disoproxil maleate).
English: PrEP educational brochure for the individual at risk (to be provided by healthcare provider [HCP]):
Maltese: Opuskolu edukattiv dwar PrEP għall-individwu f'riskju (li jrid jingħata mill-fornitur tal-kura tas-saħħa [HCP, healthcare provider]):
English: • Reminders for evaluations/counselling at the initial visit and follow-up.
Maltese: • Noti ta' tfakkir għal evalwazzjonijiet/konsulenza fil-viżita inizjali u s-segwitu.
English: Placebo Emtricitabine/tenofovir disoproxil
Maltese: Plaċebo Emtricitabine/tenofovir disoproxil
English: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of 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 primarjament eliminati mill-kliewi, l-għoti ta' emtricitabine/tenofovir disoproxil flimkien ma' prodotti mediċinali li jnaqqsu l-funzjoni tal-kliewi jew jikkompetu għas-sekrezzjoni tubulari attiva (eż. cidofovir) jista' jżid il-konċentrazzjonijiet fis-serum ta' emtricitabine, tenofovir u/jew il-prodotti mediċinali li jingħataw flimkien.
English: Table 7: Efficacy and adherence in study CO-US-104-0288 (iPrEx, matched case-control analysis)
Maltese: L-effikaċja u l-aderenza fl-istudju CO-US-104-0288 (iPrEx, analiżi b'kontroll ta' każijiet imqabbla)
English: Cmax: ↑ 38% (↑ 14 to ↑ 67)
Maltese: ↑ 38% (↑ 14 sa ↑ 67)
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6) Cmin: NC
Maltese: AUC: ↓ 2% (↓ 5 sa ↑ 0) Cmax: ↓ 1% (↓ 7 sa ↑ 6) Cmin: NC
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucosegalactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: If available, 90% confidence intervals are shown in parentheses.
Maltese: Jekk disponibbli, intervalli ta' kunfidenza ta' 90% huma murija f'parentesi.
English: HIV-1 infected 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 infettati bl-HIV-1 b'disfunzjoni tal-fwied li kienet teżisti minn qabel, inkluż epatite attiva kronika, għandhom frekwenza miżjuda ta' anormalitajiet tal-funzjoni tal-fwied matul terapija antiretrovirali kombinata (CART) u għandhom ikunu mmonitorjati skont il-prattika standard.
English: HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced susceptibility to tenofovir disoproxil.
Maltese: L-HIV-1 li kellha 3 mutazzjonijiet assoċjati ma' l-analogi ta' thymidine (TAMs) jew aktar li kienu jinkludu l-mutazzjoni M41L jew L210W reverse transcriptase wriet tnaqqis fis-sensittività għal tenofovir disoproxil.
English: Emtricitabine/tenofovir disoproxil should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or other cytidine analogues, such as lamivudine (see section 4.5).
Maltese: Emtricitabine/tenofovir disoproxil m'għandux jingħata fl-istess ħin ma' prodotti mediċinali oħra li fihom emtricitabine, tenofovir disoproxil, tenofovir alafenamide, jew analogi ta' cytidine oħra, bħal lamivudine (ara sezzjoni 4.5).
English: Treatment of HIV-1 infection:
Maltese: Trattament tal-infezzjoni tal-HIV-1:
English: Individuals over the age of 65 years are more likely to have decreased renal function, therefore caution should be exercised when administering emtricitabine/tenofovir disoproxil to older people.
Maltese: Individwi li għandhom iżjed minn 65 sena huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta emtricitabine/tenofovir disoproxil jingħata lil persuni anzjani.
English: Paediatrics with renal impairment:
Maltese: Individwi b'indeboliment renali:
English: AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2) Cmin: NC
Maltese: AUC: ↓ 4% (↓ 7 sa ↓ 1) Cmax: ↓ 4% (↓ 9 sa ↑ 2) Cmin: NC
English: • That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil-containing products such as Emtricitabine/Tenofovir disoproxil Mylan
Maltese: • Li hemm riskju miżjud ta' mard tal-kliewi f'pazjenti infettati bl-HIV assoċjat ma' prodotti li fihom tenofovir disoproxil fumarate bħal Emtricitabine/Tenofovir disoproxil Mylan
English: The adverse reactions considered at least possibly related to treatment with the components of emtricitabine/tenofovir disoproxil from clinical study and post-marketing experience in HIV-1 infected patients are listed in Table 3, below, by body system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi kkunsidrati li kienu mill-inqas possibbilment relatati mat-trattament bilkomponenti ta' emtricitabine/tenofovir disoproxil, li dehru fi studju kliniku u mill-esperjenza miksuba wara li l-prodott tpoġġa fuq is-suq f'pazjenti infettati bl-HIV-1, huma elenkati f'Tabella 3, hawn taħt, skond il-klassi ta' sistema ta' l-organi fil-ġisem u skond il-frekwenza.
English: Among 28 patients receiving 96 weeks of treatment with tenofovir disoproxil, BMD Z scores declined by -0.341 for lumbar spine and -0.458 for total body.
Maltese: Fost 28 pazjent li rċevew 96 ġimgħa ta' trattament b'tenofovir disoproxil, il-punteġġi Z tal-BMD naqsu bi -0.341 għallispina lumbari u -0.458 għall-ġisem kollu.
English: In infants and children older than 4 months, the majority of patients taking emtricitabine achieved or maintained complete suppression of plasma HIV 1 RNA through 48 weeks (89% achieved ≤ 400 copies/mL and 77% achieved ≤ 50 copies/mL).
Maltese: Fi trabi u tfal li għandhom aktar minn 4 xhur, il-maġġoranza tal-pazjenti li jieħdu emtricitabine kisbu jew żammew trażżin komplut ta' HIV-1 RNA fil-plażma matul 48 ġimgħa (89% kisbu ≤ 400 kopja/mL u 77% kisbu ≤ 50 kopja/mL).
English: Didanosine: The co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 2).
Maltese: L-għoti ta' emtricitabine/tenofovir disoproxil flimkien ma' didanosine mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 2).
English: McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Maltese: McDermott Laboratories Limited li jikkummerċja bħala Gerard Laboratories li jikkummerċja bħala Mylan Dublin
English: A small clinical study was conducted to evaluate the safety, antiviral activity and pharmacokinetics of tenofovir disoproxil in combination with emtricitabine in HIV infected patients with renal impairment.
Maltese: Sar studju kliniku żgħir biex jevalwa s-sigurtà, l-attività antivirali u l-farmakokinetika ta' tenofovir disoproxil flimkien ma' emtricitabine f'pazjenti infettati bl-HIV li kellhom indeboliment renali.
English: A higher risk of renal impairment has been reported in HIV-1 infected patients receiving tenofovir disoproxil in combination with a ritonavir or cobicistat boosted protease inhibitor.
Maltese: Riskju ogħla ta' indeboliment tal-kliewi kien irrapportat f'pazjenti infettati bl-HIV-1 li jingħataw tenofovir disoproxil flimkien ma' ritonavir jew impeditur tal-protease msaħħaħ b'cobicistat.
English: AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11) Cmin: NC
Maltese: AUC: ↓ 9% (↓ 16 sa ↓ 1) Cmax: ↓ 7% (↓ 22 sa ↑ 11) Cmin: NC
English: Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1).
Maltese: Emtricitabine/Tenofovir disoproxil Mylan huwa indikat ukoll għat-trattament ta' adolexxenti infettati b'HIV-1, b'reżistenza għal NRTI jew tossiċitajiet li jipprekludu l-użu ta' sustanzi ppreferuti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia abdominal pain, abdominal distension, flatulence
Maltese: amylase għoli li jinkludi amylase pankreatika għolja, lipase fis-serum għoli, rimettar, uġigħ addominali, dispepsja uġigħ addominali, nefħa addominali, gass fl-istonku
English: AUC: ↑ 32% (↑ 25 to ↑ 38) Cmax: ↔
Maltese: ↑ 32% (↑ 25 għal ↑ 38) Cmax: ↔
English: Co-administration is not recommended because it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Maltese: L-għoti flimkien mhux rakkomandat għaliex dan jirriżulta f'żieda ta' 40-60% fl-esponiment sistematiku għal didanosine li jista' jżid ir-riskju ta' reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: The 144 week secondary endpoint data are also presented in Table 4.
Maltese: Linformazzjoni mir-riżultat aħħari sekondarju wara 144 ġimgħa hi ppreżentata wkoll f'Tabella 4.
English: Other medicines and Emtricitabine/Tenofovir disoproxil Mylan
Maltese: Mediċini oħra u Emtricitabine/Tenofovir disoproxil Mylan
English: Consideration should be given to interrupting use of with emtricitabine/tenofovir disoproxil in individuals with creatinine clearance decreased to < 60 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Maltese: Għandha titqies l-interruzzjoni tal-użu ta' emtricitabine/tenofovir disoproxil f'individwi li t-tneħħija tal-kreatinina tagħhom tkun naqset għal < 60 mL/min jew bi tnaqqis fil-phosphate fis-serum għal < 1.0 mg/dL (0.