FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study of 498 men, the mean changes from baseline to week 24 in BMD ranged from 0.4% to 1.0% across hip, spine, femoral neck and trochanter in men who received daily emtricitabine/tenofovir disoproxil prophylaxis (n = 247) vs. placebo (n = 251).
Maltese: Fi studju ta' 498 raġel, il-bidliet medji mil-linja bażi għal ġimgħa 24 fil-BMD varjaw minn 0.4% sa 1.0% fil-ġenbejn, is-sinsla tad-dahar, l-għonq femorali u t-trokanter fl-irġiel li ngħataw profilassi ta' emtricitabine/tenofovir disoproxil kuljum (n = 247) kontra plaċebo (n = 251).
English: NC = not calculated.
Maltese: NC = mhux ikkalkulat (not calculated)
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl oestradiol/tenofovir disoproxil
Maltese: Norgestimate/Ethinyl oestradiol/ Tenofovir disoproxil
English: Other medicines and Emtricitabine/Tenofovir disoproxil Zentiva Do not take Emtricitabine/Tenofovir disoproxil Zentiva if you are already taking other medicines that contain the components of Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Maltese: Mediċini oħra u Emtricitabine/Tenofovir disoproxil Zentiva Tiħux Emtricitabine/Tenofovir disoproxil Zentiva jekk diġà qed tieħu mediċini oħra li fihom ilkomponenti ta' Emtricitabine/Tenofovir disoproxil Zentiva, emtricitabine u tenofovir disoproxil, jew kwalunkwe mediċina antivirali oħra li fihom tenofovir alafenamide, lamivudine jew adefovir dipivoxil.
English: When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/ml at week 48.
Maltese: Meta t-tagħrif nieqes ġie eskluż, 91% tal-pazjenti fil-grupp ta' trattament ta' tenofovir disoproxil u 94% tal-pazjenti filgrupp ta' trattament ta' stavudine jew zidovudine kellhom konċentrazzjonijiet ta' HIV 1 RNA ta' < 400 kopja/mL f'ġimgħa 48.
English: Outer carton / bottle label
Maltese: Kartuna ta' barra / tikketta tal-flixkun
English: The adverse reaction profile of emtricitabine and tenofovir disoproxil in a limited number of HIVinfected 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: ANTI-INFECTIVES Hepatitis B virus (HBV) antiviral agents Adefovir dipivoxil /tenofovir disoproxil
Maltese: ANTIINFETTIVI Aġenti antivirali tal-virus talepatite B (HBV)
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1)
Maltese: AUC: ↓ 7% (↓ 13 sa ↓ 1) Cmax: ↓ 11% (↓ 20 sa ↑ 1)
English: Protease inhibitors Atazanavir / ritonavir / tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Maltese: ANTI-INFETTIVI Antiretrovirali Impedituri ta' protease Atazanavir / ritonavir / tenofovir disoproxil (300 mg q.d. / 100 mg q.d. / 245 mg q.d.)
English: In 3 of 10 subjects who had acute HIV infection at study enrollment, M184I and M184V mutations were detected in the HIV of 2 of 2 subjects in the emtricitabine/tenofovir disoproxil group and 1 of 8 subjects in the placebo group.
Maltese: Fi 3 minn 10 individwi li kellhom infezzjoni akuta tal-HIV meta rreġistraw fl-istudju, kienu skoperti l-mutazzjonijiet M184I u M184V fl-HIV ta' 2 minn 2 individwi fil-grupp ta' emtricitabine/tenofovir disoproxil u 1 minn 8 individwi fil-grupp tal-plaċebo.
English: AUC: ↓ 12% (↓ 16 to ↓ 8) Cmax: ↓ 16% (↓ 22 to ↓ 10) Cmin: ↓ 15% (↓ 12 to ↓ 9)
Maltese: AUC: ↓ 12% (↓ 16 sa ↓ 8) Cmax: ↓ 16% (↓ 22 sa ↓ 10)
English: Tenofovir: AUC: ↑50% (↑ 42 to ↑ 59)
Maltese: AUC: ↑50% (↑ 42 għal ↑ 59)
English: AUC: ↑ 6% (↓ 1 to ↑ 13) Cmax: ↑13% (↑ 1 to ↑ 27)
Maltese: AUC: ↑ 6% (↓ 1 sa ↑ 13) Cmax: ↑13% (↑ 1 sa ↑ 27) Cmin: NC
English: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg film-coated tablets Emtricitabine/tenofovir disoproxil
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg pilloli miksijin b'rita Emtricitabine/tenofovir disoproxil
English: Cohort
Maltese: UŻU
English: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108)
Maltese: AUC: ↓ 4% (↓ 15 għal ↑ 8) Cmax: ↑ 102% (↓ 96 għal ↑
English: Involved in Transactional Sex Last 6 Month, N (%) Known HIV+ Partner Last 6 Months, N (%) Syphilis Seroreactivity, N (%) Serum Herpes Simplex Virus Type 2 Infection, N (%) Urine Leukocyte Esterase Positive, N (%) URAI = unprotected receptive anal intercourse
Maltese: Infezzjoni tat-Tip 2 tal-Virus tas-Serum Herpes Simplex, N (%) Pożittiv għal Esterase Lewkoċiti fl-Awrina, N (%)
English: Cmax: ↓ 24% (↓ 35 to ↓ 11) Cmin: ↔
Maltese: Cmax: ↓ 24% (↓ 44 għal ↓ 12) Cmin: NC
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291.5 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir).
Maltese: Kull pillola miksija b'rita fiha 200 mg emtricitabine u 245 mg tenofovir disoproxil (ekwivalenti għal 291.5 mg tenofovir disoproxil phosphate jew 136 mg tenofovir).
English: Blue, oval biconvex film-coated tablet without half-score with dimensions approx. 19.35 x 9.75 mm.
Maltese: Pillola miksija b'rita, blu, ovali konvessa miż-żewġ naħat mingħajr sinjal imnaqqax li jaqsam il-pillola min-nofs b'qies madwar 19.35 x 9.75 mm.
English: Renal safety with emtricitabine/tenofovir disoproxil has only been studied to a very limited degree in HIV-1 infected patients with impaired renal function (creatinine clearance < 80 ml/min).
Maltese: Is-sikurezza tal-kliewi bi Emtricitabine/tenofovir disoproxil ġiet studjata biss sa livell limitat ħafna f'pazjenti infettati bl-HIV 1 b'funzjoni tal-kliewi indebolita (tneħħija tal-kreatinina < 80 mL/min).
English: • Emtricitabine/Tenofovir disoproxil Zentiva can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
Maltese: • Emtricitabine/Tenofovir disoproxil Zentiva jista' jingħata minflok emtricitabine u tenofovir disoproxil użati separatament fl-istess dożi.
English: Darunavir / ritonavir / tenofovir disoproxil (300 mg q.d./100 mg q.d./
Maltese: Darunavir / ritonavir / tenofovir disoproxil (300 mg q.d. / 100 mg q.d. / 245 mg q.d.)
English: The co-administration of Emtricitabine/Tenofovir disoproxil Zentiva and didanosine is not recommended (see section 4.4 and Table 2).
Maltese: L-għoti ta' Emtricitabine/Tenofovir disoproxil Zentiva flimkien ma' didanosine mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 2).
English: Lopinavir/ritonavir/emtricitabine Interaction not studied.
Maltese: Lopinavir/ritonavir/emtricitabine L-interazzjoni ma ġietx studjata.
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 l-istudju.
English: Limited pharmacokinetic data are available for emtricitabine and tenofovir after co-administration of separate preparations or as emtricitabine/tenofovir disoproxil in patients with renal impairment.
Maltese: Hemm dejta farmakokinetika limitata disponibbli għal emtricitabine u tenofovir wara l-għoti flimkien ta' preparazzjonijiet separati jew bħala emtricitabine / tenofovir disoproxil f'pazjenti b'indeboliment renali.
English: Emtricitabine/Tenofovir disoproxil Zentiva is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
Maltese: Profilassi ta' qabel l-esponiment (pre-exposure prophylaxis, PrEP) Emtricitabine/Tenofovir disoproxil Zentiva huwa indikat flimkien ma' prattiki ta' sess aktar sigur għal profilassi ta' qabel l-esponiment sabiex jitnaqqas ir-riskju ta' infezzjoni tal-HIV-1 miksuba sesswalment f'adulti u adolexxenti f'riskju għoli (ara sezzjonijiet 4.2, 4.4 u 5.1).
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 Zentiva, 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: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22)
Maltese: AUC: ↓ 1% (↓ 8 għal ↑ 6) Cmax: ↑ 7% (↓ 6 għal ↑
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: Study Drug Quantification
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Consideration should be given to interrupting treatment with Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva f'pazjenti bi tneħħija tal-kreatinina mnaqqsa għal < 50 mL/min jew tnaqqis fil-phosphate fis-serum għal < 1.0 mg/dL (0.
English: Musculoskeletal and connective tissue disorders Very common elevated creatine kinase
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni ħafna creatine kinase għolja
English: Race, N (%)
Maltese: Xhur, N (%) Seroreattività tas-Sifilide, N (%)
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9)
Maltese: AUC: ↑ 4% (↓ 3 sa ↑ 11) Cmax: ↑ 3% (↓ 3 sa ↑ 9) Cmin: NC
English: HIV paediatric renal educational brochure:
Maltese: Opuskolu edukattiv dwar PrEP għal dawk li jagħtu r-riċetti:
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14)
Maltese: AUC: ↑ 5% (↓ 2 sa ↑ 13) Cmax: ↑ 5% (↓ 3 sa ↑ 14) Cmin: NC
English: • Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil Zentiva.
Maltese: • M'għandekx tredda' matul it-trattament b'Emtricitabine/Tenofovir disoproxil Zentiva.
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: HIV-1 RNA < 400 copies/ml (TLOVR)
Maltese: RNA tal-HIV-1 < 400 kopja/mL(TLOVR) Valur p % ta' differenza (95% CI)
English: AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5)
Maltese: AUC: ↓ 5% (↓ 9 sa ↓ 1) Cmax: ↓ 11% (↓ 17 sa ↓ 5) Cmin: NC
English: Cmax: ↑ 25% (↑ 8 to ↑ 45) Cmin: ↔
Maltese: Cmax: ↑ 25% (↑ 8 sa ↑ 45)
English: EXP:
Maltese: AUC:
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Maltese: AUC: ↓ 25% (↓ 42 għal- ↓ Cmax: ↓ 28% (↓ 50 għal - ↑ Cmin: ↓ 26% (↓ 46 għal - ↑ Tenofovir:
English: Uncommon hypokalaemia1
Maltese: Mhux komuni ipokalimja1
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: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull pillola, jiġifieri essenzjalment hija ‘mingħajr sodium'.
English: Common elevated amylase including elevated pancreatic amylase, elevated serum lipase, vomiting, abdominal pain, dyspepsia abdominal pain, abdominal distension, flatulence
Maltese: Komuni amylase għoli li jinkludi amylase pankreatika għolja, lipase fis-serum għoli, rimettar, uġigħ addominali, dispepsja uġigħ addominali, nefħa addominali, gass fl-istonku
English: 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 tal-mutazzjoni M184V/I b'emtricitabine jew il-mutazzjoni K65R b'tenofovir.
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24)
Maltese: AUC: ↓ 4% (↓ 32 sa ↑ 34) Cmax: ↓ 5% (↓ 27 sa ↑ 24) Cmin: NC
English: Darunavir/ritonavir/emtricitabine Interaction not studied.
Maltese: Darunavir/ritonavir/emtricitabine L-interazzjoni ma ġietx studjata.
English: Lopinavir/ritonavir / tenofovir disoproxil (400 mg b.i.d.
Maltese: Lopinavir / ritonavir / tenofovir disoproxil (400 mg b.i.d. / 100 mg b.i.d / 245 mg q.d.)
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 sindromeli jinkludi s-sindromu ta' Fanconi
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infections, combinations; ATC code: J05AR03.
Maltese: Antivirali għal użu sistemiku, antivirali għat-trattament ta' infezzjonijiet tal-HIV, kombinazzjonijiet.;
English: Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva 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: Consideration should be given to interrupting use of Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva 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.
English: Osteonecrosis
Maltese: ipertrigliċeridimija
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: Emtricitabine/Tenofovir disoproxil Zentiva 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 Zentiva 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: Studies with emtricitabine
Maltese: Famciclovir/Emtricitabine
English: Cmin: ↑ 63% (↑ 45 to ↑ 84) Ritonavir:
Maltese: Cmin: ↑ 63% (↑ 45 għal ↑ 84)
English: AUC: ↑ 98% (↑ 77 to ↑ 123) Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑ 197)
Maltese: AUC: ↑ 98% (↑ 77 għal ↑ Cmax: ↑ 79% (↑ 56 għal ↑ Cmin: ↑ 163% (↑ 137 għal ↑
English: • Emtricitabine/Tenofovir disoproxil Zentiva is also used to reduce the risk of getting HIV-1 infection in adults, and adolescents aged 12 years to less than 18 years who weigh at least 35 kg,
Maltese: • Emtricitabine/Tenofovir disoproxil Zentiva jintuża wkoll biex jitnaqqas ir-riskju li tieħu infezzjoni tal-HIV-1 fl-adulti, u adolexxenti minn età ta' 12-il sena sa inqas minn 18-il sena u li jiżnu tal-inqas 35 kg, meta jittieħed kuljum, flimkien ma' prattiki ta' sess aktar siguri:
English: Cmax: ↔ Cmin: ↑ 42% (↑ 37 to ↑ 49)
Maltese: Cmin: ↑ 42% (↑ 37 sa ↑ 49)
English: Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Emtricitabine/Tenofovir disoproxil Zentiva in patients with hepatic impairment (see sections 4.2 and 5.2).
Maltese: Fuq il-bażi tal-metaboliżmu epatiku minimu u r-rotta ta' eliminazzjoni tal-kliewi għal emtricitabine, huwa improbabbli li jkun meħtieġ aġġustament fid-doża għal Emtricitabine/Tenofovir disoproxil Zentiva f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.2 u 5.2).
English: Cmin: ↑ 48% (↑ 34 to ↑ 63) Emtricitabine:
Maltese: Cmin: ↑ 48% (↑ 34 għal ↑ 63)
English: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0)
Maltese: AUC: ↓ 11% (↓ 14 għal ↓ 7) Cmax: ↓ 7% (↓ 13 għal ↓ 0) Cmin: NC
English: Co-administration of tenofovir disoproxil and didanosine 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 ta' tenofovir disoproxil u didanosine 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 mean (%CV) tenofovir Cmax and AUC0 - ∞ values were 223 (34.8%) ng/ml and 2,050 (50.8%) ng·h/ml, respectively, in normal subjects compared with 289 (46.0%) ng/ml and 2,310 (43.5%) ng·h/ml in subjects with moderate hepatic impairment, and 305 (24.8%) ng/ml and 2,740 (44.0%) ng·h/ml in subjects with severe hepatic impairment.
Maltese: Il-medja (%CV) tal-valuri ta' Cmax ta' tenofovir u l-valuri ta' l-AUC0 ∞ kienu ta' 223 (34.8%) ng/mL u 2,050 (50.8%) ng-h/ml rispettivament, f'individwi normali, meta pparagunata ma' 289 (46.0%) ng/ml u
English: Use is not recommended in HIV-1 uninfected individuals with CrCl < 60 ml/min as it has not been studied in this population (see sections 4.4 and 5.2).
Maltese: Lużu f'individwi mhux infettati bl-HIV-1 b'CrCl < 60 mL/min mhux rakkomandat minħabba li ma ġiex studjat f'din ilpopolazzjoni (ara sezzjonijiet 4.4 u 5.2).
English: • diarrhoea, being sick (vomiting), feeling sick (nausea),
Maltese: • dijarea, tibda tirremetti (rimettar), tħossok imdardar (nawseja),
English: Individuals with renal impairment
Maltese: Individwi b'indeboliment renali
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide or other cytidine analogues, such as lamivudine (see section 4.4).
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva m'għandux jingħata fl-istess ħin ma' prodotti mediċinali oħrajn li fihom emtricitabine, tenofovir disoproxil, tenofovir alafenamide jew analogi ta' cytidine oħra, bħal lamivudine (ara sezzjoni 4.4).
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24)
Maltese: ↓ 34% (↓ 41 għal ↑ 25) Cmin: ↓ 34% (↓ 43 għal ↑ 24)
English: Emtricitabine/Tenofovir disoproxil Zentiva has not been studied in patients over 65 years of age.
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva ma ġiex studjat f'pazjenti li għandhom iktar minn 65 sena.
English: In study GS-US-104-0352, 89 HIV-1 infected paediatric patients with a median age of 7 years (range 2 to 15 years) were exposed to tenofovir disoproxil for a median of 331 weeks.
Maltese: Fl-istudju GS-US-104-0352, 89 pazjent pedjatriku infettati bl-HIV-1 b'eta medjana ta' 7 snin (firxa bejn sentejn sa 15 il sena) kienu esposti għal tenofovir disoproxil għal medjan ta' 331 ġimgħa.
English: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg / 245 mg film-coated tablets
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg pilloli miksija b'rita
English: Uncommon rhabdomyolysis1, muscular weakness1
Maltese: Trattament tal-infezzjoni talHIV-1
English: AUC: ↑ 40% (↑ 31 to ↑ 50) Cmax: ↔
Maltese: AUC: ↑ 40% (↑ 31 għal
English: In the iPrEx 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 after enrollment in the study.
Maltese: Flistudju kliniku iPrEx, l-ebda wieħed mill-varjanti tal-HIV-1 li jesprimu K65R, K70E, M184V, jew M184I ma kienu skoperti fiż-żmien tas-serokonverżjoni fost individwi li infettaw ruħhom bl-HIV-1 wara li rreġistraw fl-istudju.
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6)
Maltese: AUC: ↓ 2% (↓ 5 għal ↑ 0) Cmax: ↓ 1% (↓ 7 għal ↑ 6) Cmin: NC
English: In HIV-1 infected adolescents (aged 12 to < 18 years), the BMD Z-scores observed in subjects who received tenofovir disoproxil were lower than those observed in subjects who received placebo.
Maltese: F'adolexxenti infettati b'HIV-1 (bejn l-etajiet ta' 12 il sena sa < 18-il sena), il-punteġġi Z tal-BMD osservati f'individwi li rċevew tenofovir disoproxil kien inqas minn dawk osservati f'individwi li rċevew plaċebo.
English: Treatment of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg One tablet, once daily.
Maltese: Trattament tal-HIV fl-adulti u adolexxenti li għandhom 12-il sena u aktar, u li jiżnu tal-anqas 35 kg Pillola waħda, darba kuljum.
English: Emtricitabine/Tenofovir disoproxil Zentiva is not always effective in preventing the acquisition of HIV-1.
Maltese: Emtricitabine/Tenofovir disoproxil Zentiva mhux dejjem huwa effettiv fil-prevenzjoni tat-teħid talHIV-1.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Emtricitabine/Tenofovir disoproxil Zentiva in either adolescent patients for the treatment of HIV-1 infection or in adults and adolescents for PrEP are provided with a physician educational pack containing the Summary of Product Characteristics and an appropriate educational brochure, as detailed below:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH, Marketing Authorisation Holder) għandu jiżgura li t-tobba kollha li huma mistennija jippreskrivu/jużaw Emtricitabine/Tenofovir disoproxil Zentiva f'pazjenti adolexxenti għat-trattament ta' infezzjoni bl-HIV-1 jew f'adulti u adolexxenti għal PrEP jingħataw pakkett edukattiv għat-tobba li fih Is-Sommarju tal-Karatteristiċi tal-Prodott u opuskolu edukattiv xieraq, kif mogħti fid-dettall hawn taħt:
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day,
Maltese: • Adolexxenti minn età ta' 12-il sena sa inqas minn 18-il sena u li jiżnu tal-inqas 35 kg: pillola waħda kuljum, kull meta possibbli mal-ikel.
English: AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2)
Maltese: AUC: ↓ 4% (↓ 7 għal ↓ 1) Cmax: ↓ 4% (↓ 9 għal ↑ 2) Cmin: NC