FrancophonIA/ELRC3.0 huggingface dataset:
English: In vivo treatment of HIV-1: In an open-label randomised clinical study (GS-01-934) in antiretroviral-naïve patients, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed HIV RNA > 400 copies/mL at weeks 48, 96 or 144 or at the time of early study drug discontinuation.
Maltese: Fi studju kliniku open-label u randomised (GS-01-934) f'pazjenti li qatt ma' kienu ngħataw mediċini antiretrovirali qabel, il-genotyping sar fuq iżolati HIV-1 tal-plażma fuq ilpazjenti kollha li kien ikkonfermat li kellhom RNA tal-HIV ta' > 400 kopja/mL f'ġimgħat 48, 96 jew 144, jew fiż-żmien tat-twaqqif bikri tal-mediċina.
English: Limited pharmacokinetic data are available for emtricitabine and tenofovir after co-administration of separate preparations or as a fixed-dose combination in patients with renal impairment.
Maltese: Hemm dejta farmakokinetika limitata disponibbli għal emtricitabine u tenofovir wara l-għoti flimkien ta' preparazzjonijiet separati jew bħala kombinazzjoni b'doża fissa f'pazjenti b'indeboliment renali.
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: The apparent clearance of tenofovir averaged approximately 307 mL/min.
Maltese: It-tneħħija apparenti ta' tenofovir kellha medja ta' madwar 307 mL/min.
English: Relative Risk Reduction (95% CI)b a P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Maltese: Tnaqqis fir-Riskju Relattiv (95% CI)b a Valuri P skont il-logrank test.
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 bl-irkupru komplet tad-doża fl-awrina (madwar 86%) u fl-ippurgar (madwar 14%).
English: hepatic steatosis, hepatitis
Maltese: stejatożi epatika, epatite
English: • diarrhoea, being sick (vomiting), feeling sick (nausea)
Maltese: • dijarea, tibda tirremetti (rimettar), tħossok imdardar (nawseja)
English: Patients receiving ledipasvir/sofosbuvir sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir concomitantly with tenofovir disoproxil and a boosted HIV protease inhibitor should be monitored for adverse reactions related to tenofovir disoproxil.
Maltese: Pazjenti li jingħataw ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir flimkien ma' tenofovir disoproxil u impeditur tal-protease tal-HIV msaħħaħ għandhom ikunu mmonitorjati għal reazzjonijiet avversi relatati ma' tenofovir disoproxil.
English: The 48-week primary endpoint data showed that the combination of emtricitabine, tenofovir disoproxil and efavirenz provided superior antiviral efficacy as compared with the fixed combination of lamivudine and zidovudine with efavirenz as shown in Table 4.
Maltese: Informazzjoni dwar ir-riżultat aħħari primarju wara 48 ġimgħa wera li l-kumbinazzjoni ta' emtricitabine, tenofovir disoproxil u efavirenz, ipprovdiet effikaċja antivirali superjuri meta mqabbla mal-kumbinazzjoni fissa ta' lamivudine u zidovudine flimkien ma' efavirenz kif muri f'Tabella 4.
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 4.4).
Maltese: Emtricitabine/tenofovir disoproxil m'għandhux 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: Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets emtricitabine/tenofovir disoproxil
Maltese: Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg pilloli miksija b'rita emtricitabine/tenofovir disoproxil
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'ċertu pazjenti b'infezzjoni tal-HIV avvanzata (AIDS) u storja ta' infezzjonijiet opportunistiċi (infezzjonijiet li jseħħu f'persuni b'sistema immunitarja dgħajfa), sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet preċedenti jistgħu jseħħu immedjatament wara li jinbeda trattament kontra l-HIV.
English: In subjects with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 (19%) µg•h/mL of emtricitabine, and over 48 hours to 42,857 (29%) ng•h/mL of tenofovir.
Maltese: F'individwi b'mard renali fl-aħħar stadju (ESRD) li jeħtieġu d-dijaliżi tad-demm, bejn dijaliżi u oħra, l-esponimenti tal-mediċina tad-dijaliżi, żdiedu sostanzjalment fi żmien 72 siegħa għal 53 (19%) µg•h/mL ta' emtricitabine, u matul 48 siegħa għal 42,857 (29%) ng•h/mL ta' tenofovir.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil meta użat ma' sofosbuvir/velpatasvir/voxilaprevir u potenzjatur farmakokinetiku (eż. ritonavir jew cobicistat) għadha ma ġietx stabbilita.
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 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 f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.2 u 5.2).
English: However, it was negative in an in vivo mouse bone marrow micronucleus assay.
Maltese: Madankollu kienu negattivi f'analiżi in vivo mikronuklejari tal-mudullun tal-ġurdien.
English: Sofosbuvir/Velpatasvir (400 mg/100 mg q.d.)
Maltese: Sofosbuvir/Velpatasvir (400 mg/100 mg q.d.) + Raltegravir (400 mg b.i.d) +
English: Seroconversions / Nb a ‘Case' = HIV seroconverter; ‘Cohort' = 100 randomly selected subjects from each of the tenofovir disoproxil 245 mg and emtricitabine/tenofovir disoproxil groups.
Maltese: Grupp = 100 individwu magħżulin b'mod każwali minn kull wieħed mill-gruppi ta' tenofovir disoproxil 245 mg u emtricitabine/tenofovir disoproxil.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil maleate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA 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: Treatment of HIV-1 infection
Maltese: Trattament tal-infezzjoni tal-HIV-1
English: Emtricitabine/tenofovir disoproxil has not been studied in patients over 65 years of age.
Maltese: Emtricitabine/tenofovir disoproxil ma ġiex studjat f'individwi li jkollhom iktar minn 65 sena.
English: Furthermore, in a small clinical study, a subgroup of patients with creatinine clearance between 50 and 60 mL/min who received tenofovir disoproxil in combination with emtricitabine every 24 hours had a 2-4-fold higher exposure to tenofovir and worsening of renal function (see section 5.2).
Maltese: Barra dan, fi studju kliniku żgħir, sottogrupp ta' pazjenti bi tneħħija ta' kreatinina ta' bejn 50 u 60 mL/min li rċevew tenofovir disoproxil flimkien ma' emtricitabine kull 24 siegħa kellhom esponiment 2-4 darbiet ogħla għal tenofovir u aggravament tal-funzjoni tal-kliewi (ara sezzjoni 5.2).
English: • Just taking this Emtricitabine/Tenofovir disoproxil Mylan may not stop you getting HIV.
Maltese: • Li sempliċement tieħu Emtricitabine/Tenofovir disoproxil Mylan jista' ma jwaqqfekx milli tieħu l-HIV.
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available (mechanism)
Maltese: Effetti fuq il-livelli talmediċina Bidla perċentwali medja flAUC, Cmax, Cmin b'intervalli ta' kunfidenza ta' 90% jekk disponibbli (mekkaniżmu)
English: Only samples from subjects randomised to emtricitabine/tenofovir disoproxil were evaluated for detectable plasma or intracellular tenofovir disoproxil-DP levels.
Maltese: Huma biss il-kampjuni minn individwi randomised għal emtricitabine/tenofovir disoproxil li kienu evalwati għal livelli misjuba ta' tenofovir disoproxil-DP fil-plażma jew intraċellulari.
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 enrolment in the study.
Maltese: Fl-istudju kliniku iPrEx, l-ebda wieħed millvarjanti tal-HIV-1 li jesprimu K65R, K70E, M184V, jew M184I ma kienu skoperti fiż-żmien tasserokonverżjoni fost individwi li infettaw ruħhom bl-HIV-1 wara li rreġistraw fl-istudju.
English: See section 2 for a list of precautions to take against HIV infection.
Maltese: Ara sezzjoni 2 għal lista ta' prekawzjonijiet li trid tieħu kontra l-infezzjoni tal-HIV.
English: Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least35 kg: One tablet,
Maltese: Trattament tal-HIV fl-adulti u adolexxenti li għandhom 12-il sena u aktar, u li jiżnu tal-anqas 35 kg:
English: In 2 of 14 subjects who had acute HIV infection at study enrolment, the K65R mutation was detected in the HIV of 1 of 5 subjects in the tenofovir disoproxil 245 mg group and the M184V mutation (associated with resistance to emtricitabine) was detected in the HIV of 1 of 3 subjects in the emtricitabine/tenofovir disoproxil group.
Maltese: Fi 2 minn 14-il individwu li kellhom infezzjoni akuta tal-HIV meta rreġistraw mal-istudju, ilmutazzjoni K65R kienet skoperta fl-HIV ta' 1 minn 5 individwi fil-grupp ta' tenofovir disoproxil 245 mg ( u l-mutazzjoni M184V (assoċjata mar-reżistenza għal emtricitabine) kienet skoperta fl-HIV ta' 1 minn 3 suġġetti fil-grupp ta' emtricitabine/tenofovir disoproxil.
English: The pharmacokinetics of emtricitabine/tenofovir disoproxil have not been studied in subjects with hepatic impairment.
Maltese: Il-farmakokinetiċi ta' emtricitabine/tenofovir disoproxil ma ġewx studjati f'individwi b'indeboliment epatiku.
English: • If you take Emtricitabine/Tenofovir disoproxil Mylan for the treatment of HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Maltese: • Jekk tieħu Emtricitabine/Tenofovir disoproxil Mylan għat-trattament ta' infezzjoni talHIV, li tieqaf tieħu l-pilloli jista' jnaqqas l-effettività tat-terapija kontra l-HIV rakkomandata mit-tabib tiegħek.
English: Assessment of adverse reactions related to emtricitabine is based on experience in three paediatric studies (n = 169) where treatment-naïve (n = 123) and treatment-experienced (n = 46) paediatric HIV infected patients aged 4 months to 18 years were treated with emtricitabine in combination with other antiretroviral agents.
Maltese: Evalwazzjoni tar-reazzjonijiet avversi marbuta ma' emtricitabine hija bbażata fuq l-esperjenza miksuba minn tliet studji pedjatriċi (n = 169) fejn pazjenti pedjatriċi infettati bl-HIV li qatt ma kienu ħadu kura qabel (n = 123) u dawk b'esperjenza bil-kura bejn l-etajiet ta' 4 xhur sa 18-il sena kienu ttrattati b'emtricitabine flimkien ma' sustanzi antriretrovirali oħra.
English: Seroconversions / N Relative Risk Reduction (95% CI)b
Maltese: Tnaqqis fir-Riskju Relattiv (95% C
English: One tenofovir disoproxil treated subject and no stavudine or zidovudine treated subjects experienced significant (> 4%) lumbar spine BMD loss at week 48.
Maltese: Individwu wieħed ittrattat b'tenofovir disoproxil u l-ebda individwu ttrattat bi stavudine jew zidovudine ma esperjenza telf tal-BMD sinifikanti (> 4%) fl-ispina lumbari f'ġimgħa 48.
English: Study Drug Quantification
Maltese: ANALĠEŻIĊI NARKOTIĊI
English: A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations.
Maltese: Tnaqqis fid-doża ta' 250 mg didanosine mogħti flimkien ma' terapija b'tenofovir disoproxil kien assoċjat ma' rapporti ta' rati għoljin ta' falliment viroloġiku f'diversi kombinazzjonijiet ittestjat.
English: Pharmacokinetic studies have not been performed with emtricitabine or tenofovir (administered as tenofovir disoproxil) in the elderly (over 65 years of age).
Maltese: Studji farmakokinetiċi ma sarux b'emtricitabine jew tenofovir (mogħti bħala tenofovir disoproxil) fuq l-anzjani (età 'l fuq minn 65 sena).
English: How to store Emtricitabine/Tenofovir disoproxil Mylan 6.
Maltese: Kif taħżen Emtricitabine/Tenofovir disoproxil Mylan 6.
English: HIV-1
Maltese: Infezzjoni tal-HIV-1:
English: The most frequent adverse reaction reported in the emtricitabine/tenofovir disoproxil group in the iPrEx study was headache (1%).
Maltese: Ir-reazzjoni avversa l-aktar frekwenti rrappurtata fil-grupp ta' emtricitabine/tenofovir disoproxil fl-istudju iPrEx kienet uġigħ ta' ras (1%).
English: Emtricitabine/tenofovir disoproxil has not been studied in HIV-1 uninfected individuals with creatinine clearance < 60 mL/min and is therefore not recommended for use in this population.
Maltese: Emtricitabine/tenofovir disoproxil ma ġiex studjat f'individwi mhux infettati bl-HIV-1 bi tneħħija talkreatinina ta' < 60 mL/min u għalhekk mhux rakkomandat għall-użu f'din il-popolazzjoni.
English: Cohort
Maltese: Lott
English: Immune Reactivation Syndrome: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: Sindromu tar-Riattivazzjoni Immuni: F'pazjenti infettati bl-HIV b'defiċjenza immuni severa fiż-żmien tal-bidu ta' CART, tista' sseħħ reazzjoni infjammatorja għal infezzjonijiet opportunistiċi asintomatiċi jew residwali.
English: NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets emtricitabine/tenofovir disoproxil
Maltese: Emtricitabine/Tenofovir disproxil Mylan 200 mg/245 mg pilloli miksija b'rita emtricitabine/tenofovir disproxil
English: Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected subjects with varying degrees of renal impairment.
Maltese: Ilparametri farmakokinetiċi kienu deċiżi primarjament wara l-għoti ta' dożi waħedhom ta' 200 mg emtricitabine jew 245 mg tenofovir disoproxil lil individwi mhux infettati b'HIV b'livelli differenti ta' indeboliment renali.
English: FTC/tenofovir disoproxil Groupa
Maltese: Grupp tal-FTC/tenofovir disoproxila
English: Also contains: lactose monohydrate.
Maltese: Fih ukoll: lactose monohydrate.
English: HIV-1 infected patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti infettati bl-HIV-1 li għandhom epatite B jew Ċ kronika ttrattati b'terapija antiretrovirali huma f'riskju miżjud għal reazzjonijiet avversi tal-fwied severi u potenzjalment fatali.
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, emtricitabine/tenofovir disoproxil renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk il-phosphate fis-serum huwa < 1.5 mg/dL (0.48 mmol/L) jew it-tneħħija tal-kreatinina tonqos għal < 50 mL/min fi kwalunkwe pazjent li jingħata emtricitabine/tenofovir disoproxil, il-funzjoni talkliewi għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl tal-konċentrazzjonijiet talglukożju fid-demm, il-potassium fid-demm u l-glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: Table 1: Dosing recommendations in adults with renal impairment
Maltese: Tabella 1: Dożi rakkomandati f'individwi b'indeboliment tal-kliewi
English: Hepatitis B virus (HBV) antiviral agents
Maltese: Pazjenti infettati kemm bl-HIV/HBV jew bl-HCV:
English: The increased dose interval for emtricitabine/tenofovir disoproxil in HIV-1 infected patients with moderate renal impairment is expected to result in higher peak plasma concentrations and lower Cmin levels as compared to patients with normal renal function.
Maltese: Iż-żieda fl-intervall tad-dożaġġ ta' emtricitabine/tenofovir disoproxil f'pazjenti infettati bl-HIV-1 b'indeboliment renali moderata huma mistennija li tirriżulta f'livelli ogħla tal-konċentrazzjonijiet massimi fil-plażma u livelli aktar baxxi ta' Cmin meta mqabbla ma' pazjenti b'funzjoni renali normali.
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day, whenever possible with food.
Maltese: • Adolexxenti minn età ta' 12-il sena sa inqas minn18-il sena u li jiżnu tal-inqas 35 kg: pillola waħda kuljum, kull meta possibbli mal-ikel.
English: While taking Emtricitabine/Tenofovir disoproxil Mylan to reduce the risk of getting HIV:
Maltese: Qabel tieħu Emtricitabine/Tenofovir disoproxil Mylan biex tnaqqas ir-riskju li tieħu l-HIV:
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 60 mL/min in any individual receiving emtricitabine/tenofovir disoproxil for pre-exposure prophylaxis, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk ilphosphate fis-serum huwa < 1.5 mg/dL (0.48 mmol/L) jew it-tneħħija tal-kreatinina tonqos għal < 60 mL/min fi kwalunkwe individwu li jirċievi emtricitabine/tenofovir disoproxil għal profilassi ta' qabel l-esponiment, il-funzjoni tal-kliewi għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, inkluż ilkejl tal-konċentrazzjonijiet tal-glukożju fid-demm, il-potassium fid-demm u l-konċentrazzjoni ta' glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 mL/min/1.73 m2.
Maltese: Seba' pazjenti kellhom valuri stmati tar-rata ta' filtrazzjoni glomerulari (GFR - glomerular filtration rate) ta' bejn 70 u 90 mL/min/1.73 m2. Fost dawn, 3 pazjenti esperjenzaw tnaqqis klinikament sinifikanti fil-GFR stmat waqt it-terapija li tjieb wara li tenofovir disoproxil twaqqaf.
English: Patients with hepatitis B or C virus infection
Maltese: Pazjenti b'infezzjoni tal-virus tal-epatite B jew Ċ
English: Tablet core
Maltese: Analiżi mITT
English: Protease inhibitors Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d.
Maltese: Impedituri tal-protease Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: Van Elteren Test
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Pre-exposure prophylaxis
Maltese: TAL-PRODOTT MEDIĊINALI
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: Emtricitabine/Tenofovir Mylan to Reduce the Risk of getting Human Immunodeficiency Virus
Maltese: Emtricitabine/Tenofovir Mylan biex inaqqas ir-riskju li jieħu infezzjoni tal-HIV
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and -0.165 in lumbar spine BMD Z-score, and -0.254 and -0.179 in total body BMD Z-score for the tenofovir disoproxil and placebo groups, respectively.
Maltese: 215 u -0.165 fil-punteġġ Z tal-BMD tal-ispina lumbari, u -0.254 u -0.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 talawtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Treatment of HIV-1 infection in the paediatric population There are no clinical studies conducted with emtricitabine/tenofovir disoproxil in the paediatric population with HIV-1 infection.
Maltese: Ma sarux studji kliniċi b'emtricitabine/tenofovir disoproxil fil-popolazzjoni pedjatrika b'infezzjoni blHIV-1.
English: In HIV 1 infected children (aged 2 to 15 years), the BMD Z scores observed in subjects who switched to tenofovir disoproxil were lower than those observed in subjects who remained on their stavudine- or zidovudine-containing regimen (see sections 4.4 and 5.1).
Maltese: Fi tfal infettati b'HIV-1 (bejn l-etajiet ta' sentejn sa 15-il sena), il-punteġġi Z tal-BMD osservati f'individwi li qalbu għal tenofovir disoproxil kien inqas minn dawk osservati f'individwi li baqgħu fil-kors tal-kura tagħhom bi stavudine jew zidovudine (ara sezzjonijiet 4.4 u 5.1).
English: Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Maltese: Il-funzjoni renali għandha tkun immonitorjata millqrib (ara sezzjoni 4.4).
English: Interaction with didanosine: Co-administration of tenofovir disoproxil and didanosine is not recommended as 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 tenofovir disoproxil flimkien ma' didanosine mhuwiex rakkomandat għax jista' jirriżulta f'żieda ta' 40-60% fl-esponiment sistemiku għal didanosine li jista' jżid ir-riskju għal reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: In study GS US 104 0352, 97 treatment-experienced patients 2 to < 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
Maltese: Fl-istudju GS US 104 0352, 97 pazjent b'esperjenza bil-kura bejn l-etajiet ta' sentejn sa < 12-il sena bi trażżin viroloġiku stabbli fuq korsijiet ta' kura li fihom stavudine jew zidovudine ġew magħżula b'mod każwali biex jissostitwixxu stavudine jew zidovudine ma' tenofovir disoproxil (n = 48) jew jibqgħu fuq il-kors ta' kura oriġinali tagħhom (n = 49) għal 48 ġimgħa.
English: As a general rule, it is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV to the infant.
Maltese: Bħala regola ġenerali, huwa rakkomandat li nisa infettati bl-HIV ma jreddgħux lit-trabi tagħhom taħt lebda ċirkustanza sabiex jevitaw li jgħaddu HIV lit-tarbija.
English: • Although there are limited clinical data on the use of emtricitabine/Tenofovir disoproxil in pregnant women, it is not usually used unless absolutely necessary.
Maltese: • Għalkemm hemm dejta klinika limitata dwar l-użu ta' emtricitabine/tenofovir disoproxil f'nisa tqal, dan normalment ma jintużax jekk mhux assolutament meħtieġ.