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: 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: L-użu f'individwi mhux infettati bl-HIV-1 b'CrCl < 60 mL/min mhux rakkomandat minħabba li ma ġiex studjat f'din il-popolazzjoni (ara sezzjonijiet 4.4 u 5.2).
English: • non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Maltese: • cidofovir (għal infezzjoni virali) • mediċini anti-infjammatorji mhux sterojdi (NSAIDs, għas-serħan mill-uġigħ fl-għadam jew fil-muskoli)
English: In patients who received treatment with tenofovir disoproxil, or stavudine or zidovudine, mean lumbar spine BMD Z-score was -1.034 and -0.498, and mean total body BMD Z-score was -0.471 and -0.386, respectively, at baseline.
Maltese: u -0.498, u l-punteġġ Z medju tal-BMD tal-ġisem kollu kien -0.471 u -0.386, rispettivament fil-linja bażi.
English: Animal studies on emtricitabine and tenofovir disoproxil do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali dwar emtricitabine u tenofovir disoproxil ma urewx effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Truvada 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: Truvada 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: The adverse reactions considered at least possibly related to treatment with the components of Truvada 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' Truvada, 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: Seroconversions / Na Incidence per 100 person-years (95% CI)
Maltese: Inċidenza kull 100 snin ta' persuna (95% CI)
English: The mean changes in CD4 cell count from baseline were +185 cells/mm3 and +196 cells/mm3, respectively.
Maltese: +196 ċelluli/mm3, rispettivament.
English: AUC: ↑ 39% Cmax: ↑ 48%
Maltese: ↑ 39% Cmax: ↑ 48% Cmin: ↑ 47%
English: Renal and bone effects in adults
Maltese: PrEP f'adulti u adolexxenti
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and0.165 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: Package leaflet: Information for the user Truvada 200 mg/245 mg film-coated tablets
Maltese: Informazzjoni għall-utent Truvada 200 mg/245 mg pilloli miksija b'rita
English: Treatment of HIV-1 infection in the paediatric population There are no clinical studies conducted with Truvada in the paediatric population with HIV-1 infection.
Maltese: Profilassi ta' qabel l-esponiment Fi studji kliniċi ta' individwi mhux infettati bl-HIV-1, kien osservat tnaqqis żgħir fil-BMD.
English: Limited pharmacokinetic data are available for emtricitabine and tenofovir after co-administration of separate preparations or as Truvada in patients with renal impairment.
Maltese: Hemm dejta farmakokinetika limitata disponibbli għal emtricitabine u tenofovir wara l-għoti flimkien ta' preparazzjonijiet separati jew bħala Truvada f'pazjenti b'indeboliment renali.
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: 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: Film-coated tablet.
Maltese: rispettivament fil-linja bażi.
English: In 2 of 14 subjects who had acute HIV infection at study enrollment, 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 Truvada group.
Maltese: Fi 2 minn 14-il individwu li kellhom infezzjoni akuta tal-HIV meta rreġistraw mal-istudju, il mutazzjoni 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' Truvada.
English: )3 + Darunavir (800 mg q.d.)
Maltese: 100 mg+100 mg q.d.)3 + Darunavir
English: • Truvada 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, when taken daily,
Maltese: • Truvada 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: 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-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali. 4.5
English: There are uncertainties associated with the long-term renal and bone effects of tenofovir disoproxil during the treatment of HIV-1 infection in the paediatric population.
Maltese: Hemm inċertezzi marbuta mal-effetti fit-tul fuq il-kliewi u l-għadam ta' tenofovir disoproxil matul ittrattament tal-infezzjoni bl-HIV-1 fil-popolazzjoni pedjatrika.
English: • Know your hepatitis B virus (HBV) infection status before starting Truvada.
Maltese: • Kun af l-istat tal-infezzjoni tal-virus tal-epatite B (HBV) tiegħek qabel tibda tieħu Truvada.
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 Truvada, 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 Truvada, il-funzjoni tal-kliewi għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl tal-konċentrazzjonijiet tal-glukożju fid-demm, ilpotassium fid-demm u l-glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
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 Truvada 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 il-phosphate 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 Truvada għal profilassi ta' qabel l-esponiment, il-funzjoni tal-kliewi għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl tal-konċentrazzjonijiet tal-glukożju fid-demm, ilpotassium fid-demm u l-glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: The rate of HIV-1 seroconversion in males was 0.24/100 person-years of Truvada exposure and the rate of HIV-1 seroconversion in females was 0.95/100 person-years of Truvada exposure.
Maltese: HIV-1 fin-nisa kienet 0.95/100 sena ta' persuna tal-esponiment ta' Truvada.
English: The increased dose interval for Truvada 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' Truvada 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: The recommended dose of Truvada to treat HIV is:
Maltese: Id-doża rakkomandata ta' Truvada biex tittratta l-HIV hija:
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: ghandhom riskju akbar li jkollhom irkupru mhux komplet tal-funzjoni renali minkejja t- twaqqif ta' tenofovir disoproxil (ara sezzjoni 4.4).
English: While taking Truvada to reduce the risk of getting HIV:
Maltese: Id-doża rakkomandata ta' Truvada sabiex jitnaqqas ir-riskju li wieħed jieħu HIV hija:
English: Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of Truvada.
Maltese: Preparazzjonijiet separati ta' emtricitabine u tenofovir disoproxil huma disponibbli għat-trattament talinfezzjoni tal-HIV-1 jekk ikun meħtieġ li titwaqqaf jew tiġi modifikata d-doża ta' wieħed millkomponenti ta' Truvada.
English: Consideration should be given to interrupting use of Truvada 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: < 60 mL/min jew bi tnaqqis fil-phosphate fis-serum għal < 1.0 mg/dL (0.
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 ta' 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: Truvada can only help reduce your risk of getting HIV before you are infected.
Maltese: Truvada jista' jgħin biss inaqqas ir-riskju tiegħek li tieħu l-HIV qabel tiġi infettat.
English: Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations < 400 or < 50 copies/mL, and change from baseline in CD4 cell count.
Maltese: Lanaliżi ta' l-effikaċja sekondarja fuq perjodu ta' 144 ġimgħa kienet tinkludi l-proporzjon ta' pazjenti b'konċentrazzjonijiet tal-RNA tal-HIV-1 ta' < 400 jew < 50 kopja/mL, u l-bidla mil-linja bażi fl għadd taċ-ċelluli tas-CD4.
English: • muscle weakness
Maltese: Mediċina Misjuba
English: Herpes virus antiviral agents Famciclovir/Emtricitabine
Maltese: Aġenti antivirali għall-virus tal-herpes
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Truvada 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 Truvada 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: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Truvada use.
Maltese: Jekk anormalitajiet renali huma suspettati jew osservati, allura konsultazzjoni ma' nefroloġista għandha tiġi kkunsidrata għall-waqfien tal-użu ta' Truvada.
English: At week 48, 83% of patients in the tenofovir disoproxil treatment group and 92% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/mL.
Maltese: Fil-ġimgħa 48, 83% tal pazjenti fil-grupp ta' trattament ta' tenofovir disoproxil u 92% tal-pazjenti fil-grupp ta' trattament ta'
English: Recommendation concerning co-administration with Truvada (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Maltese: Rakkomandazzjoni dwar lgħoti flimkien ma' Truvada (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
English: Truvada is not always effective in preventing the acquisition of HIV-1.
Maltese: Truvada mhux dejjem huwa effettiv fil-prevenzjoni tat-teħid tal-HIV-1.
English: • PrEP educational brochure for the individual at risk entitled ‘Important Information About
Maltese: • Opuskolu edukattiv dwar PrEP għall-individwu f'riskju bit-titolu‘Tagħrif Importanti Dwar
English: The primary efficacy endpoint for this study was the achievement and maintenance of confirmed HIV-1 RNA concentrations < 400 copies/mL over 48 weeks.
Maltese: stavudine jew zidovudine kellhom konċentrazzjonijiet ta' HIV-1 RNA ta' < 400 kopja/mL.
English: Only samples from subjects randomized to Truvada were evaluated for detectable plasma or intracellular tenofovir disoproxil-DP levels.
Maltese: Huma biss il-kampjuni minn individwi magħżula b'mod każwali għal Truvada li kienu evalwati għal livelli misjuba ta' tenofovir disoproxil-DP fil-plażma jew intraċellulari.
English: The mean rate of BMD gain was less in the tenofovir disoproxil group compared to the placebo group.
Maltese: BMD kienet inqas fil-grupp ta' tenofovir disoproxil meta mqabbla mal-grupp tal-plaċebo.
English: Do not take Truvada if you are already taking other medicines that contain the components of Truvada (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Maltese: Tiħux Truvada jekk diġà qed tieħu mediċini oħra li fihom il-komponenti ta' Truvada (emtricitabine u tenofovir disoproxil) jew kwalunkwe mediċina antivirali oħra li fihom tenofovir alafenamide,
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: Il-valuri P għal URAI jirreferu għall-ipotesi negattiva li l-effikaċja varjat bejn l-istrati tassottogruppi (URAI, l-ebda URAI).
English: At 48 weeks, 70% and 64% of patients demonstrated HIV-1 RNA < 50 copies/mL with the once and twice daily regimens of lopinavir/ritonavir, respectively.
Maltese: RNA ta' l-HIV-1 < 50 kopja/mL bil-korsijiet fejn ingħataw lopinavir/ritonavir darba u darbtejn kuljum rispettivament.
English: The safety and efficacy of Truvada in children under the age of 12 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Truvada fit-tfal taħt l-età ta' 12-il sena ma ġewx determinati s'issa.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: tenofovir disoproxil, sofosbuvir/velpatasvir/voxilapre vir u darunavir/ritonavir tista' żżid ir-reazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Cohort
Maltese: LOTT
English: Do not take Truvada to reduce your risk unless you are confirmed to be HIV negative.
Maltese: Tiħux Truvada biex tnaqqas ir-riskju tiegħek sakemm ma jkunx ikkonfermat li inti negattiv għall-HIV.
English: Hispanic/Latino Ethnicity, N (%) Sexual Risk Factors at Screening Number of Partners Previous 12 Weeks, Mean (SD) URAI Previous 12 Weeks, N (%)
Maltese: Etniċità Ispanika/Latina, N (%) Fatturi ta' Riskju Sesswali fl-Iskrinjar Numru ta' Sieħba fit-12-il Ġimgħa ta' Qabel, Medja (SD) URAI fit-12-il Ġimgħa ta' Qabel, N (%) URAI ma' Sieħeb bl-HIV+ (jew stat mhux magħruf) fis-6 Xhur ta' Qabel, N (%)
English: Truvada should only be used in individuals with creatinine clearance (CrCl) < 80 mL/min if the potential benefits are considered to outweigh the potential risks.
Maltese: < 80 mL/min jekk il-benefiċċji potenzjali jkunu kkunsidrati li jiżbqu r-riskji potenzjali.
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 mill-qrib (ara sezzjoni 4.4).
English: Treatment of HIV-1 infection Pre-exposure prophylaxis
Maltese: Trattament tal-infezzjoni bl-HIV-1 fil-popolazzjoni pedjatrika
English: • Truvada is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults • It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least
Maltese: • Truvada jintuża għat-trattament tal-infezzjoni tal-Virus tal-Immunodefiċjenza Umana 1 (HIV-1), f'adulti
English: Patients infected with HBV who discontinue Truvada should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Maltese: Pazjenti infettati bl-HBV li jwaqqfu Truvada għandhom jiġu mmonitorjati mill-qrib b'segwitu kemm kliniku kif ukoll tal-laboratorju mill-inqas għal diversi xhur wara li jitwaqqaf it-trattament.
English: o Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
Maltese: o Għandek tiġi ttestjat għal infezzjonijiet oħra trasmessi sesswalment bħal sifilide u gonorrea.
English: FTC/tenofovir disoproxil Groupa Tenofovir disoproxil Groupa
Maltese: Grupp tal-FTC/tenofovir disoproxila
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: emtricitabine, u matul 48 siegħa għal 42,857 (29%) ng•h/mL ta' tenofovir.
English: However, in some HIV-1 infected patients, declines in creatinine clearance did not completely resolve despite tenofovir disoproxil discontinuation.
Maltese: Madankollu, f'xi pazjenti infettati bl-HIV-1, tnaqqis fit tneħħija tal-kreatinina m'għaddietx kompletament minkejja t-twaqqif ta' tenofovir disoproxil.
English: Pre-exposure prophylaxis (PrEP):
Maltese: Profilassi ta' qabel l-esponiment:
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: tenofovir disoproxil, sofosbuvir/velpatasvir u atazanavir/ritonavir tista' żżid ir-reazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: tenofovir disoproxil, sofosbuvir/velpatasvir u darunavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: If serum phosphate is confirmed to be < 3.0 mg/dL (0.96 mmol/L) in any paediatric patient receiving Truvada, 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-fosfat fis-serum jiġi kkonfermat li hu < 3.0 mg/dL (0.96 mmol/L) fi kwalunkwe pazjent pedjatriku li jkun qed jirċievi Truveda, il-funzjoni renali għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, b'kejl li jinkludi l-glukożju fid-demm, potassju fid-demm u konċentrazzjonijiet tal-glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: tenofovir disoproxil, ledipasvir/sofosbivir u atazanavir/ritonavir tista' żżid ir-reazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Adefovir dipivoxil and Truvada should not be administered concomitantly (see section 4.4).
Maltese: Adefovir dipivoxil u Truvada ma għandhomx jingħataw flistess ħin (ara sezzjoni 4.4).
English: Cmin: ↑ 47%
Maltese: AUC: ↑ 143%
English: What you need to know before you take Truvada Do not take Truvada to treat HIV or to reduce the risk of getting HIV if you are allergic to emtricitabine, tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).
Maltese: HIV jew biex tnaqqas ir-riskju li tieħu HIV jekk inti allerġiku għal emtricitabine, tenofovir, tenofovir disoproxil, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Male
Maltese: JIS
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: tenofovir disoproxil, sofosbuvir/velpatasvir u lopinavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Cmin: NC Emtricitabine:
Maltese: Kodiċi ATC:
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
English: • Mycobacerium tuberculosis test.
Maltese: • Test ta' Mycobacerium tuberculosis.
English: Rare: transpiration.
Maltese: Rari: transpirazzjoni.
English: Osteomyelitis:
Maltese: Osteomjelite:
English: Musculoskeletal system:
Maltese: Is-sistema muskolo-skeletrika:
English: Gram-negative aerobes
Maltese: Aerobi Gram-negattivi
English: Fax: +351 219 615 102 e-mail: geral@hikma.pt
Maltese: +351 219 615 102 e-mail: geral@hikma.pt
English: Fax: +351 219 615 102 geral@hikma.pt
Maltese: +351 219 615 102 geral@hikma.pt
English: ESBL: Extended Spectrum Beta-lactamases MRSA: Methicillin-resistant Staphylococcus aureus
Maltese: Extended Spectrum Beta-lactamases MRSA: Methicillin-resistant Staphylococcus aureus
English: Common: rash.
Maltese: Komuni: raxx.