FrancophonIA/ELRC3.0 huggingface dataset:
English: Emtricitabine/Tenofovir disoproxil Krka should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Maltese: Emtricitabine/Tenofovir disoproxil Krka għandu jiġi evitat f'pazjenti li ngħataw antiretrovirali filpassat li għandhom l-HIV-1 bil-mutazzjoni K65R (ara sezzjoni 5.1).
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
Maltese: It-twaħħil in vitro ta' emtricitabine ma' proteini tal-plażma umana kienet ta' < 4% u indipendenti mill-konċentrazzjoni fil-medda ta' 0.
English: interleukin-2 (to treat cancer) cidofovir (for viral infection) non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Maltese: - vancomycin (għal infezzjoni batterjali) - interleukin-2 (għat-trattament tal-kanċer) - cidofovir (għal infezzjoni virali) - mediċini anti-infjammatorji mhux sterojdi (NSAIDs, għas-serħan mill-uġigħ fl-għadam jew fil muskoli)
English: Both emtricitabine and tenofovir have activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus.
Maltese: Kemm emtricitabine kif ukoll tenofovir għandhom attività li hi speċifika għall-virus ta' limmunodefiċjenza uman (HIV-1 u HIV-2) u l-virus ta' l-epatite B.
English: Immune system disorders: Common:
Maltese: Disturbi fis-sistema immuni: Komuni:
English: - The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil /efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine+tenofovir disoproxil group to the lamivudine/zidovudine group among all patients).
Maltese: emtricitabine/tenofovir disoproxil/efavirenz u f'10/29 (34.5%) iżolati analizzati fil-grupp ta' lamivudine/zidovudine/efavirenz (valur p ta' < 0.05, it-Test Exact ta' Fisher li qabbel il-grupp ta'emtricitabine+tenofovir disoproxil mal- grupp ta' lamivudine/zidovudine fost il-pazjenti kollha).
English: Get tested for HIV regularly.
Maltese: Għandek tiġi ttestjat għall-HIV regolarment.
English: IMMUNOSUPPRESSANTS Tacrolimus/Tenofovir disoproxil /Emtricitabine
Maltese: Tacrolimus/Tenofovir disoproxil/Emtricitabine
English: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg and in 23 HIV1 infected children aged 2 to < 12 years.
Maltese: Il-farmakokinetika fl-istat fiss ta' tenofovir kienet evalwata fi 8 pazjenti adolexxenti infettati bl-HIV-1 (età minn 12 sa < 18 sena) b'piż tal-ġisem ta' ≥ 35 kg u fi 23 tifel u tifla infettati blHIV-1 li kellhom minn sentejn sa < 12 sena.
English: In study GS-US-104-0321, 87 HIV 1 infected treatment-experienced patients 12 to < 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Maltese: Fl-istudju GS-US-104-0321, 87 pazjent infettat b'HIV-1 b'esperjenza fil-kura, ta' bejn 12 sa 18-il sena, kienu ttrattati b'tenofovir disoproxil (n = 45) jew plaċebo (n = 42) flimkien ma' kors ta' kura ottimizzata fl-isfond (OBR - optimised background regimen) għal 48 ġimgħa.
English: Assessment of adverse reactions related to tenofovir disoproxil is based on two randomised trials (studies GS-US-104-0321 and GS-US-104-0352) in 184 HIV 1 infected paediatric patients (aged 2 to < 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Maltese: L-evalwazzjoni ta' reazzjonijiet avversi marbuta ma' tenofovir disoproxil hija bbażata fuq żewġ provi randomised (studji GS-US-104-0321 u GS-US-104-0352) f'184 pazjent pedjatriku infettat bl-HIV-1 (bejn l-etajiet ta' sentejn sa < 18-il sena) li rċevew trattament b'tenofovir disproxil (n = 93) jew plaċebo/komparatur attiv (n = 91) flimkien ma' sustanzi antiretrovirali oħra għal 48 ġimgħa (ara sezzjoni 5.1).
English: Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV 1 infected paediatric patients aged 2 to < 12 years in clinical study GS-US-104-0352 (see sections 4.8 and 5.1).
Maltese: Reazzjonijiet avversi fuq il-kliewi konsistenti ma' tubulopatija renali prossimali ġew irrappurtati f'pazjenti pedjatriċi infettati bl-HIV-1 bejn l-etajiet ta' sentejn sa < 12-il sena fl-istudju kliniku GS-US-104-0352 (ara sezzjonijiet 4.8 u 5
English: Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Maltese: Studju mwettaq b'voxilaprevir 100 mg addizzjonali sabiex jinkisbu l-esponimenti għal voxilaprevir mistennija f'pazjenti infettati b'HCV.
English: Pre-exposure prophylaxis: No new adverse reactions to emtricitabine/tenofovir disoproxil were identified from two randomised placebo-controlled studies (iPrEx, Partners PrEP) in which 2,830 HIV-1 uninfected adults received emtricitabine/tenofovir disoproxil once daily for pre-exposure prophylaxis.
Maltese: L ebda reazzjoni avversa ġdida għal emtricitabine/tenofovir disoproxil ma kienet identifikata minn żewġ studji każwali, bi plaċebo bħala kontroll (iPrEx, Partners PrEP) li fihom 2,830 adult mhux infettat bl-HIV 1 ingħataw emtricitabine/tenofovir disoproxil darba kuljum għal profilassi ta' qabel l-esponiment.
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% filġenbejn, 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: NARCOTIC ANALGESICS Methadone/Tenofovir disoproxil
Maltese: ANALĠEŻIĊI NARKOTIĊI Methadone/Tenofovir disoproxil
English: rhabdomyolysis 1, muscular weakness
Maltese: 1, dgħjufija fil-muskoli
English: In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/mL.
Maltese: Ir-rabta in vitro ta' tenofovir ma' proteini tal-plażma jew proteini fis-serum kienet anqas minn 0.7 u 7.2%, rispettivament, ogħla mill-medda tal-konċentrazzjoni ta' tenofovir 0.01 sa 25 μg/mL.
English: hypophosphataemia
Maltese: ipofosfatimja
English: AUC: ↑ 65% (↑ 59 to ↑ 71) Cmax: ↑ 61% (↑ 51 to ↑ 72) Cmin: ↑ 115% (↑ 105 to ↑ 126)
Maltese: AUC: ↑ 65% (↑ 59 sa ↑ 71) Cmax: ↑ 61% (↑ 51 sa ↑ 72) Cmin: ↑ 115% (↑ 105 sa ↑ 126)
English: renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)
Maltese: kollass tal-kliewi (akut u kroniku), nekrożi tubulari akuta, nefrite (li tinkludi nefrite interstizzjali akuta) dijabete insipidus nefroġenika
English: In addition to the adverse reactions reported in adults, anaemia (9.5%) and skin discolouration (31.8%) occurred more frequently in clinical trials in paediatric patients than in adults (see section 4.8, Tabulated summary of adverse reactions).
Maltese: Minbarra r-reazzjonijiet avversi rrappurtati fl-adulti, anemija (9.5%) u telf ta' kulur tal-ġilda (31.8%) ġew osservati fi frekwenza aktar komuni fil-provi kliniċi f'pazjenti pedjatriċi milli f'adulti (ara sezzjoni 4.8, Sommarju tabulat ta' reazzjonijiet avversi).
English: anaemia
Maltese: anemija
English: ORAL CONTRACEPTIVES Norgestimate/Ethinyl oestradiol/Tenofovir disoproxil
Maltese: Norgestimate/Ethinyl oestradiol/ Tenofovir disoproxil
English: Relative risk reduction calculated for mITT cohort based on incident (post-baseline) seroconversion.
Maltese: Tnaqqis fir-riskju relattiv ikkalkulat għal koorti tal-mITT ibbażat fuq serokonverżjoni inċidentali (wara l-linja bażi).
English: AUC: ↑ 142% (↑ 123 to ↑ 164) Cmax: ↑ 55% (↑ 41 to ↑ 71) Cmin: ↑ 301% (↑ 257 to ↑ 350)
Maltese: AUC: ↑ 142% (↑ 123 sa ↑ 164) Cmax: ↑ 55% (↑ 41 sa ↑ 71) Cmin: ↑ 301% (↑ 257 sa ↑ 350)
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 b' impedituri tal-protease, u b' impedituri tal-analogi tan-nukleosidi u mhux nukleosidi tar-reverse transcriptase ta' l-HIV.
English: Prophylaxis (PrEP) Indication' - PrEP Checklist for prescribers - PrEP educational brochure for the individual at risk entitled ‘Important Information
Maltese: Indikazzjoni ta' Profilassi ta' Qabel l-Esponiment (PrEP)' - Lista ta' Kontroll għall-PrEP għal dawk li jagħtu r-riċetti - Opuskolu edukattiv dwar PrEP għall-individwu f'riskju bit-titolu‘Tagħrif Importanti Dwar
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300.7 mg of tenofovir disoproxil succinate or 136 mg of tenofovir).
Maltese: Kull pillola fiha 200 mg ta' emtricitabine u 245 mg ta' tenofovir disoproxil (ekwivalenti għal 300.7 mg ta' tenofovir disoproxil succinate jew 136 mg ta' tenofovir).
English: Emtricitabine/Tenofovir disoproxil Krka film coated tablets are blue, oval, biconvex tablets, of dimensions 20 mm x 10 mm.
Maltese: Il-pillolia miksija b'rita ta' Emtricitabine/Tenofovir disoproxil Krka huma blu, ovali, mżaqqa fuq żewġ naħat, b'daqs ta' 20 mm x 10 mm.
English: Pharmacokinetic studies have not been performed with emtricitabine/tenofovir disoproxil in children and adolescents (under 18 years of age).
Maltese: Ma twettqux studji farmakokinetiċi b' emtricitabine/tenofovir disoproxil fit-tfal u adolexxenti (taħt letà ta' 18-il sena).
English: Emtricitabine/Tenofovir disoproxil Krka is available in carton boxes of 28 and 84 film-coated tablets in blisters.
Maltese: Emtricitabine/Tenofovir disoproxil Krka jiġi f'kaxex tal-kartun ta' 28 u 84 pillola miksija b'rita f'folji.
English: Severe renal impairment (CrCl < 30 mL/min) and haemodialysis patients
Maltese: Pazjenti b'indeboliment tal-kliewi sever (CrCl <30 mL/min) u fuq l-emodijaliżi
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Krka to treat HIV is:
Maltese: Id-doża rakkomandata ta' Emtricitabine/Tenofovir disoproxil Krka biex tittratta l-HIV hija:
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 lmutazzjonijiet 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: HIV-1 RNA < 50 copies/mL (TLOVR)
Maltese: RNA tal-HIV-1 < 50 kopja/mL (TLOVR) Valur p % differenza (95%CI)
English: Emtricitabine/Tenofovir disoproxil Krka is indicated in combination with safer sex practices for preexposure 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: Emtricitabine/Tenofovir disoproxil Krka 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: Treatment of HIV-1 infection:
Maltese: Infezzjoni tal-HIV-1:
English: 28 film-coated tablets: EU/1/16/1151/001 84 film-coated tablets: EU/1/16/1151/003
Maltese: EU/1/16/1151/001 84 pillola miksija b'rita:
English: The rate of HIV-1 seroconversion in males was 0.24/100 person-years of emtricitabine/tenofovir disoproxil exposure and the rate of HIV-1 seroconversion in females was 0.95/100 person-years of emtricitabine/tenofovir disoproxil exposure.
Maltese: Ir-rata ta' serokonverżjoni tal-HIV-1 fl-irġiel kienet 0.24/100 sena ta' persuna tal-esponiment ta' emtricitabine/tenofovir disoproxil u r-rata ta' serokonverżjoni tal-HIV-1 fin-nisa kienet 0.95/100 sena ta' persuna tal-esponiment ta' emtricitabine/tenofovir disoproxil.
English: Limited data from clinical studies support once daily dosing in HIV-1 uninfected individuals with CrCl 60-80 mL/min.
Maltese: Dejta limitata minn studji kliniċi tappoġġja doża ta' darba kuljum f'individwi mhux infettati blHIV 1 b'CrCl 60 80 mL/min.
English: Difference (95%CI) 32 (9 to 55)
Maltese: 32 (9 sa 55)
English: Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg film-coated tablets Emtricitabine/Tenofovir disoproxil
Maltese: Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg pilloli miksija b'rita Emtricitabine/Tenofovir disoproxil
English: Emtricitabine/Tenofovir disoproxil Krka 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, together with safer sex practices:
Maltese: - Emtricitabine/Tenofovir disoproxil Krka 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: Taking Emtricitabine/Tenofovir disoproxil Krka with other medicines that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including aminoglycosides (for bacterial infection) amphotericin B (for fungal infection) foscarnet (for viral infection) ganciclovir (for viral infection) pentamidine (for infections) vancomycin (for bacterial infection)
Maltese: Jekk tieħu Emtricitabine/Tenofovir disoproxil Krka ma' mediċini oħra li jistgħu jagħmlu ħsara lill-kliewi tiegħek: b'mod speċjali hu importanti li tgħid lit-tabib tiegħek jekk qed tieħu kwalunkwe minn dawn il-mediċini, li jinkludu - aminoglycosides (għal infezzjoni batterjali) - amphotericin B (għal infezzjoni fungali) - foscarnet (għal infezzjoni virali) - ganciclovir (għal infezzjoni virali) - pentamidine (għall-infezzjonijiet)
English: AUC: ↓ 4% (↓ 15 to ↑ 8)
Maltese: AUC: ↓ 2% (↓ 5 sa ↑ 0)
English: Didanosine: The co-administration of Emtricitabine/Tenofovir disoproxil Krka and didanosine is not recommended (see section 4.4 and Table 2).
Maltese: L-għoti ta' Emtricitabine/Tenofovir disoproxil Krka flimkien ma' didanosine mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 2).
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 għal medjan ta' 331 ġimgħa.
English: This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Maltese: Din ir-reazzjoni avversa tista' sseħħ bħala konsegwenza ta' tubulopatija renali prossimali.
English: Table 1: Dosing recommendations in adults with renal impairment
Maltese: Tabella 1: Dożi rakkomandati f'adulti b'indeboliment tal-kliewi
English: AUC: ↓ 27% (↓ 35 to ↓ 18) Cmax: ↓ 37% (↓ 48 to ↓ 25) GS-331007
Maltese: AUC: ↓ 27% (↓ 35 sa ↓ 18) Cmax: ↓ 37% (↓ 48 sa ↓ 25)
English: Emtricitabine/Tenofovir disoproxil Krka contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Maltese: Emtricitabine/Tenofovir disoproxil Krka fih sodium Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Key Couple Characteristics, N (%) or Median (Q1, Q3) Married to study partner
Maltese: Karatteristiċi Prinċipali tal-Koppja, N (%) jew Medjana (Q1, Q3)
English: ANTI-INFECTIVES
Maltese: ANTINFETTIVI
English: Excipient(s) with known effect Each film-coated tablet contains 80 mg lactose monohydrate.
Maltese: Eċċipjent b'effett magħruf Kull pillola miksija b'rita fiha 80 mg ta' lactose monohydrate.
English: AUC: ↑ 96% (↑ 74 to ↑ 121) Cmax: ↑ 68% (↑ 54 to ↑ 84) Cmin: ↑ 118% (↑ 91 to ↑ 150) Sofosbuvir:
Maltese: AUC: ↑ 96% (↑ 74 sa ↑ 121) Cmax: ↑ 68% (↑ 54 sa ↑ 84) Cmin: ↑ 118% (↑ 91 sa ↑ 150)
English: If Emtricitabine/Tenofovir disoproxil Krka is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule - That paediatric patients should have their baseline renal function assessed prior to initiating Emtricitabine/Tenofovir disoproxil Krka therapy - The importance of regular monitoring of renal function during Emtricitabine/Tenofovir disoproxil Krka therapy - Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment - That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil, renal function should be re-evaluated within one week.
Maltese: Jekk Emtricitabine/Tenofovir disoproxil Krka jintuża ma' prodotti mediċinali nefrotossiċi, il-funzjoni tal-kliewi għandha tiġi mmonitorjata mill-qrib skont l-iskeda rakkomandata - Li pazjenti pedjatriċi għandu jkollhom il-funzjoni renali fil-linja bażi tagħhom evalwata qabel ma tinbeda t-terapija bi Emtricitabine/Tenofovir disoproxil Krka - L-importanza tal-monitoraġġ regolari tal-funzjoni tal-kliewi matul it-terapija bi Emtricitabine/Tenofovir disoproxil Krka - L-iskeda rakkomandata għall-monitoraġġ tal-funzjoni tal-kliewi b'konsiderazzjoni tal-preżenza jew in-nuqqas ta' fatturi addizzjonali ta' riskju għal indeboliment tal-kliewi - Jekk il-fosfat fis-serum jiġi kkonfermat li hu < 3.0 mg/dL (0.96 mmol/L) fi kwalunkwe pazjent pedjatriku li jirċievi tenofovir disoproxil, il-funzjoni tal-kliewi għandha tiġi evalwata mill-ġdid fi żmien ġimgħa.
English: Lopinavir/Ritonavir/Emtricitabine Interaction not studied.
Maltese: Lopinavir/Ritonavir/Emtricitabine L-interazzjoni ma ġietx studjata.
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 didanosinerelated 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: Emtricitabine/Tenofovir disoproxil Krka contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Emtricitabine/Tenofovir disoproxil Krka fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Emtricitabine/Tenofovir disoproxil Krka 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 Krka 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: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucosegalactose m'għandhomx jieħdu din il-prodott mediċina.
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24) Sofosbuvir:
Maltese: ↓ 34% (↓ 41 sa ↓ 25) Cmax: ↓ 34% (↓ 41 sa ↑ 25) Cmin: ↓ 34% (↓ 43 sa ↑ 24)
English: Cmax: ↓ 19% (↓ 40 to ↑ 10) GS-331007
Maltese: Cmax: ↓ 19% (↓ 40 sa ↑ 10)
English: Consideration should be given to interrupting treatment with Emtricitabine/Tenofovir disoproxil Krka 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 Krka f'pazjenti bi tneħħija tal-kreatinina mnaqqsa għal < 50 mL/min jew tnaqqis filphosphate fis-serum għal < 1.0 mg/dL (0.
English: Table 3: Tabulated summary of adverse reactions associated with tenofovir disoproxil and emtricitabine based on clinical study and post-marketing experience
Maltese: Tabella 3: Sommarju tabulat ta' reazzjonijiet avversi assoċjati mal-komponenti individwali ta' tenofovir disoproxil u emtricitabine bbażati fuq studju kliniku u esperjenza ta' wara t-tqegħid fis-suq
English: UAB KRKA Lietuva Tel: + 370 5 236 27 40
Maltese: Tel: + 370 5 236 27 40
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 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: 28 film-coated tablets 84 film-coated tablets for bottle:
Maltese: 28 pillola miksija b'rita 84 pillola miksija b'rita għal fliexken:
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: Do not take Emtricitabine/Tenofovir disoproxil Krka if you are already taking other medicines that contain the components of Emtricitabine/Tenofovir disoproxil Krka (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Maltese: Tiħux Emtricitabine/Tenofovir disoproxil Krka jekk diġà qed tieħu mediċini oħra li fihom il-komponenti ta' Emtricitabine/Tenofovir disoproxil Krka (emtricitabine u tenofovir disoproxil) jew kwalunkwe mediċina antivirali oħra li fihom tenofovir alafenamide, lamivudine jew adefovir dipivoxil.
English: Cmin: ↑ 45% (↑ 27 to ↑ 64) Emtricitabine:
Maltese: Cmin: ↑ 45% (↑ 27 sa ↑ 64)
English: Emtricitabine/Tenofovir disoproxil Krka 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 Krka 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: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Emtricitabine/Tenofovir disoproxil Krka 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 Krka 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: Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Maltese: Dejta ġġenerat minn dożaġġ fl-istess ħin b'ledipasvir/sofosbuvir.