FrancophonIA/ELRC3.0 huggingface dataset:
English: Emtricitabine/Tenofovir disoproxil Krka.
Maltese: Emtricitabine/Tenofovir disoproxil Krka tista' tikkawża sturdament.
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14) Cmin: NC
Maltese: AUC: ↑ 5% (↓ 2 sa ↑ 13) Cmax: ↑ 5% (↓ 3 sa ↑ 14)
English: 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: Relative risk reduction calculated on incident (post-baseline) seroconversion from the double-blind treatment period and through the 8-week follow-up period.
Maltese: It-tnaqqis fir-riskju relattiv ikkalkulat fuq l-inċidenza ta' serokonverżjoni (wara l-linja bażi) minn perjodu ta' trattament double-blind u matul il-perjodu ta' segwitu ta' 8 ġimgħat.
English: Cmin: ↑ 48% (↑ 34 to ↑ 63) Emtricitabine:
Maltese: Cmin: ↑ 48% (↑ 34 sa ↑ 63)
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 < 60mL/min mhux rakkomandat minħabba li ma ġiex studjat f'din ilpopolazzjoni (ara sezzjonijiet 4.4 u 5.2).
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: Il-parametri 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: Renal impairment: As Emtricitabine/Tenofovir disoproxil Krka may cause renal damage monitoring of renal function is recommended (see section 4.4).
Maltese: Indeboliment renali: Billi Emtricitabine/Tenofovir disoproxil Krka jista' jikkawża ħsara renali, ilmonitoraġġ tal-funzjoni renali hu rakkomandat (ara sezzjoni 4.4).
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 fuq l-anzjani (mogħti bħala tenofovir disoproxil) (età 'l fuq minn 65 sena).
English: Treatment of HIV-1 infection
Maltese: Trattament tal infezzjoni bl-HIV-1
English: HIV paediatric renal educational brochure:
Maltese: Opuskolu edukattiv dwar il-kliewi u l-HIV:
English: Tests may also show: decreases in phosphate in the blood increased creatine kinase
Maltese: It-testijiet jistgħu juru wkoll: - tnaqqis fil-phosphate fid-demm - creatine kinase għolja
English: Tenofovir disoproxil is indicated for the treatment of HBV and emtricitabine has shown activity against HBV in pharmacodynamic studies but the safety and efficacy of emtricitabine/tenofovir disoproxil have not been specifically established in patients with chronic HBV infection.
Maltese: Tenofovir disoproxil huwa indikat għat-trattament tal-HBV u emtricitabine wera attività kontra l-HBV fi studji farmakodinamiċi iżda s-sigurtà u l-effikaċja ta' Emtricitabine/tenofovir disoproxil ma ġewx stabbiliti speċifikament f'pazjenti b'infezzjoni kronika tal-HBV.
English: In vivo - treatment of HIV-1: In an open-label randomised clinical study (GS-01-934) in antiretroviralnaïve 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: Cmin: ↑ 63% (↑ 45 to ↑ 84) Ritonavir:
Maltese: Cmin: ↑ 63% (↑ 45 sa ↑ 84)
English: Cmax: ↓ 23% (↓ 30 to ↑ 16) Efavirenz:
Maltese: Cmax: ↓ 23% (↓ 30 sa ↑ 16)
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: Emtricitabine/Tenofovir disoproxil Krka 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 Krka 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: 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: Studji b'emtricitabine 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: Consideration should be given to interrupting use of Emtricitabine/Tenofovir disoproxil Krka 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 Krka 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: At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as > 4% loss).
Maltese: F'ġimgħa 48, sitt adolexxenti fil-grupp ta' tenofovir disoproxil u adolexxent wieħed fil-grupp tal-plaċebo kellhom telf tal-BMD sinifikanti fl-ispina lumbari (imfisser bħala telf ta' > 4%).
English: 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 has not been studied in individuals over the age of 65 years.
Maltese: Emtricitabine/tenofovir disoproxil ma ġiex studjat f'individwi li jkollhom iktar minn 65 sena.
English: PrEP Checklist for prescribers:
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.
Maltese: Prevenzjoni 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: 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: 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: Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg film-coated tablets
Maltese: Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg pilloli miksija b'rita
English: Recommendation concerning coadministration with Emtricitabine/Tenofovir disoproxil Krka (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Maltese: Rakkomandazzjoni dwar l-għoti flimkien ma' Emtricitabine/Tenofovir disoproxil Krka (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
English: FTC/tenofovir disoproxil Group
Maltese: Grupp tal-FTC/tenofovir disoproxil
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 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: Common side effects (may affect up to 1 in 10 people) pain, stomach pain difficulty sleeping, abnormal dreams problems with digestion resulting in discomfort after meals, feeling bloated, flatulence rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches other allergic reactions, such as wheezing, swelling or feeling light-headed
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) - uġigħ, uġigħ fl-istonku - diffikultà biex torqod, ħolm anormali - problemi bid-diġestjoni li jwasslu għal skonfort wara l-ikel, tħossok minfuħ, gass fl-istonku - raxx (fosthom tikek ħomor jew dabriet xi kultant bl-infafet u nefħa tal-ġilda), li jistgħu jkunu reazzjonijiet allerġiċi, ħakk, tibdil fil-kulur tal-ġilda li jinkludi l-iskurament fi dbabar tal-ġilda - reazzjonijiet allerġiċi oħrajn, bħal tħarħir, nefħa jew ikollok il-mejt
English: - That a multidisciplinary approach is recommended for the management of paediatric patients - That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil-containing products such as Emtricitabine/Tenofovir disoproxil Krka - That Emtricitabine/Tenofovir disoproxil Krka is not recommended for use in paediatric patients with renal impairment - That use of Emtricitabine/Tenofovir disoproxil Krka should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Maltese: - Li approċċ multidixxiplinarju hu rakkomandat għall-ġestjoni ta' pazjenti pedjatriċi - Li hemm riskju miżjud ta' mard tal-kliewi f'pazjenti infettati bl-HIV assoċjat ma' prodotti li fihom tenofovir disoproxil bħal Emtricitabine/Tenofovir disoproxil Krka - Li Emtricitabine/Tenofovir disoproxil Krka mhux rakkomandat għall-użu f'pazjenti pedjatriċi b'indeboliment tal-kliewi - Li Emtricitabine/Tenofovir disoproxil Krka m'għandux jintuża jekk qed jingħataw fl-istess ħin jew riċentement intużaw prodotti mediċinali nefrotossiċi.
English: 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: 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 Krka 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 Krka 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, il-potassium fid-demm u lglukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: See Table
Maltese: Tabella 10:
English: Pre-exposure prophylaxis
Maltese: Profilassi ta' qabel lesponiment
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 Krka in patients with hepatic impairment (see sections 4.2 and
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 Krka f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.2 u 5.2).
English: Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑ 197)
Maltese: AUC: ↑ 98% (↑ 77 sa ↑ 123) Cmax: ↑ 79% (↑ 56 sa ↑ 104) Cmin: ↑ 163% (↑ 137 sa ↑ 197)
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Maltese: L-użu ma' ledipasvir u sofosbuvir, sofosbuvir u velpatasvir jew sofosbuvir, velpatasvir u voxilaprevir L-għoti flimkien ta' tenofovir disoproxil ma' ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir intwera li jżid il-konċentrazzjonijiet ta' tenofovir fil-plażma, b'mod speċjali meta jintuża flimkien ma' kors kontra l-HIV li jinkludi tenofovir disoproxil u aġent li jżid l-effett farmakokinetiku (ritonavir jew cobicistat).
English: Individuals over the age of 65 years are more likely to have decreased renal function, therefore caution should be exercised when administering Emtricitabine/Tenofovir disoproxil Krka to older people.
Maltese: Individwi li għandhom iżjed minn 65 sena huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta Emtricitabine/Tenofovir disoproxil Krka jingħata lil persuni anzjani.
English: Adefovir dipivoxil: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0) Cmin: NC
Maltese: AUC: ↓ 11% (↓ 14 sa ↓ 7) Cmax: ↓ 7% (↓ 13 sa ↓ 0) Cmin: NC
English: Manufacturers
Maltese: Reżistenza
English: Hispanic/Latino Ethnicity, N (%) Sexual Risk Factors at Screening Number of Partners Previous 12 Weeks, Mean (SD) URAI Previous 12 Weeks, N (%) URAI with HIV+ (or unknown status) Partner Previous 6 Mos, N
Maltese: Età (Snin), Medja (SD) Razza, N (%) Amerikani Suwed/Afro-Amerikani Bojod Imħalltin/Oħrajn Asjatiċi Etniċità Ispanika/Latina, N (%) Fatturi ta' Riskju Sesswali fl-Iskrinjar
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 Krka, renal function should be reevaluated 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 Krka, ilfunzjoni tal-kliewi għandha tiġi evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl talkonċentrazzjonijiet tal-glukożju fid-demm, il-potassium fid-demm u l-glukożju fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: Individuals with renal impairment: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any adults with renal impairment receiving Emtricitabine/Tenofovir disoproxil Krka (see sections 4.2, 4.4 and 5.2).
Maltese: Billi tenofovir disoproxil jista' jikkawża tossiċità renali, monitoraġġ mill-qrib tal-funzjoni renali hu rakkomandat fi kwalunkwe adulti b'indeboliment renali li jkunu qed jirċievu Emtricitabine/Tenofovir disoproxil Krka (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: The adverse reactions considered at least possibly related to treatment with the tenofovir disoproxil and emtricitabine 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' tenofovir disoproxil u emtricitabine, 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: 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: Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Maltese: Impedituri tal-protease Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: Do not take Emtricitabine/Tenofovir disoproxil Krka 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: Discontinuation of Emtricitabine/Tenofovir disoproxil Krka therapy in patients infected with HBV may be associated with severe acute exacerbations of hepatitis.
Maltese: It-twaqqif tat-terapija b'Emtricitabine/Tenofovir disoproxil Krka f'pazjenti infettati bl-HBV jista' jkun assoċjat ma' aggravamenti akuti severi tal-epatite.
English: Talk to your doctor if you are over 65.
Maltese: - Kellem lit-tabib tiegħek jekk għandek iktar minn 65 sena.
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: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir u darunavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: If clinical symptoms consistent with acute viral infection are present and recent (< 1 month) exposures to HIV-1 are suspected, use of Emtricitabine/Tenofovir disoproxil Krka should be delayed for at least one month and HIV-1 status reconfirmed before starting Emtricitabine/Tenofovir disoproxil Krka for pre-exposure prophylaxis.
Maltese: Jekk ikun hemm preżenti sintomi kliniċi konsistenti ma' infezzjoni virali akuta u huma ssuspettati esponimenti riċenti (< 1 xahar) għall-HIV-1, l-użu ta' Emtricitabine/Tenofovir disoproxil Krka għandu jiġi ttardjat mill-inqas għal xahar u l-istat tal-HIV-1 ikkonfermat mill-ġdid qabel ma Emtricitabine/Tenofovir disoproxil Krka jinbeda għal profilassi ta' qabel l-esponiment.
English: neutropenia
Maltese: Koorti
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 bi emtricitabine/tenofovir disoproxil fil-popolazzjoni pedjatrika b'infezzjoni blHIV-1.
English: Uncommon side effects (may affect up to 1 in 100 people) pain in the abdomen (tummy) caused by inflammation of the pancreas swelling of the face, lips, tongue or throat anaemia (low red blood cell count) breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna) - uġigħ ta' żaqq ikkawżat minn infjammazzjoni fil-frixa - nefħa fil-wiċċ, xofftejn, ilsien jew griżmejn - anemija (għadd baxx ta' ċelluli tad-demm ħomor) - kollass tal-muskoli, uġigħ jew dgħjufija fil-muskoli li jistgħu jseħħu minħabba ħsara liċ-ċelluli tubuli tal-kliewi
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil meta użat ma' sofosbuvir/velpatasvir u potenzjatur farmakokinetiku (eż. ritonavir jew cobicistat) għadha
English: - That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil-containing products such as Emtricitabine/Tenofovir disoproxil Krka - That Emtricitabine/Tenofovir disoproxil Krka should only be used in patients with impaired renal function if the potential benefits are considered to outweigh the potential risks - That use of Emtricitabine/Tenofovir disoproxil Krka should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Maltese: - Li hemm riskju miżjud ta' mard tal-kliewi f'pazjenti infettati bl-HIV assoċjat ma' prodotti li fihom tenofovir disoproxil bħal Emtricitabine/Tenofovir disoproxil Krka - Li Emtricitabine/Tenofovir disoproxil Krka għandu jintuża biss f'pazjenti li għandhom indeboliment tal-funzjoni tal-kliewi jekk il-benefiċċji potenzjali huma meqjusin li jissupperaw ir-riskji potenzjali - Li Emtricitabine/Tenofovir disoproxil Krka ma għandux jintuża jekk qed jintużaw fl-istess ħin jew intużaw reċentement prodotti mediċinali nefrotossiċi.
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 (%)
Maltese: Infezzjoni tat-Tip 2 tal-Virus tas-Serum Herpes Simplex, N (%)
English: Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil Krka.
Maltese: - M'għandekx tredda' matul it-trattament bi Emtricitabine/Tenofovir disoproxil Krka.
English: Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.)
Maltese: Sustanzi antivirali tal-virus tal-Epatite Ċ (HCV) Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) +
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Maltese: Iddaqsijiet tal-pakketti li ġejjin huma disponibbli: kartuni ta' barra li fihom flixkun 2 ta' 30 pillola miksija b'rita u 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: Taking Emtricitabine/Tenofovir disoproxil Krka with other medicines containing didanosine (for treatment of HIV infection): Taking Emtricitabine/Tenofovir disoproxil Krka with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Maltese: Li tieħu Emtricitabine/Tenofovir disoproxil Krka ma' mediċini antivirali oħra li fihom didanosine jista' jgħolli l-livelli ta' didanosine fid-demm tiegħek u jista' jnaqqas l-għadd taċ-ċelluli CD4 tiegħek.