Austrália - inglês - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - emtricitabine, quantity: 200 mg; tenofovir disoproxil succinate, quantity: 300.6 mg - tablet, film coated - excipient ingredients: macrogol 3350; indigo carmine aluminium lake; magnesium stearate; isopropyl alcohol; polyvinyl alcohol; microcrystalline cellulose; titanium dioxide; lactose monohydrate; purified talc; croscarmellose sodium; purified water; pregelatinised maize starch - treatment of hiv-1 infection,tenofovir/emtricitabine sandoz is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis,tenofovir/emtricitabine sandoz is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see section 5.1 pharmacodynamic properties, clinical trials).

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - efavirenz; emtricitabine; tenofovir disoproxil - film-coated tablet - 600 mg/200 mg/245 milligram(s) - antivirals for treatment of hiv infections, combinations; emtricitabine, tenofovir disoproxil and efavirenz

Estados Unidos - inglês - NLM (National Library of Medicine)

bryant ranch prepack - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)] . emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)]. emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)] . pregnancy  exposure  registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil

Estados Unidos - inglês - NLM (National Library of Medicine)

bryant ranch prepack - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)] . emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2)]. emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)] . pregnancy  exposure  registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil

Estados Unidos - inglês - NLM (National Library of Medicine)

a-s medication solutions - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies (14)] . emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep [see dosage and administration (2.2), warnings and precautions (5.2 )]. emtricitabine and tenofovir disoproxil fumarate for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions (5.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate ta

Estados Unidos - inglês - NLM (National Library of Medicine)

cipla usa inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - emtricitabine is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (ftc) (2.3%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the rate of miscarriage for individual drugs is not reported in the apr. in the u.s., general population, the estimated background risk of miscarriage in clinic

Estados Unidos - inglês - NLM (National Library of Medicine)

remedyrepack inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - emtricitabine is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (ftc) (2.3%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the rate of miscarriage for individual drugs is not reported in the apr. in the u.s., general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15–20%. in animal reproduction studies, no adverse developmental effects were observed when ftc was administered at exposures ≥60 times that of the recommended daily dose of emtricitabine (see data) . data human data based on prospective reports to the apr of exposures to ftc-containing regimens during pregnancy resulting in live births (including over 2,700 exposed in the first trimester and over 1,200 exposed in the second/third trimester), there was no increase between ftc and overall birth defects compared with the background birth defect rate of 2.7% in a u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.4% (95% ci: 1.9% to 3.1%) with first trimester exposure to ftc-containing regimens and 2.3% (95% ci: 1.5% to 3.3%) with the second/third trimester exposure to ftc-containing regimens. prospective reports from the apr of overall major birth defects in pregnancies exposed to ftc are compared with a u.s. background major birth defect rate. methodologic limitations of the apr include the use of macdp as the external comparator group. limitations of using an external comparator include differences in methodology and populations, as well as confounding due to the underlying disease. additionally, published observational studies on ftc exposure in pregnancy have not shown an increased risk for major malformations. animal data ftc was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with ftc in mice at exposures (auc) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the recommended daily dose. in a pre/postnatal development study in mice, ftc was administered orally at doses up to 1,000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth (in utero) through sexual maturity at daily exposures (auc) of approximately 60 times higher than human exposures at the recommended daily dose. risk summary the centers for disease control and prevention recommend that hiv-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1 .   based on published data, ftc has been shown to be present in human breast milk. it is not known if ftc affects milk production or has effects on the breastfed child. because of the potential for: (1) hiv transmission (in hiv-negative infants); (2) developing viral resistance (in hiv-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking emtricitabine. the safety and efficacy of ftc in patients between 3 months and 21 years of age is supported by data from three open-label, nonrandomized clinical trials in which ftc was administered to 169 hiv-1 infected treatment-naive and experienced (defined as virologically suppressed on a 3tc containing regimen for which ftc was substituted for 3tc) subjects [see clinical studies ( 14.4)] . the pharmacokinetics of ftc were studied in 20 neonates born to hiv-1 positive mothers [see clinical studies ( 14.4)] . all neonates were hiv-1 negative at the end of the trial; the efficacy of ftc in preventing or treating hiv-1 could not be determined. clinical trials of emtricitabine did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. in general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. modify the dose or dosing interval for emtricitabine in patients with creatinine clearance below 50 ml/min or in patients with end stage renal disease requiring dialysis [see dosage and administration ( 2.6)] .

Estados Unidos - inglês - NLM (National Library of Medicine)

aurobindo pharma limited - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - emtricitabine capsules are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. emtricitabine capsules are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (ftc) (2.3%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the rate of miscarriage for individual drugs is not reported in the apr. in the u.s. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15 to 20%. in animal reproduction studies, no adverse developmental effects were observed when ftc was administered at exposures ≥60 times that of the recommended daily dose of emtricitabine (see data) . data human data based on prospective reports to the apr of exposures to ftc-containing regimens during pregnancy resulting in live births (including over 2,700 exposed in the first trimester and over 1,200 exposed in the second/third trimester), there was no increase between ftc and overall birth defects compared with the background birth defect rate of 2.7% in a u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.4% (95% ci: 1.9% to 3.1%) with first trimester exposure to ftc-containing regimens and 2.3% (95% ci: 1.5% to 3.3%) with the second/third trimester exposure to ftc-containing regimens. prospective reports from the apr of overall major birth defects in pregnancies exposed to ftc are compared with a u.s. background major birth defect rate. methodologic limitations of the apr include the use of macdp as the external comparator group. limitations of using an external comparator include differences in methodology and populations, as well as confounding due to the underlying disease. additionally, published observational studies on ftc exposure in pregnancy have not shown an increased risk for major malformations. animal data ftc was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). no significant toxicological effects were observed in embryo-fetal toxicity studies performed with ftc in mice at exposures (auc) approximately 60 times higher and in rabbits at approximately 120 times higher than human exposures at the recommended daily dose. in a pre/postnatal development study in mice, ftc was administered orally at doses up to 1,000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth (in utero ) through sexual maturity at daily exposures (auc) of approximately 60 times higher than human exposures at the recommended daily dose. risk summary the centers for disease control and prevention recommend that hiv-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. based on published data, ftc has been shown to be present in human breast milk. it is not known if ftc affects milk production or has effects on the breastfed child. because of the potential for: (1) hiv transmission (in hiv-negative infants); (2) developing viral resistance (in hiv-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking emtricitabine. the safety and efficacy of ftc in patients between 3 months and 21 years of age is supported by data from three open-label, nonrandomized clinical trials in which ftc was administered to 169 hiv-1 infected treatment-naïve and experienced (defined as virologically suppressed on a 3tc containing regimen for which ftc was substituted for 3tc) subjects [see clinical studies (14.4)] . the pharmacokinetics of ftc were studied in 20 neonates born to hiv-1 positive mothers [see clinical studies (14.4)] . all neonates were hiv-1 negative at the end of the trial; the efficacy of ftc in preventing or treating hiv-1 could not be determined. clinical trials of emtricitabine did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. in general, dose selection for the elderly patient should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. modify the dose or dosing interval for emtricitabine in patients with creatinine clearance below 50 ml/min or in patients with end stage renal disease requiring dialysis [see dosage and administration (2.6)] .

Estados Unidos - inglês - NLM (National Library of Medicine)

gilead sciences, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s) - emtricitabine 200 mg - emtriva® is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. emtriva is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtriva during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (ftc) (2.3%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the rate of miscarriage for individual drugs is not reported in the apr. in the u.s. general population, the estimated background risk of miscarriage in clinically recognized p

Malta - inglês - Medicines Authority

teva pharma b.v. swensweg 5, 2031 ga haarlem, netherlands - emtricitabine, tenofovir disoproxil - film-coated tablet - emtricitabine 200 mg tenofovir disoproxil 245 mg - antivirals for systemic use