США - англійська - NLM (National Library of Medicine)

eci pharmaceuticals llc - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: - the dosage of this product is for hiv-1 and not for hbv. lamivudine is contraindicated in patients with previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263. risk summary available data from the antiretroviral pregnancy registry show no difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% in the us reference population of the metropolitan atlanta congenital defects program (macdp). lamivudine produced embryonic toxicity in rabbits at a dose that produced similar human exposure

США - англійська - NLM (National Library of Medicine)

viiv healthcare company - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - epivir is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv‑1) infection. limitations of use: epivir is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to epivir 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 difference in the overall risk of birth defects for lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data) . the apr uses the macdp as the u.s. reference population for birth defects in the general population. the macdp evaluates women and infants from a limited geographic area and does not include outcome

США - англійська - NLM (National Library of Medicine)

bryant ranch prepack - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine and zidovudine tablets, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. lamivudine and zidovudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine or zidovudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine tablets 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 difference in the overall risk of birth defects for lamivudine or zidovudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data). the apr uses the macdp as the u.s. reference population for birth defects in the general population. the macdp evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks' gestation. the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15% to 20%. the background risk for major birth defects and miscarriage for the indicated population is unknown. hyperlactatemia, which may be due to mitochondrial dysfunction, has been reported in infants with in utero exposure to zidovudine-containing products. these events were transient and asymptomatic in most cases. there have been few reports of developmental delay, seizures, and other neurological disease. however, a causal relationship between these events and exposure to zidovudine-containing products in utero or peri-partum has not been established (see data). in animal reproduction studies, oral administration of lamivudine to pregnant rabbits during organogenesis resulted in embryolethality at systemic exposure (auc) similar to the recommended clinical dose; however, no adverse development effects were observed with oral administration of lamivudine to pregnant rats during organogenesis at plasma concentrations (cmax ) 35 times the recommended clinical dose. administration of oral zidovudine to female rats prior to mating and throughout gestation resulted in embryotoxicity at doses that produced systemic exposure (auc) approximately 33 times higher than exposure at the recommended clinical dose. however, no embryotoxicity was observed after oral administration of zidovudine to pregnant rats during organogenesis at doses that produced systemic exposure (auc) approximately 117 times higher than exposures at the recommended clinical dose. administration of oral zidovudine to pregnant rabbits during organogenesis resulted in embryotoxicity at doses that produced systemic exposure (auc) approximately 108 times higher than exposure at the recommended clinical dose. however, no embryotoxicity was observed at doses that produced systemic exposure (auc) approximately 23 times higher than exposures at the recommended clinical dose (see data). data human data: lamivudine : based on prospective reports to the apr of over 11,000 exposures to lamivudine during pregnancy resulting in live births (including over 4,500 exposed in the first trimester), there was no difference between the overall risk of birth defects for lamivudine 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 3.1% (95% ci: 2.6% to 3.6%) following first trimester exposure to lamivudine-containing regimens and 2.8% (95% ci: 2.5% to 3.3%) following second/third trimester exposure to lamivudine-containing regimens. lamivudine pharmacokinetics were studied in pregnant women during 2 clinical trials conducted in south africa. the trial assessed pharmacokinetics in 16 women at 36 weeks' gestation using 150 mg lamivudine twice daily with zidovudine, 10 women at 38 weeks' gestation using 150 mg lamivudine twice daily with zidovudine, and 10 women at 38 weeks' gestation using lamivudine 300 mg twice daily without other antiretrovirals. these trials were not designed or powered to provide efficacy information. lamivudine concentrations were generally similar in maternal, neonatal, and umbilical cord serum samples. in a subset of subjects, amniotic fluid specimens were collected following natural rupture of membranes and confirmed that lamivudine crosses the placenta in humans. based on limited data at delivery, median (range) amniotic fluid concentrations of lamivudine were 3.9 (1.2 to 12.8)–fold greater compared with paired maternal serum concentration (n = 8). zidovudine: based on prospective reports to the apr of over 13,000 exposures to zidovudine during pregnancy resulting in live births (including over 4,000 exposed in the first trimester), there was no difference between the overall risk of birth defects for zidovudine 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 3.2% (95% ci: 2.7% to 3.8%) following first trimester exposure to zidovudine-containing regimens and 2.8% (95% ci: 2.5% to 3.2%) following second/third trimester exposure to zidovudine-containing regimens. a randomized, double-blind, placebo-controlled trial was conducted in hiv–1-infected pregnant women to determine the utility of zidovudine for the prevention of maternal-fetal hiv-1 transmission. zidovudine treatment during pregnancy reduced the rate of maternal-fetal hiv-1 transmission from 24.9% for infants born to placebo-treated mothers to 7.8% for infants born to mothers treated with zidovudine. there were no differences in pregnancy-related adverse events between the treatment groups. of the 363 neonates that were evaluated, congenital abnormalities occurred with similar frequency between neonates born to mothers who received zidovudine and neonates born to mothers who received placebo. the observed abnormalities included problems in embryogenesis (prior to 14 weeks) or were recognized on ultrasound before or immediately after initiation of trial drug [see clinical studies (14.2) ]. zidovudine has been shown to cross the placenta and concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery [see clinical pharmacology (12.3) ]. there have been reports of mild, transient elevations in serum lactate levels, which may be due to mitochondrial dysfunction, in neonates and infants exposed in utero or peri-partum to zidovudine-containing products. there have been few reports of developmental delay, seizures, and other neurological disease. however, a causal relationship between these events and exposure to zidovudine-containing products in utero or peri-partum has not been established. the clinical relevance of transient elevations in serum lactate is unknown. animal data: lamivudine : lamivudine was administered orally to pregnant rats (at 90, 600, and 4,000 mg per kg per day) and rabbits (at 90, 300, and 1,000 mg per kg per day and at 15, 40, and 90 mg per kg per day) during organogenesis (on gestation days 7 through 16 [rat] and 8 through 20 [rabbit]). no evidence of fetal malformations due to lamivudine was observed in rats and rabbits at doses producing plasma concentrations (cmax ) approximately 35 times higher than human exposure at the recommended daily dose. evidence of early embryolethality was seen in the rabbit at system exposures (auc) similar to those observed in humans, but there was no indication of this effect in the rat at plasma concentrations (cmax ) 35 times higher than human exposure at the recommended daily dose. studies in pregnant rats showed that lamivudine is transferred to the fetus through the placenta. in the fertility/pre-and postnatal development study in rats, lamivudine was administered orally at doses of 180, 900, and 4,000 mg per kg per day (from prior to mating through postnatal day 20). in the study, development of the offspring, including fertility and reproductive performance, was not affected by maternal administration of lamivudine. zidovudine: a study in pregnant rats (at 50, 150, or 450 mg per kg per day starting 26 days prior to mating through gestation to postnatal day 21) showed increased fetal resorptions at doses that produced systemic exposures (auc) approximately 33 times higher than exposure at the recommended daily human dose (300 mg twice daily). however, in an oral embryo-fetal development study in rats (at 125, 250, or 500 mg per kg per day on gestation days 6 through 15), no fetal resorptions were observed at doses that produced systemic exposure (auc) approximately 117 times higher than exposures at the recommended daily human dose. an oral embryo-fetal development study in rabbits (at 75, 150, or 500 mg per kg per day on gestation days 6 through 18) showed increased fetal resorptions at the 500 mg-per-kg-per-day dose, which produced systemic exposures (auc) approximately 108 times higher than exposure at the recommended daily human dose; however, no fetal resorptions were noted at doses up to 150 mg per kg per day, which produced systemic exposure (auc) approximately 23 times higher than exposures at the recommended daily human dose. these oral embryo-fetal development studies in the rat and rabbit revealed no evidence of fetal malformations with zidovudine. in another developmental toxicity study, pregnant rats (dosed at 3,000 mg per kg per day from days 6 through 15 of gestation) showed marked maternal toxicity and an increased incidence of fetal malformations at exposures greater than 300 times the recommended daily human dose based on auc. however, there were no signs of fetal malformations at doses up to 600 mg per kg per day. risk summary the centers for disease control and prevention recommends that hiv-1-infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. lamivudine and zidovudine are present in human milk. there is no information on the effects of lamivudine or zidovudine on the breastfed infant or the effects of the drugs on milk production. because of the potential for (1) hiv-1 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 receiving lamivudine and zidovudine tablets. lamivudine and zidovudine tablets are not recommended for use in pediatric patients who weigh less than 30 kg because it is a fixed-dose combination tablet that cannot be adjusted for this patient population [see dosage and administration ( 2.2 )]. clinical trials of lamivudine and zidovudine tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, caution should be exercised in the administration of lamivudine and zidovudine tablets in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology ( 12.3 )]. lamivudine and zidovudine tablets are not recommended for patients with creatinine clearance less than 50 ml per min because lamivudine and zidovudine tablets are a fixed-dose combination and the dosage of the individual components cannot be adjusted. if a dose reduction of the lamivudine or zidovudine components of lamivudine and zidovudine tablets are required for patients with renal impairment then the individual components should be used [see dosage and administration ( 2.3 ), clinical pharmacology ( 12.3 )]. lamivudine and zidovudine tablets are a fixed-dose combination and the dosage of the individual components cannot be adjusted. zidovudine is primarily eliminated by hepatic metabolism and zidovudine concentrations are increased in patients with impaired hepatic function, which may increase the risk of hematologic toxicity. frequent monitoring of hematologic toxicities is advised.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - lamivudine, quantity: 300 mg; abacavir hydrochloride monohydrate, quantity: 714.162 mg (equivalent: abacavir, qty 600 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; ferric oxide; titanium dioxide; hypromellose; sunset yellow fcf; polysorbate 80; macrogol 400 - abacavir/lamivudine lapl is a combination of two nucleoside analogues (abacavir and lamivudine). abacavir/lamivudine lapl is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - lamivudine, quantity: 300 mg; abacavir hydrochloride monohydrate, quantity: 714.162 mg (equivalent: abacavir, qty 600 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; ferric oxide; titanium dioxide; hypromellose; sunset yellow fcf; polysorbate 80; macrogol 400 - abacavir/lamivudine lapl is a combination of two nucleoside analogues (abacavir and lamivudine). abacavir/lamivudine lapl is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - lamivudine, quantity: 300 mg; abacavir hydrochloride monohydrate, quantity: 714.162 mg (equivalent: abacavir, qty 600 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; ferric oxide; titanium dioxide; hypromellose; sunset yellow fcf; polysorbate 80; macrogol 400 - abacavir/lamivudine lupin is a combination of two nucleoside analogues (abacavir and lamivudine). abacavir/lamivudine lupin is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - lamivudine, quantity: 300 mg; abacavir hydrochloride monohydrate, quantity: 714.162 mg (equivalent: abacavir, qty 600 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; ferric oxide; titanium dioxide; hypromellose; sunset yellow fcf; polysorbate 80; macrogol 400 - abacavir/lamivudine lupin is a combination of two nucleoside analogues (abacavir and lamivudine). abacavir/lamivudine lupin is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age.

США - англійська - NLM (National Library of Medicine)

glaxosmithkline llc - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 100 mg - epivir-hbv is indicated for the treatment of chronic hepatitis b virus (hbv) infection associated with evidence of hepatitis b viral replication and active liver inflammation [see clinical studies (14.1, 14.2)]. the following points should be considered when initiating therapy with epivir-hbv: epivir-hbv is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine 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 substantial difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% reported in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp). the apr uses the macdp as a u.s. reference popul

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - lamivudine -

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - lamivudine -