ארצות הברית - אנגלית - NLM (National Library of Medicine)

bryant ranch prepack - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection. limitation of use: the dosage of this product is for hiv-1 and not for hbv. lamivudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis) to any of the components of the product. pregnancy category c. there are no adequate and well-controlled studies of lamivudine in pregnant women. animal reproduction studies in rats and rabbits revealed no evidence of teratogenicity. increased early embryolethality occurred in rabbits at exposure levels similar to those in humans. lamivudine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. lamivudine pharmacokinetics were studied in pregnant women during 2 clinical studies conducted in south africa. the study assessed pharmacokinetics in: 16 women at 36 weeks gestation usin

ארצות הברית - אנגלית - NLM (National Library of Medicine)

aurobindo pharma limited - 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 tablets are 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 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. th

ארצות הברית - אנגלית - NLM (National Library of Medicine)

remedyrepack inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 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: - the dosage of this product is for hiv-1 and not for hbv. lamivudine tablets are 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 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 populatio

ארצות הברית - אנגלית - NLM (National Library of Medicine)

remedyrepack inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine are nucleoside analogues 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 tablets are 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 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 po

ארצות הברית - אנגלית - NLM (National Library of Medicine)

laurus labs limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adult and pediatric patients weighing at least 35 kg. efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are contraindicated: - in patients with a previous hypersensitivity reaction (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components contained in the formulation [see warnings and precautions (5.8)] . - when coadministered with elbasvir and grazoprevir [see warnings and precautions (5.3) and drug interactions (7.5)]. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz, lamivudine and tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary: there are r

ארצות הברית - אנגלית - NLM (National Library of Medicine)

prasco laboratories - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 100 mg - lamivudine tablets (hbv) are 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 lamivudine tablets (hbv): lamivudine tablets (hbv) are 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

סינגפור - אנגלית - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - lamivudine - tablet, film coated - 100 mg - lamivudine 100 mg

ארצות הברית - אנגלית - NLM (National Library of Medicine)

state of florida doh central pharmacy - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir sulfate 600 mg - epzicom tablets, in combination with other antiretroviral agents, are indicated for the treatment of hiv-1 infection. additional important information on the use of epzicom for treatment of hiv-1 infection: - epzicom is one of multiple products containing abacavir. before starting epzicom, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir. - in one controlled study (cna30021), more patients taking ziagen 600 mg once daily had severe hypersensitivity reactions compared with patients taking ziagen 300 mg twice daily. - as part of a triple-drug regimen, epzicom tablets are recommended for use with antiretroviral agents from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors. see warnings, adverse reactions, and description of clinical studies. there have been no clinical trials conducted with epzicom (see clinical pharmacology for informa

ארצות הברית - אנגלית - NLM (National Library of Medicine)

physicians total care, inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir sulfate 600 mg - epzicom tablets, in combination with other antiretroviral agents, are indicated for the treatment of hiv-1 infection. additional important information on the use of epzicom for treatment of hiv-1 infection: - epzicom is one of multiple products containing abacavir. before starting epzicom, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir. - in one controlled study (cna30021), more patients taking ziagen 600 mg once daily had severe hypersensitivity reactions compared with patients taking ziagen 300 mg twice daily. - as part of a triple-drug regimen, epzicom tablets are recommended for use with antiretroviral agents from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors. see warnings, adverse reactions, and description of clinical studies. there have been no clinical trials conducted with epzicom (see clinical pharmacology for informa

ארצות הברית - אנגלית - NLM (National Library of Medicine)

acetris health, llc - zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - zidovudine 300 mg - zidovudine tablets, a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. zidovudine tablets are indicated for the prevention of maternal-fetal hiv-1 transmission [see dosage and administration (2.3)]. the indication is based on a dosing regimen that included 3 components: 1. antepartum therapy of hiv-1-infected mothers 2. intrapartum therapy of hiv-1-infected mothers 3. post-partum therapy of hiv-1-exposed neonate points to consider prior to initiating zidovudine tablets in pregnant women for the prevention of maternal-fetal hiv-1 transmission include: • in most cases, zidovudine tablets for prevention of maternal-fetal hiv-1 transmission should be given in combination with other antiretroviral drugs. • prevention of hiv-1 transmission in women who have received zidovudine tablets for a prolonged period before pregnancy has not been evaluated. • because the fetus is most susceptible to the potential teratogen