European Union - English - EMA (European Medicines Agency)

teva b.v. - lamivudine - hepatitis b, chronic - antivirals for systemic use - lamivudine teva is indicated for the treatment of chronic hepatitis b in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablets, usp a combination of 2 nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. lamivudine and zidovudine tablets, usp 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 g

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablets, a combination of 2 nucleoside analogues, are 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 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 defe

United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - combivir, a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of hiv-1 infection. combivir tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, stevens-johnson syndrome) to any of the components of the product. pregnancy category c. fetal risk summary: there are no adequate and well-controlled studies of combivir (lamivudine and zidovudine) in pregnant women. clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of hiv-1 infection to the fetus. animal reproduction studies performed with lamivudine and zidovudine showed increased embryotoxicity and fetal malformations (zidovudine), and increased embryolethality (lamivudine). combivir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. antiretroviral pregnancy registry: to monitor maternal-fetal outcomes of pre

United States - English - NLM (National Library of Medicine)

rebel distributors corp - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - combivir, a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of hiv-1 infection. combivir tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, stevens-johnson syndrome) to any of the components of the product. pregnancy category c. fetal risk summary: there are no adequate and well-controlled studies of combivir (lamivudine and zidovudine) in pregnant women. clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of hiv-1 infection to the fetus. animal reproduction studies performed with lamivudine and zidovudine showed increased embryotoxicity and fetal malformations (zidovudine), and increased embryolethality (lamivudine). combivir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. antiretroviral pregnancy registry: to monitor maternal-fetal outcomes of pre

United States - English - NLM (National Library of Medicine)

state of florida doh central pharmacy - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - combivir, a combination of 2 nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of hiv-1 infection. combivir tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis, stevens-johnson syndrome) to any of the components of the product. pregnancy category c. fetal risk summary: there are no adequate and well-controlled trials of combivir (lamivudine and zidovudine) in pregnant women. clinical trial data demonstrate that maternal zidovudine treatment during pregnancy reduces vertical transmission of hiv-1 infection to the fetus. animal reproduction studies performed with lamivudine and zidovudine showed increased embryotoxicity and fetal malformations (zidovudine), and increased embryolethality (lamivudine). combivir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. antiretroviral pregnancy registry: to monitor maternal-fetal outcomes of pregna

United States - English - NLM (National Library of Medicine)

shanghai desano bio-pharmaceutical co., ltd. - 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 popul

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - lamivudine, quantity: 300 mg - tablet, film coated - excipient ingredients: magnesium stearate; propylene glycol; microcrystalline cellulose; sodium starch glycollate type a; titanium dioxide; hypromellose - lamivudine tablets in combination with other antiretroviral agents is indicated for the treatment of hiv infected adults and children.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - lamivudine, quantity: 150 mg - tablet, film coated - excipient ingredients: magnesium stearate; sodium starch glycollate type a; propylene glycol; microcrystalline cellulose; titanium dioxide; hypromellose - lamivudine tablets in combination with other antiretroviral agents is indicated for the treatment of hiv infected adults and children.

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine and zidovudine tablets a combination of 2 nucleoside analogues, are 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 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 bi