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

lupin pharmaceuticals, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s), abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - lamivudine 150 mg - abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. limitations of use: - limited data exist on the use of abacavir, lamivudine and zidovudine tablets alone in patients with higher baseline viral load levels (greater than 100,000 copies per ml) [see clinical studies (14)] . abacavir, lamivudine and zidovudine tablets are contraindicated in patients: - who have the hla-b*5701 allele [see warnings and precautions (5.1)]. - with prior hypersensitivity reaction to abacavir [see warnings and precautions (5.1)], lamivudine, or zidovudine. - with moderate or severe hepatic impairment [see use in specific populations (8.7)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir, lamivudine and zidovudine tablets during pregnancy. healthcare providers are encouraged to register patients

Bélgica - inglés - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - zidovudine 300 mg; lamivudine 150 mg - film-coated tablet - 150 mg - 300 mg - zidovudine 300 mg; lamivudine 150 mg - zidovudine and lamivudine

Nueva Zelanda - inglés - Medsafe (Medicines Safety Authority)

viatris limited - lamivudine 150mg; zidovudine 300mg - film coated tablet - active: lamivudine 150mg zidovudine 300mg excipient: colloidal silicon dioxide magnesium stearate microcrystalline cellulose opadry white propylene glycol purified water sodium starch glycolate - indicated for the treatment of hiv infected adults and adolescents over the age of 12 years, with progressive immunodeficiency (cd4+ count = < 500 cells/mm³).

Malta - inglés - Malta Medicines Authority

accord healthcare limited - lamivudine; zidovudine - film-coated tablet - lamivudine 150 mg; zidovudine 300 mg - antivirals for systemic use

Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

aurobindo pharma ltd - zidovudine - capsule - 100mg

Reino Unido - inglés - MHRA (Medicines & Healthcare Products Regulatory Agency)

aurobindo pharma ltd - zidovudine - capsule - 250mg

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

nucare pharmaceuticals,inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), zidovudine (unii: 4b9xt59t7s) (zidovudine - unii:4b9xt59t7s) - lamivudine 150 mg - lamivudine and zidovudine tablets, usp a combination of two nucleoside analogues, are indicated in combination with other antiretrovirals for the treatment of hiv-1 infection. lamivudine and zidovudine tablets, usp 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 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). lamivudine and zidovudine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. antiretrovi

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

pd-rx pharmaceuticals, inc. - 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 defects in the general population.

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

lake erie medical dba quality care products llc - 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 category c pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263. fetal risk summary there are no adequate and well-controlled trials of 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 embryot

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

remedyrepack inc. - 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 defects in the general population.