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

american health packaging - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - abacavir 300 mg - abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv-1) infection. abacavir 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)]. - with moderate or severe hepatic impairment [see use in specific populations (8.6)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir 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 abacavir compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see dat

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

zydus lifesciences limited - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. abacavir and lamivudine is 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)] or lamivudine. - 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 and 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 abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital

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

zydus pharmaceuticals usa inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection. abacavir and lamivudine is 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)] or lamivudine. - 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 and 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 abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital

Ireland - English - HPRA (Health Products Regulatory Authority)

generics (uk) limited - abacavir sulfate ; lamivudine - film coated tablet - 600mg/300 milligram - lamivudine and abacavir

United States - English - 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

Kenya - English - Pharmacy and Poisons Board

abacavir sulfate and lamivudine tablets for oral… - tablet for oral suspension - abacavir sulfate usp equivalent to abacavir… - lamivudine and abacavir

Kenya - English - Pharmacy and Poisons Board

aurobindo pharma ltd aurobindo - abacavir sulfate usp and lamivudine usp - film-coated tablet - abacavir sulfate 600 mg and lamivudine 300 mg - lamivudine and abacavir

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - abacavir sulfate; lamivudine - film-coated tablet - 600 mg/300 milligram(s) - antivirals for treatment of hiv infections, combinations; lamivudine and abacavir

United States - English - 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

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

sun pharma anz pty ltd - abacavir sulfate,lamivudine -