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

remedyrepack inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - 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 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)] 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 tablets during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. 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 defects

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

prasco laboratories - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - 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 tablets are contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine 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 abacavir or 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 outcomes for b

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

lupin pharmaceuticals, inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - 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 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)] 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 tablets during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. 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 defe

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

lupin limited - 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)] . teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of abacavir, lamivudine and zidovudine tablets in pregnant women. reproduction studies with abacavir, lamivudine, and zidovudine have been p

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

arrotex pharmaceuticals pty ltd - lamivudine, quantity: 300 mg; abacavir sulfate, quantity: 702.76 mg (equivalent: abacavir, qty 600 mg) - tablet, film coated - excipient ingredients: hypromellose; titanium dioxide; sunset yellow fcf aluminium lake; macrogol 8000; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose - abacavir and lamivudine combination tablets are a combination of two nucleoside analogues (abacavir and lamivudine). ,abacavir and lamivudine combination tablets are indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age.

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

cipla usa inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - 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 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)] 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 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 abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan at

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

aurobindo pharma limited - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - 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 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)] 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 atl

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

teva pharmaceuticals usa, inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - 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 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)] 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 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 abacavir or lamivudine compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital de

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

avkare - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - 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 tablets are contraindicated in patients:abacavir and lamivudine tablets are contraindicated in patients: - who have the hla-b*5701 allele [see warnings and precautions ( 5.1)]. 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 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)]. with moderate

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

state of florida doh central pharmacy - 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. additional important information on the use of abacavir tablets for treatment of hiv-1 infection: - abacavir tablets are one of multiple products containing abacavir. before starting abacavir tablets, 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 [see warnings and precautions (5.1), adverse reactions (6)]. abacavir tablets are contraindicated in patients with: - previously demonstrated hypersensitivity to abacavir or any other component of the products. never restart abacavir tablets or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of hla-b*5701 status [see warnings and precautions (5.1), adverse reactions (6)]. - moderate or severe hepatic impairment [see dosage and administration (2.3)