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

viiv healthcare company - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), dolutegravir sodium (unii: 1q1v9v5wyq) (dolutegravir - unii:dko1w9h7m1), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - triumeq and triumeq pd are indicated for the treatment of hiv-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg. limitations of use: triumeq and triumeq pd alone are not recommended in patients with resistance‑associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (insti) resistance because the dose of dolutegravir in triumeq and triumeq pd is insufficient in these subpopulations. see full prescribing information for tivicay (dolutegravir). triumeq and triumeq pd are contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to triumeq during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1‑800‑258‑4263. risk summary data from an ongoing birth outcome surveillance study has identified an increased risk of neural tube defects when dolutegravir, a componen

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)

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

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

viiv healthcare pty ltd - abacavir sulfate, quantity: 702 mg (equivalent: abacavir, qty 600 mg); lamivudine, quantity: 300 mg; dolutegravir, quantity: 50 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; povidone; magnesium stearate; purified water; mannitol; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - triumeq is indicated for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-na?ve or are infected with hiv without documented or clinically suspected resistance to any of the three antiretroviral agents (dolutegravir, abacavir or lamivudine) in triumeq.

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

mylan pharmaceuticals inc. - 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: 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. 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 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 births that occurred at less than 20 weeks’ gestation. the rate of miscarriage is not reported in the apr. the estim

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

cipla usa inc. - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - abacavir 300 mg - abacavir tablets usp 300 mg, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv-1) infection. abacavir tablet 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)] . - 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 sulfate 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)

aurobindo pharma limited - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - abacavir 20 mg in 1 ml - abacavir oral solution, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection. abacavir oral solution 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)]. - 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 data). the apr uses the macd

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

glaxo operations uk ltd - dolutegravir sodium (unii: 1q1v9v5wyq) (dolutegravir - unii:dko1w9h7m1) - dolutegravir 50 mg

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

a-s medication solutions - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs), dolutegravir sodium (unii: 1q1v9v5wyq) (dolutegravir - unii:dko1w9h7m1), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - abacavir 600 mg - triumeq is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and in pediatric patients weighing at least 40 kg. limitations of use: triumeq is contraindicated in patients:   pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to triumeq during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1‑800‑258‑4263. risk summary preliminary data from an observational study has identified a possible increased risk of neural tube defects when dolutegravir, a component of triumeq, is administered at the time of conception compared with non-dolutegravir-containing antiretroviral regimens. as defects related to closure of the neural tube occur from conception through the first 6 weeks of gestation, embryos exposed to dolutegravir from the time of conception through the first 6 weeks of gestation are at potential risk. in addition, 2

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - abacavir sulfate 702mg equivalent to abacavir 600 mg;  ; dolutegravir sodium 52.6mg equivalent to dolutegravir 50 mg;  ;  ;  ; lamivudine 300mg;   - film coated tablet - 50mg/600mg/300mg - active: abacavir sulfate 702mg equivalent to abacavir 600 mg   dolutegravir sodium 52.6mg equivalent to dolutegravir 50 mg       lamivudine 300mg   excipient: magnesium stearate mannitol microcrystalline cellulose opadry purple 85f90057 povidone sodium starch glycolate - triumeq is indicated for the treatment of human immunodeficiency virus (hiv) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-na?ve or are infected with hiv without documented or clinically suspected resistance to any of the three antiretroviral agents (dolutegravir, abacavir or lamivudine) in triumeq.