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

redpharm drug, inc. - emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 17 kg [see clinical studies ( 14)] . emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection. individuals must have a negative hiv-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep [see dosage and administration ( 2.2), warnings and precautions ( 5.2)]. emtricitabine and tenofovir disoproxil fumarate tablets for hiv-1 prep is contraindicated in individuals with unknown or positive hiv-1 status [see warnings and precautions ( 5.2)] . pregnancy  exposure  registry there is a pregnancy exposure regist

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

strides pharma science limited - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - abacavir 300 - 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 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 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

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

apotex corp - 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 data). the apr uses the macdp a

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)

camber 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 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 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 major birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data). the apr

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

mylan institutional inc. - carbamazepine (unii: 33cm23913m) (carbamazepine - unii:33cm23913m) - carbamazepine 200 mg - carbamazepine tablets usp and carbamazepine tablets usp (chewable) are indicated for use as an anticonvulsant drug. evidence supporting efficacy of carbamazepine tablets usp and carbamazepine tablets usp (chewable) as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - partial seizures with complex symptomatology (psychomotor, temporal lobe). patients with these seizures appear to show greater improvement than those with other types. - generalized tonic-clonic seizures (grand mal). - mixed seizure patterns which include the above, or other partial or generalized seizures. absence seizures (petit mal) do not appear to be controlled by carbamazepine tablets usp and carbamazepine tablets usp (chewable) (see precautions , general ). carbamazepine tablets usp and ca

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)

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

aurobindo pharma limited - 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 data) . the apr uses the macdp as the

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)

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