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

remedyrepack inc. - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg

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

avera mckennan hospital - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg

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

nucare pharmaceuticals,inc. - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg - isentress® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in patients 4 weeks of age and older. - the use of other active agents with isentress is associated with a greater likelihood of treatment response [see clinical studies (14)] . none pregnancy category c isentress should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no adequate and well-controlled studies in pregnant women. in addition, there have been no pharmacokinetic studies conducted in pregnant patients. developmental toxicity studies were performed in rabbits (at oral doses up to 1000 mg/kg/day) and rats (at oral doses up to 600 mg/kg/day). the reproductive toxicity study in rats was performed with pre-, peri-, and postnatal evaluation. the highest doses in these studies produced systemic exposures in these species approximately 3- to 4-fold the exposure

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

dispensing solutions, inc. - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg - isentress® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection. this indication is based on analyses of plasma hiv-1 rna levels in three double-blind controlled studies of isentress. two of these studies were conducted in clinically advanced, 3-class antiretroviral (nnrti, nrti, pi) treatment-experienced adults through 96 weeks and one was conducted in treatment-naïve adults through 156 weeks. the use of other active agents with isentress is associated with a greater likelihood of treatment response [see clinical studies (14)] . isentress is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in children and adolescents 2 years of age and older and weighing at least 10 kg [see use in specific populations (8.4)] . this indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24-weeks in a multi-center, open-label, non

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

viiv healthcare company - dolutegravir sodium (unii: 1q1v9v5wyq) (dolutegravir - unii:dko1w9h7m1) - dolutegravir 10 mg - tivicay and tivicay pd are indicated in combination with other antiretroviral agents for the treatment of hiv‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [insti]-naïve) aged at least 4 weeks and weighing at least 3 kg [see microbiology (12.4)]. tivicay is indicated in combination with rilpivirine as a complete regimen for the treatment of hiv-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent. tivicay and tivicay pd are contraindicated in patients: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to tivicay or tivicay pd during pregnancy. healthcare providers

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

remedyrepack inc. - dolutegravir sodium (unii: 1q1v9v5wyq) (dolutegravir - unii:dko1w9h7m1) - dolutegravir 50 mg

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

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

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

viiv healthcare pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg); dolutegravir, quantity: 50 mg - tablet, film coated - excipient ingredients: macrogol 3350; silicified microcrystalline cellulose; povidone; sodium starch glycollate type a; polyvinyl alcohol; microcrystalline cellulose; magnesium stearate; lactose monohydrate; iron oxide yellow; croscarmellose sodium; iron oxide red; mannitol; purified talc; titanium dioxide; sodium stearylfumarate; polysorbate 20 - juluca (dolutegravir/rilpivirine) is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor (see section 5.1 pharmacodynamic properties, clinical trials).

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

viiv healthcare pty ltd - lamivudine, quantity: 300 mg; dolutegravir sodium, quantity: 52.6 mg (equivalent: dolutegravir, qty 50 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; povidone; mannitol; titanium dioxide; microcrystalline cellulose; sodium stearylfumarate; magnesium stearate; hypromellose; macrogol 400 - dovato (a fixed dose combination of dolutegravir and lamivudine) is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults and adolescents (from 12 years of age weighing at least 40kg): ? in antiretroviral treatment-na?ve patients with no antiretroviral treatment history who have no known or suspected resistance to either antiretroviral component; or ? to replace the current antiretroviral regimen in those who are virologically suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to the integrase inhibitor class or lamivudine (see section 5.1 pharmacodynamic properties, clinical trials).

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

viiv healthcare pty ltd - dolutegravir sodium, quantity: 10.5 mg (equivalent: dolutegravir, qty 10 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate; sodium stearylfumarate; mannitol; microcrystalline cellulose; povidone; polyvinyl alcohol; titanium dioxide; macrogol 3350; purified talc - tivicay and tivicay pd are indicated for the treatment of human immunodeficiency virus (hiv) infection in combination with other antiretroviral agents in adults and children of at least 4 weeks in age or older and weighing 3 kg or more (see section 4.4 special warnings and precautions for use, dual regimens).