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

merck sharp & dohme llc - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg - adult patients: isentress® and isentress® hd are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients. pediatric patients: isentress is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 2 kg. isentress hd is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 40 kg. none pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women. 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 rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital d

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

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 651.6 mg (equivalent: raltegravir, qty 600 mg) - tablet, film coated - excipient ingredients: hypromellose; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; carnauba wax; titanium dioxide; lactose monohydrate; triacetin; iron oxide yellow; iron oxide black - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

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

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 434.4 mg (equivalent: raltegravir, qty 400 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; calcium hydrogen phosphate; hypromellose; poloxamer; sodium stearylfumarate; magnesium stearate; butylated hydroxytoluene; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

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

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 108.6 mg (equivalent: raltegravir, qty 100 mg) - tablet, chewable - excipient ingredients: hyprolose; sucralose; saccharin sodium; sodium citrate dihydrate; mannitol; sodium stearylfumarate; magnesium stearate; iron oxide yellow; crospovidone; iron oxide red; purified water; strong ammonia solution; ethylcellulose; oleic acid; medium chain triglycerides; sorbitol; ammonium glycyrrhizinate; fructose; flavour; hypromellose; macrogol 400 - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

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

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 27.16 mg (equivalent: raltegravir, qty 25 mg) - tablet, chewable - excipient ingredients: hyprolose; sucralose; saccharin sodium; sodium citrate dihydrate; mannitol; sodium stearylfumarate; magnesium stearate; iron oxide yellow; crospovidone; purified water; strong ammonia solution; ethylcellulose; oleic acid; medium chain triglycerides; sorbitol; ammonium glycyrrhizinate; fructose; flavour; hypromellose; macrogol 400 - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - raltegravir potassium 434.4mg equivalent to raltegravir 400 mg;   - film coated tablet - 400 mg - active: raltegravir potassium 434.4mg equivalent to raltegravir 400 mg   excipient: calcium hydrogen phosphate hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink poloxamer 407 sodium stearyl fumarate - isentress is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection.

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

Canada - English - Health Canada

merck canada inc - raltegravir (raltegravir potassium) - tablet - 400mg - raltegravir (raltegravir potassium) 400mg - hiv integrase inhibitors

Canada - English - Health Canada

merck canada inc - raltegravir (raltegravir potassium) - tablet (chewable) - 25mg - raltegravir (raltegravir potassium) 25mg - hiv integrase inhibitors