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

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.

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.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - raltegravir as potassium - film coated tablets - raltegravir as potassium 400 mg - raltegravir - raltegravir - isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients.this indication is based on safety and efficacy data from two double-blind, placebo-controlled trials in treatment-experienced patients and one double-blind, active-controlled trial in treatment-naive patients.

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - raltegravir potassium 434.4mg eqv free phenol - tablet, film coated - 400 mg - raltegravir potassium 434.4mg eqv free phenol 400 mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme ltd - raltegravir - tablet - 400mg

Canada - English - Health Canada

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

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

state of florida doh central pharmacy - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg - isentress1 is indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients. this indication is based on analyses of plasma hiv-1 rna levels up through 48 weeks 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 and one was conducted in treatment-naïve adults. the use of other active agents with isentress is associated with a greater likelihood of treatment response [see clinical studies (14)] . the safety and efficacy of isentress have not been established in pediatric patients. registered trademark of merck & co., inc. copyright © 2007, 2009 merck & co., inc. all rights reserved 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 addi

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

h.j. harkins company inc. - 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 4 weeks of age and older. 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 8.1 pregnancy 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 atlant

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

hetero labs limited - raltegravir (potÁsico) - raltegravir (potÁsico)....400 mg