Amerika Syarikat - Inggeris - 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

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

physicians total care, 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 through 96 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)] . 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, noncomparative study

Amerika Syarikat - Inggeris - 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

Kesatuan Eropah - Inggeris - myHealthbox

merck sharp & dohme limited - lamivudine, raltegravir potassium - film-coated tablets - 150 mg of lamivudine and 300 mg of raltegravir - hiv infections - antivirals for systemic use - indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the insti (integrase strand transfer inhibitor) and nrti (nucleoside reverse transcriptase inhibitor) classes

New Zealand - Inggeris - 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.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

direct rx - 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)]. 8.1 pregnancy 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 at the recommended human dose. in both

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

redpharm drug, 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 8.1 pregnancy 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 at the recommended human dose. in both

Uganda - Inggeris - National Drug Authority

m/s hetero labs limited - raltegravir potassium - oral solid ordinary film-coated tablets - 400 mg

Singapura - Inggeris - 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

Singapura - Inggeris - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - raltegravir potassium 108.6 mg eqv raltegravir - tablet, chewable - 100 mg - raltegravir potassium 108.6 mg eqv raltegravir 100 mg