European Union - English - 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

European Union - English - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudine, raltegravir potassium - hiv infections - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis is 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 (see sections 4.2, 4.4 and 5.1).

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.

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

remedyrepack inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - lamivudine tablet is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-l) infection.   limitation of use: the dosage of this product is for hiv-1and not for hbv. lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. teratogenic effects pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry at 1-800-258-4263.  risk summary available data from the antiretroviral pregnancy registry show no difference in the risk of overall major birth defects for lamivudine compared with the background rate for major birth defects of 2.7% in the us reference population of the metropolitan atlanta congenital defects program (macdp). lamivudine produced embryonic toxicity in rabbits at

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

camber pharmaceuticals, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - lamivudine tablet is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-l) infection. limitations of use: • the dosage of this product is for hiv-1 and not for hbv. lamivudine tablets are contraindicated in patients with a previous hypersensitivity reaction to lamivudine. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine 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 lamivudine 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 u.s. reference population for birth defects in the general popu

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

lannett company, inc. - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 10 mg in 1 ml - lamivudine oral solution, usp is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection.  limitations of use:   -  the dosage of this product is for hiv-1 and not for hbv. lamivudine oral solution is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. pregnancy exposure registry   there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine 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 lamivudine 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 u.s. reference population for birth defects in the gene

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

state of florida doh central pharmacy - lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95) - lamivudine 150 mg - lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection. limitation of use: the dosage of this product is for hiv-1 and not for hbv. lamivudine tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., anaphylaxis) to any of the components of the products. pregnancy category c there are no adequate and well-controlled studies of lamivudine tablets in pregnant women. animal reproduction studies in rats and rabbits revealed no evidence of teratogenicity. increased early embryolethality occurred in rabbits at exposure levels similar to those in humans. lamivudine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. lamivudine pharmacokinetics were studied in pregnant women during 2 clinical studies conducted in south africa. the study assessed pharmacokinetics in: 16 women at 36 week