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

aft pharmaceuticals pty ltd - levetiracetam, quantity: 10 % w/v - oral liquid, solution - excipient ingredients: acesulfame potassium; propyl hydroxybenzoate; purified water; maltitol solution; glycerol; sodium citrate dihydrate; methyl hydroxybenzoate; ammonium glycyrrhizinate; citric acid monohydrate; flavour - levetiracetam-aft oral solution is indicated for:,use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme),and,add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (ige).,levetiracetam-aft concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

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

thame laboratories ltd - levetiracetam - oral solution - 100mg/1ml

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

accord healthcare ltd - levetiracetam - oral solution - 100mg/1ml

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

roxane laboratories, inc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for ucb, inc.’s levetiracetam tablets and oral solution. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam oral solution, usp is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. none. levetiracetam levels may decrease during pregnancy [see warnings and precautions (

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

apotex corp. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older. levetiracetam extended-release tablets are contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam extended-release tablets, during pregnancy. encourage women who are taking levetiracetam extended-release tablets during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary prolonged experience with levetiracetam tablets in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy re

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

florida pharmaceutical products, llc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam extended-release tablets usp are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. none. levetiracetam extended-release levels may decrease during pregnancy [ see warnings and   precautions ( 5.8 ) ] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (equivalent to the maximum recommended human dose of 3000 mg [mrhd]

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

avkare, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam extended-release tablets usp are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. none. levetiracetam extended-release levels may decrease during pregnancy [ see warnings and   precautions ( 5.8 ) ] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (equivalent to the maximum recommended human dose of 3000 mg [mrhd]

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

intellipharmaceutics corp. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam extended-release tablets usp is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. levetiracetam extended-release tablets is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4) ]. levetiracetam extended-release tablets levels may decrease during pregnancy [see warnings and precautions (5.9) ]. pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal

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

lotus pharmaceutical co., ltd. nantou plant - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 750 mg - levetiracetam extended-release tablets is indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. none. levetiracetam extended-release tablets levels may decrease during pregnancy [see warnings and precautions (5.8) ]. pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (equivalent to the maximum recommended human dose of 3,000 mg [mrhd] on a mg/m2 basis) and with

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

actavis pharma, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. levetiracetam extended-release tablets are contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4) ]. levetiracetam extended-release tablets levels may decrease during pregnancy [see  warnings and precautions (5.9) ]. pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal