美国 - 英文 - NLM (National Library of Medicine)

prinston pharmaceutical inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 250 mg - levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children four 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 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 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 (5.9)]. there are no adequate and well-controlled studie

美国 - 英文 - NLM (National Library of Medicine)

physicians total care, 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 ≥ 16 years of age with epilepsy. none teratogenic effects 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 (approximately equivalent to the maximum recommended human dose of 3000 mg [mrhd] on a mg/m2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (

美国 - 英文 - NLM (National Library of Medicine)

physicians total care, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam tablets, usp are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. levetiracetam tablets, usp are 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 tablets, usp are 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 (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 should be used during pregnancy only if the potential benefit justifies the potent

美国 - 英文 - NLM (National Library of Medicine)

solco healthcare u.s., llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam extended-release tablets are indicated for the treatment of partial-onset 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 registri

美国 - 英文 - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam tablets are contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4) ]. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam 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/. ri

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - levetiracetam, quantity: 10 % w/v - injection, concentrated - excipient ingredients: glacial acetic acid; sodium chloride; water for injections; sodium acetate trihydrate - 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.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - levetiracetam, quantity: 100 mg/ml - solution - excipient ingredients: propyl hydroxybenzoate; purified water; ammonium glycyrrhizinate; acesulfame potassium; methyl hydroxybenzoate; sodium citrate dihydrate; glycerol; citric acid monohydrate; maltitol; flavour - levetiracetam gh 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),,? add-on therapy in the treatment of primary generalized tonic clonic (pgtc) seizures in adults and,children from 4 years of age with idiopathic generalized epilepsy (ige)

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - levetiracetam, quantity: 100 mg/ml - injection, concentrated - excipient ingredients: glacial acetic acid; water for injections; sodium chloride; sodium acetate trihydrate - levetiracetam (film-coated tablets and 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 sun concentrated injection after dilution is an alternative for patients when oral administration is temporarily not feasible.

美国 - 英文 - NLM (National Library of Medicine)

remedyrepack inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam 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 tablets 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. however, due to ucb inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. levetiracetam 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 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 blood levels may decrease during pregnancy [see warnings and precautions (5.9)]. p r e gnancy category c there are no adequate a

美国 - 英文 - NLM (National Library of Medicine)

pharmtak, 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) ]. extended-release levetiracetam tablets levels may decrease during pregnancy [see warnings and precautions (5.9) ]. 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