Malta - Ingliż - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - topiramate - film-coated tablet - topiramate 100 mg - antiepileptics

Malta - Ingliż - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - topiramate - film-coated tablet - topiramate 200 mg - antiepileptics

Stati Uniti - Ingliż - NLM (National Library of Medicine)

state of florida doh central pharmacy - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets, usp and topiramate capsules (sprinkle) are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1) ]. topiramate tablets, usp and topiramate capsules (sprinkle) are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.2) ]. none. pregnancy category d . [see warnings and precautions (5.7)]   topiramate can cause fetal harm when administered to a pregnant woman. data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft

Stati Uniti - Ingliż - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets, usp and topiramate capsules (sprinkle) are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies (14.1) ]. topiramate tablets, usp and topiramate capsules (sprinkle) are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies (14.2)] none.  pregnancy category d.[see warnings and precautions (5.6)] topiramate can cause fetal harm when administered to a pregn

Stati Uniti - Ingliż - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-free number 1-888-233-2334. information about the north american drug pregnancy

Stati Uniti - Ingliż - NLM (National Library of Medicine)

american health packaging - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-fr

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - topiramate, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; lactose; saccharin sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; xanthan gum; polyvinyl alcohol; iron oxide black; lecithin; flavour - epilepsy (adults and children 2 years and over),? monotherapy in patients with newly diagnosed epilepsy,? conversion to monotherapy in patients with epilepsy,? add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.,migraine (adult),prophylaxis of migraine headache in adults. the usefulness of topiramate in the acute treatment of migraine headache has not been studied.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - topiramate, quantity: 100 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; lactose; saccharin sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; iron oxide black; lecithin; flavour - epilepsy (adults and children 2 years and over),? monotherapy in patients with newly diagnosed epilepsy,? conversion to monotherapy in patients with epilepsy,? add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.,migraine (adult),prophylaxis of migraine headache in adults. the usefulness of topiramate in the acute treatment of migraine headache has not been studied.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - topiramate, quantity: 50 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; lactose; saccharin sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; iron oxide black; lecithin; flavour - epilepsy (adults and children 2 years and over),? monotherapy in patients with newly diagnosed epilepsy,? conversion to monotherapy in patients with epilepsy,? add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.,migraine (adult),prophylaxis of migraine headache in adults. the usefulness of topiramate in the acute treatment of migraine headache has not been studied.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - topiramate, quantity: 25 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; lactose; saccharin sodium; magnesium stearate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; flavour - epilepsy (adults and children 2 years and over),? monotherapy in patients with newly diagnosed epilepsy,? conversion to monotherapy in patients with epilepsy,? add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.,migraine (adult),prophylaxis of migraine headache in adults. the usefulness of topiramate in the acute treatment of migraine headache has not been studied.