Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 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

Australija - anglų - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - topiramate, quantity: 100 mg - tablet, film coated - excipient ingredients: titanium dioxide; iron oxide yellow; hypromellose; colloidal anhydrous silica; magnesium stearate; macrogol 8000; croscarmellose sodium; methylcellulose; hyprolose - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as 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. prophylaxis of migraine headache in adults.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 100 mg - topiramate tablets, usp 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 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)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy category

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - topiramate 100mg;   - film coated tablet - 100 mg - active: topiramate 100mg   excipient: colloidal silicon dioxide croscarmellose sodium opadry yellow 85g32313 magnesium stearate mannitol microcrystalline cellulose pregelatinised maize starch - topiramate actavis is indicated in adults and children. topiramate actavis tablet range is not suitable for any children weighing less than 25 kg and is not suitable as monotherapy for children or adolescents weighing less than 50 kg. - as monotherapy in patients with newly diagnosed epilepsy - for conversion to monotherapy in patients with epilepsy - as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with lennox-gastaut syndrome.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - topiramate, quantity: 200 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; macrogol 8000; titanium dioxide; magnesium stearate; iron oxide red; colloidal anhydrous silica; methylcellulose; hyprolose; hypromellose - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as 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. prophylaxis of migraine headache in adults.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - topiramate, quantity: 50 mg - tablet, film coated - excipient ingredients: iron oxide yellow; hyprolose; hypromellose; methylcellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; colloidal anhydrous silica; macrogol 8000 - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as 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. prophylaxis of migraine headache in adults.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - topiramate, quantity: 25 mg - tablet, film coated - excipient ingredients: hyprolose; croscarmellose sodium; hypromellose; colloidal anhydrous silica; titanium dioxide; magnesium stearate; methylcellulose; macrogol 8000 - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as 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. prophylaxis of migraine headache in adults.

Naujoji Zelandija - anglų - Medsafe (Medicines Safety Authority)

apotex nz ltd - topiramate 100mg;   - tablet - 100 mg - active: topiramate 100mg   excipient: colloidal silicon dioxide croscarmellose sodium hyprolose hypromellose iron oxide yellow macrogol 8000 magnesium stearate methylcellulose titanium dioxide - apo-topiramate is indicated in adults and children, 2 years and over: · as monotherapy in patients with newly diagnosed epilepsy · for conversion to monotherapy in patients with epilepsy · as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with lennox-gastaut syndrome

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 200 mg - topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age 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. topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache. 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 palate (oral clefts) and for being small for gestational age. when multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofaci

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

remedyrepack inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age 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. topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache. 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 palate (oral clefts) and for being small for gestational age. when multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacia