Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

natco pharma limited - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide 50 mg - lacosamide is indicated in patients 17 years and older with partial-onset seizures as adjunctive therapy. none. pregnancy category c lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures. lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. there are no adequate and well-controlled studies in pregnant women. lacosamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. or

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

indoco remedies limited - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. pediatric use information is approved for ucb, inc.’s vimpat® (lacosamide) injection. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none.   pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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   there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. devel

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

major pharmaceuticals - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.'s vimpat® (lacosamide) tablet. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. de

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

fresenius kabi usa, llc - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. pediatric use information is approved for ucb, inc.'s vimpat ® (lacosamide) injection. however, due to ucb, inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide 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 there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women. lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. develo

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - lacosamide, quantity: 50 mg - tablet, film coated - excipient ingredients: magnesium stearate; crospovidone; microcrystalline cellulose; hyprolose; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black; indigo carmine aluminium lake - lacosamide film-coated tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - lacosamide, quantity: 200 mg - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; crospovidone; hyprolose; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - lacosamide film-coated tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - lacosamide, quantity: 100 mg - tablet, film coated - excipient ingredients: crospovidone; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; hyprolose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - lacosamide film-coated tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - lacosamide, quantity: 150 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; hyprolose; crospovidone; magnesium stearate; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - lacosamide film-coated tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - lacosamide, quantity: 150 mg - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; hyprolose; crospovidone; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - lacosamide film-coated tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - lacosamide, quantity: 100 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; hyprolose; crospovidone; magnesium stearate; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - lacosamide film-coated tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.