Χώρα: Ινδονησία
Γλώσσα: Ινδονησιακά
Πηγή: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 VIAL @ 5 ML
2023-01-25
1 LEVEXA LEVETIRACETAM INJECTION COMPOSITION : LEVEXA Injection 100 mg/mL, each mL contains : Levetiracetam 100 mg. DESCRIPTION OF THE DOSAGE FORM LEVEXA Injection 100 mg/mL is a clear colorless solution in Type 1, 5 mL tubular glass vials sealed with 20 mm grey serum rubber stoppers and blue color flip off aluminum seal. The excipients ingredients include sodium chloride, sodium acetate trihydrate, glacial acetic acid, water for injection. PHARMACOLOGY : MECHANISM OF ACTION The active substance, Levetiracetam, is a pyrrolidone derivative (S-enantiomer of alfa-ethyl-2- oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances. The mechanism of action of Levetiracetam still remains to be fully elucidated. In vitro and in vivo experiments suggest that Levetiracetam does not alter basic cell characteristic and normal neurotransmission. In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N-type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores. In addition, it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β- carbolines. Furthermore, Levetiracetam has been shown in in vitro studies to bind to a specific site in rodent brain tissue. This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis. Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti -seizure protection in the mouse audiogenic model of epilepsy. This finding suggests that the interaction between levetiracetam and the synaptic vesicle protein 2A seems to contribute to the antiepileptic mechanism of action of the medicinal product. PHARMACOKINETICS (LEVETIRACETAM TABLET) This study was designed as a randomized, single blind, two periods, single dose, two-period, two-treatment, two-sequence, cross-over study with one week washout period Διαβάστε το πλήρες έγγραφο