1115-RIV-01 0.5/2 mg Tablets 0.5 /2 Clonazepam 1. 1.1 / ATC code: N03AE01 1.2 1.3 1.4 1.5 clonazepam 0.5 mg 2 mg lactose lactose 2.4.1 ( ) 0.5 mg : Lactose monohydrate Maize Starch Starch pregelatinised Iron oxide red Iron oxide yellow Talc Magnesium stearate 2 mg : Lactose anhydrous Starch pregelatinised Microcrystalline cellulose Magnesium stearate 1
2. 2.1 ( petit mal)(lennox-gastaut ) (myoclonic seizures) (atonic seizures, drop syndrome) (infantile spasms, West-Syndrome) (complex partial seizures) 2.2 0.5 mg 0.5 mg 30-60 6-8 8-12 10 ( 30 kg ) 0.01-0.03 mg/kg 2 3 3 0.25-0.5m 0.1 mg/kg 0.2 mg/kg 10 ()() 10-16 1-1.5 m 2-3 3 0.25-0.5m( 3-6 mg) 1.5 mg 3 3 0.5 m 3-6 mg 20 mg 3 1-3 2
2.2.1 clonazepam ( 3.2.5 ) clonazepam clonazepam ( 2.4.1 [ ]) ( 2.6 ) 2.3 benzodiazepines 2.4 2.4.1 ( ) / / / ( 2.4.4 ) 3
2.5.4 () () ( 2.4.4 ) ( )( 2.4.3 ) / ( Lapp - ) (Porphyria) clonazepam porphyrogenic effect 2.4.2 benzodiazepines ( 2.6 )/ - 2.4.3 clonazepam 4
( 2.6 ) 2.4.4 -(DDI) Phenytoin phenobarbital carbamazepine valproate clonazepam Clonazepam sertraline fluoxetine clonazepam -(DDI) clonazepam valproic acid ( ) ( 2.4.1 [ ]) ( ) 2.7 2.5 2.5.1 clonazepam 5
2.5.2 2.5.1 2.5.3 2.5.4 2.4.1 ( ) 2.5.5 3.2.5 2.5.6 2.4.1 ( ) 2.6 2.6.1 : benzodiazepines (anaphylaxis) : ( ) : (paradoxical reaction) (vivid dreams) 2.4.2 6
: ( ) benzodiazepines : () : : clonazepam : : : : : : () ( ) : benzodiazepine ( ): 7
2.7 Benzodiazepines benzodiazepine Benzodiazepines ( ), 1-2 / flumazenil ( ) benzodiazepine flumazenil ( 1 ) Flumazenil ( ) flumazenil ( ) Benzodiazepine ( flumazenil) benzodiazepines benzodiazepine () 3. 3.1 3.1.1 Clonazepam benzodiazepines () benzodiazepines GABA clonazepam clonazepam () 8
Clonazepam EEG clonazepam 3.2 3.2.1 clonazepam Clonazepam 1-4 25 90% clonazepam Clonazepam 3 5 7 2 mg clonazepam 55 ng/ml Clonazepam Clonazepam 20 70 ng/ml Clonazepam 17 ng/ml 3.2.2 Clonazepam 0.5-1 3 / 82-86% 3.2.3 Clonazepam 7-amino-clonazepam N- 7-acetamino-clonazepam C-3 P450 3A4 clonazepam (nitroreduction) () 3.2.4 30-40 55 / 50-70% 10-30% clonazepam 2% 9
3.2.5 clonazepam clonazepam Clonazepam 3.3 3.3.1 clonazepam 2 18 300 // 3.3.2 clonazepam 3.3.3 10 100 // 3.3.4 20 40 // clonazepam - 20 // clonazepam ( )( 2.5.1 ) 10
4. 4.1 30 (EXP) 4.2 2-1000 0.5 2 003077 003078 2012 09 CDS 6.0 10.12-RIV-3-B-01 Roche Farma S.A. Severo Ochoa, 13 Poligono Industrial de Leganes 28914 Leganes/Madrid, Spain 134 9 (02)27153111 11