Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
DIAZEPAM
CP Pharmaceuticals Ltd trading as Wockhardt UK
20 Milligram
Rectal Solution
1997-09-05
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diazepam RecTubes 20mg Rectal Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diazepam 20 mg in 5.0 ml (4mg/ml). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Rectal solution A clear, colourless or almost yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diazepam rectal tubes may be used in severe or disabling anxiety and agitation; epileptic and febrile convulsions; to relieve muscle spasm caused by tetanus; as a sedative in minor surgical and dental procedures, or other circumstances in which a rapid effect is required but where intravenous injection is impracticable or undesirable. Diazepam rectal tubes may be of particular value for the immediate treatment of convulsions in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage depends on age and weight. Children: 0.5mg/kg. (Not recommended for use in children less than one year old) Adults: 0.5mg/kg. If convulsions are not controlled other anticonvulsive measures should be instituted. The dose can be repeated every 12 hours. Elderly and debilitated patients should be given not more than one half the appropriate adult dose. Dosage reduction may also be required in patients with liver or kidney dysfunction. The solution is administered rectally. Adults should be in the lateral position; children should be in the prone or lateral position. (a) Tear open the foil pack. Remove the cap. (b) Insert the tube nozzle completely into the rectum. For children under 15kg, insert only half way. Hold the tube with the spout downwards. The contents of the tube should be completely IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/01/2007_ _CRN 20 Přečtěte si celý dokument