DIAZEPAM Solution for injection

Active ingredients: Diazepam

Product name and form

Diazepam 5mg/ml Solution for Injection.

Pharmaceutical Form

Solution for Injection.

Clear, colourless to pale yellow liquid.

Qualitative and quantitative composition

Diazepam 5mg/ml.

Excipients – Contains Benzoic acid (E210) 1mg/ml, Ethanol 96% 100mg/ml, Sodium benzoate (E211) 49mg/ml, Benzyl alcohol 15mg/ml, Propylene glycol 400mg/ml and Sodium Content – 0.34mmol/ml.

For a full list of excipients, see section 6.1.

Active Ingredient
Description

Diazepam is a psychotropic substance from the class of 1,4-benzodiazepines with marked properties of suppression of tension, agitation and anxiety as well as sedative and hypnotic effects. In addition, diazepam demonstrates muscle relaxant and anticonvulsive properties. It is used in the short-term treatment of anxiety and tension states, as a sedative and premedicant, in the control of muscle spasm and in the management of alcohol withdrawal symptoms.

List of Excipients

Benzoic acid (E210)
Ethanol
Propylene glycol
Sodium benzoate (E211)
Benzyl alcohol
Water for Injections

Pack sizes and marketing

Amber Type I PhEur glass ampoules (2ml or 4ml) packed in 10s in an outer printed carton.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Marketing authorization dates and numbers

PL 29831/0065

Date of first authorisation: 30/05/1985
Date of latest renewal: 09/03/2005