Diazepam desitin

Shelf life

3 years.

Incompatibilities

None known.

List of excipients

Benzyl alcohol

Ethanol (96%)

Propylene glycol

Benzoic acid

Sodium benzoate

Purified Water

Preclinical safety data

Chronic toxicity studies in animals have demonstrated no evidence of drug-induced changes. There are no long-term animal studies to investigate the carcinogenic potential of diazepam. Several investigations pointed to a weakly mutagenic potential at doses far above the human therapeutic dose.

Local tolerability has been studied following single and repeat dose applications into the conjunctival sac of rabbits and the rectum of dogs. Only minimal irritation was observed. There were no systemic changes.

Date of revision of the text

04/12/2011

Marketing authorisation holder

Desitin Arzneimittel GMBH

Weg beim Jäger 214

22335 Hamburg

Germany

Special precautions for storage

Do not store above 25 °C.

Short-term exposure to higher temperatures (e.g. in emergencies), is of no consequence.

Nature and contents of container

Pack of 5 rectal tubes. Each tube contains 2.5 ml solution.

The tubes are made of low density polyethylene.

Marketing authorisation number(s)

PL 14040/0002

Special precautions for disposal and other handling

The foil should be removed only before use.

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. Unscrew the cap and remove.

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 emptied by using firm pressure with the index finger and thumb.

c) To avoid suction, maintain pressure on the tube until it is withdrawn from the rectum. Press together the patients buttocks for a short time.

Date of first authorisation/renewal of the authorisation

22/03/2007