Dolethal 200mg/ml Solution for injection

Introduction

Company name: Vétoquinol UK Ltd

Address: Vétoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

Telephone: 01280 814500

Fax: 01280 825460

Email: office@vetoquinol.co.uk

Website: www.vetoquinol.co.uk

Presentation

A pink liquid solution for injection containing 200mg/ml pentobarbital sodium

Other constituents include: benzyl alcohol 10.40mg/ml and ponceau 4R (E124) 0.01mg/ml

Uses

For euthanasia of small animals (mainly dogs and cats) and cattle.

Dosage and administration

0.7 ml per kg bodyweight by rapid intravenous injection. The product solution is not intended for dilution with water or any other fluid.

Contra-indications, warnings, etc

Not to be used in animals intended for human consumption.

Do not use for anaesthesia.

Special precautions for use in animals

Any volume administered outside the vein will reduce the efficacy of the dose.

Operator warnings

Wear suitable protective gloves when handling the product. Avoid accidental self-administration and self-injection.

In the case of accidental self-administration, by injection, ingestion or skin absorption, seek URGENT medical attention, advising medical service of barbiturate poisoning.

In the event of an accident the following action should be taken:

Skin Wash immediately with water and then thoroughly with soap and water

Eyes Wash immediately with cold water and obtain medical attention

Ingestion Obtain medical attention immediately. Wash out mouth. Keep warm and rest.

Accidental Self-injection Obtain URGENT medical attention, advising medical services of barbiturate poisoning. Do not leave patient unattended.

Advice to Doctor Maintain airways and give symptomatic and supportive treatment

Interaction with other medicinal products and other forms of interaction

The effects of the product are increased by concomitant administration of sedatives (xylazine or acepromazine).

Overdose (symptoms, emergency procedures, antidotes) if necessary

In the event of accidental administration to an animal not presented for euthanasia, measures such as artificial respiration, administration or oxygen and the use of analeptics are appropriate.

Withdrawal periods

Not to be used in animals intended for human consumption.

Pharmaceutical precautions

The product solution is not intended for dilution with water or any other fluid.

Protect from light.

Following withdrawal of the first dose, use the product within 3 months. Discard unused materials.

Any unused product must be destroyed in accordance with the Misuse of Drugs Regulations (2001). Any waste materials should be disposed of in accordance with local requirements.

Legal category

POM-V CD(Sch 3)

Packaging Quantities

Cartons containing colourless multidose glass bottles containing 100 or 250ml non-sterile aqueous solution. Not all pack sizes may be marketed.

Further information

The active ingredient in Dolethal is pentobarbital, which is a barbiturate. Barbiturates act by depressing the central nervous system, inhibiting accumulation of calcium in nervous tissue, which leads to liberation of norepinephrine, acetylcholine, glutamate and gamma-aminobutyric acid. This leads to sedation and coma.

Barbiturates also act on cardiac and respiratory systems bringing on apnoea and cardiac arrest.

Marketing authorisation number

Vm 08007/4034.

GTIN (Global Trade Item No)

Dolethal

03605870004720