Introduction

Dechra

Company name: Dechra Veterinary Products

Address: (A business unit of Dechra Pharmaceuticals PLC)

Cartmel Drive

Harlescott

Shrewsbury SY1 3TB

Telephone: 01743 441632

Fax: 01743 462111

Email: info@dechra-uk.com

Website: www.dechra-uk.com

Presentation

Somulose is a clear, straw coloured solution for injection containing:

Secobarbital Sodium (Quinalbarbitone)	400 mg/ml
Cinchocaine Hydrochloride	25 mg/ml

Uses

Somulose is indicated for euthanasia of cats, dogs, horses and cattle.

Secobarbitone is a hypnotic derivative of barbituric acid with a rapid onset of action, which profoundly depresses the central nervous system, including the respiratory centres.

Cinchocaine has marked cardiotoxic effects at high doses. When given in combination, the barbiturate produces rapid loss of consciousness and cessation of respiration while the Cinchocaine depresses the cardiac conduction resulting in early cardiac arrest. Since cardiac arrest is not dependent on development of profound hypoxia, euthanasia with Somulose is generally not accompanied with the gasping which may occur with other agents.

Dosage and administration

Somulose is for intravenous administration only.

Recommended dose:

Dogs and cats intravenously: 0.25 ml/kg body weight

Horses and cattle intravenously: 1.0 ml/10 kg body weight

N.B. Speed of injection is very important. Administer the full dose over 10–15 seconds, in order to minimise premature cardiac arrest. Additionally, an injection rate that is too slow may induce normal collapse, but prolong the period until death. It is always advisable to have an alternative method of euthanasia available.

As with other methods of euthanasia, care should be taken not to excite the animal during preparation. Many authorities recommend that the procedure should be carried out in familiar surroundings, avoiding harsh lights and sudden noises where possible. During the preparation and administration, it is often helpful to handle the animal carefully, but firmly, comforting it with gentle talk and coaxing as one would for the quiet induction of anaesthesia. This can also serve to calm apprehensive animals.

Once the required dose has been withdrawn from the vial, the mini-spike or needle should be removed from the syringe and discarded into a closed container. A sterile catheter should then be inserted into the injection site, and the syringe connected to it. Perivascular administration of Secobarbitone may delay the onset of effect and cause pain and result in excitement. Placement of a venous catheter is therefore recommended and care should be taken to ensure (by aspiration) that the injection is correctly placed in the vein.

In horses and cattle the use of a pre-placed 14 gauge jugular catheter is strongly recommended. In horses, the administration of detomidine, or suitable alternative, by slow IV injection is recommended to produce profound sedation prior to euthanasia. However, this may produce a slower onset of euthanasia.

Contra-indications, warnings, etc

Somulose must not be used for anaesthesia, it is non-sterile.

Operator warnings: This is a potent drug which is highly toxic in man. Extreme care should be taken to avoid accidental self-administration.

Use an intravenous catheter instead of a needle whenever possible.

Due to rapid onset of Secobarbitone effect if accidentally self-administered, this product should only be administered in the presence of an assistant/other individual.

Wear suitable protective gloves when handling the product.

Wash off splashes from skin and eyes immediately.

In the event of accidental self-administration, by injection or skin absorption, seek urgent medical assistance advising medical service of barbiturate and local anaesthetic poisoning and show the label.

Advice to doctor: Do not leave patient unattended. Maintain airways and give symptomatic and supportive treatment.

Cinchocaine can cause hypersensitivity following skin contact. Hypersensitivity to Cinchocaine may lead to contact dermatitis, which can become severe. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

Handle this product with great care to avoid exposure, taking all recommended precautions.

If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes, or difficulty breathing may occur, although these have not been reported and are more serious symptoms that require urgent medical attention.

Wash hands after use.

General precautions: For animal treatment only.

Withdrawal period: Not to be used in animals intended for human or animal consumption. Treated animals may never be slaughtered for human or animal consumption. Horses must have been declared as not intended for human consumption under national horse passport legislation.

Pharmaceutical precautions

Store between 10 and 25°C. Do not refrigerate or freeze. Protect from frost. Protect from light. Keep out of the reach and sight of children.

When the container is broached for the first time, the date on which any product remaining in the container should be discarded should be calculated. This discard date should be written in the space provided on the label.

Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Do not use if the solution is not clear or if any sediment is observed.

Disposal: Dispose of any part used product and empty containers in accordance with national requirements.

It is strongly recommended that carcasses of animals euthanased with Somulose are incinerated.

Dispose of any unused product in accordance with the Misuse of Drugs Regulations 2001.

Legal category

POM-V

Packaging Quantities

Vials containing 25 ml and 50 ml.

Further information

CD (Sch. 2).

Veterinary medicinal product authorised for use in UK and Ireland.

To be supplied only on veterinary prescription.

Manufacturer: Dales Pharmaceuticals, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, UK.