Introduction

Company name: Virbac Limited

Address: Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk

IP30 9UP

Telephone: 01359 243243

Fax: 01359 243200

Website: www.virbac.co.uk

Presentation

Virbaxyl 10% is a clear, colourless aqueous solution for injection. Each ml contains 100 mg xylazine base. The product contains 0.18% w/v methyl hydroxybenzoate and 0.02% w/v propyl hydroxybenzoate as antimicrobial preservatives.

Uses

Virbaxyl 10% is a sedative with analgesic and muscle relaxant properties for use in horses only in cases where sedation is required, including:

1.Handling fractious animals e.g. for transportation.

2.Medical examinations e.g. X-ray examination, removal of bandages, examination of the penis and oral cavity.

3.Premedication for minor superficial operations and local or regional anaesthesia.

4.Elimination of defaecation when examining and treating the vagina, uterus and hindquarters.

Dosage and administration

Horses

Virbaxyl 10% is given by slow intravenous injection. Dosage depends upon the degree of sedation required and the response of the animal, and is 0.5–1 ml/100 kg bodyweight. Animals do not usually become recumbent with Virbaxyl 10% and light to deep sedation with variable degree of analgesia is obtained. Effects are usually seen within 5 minutes and persist for approximately 20 minutes. Virbaxyl 10% may be employed as a premedication to barbiturate anaesthesia or in combination with regional or local anaesthesia. Nervous or excitable horses may require higher doses. Older horses and those having undergone severe physical exertion before treatment should receive the lowest dose rate.

Contra-indications, warnings, etc

1.Not to be used in horses intended for human consumption.

2.Do not administer by the intra-carotid route.

3.Virbaxyl 10% should not be administered in the last month of pregnancy because of the risk of inducing premature parturition.

4.As the safety of xylazine during organogenesis has not been fully demonstrated by current methods it should be used with caution during the 1st month of pregnancy.

5.Careful consideration should be given before administering to animals exposed to stress conditions such as extreme heat, cold, high altitude or fatigue.

6.Side effects such as brachycardia, cardiac arrhytmia and polyuria may occur.

7.Following intravenous administration, a transient rise followed by a fall in blood pressure usually occur.

Operator warnings

1.Xylazine is an alpha adrenoceptor agonist acting primarily on alpha-2 receptors.

2.Precautions should be taken to avoid accidental injection/self-injection.

3.Wash splashes from the skin immediately.

4.In the event of accidental injection/self-injection, seek urgent medical advice and show label and other product literature. DO NOT DRIVE as sedation and changes in blood pressure may occur.

Advice to doctors

Xylazine is an alpha adrenoceptor agonist whose toxicity may cause clinical effects including sedation, respiratory depression, and coma, bradycardia hypotension and hyperglycaemia. Ventricular arrhythmias have also been reported. Treatment should be supportive with appropriate intensive therapy.

Pharmaceutical precautions

1.Store in a dry place below 25°C.

2.Following withdrawal of the first dose, use the product within 9 months. Dispose of unused material safely.

Legal category

POM-V

Packaging Quantities

Vials of 50 ml.

Further information

Nil.

Marketing authorisation number

11188/4001.