Introduction

Company name: Animalcare Limited

Address: Common Road

Dunnington

York YO19 5RU

Telephone: 01904 487687

Fax: 01904 487611

Email: animalcare@animalcare.co.uk

Presentation

Xylacare 2% is a clear, colourless aqueous solution for injection. Each ml contains 20 mg Xylazine base. Contains Methyl hydroxybenzoate 1.8 mg/ml and Propyl hydroxybenzoate 0.2 mg/ml as preservatives.

Uses

Xylacare 2% is a sedative with analgesic and muscle relaxant properties for use in cattle, horses, dogs and cats 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 defecation when examining and treating the vagina, uterus and hindquarters.

Dosage and administration

Cattle

Xylacare 2% solution is given by intramuscular injection taking precautions against contamination. The dose rate is 0.05-0.3 mg/kg xylazine (0.25 to 1.5 ml Xylacare 2% per 100kg bodyweight), according to the degree of sedation required. Very fractious animals may require higher dosage rates not exceeding 0.3 mg/kg (Dose rate 4).

Dose	mg/kg	mg/50kg	ml/50kg
1	0.05	2.5	0.12
2	0.10	5.0	0.25
3	0.20	10	0.50
4	0.30	15	0.75

Horses

Xylacare 2% is given by slow intravenous injection. Dosage depends upon the degree of sedation required and the response of the animal and is 0.6-1 mg/kg (3-5 ml/100 kg) bodyweight. 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. The horse does not usually become recumbent with Xylacare 2% 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. Xylacare 2% may be employed in the horse as a premedication to barbiturate anaesthesia or in combination with regional or local anaesthesia.

Dogs

Xylacare 2% is administered intramuscularly at dose rates of 1-3 mg/kg (0.05-0.15 ml/kg bodyweight). It may be used in combination with a local anaesthetic. Premedication with atropine may be desirable in some cases. Xylacare 2% is synergistic with the barbiturates and reduces the dosage of the latter by approximately one half.

Cats

Xylacare 2% is administered intramuscularly at a dose rate of 3 mg/kg (0.15 ml/kg bodyweight). Premedication with atropine may occasionally be desirable.

Contra-indications, warnings, etc

Do not administer by the intra-carotid route.

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

Following the use of Xylacare 2% in cattle, profuse salivation, bloat and polyuria may occur. Tympany should be avoided in recumbent cattle by maintaining the animal in sternal recumbency. Provision should also be made for facilitating dependent drainage from the mouth to avoid inhalation asphyxia.

Side effects such as bradycardia, cardiac arrhythmia and polyuria may occur in the horse. Following intravenous administration to horses a transient rise followed by a fall in blood pressure usually occurs. Vomiting is commonly observed in dogs and cats following use of the product. Xylacare 2% should not be administered during the later stages of pregnancy because of the risk of inducing premature parturition. As the safety of xylazine use during organogenesis has not been fully demonstrated by current methods it should be used with caution during the first month of pregnancy.

Protection of Consumers

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 14 days from the last treatment. Not for use in animals from which milk is produced for human consumption. Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.

Operator warning

Xylazine is an alpha adrenoceptor agonist acting primarily on alpha-2 receptors. Precautions should be taken to avoid accidental injection/self injection. Wash splashes from skin and eyes immediately.

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 and hypotension and hyperglycaemia. Ventricular arrhythmias have also been reported. Treatment should be supportive with appropriate intensive therapy.

General Precautions

Keep out of the reach of children.

For animal treatment only.

Pharmaceutical precautions

Store below 25° C. Keep vial in outer carton.

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

Discard unused material.

Disposal advice: Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Vials of 25ml.

Further information

Nil.

Marketing authorisation number

Vm 10347/4020.