Introduction

Company name: Bayer plc

Address: Animal Health Division

Bayer House, Strawberry Hill,

Newbury

Berkshire RG14 1JA

Telephone: 01635 563000

Fax: 01635 563622

Email: animal.health@bayerhealthcare.com

Website: www.bayer.co.uk/products/animalhealth.html

Presentation

A water soluble crystalline white powder and solvent for solution for injection. Each vial contains 583 mg xylazine hydrochloride. Each pack contains 1 vial of 50 ml of solvent which contains 0.70 mg/ml methyl hydroxybenzoate (Ph Eur) and 0.30 mg/ml propyl hydroxybenzoate (Ph Eur) as preservatives.

Uses

For use in horses and zoo animals 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 teats, penis and oral cavity.

3) Premedication for minor superficial operations, painful manipulative procedures and local or regional anaesthesia.

Dosage and administration

To avoid accidental self injection the following procedure should be adopted; use 2 sterile needles one to fill syringe from bottle and one to inject the patient. Once the required dose has been withdrawn from the vial, the syringe should be removed from the needle. A separate sterile needle should be inserted into the injection site and the syringe connected to it. The needles should be discarded into a closed container.

Syringes and needles must be sterile. Clean area of injection site and swab with spirit.

Rompun Dry Substance is dissolved in the solvent provided and given by intramuscular or intravenous injection in the horse and by intramuscular injection only in zoo animals. Intravenous injection in the horse should be slow, taking from one to two minutes to administer.

Dissolving one bottle of Rompun Dry Substance in 10 ml of solvent yields a 5% (50 mg/ml) solution and in 5 ml a 10% (100 mg/ml) solution.

Horse
	mg/kg	ml 5% solution	ml 10% solution
		per 50 kg BW	per 50 kg BW
i/v	0.6–1.0	0.6–1.0	0.3–0.5
i/m	2.4–3.0	2.4–3.0	1.2–1.5

Intravenous injection should be slow taking 1-2 minutes

These dosages are effective in most cases.

Dosage depends on the degree of sedation required and the response of the animal. Nervous or highly excitable horses generally require a slightly higher dose. Experience has shown that older horses and those that have undergone severe exertion before treatment respond more readily to Rompun.

Depending on the dosage, light to deep sedation with individually variable analgesia is obtained. The horse does not become recumbent.

If it is desirable to achieve the maximum possible sedation the intramuscular route and the highest dose rate are recommended.

Animals should not be disturbed until Rompun has taken its full effect. This is usually obtained within 5 minutes of intravenous injection and 15 minutes of intramuscular injection. Sedation lasts for approximately 20 minutes.

If the required depth of sedation is not achieved, it is unlikely that repetition of the dose will prove more effective. It is advisable to allow complete recovery, repeating the procedure after 24 hours using a higher dose rate.

For operations and painful procedures, additional local or regional anaesthesia should be used.

Zoo Animals

The dose rates are variable. Veterinary surgeons are advised to contact the company prior to use in species other than those shown below.

	mg/kg	ml 5% solution per 10 kg BW	ml 10% solution per 10 kg BW
Roe deer (Capreolus capreolus)	2–3	0.4–0.6	0.2–0.3
Red deer (Cervus elaphus)	2–3	0.4–0.6	0.2–0.3
Fallow deer (Dama dama)	6–8	1.2–1.6	0.6–0.8

Before zoo animals are approached after treatment 20 minutes should be allowed to elapse and full sedation will last approximately 30 minutes.

It should not be assumed that the animal is fully sedated and personal precautions should not be neglected.

Rompun dry substance can be used to control cattle destined for slaughter under the Bovine Spongiform Encephalopathy Order.

Sedated or immobilized animals should remain under supervision until normal. They should be segregated to avoid bullying by others.

Use During Pregnancy and Lactation

Do not use in the latter stages of pregnancy except at 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.

Contra-indications, warnings, etc

Not for use in zoo animals intended for human consumption.

Caution is required when pulmonary disease is present or suspected.

In recumbent ruminants tympany should be prevented by maintaining sternal recumbency.

For operations on ruminants in lateral or dorsal recumbency it is advisable to lower the head and neck in order to avoid inhalation of saliva or ruminal fluids.

It must be noted that the swallowing reflex is reduced during the period when the action of the drug is at its peak.

When high doses are to be employed the animal should be fasted for some hours beforehand.

After high doses animals are likely to remain drowsy for several hours and should be kept in the shade.

In case of accidental overdosage leading to respiratory failure cold water douches and artificial respiration are indicated.

In the event of respiratory failure manual compression of the thorax is usually sufficient to restore normal respiration.

Following intravenous injection in horses there is a transient rise followed by a fall in blood pressure.

With horses and zoo animals the usual precautions required for handling should always be observed even when a high dose of Rompun has been given.

Transient hyperglycaemia is a common finding after Rompun sedation.

Operator Warnings

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

Care should be taken to avoid accidental self-administration (see above).

It is recommended that once the required dose has been withdrawn from the vial, the needle should be kept guarded until the product is administered. Alternatively, it should be removed from the syringe and immediately inserted into the injection site and the syringe should then be connected to it.

Wash splashes from skin and eyes immediately.

In the event of accidental self-administration, seek medical advice and show the label and other product literature to medical staff. DO NOT DRIVE as changes in blood pressure may occur.

Information for Doctors

1.Human sedative dose: 0.3-0.6 mg/kg (1-2 ml Rompun 2%; 0.25-0.5 ml Rompun Dry Substance 10% solution).

2.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.

3.Treatment should be supportive with appropriate intensive therapy.

Withdrawal Periods

Horse

Meat:

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.

Zoo Animals: Contra-indicated for animals intended for human consumption.

Pharmaceutical precautions

Do not store above 25°C

Store in a dry place.

Reconstitute the solution immediately before use.

Discard any unused solution.

Use solvent within 28 days of first broaching vial.

Do not use solvent if it becomes visibly contaminated.

Any unused product and containers should be disposed of in accordance with national requirements.

Further information

Xylazine, 5, 6-dihydro-2-(2, 6-xylidino)-4H-1, 3-thiazine, is a thiazine derivative with sedative, hypnotic, local anaesthetic and hypotensive properties. It also has muscle relaxant and analgesic effects; the degree of relaxation/analgesia depends upon the animal species.

Xylazine is an agonist of the alpha-2 adrenergic receptors. It acts on pre-synaptic and post-synaptic receptors of the central and peripheral nervous system. Both the sedation and the analgesia are due to stimulation of central alpha-2 adrenergic receptors.

Xylazine is absorbed extremely rapidly and distributed widely throughout tissues. After intramuscular injection maximum plasma concentrations are achieved within 12-14 minutes in all species.

Bioavailability varies after intramuscular injection; in the dog it is between 52 and 90%, in the sheep. 17-73% and in the horse 40-48%. Metabolism is extremely rapid. The molecule is broken down into several metabolites. Elimination after intramuscular and intravenous application takes place with a half-life of between 23 and 60 minutes depending on species. The half-life for total elimination, which is dependent on the route of administration and dosage, is 2-3 hours.

Analeptics will shorten the period or reduce the depth of sedation. Alpha-2 blockers such as atipamazole are effective in reversing the sedation and other physiological effects of the drug.

Legal category

POM-V

Packaging Quantities

Carton containing 5 bottles of 500 mg Xylazine and one 50 ml bottle of solvent each with a pierceable rubber stopper.

Marketing authorisation number

Vm 00010/4092.