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 clear colourless sterile aqueous solution for injection. Each ml contains 23.32 mg xylazine hydrochloride (equivalent to 20 mg xylazine) and 1 mg methyl 4-hydroxybenzoate (E218) as a preservative.

Uses

Xylazine is an alpha-2 agonist with sedative, some analgesic and muscle relaxant properties, for use in cattle, horses, dogs and cats. In cattle, which are more sensitive to the agent, the degree of sedation can be predetermined according to the dose administered.

Indications: All 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 teats, penis and oral cavity.

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

Dosage and administration

Use two sterile needles one to fill the syringe from the 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 Once the required dose has been withdrawn from the vial, the syringe should be removed from the needle.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.

Cattle

Rompun is given by intramuscular injection. The dose rate is 0.05–0.3 mg/kg (0.25–1.5 ml per 100 kg) bodyweight, according to the degree of sedation required. Very fractious animals may require the higher dose rates not exceeding 0.3 mg/kg (Dose rate 4)

Dose	mg/kg	mg/50 kg	ml/50 kg
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

Dose 1

Sedation, with a slight decrease of muscle tone. The ability to stand is maintained.

Dose 2

Sedation, marked decrease of muscle tone and some analgesia. The animal usually remains standing, but may lie down.

Dose 3

Deep sedation, further decrease of muscle tone and a degree of analgesia. The animal lies down.

Dose 4

Very deep sedation, a profound decrease in muscle tone and a degree of analgesia. The animal lies down.

Animals should not be disturbed until Rompun has taken its full effect. The first effects are usually seen within 5 minutes of injection and the maximum effect is produced ten minutes later. There is no struggling or excitement during induction or recovery.

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 with a higher dose after 24 hours.

When any surgical treatment is carried out using xylazine, additional local anaesthesia should be employed.

Horses

Administer by slow intravenous injection, taking from one to two minutes to administer. Dosage depends on 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 highly excitable horses generally require the 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.

Animals should not be disturbed until Rompun has taken its full effect. This is usually obtained within 5 minutes of intravenous injection and 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 using Rompun Dry Substance, with a higher dose rate, after 24 hours.

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

Rompun can also be administered to horses as a premedicant for operations on the recumbent animal using chloral hydrate, barbiturates, ketamine or halothane.

Cats

Administer intramuscularly at a dose rate of 3 mg/kg (0.15 ml/kg) bodyweight. The effect is adequate for procedures that are not associated with any considerable degree of pain. Premedication with atropine is advantageous. When used in conjunction with ketamine, Rompun premedication eliminates muscular stiffness during anaesthesia and maintains sedation throughout the recovery period.

Barbiturate anaesthesia should not be induced until sedation is at its deepest, i.e. about 20 minutes after administration of Rompun. Under these conditions the dose of barbiturates is reduced by about half.

Dogs

Administer by intramuscular injection at a dose rate of 1–3 mg/kg (0.05–0.15 ml/kg) bodyweight. Other routes of administration may be used, but the effect is less predictable. Good sedation is usually achieved at the lower end of the dose range given above, but excitable or vicious animals require a higher dose. The effect is adequate for procedures that are not associated with any considerable degree of pain. For painful procedures use in combination with a local anaesthetic. Premedication with atropine may be advantageous.

When used for pre-anaesthetic medication, Rompun reduces the dose required in the case of barbiturates by about half. Rompun can also be used as a premedicant for ketamine induced anaesthesia.

Further Information Applicable to all Species

1.Analeptics will shorten the period or reduce the depth of sedation.

2.Limited information available suggests tha alpha-2 blockers such as atipamezole may be effective in reversing the sedation and other physiological effects of the drug.

3.Transient hyperglycaemia is a common finding after xylazine sedation.

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

All Species

Observe aseptic precautions.

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

Sedated animals should remain under observation until normal. Segregate sedated animals.

Concurrent administration of adrenoceptor stimulants is not recommended.

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

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

Use with care in elderly or debilitated patients which may be adversely affected by profound cardiovascular changes.

Caution is required when pulmonary disease is present.

Cattle

Tympany should be prevented in recumbent cattle by sternal recumbency.

For operations in lateral or dorsal recumbency, lower head and neck to prevent inhalation of ruminal contents.

Maintain recumbent and drowsy animals in the shade. In case of accidental overdosage leading to respiratory failure, cold water douches and artificial respiration are indicated.

After dose levels 3 and 4 cattle are likely to remain drowsy for several hours and should be kept in the shade.

Horses

Following intravenous injection in horses a transient rise and fall in blood pressure may be seen.

With horses the usual precautions required in handling should always be observed even when a high dose of xylazine has been given.

The concurrent intravenous use of potentiated sulphonamides with alpha-2 agonists has been reported to cause cardiac arrhythmias which may be fatal. Whilst no such effects have been reported with Rompun, it is recommended that intravenous administration of Trimethoprim/Sulphonamide containing products should not be undertaken when horses have been sedated with xylazine.

Dogs and Cats

In cats and dogs if the stomach is full, vomiting occurs before sedation is complete. This is an advantage if general anaesthesia is to follow. The emetic effect is reduced by fasting for 6 to 24 hours beforehand.

In the cat and dog, because of the emetic effect which is sometimes produced, do not use Rompun in mechanical complications of the alimentary tract e.g. obstruction of the oesophagus, gastric torsion or hernia.

Premedication with atropine in cats and dogs may reduce salivation and bradycardia effects.

Withdrawal Periods

Animals must not be slaughtered for human consumption during treatment.

Cattle: Meat: 6 days; Milk: 24 hours

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.

Operator Warnings

Xylazine is a powerful alpha-adrenergic agonist acting primarily on alpha-2 receptors.

Care should be taken to avoid accidental self-injection (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 in the injection site, and the syringe should then be connected to it.

In the event of accidental self-administration, seek medical advice and show the product label and other product literature. DO NOT DRIVE as variations in blood pressure may be seen.

Wash splashes from skin and eyes immediately.

Pharmaceutical precautions

Do not store above 25°C.

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

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

Legal category

POM-V

Packaging Quantities

Bottles of 25 ml with pierceable rubber stoppers.

Further information

Xylazine is an alpha-2 agonist with sedative, some analgesic and muscle relaxant properties, for use in cattle, horses, dogs and cats. In cattle, which are more sensitive to the agent, the degree of sedation can be predetermined according to the dose administered. A strong emetic effect is usual in cats and dogs. Xylazine induces strong cardiovascular effects e.g. bradycardia and increased blood pressure. Hyperglycaemia is also induced. The duration of action of the agent varies between species.

In the case of overdosage alpha2-adrenoceptor blockers may reverse the effects.

Marketing authorisation number

Vm 00010/4093