LARGE ANIMAL IMMOBILON AND REVIVON MUST NOT BE ADMINISTERED TO ANIMALS INTENDED FOR HUMAN OR ANIMAL CONSUMPTION.

Veterinary surgeons administering Large Animal Immobilon, or any other immobilising medicine not licensed for use in a food-producing animal,must mark permanently, with an appropriate tag in each ear, any deer (farmed or wild), or if relevant dispose of the cascass, to ensure, so far as practicable, that such animals will not enter the food chain.

Large Animal Immobilon is not recommended for use in Fallow Deer.

Large Animal Immobilon must not be used in feline species.

Large Animal Immobilon should not be used in horses with cardiac arrhythmias or a history of endocarditis, or with liver damage.

Large Animal Immobilon must not be used intramuscularly in the horse except in the circumstances of an emergency where intravenous injection is not possible.

Large Animal Revivon must not be used intramuscularly except in an emergency.

Immobilon and Revivon must not be diluted or mixed with any other substances.

Animals should be treated individually and not in groups.

There is a risk of respiratory depression in the new born when the drug is given to a parturient animal.

The use of etorphine particularly in elderly animals carries a degree of risk, and the usual precautionary procedures, such as the maintenance of free air passages must be followed.

Muscular tremor occurs in most horses, but will generally diminish if the animal is left recumbent for a few minutes before the operative procedure is started.

Signs of tachycardia, hypertension and mild tranquillisation may be seen following remobilisation. In case of gross overdose, an equal volume of Large Animal Revivon should be administered by intravenous injection.

Protect horses eyes from sun or bright light following administration of Large Animal Immobilon.

Animals MUST be kept stabled, protected from extremes of temperature and under close supervision for at least 24 hours, particularly for the first eight hours following administration of Large Animal Immobilon.

Care must be taken to avoid hypothemia and hyperthermia (see above)

Entero-hepatic re-cycling of etorphine may occur, causing excitement, `walking' and `headpressing', six to eight hours after remobilisation. These effects can be reversed by a further half-dose of Large Animal Revivon administered subcutaneously.

Product use can cause paraphimosis, usually as a sequel to priapism. When extrusion of the penis occurs, the owner should be advised to inform his veterinary surgeon if retraction of the penis does not take place within 7 hours. When considering treatment the veterinary surgeon may contact the Company, however, conservative and therapeutic measures are advised and the following have been recommended in published papers for the treatment of this rare condition:

To AVOID ACCIDENTAL SELF-INJECTION the following procedure should be adopted:

Large Animal Immobilon is a very potent neuroleptanalgesic which is highly toxic to humans. It causes dizziness, nausea and pinpoint pupils, followed by respiratory depression, lowered blood pressure, cyanosis and in extreme cases, loss of consciousness, respiratory failure and cardiac arrest.

If there is any danger that Large Animal Immobilon may have been injected or absorbed, the following steps should be taken IMMEDIATELY.

BEFORE CALLING MEDICAL ASSISTANCE INJECT A REVERSING AGENT.

With any topical contact such as spillage on the skin, or immediate clothing, or, splashing into eyes, mouth or nose, IMMEDIATE washing with plenty of water may prevent significant absorption but THIS SHOULD NEVER BE ASSUMED. DO NOT drive if accidental exposure is suspected.

Reversing agents: Inject 2–3 mls Narcan (0.4 mg/ml naloxone) preferably intravenously or alternatively intramuscularly and repeat at intervals of 2 to 3 minutes until symptoms are reversed (usually 2–3 treatments are sufficient). In the event of Narcan being unavailable, or in a situation of extreme emergency the following information is provided for possible guidance:

Inject 0.1 ml of Large Animal Revivon* preferably intravenously or alternatively intramuscularly. If the actual volume of Large Animal Immobilon injected or absorbed is known, inject an equal quantity of Large Animal Revivon*.

If respiratory depression is not reversed, repeat the dose after 2 to 3 minutes. Recurrence of morphine-like effects may occur due to entero-hepatic recycling. Large Animal Revivon* may itself induce an hallucinatory state.

* Veterinary Marketing Authorisation Only.