Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A clear colourless solution for intravenous injection containing detomidine hydrochloride 10mg/ml and methyl parahydroxybenzoate 1mg/ml as a preservative.

Uses

Equimidine has sedative and analgesic properties and is indicated for use either alone or in combination with butorphanol to facilitate the handling of horses for clinical examinations, minor surgical procedures and other manipulations. It can also be used with ketamine for short duration general anaesthesia appropriate for short surgical procedures such as castration.

Dosage and administration

For SLOW intravenous administration only. As this is a multi dose bottle the surface of the bung should be cleaned and disinfected prior to penetration of the bung with a sterile needle. The needle should be passed carefully into the bottle prior to withdrawal of the dose and then withdrawn carefully to avoid damage (see also operator warnings below). The following procedure is recommended: 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sterile needles, one to fill the syringe from the bottle and one to inject the patient; once the required dose has been withdrawn from the vial, the syringe should be removed from the needle; a separate sterile needle should be inserted into the injection site and the syringe connected to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. Return bottle to cardboard carton after use

Equimidine alone for sedation - Dosage Table:

Anticipated Level of Sedation	Light	Moderate	Profound
Dosage (I/V) mcg/kg	10 - 20	20 - 40	40 - 80
Dose (I/V) ml/100kg	0.1 – 0.2	0.2 – 0.4	0.4 – 0.8
Commencement of effect (mins)	3	2	1
Duration of action (hrs)	0.5 – 1.0	0.5 – 1.0	0.5 – 2.0

Equimidine with butorphanol for sedation: Dosage 0.12 ml Equimidine/100kg (12 mcg/kg detomidine hydrochloride) intravenously followed within 5 minutes by 25mcg/kg butorphanol (e.g. 0.25 ml/100kg of a 10mg/ml solution) intravenously. Clinical experience has shown that 5mg detomidine HCl (0.5 ml Equimidine) and 10mg (e.g. 1 ml of a 10 mg/ml solution) of butorphanol affords effective and very safe sedation in horses above 200 kg bodyweight.

Equimidine with ketamine (short duration anaesthesia): Ketamine should not be used as the sole anaesthetic agent in horses. It is important to follow the following procedures to obtain satisfactory surgical anaesthesia. Administer Equimidine at a dose rate of 20 mcg/kg by slow intravenous injection. Allow 5 minutes for the horse to become deeply sedated then administer ketamine at a dose rate of 2.2 mg/kg as an intravenous bolus. Onset of anaesthesia is gradual with the horse taking approximately 1 minute to become recumbent (in large fit horses recumbency may take up to 3 minutes). Anaesthesia will deepen for a further 1-2 minutes and during this time the horse should be left quietly. Horses regain sternal recumbency approximately 20 minutes after ketamine injection. The period of surgical anaesthesia is about 10-15 minutes and if it is necessary to prolong anaesthesia thiopentone sodium can be given as intravenous boluses of 1 mg/kg as required. Total doses of 5 mg/kg (5 x 1 mg/kg injections) have been given. Doses greater than this may reduce the quality of recovery. Thiopentone can also be given (as above) to deepen the anaesthesia if needed. The horse should be allowed to stand in its own time. Ataxia may be a problem if it stands prematurely and it should be encouraged to remain recumbent. To facilitate handling and administration some horses have received acepromazine by intramuscular injection at a dose rate of 0.03 mg/kg at least 45 minutes prior to induction of anaesthesia.

Contra-indications, warnings, etc

Before using any combination read the contra indications and warnings appearing on the other product’s information sheets (Data Sheet, Summary of the Product Characteristics (SPC) or Inclusion Leaflet).

For Animal treatment only

Do not use in horses intended for human consumption.

Do not use with sympathomimetic amines.

Do not use in the last month of pregnancy.

Do not use with potentiated sulphonamide drugs.

Do not mix with other products.

Do not use in horses with pre-existing AV blocks, with severe coronary insufficiency, respiratory disease or chronic renal failure. Careful consideration should be given to administration to animals in shock and to animals with liver or kidney disease.

Do not offer food or water until drug effect has passed.

Give by slow intravenous injection only.

Administration of Equimidine may cause benign, reversible cardiac arrhythmia, in-coordination of the limbs and sweating. Slight tremor of individual muscles or muscle groups may occasionally be observed. An diuretic effect is usually observed within 45 to 60 minutes of treatment.

Equimidine should be used with care with other sedatives and anaesthetics because of an additive/synergistic effect.

Equimidine with butorphanol for sedation: Do not use this combination in horses intended for human consumption or in horses with a history of liver disease. This combination should not be used in pregnant mares or in animals suffering from colic. Routine cardiac auscultation should be used prior to use of this combination. Do not use in horses with pre-existing cardiac dysrhythmia or bradycardia. Mild to severe ataxia may be encountered but clinical studies have shown that horses are unlikely to collapse. Normal precautions should be taken to prevent patient self injury.

Equimidine with ketamine (short duration anaesthesia): Allow sedation to develop for at least 5 minutes before giving ketamine. The two agents should never be co-administered in the same syringe. It is recommended that feed is withdrawn for at least 12 hours prior to anaesthesia. Excitable horses can be poor subjects for anaesthesia. Considerate, quiet and careful handling during the administration of agents is necessary to cause the minimum upset possible. If sedation with Equimidine fails to occur then the procedure should be abandoned. In these circumstances ketamine must not be injected into the horse.

Operator Warnings: Care should be taken to avoid accidental self-injection. In case of accidental self administration, seek medical advice immediately and show package insert or label to the physician. DO NOT DRIVE as changes in blood pressure may be seen. Wear protective rubber gloves when using this product. Wash off splashes from skin or eyes.

Pharmaceutical precautions

Protect from light. Store the product in the outer carton in order to protect from light. Following withdrawal of the first dose, use the product within 28 days. Discard any unused material. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. Keep out of the reach of children.

Legal category

POM-V

Packaging Quantities

Multidose Type 1 clear glass vial with pierceable rubber stopper containing 10ml.

Further information

UK authorised veterinary medicinal product. Where appropriate Equimidine may be used with local anaesthetics. Induction of anaesthesia with Equimidine and ketamine may delay the effects of maintenance with halothane and special care must be taken to avoid overdosage. When Equimidine is used as premedication prior to general anaesthesia its use may delay the onset of induction. In cases of suspected overdose or if the effects of detomidine become life threatening, an alpha-2 antagonist (atipamezole) is recommended at 5-10 x the dose of detomidine in mcg/kg. A/V blocks may be prevented by I/V administration of atropine at 0.02mg/kg.

Marketing authorisation number

Vm 25929/4000 held by Provivo Oy, Liedontie 45, 04600 Mantsala, Finland.

Manufactured by Ballinskelligs Veterinary Products, Co Kerry, Ireland.

Distributed by Fort Dodge Animal Health Ltd, Flanders Road, Hedge End, Southampton SO30 4QH.

Registered trademark of Fort Dodge Animal Health Ltd.