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Date: Sunday, April 14, 2024 7:47

Release 3.120
AceSedate 10 mg/ml solution for injection for horses
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Neurological preparations: Others
Active ingredient: Acepromazine Maleate
Product:AceSedate 10 mg/ml solution for injection for horses
Product index: AceSedate 10 mg/ml solution for injection for horses
Withdrawal notes: Not authorised for use in horses intended for human consumption.
Incorporating:
Presentation
AceSedate contains 10 mg/ml acepromazine (as acepromazine maleate 13.55 mg/ml) and the excipient phenol (3 mg/ml).
Uses
Anaesthetic Premedication: Following acepromazine administration, the amount of anaesthetic necessary to induce anaesthesia is considerably reduced. This reduction is approximately one-third of a suitable induction agent.
Tranquilisation: Acepromazine tranquilisation (ataraxy) involves a modification of temperament which is not associated with hypnosis, narcosis or marked sedation. This is achieved with low doses of acepromazine. At low doses, acepromazine reduces anxiety which is beneficial for use in horses prior to shoeing or transportation.
Sedation: At higher dose rates acepromazine is a sedative, as an adjunct to, or replacement for, physical restraint eg dentistry, handling and shoeing. The relaxant effects aid examination of the penis in horses and the treatment of tetanus and choke.
Dosage and administration
By intramuscular injection: 0.03-0.10 mg per kg bodyweight. Approximately equivalent to 0.15-0.5 ml of 10 mg/ml injection per 50 kg (approx. 1 cwt) bodyweight.
By intravenous injection: As for intramuscular, except that it is recommended the injection is made slowly.
Normally, single doses of acepromazine are administered. Long term use is not recommended. On the rare occasions that repeat dosing is required, the dosing interval should be 36-48 hours.
Contra-indications, warnings, etc
Do not administer to breeding stallions. Paralysis of the retractor penis muscle has been associated with the use of parenterally administered acepromazine in horses.
Do not use this product in conjunction with organophosphates and/or procaine hydrochloride, as it may enhance activity and potential toxicity.
Do not, in any circumstances, ride horses within the 36 hours following administration of the product.
Do not administer to pregnant mares.
Duration of action may be prolonged and this should be remembered when riding, as acepromazine may affect performance and appear in drug tests for some time.
Acepromazine has little, if any, analgesic effect so that painful procedures must be avoided, particularly where animals are known to have unpredictable temperaments. Therefore, the usual precautions should be maintained when handling sedated horses.
During sedation, horses will normally retain visual and auditory acuity, so that loud sounds and rapid movements may cause arousal from the sedated state. It is therefore important to keep treated horses in a quiet environment and avoid sensory stimulation as far as possible.
Take adequate precautions to maintain sterility.
Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur, discard the product. The closure may be safely punctured up to 38 times.
Situations may arise where general anaesthesia is required in the 4-6 hours following use of the product. In such cases care should be taken to reduce the induction dose of other premedicants and anaesthetic agents, particularly parenteral barbiturates, so as to avoid potentiation and additive depressant effects.
When administered to male horses (geldings or stallions), use the lowest dose recommended to produce the required effect.
Acepromazine is an adrenoceptor blocking drug and this causes hypotension and lowered p.c.v. The product should therefore be administered with great caution, and at low dose rates only to debilitated horses and animals in states of hypovolaemia, anaemia and shock, or with cardiovascular disease. Rehydration should precede acepromazine administration.
Acepromazine has caused paraphimosis, sometimes 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 2-3 hours. Suitable treatments have been described in the veterinary literature e.g. manual compression during the period of general anaesthesia, penile support and manual compression, use of an Esmarch bandage.
Accidental intracarotid injection in horses can produce clinical signs ranging from disorientation to convulsive seizures and death.
Tranquilisers are additive to the actions of other depressants and will potentiate general anaesthesia.
Transient dose-dependent hypotension may occur in cases of accidental overdose. Therapy should consist of discontinuing any other hypotensive treatment, supportive care such as intravenous infusion of warm isotonic saline to correct hypotension and close monitoring. In severe cases treatment with norepinephrine may be indicated but its use must be based on a careful evaluation of the benefit risk balance by the responsible veterinary surgeon.
Epinephrine (adrenaline) is contra-indicated in the treatment of acute hypotension produced by overdosage of acepromazine maleate, since further depression of systemic blood pressure can result.
Withdrawal period:
Not authorised for use in horses intended for human consumption.
User warnings:
This product contains a potent sedative; care should be taken when handling and administering this product to avoid accidental self-exposure. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician but DO NOT DRIVE as sedation may occur. Symptomatic treatment may be required.
This product may cause irritation of skin and eyes. Avoid contact with skin and eyes. If accidental eye contact occurs, flush gently with fresh running water for 15 minutes and seek medical advice if any irritation persists. In the event of accidental skin contact, wash the contaminated area with large amounts of soap and water. Medical advice should be sought if irritation persists.
Wash hands and exposed skin thoroughly after use.
Pharmaceutical precautions
Do not store above 25°C. Keep the vial in the outer carton in order to protect from light. Do not freeze.
Shelf life after first opening the immediate packaging: 28 days.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
20 ml or 50 ml amber glass vials, closed with a grey chlorobutyl rubber bung and aluminium crimped seal with a plastic flip-cap. Not all pack sizes may be marketed.
Marketing Authorisation Holder (if different from distributor)
Jurox (UK) Limited
Further information
Acepromazine is a phenothiazine. It is a central nervous system depressant with associated activity on the autonomic system. Phenothiazines have a central action due to inhibition of dopamine pathways, resulting in alteration of mood, reduction in fear and removal of learned or conditioned responses.
Acepromazine possesses anti-emetic, hypothermic, hypotensive and anti-spasmodic properties and shows a marked potentiating effect on barbiturate anaesthesia.
Marketing Authorisation Number
Vm 42058/4222
Significant changes
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