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Date: Sunday, April 14, 2024 8:47

Release 3.122
AceSedate 2 mg/ml solution for injection for dogs and cats
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Neurological preparations: Others
Active ingredient: Acepromazine Maleate
Product:AceSedate 2 mg/ml solution for injection for dogs and cats
Product index: AceSedate 2 mg/ml solution for injection for dogs and cats
Incorporating:
Presentation
AceSedate contains 2 mg/ml acepromazine (as acepromazine maleate 2.71 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.
Sedation: At higher dose rates acepromazine is a sedative.
Dosage and administration
Premedication: 0.03 - 0.125 mg per kg bodyweight by intramuscular, subcutaneous or slow intravenous injection.
Other uses: By intramuscular or subcutaneous injection 0.0625 - 0.125 mg per kg bodyweight. Approximately equivalent to 0.625 - 1.25 ml of 2 mg/ml injection per 20 kg bodyweight. By intravenous injection - as for intramuscular, except that it is recommended the injection is made slowly.
The maximum dose that should be given is 4 mg acepromazine per animal. Normally single doses of acepromazine are administered.
Take adequate precautions to maintain sterility. Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur, discard the product.
Contra-indications, warnings, etc
Do not use in pregnant animals.
Do not use on a long term basis in individual animals.
Acepromazine is hypotensive. Particular care should therefore be taken in hypovolaemic animals; rehydration should precede acepromazine administration.
In some dogs, particularly Boxers and other short-nosed breeds, spontaneous fainting or syncope may occur due to sinoatrial block caused by excessive vagal tone. An attack may be precipitated by an injection of acepromazine, so a low dose should be used. Where there is a history of this type of syncope, or if it is suspected because of excessive sinus arrhythmia, it may be advantageous to control the dysrhythmia with atropine given just before the acepromazine.
Large breeds: It has been noted that large breeds of dog are particularly sensitive to acepromazine and the minimum dose possible should be used in these breeds
Cardiac dysrhythmia may follow rapid intravenous injection.
The safety of the veterinary medicinal product has not been established during pregnancy.
Acepromazine is 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.
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.
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.
This veterinary medicinal product can be mixed in the same syringe with aqueous solutions for injection containing buprenorphine as hydrochloride, methadone as hydrochloride, butorphanol as tartrate, and medetomidine and dexmedetomidine as hydrochlorides. Syringes with these mixtures should be used as soon as practicable. Any unused mixed solution remaining in the syringe should be disposed appropriately.
In the absence of further compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Cardboard box with one glass vial of 20 ml with a chlorobutyl rubber stopper and aluminium crimped seal.
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 42058/4219
Significant changes
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