Temprace 0.5 mg/ml Solution for Injection for Dogs and Cats

Composition

Each ml contains:

Active substance:

Acepromazine 0.5 mg

(equivalent to 0.678 mg acepromazine maleate)

Excipients:

Clear yellow to orange solution.

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Pharmacological properties

4.1 ATCvet code:

QN05AA04

4.2 Pharmacodynamics

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, vasodilatory (and therefore hypotensive) and anti-spasmodic properties.

4.3 Pharmacokinetics

The length of action of acepromazine appears to be prolonged and to be dose dependent.

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Target species

Dogs, cats.

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Indications

For anaesthetic premedication, tranquilisation and sedation.

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Dosage

Intravenous use. It is recommended that the injection is made slowly.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Premedication: 0.03−0.125 mg acepromazine per kg bodyweight, corresponding to 0.6−2.5 ml veterinary medicinal product per 10 kg bodyweight

Other uses: 0.0625−0.125 mg acepromazine per kg bodyweight, corresponding to 1.25−2.5 ml veterinary medicinal product per 10 kg bodyweight.

The maximum dose that should be given is 4 mg acepromazine per animal.

Normally single doses of acepromazine are administered (see section 3.5, Special precautions for safe use in the target species). Following acepromazine administration, the amount of anaesthetic necessary to induce anaesthesia may be considerably reduced.

Take adequate precautions to maintain sterility. Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur, discard the veterinary medicinal product.

The maximum number of vial punctures when using needle sizes 21G and 23G should not exceed 100 and when using a 18G needle, the maximum should not exceed 40.

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Contraindications

Do not use in pregnant animals.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use on a long term basis in individual animals.

See also section 3.8.

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Adverse reactions

Dogs, cats:

a Following rapid intravenous injection. See also section 3.5 (Special precautions for safe use in the target species).

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Acepromazine is hypotensive and can cause a transient reduction in haematocrit. The veterinary medicinal product should therefore be administered with great caution, and at low dose rates only, to animals in states of hypovolaemia, anaemia and shock or with cardiovascular disease. Rehydration should precede acepromazine administration. Acepromazine may cause hypothermia due to depression of the thermoregulatory centre and peripheral vasodilation.

Acepromazine has negligible analgesic effects. Painful activities should be avoided when handling tranquillized animals.

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.

In dogs with the ABCB1-1Δ (also called MDR1) mutation, acepromazine tends to cause more profound and prolonged sedation. In these dogs the dose should be reduced by 25%-50%.

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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

This veterinary medicinal product contains a potent sedative, care should be taken, when handling and administering the veterinary medicinal 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.

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, contaminated clothing should be removed and the area washed with large amounts of soap and water. Medical advice should be sought if irritation persists.

Wash hands and exposed skin thoroughly after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

Pregnancy:

Do not use (during the whole or part of the pregnancy).

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Interactions

Acepromazine is additive to the actions of other CNS depressants and will potentiate general anaesthesia (see section 3.9).

Do not use this veterinary medicinal product in conjunction with organophosphates and/or procaine hydrochloride, as it may enhance activity and potential toxicity.

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Overdose

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.

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Special warnings

Since the individual response to acepromazine may be variable, reliable sedation may not be achieved in some animals. In these individuals, other drugs or drug combinations should be considered.

In the absence of suitable studies regarding efficacy, the veterinary medicinal product should not be administered via the subcutaneous or intramuscular routes.

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Withdrawal period

Not applicable.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Clear type I glass vials closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.

Pack sizes: 10 ml, 20 ml and 100 ml.

Not all pack sizes may be marketed.

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Storage

Keep the vial in the outer carton in order to protect from light.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months. Shelf life after first opening the immediate packaging: 28 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

41821/4053

8 DATE OF FIRST AUTHORISATION

09 April 2018

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2024

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 21 August 2025

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Registration holder

Le Vet Beheer B.V.

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