Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
ACP Injection 2 mg/ml
Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
ACP Injection 2 mg/ml is a pale yellow solution which contains acepromazine maleate equivalent to 2 mg acepromazine base per ml with 0.3% w/v phenol as preservative.
The 2 mg/ml solution is intended for use only in cats and dogs.
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.
Tranquillisation
Acepromazine tranquillisation (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.
Acepromazine possesses anti-emetic, hypothermic, hypotensive and anti-spasmodic properties and shows a marked potentiating effect on barbiturate anaesthesia.
Premedication: 0.03–0.125 mg/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. Long term use is not recommended.
Contra-indications, warnings, etc
Take adequate precautions to maintain sterility. 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. Cardiac dysrhythmia may follow rapid intravenous injection.
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.
Overdosage
Slow intravenous injection of norepinephrine (noradrenaline) should be used whenever a hypertensive agent is required to reverse any fall in blood pressure.
Epinephrine (adrenaline) is contra-indicated in the treatment of acute hypotension produced by over-dosage of acepromazine maleate, since further depression of systemic blood pressure can result. Other pressoramines such as norepinephrine or neosynephrine should be administered to reverse hypotensive effects. However, the reversing effect of norepinephrine is likely to be transient and repeated doses will normally be required.
Not for use in pregnant animals.
For animal treatment only.
Care should be taken when handling and administering this product to avoid exposure.
Take precautions to avoid accidental injection of self-administration of this potent drug. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Symptomatic treatment may be required.
Avoid contact with 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.
Special warnings for each target species
Subcutaneous injection is non-irritant and efficacious, especially in cats.
Do not store above 25°C. Protect from light. Following withdrawal of the first dose, use remainder of the product within 28 days. Discard unused material. When the container is broached for the first time, using the in-use shelf-life which is specified on this package insert, the date on which any product remaining in the container should be discarded should be worked out. This discard date should be written in the space provided on the label. Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur, discard the product. Keep out of reach of children.
POM-V
Nature and composition of immediate packaging
20ml clear glass (Type 11) vial, closed with a grey chlorobutyl rubber bung and aluminium crimped seal.
Subcutaneous injection is non irritant and efficacious, especially in cats.
Use during pregnancy, lactation or lay
No formal studies on the safety of ACP Injection in pregnant animals have been conducted (see section 4.3, Contraindications).
Interaction with other medicinal products and other forms of interaction
Acepromazine is additive to the actions of other depressants and will potentiate general anaesthesia (see section 4.2, indications for use).
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antipsychotics
ATC vet code: QN05AA04
Pharmacodynamic Properties
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, hypthermic, hypotensive and anti-spasmodic properties and shows a marked potentiating effect on barbiturate anaesthesia.
Pharmacokinetic Particulars
The length of action of acepromazine appears to be prolonged and to be dose dependant.
PHARMACEUTICAL PARTICULARS
List of excipients:
Phenol
Sodium hydroxide or
Maleic acid
Water for injections
Incompatibilities
None known
Shelf Life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Marketing authorisation number
Vm 12501/4124.