Alfaxan Multidose 10 mg/ml Solution for Injection for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Alfaxalone

Available from:

Zoetis UK Limited

ATC code:

QN01AX05

INN (International Name):

Alfaxalone

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Neurological Agent general anaesthetic

Authorization status:

Authorized

Authorization date:

2019-01-17

Summary of Product characteristics

Unlimited renewal: February 2024
AN: 02831/2023
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Alfaxan Multidose 10 mg/ml solution for injection for dogs and cats
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains:
Active substance:
Alfaxalone
10 mg
Excipients:
Ethanol
150 mg
Chlorocresol
1 mg
Benzethonium chloride
0.2 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
Clear colourless solution
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an induction agent prior to inhalation anaesthesia. As a sole
anaesthetic agent for
the induction and maintenance of anaesthesia for the performance of
examination or
surgical procedures.
4.3 CONTRAINDICATIONS
Do not use in combination with other intravenous anaesthetic agents.
Do not use on animals with hypersensitivity to the active substance or
any other
excipients.
Unlimited renewal: February 2024
AN: 02831/2023
Page 2 of 8
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The analgesic properties of alfaxalone are limited, therefore
appropriate peri-
operative analgesia should be provided in cases where procedures are
anticipated to
be painful.
4.5 SPECIAL PRECAUTIONS FOR USE
(i) Special precautions for use in animals
The safety of the veterinary medicinal product in animals less than 12
weeks of age
has not been demonstrated.
Transient post induction apnoea frequently occurs, particularly in
dogs – see section
4.6 for details. In such cases, endotracheal intubation and oxygen
supplementation
should be employed. Facilities for intermittent positive pressure
ventilation should be
available. In order to minimise the possibility of apnoea, administer
the veterinary
medicinal product by slow intravenous injection and not as a rapid
dose. The use of a
preplaced catheter in dogs and cats is recommended as best practice
for anaesthetic
procedures.
Especially when using higher doses of the veterinary med