Alfaxan 10mg/ml Soution for Injection
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
10-05-2013
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Active ingredient:
alfaxalone 10 mg/ml
Available from:
Jurox (UK) plc
ATC code:
QN01AX05
Pharmaceutical form:
Solution for injection
Therapeutic group:
alfaxalone
Therapeutic area:
Cats, Dogs
Authorization date:
2011-05-13
Summary of Product characteristics
Revised: September 2013
AN: 00543/2013
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alfaxan 10 mg/ml solution for Injection for Dogs and Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Alfaxalone 10 mg/ml
For a 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.
4.4 SPECIAL WARNINGS
During recovery, it is preferable that animals are not handled or disturbed. This may
lead to paddling, minor muscle twitching or movements that are more violent. While
better avoided, such reactions are clinically insignificant.
4.5 SPECIAL PRECAUTIONS FOR USE
(i) Special precautions for use in animals
Appropriate analgesia should be provided in cases where procedures
are anticipated to be painful.
The safety of the veterinary medicinal product in animals less than 12
weeks of age has not been demonstrated.
Transient post ind
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