Alfaxan Multidose 10 mg/ml solution for injection for dogs and cats

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Alfaxalone

Fáanlegur frá:

Jurox (Ireland) Limited

ATC númer:

QN01AX05

INN (Alþjóðlegt nafn):

Alfaxalone

Skammtar:

10 milligram(s)/millilitre

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

alfaxalone

Leyfisstaða:

Authorised

Leyfisdagur:

2019-01-07

Vara einkenni

Health Products Regulatory Authority
01 October 2020
CRN009V7G
Page 1 of 6
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
​
Benzathonium 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.
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.
Health Products Regulatory Authority
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