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

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Alfaxalone

Dostopno od:

Jurox (UK) Limited

Koda artikla:

QN01AX05

INN (mednarodno ime):

Alfaxalone

Odmerek:

10 milligram(s)/millilitre

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

VPO: Veterinary Practitioner Only as defined in relevant national legislation

Terapevtsko območje:

alfaxalone

Status dovoljenje:

Authorised

Datum dovoljenje:

2019-01-07

Lastnosti izdelka

Health Products Regulatory Authority
17 January 2019
CRN000Y7R
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
​
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.
Health Products Regulatory Authority
17 January 2019
CRN000Y7R
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
p