Alfaxan Multidose Anaesthetic Injection

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

ALPHAXALONE

Available from:

ZOETIS AUSTRALIA PTY LTD

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

ALPHAXALONE ANAESTHETIC Active 10.0 mg/ml

Units in package:

10mL; 20ml

Class:

VM - Veterinary Medicine

Therapeutic area:

ANAESTHETICS/ANALGESICS

Product summary:

Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
Alfaxan Multidose Anaesthetic Injection
83248/114856
Label Name:
Alfaxan Multidose Anaesthetic Injection
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
10 mg/mL alfaxalone
Claims:
As an induction agent prior to gaseous anaesthesia, or
As a sole anaesthetic agent for the induction and maintenance of
anaesthesia for the
performance of examination or surgical procedures.
Net Contents:
10 mL, 20 mL
Directions for Use:
Restraints:
Contraindications:
Alfaxan Multidose is contraindicated for use in combination with other
intravenous
anaesthetic agents.
Precautions:
Alfaxan Multidose should be given by slow continuous injection and NOT
as a rapid dose.
Some patients, especially dogs, may undergo a short period of apnoea
on induction using
Alfaxan Multidose by the intravenous route. This can be avoided by
inducing anaesthesia
by slow continuous intravenous injection over 60 seconds, while
assessing the degree of
anaesthesia achieved.
Appropriate analgesia should be provided in cases where procedures are
anticipated to be
painful.
As with all general anaesthetic agents:
• It is advisable to ensure that the patient has been fasted before
receiving the anaesthetic.
• Additional monitoring is advised and particular attention should
be paid to respiratory
parameters in aged animals, or in cases where there may be additional
physiological stress
imposed by pre-existing pathology or shock.
• Following induction of anaesthesia, the use of an endotracheal
tube is recommended to RLP APPROVED
maintain airway patency.
• It is advisable to administer supplemental oxygen during
maintenance of anaesthesia.
• Respiratory embarrassment may occur – ventilation of the lungs
with oxygen should be
considered if haemoglobin saturation with oxygen (SpO2%) falls below
90% or if apnoea
persists for longer than 60 seconds.
• If cardiac arrhythmias are detected, attention to respiratory
ventilation with oxygen is the
first pri

Summary of Product characteristics

ALFAXAN MULTIDOSE ANAESTHETIC INJECTION
Page 1 of 7
Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
ISSUED:
29 MARCH 2018
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
ALFAXAN MULTIDOSE ANAESTHETIC INJECTION
PRODUCT IDENTIFIER:
10 mg/mL Alfaxalone solution for injection.
PRODUCT CODE:
520400 (20 mL); TBD (10 mL)
RECOMMENDED USE:
An injectable steroid anaesthetic for use in dogs and cats. It can be
used as an induction agent prior to gaseous anaesthesia or as a
sole anaesthetic agent for the induction and maintenance of
anaesthesia for the performance of examination or surgical
procedures.
RESTRICTIONS ON USE:
For animal treatment only.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
EMAIL:
[e-mail]
NATIONAL POISONS INFORMATION CENTRE:
13 1126 (24 hours)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9am – 5pm, Monday to Friday)
SECTION 2: HAZARDS IDENTIFICATION
GHS HAZARD CLASSIFICATIONS: This product has been assessed according
to GHS and is classified as follows:
GHS CATEGORY
HAZARD CODE
HAZARD STATEMENT
Flammable Liquid Category 3
H226
Flammable liquid and vapour
Eye Irritant Category 2A
H319
Causes serious eye irritation
GHS LABEL ELEMENTS:
Signal Word:
WARNING
Pictograms:
Flame Exclamation Mark
ALFAXAN MULTIDOSE ANAESTHETIC INJECTION
Page 2 of 7
Issued by: Jurox Pty Limited
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
Precautionary Statements:
Prevention
P210 Keep away from heat / sparks / open flames / hot surfaces – No
smoking.
P233 Keep container tightly closed.
P241 Use explosion-proof electrical/ventilating/lighting/intrinsically
safe
equipment.
P242 Use only non-sparking tools.
P243 Take precautionary measures against static discharge.
P264 Wash hands thoroughly after handling.
P280 Wear protective gloves / eye protection / face protection.
Response
P370 + P37

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
REGISTERED NAME
Alfaxan® Anaesthetic Injection
ACTIVE CONSTITUENTS
Alfaxalone 10 mg/mL
DESCRIPTION
Alfaxan® is a clear, colourless, sterile solution for injection
presented in a multi-use injection vial.
ACTIONS
Alfaxalone (3-α-hydroxy-5-α-pregnane-11,20-dione) is a neuroactive
steroid molecule with properties of a general anaesthetic. The
primary mechanism for the anaesthetic action of alfaxalone is
modulation of neuronal cell membrane chloride ion transport, induced
by binding of alfaxalone to GABA-A cell surface receptors.
PHARMACOKINETIC PARTICULARS
The volume of distribution after a single injection of clinical doses
of Alfaxan® in dogs and cats is 2.4 L/kg and 1.8 L/kg, respectively.
In
cats, the mean terminal plasma elimination half-life (t1/2) for
alfaxalone is approximately 45 minutes for a 5 mg/kg dose. Mean plasma
clearance for a 5 mg/kg dose is 25.1 ± 7.6 mL/kg/min. In dogs, the
mean terminal plasma elimination half-life (t1/2) for alfaxalone is
approximately 25 minutes for a 2 mg/kg dose. Plasma clearance for a 2
mg/kg dose is 59.4 ± 12.9 mL/kg/min. Alfaxalone metabolites
are likely to be eliminated from the dog and cat by the hepatic/faecal
and renal routes, similar to other species.
CONTRAINDICATIONS
Alfaxan® is contraindicated for use in combination with other
intravenous anaesthetic agents.
ALFAXAN
®
Anaesthetic Injection
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
PRECAUTIONS
ALFAXAN® SHOULD BE GIVEN BY SLOW CONTINUOUS INJECTION AND NOT AS A
RAPID DOSE. Some patients, especially dogs, may undergo
a short period of apnoea on induction using Alfaxan® by the
intravenous route. This can be avoided by inducing anaesthesia by slow
continuous intravenous injection over 60 seconds, while assessing the
degree of anaesthesia achieved.
Appropriate analgesia should be provided in cases where procedures are
anticipated to be painful.
AS