COMPANION FELV VACCINE AGAINST FELINE LEUKAEMIA VIRUS (FELV)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

ALUMINIUM HYDROXIDE; QUIL-A; RECOMBINANT GP70 SUB-TYPE A

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

feline leukaemia(102ug/dose)

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

ALUMINIUM HYDROXIDE MINERAL-ALUMINIUM-BASE Active 3.0 mg/do; QUIL-A PLANT Active 10.0 ug/do; RECOMBINANT GP70 SUB-TYPE A VACCINE-ANTIGEN/ANTIBODY Active 102.0 ug/do

Units in package:

1 SD Vial; 10 SD Vls; 20 SD Vls; 25 SD Vls; 40 SD Vls; 5 SD Vials; 50 SD Vls; Vial=1.1mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

CAT | CAT - QUEEN | CAT - TOM | KITTEN

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

FELINE LEUKAEMIA VIRUS | DISEASE CAUSED BY

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: CAT: [FELINE LEUKAEMIA VIRUS]; Poison schedule: 0; Withholding period: ; Host/pest details: CAT: [FELINE LEUKAEMIA VIRUS]; For the vaccination of cats against feline leukaemia virus (FeLV).AVOID USING in cats receiving corticosteroids. AVOID USING in pregnant queens

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

INTERVET AUSTRALIA PTY LIMITED
COMPANION FELV VACCINE AGAINST FELINE LEUKAEMIA VIRUS (FELV)
COMPANY NAME:
PRODUCT NAME:
PRODUCT NO:
LABEL NAME:
COMPANION FELV VACCINE AGAINST FELINE LEUKAEMIA VIRUS (FELV)
SIGNAL HEADINGS:
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
ACTIVE CONSTITUENTS:
Each single dose vial (1.1 mL) contains:
Recombinant gp70 sub-type A (vaccinal antigen) 102 micrograms / dose;
Quil A (adjuvant) 10 micrograms / dose;
Aluminium hydroxide (adjuvant) 3 milligrams / dose
CLAIMS:
For the vaccination of cats against feline leukaemia virus (FeLV).
NET CONTENTS:
5 single dose vials
10 single dose vials
20 single dose vials
25 single dose vials
40 single dose vials
50 single dose vials
single dose vials
DIRECTIONS FOR USE:
DIRECTIONS FOR USE:
Only healthy cats possessing normal temperatures should be vaccinated.
CONTRAINDICATIONS:
CONTRAINDICATIONS:
This product should not be used in cats receiving corticosteroids or
in pregnant queens.
DOSAGE AND
ADMINISTRATION:
DOSAGE AND ADMINISTRATION
Note: The removable label should only be removed after the dose has
been given.
Primary vaccination subcutaneously or intramuscularly 2 doses of
vaccine at a 2 to 3 week
interval to cats 9 weeks of age or over.
An annual booster is recommended.
56446/100867 RLP APPROVED
For Official Use Only
FIRST AID
INSTRUCTIONS:
First Aid
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia
131126.
FIRST AID WARNINGS:
ADDITIONAL USER
SAFETY:
Additional User Safety
Take care to avoid accidental self-injection.
Accidental self-administration may result in local bruising, pain and
swelling. In the event
of self-administration, seek medical attention and show the package
insert or label to the
Medical Practitioner.
Additional information is in the Material Safety Data Sheet.
DISPOSAL:
DISPOSAL
Dispose of empty container by wrapping with paper and putting in
garbage.
Discarded needles should immediately be placed in a designated and
appropriately
labelled “sharps” container.
STORAGE:
STORAGE
Store

Summary of Product characteristics

PRODUCT NAME: COMPANION™ FELV VACCINE AGAINST FELINE
LEUKEMIA VIRUS (FELV)
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Companion FeLV Vaccine Against Feline Leukaemia Virus (FeLV).
TRADE NAME:
COMPANION™ FELV VACCINE AGAINST FELINE LEUKEMIA VIRUS (FELV)
PRODUCT CODE:
3976
RECOMMENDED USE:
For the vaccination of cats against Feline leukaemia virus (FeLV).
APVMA NO:
56446
CREATION DATE:
November, 2006
THIS VERSION ISSUED:
July, 2009
and is valid for 5 years from this date.
STATEMENT OF HAZARDOUS NATURE:
THIS PRODUCT IS CLASSIFIED AS:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
None allocated.
SUSDP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Slightly turbid colourless liquid.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. In addition product is unlikely to cause any discomfort in
normal use.
LONG TERM EXPOSURE:
No data for health effects associated with long term skin exposure.
EYE CONTACT:
SHORT TERM EXPOSURE
: This product may be mildly irritating to eyes, but is unlikely to
cause anything more than mild
discomfort which