LEUCOGEN VACCINE AGAINST FELINE LEUKAEMIA VIRUS (FELV)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

QUIL; ALUMINIUM HYDROXIDE; RECOMBINANT GP70 SUB-TYPE A

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

feline leukaemia(102ug/dose)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

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

Units in package:

10 x 1.1mL

Class:

VM - Veterinary Medicine

Therapeutic group:

CAT | CAT - QUEEN | CAT - TOM | KITTEN

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

FELINE LEUKAEMIA VIRUS | VACCINE | DISEASE CAUSED BY | EQUINE ROTAVIRUS

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A.; Host/pest details: CAT: [FELINE LEUKAEMIA VIRUS, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: CAT: [FELINE LEUKAEMIA VIRUS, VACCINE]; For the vaccination of cats against feline leukaemia virus (FeLV).Do not vaccinate cats receiving corticosteroids. Vaccination of pregnant queens is not recommended.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Virbac (Australia) Pty Limited
Page
1
of
2
Product Name:
leucogen® Vaccine against
feline leukaemia
virus
(Fe
LV)
APVMA
Number:
40189/61119
Version Date:
22
October
2013
Pack sizes:
10
x
1.1
ml
single
dose
vials
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary
Products)
Select
appropriate:
D
New Product (include all applicable RLPs) OR
x
Variation
(highlight
Instructions
that
are
being
varied).
Approval
no.
of
label
being
varied:
40189/0506
Signal
heading:
FOR ANIMAL TREATMENT ONLY
Product name:
Leucogen®Vaccine
against
feline
leukaemia
virus
(FeLV)
Active constituentls:
Each
1.1
mL (dose) vial contains:
RECOMBINANT
gp?O
SUB-TYPE A (vaccinal antigen) 102 micrograms
I
dose;
QUIL A (adjuvant) 10 micrograms
I
dose;
ALUMINIUM HYDROXIDE (adjuvant) 3 milligrams
I
dose.
Statement
of
claims:
For
the
vaccination
of
cats
against
feline
leukaemia
virus
(FeLV).
Net
contents:
1 0 x 1
.1
m L dose vials
Directions
for
Use
READ THE OUTER CARTON BEFORE USING THIS PRODUCT
Heading:
DIRECTIONS FOR USE:
Restraints:
N/A
Contraindications:
N/A
Precautions:
DO
NOT
vaccinate
cats receiving
corticosteroids.
Vaccination
of
pregnant
queens
is
not
recommended.
Side
effects:
Adverse post-vaccination reactions such as
anaphylaxis/hypersensitivity occur
very rarely and may require appropriate treatment.
Dosage
&
Primary
vaccination:
Inject subcutaneously or intramuscularly 2 doses of
administration:
vaccine at a 2
to
3 week interval
to
cats 9 weeks of age or over.
An
annual
booster
is
recommended. Leucogen® can
be
used as a diluent for Feligen®
RCP Trivalent living vaccine.
General directions:
N/A
Withholding
Period/s:
N/A
Trade
Advice:
N/A
Safety
Directions:
N/A
First
Aid:
If poisoning occurs, contact a doctor or Poisons Information Centre,
phone Australia 13
11
26.
RLP
Approved
Virbac (Australia) Pty Limited
Page
2
of
2
PRODUCT NAME:
leucogen® Vaccine against
feline
leukaemia
virus
{Fe
LV)
APVMA
Number:
40189/61119
VERSION DATE:
22 October 2013
PACK
SIZES:
10
x
1.1
ml
single
dose
vials
Additional
user
Take Care to Avoid Self-In

Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD. 
DOCUMENT NO: 
LEUCOGEN.DOC 
REVISION D 
SAFETY DATA SHEET 
Product Name: 
Leucogen Vaccine Against Feline Leukaemia Virus (FELV) 
PAGE: 1 OF 5
DATE OF ISSUE
1 MARCH, 2013

EMERGENCY: VIRBAC: 02 9772 9772 OR 1800 242 100 (BUSINESS HOURS
ONLY) 
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND) 
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER  
COMPANY: 
VIRBAC (AUSTRALIA) PTY. LTD 
ABN 77 003 268 871

ADDRESS 
361 Horsley Rd, Milperra, NSW 2214, Australia 

Locked Bag 6000, Milperra Business Centre, NSW 1891, Australia 
TELEPHONE: 
[phone] or 1800 242 100 
FAX: 
[phone] 
EMERGENCY PHONE 
As above during business hours.  After Hours - Poisons Information
Centre: 13 1126 
from anywhere in Australia, (0800 764 766 in New Zealand)

CHEMICAL NATURE:  
Recombinant Leukaemia antigen in vaccine form. Presented in 1.1mL
single dose 
vials.

TRADE NAME:  
Leucogen Vaccine Against Feline Leukaemia Virus (FELV)

PRODUCT CODE:  LEUCOGEN 
PRODUCT USE:  
For the vaccination of cats against feline Leukaemia virus
(FeLV) as directed on 
product label.

CREATION DATE: 
SEPTEMBER, 2002 
THIS VERSION ISSUED: 
MARCH, 2013 and is valid for 5 years from this date. 
SECTION 2 - HAZARDS IDENTIFICATION 
STATEMENT OF HAZARDOUS NATURE  
This product is classified as: Not classified as hazardous
according to the criteria of SWA Australia.  
Not a Dangerous Good according to the Australian Dangerous Goods
(ADG) Code.

RISK PHRASES: Not Hazardous - No criteria found. 
SAFETY PHRASES: Not Hazardous - No criteria found. 
SUSMP CLASSIFICATION: None allocated. 
ADG CLASSIFICATION: None allocated. Not a Dangerous Good. 
UN NUMBER: None allocated 
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.  
PREVENTION 
P281: Use personal protective equipment as required. 
RESPONSE 
P353: Rinse skin or shower with water. 
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT i