FELIGEN RCP TRIVALENT LIVING VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

FELINE CALICIVIRUS - LIVE; LIVE FELINE HERPES VIRUS; FELINE PANLEUCOPENIA VIRUS - LIVE

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

feline rhinotracheitis+feline calicivirus+feline parvovirus

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

FELINE CALICIVIRUS - LIVE VACCINE-VIRAL Active 12589.254 TCI50/Vi; LIVE FELINE HERPES VIRUS VACCINE-VIRAL Active 100000.0 TCI50/Vi; FELINE PANLEUCOPENIA VIRUS - LIVE VACCINE-VIRAL Active 1000.0 TCI50/Vi

Units in package:

20 x 1mL dose vials; 25 x 1 mL single dose vials

Class:

VM - Veterinary Medicine

Therapeutic group:

CAT | CAT - QUEEN | CAT - TOM | KITTEN

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

FELINE CALICIVIRUS | FELINE ENTERITIS | FELINE LEUKAEMIA VIRUS | FELINE RHINOTRACHEITIS | CALICIVIRUS (FELINE) | DISEASE CAUSED BY | ENTERITIS (FELINE) | FCV | FELINE HERPESVIRUS TYPE 1 | FELINE INFECTIOUS ENTERITIS | FELINE PANLEUCOPENIA (FP) | FHV-1 | FVR | HERPESVIRUS 1 (FELINE) | HERPESVIRUS TYPE 1 (FELINE) | PANLEUCOPENIA (FELINE) | RHINOTRACHEITIS (FELINE)

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [FELINE CALICIVIRUS, FELINE ENTERITIS, FELINE LEUKAEMIA VIRUS, FELINE RHINOTRACHEITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [FELINE CALICIVIRUS, FELINE ENTERITIS, FELINE LEUKAEMIA VIRUS, FELINE RHINOTRACHEITIS]; For vaccination of cats against panleucopaenia, calicivirus and rhinotracheitis and, when reconstituted with leucogen, against feline leukaemia virus (FeLV).Only healthy cats possessing normal temperatures should be vaccinated. Do not vaccinate cats receiving corticosteroids. Do not vaccinate pregnant queens.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

VIRBAC (AUSTRALIA) PTY LIMITED
Page
1 of 3
PRODUCT NAME:
FELIGEN
RCP Trivalent living vaccine
APVMA NUMBER:
40759/61118
VERSION DATE:
12 December 2013
PACK
sizes:
20 x 1mL single dose vials
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY
PRODUCTS)
Select appropriate:
1:1 New Product (include all applicable RLPs) OR
x Variation (highlight instructions that are being varied). Approval
no. of label being
varied:
40759/55016
Signal heading:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Product name:
RLP
FELIGEN
® RCP TRIVALENT LIVING VACCINE
Approved
Active constituent/s:
Each single dose vial contains (minimum titres in TCID50):
- live, attenuated feline herpes virus (rhinotracheitis)
105
- live, attenuated feline calicivirus
104.1
- live, attenuated feline parvovirus (panleucopaenia)
103
Statement of claims:
FOR THE VACCINATION OF CATS AGAINST PANLEUCOPAENIA, CALICIVIRUS AND
RHINOTRACHEITIS AND, WHEN RECONSTITUTED WITH LEUCOGEN
®
, AGAINST FELINE
LEUKAEMIA VIRUS (FELV).
Net contents:
20 x
1 mL single dose vials
Directions for Use
Heading:
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
Restraints:
N/A
Contraindications:
N/A
Precautions:
DO NOT VACCINATE CATS RECEIVING CORTICOSTEROIDS.
DO NOT VACCINATE PREGNANT QUEENS.
Side effects:
Adverse post-vaccination reactions such as
anaphylaxis/hypersensitivity occur
rarely and may require appropriate treatment.
DOSAGE &
ADMINISTRATION:
ONLY HEALTHY CATS POSSESSING NORMAL TEMPERATURES SHOULD BE VACCINATED.
DO NOT USE CHEMICALS TO DISINFECT THE SKIN, NEEDLES OR SYRINGES BEFORE
VACCINATION AS THIS COULD INACTIVATE THE VIRUSES.
Use immediately after reconstitution with 1 mL of a suitable diluent
transferred
aseptically. Suitable diluents include water for injections BP and
Leucogen
®
vaccine.
UNDER NORMAL CIRCUMSTANCES:
Primary vaccination in cats over 12 weeks of age: inject
subcutaneously or
intramuscularly 2 doses of vaccine at an interval of 1 month. Leucogee
vaccine can be used as a diluent for bot

Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
FELIGEN RCP.DOC
REVISION D
SAFETY DATA SHEET
Product Name:
Feligen RCP Trivalent Living Vaccine
PAGE: 1 OF 5
DATE OF ISSUE
8 APRIL, 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; answering machine after hours
CHEMICAL NATURE:
Mixture of viruses and other ingredients (see below for details).
TRADE NAME:
Feligen RCP Trivalent Living Vaccine
PRODUCT CODE:
FELIGEN3
PRODUCT USE:
For active immunisation of cats against feline rhinotracheitis, feline
calicivirus, feline
panleucopaenia (feline infectious enteritis).
CREATION DATE:
JULY, 2002
THIS VERSION ISSUED:
APRIL, 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:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
RESPONSE
P337: If eye irritation persists: seek medical attention.
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P332+P313: If skin irritation occurs: Get medical advice.
P337+P313: If eye irritation persists: Get medical advice.
P391: Collect spillage.
P370+P378: In case of fire: Not Combustible. Use extinguishing media
suited to burning materials.
STORAGE
P402+P404: Store in