CANIGEN C4 DHA2PPI QUADRIVALENT LIVING VACCINE
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
01-07-2013
Active ingredient:
CANINE ADENO VIRUS TYPE 2; CANINE DISTEMPER VIRUS; CANINE PARAINFLUENZA VIRUS; CANINE PARVO VIRUS
Available from:
VIRBAC (AUSTRALIA) PTY LTD
INN (International Name):
canine distemper virus+canine adenovirus+canine parvovirus + others
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
CANINE ADENO VIRUS TYPE 2 VACCINE-VIRAL Active 0.0 P; CANINE DISTEMPER VIRUS VACCINE-VIRAL Active 0.0 P; CANINE PARAINFLUENZA VIRUS VACCINE-VIRAL Active 0.0 P; CANINE PARVO VIRUS VACCINE-VIRAL Active 0.0 P
Units in package:
10 x 1mL; 20 x 1mL
Class:
VM - Veterinary Medicine
Therapeutic group:
DOG | BITCH | CASTRATE | PUPPY
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
CANINE ADENOVIRUS - TYPE 2 | CANINE DISTEMPER | CANINE PARAINFLUENZA | CANINE PARVOVIRUS | VACCINE | EQUINE ROTAVIRUS | PARVOVIRUS
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [CANINE ADENOVIRUS - TYPE 2, CANINE DISTEMPER, CANINE PARAINFLUENZA, CANINE PARVOVIRUS, VACCINE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CANINE ADENOVIRUS - TYPE 2, CANINE DISTEMPER, CANINE PARAINFLUENZA, CANINE PARVOVIRUS, VACCINE]; For vaccination of dogs against distemper, infectious hepatitis, parvovirus and parainfluenza and the reduction of shedding of parvovirus.Do not vaccinate dogs with a compromised immune status or receiving immunosuppressive drugs. Do not vaccinate pregnant bitches.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
VIRBAC (AUSTRALIA) PTY LIMITED
Page
1
of 2
PRODUCT NAME:
Canigen C4 DH
A2
PPi Quadrivalent Living Vaccine
APVMA NUMBER:
47373/61116
VERSION DATE:
12 December 2013
PACK SIZES:
10 and 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:
47373/55200
Signal heading:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
RLP
Product name:
CANIGEN
® C4 DH
A2
PP1 QUADRIVALENT LIVING VACCINE
Approv
Active constituent/s:
Each single dose vial contains (minimum titres in
TCID50):
- live, attenuated canine distemper virus
10
3
- live, attenuated canine adenovirus type 2 (infectious hepatitis)
104
- live, attenuated canine parvovirus
105
- live, attenuated canine parainfluenza virus
10
5
Statement of
claims:
FOR VACCINATION OF DOGS AGAINST DISTEMPER, INFECTIOUS HEPATITIS,
PARVOVIRUS AND PARAINFLUENZA AND THE REDUCTION OF SHEDDING OF
PARVOVIRUS.
Net contents:
10
and 20 x 1mL 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 DOGS WITH A COMPROMISED IMMUNE STATUS OR RECEIVING
IMMUNOSUPPRESSIVE DRUGS.
DO NOT VACCINATE PREGNANT BITCHES.
Side effects:
Adverse post-vaccination reactions such as
anaphylaxis/hypersensitivity occur
rarely and may require appropriate treatment.
DOSAGE &
ADMINISTRATION:
ONLY HEALTHY DOGS WITH NORMAL TEMPERATURES SHOULD BE VACCINATED AFTER
A
CLINICAL EXAMINATION.
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
(i.e. water
for injections BP) transferred aseptically.
VIRBAC (AUSTRALIA) PTY LIMITED
Page 2
of 2
PRODUCT NAME:
Canigen C4 DH
A2
PPi Quadrivalent Living Vaccine
APVMA NUMBER:
47373/61116
VER
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Summary of Product characteristics
VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
CANIGEN
DHA2PPI.DOC
REVISION D
SAFETY DATA SHEET
Product Name:
Canigen DHA2PPi Quadrivalent Living Vaccine
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:
(02) 9772 9772 or 1800 242 100
FAX:
(02) 9772 9773
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:
Freeze dried virus and other ingredients.
TRADE NAME:
Canigen DH
A2
PPi Quadrivalent Living Vaccine
PRODUCT CODE: CANIGEN4
PRODUCT USE:
For the active immunisation of dogs against canine distemper,
contagious hepatitis,
canine parvovirus and canine parainfluenza type II viruses.
CREATION DATE:
JULY, 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: S4
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 induce vomiting.
P332+P313: If
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