CANVAC 4 + CCI COMBINATION VACCINE PACK

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

20-06-2017

Active ingredient:

BORDETELLA BRONCHISEPTICA (INACTIVATED CELL FREE EXTRACT; CANINE DISTEMPER VIRUS - LIVING; CANINE PARAINFLUENZA VIRUS; CANINE ADENOVIRUS TYPE 2 LIVE (CAV II); CANINE PARVO VIRUS TYPE 2

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

canine distemper virus+canine adenovirus+canine parvovirus + others

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

BORDETELLA BRONCHISEPTICA (INACTIVATED CELL FREE EXTRACT VACCINE-MICROBIAL Active 0.0 qs dose; CANINE DISTEMPER VIRUS - LIVING VACCINE-VIRAL Active 0.0 qs dose; CANINE PARAINFLUENZA VIRUS VACCINE-VIRAL Active 0.0 qs dose; CANINE ADENOVIRUS TYPE 2 LIVE (CAV II) VACCINE-VIRAL Active 0.0 qs dose; CANINE PARVO VIRUS TYPE 2 VACCINE-VIRAL Active 0.0 qs dose

Units in package:

!25x1 dose; !vials; #vials; %25 x 1mL; %syringes/; %vials; &20x1 dose; &vials; *100 x 1; *dose vial; @20 x 1mL; @syringes/; @vials

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [BORDETELLA BRONCHISEPTICA, CANINE DISTEMPER, CANINE PARVOVIRUS, HEPATITIS :- INFECTIOUS, PARAINFLUENZA VIRUS TYPE 2 (INFECTIONS)]; For the protection of dogs against canine distemper, infectious canine hepatitis, canine parvovirus and respiratory disease caused by canine parainfluenza and canine adenovirus type 2.Plus CCI component - Bordetella bronchiseptica infection.This product should not be used in pregnant bitches or puppies less than 6 weeks of age, or in ferrets. Dogs should not be vaccinated when: incubating an infectious disease; seriously debilitated by ...; under treatment with immunosuppressive drugs.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

AUSTRALIAN
GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
RLP
APPENDIX 2
Approved
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
[]
New Product (include all applicable RLPs)
OR
0 Variation (highlight instructions that are being varied). Approval
no.
of
label being varied: 61300/54869.
Signal
heading:
Product
name:
Active
constituenVs:
Statement
of
claims:
Net
contents:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH
OF
CHILDREN
FOR
ANIMAL TREATMENT ONLY
CANVAC® 4 + CCI COMBINATION VACCINE PACK
CANVAC 4 VACCINE:
Living Canine Distemper Virus
(<:
10
70
TCID
5
ofL)
Canine Adenovirus type 2
(<:
10
65
TCIDsofL)
Canine Parvovirus type 2
(<:
10 "·'
TCIDsofL)
Canine Parainfluenza Virus
(<:
10
'·
5
TCID
5
ofL)
CANVAC CCI VACCINE:
Canvac CCi Vaccine
is
an
inactivated vaccine prepared from a cell-free extract
of
Bordetella bronchiseptica (7.5
~g/mL).
It
is
adjuvanted with
an
immunostimulating
complex
to
enhance the response to vaccination and to increase the duration
of
immunity.
CANVAC 4 VACCINE:
For the
protection
of
dogs against canine
distemper,
infectious canine
hepatitis,
canine parvovirus and respiratory disease caused
by
canine parainfluenza and canine
adenovirus type
2.
CANVAC CCI VACCINE:
Canvac CCi Vaccine
is
used for the immunisation
of
dogs
as
an
aid
in
the prevention
of
Borde/ella
bronchiseptica
infection,
a
contributing
factor to
the
canine
cough
syndrome.
The vaccine
is
intended for the immunisation
of
dogs against colonization
of
the upper
and lower respiratory tract and the nose and throat with
Borde/ella bronchiseptica.
It
may
be
given alone or used as a diluent for other vaccines
in
the Canvac® range. For
optimal
effect
on
the
incidence
and
transmission
of
infectious
tracheobronchitis
(canine
cough)
vaccination
with
a
multicomponent
vaccine
containing
canine
distemper
virus,
canine
parainfluenza
virus
and
canine
adenovirus
type
2
is
recommended.
CONTENTS FOR 1 00 PACK:
Canvac 4 Vaccine 1
00
x 1 dose vials
Canvac CCi Vaccine 100 x 1
mL
vials

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Summary of Product characteristics

PRODUCT NAME: CANVAC® 4 VACCINE
PAGE: 1 OF 4
This revision issued: October, 2015
MATERIAL SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: 1800 814 883
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: 1800 814 883
Fax: (02) 8876 0444
Email: australia.animalhealth@zoetis.com
CHEMICAL NATURE:
Freeze dried virus plus other stabilising ingredients.
TRADE NAME:
CANVAC
® 4 VACCINE
OTHER NAME:
COMBINED CANINE DISTEMPER, INFECTIOUS HEPATITIS, PARVOVIRUS AND
PARAINFLUENZA VIRUS VACCINE, LIVING
PRODUCT USE:
When reconstituted, for the immunisation of dogs against Canine
Distemper,
Infectious Hepatitis, Parvovirus and Parainfluenza. Administered by
injection.
CREATION DATE:
MAY, 2004
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid until August, 2016.
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 (Aust), S2 (NZ)
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Vial with pale fawn coloured freeze dried pellet
ODOUR:
No data - expected to be mild.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
THE ACTIVE VIRUSES ARE INFECTIOUS TO ANIMALS ONLY.
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely. Long
term inhalation of high
amoun

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