CANVAC BB VACCINE

Country: Ավստրալիա

language: անգլերեն

source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

active_ingredient:

THIOMERSAL; BORDETELLA BRONCHISEPTICA (INACTIVATED CELL FREE EXTRACT

MAH:

ZOETIS AUSTRALIA PTY LTD

INN:

vaccine - canine Bordetella(20ug/mL)

pharmaceutical_form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

composition:

THIOMERSAL MERCURY Active 0.1 mg/ml; BORDETELLA BRONCHISEPTICA (INACTIVATED CELL FREE EXTRACT VACCINE-MICROBIAL Active 0.0 U

units_in_package:

20 x 1mL; Syringe

class:

VM - Veterinary Medicine

manufactured_by:

ZOETIS AUSTRALIA

therapeutic_group:

DOG | BITCH | CASTRATE | PUPPY

therapeutic_area:

IMMUNOTHERAPY

therapeutic_indication:

BORDETELLA SPP. | BORDETELLA BRONCHISEPTICA

leaflet_short:

Poison schedule: 0; Withholding period: WHP:NiL; Host/pest details: DOG: [BORDETELLA SPP.]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [BORDETELLA SPP.]; For immunisation of dogs against Bordetella bronchiseptia infection, a contributing factor to the canine cough syndrome.Not to be used in dogs when they are: incubating an infectious disease; seriously debilitated by another infectious disease, parasitic infestation or malnutrition; or under treatment with immunosuppressive drugs.

authorization_status:

Registered

authorization_date:

2023-07-01

PIL

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APPENDIX 2
AUSTRALIAN
GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
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: 51774/0207.
Signal
heading:
PRODUCT
NAME:
ACTIVE
CONSTITUENVS:
Statement
of
claims:
Net
contents:
DIRECTIONS
FOR
USE
Heading:
RESTRAINTS:
Contraindications:
PRECAUTIONS:
Side
effects:
RLP
Approved
Dosage
&
ADMINISTRATION:
FOR ANIMAL TREATMENT ONLY
CANVAC®
88
VACCINE
Canvac
BB
Vaccine
is
an
inactivated vaccine prepared from a cell-free extract of
Bordetel/a bronchiseptica
(20~g/mL).
An
aluminium salt
is
included
to
enhance the
response
to
vaccination and to increase the duration of immunity. Thiomersal
0.1
mg/mL
is
added as a preservative.
Canvac
BB
Vaccine
is
used
for
the
immunisation
of
dogs
against
Bordetel/a
bronchiseptica
infection, a contributing factor
to
the canine cough syndrome.
20 x 1
mL dose syringes
DIRECTIONS FOR USE
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Contents must
be
left
in
outer package until immediately before use
SHAKE GENTLY BEFORE USE
N/A
N/A
This product should not
be
used
·in
dogs when they are:
1.
incubating an infectious disease;
2.
seriously debilitated
by another infectious disease,
parasitic infestation or
malnutrition;
or
3.
under treatment with immunosuppressive drugs.
As
Canvac
BB
Vaccine
is
an
inactivated vaccine,
untoward systemic
effects
are
uncommon and the vaccine may
be
used
in
pregnant bitches. Careful palpation
of
the
site of injection may reveal a small fibrous nodule
in
some dogs about a week after
vaccination. This nodule will regress, becoming impalpable within two
to six weeks.
In
a very few small, smooth-coated dogs a nodule may
be
visible for a limited period.
Some animals may show transient post-vaccination reactions including
injection site
pain, lethargy and/or vomiting.
Systemic allergic reactions such as anaphylaxis are thou

SPC

PRODUCT NAME: CANVAC™ BB VACCINE
PAGE: 1 OF 5
THIS REVISION ISSUED: JANUARY, 2005
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: [phone]
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel:
[phone]
Fax:
[phone]
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
SUBSTANCE:
Bacterial cell extracts and other ingredients in buffered saline
suspension.
TRADE NAME:
CANVAC™ BB VACCINE
OTHER NAMES:
_Bordetella bronchiseptica_ Vaccine
PFIZER MSDS CODE:
0989
PRODUCT USE:
For vaccination by injection of dogs against _Bordetella
bronchiseptica_ (canine cough).
CREATION DATE:
MAY, 2004
REVISION DATE:
DECEMBER, 2004
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of NOHSC
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.
SUSDP CLASSIFICATION:
None allocated (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
: White aqueous suspension.
ODOUR:
No odour.
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
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely.
Available data indicates that this
product is not harmful. In addition product is unlikely to cause any
discomfort or irritation.
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 s