BOTULINUM VACCINE BIVALENT

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CLOSTRIDIUM BOTULINUM TYPE C TOXOID; CLOSTRIDIUM BOTULINUM TYPE D TOXOID; THIOMERSAL

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

Cl botulinum type C(6IU/mL)+Cl botulinum type D(1.5IU/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

CLOSTRIDIUM BOTULINUM TYPE C TOXOID VACCINE-TOXOID Active 0.0 P; CLOSTRIDIUM BOTULINUM TYPE D TOXOID VACCINE-TOXOID Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

#200 Doses; #500mL; *100mL; *40 Doses; Dose=2.5mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

BOTULISM

Product summary:

Poison schedule: 0; Withholding period: WHP: Nil.; Host/pest details: CATTLE: [BOTULISM]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [BOTULISM]; For the prevention of botulism in cattle and sheep.See CAUTION - AVOID CARCASS DAMAGE on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

..
,.
APPENDIX 2
•
•
Australian Government
Australian Pesticides
and
Veterinary Medicines Authority
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
Cl
New Product (include all applicable RLPs)
OR
liD
Variation (highlight instructions that are being varied). Approval
no.
of
label being varied: 36586/1[2]/1105
Signal heading:
Product name:
Active constituent/s:
Statement
of
claims:
Net contents:
Directions for
Use
Heading:
Restraints:
Contraindications:
Precautions:
Side effects:
Dosage
&
administration:
+
RLP
Approved
FOR ANIMAL TREATMENT ONLY
Botulinum
Vaccine Bivalent
;, 6
IU/ml
Cl.
botulinum
Type
C,
;,1.5
IU/ml
Cl.
botulinum
Type D
Thiomersal
0.1
mg/ml
is
added as
an
antiseptic
For the prevention
of
botulism in cattle and sheep
Botulinum
Vaccine
Bivalent
contains
toxoids
prepared
from
cultures
of
both
Clostridium botulinum
Type C
("
6
IU/ml)
and
Clostridium botulinum
Type D
("
1.5
IU/ml).
The aluminium salt acts as
an
adjuvant and thereby increases the level and
duration
of
immunity
conferred
by
the
vaccines.
The
type
of
adjuvant and
the
purification procedures
used
ensure maximum protection
of
stock with minimum risk
of
local reactions at the site of injection.
Thiomersal
0.1
mg/ml
is added as
an
antiseptic.
100mL and 500mL
DIRECTIONS FOR USE
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Contents must
be
left
in
outer package until immediately before use
Shake
well
before use and keep
thoroughly
mixed
during
use
N/A
N/A
N/A
Localised swelling may develop
at
the site
of
injection and a
firm
nodular
lump
may persist
for
some weeks, even months. There may
be
some
temporary
lameness.
The recommended dose
for
cattle
of
all ages is 5 mL, and
for
sheep
of
all
ages
is 2
ml.
The
route
of
inoculation
is
subcutaneous
uust
under
the
skin).
The
recommended site
for
injection is high on the neck, behind the ear.
DEVELOPMENT
OF
IMMUNITY
One dose of vaccine
is
sufficient to confer moderately
good
protection
but,
whenever
possible, each animal should
be
given a second dose
of

Summary of Product characteristics

PRODUCT NAME: ULTRAVAC
® BOTULINUM VACCINE
PAGE: 1 OF 5
THIS REVISION ISSUED: APRIL, 2010
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:
Aqueous suspension of _Clostridium botulinum_ Types C & D Toxoids.
TRADE NAME:
ULTRAVAC
®
BOTULINUM VACCINE
PFIZER MSDS CODE:
0053
PRODUCT USE:
Animal vaccine for the prevention of botulism in cattle as described
on the product
label.
CREATION DATE:
JUNE, 2004
THIS VERSION ISSUED:
APRIL, 2010
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.
SUSDP CLASSIFICATION:
None allocated.
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
: Aqueous suspension.
ODOUR:
No data.
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 should
present no hazar