ULTRAVAC BOTULINUM VACCINE

Land: Ástralía

Tungumál: enska

Heimild: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Virkt innihaldsefni:

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

Fáanlegur frá:

ZOETIS AUSTRALIA PTY LTD

INN (Alþjóðlegt nafn):

Cl botulinum type C+Cl botulinum type D

Lyfjaform:

MISC. VACCINES OR ANTI SERA

Samsetning:

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

Einingar í pakka:

!200x2.5mL; !500mL; !500x1mL; #100x2.5mL; #250mL; #250x1mL; *25x500mL; *5000x2.5; ^100mL; ^100x1mL; ^40x2.5mL

Tegund:

VM - Veterinary Medicine

Framleitt af:

ZOETIS AUSTRALIA

Meðferðarhópur:

CATTLE | SHEEP | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | EWE | HEIFER | H

Lækningarsvæði:

IMMUNOTHERAPY

Ábendingar:

BOTULISM

Vörulýsing:

Poison schedule: 0; Withholding period: WHP: MEAT: NIL MILK: NIL EXPORT SLAU GHTER INTERVAL (ESI): ESI not applicabl e.; Host/pest details: CATTLE: [BOTULISM]; SHEEP: [BOTULISM]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [BOTULISM]; SHEEP: [BOTULISM]; For the prevention of botulism in cattle and sheep.

Leyfisstaða:

Registered

Leyfisdagur:

2023-07-01

Upplýsingar fylgiseðill

APPENDIX2
Australian Government
Australian Pestiddes
and
Veterinary Medicines Authority
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)
(Veterinary Products)
Select appropriate:
[J
New Product (include all applicable RLPs)
OR
IRI
Variation (highlight instructions that are being varied}. Approval
no.
of label
being varied:
59537/1 [2,3]/0509
Signal heading:
Product name:
Active
constituent/s:
Statement
of
claims:
Net contents:
Directions for Use
Heading:
Restraints:
Contraindications:
Precautions:
Side effects:
Dosage &
administration:
FOR ANIMAL TREATMENT ONLY
Ultravac® Botulinum Vaccine
Cl.
botulinum
type
C
<:
5
IU/mL,
C/.
botulinum
type
D
;;,
1.0
IU/mL
(toxoids).
0.1
mg/mL
Thiomersal added
as
an
antiseptic
For
the
prevention
of
botulism
in
cattle and sheep.
1
OOmL,
250
mL
and 500
mL
DIRECTIONS FOR USE
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Shake
well
before use and keep
thoroughly
mixed
during
use
This
product
can
be
stored
and used
for
up
to
30
days
after
first
opening
Handle
aseptically
and
store
refrigerated and protected
from
light
Please refer
to
the
resealing
section
and
the
product
insert
for
further
information
on
storage
and
handling
after
opening
It
is
important
that
the
vaccine
is
kept
properly
mixed
before and
during
use.
The
ro""'
of
'"~•l•tioo
I•
~"'"'""•oo•
U••l
""'•'
'*
N/A
N/A
-...
Take care to avoid self-injection
A
RLP
~
Localised swelling may develop at the site of injection and a firm,
nodular
lump may persist for some weeks, even months.
This
product
can
be
stored
and used
for
up
to
30
days
after
first
opening
The
route
of
inoculation
is
subcutaneous
Uust
under
the
recommended site for injection
is
high
on
the neck, behind the ear.
The recommended dose for cattle of all ages
is
2.5
mL,
and
for
18 Wormald Street, Symonston ACT 2609
PO Box 6182, Kingston ACT 2604 Australia
Tel:
+61
2 6210 4700 Fax:
+61
2 6210 4874
www.apvma.gov.au ABN 19 495 043 447
skin).
The
of
all
'
General
directions:
ages
is
1
mL.
One dose of vaccine
is
sufficient to confer protection
in
are

Vara einkenni

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