WEBSTERS BIVALENT BOTULINUM VACCINE FOR SHEEP AND CATTLE

País: Austràlia

Idioma: anglès

Font: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
19-06-2017

ingredients actius:

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

Disponible des:

VIRBAC (AUSTRALIA) PTY LTD

Designació comuna internacional (DCI):

Cl botulinum type C+Cl botulinum type D

formulario farmacéutico:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composición:

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 0.13 g/L

Unidades en paquete:

200mL; 500mL

clase:

VM - Veterinary Medicine

Fabricat per:

VIRBAC

Grupo terapéutico:

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

Área terapéutica:

IMMUNOTHERAPY

indicaciones terapéuticas:

BOTULISM | VACCINE | EQUINE ROTAVIRUS

Resumen del producto:

Poison schedule: 0; Withholding period: WHP: Nil ESI: Not required.; Host/pest details: CATTLE: [BOTULISM, VACCINE]; SHEEP: [BOTULISM, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [BOTULISM, VACCINE]; SHEEP: [BOTULISM, VACCINE]; For the prevention of botulism caused by Cl. Botulinum types C and D.

Estat d'Autorització:

Registered

Data d'autorització:

2023-07-01

Informació per a l'usuari

                                Virbac (Australia) Pty Limited
Page
1
of
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Product Name:
Websters Bivalent Botulinum Vaccine
for
Sheep and Cattle
APVMA Number:
47948/60352
Version Date:
09 Sep 2013
Pack sizes:
200
ml/
500
ml
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary
Products)
Select appropriate:
D New Product (include all applicable RLPs)
OR
x Variation (highlight instructions that are being varied). Approval
no.
of
label being
varied
4794811007
Signal
heading:
Product
name:
Active constituentls:
Statement of
claims:
Net
contents:
Directions for
Use
Heading:
FOR
ANIMAL
TREATMENT
ONLY
WEBSTERS
BIVALENT
BOTULINUM
VACCINE
FOR
SHEEP
AND
CATTLE
i
poisoning).
c
(5.0
Botulism occurs throughout Australia and many other countries and can
affect all species
livestock-
cattle, sheep, horses, pigs and poultry.
It is caused by the ingestion
of
CL
botulinum toxin in feed (especially mouldy hay, decaying vegetation
and the carcasses
of
dead cattle, sheep and rabbits) or from contaminated water.
For
the
of
botulism caused
Clostridium botulinum
types C and
D.
200mL
I
500
mL
READ
THE ENCLOSED
BEFORE USING THIS
DIRECTIONS FOR USE:
Restraints:
N/ A
Contraindications:
N/A
Precautions:
Side
effects:
Dosage
&
administration:
NIA
RLP
N/A
MIXED
ONCE OPENED, VACCINE
SHOULD
BE
USED WITHIN 24 HOURS
VACCINATION
PROGRAM
CATTLE
Dosage:
5 mL dose by subcutaneous injection, (under the skin,
NOT
into the muscle).
Cattle
of
all
ages:
5
mL
dose followed by a second 5
mL
dose 4 to 6 weeks later.
A 5 mL annual booster dose is recommended.
Optimal immunity requires 2 doses
of
5
mL
each, 4 to 6 weeks apart.
However, the
giving
of
the second 5 mL dose is not always possible
in
extensive pastoral areas.
In
these circumstances the immunity produced by a single 5 mL dose will
provide
worthwhile protection.
Immunity develops within 14 days
of
vaccination.
SHEEP
Dosage:
2 mL dose by subcutaneous injection, (under the skin, NOT into the
muscle).
Sheep
of
all
: 2 mL dose followed by a second 2 mL dose 12 months later. This
I
I
I
Virbac {Australia) Pty limited
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Fitxa tècnica

                                abcdefg
_ _
_FORT DODGE AUSTRALIA Pty Limited _
_ACN 000 074 902 _
_MATERIAL SAFETY _
_1 Maitland Place _
_DATA SHEET _
_Baulkham Hills NSW 2153 _
_ _
_Telephone: (02) 9899 0444 _
_ _
_Facsimile: _
_(02) 9899 2151 _
_ _
_Emergency: 1800 033 111_
_ _
WORK HAZARD ASSESSMENT
Not classified as hazardous according to the criteria of Worksafe
Australia.
l IDENTIFICATION
Product Name: Websters Bivalent Botulinum Vaccine for
Sheep and Cattle (47948).
Other Names:
None.
Product Code:
None.
UN No:
None allocated
Hazchem Code:
None allocated
Dangerous Goods Class:
None allocated
Sub Risk Class:
None allocated
Packaging Group:
None allocated
Poison Schedule:
Not scheduled.
Chemical Family:
Blend of ingredients (see below). Active ingredient is a deactivated
bacterium.
Uses:
Disease prevention by vaccination in cattle and sheep.
Physical Appearance & Properties
Appearance & Odour:
Fluid bacterial vaccine in a vial. No data re odour.
Melting/softening point:
Decomposes before melting.
Boiling point and vapour pressure: Not applicable.
Volatile materials:
No specific data. Expected to be low at 100°C.
Flashpoint:
Does not burn.
Specific gravity:
No data.
Solubility in water:
No data.
Corrosiveness:
Not corrosive.
Ingredients
Worksafe Exposure Limits
Chemical Entity
CAS No
Proportion, %
TWA, mg/m
3
STEL, mg/m
3
Purified toxoids of _Clostridium botulinum_ Type C & D
not set
pure *
not set
not set
* Commercially pure.
This is a commercial product whose exact ratio of components may vary.
Trace quantities of impurities are also likely.
ll HEALTH HAZARD DATA
Health Effects:
No specific data is available for the product for chronic exposure
symptoms. The
ingredients are not listed as carcinogenic in Worksafe’s document
“Exposure Standards
for Atmospheric Contaminants in the Occupational Environment” (May
1995), nor in
NOHSC’s “List of Designated Hazardous Substances” (April 1999).
Issued by: Fort Dodge Australia Pty Limited
Product: Websters Bivalent Botulinum Vaccine for Sheep and Cattle
(47948).
Phone: (02)9899 0444
Pa
                                
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