WEBSTERS BIVALENT BOTULINUM VACCINE FOR SHEEP AND CATTLE

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
CLOSTRIDIUM BOTULINUM TYPE C TOXOID; CLOSTRIDIUM BOTULINUM TYPE D TOXOID; THIOMERSAL
Available from:
Virbac (Australia) Pty Ltd
INN (International Name):
Cl botulinum type C+Cl botulinum type D
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 0.13 g/L
Units in package:
200mL; 500mL
Class:
VM - Veterinary Medicine
Manufactured by:
VIRBAC
Therapeutic group:
CATTLE | SHEEP | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | EWE | HEIFER | H
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
BOTULISM | VACCINE | EQUINE ROTAVIRUS
Product summary:
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.
Authorization status:
Registered
Authorization number:
47948
Authorization date:
2020-07-01

Virbac (Australia) Pty Limited

Page

Product Name:

Websters Bivalent Botulinum Vaccine

Sheep and Cattle

APVMA Number:

47948/60352

Version Date:

09 Sep 2013

Pack sizes:

TEMPLATE

RELEVANT

LABEL

PARTICULARS

(RLPs)

(Veterinary

Products)

Select appropriate:

D New Product (include all applicable RLPs)

x Variation (highlight instructions that are being varied). Approval no.

label being

varied

4794811007

Signal

heading:

Product

name:

Active constituentls:

Statement of

claims:

contents:

Directions for

Heading:

ANIMAL

TREATMENT

ONLY

WEBSTERS

BIVALENT

BOTULINUM

VACCINE

SHEEP

CATTLE

poisoning).

(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

botulinum toxin in feed (especially mouldy hay, decaying vegetation and the carcasses

dead cattle, sheep and rabbits) or from contaminated water.

botulism caused

Clostridium botulinum

types C and

200mL

READ

THE ENCLOSED

BEFORE USING THIS

DIRECTIONS FOR USE:

Restraints:

N/ A

Contraindications:

Precautions:

Side

effects:

Dosage

&

administration:

MIXED

ONCE OPENED, VACCINE

SHOULD

USED WITHIN 24 HOURS

VACCINATION

PROGRAM

CATTLE

Dosage:

5 mL dose by subcutaneous injection, (under the skin,

into the muscle).

Cattle

ages:

dose followed by a second 5

dose 4 to 6 weeks later.

A 5 mL annual booster dose is recommended.

Optimal immunity requires 2 doses

each, 4 to 6 weeks apart.

However, the

giving

the second 5 mL dose is not always possible

extensive pastoral areas.

these circumstances the immunity produced by a single 5 mL dose will provide

worthwhile protection.

Immunity develops within 14 days

vaccination.

SHEEP

Dosage:

2 mL dose by subcutaneous injection, (under the skin, NOT into the muscle).

Sheep

: 2 mL dose followed by a second 2 mL dose 12 months later. This

Virbac {Australia) Pty limited

Page

Product Name:

Websters Bivalent Botulinum

Vaccine

for

Sheep

and

Cattle

APVMA

Number:

47948/60352

Version Date:

2013

Pack

sizes:

General

directions:

CAUTION: AVOID CARCASS DAMAGE

Sterilise all injection apparatus by boiling

equivalent) before use.

Avoid use

strong disinfectants

apparatus.

Maintain cleanliness at all times;

Keep needles sharp and clean, replace frequently;

Use shortest needle possible, certainly not exceeding 15 mm;

far as possible avoid injection of animals during

weather

under

dusty

conditions;

This product should be injected only under the skin;

possible, inject high on the neck behind the ear.

Withholding Period/s:

ZERO (0) DAYS.

Trade Advice:

EXPORT SLAUGHTER INTERVAL (ESI): Not required.

Safety Directions:

First

Aid:

poisoning occurs, contact a doctor

Poisons Information Centre.

Phone Australia

131126.

Additional user safety:

Take Care to Avoid Self-Injection

the event

self-administration, seek medical attention

you are

Concerned, show the packaQe leaflet

the label, to the Medical Practitioner.

Environmental

statements:

Disposal:

Dispose

empty container by wrapping

paper and putting

garbage.

Discarded

needles should immediately be placed

a designated and appropriately labelled 'sharps'

container.

Please note instruction leaflet and carton only recyclable.

Storage:

Store

2°C to 8°C. (Refrigerate.

freeze).

Protect from light.

Use before the expiry

date on the label.

Once opened, vaccine should be used within 24 hours.

All opened but

unused vaccine must be discarded.

KEEP OUT OF REACH OF CHILDREN.

Name

&

address:

VIRBAC (AUSTRALIA) PTY. LIMITED

Horsley Road, Milperra

2214

Freecall Customer Service Line: 1800 009 84 7

www. vlrbac.com.au

The

following

is

for

APVMA

use

only:

APVMA approval no.

APVMA No: 47948/60352

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

STEL, mg/m

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

Page 1 of 4

Issued: 4 Jul 2002

Revision 2

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty Limited

Product: Websters Bivalent Botulinum Vaccine for Sheep and Cattle

(47948).

Phone: (02)9899 0444

Page 2 of 4

Issued: 4 Jul 2002

Revision 2

Acute Effects:

Swallowed:

Data suggests that this product should present no significant problems to typical persons

in normal use.

Eye:

Data suggests that this product should present no significant problems to typical persons

in normal use.

Skin:

Data suggests that this product should present no significant problems to typical persons

in normal use.

Inhalation:

Data suggests that this product should present no significant problems to typical persons

in normal use.

First Aid:

If poisoning occurs, contact a Doctor or Poisons Information Centre. Phone 13 1126 from

anywhere in Australia. If possible have this MSDS or product label with you.

Swallowed:

If swallowed, do NOT induce vomiting. Wash mouth with water and give a glass of water

to drink.

Self Injection:

Accidental self injection may lead to an inflammatory response and medical advice should

be sought on the management of deep injections, particularly those near a joint or

associated with bruising. If possible the application of gentle squeezing pressure with

absorbent material (e.g. facial tissues) at the injection site will swab up unabsorbed

vaccine. Strong squeezing of the site should be avoided. The damaged area should be

thoroughly cleansed and a topical antiseptic applied.

Eyes:

If product gets in eyes, wash eyes to remove material. No further measures should

normally be required.

Skin:

If product gets on skin, wash skin to remove material. No further measures should

normally be required.

Inhalation:

No first aid measures normally required. However, if vapours or mists have been inhaled,

and irritation has developed, remove to fresh air and observe until recovered. If irritation

becomes painful or persists more than about 30 minutes, seek medical advice.

Advice to Doctor:

Treat symptomatically. Accidental self injection may lead to an inflammatory response.

Deep injections, particularly those near a joint or associated with bruising should be

treated medically or surgically.

lll PRECAUTIONS FOR USE

Exposure Standards:

A time weighted average (TWA) concentration for an 8 hour day, and 5 day week has not

been established by Worksafe Australia for any of the major ingredients in this product.

There is a blanket limit of 10mg/m

for dusts or mists when limits have not otherwise been

established. The nature of this product makes it unlikely that this level will be approached

in normal use.

Engineering Controls:

In industrial situations, concentration values below the TWA value should be maintained.

Values may be reduced by process modification, use of local exhaust ventilation,

capturing substances at the source, or other methods. If you believe air borne

concentrations of mists, dusts or vapours are high, you are advised to modify the process

or environment to reduce the problem.

Personal Protection:

The following instructions are meant for people coming into frequent and lengthy contact

with this product. For occasional use, take precautions suitable for the conditions under

which the product is being used.

Respiratory Protection:

It is usually safe to not use a dust mask or respirator protection on account of this product.

However, if the product is being used in dusty or confined conditions, use of a mask or

respirator may be preferred. For help in selecting suitable equipment, consult AS/NZS

1715.

Protective Gloves:

Protective gloves are not normally necessary when using this product. However, it is

always prudent to wear gloves. For help in selecting suitable equipment, consult AS 2161.

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty Limited

Product: Websters Bivalent Botulinum Vaccine for Sheep and Cattle

(47948).

Phone: (02)9899 0444

Page 3 of 4

Issued: 4 Jul 2002

Revision 2

Eye Protection:

Protective eyewear is not normally necessary when using this product. However, it is

always prudent to use protective eyewear. Consult AS1336 and AS/NZS 1337 for advice

on Industrial Eye Protection.

Clothing:

This product is essentially safe to use without special protective clothing. However, its use

is recommended as a good industrial practice. Consult AS2919 for advice on Industrial

Clothing.

Safety Boots:

Wearing safety boots in industrial situations is advisory. Consult AS/NZS2210 for advice

on Occupational Protective Footwear.

Always wash hands before smoking, eating or using the toilet. Wash contaminated

clothing and other protective equipment before storing or re-using.

lV SAFE HANDLING INFORMATION

Storage & Transport

Store and transport refrigerated (2-8ºC. DO NOT FREEZE). This product has no UN

classification. Not a Scheduled Poison. Containers should be kept closed in order to

minimise contamination. Keep from extreme heat and open flames, and make sure that

the product does not come into contact with substances listed under "Materials to avoid"

below.

Spills & Disposals

Sweep up broken containers. Mop up liquid. Dispose of empty container by wrapping with

paper and putting in garbage. Discarded needles should immediately be placed in a

designated and appropriately labeled sharps container. In the event of a major spill,

prevent spillage from entering drains or water courses. No special protective clothing is

normally necessary. However use judgement and take care. Stop leak if safe to do so,

and contain spill. Absorb onto sand, vermiculite or other suitable absorbent material.

Sweep up and shovel or collect recoverable product into labelled containers for recycling

or salvage. After spills, wash area preventing runoff from entering drains. If a significant

quantity of material enters drains, advise emergency services. Full details regarding

disposal of used containers, spillage and unused material may be found on the label. If

there is any conflict between this MSDS and the label, instructions on the label prevail.

Dispose of only in accord with all regulations.

Fire & Explosion Hazard

There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire.

Flashpoint:

Does not burn.

Flammability limits:

Not applicable. This product does not burn.

Extinguishing Media:

This product does not burn. Use extinguishing media suited to the materials that are

burning.

Special Fire Fighting procedures: No special fire fighting clothing is necessary on account of this product. However, as

a minimum, wear safety shoes and overalls.

Unusual Fire & Explosion Hazards: Fire decomposition products from this product are not normally hazardous.

Stability:

This product is unlikely to spontaneously decompose.

Polymerisation:

This product is unlikely to spontaneously polymerise.

Decomposition Products:

Carbon dioxide.

Materials to avoid:

No particular incompatibilities.

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty Limited

Product: Websters Bivalent Botulinum Vaccine for Sheep and Cattle

(47948).

Phone: (02)9899 0444

Page 4 of 4

Issued: 4 Jul 2002

Revision 2

V OTHER INFORMATION

This MSDS is prepared in accord with the Worksafe Australia document “National Code of Practice for the Preparation

of Material Safety Data Sheets”, 1994.

Contact Point:

Technical Services Manager

FORT DODGE AUSTRALIA Pty Limited

1 Maitland Place

Baulkham Hills NSW 2153

Telephone:

(02)9899 0444

Facsimile:

(02)9899 2151

Emergency:

1800 033 111

Poisons Information Centre:

13 1126 (from anywhere in Australia)

Please read all labels carefully before using product.

DISCLAIMER: This MSDS summarises our best knowledge of the health and safety hazard information of the product and how to safely handle and

use the product in the workplace. Each user should read this MSDS and consider the information in the context of how the product will be handled

and used in the workplace including in conjunction with other products. If clarification or further information is needed to ensure that an appropriate

risk assessment can be made, the user should contact this company.

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