WEBSTERS LOW VOLUME 3 IN 1 VACCINE (INCLUDING CHEESY GLAND) FOR SHEEP AND LAMBS

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

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Active ingredient:
CLOSTRIDIUM PERFRINGENS TYPE D TOXOID; CLOSTRIDIUM TETANI - TOXOID; CORYNEBACTERIUM PSEUDOTUBERCULOSIS - TOXOID; THIOMERSAL
Available from:
Virbac (Australia) Pty Ltd
INN (International Name):
Corynebacterium pseudotubercul+Cl perfringens toxoid (D) + others
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
CLOSTRIDIUM PERFRINGENS TYPE D TOXOID VACCINE-TOXOID Active 5.0 IU/ml; CLOSTRIDIUM TETANI - TOXOID VACCINE-TOXOID Active 2.5 IU/ml; CORYNEBACTERIUM PSEUDOTUBERCULOSIS - TOXOID VACCINE-TOXOID Active 1.0 IU/ml; THIOMERSAL MERCURY Other 0.13 g/L
Units in package:
100mL; 200mL; 500mL
Class:
VM - Veterinary Medicine
Manufactured by:
VIRBAC
Therapeutic group:
LAMB | SHEEP | EWE | HOGGET | LAMB | OVINE | RAM | WEANER | WETHER
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
CHEESY GLAND | ENTEROTOXAEMIA (PULPY KIDNEY) | TETANUS | CLOSTRIDIUM PERFRINGENS TYPE D | LYMPHADENITIS | LYMPHANGITIS | TETANUS VACCINATION
Product summary:
Poison schedule: 0; Withholding period: WHP: Nil. ESI: Not Required.; Host/pest details: LAMB: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS]; SHEEP: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS]; Poison schedule: 0; Withholding period: ; Host/pest details: LAMB: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS]; SHEEP: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS]; For the prevention of Cheesy Gland (C.pseudotuberculosis), Enterotoxaemia (Cl. Perfringens type D) and Tetanus(Cl. tetani) in sheep and lambs.
Authorization status:
Registered
Authorization number:
50633
Authorization date:
2019-07-01

Virbac

(Australia)

Limited

Page

1 of 4

Product

Name:

Websters

Low

Volume

3

in

1

Vaccine

{Including

Cheesy

Gland}

for

Sheep

and

Lambs

APVMA

Number:

50633/60413

Version Date:

2013

Pack

sizes:

TEMPLATE

FOR

RELEVANT

LABEL

PARTICULARS

(RLPs)

(Veterinary

Products)

Select appropriate:

New Product (include all applicable RLPs} OR

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

label being

varied

50633/1107

Signal

heading:

FOR ANIMAL TREATMENT ONLY

Product

name:

WEBSTERS

LOW VOLUME 3 IN 1 VACCINE

(including Cheesy Gland) for Sheep and Lambs

Active

constituenVs:

Each

contains aluminium adjuvanted toxoid and cellular antigen from

Corynebacterium pseudotuberculosis (ovis)

Clostridium perfringens

type D

tetani

CONTAINS:

0.13

thiomersal

Statement of

claims:

For the prevention of Cheesy Gland (C.

pseudotuberculosis),

Enterotoxaemia (Cl.

perfringens

type D) and Tetanus (Cl.

tetam)

in

sheep

and lambs.

contents:

/200

/500

Directions for

READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

Heading:

DIRECTIONS FOR USE:

Restraints:

NlA

Contraindications:

NlA

Precautions:

NlA

Side

effects:

NlA

Dosage

&

SHAKE WELL BEFORE USE AND KEEP THOROUGHLY MIXED DURING

administration:

USE.

ONCE OPENED, VACCINE SHOULD

BE

USED WITHIN 24 HOURS.

Sheep:

Dosage:

dose

subcutaneous injection, (under the skin,

NOT

into the

muscle}.

Lambs:

dose at marking followed by a second

dose 4

weeks later.

annual booster dose will maintain a high level

immunity.

Ewes (fully vaccinated

as

lambs):

annual booster dose.

Administer

weeks before lambing

possible.

This will ensure that high levels

protective antibodies are passed to the lambs

the colostrum to protect

Approvec!

them

their first

weeks of life and at marking.

Slaughter lambs from vaccinated ewes:

dose at marking. This will

usually be sufficient to protect prime lambs from vaccinated ewes going

early slaughter.

Unvaccinated rams, ewes and wethers:

all unvaccinated sheep

introduced onto a property should be vaccinated with a

dose followed

by a second

dose 4

weeks later.

1

annual booster dose is

required.

Rams:

as far as possible, the

annual booster dose for rams should be

given before or at joining.

Virbac

(Australia)

Pty

Limited

Page

Product

Name:

APVMA

Number:

Version

Date:

Pack

sizes:

General

directions:

Websters Low Volume 3 in 1 Vaccine (Including Cheesy Gland)

Sheep and Lambs

50633/60413

2013

100 mL

Note:

Bloat:

areas where bloat conditions occur

spring and autumn, the

booster dose should be given before the danger period.

Enterotoxaemla:

Although Enterotoxaemia occurs most commonly in

forward lambs, sheep fed grain

drought conditions or grazed on wheat

stubble may

affected.

2 doses

vaccine

interval

not less than

4 weeks are required for strong protection.

Cheesy gland (CLA) control:

Shearing and dipping are the times

maximum exposure to this disease.

For optimum control annual booster

doses should occur

3 weeks before shearing.

Diseases

Enterotoxaemia

(Pulpy Kidney)

Tetanus

Caseous

lymphadenitis (CLA

or Cheesy Gland)

Caused

Clostridium

perfringens

type D

Clostridium tetani

Corynebacterium

pseudotuberculosis

(ovis)

VACCINATION PROGRAMME

Effect

Can cause sudden death,

mainly in young animals

good condition.

Often seen in

connection with a sudden

change

feed condition or

very generous feeding.

Can cause gradual onset

stiffness, muscle cramp,

spasms and death.

Occurs

commonly

association with

deep wounds, nail punctures,

marking

shearing.

Causes abscesses

lymph

nodes

sheep after invading

fresh cuts.

Mostly associated

with shearing and

contaminated sheep clips.

Full active immune response requires 2 injections.

A priming dose must be

followed by a secondary dose 4 to 6 weeks later to produce maximum

response.

The initial immunising course

2 injections 4 to 6 weeks apart

should be followed by

annual booster injection to maintain immunity.

RESEALING INSTRUCTIONS

A partially used pack can

kept for the next day if the following steps are

taken

Unscrew the delivery tube from the vaccine pack.

Empty the delivery tube and vaccinator by depressing the plunger

several times.

Disinfect the stopper.

Store the vaccine

the refrigerator.

not freeze.

Virbac (Australia)

Pty

Limited

Page

3

Product

Name:

Websters

low

Volume

3

in

1

Vaccine

(Including

Cheesy

Gland)

for

Sheep

and

Lambs

APVMA

Number:

50633/60413

Version

Date:

09 Sep 2013

Pack sizes:

Note:

Before re-use the delivery tube and cap should be sterilised by boiling

least ten minutes.

The plastic delivery tube may become opaque.

Frequent

attachment of the connecting tube may cause the stopper to leak.

Therefore,

the tube should not be attached more than twice.

Opened packs should be

used as quickly as possible.

Re-opening increases the risk

vaccine

contamination.

A. Single doses

Single doses

the vaccine may be withdrawn from the pack using a

sterilised hypodermic needle and syringe after disinfecting the stopper

vaccine pack.

B. Use with automatic vaccinator

automatic vaccinator may be attached to the pack as follows:

Remove the sterilised plastic cap and tube from the pack.

Connect the tube to the automatic vaccinator.

Disinfect the stopper with a suitable antiseptic, eg. methylated

spirits.

Screw the cap on to the plastic bottle

the vaccine which will

cause the needle to penetrate the stopper.

Prime the automatic vaccinator by depressing the plunger several

times and vaccine will flow to the needle.

CAUTION.

TO

AVOID CARCASS DAMAGE

Sterilise all injection apparatus

boiling (or equivalent) before use.

Avoid

strong disinfectants on apparatus.

Maintain cleanliness at all times;

Keep needles sharp and clean, replace frequently;

Use shortest needle possible, certainly not exceeding 15 mm;

As far as possible avoid injection

animals during

weather or under

dusty conditions;

This product should

injected only under the skin;

If possible, inject high on the neck behind the ear.

Withholding Period/s:

ZERO (0) DAYS.

Trade

Advice:

EXPORT SLAUGHTER INTERVAL (ESI): ESI not required.

Safety Directions:

NIA

First

Aid:

poisoning occurs, contact a doctor or Poisons Information Centre.

Phone

Australia 131126.

Additional user

Take Care to Avoid Self-Injection

safety:

the event

self-administration, seek medical attention if you are

Concerned, show the package leaflet

the label, to the Medical Practitioner.

Environmental

N/A

statements:

Virbac (Australia)

Pty

Limited

Page

Product

Name:

Websters

low

Volume

3

in

1

Vaccine

(Including

Cheesy

Gland)

for

Sheep

and

lambs

APVMA Number:

50633/60413

Version

Date:

2013

Pack

sizes:

200 mL/ 500

Disposal:

Dispose

empty containers and outer packaging and opened unused or

expired vaccine by wrapping with paper and putting in the garbage.

Discarded

needles should immediately be placed

a designated and appropriately

labelled "sharps" container.

The container should be

a type to reduce the

possibility

injury

handlers during collection and disposal.

Incineration is

the preferred method

disposal, otherwise "sharps" should be buried at a

suitable site, such as

farm chemical disposal pit located away from

watercourses.

Storage:

Store between 2°C and 8°C (Refrigerate.

not freeze).

Protect from light.

Use before expiry date marked

the label. Once opened, vaccine should be

used within 24 hours. KEEP OUT

OF

REACH OF CHILDREN

Name

& address:

VIRBAC (AUSTRALIA) PTY. LIMITED

Horsley Road, Milperra NSW 2214

-----

Freecall Customer Service Line: 1800 009 847

www_

virbac_com_au

The

following

is

for

APVMA

use

only:

APVMA approval

APVMA No: 50633/60413

Issued by: Fort Dodge Australia Pty

Limited

Product: Websters* Low Volume 3 in 1 Vaccine (Including Cheesy

Gland) for Sheep and Lambs (50633).

Phone: (02)9899 0444

Page 1 of 4

Issued: 4 Jul 2002

Revision 1

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 Low Volume 3 in 1 Vaccine (Including

Cheesy Gland) for Sheep and Lambs (50633).

Other Names:

3 in 1 Vaccine

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:

Water solution of ingredients (see below). Active ingredients are inactivated

Clostridial bacteria.

Uses:

Disease prevention by vaccination in sheep.

Physical Appearance & Properties

Appearance & Odour:

Fluid bacterial vaccine in a vial. No data re odour.

Melting/softening point:

Approximately 0°C.

Boiling point and vapour pressure: Approximately 100°C at 100kPa.

Volatile materials:

Water component.

Flashpoint:

Does not burn.

Specific gravity:

No data.

Solubility in water:

Completely soluble.

Corrosiveness:

Not corrosive.

Ingredients

Worksafe Exposure Limits

Chemical Entity

CAS No

Proportion per mL

TWA, mg/m

STEL, mg/m

Formalin-inactivated antigens of

Clostridium perfringens Type D

not set

no data

not set

not set

Clostridium tetani

not set

no data

not set

not set

Formalin-inactivated anaculture of Corynebacterium pseudotuberculosis

not set

no data

not set

not set

Thiomersal

54-64-8

0.13 mg

not set

not set

Distilled water

7732-18-5

to volume

not set

not set

Other ingredients

secret

no data

not set

not set

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty

Limited

Product: Websters* Low Volume 3 in 1 Vaccine (Including Cheesy

Gland) for Sheep and Lambs (50633).

Phone: (02)9899 0444

Page 2 of 4

Issued: 4 Jul 2002

Revision 1

This is a commercial product whose exact ratio of components may vary. Trace quantities of impurities are also

likely.

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty

Limited

Product: Websters* Low Volume 3 in 1 Vaccine (Including Cheesy

Gland) for Sheep and Lambs (50633).

Phone: (02)9899 0444

Page 3 of 4

Issued: 4 Jul 2002

Revision 1

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).

Acute Effects:

Swallowed:

Single dose oral toxicity is considered to be low. No hazards are anticipated from

swallowing small amounts incidental to normal handling operations.

Eye:

Eye contact with this product is considered unlikely to cause any significant irritation

or pain.

Skin:

Exposure to this product is not likely to cause significant irritation, nor is it likely to be

absorbed through skin in harmful amounts.

Inhalation:

No inhalation hazards incidental to normal handling operations are anticipated from

this product when used at room temperatures.

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.

Accidental self-injection:

If possible the application of gentle squeezing pressure with absorbent material (e.g.

facial tissue) 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.

Swallowed:

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

water to drink.

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 self injection 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.

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty

Limited

Product: Websters* Low Volume 3 in 1 Vaccine (Including Cheesy

Gland) for Sheep and Lambs (50633).

Phone: (02)9899 0444

Page 4 of 4

Issued: 4 Jul 2002

Revision 1

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.

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

No special transport requirements. This product has no UN classification. Not a

Scheduled Poison. Containers should be kept closed in order to minimise

contamination. Store between 2°C and 8°C. DO NOT FREEZE. Protect from light.

Use before the expiry date on the label. This product is packaged in single use vials.

All opened but unused vaccine must be discarded as instructed on the label.

Spills & Disposals

Minor spills do not normally need any special cleanup measures. 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 product, and dispose of

promptly. After spills, wash area preventing runoff from entering drains. If a

significant quantity of material enters drains, advise emergency services. This

material may be suitable for approved landfill. 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.

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty

Limited

Product: Websters* Low Volume 3 in 1 Vaccine (Including Cheesy

Gland) for Sheep and Lambs (50633).

Phone: (02)9899 0444

Page 5 of 4

Issued: 4 Jul 2002

Revision 1

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: When fighting fires involving significant quantities of this product, wear safety

boots, non-flammable overalls, gloves, hat and preferably, goggles.

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

Likely to decompose only after heating to dryness followed by further strong heating.

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.

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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