EQUIVAC T VACCINE

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

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Active ingredient:
CLOSTRIDIUM TETANI UF TOXOID; THIOMERSAL
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
Cl tetani - toxoid
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
CLOSTRIDIUM TETANI UF TOXOID VACCINE-TOXOID Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml
Units in package:
10mL Vial; 1mL Syr
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
CATTLE | DOG | GOAT | HORSE | PIGS | SHEEP | BEEF | BILLY | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUCK | BUFFALO |
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
TETANUS | TETANUS VACCINATION
Product summary:
Poison schedule: 0; Withholding period: WHP: Meat:Nil Milk:Nil; Host/pest details: CATTLE: [TETANUS]; DOG: [TETANUS]; GOAT: [TETANUS]; HORSE: [TETANUS]; PIGS: [TETANUS]; SHEEP: [TETANUS]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [TETANUS]; DOG: [TETANUS]; GOAT: [TETANUS]; HORSE: [TETANUS]; PIGS: [TETANUS]; SHEEP: [TETANUS]; For the immunisation of horses, dogs, cattle, sheep, goats and pigs against tetanus.
Authorization status:
Registered
Authorization number:
51772
Authorization date:
2020-07-01

Australian Government

Australian Pesticides and

Veterinary Medicines Authority

APPENDIX 2

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)

(Veterinary Products)

Select appropriate:

New Product (include all applicable RLPs) OR

Er Variation (highlight instructions that are being varied). Approval no. of label being varied: 51772/0306.

Signal heading:

FOR ANIMAL TREATMENT ONLY

Product name:

Equivac® T Vaccine

Active constituent/s:

Equivac T is a purified adjuvanted vaccine containing the formalinised toxin of

Clostridium

tetani

Lf/mL) The adjuvant, which is an aluminium salt, increases the level and

duration of the immunity afforded by the vaccine. The type of adjuvant and the purification

procedures used ensure maximum protection of animals with minimum risk of local

reactions at the site of injection. Thiomersal 0.1 mg/mL is added as a preservative.

Statement of claims:

For the immunisation of horses, dogs, cattle, sheep, goats and pigs against tetanus.

Net contents:

1mL dose syringe.

10mL dose vial.

Directions

for Use

Heading:

"Ak\

4,10.

Approved

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

Use all product within 12 hours of opening.

It is important that the vaccine is kept properly mixed before and during use. There may

be settling of the adjuvant after storage but material is easily resuspended by inversion of

the syringe or vial.

Before vaccine is injected, the proposed site of inoculation on the animal's skin may be

cleaned by swabbing with cotton-wool soaked in a suitable antiseptic solution, such as

methylated spirits.

Restraints:

Contraindications:

Precautions:

Side effects:

Localised swelling may develop at the site of injection and a firm nodular lump may

persist for some weeks or even months. There may be temporary lameness. Allergic

reactions such as anaphlylaxis occur rarely with all vaccines and may require appropriate

treatment.

Dosage &

administration:

The intramuscular route is recommended for the vaccination of horses.

The subcutaneous route should be used in dogs, cattle, sheep, goats and pigs.

SPECIES

DOSE

RECOMMENDED SITES FOR INOCULATION

Horses

1 mL

The side of the neck or body away from harness

Cattle

1 mL

High on the side of the neck

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

Sheep and Goats 1 mL The side of the neck (just below and behind the base of the ear)

Pigs

1 mL

At the base of, and immediately behind the ear

Dogs

1 mL

Any suitable site

After the initial dose, a period of 9 to 14 days is required for the development of effective

immunity. A single dose of Equivac T given to an unimmunised animal at the time of

wounding or surgery may not prevent tetanus (see Use of Antitoxin). A second dose

given four weeks after the initial dose should ensure a high level of immunity. If a third

(booster) dose is given a year later, long-lasting immunity will ensue. It is advisable,

particularly in valuable animals, to repeat the booster dose at intervals of approximately

five years.

Equivac T may be used as a diluent for the Canvace 3 (APVMA No. 52773,

) and Canvac

® 4 (APVMA No. 52778, ) vaccines. Two doses of

Equivac T can be administered as a diluent for Canvac 3 or Canvac 4 vaccinations and

given at 12-14 and 16-18 weeks of age.

General directions:

INDICATIONS FOR USE

Equivac T is used for the immunisation of animals against tetanus. The susceptibility of

animals to tetanus varies considerably according to species, e.g. horses, sheep and

goats are highly susceptible; cats, dogs, pigs and cattle are moderately susceptible; birds

are highly resistant. If losses in animals have occurred from tetanus, veterinary advice

should be sought in order to ensure that the correct diagnosis is made and the most

effective vaccination programme instituted.

USE OF ANTITOXIN

If immediate short-term protection against tetanus is required, Equivac ®

TAT (APVMA

No. 51771, ) (tetanus antitoxin) should be used. Preferably, active

immunisation with Equivac T should be commenced at the same time (see Equivac TAT

(APVMA No. 51771, ) [tetanus antitoxin] leaflet). Antitoxin has limited

usefulness owing to the shortness of its protective action.

CAUTION: AVOID CARCASE DAMAGE

Sterilise all injection apparatus (e.g. needles) by boiling in water for 10 minutes (or

equivalent) before use. Avoid use of strong disinfectants on apparatus.

Maintain cleanliness at all times during vaccination.

Great care must be taken to

avoid contamination of the vaccine, needle and internal parts of the syringe by

contact with unsterile surfaces or unwashed hands.

Keep needles sharp and clean. Replace frequently.

Use needles of appropriate gauge and length. For subcutaneous administration, use

shortest needle possible.

As far as possible avoid injection of animals during wet weather or under dusty

conditions.

This product must be injected

only under the skin

(subcutaneously)

meat

producing animals.

Intramuscular injections should be made into muscle tissue on the side of the neck.

Subcutaneous injections should be made under the skin high on the neck behind the ear.

Withholding Period/s:

Meat (Horses): Zero (0) days

Meat (Cattle, Sheep, Goats, Pigs): Zero (0) days

Milk: Zero (0) days

Trade Advice:

ESI not applicable

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

Safety Directions:

First Aid:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia

131126. This material may cause a mild allergic reaction in sensitive individuals on skin

contact. Avoid skin contact. If skin or hair contact occurs, remove contaminated clothing

and flush skin and hair with running water. If splashed in eyes, wash out immediately with

water.

Additional user safety:

Take care to avoid accidental self-injection. In the event of self-administration, seek

medical attention if you are concerned and show the package leaflet or the label, to the

Medical Practitioner.

Environmental

statements:

Disposal:

Dispose of empty containers by wrapping in paper and putting in garbage. Dispose of

empty syringes and needles by immediately placing into a designated and appropriately

labelled 'sharps' container.

Storage:

Store between 2°C and 8°C. (Refrigerate. Do not freeze). Protect from light.

Name & address:

Zoetis Australia Pty Ltd

38-42 Wharf Road

West Ryde NSW 2114

AUSTRALIA

The following is for APVMA use only:

APVMA approval no.

APVMA No: 51772/60129

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

Product Name: Equivac

®

T Vaccine

Page: 1 of 5

This revision issued:

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Section 1 - Identification of Chemical Product and Company

Pfizer Australia Pty Ltd

38-42 Wharf Road

West Ryde NSW 2114

Tel: (02) 9850 3333

Fax: (02) 9850 3399

____________________________________

Pfizer Australia Pty Ltd

A.B.N. 50 008 422 348

Substance:

Saline suspension of vaccine ingredients.

Trade Name:

EQUIVAC

®

T VACCINE

Pfizer MSDS Code:

0343

Product Use:

Vaccine for the prevention of tetanus in horses, dogs, cattle, sheep, goats and pigs

Creation Date:

August, 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. (NZ S2)

ADG Classification:

None allocated. Not a Dangerous Good.

UN Number:

None allocated

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Physical Description & colour

: Aqueous liquid suspension.

Odour:

No odour.

Major Health Hazards:

no significant risk factors have been found for this product.

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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 hazards in

normal use. However product may be mildly irritating, but is unlikely to cause anything more than mild discomfort

which should disappear once contact ceases.

Long Term exposure:

No data for health effects associated with long term skin exposure.

Eye Contact:

Short term exposure

: Exposure via eyes is considered to be unlikely. This product may be mildly irritating to eyes,

but is unlikely to cause anything more than mild discomfort which should disappear once product is removed.

Long Term exposure

: No data for health effects associated with long term eye exposure.

Ingestion:

Short term exposure

: Significant oral exposure is considered to be unlikely. This product is unlikely to cause any

irritation problems in the short or long term.

Long Term exposure

: No data for health effects associated with long term ingestion.

Product Name: Equivac

®

T Vaccine

Page: 2 of 5

This revision issued:

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Carcinogen Status:

SWA:

No significant ingredient is classified as carcinogenic by SWA.

NTP:

No significant ingredient is classified as carcinogenic by NTP.

IARC:

No significant ingredient is classified as carcinogenic by IARC.

Section 3 - Composition/Information on Ingredients

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Cl. tetani Toxoid

not set

<0.1

not set

not set

Other non hazardous ingredients

secret

<10

not set

not set

Water

7732-18-5

to 100

not set

not set

This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non

hazardous ingredients are also possible.

The TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day for a 5

day working week. The STEL (Short Term Exposure Limit) is an exposure value that should not be exceeded for more than 15 minutes and should

not be repeated for more than 4 times per day. There should be at least 60 minutes between successive exposures at the STEL. The term "peak "is

used when the TWA limit, because of the rapid action of the substance, should never be exceeded, even briefly.

Section 4 - First Aid Measures

General Information:

You should call The Poisons Information Centre if you feel that you may have been poisoned, burned or irritated by

this product. The number is 13 1126 from anywhere in Australia (0800 764 766 in New Zealand) and is available at all

times. Have this MSDS with you when you call.

Self Injection: Accidental self injection may lead to an inflammatory response. 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.

Inhalation:

First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.

Skin Contact:

Irritation is unlikely. However, if irritation does occur, flush with lukewarm, gently flowing water for 5

minutes or until chemical is removed. If in doubt obtain medical advice.

Eye Contact:

No effects expected. If irritation does occur, flush contaminated eye(s) with lukewarm, gently flowing

water for 5 minutes or until the product is removed. Obtain medical advice if irritation becomes painful or lasts more

than a few minutes.

Ingestion:

First aid is not generally required. If in doubt contact a Poisons Information Centre or a doctor.

Section 5 - Fire Fighting Measures

Fire and Explosion Hazards

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

involved in a fire.

Only small quantities of decomposition products are expected from this products at temperatures normally achieved in

a fire. This will only occur after heating to dryness.

Extinguishing Media

: Not Combustible. Use extinguishing media suited to burning materials.

Fire Fighting

: If a significant quantity of this product is involved in a fire, call the fire brigade.

Flash point

:

Does not burn.

Upper Flammability Limit:

Does not burn.

Lower Flammability Limit:

Does not burn.

Autoignition temperature:

Not applicable - does not burn.

Flammability Class:

Does not burn.

Section 6 - Accidental Release Measures

Accidental release

: In the event of a major spill, prevent spillage from entering drains or water courses. As a

minimum, wear overalls, goggles and gloves. Suitable materials for protective clothing include rubber, PVC. Eye/face

protective equipment should comprise as a minimum, protective glasses and, preferably, goggles. If there is a

significant chance that vapours or mists are likely to build up in the cleanup area, we recommend that you use a

respirator. Usually, no respirator is necessary when using this product. However, if you have any doubts consult the

Australian Standard mentioned below (section 8).

Product Name: Equivac

®

T Vaccine

Page: 3 of 5

This revision issued:

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Stop leak if safe to do so, and contain spill. Absorb onto sand, vermiculite or other suitable absorbent material. If spill

is too large or if absorbent material is not available, try to create a dike to stop material spreading or going into drains

or waterways. Sweep up and shovel or collect recoverable product into labelled containers for recycling or salvage,

and dispose of promptly. Recycle containers wherever possible after careful cleaning. Refer to product label for

specific instructions. 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. Ensure legality of disposal by consulting regulations prior to disposal. Thoroughly launder protective clothing

before storage or re-use. Advise laundry of nature of contamination when sending contaminated clothing to laundry.

Section 7 - Handling and Storage

Handling

: Keep exposure to this product to a minimum, and minimise the quantities kept in work areas. Check

Section 8 of this MSDS for details of personal protective measures, and make sure that those measures are followed.

The measures detailed below under "Storage" should be followed during handling in order to minimise risks to

persons using the product in the workplace. Also, avoid contact or contamination of product with incompatible

materials listed in Section 10.

Storage: Store at 2 to 8°C (Refrigerate. Do not freeze). Protect from light.

1. Store in original containers.

2. Keep containers securely sealed.

3. Store in a cool, dry, well-ventilated area.

4. Store away from incompatible materials and foodstuff containers.

5. Protect containers against physical damage and check regularly for leaks.

6. Observe manufacturer's storage and handling recommendations.

Section 8 - Exposure Controls and Personal Protection

The following Australian Standards will provide general advice regarding safety clothing and equipment:

Respiratory equipment: AS/NZS 1715, Protective Gloves: AS 2161, Industrial Clothing: AS2919, Industrial Eye

Protection: AS1336 and AS/NZS 1337, Occupational Protective Footwear: AS/NZS2210.

SWA Exposure Limits

TWA (mg/m

3

)

STEL (mg/m

3

)

Exposure limits have not been established by SWA for any of the known significant ingredients in this product.

No special equipment is usually needed when occasionally handling small quantities. The following instructions are

for bulk handling or where regular exposure in an occupational setting occurs without proper containment systems.

Ventilation:

No special ventilation requirements are normally necessary for this product. However make sure that

the work environment remains clean and that vapours and mists are minimised.

Eye Protection:

Eye protection is not normally necessary when this product is being used. However, if in doubt,

wear suitable protective glasses or goggles.

Skin Protection:

The information at hand indicates that this product is not harmful and that normally no special skin

protection is necessary. However, we suggest that you routinely avoid contact with all chemical products and that you

wear suitable gloves (preferably elbow-length) when skin contact is likely.

Protective Material Types:

There is no specific recommendation for any particular protective material type.

Respirator:

Usually, no respirator is necessary when using this product. However, if you have any doubts consult

the Australian Standard mentioned above.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

Aqueous liquid suspension.

Odour:

No odour.

Boiling Point:

Approximately 100°C at 100kPa.

Freezing/Melting Point:

Approximately 0°C.

Volatiles:

Water component.

Vapour Pressure:

2.37 kPa at 20°C (water vapour pressure).

Vapour Density:

No data.

Specific Gravity:

1.01

Water Solubility:

Completely soluble in water.

pH:

No data. Expected to be neutral.

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water distribution

No data

Autoignition temp:

Not applicable - does not burn.

Product Name: Equivac

®

T Vaccine

Page: 4 of 5

This revision issued:

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Section 10 - Stability and Reactivity

Reactivity:

This product is unlikely to react or decompose under normal storage conditions. However, if you have

any doubts, contact the supplier for advice on shelf life properties.

Conditions to Avoid:

Refrigerate, preferably between 2 and 8°C, but do not freeze. Protect this product from light.

Store in the closed original container in a dry, cool, well-ventilated area out of direct sunlight.

Incompatibilities:

No particular Incompatibilities.

Fire Decomposition:

No specific data. Based on composition of proteins and fats, the following might be expected:

Carbon dioxide, and if combustion is incomplete, carbon monoxide and smoke. Nitrogen and its compounds, and

under some circumstances, oxides of nitrogen. Oxides of sulfur (sulfur dioxide is a respiratory hazard) and other sulfur

compounds. Water.

Polymerisation:

This product will not undergo polymerisation reactions.

Section 11 - Toxicological Information

Target Organs:

There is no data to hand indicating any particular target organs.

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Ingredient

Risk Phrases

No ingredient mentioned in the HSIS database is present in this product at hazardous concentrations.

Principal routes of exposure are by skin contact, accidental injection (needle stick injury), ingestion and/or inhalation

of syringe expressed aerosols. As with any chemical product, contact with unprotected bare skin; inhalation of vapour,

mist or dust in the work place atmosphere; or ingestion in any form, should be avoided by observing good

occupational work practice. Inactivated cultures and toxoids are not regarded as pathogenic in humans.

Section 12 - Ecological Information

Insufficient data to be sure of status.

Section 13 - Disposal Considerations

Disposal:

Instructions concerning the disposal of this product and its containers are given on the product label.

These should be carefully followed.

Section 14 - Transport Information

ADG Code:

This product is not classified as a Dangerous Good. No special transport conditions are necessary

unless required by other regulations.

Section 15 - Regulatory Information

AICS:

We are unable to verify the presence of all of the ingredients in this product on the public AICS database.

However this is not a necessary requirement for registered Ag/Vet products. If you have any reason to be concerned

about this, we suggest you call us on the number below.

Section 16 - Other Information

This MSDS contains only safety-related information. For other data see product literature.

Acronyms:

ADG Code

Australian Code for the Transport of Dangerous Goods by Road and Rail, 7th Edition

AICS

Australian Inventory of Chemical Substances

CAS number

Chemical Abstracts Service Registry Number

Hazchem Number

Emergency action code of numbers and letters that provide information to emergency

services especially firefighters

IARC

International Agency for Research on Cancer

SWA

Safe Work Australia, formerly ASCC and NOHSC

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

UN Number

United Nations Number

Product Name: Equivac

®

T Vaccine

Page: 5 of 5

This revision issued:

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Contact Points

Pfizer

(02)9850 3333 (Business hours)

Ask for Environmental Health & Safety Manager

Police and Fire Brigade:

Dial 000

If ineffective:

Dial Poisons Information Centre

(

13 1126 from anywhere in Australia)

Please read all labels carefully before using product.

This MSDS copyright © Kilford & Kilford Pty Ltd, May, 2010.

http://www.kilford.com.au/

Phone (02)9251 4532

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