EQUITY OESTRUS CONTROL VACCINE FOR HORSES

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

Buy It Now

Active ingredient:
GNRF - PROTEIN CONJUGATE; THIOMERSAL
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
GnRF-protein conjugate(200ug/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
GNRF - PROTEIN CONJUGATE BIOLOGICAL-PROTEIN Active 200.0 ug/ml; THIOMERSAL MERCURY Other 0.1 mg/ml
Units in package:
1 x 10mL; 1 x 1mL; 10 x 1mL; 20 x 1mL
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
HORSE FILLY (YOUNG FEMALE) | HORSE MARE (FEMALE) | FEMALE HORSE | HORSE - YOUNG FEMALE
Therapeutic area:
ENDOCRINE SYSTEM
Therapeutic indications:
EQUINE OESTRUS CYCLE | CTRL OF OESTRUS REL.BEHAVIOUR
Product summary:
Poison schedule: 4; Withholding period: WHP: Meat: Nil.; Host/pest details: HORSE FILLY (YOUNG FEMALE): [EQUINE OESTRUS CYCLE]; HORSE MARE (FEMALE): [EQUINE OESTRUS CYCLE]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE FILLY (YOUNG FEMALE): [EQUINE OESTRUS CYCLE]; HORSE MARE (FEMALE): [EQUINE OESTRUS CYCLE]; An aid in the control of oestrus and oestrus related behaviour in fillies and mares not intended for breeding.Do not use this product in horses intended for breeding, or in pregnant mares.
Authorization status:
Registered
Authorization number:
53542
Authorization date:
2020-07-01

APPENDIX 2

Australian Government

Australian Pesticides and

Veterinary Medicines Authority

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)

(Veterinary Products)

Select appropriate:

Cl

New Product (include all applicable RLPs)

0 Variation (highlight instructions that are being varied). Approval

label being varied: 53542/0108.

Signal

heading:

Product

name:

Active

constituenUs:

Statement

claims:

contents:

Directions

Heading:

Restraints:

Contraindications:

Precautions:

Side

effects:

Dosage

&

administration:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS

FOR ANIMAL TREATMENT ONLY

U.WL

Equity® Oestrus Control Vaccine for Horses

Approved

Equity Oestrus Control Vaccine for Horses is prepared from

analogue of gonadotropin

releasing

factor

(GnRF)

linked

carrier

protein.

adjuvanted

with

immunostimulating complex

increase the level and duration

immunity. Each mL

vaccine provides 200

GnRF-protein conjugate.

Thiomersal

mg/mL has been added as a preservative.

the control of oestrus and oestrus-related behaviour

fillies and mares not

intended for breeding.

Product

in 1

mL dose syringe

packs of

10 or 20.

Product

also

dose vial.

DIRECTIONS FOR USE

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

Contents must

left

outer package until immediately before

use.

not use this product in horses intended for breeding, or

pregnant mares. The long

term effect

this product

fertility

breeding horses

poorly known and effect may

extended for multiple breeding seasons. The extent and duration

effect

booster

doses of vaccine have not been studied.

Some swelling may develop at the site of vaccination

a small number

horses but

resolves quickly, usually within a few days.

The dose

all occasions is 1 mL injected intramuscularly.

The most convenient site for

injection

the centre of the side of the neck. Before the vaccine

injected, the proposed

site of inoculation

the horse's skin

cleaned

swabbing with cotton-wool

soaked

a suitable antiseptic solution, such as methylated spirits.

For primary immunisation two doses of vaccine should

administered 4 weeks apart.

Effective control of oestrus (associated with the development of anti-GnRF antibodies)

develops approximately 10

days after administration of the second dose

vaccine

most horses.

Primary immunisation should

completed

advance of when the

18 Wormald Street, Symonston ACT 2609

PO Box 6182, Kingston

2604 Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

www.apvma.gov.au ABN

495 043 447

General

directions:

desired vaccination

effect

needed.

For continued

effect,

further booster doses will

probably

required.

INDICATIONS FOR USE

Equity Oestrus Control Vaccine for Horses

used as

the control

oestrus and

oestrus-related behaviour

fillies

mares. Oestrus-related behaviour varies between

horses

though

often

characterised

squealing,

nervousness,

squatting

urinating,

increased agitation

clitoral

"winking".

Some horses display aspects of

oestrus-related

behaviour when

they

oestrus,

but generally

this

type

behaviour

increased

during

oestrous

period

of the

oestrous

cycle.

Following

vaccination, ovarian activity

suppressed, leading to markedly reduced oestrus-related

behaviour

most horses.

Through its inhibitory effect

GnRF and indirectly

luteinizing hormone (LH) and

follicle-stimulating

hormone (FSH),

Equity Oestrus Control Vaccine for Horses aids

preventing

follicular

development

ovaries.

ovaries

vaccinated

horses

become small and inactive. Cyclic oestrus activity commences

decline or will cease

within about two weeks following the second dose

vaccine

most horses. Vaccine-

induced suppression

oestrus should last for at least three months and

a percentage

of horses will

continue for six

months

longer.

If continued

anoestrus is

desired,

additional booster doses will probably

required.

a field study conducted

Zoetis (results

file) using

multiparous mares that were

demonstrated

normal oestrus cycling at the time

treatment with Equity Oestrus

Control Vaccine for Horses, two injections 4 weeks apart, 98% (60/61) became anoestrus

or transitional within 4 weeks after

second treatment (versus

(3/20) of controls,

at the same point

time), with anoestrus maintained through to

breeding season

following year. At the start

second year breeding

season,

88% (53/60) of

treated mares

resumed active cycling, with 85% (45/53) conception

this group.

100% of control mares had conceived at the same point

time.

the end

the full

second breeding season post-treatment with Equity Oestrus Control Vaccine for Horses,

a total of

resumed cycling and

a confirmed pregnancy

second breeding season after induced immune anoestrus

Zoetis Clinical Study Report (Ref.

3350E-02-04-154). Zoetis Kalamazoo, Michigan,

United States.

NOTE

This vaccine

been fully tested for potency, sterility and safety before issue but it must

stressed that the correct vaccination procedure

field

equally important if

secondary injection-related infection

prevented. Very occasionally, pathogenic

organisms from

animal's skin or lying dormant

the animal's tissues are activated at

the time of vaccination and are able

initiate a local infection at

site of injection. This

may lead

the horse's death, but fortunately is

rare occurrence. To the maximum

extent permitted

law, Zoetis does not accept any claim, loss, liability, cost or expense

respect

Disability or death of horses following vaccination

a result

failure

use the

correct vaccination procedure described

the label.

The failure of any horse to conceive or maintain a pregnancy following use of the

product.

Withholding

Period/s:

Zero (0) days

Trade

Advice:

not applicable

Safety

Directions:

Caution: Care should

taken

avoid accidental self-injection

needle-stick injury

when administering this product. Accidental self-injection may affect fertility

both men

women. As this vaccine may affect pregnancy, particular care should

taken

women

child bearing age.

the event of accidental self-injection, seek medical advice

Wormald

Street,

Symonston

2609

6182,

Kingston

2604

Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

www.apvma.gov.au

495 043 447

immediately. Caution should be exercised at all times when handling horses.

First

Aid:

If poisoning occurs, contact a doctor

Poisons Information Centre.

Phone Australia

131126. This material may cause a mild allergic reaction

sensitive individuals

skin

contact. Avoid skin contact. If skin

hair contact occurs, remove contaminated clothing

and flush skin and hair with running water. If splashed

eyes, wash out immediately with

water.

Additional

user

safety:

Take care

avoid accidental self-injection. Accidental self-administration may result

local bruising, pain and swelling.

the event

self-administration, seek medical

attention and show the package leaflet or the label, to the Medical Practitioner.

Environmental

statements:

Disposal:

Dispose

containers

syringes

wrapping

paper and

putting

garbage.

Discarded

needles should

immediately

placed

designated and

appropriately

labelled 'sharps' container.

Storage:

Store between

and 8°C. (Refrigerate.

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: 53542/60097

Wormald

Street,

Symonston

2609

6182,

Kingston

2604

Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

www.apvma.gov.au

ABN

19

495 043 447

Product Name: Equity

®

Oestrus Control Vaccine for Horses

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:

Equine hormones in water solution.

Trade Name:

Equity

®

Oestrus Control Vaccine for Horses

Pfizer MSDS Code:

0814

Product Use:

For use in the control of oestrus and oestrus-related behavior in fillies and mares not

intended for breeding.

Creation Date:

July, 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:

Hazardous according to the criteria of SWA Australia.

Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code.

Risk Phrases:

R62, R63. Possible risk of impaired fertility. Possible risk of harm to the unborn child.

Safety Phrases:

S24/25. Avoid contact with skin and eyes.

SUSDP Classification:

S4, NZS2

ADG Classification:

None allocated. Not a Dangerous Good.

UN Number:

None allocated

E

E

E

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c

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v

v

e

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r

r

r

v

v

v

i

i

i

e

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e

w

w

w

Physical Description & colour

: Clear liquid. Presented in disposable glass syringe containing 1 mL

Odour:

No data.

Major Health Hazards:

possible risk of impaired fertility, possible risk of harm to the unborn child.

P

P

P

o

o

o

t

t

t

e

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n

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s

s

This vaccine may be immunogenic in humans and may interfere with GnRF function. This vaccine may cause atrophy

of sex organs, infertility and abortion by accidental self injection.

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.

Product Name: Equity

®

Oestrus Control Vaccine for Horses

Page: 2 of 5

This revision issued:

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Long Term exposure

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

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

I

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n

n

n

g

g

g

r

r

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e

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d

d

d

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s

C

C

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A

A

A

S

S

S

N

N

N

o

o

o

C

C

C

o

o

o

n

n

n

c

c

c

,

,

,

%

%

%

T

T

T

W

W

W

A

A

A

(

(

(

m

m

m

g

g

g

/

/

/

m

m

m

3

3

3

)

)

)

S

S

S

T

T

T

E

E

E

L

L

L

(

(

(

m

m

m

g

g

g

/

/

/

m

m

m

3

3

3

)

)

)

Liquid solution containing protein conjugate of Gonadotropin releasing factor (GnRF)

not set

>60

not set

not set

Synthetic adjuvant

no data

not set

not set

Thiomersal

54-64-8

0.01

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. 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. Seek urgent medical advice. Show this MSDS to a medical practitioner.

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:

If this product comes in contact with the eyes:

Immediately hold the eyes open and wash with fresh running water.

Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by

occasionally lifting the upper and lower lids.

If pain persists or recurs seek medical attention.

Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.

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.

Fire decomposition products from this product are likely to be irritating if inhaled.

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.

Product Name: Equity

®

Oestrus Control Vaccine for Horses

Page: 3 of 5

This revision issued:

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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).

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. 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. 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 2-8°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:

We suggest that protective clothing be made from the following materials: rubber,

PVC.

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

Clear liquid. Presented in disposable glass syringe containing 1 mL

Odour:

No data.

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.

Product Name: Equity

®

Oestrus Control Vaccine for Horses

Page: 4 of 5

This revision issued:

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Specific Gravity:

1.052

Water Solubility:

Completely soluble in water.

pH:

No data.

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water distribution

No data

Autoignition temp:

Not applicable - does not burn.

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:

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. Water. Carbon monoxide poisoning produces headache, weakness, nausea, dizziness,

confusion, dimness of vision, disturbance of judgment, and unconsciousness followed by coma and death.

Polymerisation:

This product will not undergo polymerisation reactions.

Section 11 - Toxicological Information

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

of syringe expressed aerosols. May impair fertility. May cause harm to the unborn child. As this vaccine may

affect pregnancy, particular care should be taken by women of child bearing age. In the event of accidental self-

injection, seek medical advice immediately. Accidental self injection may affect fertility in both males and females. The

effect in humans is to interfere with gonadotropin releasing factor (GnRF) function within the endocrine system.

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.

Section 12 - Ecological Information

This product is biodegradable. It will not accumulate in the soil or water or cause long term problems.

Section 13 - Disposal Considerations

Disposal:

Containers should be emptied as completely as practical before disposal. If possible, recycle containers

either in-house or send to recycle company. If this is not practical, send to a commercial waste disposal site. This

product should be suitable for landfill. However, check with local Waste Disposal Authority before sending there. Note

that product properties may have been changed in use, significantly altering it's suitability for landfill. Please do NOT

dispose into sewers or waterways.

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.

There are several possible reasons why this may occur. 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

Product Name: Equity

®

Oestrus Control Vaccine for Horses

Page: 5 of 5

This revision issued:

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

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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