GUDAIR VACCINE

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

Buy It Now

Active ingredient:
MYCOBACTERIUM PARATUBERCULOSIS; THIOMERSAL
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
M. paratuberculosis(2.5mg/mL)
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
MYCOBACTERIUM PARATUBERCULOSIS VACCINE Active 2.5 mg/ml; THIOMERSAL MERCURY Other 0.1 mg/ml
Units in package:
100mL; 250mL
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
GOAT | SHEEP | BILLY | BUCK | CAPRA HIRCUS | DOE | EWE | HOGGET | KID | LAMB | OVINE | RAM | WEANER | WETHER
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
JOHNE'S DISEASE | MYCOBACTERIUM PARATUBERCULOSIS SHEDDING
Product summary:
Poison schedule: 0; Withholding period: WHP:(Meat Milk):Nil; Host/pest details: GOAT: [JOHNE'S DISEASE]; SHEEP: [JOHNE'S DISEASE, MYCOBACTERIUM PARATUBERCULOSIS SHEDDING]; Poison schedule: 0; Withholding period: ; Host/pest details: GOAT: [JOHNE'S DISEASE]; SHEEP: [JOHNE'S DISEASE, MYCOBACTERIUM PARATUBERCULOSIS SHEDDING]; Active immunisation for the control of Johne's disease and reduction in faecal Mycobacterium paratuberculosis shedding in sheep. Active immunisation as an aid in the control of Johne's disease in goats.Do not vaccinate sheep or goats younger than 1 month. NOTE: VACCINATED ANIMALS ARE LIKELY TO GIVE POSITIVE RESULTS WHEN TESTED FOR TUBERCULOSIS OR JOHNE'S DISEASE.
Authorization status:
Registered
Authorization number:
53839
Authorization date:
2020-07-01

Australfan Government

Australian Pesticides

and

Veterinary

Medicines

Authority

APPENDIX 2

Approved

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)

(Veterinary Products)

Select appropriate:

[J

New Product (include all applicable RLPs) OR

x

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

label being varied:

53839/0808

Signal heading:

Product name:

Active constituent/s:

Statement

claims:

Net contents:

Directions for Use

Heading:

READ SAFETY DIRECTIONS

FOR ANIMAL TREATMENT ONLY

Gudair® Vaccine

This vaccine contains a suspension

the microorganism,

Mycobacterium avium

subsp.

paratuberculosis,

strain 316F, inactivated by heat and adjuvanted with mineral

a multiple emulsion. It contains

dried microorganisms per

Additional Constituent: Thiomersal

mg/ml

preservative

Active immunisation for the control

Johne's disease and reduction

faecal

Mycobacterium avium

subsp.

paratuberculosis

shedding

sheep. Active

immunisation as

the control

Johne's disease

goats.

INDICATIONS FOR USE

Gudair® Vaccine

indicated for the control of Johne's disease

sheep, and

the control

Johne's disease

goats.

Transmission

Mycobacterium avium

subsp.

paratuberculosis

sheep and goats

primarily by the faecal-oral route. The bacteria enter through the Peyer's patches

the small

intestine and

infect the terminal

ileum,

caecum,

colon

associated

mesenteric lymph nodes and vessels. Johne's disease has a prolonged incubation

period

with

clinical

disease,

characterised

by weight

loss

emaciation,

most

commonly seen

sheep older than two years

age. About 1

clinical cases

show diarrhoea

the end stage

the disease. Some animals become carriers of the

infection, intermittently shedding the bacteria into their environment. These subclinical

carriers can develop into active clinical cases which usually die from malabsorption.

Milk production

infected sheep and goats

reduced and wool break and poor

fleece condition have been reported

infected sheep.

infected or at-risk flocks, vaccination can be carried out on all

the flock, including

adult animals. Following whole flock vaccination, a significant decrease

the number

clinically affected animals may not be observed for several months, but the number

mortalities may decrease substantially. There will then be a gradual decrease

prevalence

infection

within

flock,

with

notable

decrease

faecal

M.paratuberculosis

shedding.

recommended that all

replacement animals

vaccinated at a young age. When vaccination

commenced at between 1 and 4

months

age, faecal

M.paratuberculosis

shedding may

prevented for

months

or longer post-vaccination.

Gudair® Vaccine

issued

packs of

Dosage and Administration

CAUTION: AVOID CARCASE DAMAGE

Shake well before use and keep thoroughly mixed during use.

Inject the vaccine subcutaneously high on the neck just behind and below the

base of the ear. This will help avoid spinal abscesses. Do not inject at any other

18 Wormald Street, Symonston ACT 2609

PO Box 6182, Kingston ACT 2604 Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

www.apvma.gov.au

ABN.

19 495 043 447

Restraints:

Contraindications:

Precautions:

Side effects:

Dosage &

administration:

site.

Ensure animals

adequately restrained

appropriate

sheep

handling device

(e.g.

lambs

a cradle) during the injection process. Ensure that

vaccine does not

enter

your

body

(self-injection,

needle

scratch,

etc).

Gudair

reactive

substance,

recommend that

a safety vaccinator that

a protective

shroud.

this vaccine

be restricted in your State

Territory. Contact

your

local Department

Agriculture (or similar)

details.

n/a

Gudair

a reactive substance,

recommend that

a safety vaccinator

that

a protective shroud.

SIDE EFFECTS

After vaccination a firm swelling usually develops at the site

injection.

months after vaccination

most

swellings will have decreased

size,

they

usually continue to decrease over time.

It is not unusual

an injection site

nodule to appear

7-15

days after vaccination, which in a small proportion

animals

become larger than

in diameter. When this vaccine is

administered

animals

already

infected

with,

sensitised

M.

paratuberculosis,

a more intense local reaction (secondary immune response)

can occur.

small

proportion

(5%)

animals the

swelling

develop

into an

abscess and burst. This

attract flies.

Accordingly, vaccinated animals

should be checked regularly

fly strike and be treated where necessary.

Alternatively, preventative fly strike treatments should be given. Vaccinated

animals,

sent

slaughter soon

after vaccination,

subject to

additional trimming due to vaccination injection site reactions.

To minimise

the risk

this occurrence, inject the vaccine subcutaneously high on the neck

just

behind and below the base

the ear.

DIRECTIONS FOR USE

The dose for sheep and goats (greater than 1 month of age)

is

1

ml.

Further

vaccine (booster) doses are not required.

CAUTION: AVOID CARCASE DAMAGE

DISPENSING

Gudair

a reactive substance,

recommend that

a safety vaccinator

that

a protective shroud.

A safety vaccinator should

attached

pack

follows:

Remove

the sterilised plastic

tube

from

pack_.

Connect the tube

a safety vaccinator that

a protective shroud.

Disinfect

stopper with a

suitab.le

antiseptic,

e.g.

methylated spirits.

general, a

(1/4 inch) needle

lambs

12mm (1/2 inch) needle

sheep

wool

will provide

correct depth of needle penetration.

5.Screw

onto

the plastic bottle of the vaccine which will cause

needle

18 Wormald Street, Symonston ACT 2609

Box 6182, Kingston ACT

2604

Australia

Tel:

2 6210 4700 Fax:

2 6210 4874

www.apvma.gov.au ABN 19 495 043 447

Precautions:

penetrate the stopper.

6.Prime the safety vacCinator by depressing the plunger several times uritil vaccine

flows through the needle.

Ensure

that

vaccine

does

enter

your

body

through

contact

with

needle (self-injection, needle scratch, etc) or entry through

open wound.

Disposable rubber gloves should

worn prior to disassembly.

NOTE: Before attachment, used metal automatic vaccinators should be re-sterilised

by taking apart and boiling for at least ten minutes.

careful not to contaminate the vaccinator during re-assembly.

RESEALING

A partially used pack can

stored

used for

days after first opening if

the following steps are taken:

Rubber gloves should be worn before this procedure

Unscrew the delivery tube from the vaccine pack.

Empty the delivery tube and safety vaccinator

depressing the plunger several

times.

Disinfect the stopper.

Store the vaccine

this original cardboard carton and place

the refrigerator.

not freeze.

not leave exposed to light or at high temperatures

long periods.

Before re-use, the delivery tube and cap should

sterilised by boiling for at least ten

minutes.

NOTE: The plastic delivery tube may become opaque.

Frequent attachment of the connecting tube may cause the stopper

leak.

Therefore, the tube should not be attached more than twice.

Opened packs should

used as quickly

possible.

Re-opening increases the risk

vaccine contamination.

NOTE: ANIMALS TREATED WITH THIS VACCINE ARE

LIKELY

TO GIVE

POSITIVE RESULTS WHEN TESTED FOR TUBERCULOSIS OR

JOHNE'S

DISEASE

INTRADERMAL TEST.

Accidental self-injection

this

vaccine

result

cross-reaction

with, and as a false

positive

test

result for, human

tuberculosis.

Withholding

Period/s:

WITHHOLDING PERIODS (MEAT, MILK): NIL

Trade

Advice:

EXPORT SLAUGHTER INTERVAL (ESI): ESI

applicable

Safety

Directions:

IMPORTANT USER SAFETY INFORMATION

First

Aid:

Ensure

that

vaccine

does

enter

your

body

through

contact

with

needle (self-injection,

needle scratch,

etc) or entry through

open wound.

especially careful

that

doesn't

enter

your

body

through contact with eyes, mouth

and skin, because the vaccine

irritant. Wash your hands thoroughly with soap

and water after use, especially if the vaccine comes into contact with your skin. If the

vaccine gets into the eyes or mouth, rinse the exposed area thoroughly with tap water

and immediately seek medical advice.

poisoning occurs, contact

doctor

Poisons

Information Centre.

Phone Australia 13

26 (Australia); New Zealand 0800 764 766.

18 Wormald Street, Symonston ACT 2609

PO Box'6182, Kingston ACT 2604 Australia

Tel:

2 6210 4700 Fax:

2 6210 4874

www.apvma.gov.au ABN 19 495 043 447

Additional user safety:

Take Care to Avoid Self Injection:

Environmental

statements:

Disposal:

Storage:

Name

&

address:

This product contains mineral oil

irritant.

the event of accidental self-

administration, it

cause significant pain and prolonged swelling for 6 to

months

at the injection site, perhaps also involving the draining lymph nodes.

Allow the

wound to bleed freely and do not squeeze or interfere with the injection site to avoid

spread of the vaccine.

Medical or surgical intervention may

required, especially if

the site

injection involves a finger joint or tendon sheath.

Contact a doctor as soon

possible, even if only a very small amount

injected, and take this package

leafleU carton with you.

ADVICE FOR THE MEDICAL PRACTITIONER

This product contains mineral oil.

Even if small amounts of this product enters the

body (eg, self injection or needle scratch, etc), it

cause intense swelling arid a

persistent granulomatous inflammatory reaction.

injected

into a finger joint or

tendon

sheath,

product

track

along

tendon.

swelling

inflammation may compromise blood supply and result

necrosis that,

rare cases,

may lead to the loss of a digit.

Following

appropriate

immediate

local

cleansing,

been

suggested

that

corticosteroids

may decrease

severity of any local

reaction.

Ascertain

patient's tetanus

immunization status,

provide

booster or primary series,

appropriate.

PROMPT surgical attention may

required if Gudair enters the body.

If the vaccine enters the body (eg accidental self-injection) it may result

cross-

reaction with, and a false positive test result for, human tuberculosis.

For further information

treatment please contact 1800 814 883 and choose option

2 or the Poisons Information Centre

26 (Australia); or 0800 POISON (0800

764 766) (New Zealand) for advice.

n/a

Disposal:

Dispose

of empty containers

by wrapping

with

paper

putting

garbage.

Discarded

needles

should

immediately

placed

a designated

appropriately labelled 'sharps' container.

Store between 2°C and

{Refrigerate. Do not freeze).

Protect from light.

Zoetis Australia Pty Ltd

38-42 Wharf

Road

West Ryde

NSW 2114

The following is

APVMA use only:

APVMA approval no.

APVMA No: 53839/57684

18 Wormald Street, Symonston ACT 2609

PO Box 6182, Kingston ACT 2604 Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

www.apvma.gov.au ABN 19 495 043 447

Product Name: Gudair® Vaccine

Page: 1 of 6

This revision issued: 24

September, 2014

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

Section 1 - Identification of the Substance/Mixture and Supplier

Zoetis Australia Pty Ltd

ABN 94 156 476 425

Level 6, 5 Rider Blvd

Rhodes NSW 2138 AUSTRALIA

Tel: 1800 814 883

Fax: (02) 8876 0444

Email: australia.animalhealth@zoetis.com

Product Identifier:

Gudair

®

Vaccine

Other names:

None.

Chemical family:

Oil-water emulsion with vaccine and other minor ingredients.

APVMA approval number:

53839

Product Use:

Animal vaccine for use as described on the product label for the control of Johne’s

Disease in sheep and goats.

Restrictions on use

For veterinary use only.

Emergency Phone:

1800 814 883 (all hours)

Section 2 - Hazards Identification

Statement of Hazardous Nature

This product is classified as:

Not classified as hazardous according to the criteria of SWA.

Not a Dangerous Good according to Australian Dangerous Goods (ADG) Code, IATA or IMDG/IMSBC criteria.

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

S23, S36, S24/25. Do not breathe vapours or mists. Wear suitable protective clothing. Avoid

contact with skin and eyes.

ADG Classification:

None allocated. Not a Dangerous Good according to Australian Dangerous Goods (ADG)

Code, IATA or IMDG/IMSBC criteria.

GHS Classification: Not hazardous.

GHS Label Elements: NONE. Not hazardous.

Signal word: NONE. Not hazardous.

PREVENTION

P102: Keep out of reach of children.

P262: Do not get in eyes, on skin, or on clothing.

P281: Use personal protective equipment as required.

RESPONSE

P352: Wash with plenty of soap and water.

P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.

P370+P378: Not combustible. Use extinguishing media suited to burning materials.

STORAGE

P410: Protect from sunlight.

P411: Store between 2°C and 8°C (refrigerate, do not freeze).

DISPOSAL

P501: Dispose of small quantities and empty containers by wrapping with paper and putting in garbage. For

larger quantities, if recycling or reclaiming is not possible, use a commercial waste disposal service.

Other/supplementary hazards. None known.

Emergency Overview

Physical Description & colour

: White oil-water emulsion.

Odour:

No data.

Major Health Hazards:

no significant risk factors have been found for this product.

Product Name: Gudair® Vaccine

Page: 2 of 6

This revision issued: 24

September, 2014

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

Section 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

STEL (mg/m

Heat inactivated Mycobacterium paratuberculosis

not set

<1

not set

not set

Thiomersal

54-64-8

<0.01

not set

not set

Adjuvant

no data

<1

not set

not set

Water

7732-18-5

no data

not set

not set

no data

no data

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 11 26 from anywhere in Australia (0800 764 766 in New

Zealand) and is available at all times. Have this SDS with you when you call.

First Aid Advice

It is recommended that a first aid kit be readily available with an eye bath, and that there is ready access to water and

soap.

Self-Injection: In all instances of accidental self-injection contact a doctor as soon as possible.

This

product contains mineral oil and is an irritant. In the event of accidental self-administration, it can cause significant

pain and prolonged swelling for 6 to 24 months at the injection site, perhaps also involving the draining lymph nodes.

Allow the wound to bleed freely and do not squeeze or interfere with the injection site to avoid spread of the vaccine.

Medical or surgical intervention may be required, especially if the site of injection involves a finger joint or tendon

sheath. Contact a doctor as soon as possible, even if only a very small amount is injected, and take the package

leaflet/ carton and SDS with you. Also accidental self-injection of this vaccine may result in cross reaction with, and a

false positive test result of human tuberculosis. Check your tetanus immunisation status.

Inhalation:

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

Skin contact:

Gudair vaccine may produce skin discomfort if it contacts the skin. Flush with lukewarm or gently

flowing water for 5 minutes or until chemical is removed. If in doubt obtain medical advice.

Eye contact:

Gudair vaccine may produce eye discomfort. Flush contaminated eyes with lukewarm or gently flowing

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

more than few minutes.

Ingestion:

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

Further Information for Medical Practitioners

The recommendations following self-injection of Gudair vaccine for medical management or surgical intervention are

as follows:

This product contains mineral oil. Even if small amounts of this product enters the body (e.g. self-injection or needle

scratch, etc.) it can cause intense swelling and a persistent granulomatous inflammatory reaction. If injected into a

finger joint or tendon sheath, the product may track along the tendon. The swelling and inflammation may

compromise blood supply and result in necrosis that, in rare cases, may lead to the loss of a digit.

Following appropriate immediate local cleansing, it has been suggested that corticosteroids may decrease the

severity of any local reaction. Ascertain the patients’ tetanus immunization status, and provide booster or primary

series, as appropriate, along with antibiotics as required.

PROMPT surgical attention may be required if Gudair enters the body. This may involve drainage to remove the oil

based vaccine material before it spreads or elicits a severe granulomatous reaction. If lesions progress to necrosis or

granulomatous ulceration surgical debridement to remove any residual vaccine material may be required, and

ultimately skin grafting may also be required.

If the vaccine enters the body (e.g. accidental self-injection) it may result in cross-reaction with, and a false positive

test result for, human tuberculosis.

For further information on treatment please contact 1800 814 883 and choose option 2 or the Poisons

Information Centre on 13 11 26 (Australia).

Product Name: Gudair® Vaccine

Page: 3 of 6

This revision issued: 24

September, 2014

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

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.

This product is likely to decompose only after heating to dryness, followed by further strong heating.

Fire decomposition products from this product may be toxic if inhaled. Take appropriate protective measures.

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

: 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. 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. 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 SDS 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 SDS 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. Make sure that the product does not come

into contact with substances listed under "Materials to avoid" in Section 10. Some liquid preparations settle or

separate on standing and may require stirring before use. Check packaging - there may be further storage

instructions on the label.

Section 8 - Exposure Controls and Personal Protection

Control Parameters:

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

Respiratory equipment: AS/NZS 1715, Protective Gloves: AS 2161, Occupational Protective Clothing: AS/NZS 4501

set 2008, 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 significant ingredients in this product.

Engineering Controls:

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.

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.

Product Name: Gudair® Vaccine

Page: 4 of 6

This revision issued: 24

September, 2014

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

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.

Safety deluge showers should, if practical, be provided near to where this product is being handled commercially.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

White oil-water emulsion.

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.

Specific Gravity:

0.94

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

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:

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, 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. Very small quantities of sodium and mercury compounds. 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 is unlikely to undergo polymerisation processes.

Section 11 - Toxicological Information

General Information:

No data.

Routes of exposure:

No data.

Symptoms of exposure:

No data.

Inhalation:

Short term exposure:

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. In addition product is unlikely to cause any discomfort in normal use.

Long Term exposure:

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

Eye Contact:

Short term exposure

: 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:

Product Name: Gudair® Vaccine

Page: 5 of 6

This revision issued: 24

September, 2014

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

Short term exposure

: Significant oral exposure is considered to be unlikely. However, this product may be mildly

irritating to mucous membranes but is unlikely to cause anything more than mild transient discomfort.

Long Term exposure

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

Specific Target Organ Toxicity (STOT) – single exposure:

No data.

Specific Target Organ Toxicity (STOT) – repeated exposure:

No data.

Aspiration Hazard:

No data.

Early Onset Symptoms Related to Exposure:

No data.

Delayed Health Effects from Exposure:

No data.

Exposure Levels and Health Effects:

No data.

Interactive Effects:

No data.

Classification of Hazardous Ingredients

Ingredient

Risk Phrases

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

Toxicological properties of the formulation have not been fully investigated. However information available on

ingredients suggest the product is not harmful or hazardous.

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

Respiratory or Skin Sensitisation:

No data.

Germ Cell Mutagenicity:

No data.

Carcinogenicity:

No data.

Reproductive Toxicity:

No data.

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 12 - Ecological Information

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

Toxicity information:

No data.

Persistence and degradability:

No data.

Bioaccumulative potential:

No data.

Mobility in soil:

No data.

Other adverse effects:

No data.

Section 13 - Disposal Considerations

Disposal:

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

Discarded needles should immediately be placed in a designated and appropriately labelled sharps container. For

larger quantities, if recycling or reclaiming is not possible, use a commercial waste disposal service.

Section 14 - Transport Information

UN Number:

This product is not classified as a Dangerous Good by ADG, IATA or IMDG/IMSBC criteria. No special

transport conditions are necessary unless required by other regulations.

Special precaution for user:

None known.

Additional Information:

None known.

Environmental Hazard:

None known.

Section 15 - Regulatory Information

Poison Schedule:

None allocated.

AICS:

All of the significant ingredients in this formulation are compliant with NICNAS regulations.

Product Name: Gudair® Vaccine

Page: 6 of 6

This revision issued: 24

September, 2014

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

Section 16 - Other Information

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

Data Sources:

The data contained in this SDS may have been gathered from confidential internal sources, raw

material suppliers, or from the published literature.

Acronyms:

ADG Code

Australian Code for the Transport of Dangerous Goods by Road and Rail (7

edition)

AICS

Australian Inventory of Chemical Substances

SWA

Safe Work Australia, formerly ASCC and NOHSC

CAS number

Chemical Abstracts Service Registry Number

Hazchem Code

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

services especially firefighters

IARC

International Agency for Research on Cancer

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSMP

Standard for the Uniform Scheduling of Medicines & Poisons

UN Number

United Nations Number

This version issued: 24 September 2014

and is valid for 5 years from this date.

Supersedes

Revision History:

Date of Revision

Reason

Contact Points:

Zoetis

1800 814 883

Police and Fire Brigade:

Dial 000

If ineffective:

Dial Poisons Information Centre

(13 1126 from anywhere in Australia)

THIS SDS SUMMARISES OUR CURRENT AND BEST KNOWLEDGE OF THE HEALTH AND SAFETY HAZARD

INFORMATION ABOUT THE PRODUCT DETAILED IN THIS SDS, AND HOW TO SAFELY HANDLE AND USE

THE PRODUCT IN THE WORKPLACE FOR THE RECOMMENDED USE. EACH USER OF THE PRODUCT MUST

REVIEW THIS SDS IN THE CONTEXT OF HOW THE PRODUCT WILL BE HANDLED AND USED IN THEIR OWN

WORKPLACE. IF CLARIFICATION OR FURTHER INFORMATION IS NEEDED TO ENSURE THAT AN

APPROPRIATE RISK ASSESSMENT CAN BE MADE, THE USER SHOULD CONTACT ZOETIS.

Please read all labels carefully before using product.

This SDS is prepared in accord with the SWA document “Preparation of Safety Data Sheets for Hazardous

Chemicals - Code of Practice” (December 2011)

© 2014 Zoetis Inc, All rights reserved.

Prepared by Kilford & Kilford Pty Ltd

End of Safety Data Sheet

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