LEPTOSHIELD VACCINE

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

Buy It Now

Active ingredient:
LEPTOSPIRA INTERROGANS SEROVAR POMONA FORMOL CULTURE; LEPTOSPIRA BORGPETERSENII SEROVAR HARDJO TYPE HARDJOBOVI; THIOMERSAL
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
vaccine - leptospirosis
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
LEPTOSPIRA INTERROGANS SEROVAR POMONA FORMOL CULTURE VACCINE-MICROBIAL Active 0.0 P; LEPTOSPIRA BORGPETERSENII SEROVAR HARDJO TYPE HARDJOBOVI VACCINE-MICROBIAL Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml
Units in package:
100mL; 250mL; 500mL; 50mL
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
CATTLE | DEER | GOAT | SHEEP | BEEF | BILLY | BOS INDICUS | BOS TAURUS | BOVINE | BUCK | BUFFALO | BULL | BULLOCK | CALF | CAPRA
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
LEPTOSPIROSIS | URINARY SHEDDING | L. HARDJO | L. INTERROGANS | L. POMONA | L. TARASSOVI
Product summary:
Poison schedule: 0; Withholding period: WHP:NIL ESI: ESI not applicable; Host/pest details: CATTLE: [LEPTOSPIROSIS, URINARY SHEDDING]; DEER: [LEPTOSPIROSIS]; GOAT: [LEPTOSPIROSIS]; SHEEP: [LEPTOSPIROSIS]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [LEPTOSPIROSIS, URINARY SHEDDING]; DEER: [LEPTOSPIROSIS]; GOAT: [LEPTOSPIROSIS]; SHEEP: [LEPTOSPIROSIS]; For the prevention of leptospiroses in cattle, sheep and goats. As an aid in the control of leptospirosis in deer. For the prevention of urinary shedding in cattle when used prior to natural challenge & to prevent the risk of human leptospiral infection.
Authorization status:
Registered
Authorization number:
51075
Authorization date:
2019-07-01

APPENDIX 2

Australian Government

Austrafian Pesticides

Veterinary Medicines Authority

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)

(Veterinary Products)

Select appropriate:

IJ New Product (include all applicable RLPs)

!&I

Variation (highlight instructions that are being

varied). Approval

of label being

varied:

51075/1 [2,3,4]/0509

Signal heading:

Product name:

Active

constituentls:

Statement of

claims:

Net contents:

Directions for Use

Heading:

FORANIMAL TREATMENT ONLY

Leptoshield® Vaccine

Leptoshield vaccine contains

Leptospira borgpetersenii

serovar

Hardjo

type

Hardjobovis

500 x

organisms/ml

Leptospira interrogans

serovar

Pomona

.:::

500 x

organisms/ml (as formol

cultures) with

mg/ml

Thiomersal added.

For the prevention

leptospirosis in cattle, sheep and

goats

caused

Leptospira

borgpetersenii

serovar

Hardjo

L.

interrogans

serovar

Pomona

and as an aid in the control

leptospirosis

in deer caused by

the named leptospires.

For the prevention

urinary shedding

the named leptospires

cattle

when used

prior

natural challenge and

prevent the

risk

human

leptospiral

infection

associated

with

shedding

the named

leptospires

in the urine and

from

the reproductive

tract

cattle.

prevention

reproductive

tract

colonisation

placental

foetal

infection

with

Hardjo.

APVMA

51075/60361

Leptoshield

available

semi-rigid packs of

50ml,

100ml,

250ml

and 500

DIRECTIONS FOR

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

This vaccine is compatible

with

the Zoetis

Quickshot

Vaccinator.

important

that

the vaccine is kept properly mixed before and

during

use.

Shake the vaccine container at regular intervals

sustain

mixing.

This

product

be stored and

used

days

after

first

opening.

On each subsequent reuse, swab the opening

with

suitable

disinfectant

(for

example, methylated

spirits)

both before and

after

using.

sterile

needle and syringe

must

be used each time

product

is removed.

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:

N/A

Some swelling usually develops at the site of vaccination, and may last for

some months before gradually subsiding.

rare occasions, allergic shock

reactions have occurred.

these cases adrenaline should

administered. A

veterinarian should

consulted regarding the use of adrenaline.

The dose on all occasions is 2 mL injected subcutaneously (just under

the skin).

VACCINATION PROGRAMMES

Herd vaccination

To begin a herd vaccination programme,

animals must

vaccinated and a

second dose given 4-6 weeks later.

annual booster dose of vaccine must

given. This programme is applicable to dairy, beef and deer herds and also

sheep and goat flocks.

For protection against

Hardjo

infection, the initial vaccination regimen or

booster

should

completed

before

season

greatest

risk

transmission

leptospires.

most

temperate

climates,

season

greatest risk

from the beginning of autumn through to the end of spring or

early summer. The season of greatest risk seems to

related to the amount

of surface water present

the environment and this

a reflection of the state

water

table.

However,

presence

maternal

antibodies

behavioral and management parameters may also influence the onset and

duration of this transmission period.

-Ya,ccination of calves

Early vaccination of calves

advisable to protect against acute leptospirosis

("redwater"). Early vaccination of calves

also advised to minimise the risk of

animals acquiring

leptospirosis infection

and to

prevent

urinary shedding.

Leptoshield

has been shown to

efficacious

the presence of maternal

antibody.

Calves

may therefore

first

vaccinated from

1 month

of age.

Lasting efficacy preventing urinary shedding of leptospires can

expected if

vaccination

commenced before first exposure. Calves that are infected prior

to vaccination may become carriers and may continue to shed leptospires

the urine for several months, despite subsequent vaccination.

Two doses should

given, 4-6 weeks apart. Calves less than 3 months of

age at the time of the second vaccination should receive a single booster dose

6 months later. This booster may

used to align calves vaccinated "out of

season" (i.e. when young, or

a town supply herd) with the annual herd

booster.

Calves greater than

3 months of age at the time of the second

vaccination require

annual booster.

Deer calves should commence a vaccination program at three months of age.

18

Wormald

Street,

Symon

stan

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

Introduced stock

the absence of a known history

vaccination, dose twice

a 4-6 week

interval. It should

noted, that those introduced animals already infected with

leptospirosis may still excrete leptospires after vaccination and may require

concurrent

treatment

with

antibiotics.

identification,

treatment

vaccination

infected animals should

discussed with

your veterinary

adviser. Note that the site of vaccination should

different from the site(s)

antibiotic injection.

Development of immunity

Detectable antibody levels develop 10 to 14 days after the second vaccination.

The second dose

vaccine 4 to 6 weeks after the first is essential before a

high level

immunity can develop.

cattle the

borgpetersenii

serovar

Hardjo

component

Leptoshield

been

demonstrated

induce

strong,

sustained

cell-mediated

immune

response against

Hardjo.

A cell-mediated immune response is associated

with protection against

Hardjo

Booster doses

maintain immunity,

animals

the herd, including

steers and

bulls,

should

revaccinated

annually

against

leptospirosis.

Breeding

females

should

given their annual

booster about a month before calving. This

provides protection for the boosted animal and temporary immunity to their

offspring

their colostrum or "first milk". The timing

of this booster may

coincide with "drying

' on some dairy farms.

Give two doses of vaccine for protective immunity. The second dose is given 4

to 6 weeks after the first, for long lasting protection. A booster dose every 12

months

required for sheep to maintain the protective level

immunity.

Level

Immunity

A

Protective

Level

months

dose

dose

booster

dose

This product can be stored

used for

to 30 days after first opening

Handle aseptically and store refrigerated and protected from light

18 Wormald Street. Sy

nston ACT 2609

PO Box 6182, Ki

ACT 2604 Australia

Tel: +

0 4700 Fax: +61 2 6210 4874

www.apvma.gov.au A

19 495 043 447

General

directions:

INDICATIONS FOR USE

Leptoshield

used for the routine immunisation

cattle, sheep, goats and

deer against leptospirosis caused

Hardjo

Pomona.

Each batch of vaccine has been fully tested before issue, ensuring that it

conforms to accepted standards of potency, sterility and safety. Trials using

this vaccine strain of

Hardjo

have demonstrated:

high efficacy

the prevention of infection and shedding when vaccinated

cattle

challenged';

full protection to calves vaccinated from 4 weeks of age,

presence of maternal antibodies, as indicated

serum antibody response,

and negative urine and kidney cultures

A.

Single Doses

Single doses of the vaccine may be withdrawn from the pack using a

sterilised hypodermic needle and syringe after disinfecting the stopper of

the vaccine pack

B.

Use with Automatic Vaccinator

An automatic vaccinator may

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, e.g. methylated spirits

Screw the cap

to the plastic bottle of the vaccine which will cause the

needle to penetrate the stopper

Prime the automatic vaccinator

depressing the plunger several times

and vaccine will flow to the needle

NOTE: Before attachment, used metal automatic vaccinators should

sterilized

taking apart and boiling

water for

least ten minutes.

careful not to contaminate the vaccinator during re-assembly

CAUTION AVOID CARCASE DAMAGE

Sterilise all

injection apparatus

boiling

water for 10 minutes (or

equivalent) before use.

Avoid use

strong disinfectants

apparatus.

Maintain cleanliness at all times during vaccination.

Great care must

taken to avoid contamination

the vaccine, needle and internal parts of

the syringe

contact with unsterile surfaces or unwashed hands.

Keep needles sharp and clean. Replace frequently.

Use the shortest possible needle, not exceeding 15

length.

As far as possible avoid injection of animals during wet weather

under

dusty conditions.

This product must

injected only under the skin (subcutaneously).

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

043447

If possible inject high

the neck behind the

ear,

i.e. under the skin on

the side of the neck

Gust

behind and below the base of the ear).

Do not

inject

any other site.

Please

refer to

resealing

section

product

insert for

further

information on storage and handling after opening.

When not

use during any given vaccination session, keep the vaccine out of

direct sunlight and as cool

possible.

not leave exposed to light or at

high temperatures for long periods.

Ideally, place the vaccine pack into this

original cardboard carton

place

either

esky with

icebrick or

refrigerator.

For Subcutaneous Use Only

Inject high

neck behind ear

Dose: 2

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

Shake the vaccine container

regular intervals to sustain mixing.

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

cleaned by swabbing with cotton-wool soaked

an antiseptic solution,

such

methylated spirits.

RESEALING

A partially used pack can

stored and used for

to 30 days after first

opening 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

Place the vaccine pack

the original outer packaging and store upright

the refrigerator.

not freeze.

not leave exposed to light or

high temperatures for long periods

Before re-use the delivery tube and cap should

sterilised by boiling

water

for at least ten minutes.

NOTE: The plastic delivery tube may become opaque.

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

Therefore, the tube should not

attached more than twice.

This pack

compatible with the Zoetis Quickshot Vaccinator

DATE FIRST OPENED: ........................................................... .

LEPTOSPIROSIS INFECTION

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

Cattle and calves

L.

Hardjo

(signs may include)

-characteristic mastitis and loss of milk productions

-acute illness with fever and anorexias

-abortion

·s,

stillbirths and birth of weak calves

-infertility

L.

Hardjo

may affect cattle of

ages but clinical signs are usually only seen

pregnant or lactating animals.

However leptospires may

present

urine for up to 1 year after the initial infection without signs of disease being

seen

L.

Pomona

produces disease

calves and adult cattle with signs as follows:

Calves -

jaundice, anaemia, haemoglobinuria ("redwater''), fever and death

may occur"-

Adult cattle -

as for calves

however cows may show milder signs which

include loss

milk productions, abortion

and the delivery of weak or stillborn

calves

Sheep, lambs and goats

L.

Hardjo

the most common leptospire infecting small ruminants

Australia

and New Zealand, however infection with

L.

Pomona

can occur

both sheep

and goats. The clinical signs seen are as follows:

-abortion, stillbirths, weak lambs and

kidss

-haemoglobinuria, anaemia, jaundice followed by death

lambs

-kidney lesionss

Deer

deer

L.

Pomona

infection can also cause severe nephritis and deaths.

LEPTOSPIROSIS IN HUMANS

Each

serovar

causes

disease

humans,

usual

means

acqUinng

infection

being

contact with

urine from

animals

shedding

leptospires.

Typical symptoms include increased body temperature, headaches, nausea,

muscle pains, and

increased sensitivity of the eyes to light. A convalescent

period of weeks to months may occur

L.

Hardjo

is responsible for a high incidence

infection

cattle handlers and

meat industry workers and it

possible that sheep, goats or deer shedding

L.

Hardjo

could also infect people.

L.

Pomona

infection may be contracted by

farm or meat industry workers from cattle, sheep, goats, deer or pigs and

shows

particular seasonal incidence.

Care should

taken to avoid direct contact with urine or aborted foetuses by

using gloves and other protective clothing

DIAGNOSIS OF LEPTOSPIROSIS

Wormald Street, Symonston

2609

Box 6182, Kingston ACT 2604 Australia

Tel:

2 6210 4700 Fax:

2 6210 4874

www.apvma.gov.au

ABN

19 495 043

447

If leptospirosis

suspected, seek veterinary

advice

confirm the disease

responsible so that a suitable control programme including vaccination can be

developed for the property. Leptospirosis is diagnosed using clinical signs and

blood tests or

the isolation of leptospires from urine or aborted foetuses.

CONTROL

Control of leptospirosis should

approached

a whole farm basis and

aimed

preventing

spread

leptospires

from

animal

animal

eventually eliminating the infection from the farm. To prevent the spread of

leptospires, all animals

the farm

should

vaccinated regularly with a

vaccine that prevents urinary shedding

environment,

leptospires

require

moisture

survive.

Draining,

restricting access

wet areas will aid

controlling the spread of leptospires.

this

always

possible,

because

certain

aspects

animal

behaviour contribute to the spread of infection, vaccination offers the most

practical method of control

Control

by

Vaccination

Isolate and treat infected animals

Isolate

vaccinate/treat

introduced

susceptible

animals

before they enter the main herd

cattle,

sheep,

goats and deer at risk of leptospirosis should

vaccinated

a regular basis depending

local veterinary advice

REFERENCES

Palit,

Middleton,

H.,

Sheers,

and Basilone,

Aust. Vet.

68:299,

1991.

Slee,

K.J.,

McOrist,

Skilbeck,

N.W.

Aust. Vet.

60:204-206, 1983.

Bolin

C.A., and Alt, D.P. AACV Proceedings, Sydney, 899-904, 1998.

Dhaliwal, G.S., Murray,

RD.,

Dobson,

H.,

Montgomery,

Ellis, W.A. Vet.

Rec.

139:

110-114,

1996.

Rados tits,

a/.,

Vet.

Med.

971-986,

2000,

B Saunders.

Fairley, R.A., Schollum,

L.M.,

Blackmore, D.K.

N.Z.

Vet.

76-78,

1984.

Naiman,

B.N.,

Alt,

Bolin, C.A., Zuerner,

Baldwin,

Infection

and Immunity, 69(12):7550-7558, 2001.

Naiman,

B.N.,

Blumerman,

Alt,

Bolin, C.A., Brown,

Zuerner,

and Baldwin,

L.lnfection and Immunity, 70(11):6147-6157, 2002

NOTE

This vaccine has been fully tested for sterility and safety before issue, but it

must

stressed that correct vaccination

procedure

the field

equally

important

secondary

infection

prevented.

Very

occasionally,

pathogenic organisms lying dormant

the animal's tissues are activated at

the time of vaccination. This may lead

losses of stock, but fortunately is of

rare

occurrence.

above

factors

beyond

control

manufacturer except

extent

of any

liability imposed

statute law

without right of exclusion, Zoetis cannot accept responsibility for any disability

or loss of stock following vaccination

respect of failure

use the correct

vaccination procedure described

the label or disability or loss to any animal

caused

the product.

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

Withholding

MEAT: Zero

{0)

days; MILK: Zero {0) days

Period/s:

Trade Advice:

EXPORT SLAUGHTER INTERVAL {ESI):

ESI

not applicable

Safety Directions:

First Aid:

poisoning occurs, contact a doctor

Poisons Information Centre.

Phone

Australia

131126;;

Zealand 0800 POISON (0800 764766).

This material

cause a mild allergic reaction

sensitive individuals on skin

contact.

Avoid

skin

contact.

skin

hair

contact

occurs,

remove

contaminated clothing and flush skin and hair with running water.

splashed

in eyes, wash out immediately with water.

Additional user

Take care to avoid accidental self-injection.

safety:

In the event

self-administration, seek medical attention

you are concerned

show

the package leaflet or the label, to the Medical Practitioner.

Environmental

statements:

Disposal:

Dispose

empty containers by wrapping with paper and putting

garbage.

Discarded

needles

should

immediately

placed

designated

appropriately labelled "sharps" container

Storage:

Store between 2°C and

(Refrigerate.

Do not freeze).

Protect from light.

Store unused material upright, at 2°C to

ac

(refrigerated) and

in

the

original cardboard packaging to protect from light.

Name & address:

Zoetis Australia Pty Ltd

38-42

Wharf

Road

West

Ryde

2114 AUSTRALIA

Australian Technical Services Toll Free 1800 814 883

www.zoetis.com.au

The following

APVMA

use only:

APVMA

approval

APVMA

No:

51075/60361

Wormald Street, Symonston

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: Leptoshield

®

Vaccine

Page: 1 of 5

This revision issued: April, 2010

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:

Water solution of ingredients.

Trade Name:

Leptoshield

®

Vaccine

Pfizer MSDS Code:

0503

Product Use:

For the prevention of leptospirosis in cattle.

Creation Date:

October, 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:

S2 (NZ)

ADG Classification:

None allocated. Not a Dangerous Good.

UN Number:

None allocated

E

E

E

m

m

m

e

e

e

r

r

r

g

g

g

e

e

e

n

n

n

c

c

c

y

y

y

O

O

O

v

v

v

e

e

e

r

r

r

v

v

v

i

i

i

e

e

e

w

w

w

Physical Description & colour

: Aqueous liquid suspension.

Odour:

No data.

Major Health Hazards:

no significant risk factors have been found for this product.

P

P

P

o

o

o

t

t

t

e

e

e

n

n

n

t

t

t

i

i

i

a

a

a

l

l

l

H

H

H

e

e

e

a

a

a

l

l

l

t

t

t

h

h

h

E

E

E

f

f

f

f

f

f

e

e

e

c

c

c

t

t

t

s

s

s

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.

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.

Product Name: Leptoshield

®

Vaccine

Page: 2 of 5

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Section 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

STEL (mg/m

Formol cultures of Leptospira interrogans serovar pomona

Leptospira borgpeterseni serovar hardjo

not set

<0.1

not set

not set

Adjuvant

secret

<0.5

not set

not set

Thiomersal

54-64-8

0.01

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:

If product is swallowed or gets in mouth, wash mouth with water and give some water to drink. If

symptoms develop, or 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 not expected to be hazardous or harmful.

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

Minor Spills:

1. Clean up all spills immediately.

2. Avoid contact with skin and eyes.

3. Wear impervious gloves and safety glasses.

4. Place spilled material in clean, dry, sealable, labelled container. Wash spill area with large quantities of water.

Major Spills:

Not applicable.

Disposal:

Product Name: Leptoshield

®

Vaccine

Page: 3 of 5

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

1. Dilute with water and flush to sewer.

2. Decontaminate empty containers with water.

3. Recycle containers if possible, or dispose of in authorised landfill. Used needles should immediately be placed in a

designated and appropriately labelled "sharps" container.

May be disposed of in accordance with any label recommendations provided by the manufacturer.

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.

This product is a Schedule 6 Poison in Australia. Observe all relevant regulations regarding sale, transport and

storage of this class of poison. Make sure that the product does not come into contact with substances listed under

"Materials to avoid" in Section 10. Check packaging - there may be further storage instructions on the label.

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.

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 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:

1.01

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.

Product Name: Leptoshield

®

Vaccine

Page: 4 of 5

This revision issued: April, 2010

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:

This product should be kept in a cool place, preferably below 30°C. 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

in very small concentrations: 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. 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

Target Organs:

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

C

C

C

l

l

l

a

a

a

s

s

s

s

s

s

i

i

i

f

f

f

i

i

i

c

c

c

a

a

a

t

t

t

i

i

i

o

o

o

n

n

n

o

o

o

f

f

f

H

H

H

a

a

a

z

z

z

a

a

a

r

r

r

d

d

d

o

o

o

u

u

u

s

s

s

I

I

I

n

n

n

g

g

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Ingredient

Risk Phrases

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

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

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:

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

Contact Points:

Pfizer

(02)9850 3333 (Business hours)

Product Name: Leptoshield

®

Vaccine

Page: 5 of 5

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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, April, 2010.

http://www.kilford.com.au/ Phone (02)9251 4532

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