GLANVAC 3 B12 VACCINE

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

Buy It Now

Active ingredient:
VITAMIN B12A = HYDROXOCOBALAMIN; CLOSTRIDIUM PERFRINGENS TYPE D - ANTISERA/ANTIGEN; CLA = CORYNEBACTERIUM PSEUDOTUBERCULOSIS OVIS; TETANUS = CLOSTRIDIUM TETANI; THIOMERSAL
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
Corynebacterium pseudotubercul(6CPU/mL) + others
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
VITAMIN B12A = HYDROXOCOBALAMIN VITAMIN-B12 Active 2.0 mg/ml; CLOSTRIDIUM PERFRINGENS TYPE D - ANTISERA/ANTIGEN VACCINE Active 0.0 P; CLA = CORYNEBACTERIUM PSEUDOTUBERCULOSIS OVIS VACCINE-MICROBIAL Active 0.0 P; TETANUS = CLOSTRIDIUM TETANI VACCINE-TOXOID Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml
Units in package:
250mL; 500mL
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
LAMB | SHEEP | EWE | HOGGET | LAMB | OVINE | RAM | WEANER | WETHER
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
CASEOUS LYMPHADENITIS (CHEESY GLAND) | ENTEROTOXAEMIA (PULPY KIDNEY) | TETANUS | VITAMIN DEFICIENCY | CLOSTRIDIUM PERFRINGENS TYPE D | PREVENTION & TREATMENT OF ANAE | TETANUS VACCINATION | TREATMENT OF BASAL METABOLIC D | TREATMENT OF DEBILITY & ANOREX
Product summary:
Poison schedule: 0; Withholding period: WHP: (Meat Milk): Nil.; Host/pest details: LAMB: [CASEOUS LYMPHADENITIS (CHEESY GLAND), ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS]; SHEEP: [CASEOUS LYMPHADENITIS (CHEESY GLAND), ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS, VITAMIN DEFICIENCY]; Poison schedule: 0; Withholding period: ; Host/pest details: LAMB: [CASEOUS LYMPHADENITIS (CHEESY GLAND), ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS]; SHEEP: [CASEOUS LYMPHADENITIS (CHEESY GLAND), ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS, VITAMIN DEFICIENCY]; For control of caseous lymphadenitis and the prevention of enterotoxaemia (pulpy kidney disease) and tetanus in sheep and lambs. For the treatment and prevention of Vitamin B12 deficiency in sheep in areas of known or suspected cobalt deficiency.See CAUTION - AVOID CARCASE DAMAGE on label.
Authorization status:
Registered
Authorization number:
50054
Authorization date:
2019-07-01

APPENDIX 2

Australian Government

Australian Pesticides

Veterinary Medicines Authority

Approved

TEMPLATE FOR RELEVANT

LABEL

PARTICULARS (RLPs)

(Veterinary

Products)

Select appropriate:

Product

(include

applicable

RLPs)

Variation

(highlight

instructions

that

being

varied)

Approval

label

being

varied· 50054/62776

Signal

heading:

ANIMAL

TREATMENT

ONLY

Product

name:

GLANVAC

3 812

VACCINE

Active

constituenUs:

pseudotuberculosis

(avis)

6 cpu/mL,

Cl.perfringens

type D

5 IU/mL,

tetani_O!:

IU/ml

ultrafiltered toxoids).

2 mg/mL hydroxocobalamin.

mg/mL Thiomersal is

added

a preservative.

Statement

claims:

control

caseous lymphadenitis (CLA

cheesy gland)

prevention

enterotoxaemia (pulpy

kidney

disease) and

tetanus

sheep and

lambs.

For the treatment and

prevention

Vitamin

deficiency

in sheep in areas

known

suspected

cobalt

deficiency.

Indications

INDICATIONS FOR USE

Glanvac 3

Vaccine is effective

the control of caseous lymphadenitis

the prevention of enterotoxaemia (pulpy kidney disease) and tetanus;

the treatment and prevention of Vitamin 812 deficiency

sheep

areas of known or suspected cobalt deficiency.

Caseous

lymphadenitis,

chronic

disease

sheep

goats.

characterised

abscesses,

containing

a cheese-like

green

pus,

superficial

internal

lymph

nodes

(glands)

lungs.

disease

caused

Corynebacterium

pseudotuberculosis

(avis)

which

gains

entry

through the respiratory tract and breaks or abrasions of the skin or mucous

membranes.

The disease is spread when superficial abscesses burst during handling or

shearing with consequent contamination of the shearing floor, holding yards

and dips.

a moist environment, the bacteria are able to survive for many

weeks. Caseous lymphadenitis

the most important single cause for partial

and total sheep carcase condemnations at slaughter

Australia.

has been

implicated

a cause of ill-thrift

ewes.

Prevalence increases with age.

Clean

properties may become

infected by the introduction

infected

animaL

If unexpected losses of animals have occurred, stockowners should consult

their veterinarians

order to ensure that a correct diagnosis

made and the

most effective vaccination programme instituted.

Australia, Vitamin 812 deficiency

sheep occurs mainly

a result of a

primary dietary deficiency of cobalt Microbial synthesis of Vitamin 812 occurs

the rumen of sheep

the presence of adequate cobalt, however soils

some parts of Australia are deficient

cobalt. Severely deficient soils occur

mainly

the southern coastal regions, however soils

other regions may

18 Wormald Street, Symonston

2609

Box 6182, Kingston

2604 Australia

Tel: +61 2 6210 4700

Fax: +61 2 6210 4874

www.apvma.gov.au

ABN 19 495 043

Net contents:

Directions for Use

Heading:

Restraints:

Contraindications:

Precautions:

Side effects:

Dosage

&

administration:

marginally cobalt deficient.

Vitamin 812

an essential nutrient which

required for the metabolism of

propionic acid.

Clinical

signs

of Vitamin

deficiency

sheep include:

decreased appetite, loss of bodyweight, retarded growth, reduced lactation,

retarded

wool

production

anaemia.

later

stages,

infertility,

diarrhoea, emaciation, weakness and increased lacrimation may

observed.

Where the diet

only marginally deficient

cobalt,

retarded growth and

reduced wool production may

the only signs observed.

One injection of 1-2 mg of hydroxocobalamin (Vitamin 812)

considered

sufficient to protect lambs for

to 14 weeks and weaners for

weeks.

However,

severely deficient areas, more frequent injections or additional

cobalt supplements may

required.

cobalt

deficiency

suspected,

stock owners

should

consult

their

veterinarians

order to ensure that a correct diagnosis is made and the most

effective treatment and prevention programme instituted.

250

ml,

500

ml

DIRECTIONS FOR USE

Read the enclosed leaflet for full instructions

It is important that the vaccine

is

kept properly mixed before and during

use.

Shake well before use and keep thoroughly mixed during use

This product

stored for

to 30 days after first opening.

Handle aseptically and store refrigerated and protected from light.

Please

refer

resealing

section

product

insert

further

information

storage

handling after opening.

When not

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

sunlight and

cool

possible.

not leave exposed to light or at high

temperatures

long.

Ideally

place

vaccine

pack

into

original

cardboard

carton

place

either an

esky

with

brick

refrigerator

For Subcutaneous Use Only

Dose: Sheep and Lambs 1

ml

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

may persist for some weeks or even months.

The dose on all occasions is 1

ml

injected subcutaneously (just under

the skin).

The recommended site for injection is high on the neck, behind 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 19 495 043 447

ear.

Give two

doses

vaccine for protective immunity.

nd dose is given 4 to 6 weeks

after

the first,

long lasting protection. A booster

dose

every 12 months is required for sheep to maintain

protective level

immun

ity.

Level of

Immun

A

Protect1ve

Level

months

dose

dose

A.

Single Doses

booster

dose

Single doses of the vaccine may

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 be attached to the pack as follows:

1. Remove the sterilized plastic cap and tube from the pack

2. Connect the tube to the automatic vaccinator

3. Disinfect the stopper with a suitable antiseptic, e.

methylated spirits

4. Screw the cap

to the plastic bottle

the vaccine which will cause the

needle to penetrate the stopper

5. Prime the automatic vaccinator by depressing the plunger several times and

vaccine will flow to the needle

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

sterilized by taking apart and boiling

water for at least ten minutes.

Be careful not to contaminate the vaccinator during re-assembly

C.

Use with a Dual Barrel Single Needle Vaccinator

Refer to

Eryvac

Vaccine

(APVMA No. 53385)

carton

leaflet for

instructions for use with a dual vaccination device.

Sheep and lambs (All ages):

Give 1

followed by a second dose

administered four weeks later.

The first dose should not

given to lambs before three weeks

age as

young lambs are less likely to develop protective immunity to CLA.

18 Wormald Street, Symonston

2609

6182, Kingston

2604 Australia

: +61 2 6210 4700 Fax: +61 2

6210

4874

.apvma.

ABN 19 495

General directions:

A booster dose of 1

given

months after the two initial doses should

confer

lifelong

immunity

against

tetanus,

against

enterotoxaemia (pulpy kidney), or caseous lymphadenitis. All animals should

receive annual booster doses

control caseous lymphadenitis. Sheep may

require

annual

booster

doses

maintain

effective

immunity

against

enterotoxaemia (pulpy kidney disease)

areas where the risk of this disease

is known

high.

Where possible, booster doses should be given prior to

the time of maximum

risk,

for example transfer to lush pasture or grain feeding

the case of enterotoxaemia.

Pregnant ewes:

If the animals have not

been

previously vaccinated, 1

should be injected at

the time of mating

a second dose of 1

should

given up to four

weeks before the expected date of lambing. If the ewes have been previously

vaccinated, a single dose of 1

should

given up

four weeks before the

expected date of lambing.

Successfully vaccinated pregnant ewes will not only

protected themselves,

will also pass

immunity to their lambs

the colostrum or 'first milk'.

this way lambs will

protected for the first six to eight weeks of their lives.

heavily CLA infected flocks, maternally derived immunity may interfere with

response of lambs to vaccination against CLA before

weeks of

age.

DEVELOPMENT

IMMUNITY

Immunity against the clostridial diseases covered

the vaccine develops

about 10 days after vaccination. The second dose, given four weeks after the

first, should ensure a high level of immunity against these diseases. Immunity

against caseous lymphadenitis develops within two weeks of administration of

the second dose.

To achieve maximum protection against caseous lymphadenitis, lambs should

vaccinated before probable exposure to infection. Booster doses should

preferably

timed

give best protection at times of maximum exposure e.g.

for caseous lymphadenitis, before shearing and dipping

Glanvac®

3812

vaccine

administered

with

Eryvac®

vaccine

(APVMA No. 53385) using a dual-barrel single-needle vaccination device,

and has been proven a safe method

vaccination

in pregnant ewes. The

co-administration

Glanvac® vaccine and Eryvac® vaccine

using

a dual-

barrel

single-needle vaccinator resulted

efficacy

(measured

using

serological outcomes such as

antibody

titres)

that

comparable

that

each vaccine administered separately,

with

an acceptable safety

profile.

Glanvac 3 812 Vaccine

a multicomponent adjuvanted product containing

Corynebacterium pseudotuberculosis

(ovis)

6 cpu/ml,

Clostridium

perfringens

typeD

IU/ml

Clostridium tetani

IU/ml

ultrafiltered toxoids)

2mg/ml hydroxocobalamin (Vitamin 812). The

adjuvant, which

aluminium salt, increases the level and duration of the

immunity conferred

the vaccine. The type of adjuvant

the purification

procedures used ensure maximum protection of stock against caseous

18 Wormald Street, Symonston

2609

PO Box 6182, Kingston ACT 2604 Australia

Tel:

2 6210 4700 Fax:

2 6210 4874

www.apvma.gov.au ABN

495 043 447

lymphadenitis, enterotoxaemia and tetanus with minimum local reactions at

the site

injection. Thiomersal

mg/mL is added

a preservative.

Unused vaccine may

stored and used for up to 30 days after first opening.

each subsequent reuse, swab the opening with a suitable disinfectant (for

example, methylated spirits) both before and after using.

A sterile needle and

syringe must

used each time product

removed.

Store

unused

material

2°C

8°C

(refrigerated)

original

cardboard packaging to protect from light.

RESEALING

A partially used pack

stored and used for up 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

Store

vaccine

this

original

cardboard

carton

place

refrigerator.

not freeze.

not leave exposed to light or at high temperatures for long periods

Before re-use the delivery tube and cap should

sterilized by boiling in 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.

Opened packs should

used

quickly as possible.

Re-opening increases the risk

vaccine contamination.

This pack

compatible with the Zoetis Quickshot Vaccinator

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

ANTITOXIN

If immediate short-term

protection

required

counter

outbreak of

tetanus,

antitoxin should

used (see the "Equivac TAT" leaflet, APVMA

Number 51771). Although antitoxin may be useful

controlling

outbreak of

tetanus,

usefulness

limited owing

to the shortness

the protective

action.

Caution: avoid carcass damage

Sterilise all injection apparatus

boiling

water for

minutes (or

equivalent) before use. Avoid use of strong disinfectants

apparatus.

Maintain cleanliness at all times during vaccination. Great care must

taken to avoid contamination of the vaccine, needle and internal parts of

the syringe

contact with unsterile surfaces or unwashed hands.

18 Wormald Street, Symonston

2609

PO Box 6182, Kingston

2604 Australia

Tel:

2 6210 4700 Fax:

2 6210 4874

www.apvma.gov.au

ABN 19

Keep needles sharp and clean. Replace frequently.

Use the shortest possible needle, not exceeding 15

mm

length.

As far

possible avoid injection of animals during wet weather or under

dusty conditions. Animals should preferably be inoculated

tern porary

yards

clean grass,

shearing sheds and fixed mustering yards are

likely

heavily

contaminated

with

clostridial

spores

Corynebacterium pseudotuberculosis (ovis).

This product must be injected only under the skin (subcutaneously).

If possible inject high

the neck behind the ear, i.e. under the skin

side of the neck

Oust

behind and below the base of the ear).

not inject

at any other site. Young lambs may be vaccinated while being held during

marking operations. Older animals, including those pregnant, are most

conveniently vaccinated while they are standing

a race.

Before vaccine is injected, the proposed site of inoculation

the animal's skin

may be cleaned by swabbing with cotton-wool soaked

an antiseptic solution,

such

methylated spirits.

Australian Technical Services Toll-Free 1800 814 883

www.zoetis.com.au

The vaccine has been fully tested and found to conform to accepted standards

of potency, safety and sterility.

NOTE

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

must be stressed that correct vaccination procedure

the field is 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 to losses of stock, but fortunately

rare

occurrence.

above

factors

beyond

control

manufacturer except to the extent of any

liability

imposed by statute law

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

or loss of stock following vaccination

respect of failure to use the correct

vaccination procedure described

the label or disability or loss to any animal

caused by the product.

Withholding Period/s:

MEAT:

Zero

(0)

days;

MILK:

Zero

(0)

days

Trade

Advice:

EXPORT SLAUGHTER INTERVAL (ESI): ESI not applicable

Safety Directions:

First Aid:

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

Phone

Australia 13

This material may cause a mild allergic reaction

sensitive individuals

skin

contact.

Avoid

skin

contact.

skin

hair

contact

occurs,

remove

contaminated clothing and flush skin and hair with running water. If splashed

eyes, wash out immediately with water.

18

Wonnald Street, Symonston

ACT

2609

PO

Box 6182, Kingston

ACT

2604

Australia

Tel:

6210

4700

Fax:

6210

4874

www.apvma.gov.au

ABN 19 495 043 447

Additional user

User Safety Information:

safety:

Take care to avoid accidental self-injection.

the event

self-injection, seek medical attention if you are concerned and

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

Allow the wound to bleed freely and do not squeeze or interfere with the

injection site to avoid spread of the vaccine.

Clean the wound thoroughly with

soap and water, and then keep it clean and dry. If pain persists after medical

examination, seek medical advice again.

Environmental

statements:

Disposal:

Dispose of empty containers

putting

garbage. Discarded needles should

immediately

placed

a designated and appropriately labelled 'sharps'

container.

Storage:

Store between 2°Cand

C (Refrigerate. Do not freeze). Protect from light.

Prolonged exposure to light will have

adverse effect

Vitamin B12.

Name

&

address;

Zoetis Australia Ply Ltd

Level6, 5 Rider Boulevard, Rhodes, NSW 2138, AUSTRALIA

Australian Technical Services Toll Free

1800 814 883

www.zoetis.com.au

The

following

is

for

APVMA

use

only:

APVMA

approval no.

APVMA

50054/62776

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

19

495 043 447

Product Name: GLANVAC® 3 B12 VACCINE

Page: 1 of 6

This version issued: 17 March 2015

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:

GLANVAC® 3 B12 VACCINE

Other names:

None.

APVMA Approval No:

50054

Chemical family:

Aqueous suspension of inactivated bacteria with added Vitamin B12.

Recommended Use:

For the control of CLA and the prevention of clostridial diseases and cobalt deficiency

in sheep.

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, S25, S36. Do not breathe mists. Avoid contact with eyes. Wear suitable protective clothing.

ADG Classification:

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

Code, IATA or IMDG/IMSBC criteria.

GHS Label Elements: None

Signal word: None – Not hazardous.

GHS Classification: 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

P353: Rinse skin or shower with 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 at temperatures preferably between 2 and 8°C, but do not freeze.

P403+P233: Store in a well-ventilated place. Keep container tightly closed.

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.

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Physical Description & colour

: Aqueous suspension.

Odour:

No data re odour.

Major Health Hazards:

no significant risk factors have been found for this product.

No specific medical attention is advised. Treat symptomatically.

Product Name: GLANVAC® 3 B12 VACCINE

Page: 2 of 6

This version issued: 17 March 2015

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

Ultrafiltered toxoids of several organisms *

not set

see below †

not set

not set

Hydroxocobalamin acetate (Vitamin B12)

22465-48-1

2mg/mL

not set

not set

Thiomersal

54-64-8

0.1mg/L

not set

not set

Other non hazardous ingredients

secret

<5

not set

not set

Water

7732-18-5

to 100

not set

not set

* Corynebacterium pseudotuberculosis, Cl. perfringens Type D, Cl. tetani

† amounts sufficient in balanced proportion to satisfy potency requirements of BP(Vet) 1993

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

hazardous ingredients are also possible.

The SWA 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 may be equalled (but should not be exceeded) for no

longer than 15 minutes and should not be repeated 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 and is available at all times. Have this SDS with you

when you call.

Self Injection: Accidental self injection may lead to an inflammatory response. In the event of self-injection, medical

advice should be sought if concerned or on the management of deep injections, particularly those near a joint or

associated with bruising. Show the package leaflet or the label to the Medical Practitioner. Allow the wound to bleed

freely and do not squeeze or interfere with the injection site to avoid spread of the vaccine. The damaged area should

be thoroughly cleansed and a topical antiseptic applied and then kept clean and dry. If pain persists after medical

examination, seek medical advice again. Check your tetanus immunisation status.

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.

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. Take special care if exposed person is wearing contact lenses.

Ingestion:

If product is swallowed or gets in mouth, do NOT induce vomiting; 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.

Most Important Symptoms and Effects, Both Acute and Delayed

Symptoms and Effects of Exposure: None known.

Medical Conditions Aggravated by Exposure: None known.

Indication of the Immediate Medical Attention and Special Treatment Needed: None known.

Notes to Physician: None.

Section 5 - Fire Fighting Measures

Hazards arising from the product

: The major hazard in fires is usually inhalation of heated and toxic or oxygen

deficient (or both), fire gases. 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 product 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.

Suitable Extinguishing Media

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

Special Protective Equipment and Precautions for Firefighters

: If a significant quantity of this product is

involved in a fire, call the fire brigade.

Hazchem Code:

None

Product Name: GLANVAC® 3 B12 VACCINE

Page: 3 of 6

This version issued: 17 March 2015

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

Section 6 - Accidental Release Measures

Personal precautions, protective equipment and emergency procedures:

This product is sold in small

packages, and the accidental release from one of these is not usually a cause for concern. For minor spills, refer to

product label for specific instructions. No special protective clothing is normally necessary because of this product.

However it is good practice to wear latex gloves when handling injectables. In the event of a major spill, prevent

spillage from entering drains or water courses and call emergency services.

Environmental Precautions: None.

Methods and Material for Containment and Cleaning Up. This product is sold in small packages. No special

measures are usually necessary following spills.

Measures for Cleaning / Collecting: Contain the source of the spill if it is safe to do so. Absorb spills with non-

combustible absorbent material and transfer into a labelled container for disposal.

Additional Consideration for Large Spills: Non-essential personnel should be evacuated from affected area.

Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel.

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

: Refrigerate, preferably between 2 and 8°C, but do not freeze. Store in the closed original container in a dry,

cool, well-ventilated area out of direct sunlight. Make sure that the product does not come into contact with

substances listed under "Incompatibilities" 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. Protect

containers against physical damage and check regularly for leaks.

This product can be stored and used for up to 30 days after first opening. Discard after 30 days. Refer to the section

of the label dealing with resealing and handling after opening.

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.

Skin Protection:

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

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

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

Protective Material Types:

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

Respirator:

Not required for the normal use of this product. If the applicable Occupational Exposure Limit (OEL) is

exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL.

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

Section 9 - Physical and Chemical Properties:

Appearance

Aqueous suspension.

Odour:

No data re odour.

Odour Threshold:

No data.

pH:

No data.

Freezing/Melting Point:

Approximately 0°C.

Product Name: GLANVAC® 3 B12 VACCINE

Page: 4 of 6

This version issued: 17 March 2015

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

Boiling Point:

Approximately 100°C at 100kPa.

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.

Upper Flammability Limit:

Does not burn.

Lower Flammability Limit:

Does not burn.

Autoignition temperature:

Not applicable - does not burn.

Flammability (solid, gas):

Not applicable.

Flammability Class:

Does not burn.

Decomposition Temperature:

No data.

Volatiles:

Water component.

Vapour Pressure:

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

Vapour Density:

As for water.

Relative Density:

No data.

Water Solubility:

Completely soluble in water.

Solvent Solubility:

No data.

Volatility:

No data.

Evaporation Rate:

As for water.

Partition Coefficient (n-octanol/water)

No data

Autoignition temp:

Not applicable - does not burn.

Viscosity:

Not applicable.

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.

Stability:

Stable if stored under normal conditions.

Conditions to Avoid:

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

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

Incompatibilities:

No particular Incompatibilities.

Hazardous decomposition products:

No specific data. Based on composition of viruses, the following might be

expected: Carbon dioxide, and if combustion is incomplete, carbon monoxide and possibly 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; also water.

Polymerisation:

This product will not undergo polymerisation reactions.

Section 11 - Toxicological Information

S

S

S

y

y

y

m

m

m

p

p

p

t

t

t

o

o

o

m

m

m

s

s

s

c

c

c

a

a

a

u

u

u

s

s

s

e

e

e

d

d

d

b

b

b

y

y

y

E

E

E

x

x

x

p

p

p

o

o

o

s

s

s

u

u

u

r

r

r

e

e

e

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.

Product Name: GLANVAC® 3 B12 VACCINE

Page: 5 of 6

This version issued: 17 March 2015

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

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:

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.

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

g

r

r

r

e

e

e

d

d

d

i

i

i

e

e

e

n

n

n

t

t

t

s

s

s

Ingredient

Risk Phrases

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

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

Insufficient data to be sure of status. Expected to not be an environmental hazard.

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.

Product Name: GLANVAC® 3 B12 VACCINE

Page: 6 of 6

This version issued: 17 March 2015

SAFETY DATA SHEET

Issued by: Zoetis Australia Pty Ltd

Phone: 1800 814 883

Poisons Information Centre: 13 1126 from anywhere in Australia

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.

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: 20 February 2015

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)

© 2015 Zoetis Inc, All rights reserved.

Prepared by Kilford & Kilford Pty Ltd

End of Safety Data Sheet

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