CANVAC BB VACCINE

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

Buy It Now

Active ingredient:
THIOMERSAL; BORDETELLA BRONCHISEPTICA (INACTIVATED CELL FREE EXTRACT
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
vaccine - canine Bordetella(20ug/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
THIOMERSAL MERCURY Active 0.1 mg/ml; BORDETELLA BRONCHISEPTICA (INACTIVATED CELL FREE EXTRACT VACCINE-MICROBIAL Active 0.0 U
Units in package:
20 x 1mL; Syringe
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
DOG | BITCH | CASTRATE | PUPPY
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
BORDETELLA SPP. | BORDETELLA BRONCHISEPTICA
Product summary:
Poison schedule: 0; Withholding period: WHP:NiL; Host/pest details: DOG: [BORDETELLA SPP.]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [BORDETELLA SPP.]; For immunisation of dogs against Bordetella bronchiseptia infection, a contributing factor to the canine cough syndrome.Not to be used in dogs when they are: incubating an infectious disease; seriously debilitated by another infectious disease, parasitic infestation or malnutrition; or under treatment with immunosuppressive drugs.
Authorization status:
Registered
Authorization number:
51774
Authorization date:
2020-07-01

APPENDIX 2

Australian

Government

Australian Pesticides and

Veterinary Medicines Authority

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)

(Veterinary Products)

Select appropriate:

New Product (include all applicable RLPs)

Variation (highlight instructions that are being varied). Approval

label being varied: 51774/0207.

Signal

heading:

Product

name:

Active

constituenVs:

Statement

claims:

contents:

Directions

for

Use

Heading:

Restraints:

Contraindications:

Precautions:

Side

effects:

Approved

Dosage

&

administration:

FOR ANIMAL TREATMENT ONLY

Canvac®

88

vaccine

Canvac

Vaccine

inactivated vaccine prepared from a cell-free extract of

Bordetel/a bronchiseptica

(20~g/mL).

aluminium salt

included

enhance the

response

vaccination and to increase the duration of immunity. Thiomersal

mg/mL

added as a preservative.

Canvac

Vaccine

used

immunisation

dogs

against

Bordetel/a

bronchiseptica

infection, a contributing factor

the canine cough syndrome.

20 x 1

mL dose syringes

DIRECTIONS FOR USE

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

Contents must

left

outer package until immediately before use

Shake gently before use

This product should not

used

·in

dogs when they are:

incubating an infectious disease;

seriously debilitated

by another infectious disease,

parasitic infestation or

malnutrition;

under treatment with immunosuppressive drugs.

Canvac

Vaccine

inactivated vaccine,

untoward systemic

effects

uncommon and the vaccine may

used

pregnant bitches. Careful palpation

site of injection may reveal a small fibrous nodule

some dogs about a week after

vaccination. This nodule will regress, becoming impalpable within two to six weeks.

a very few small, smooth-coated dogs a nodule may

visible for a limited period.

Some animals may show transient post-vaccination reactions including injection site

pain, lethargy and/or vomiting.

Systemic allergic reactions such as anaphylaxis are thought

occur rarely with all

vaccines and

require appropriate treatment. Systemic hypersensitivity reactions,

mainly

characterised

urticaria

facial

oedema,

have

also

been

reported,

particularly

animals receiving a second injection of Canvac

Vaccine 4

weeks after the first injection. Premedication with antihistamine may

indicated

animals at risk.

REMOVAL OF THE NEEDLE COVER

not attempt

screw

needle cover

Ease

twisting syringe to and fro gently

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

General

directions:

The vaccine

injected subcutaneously.

dose (one syringe) is recommended for dogs of all ages.

Gentle massage at the site

injection will help

disperse the vaccine.

Canvac

Vaccine is

adjuvanted vaccine; there may

settling

adjuvant

after storage but

material

easily resuspended

inversion of the syringe.

INDICATIONS FOR USE

The vaccine is

used

for the immunisation

dogs against colonization of the upper

lower respiratory tract and

nose

throat with

Bordetella bronchiseptica.

given alone or used as a diluent for other vaccines

the Canvac range. For

optimal

effect

incidence

transmission

of infectious

tracheobronchitis

(canine

cough)

vaccination

with

multicomponent

vaccine

containing

canine

distemper

virus,

canine

parainfluenza

virus

canine

adenovirus

type

recommended.

Vaccination Programmes

For primary immunisation, puppies

dogs should

given two doses of vaccine

with

interval of 4 weeks between doses.

When used

part of a general vaccination programme for young puppies, Canvac

Vaccine may form one component of a broader vaccination regime. For instance,

part of a primary immunisation course of three doses

vaccine

young puppies,

Canvac

Vaccine may be given

combination with CANVAC 3 vaccine or

CANVAC 4 vaccine at

weeks of

age,

and again at 16

weeks of age.

The epidemiology of each disease,

persistence

maternal antibody and

dog's history must all

considered when deciding

a vaccination programme for a

particular animal.

Annual booster vaccinations are recommended to maintain adequate immunity,

booster

recommended before exposure to possible sources of infection, such as

shows, boarding kennels or obedience classes, especially

more than six months

have elapsed since the last dose of vaccine was administered.

Development

of

Immunity

Immunity develops about ten days to two weeks following the second dose of vaccine

sero-negative dogs.

USE

AS

A DILUENT

Canvac

Vaccine may be used

a diluent for Canvac

Vaccine, CANVAC 3

vaccine

CANVAC 4 vaccine.

NOTE:

This vaccine

been

fully tested for sterility and safety before issue but it must

stressed

that

correct vaccination

procedure is equally important if secondary

infection is

prevented.

above factors are beyond the control

of the

manufacturer except to the extent

any liability imposed

statute law without right

of exclusion, Zoetis cannot accept responsibility for any disability or loss

animals

following vaccination

respect of failure

use the correct vaccination procedure

described

the label or disability or loss

any animal caused

the product.

Zoetis provides technical support

veterinarians using their products. If

have

any enquiries regarding

Canvac BB Vaccine,

please telephone

our Australian toll

free number 1800

883.

Withholding

Period/s:

Trade

Advice:

Safety

Directions:

First

Aid:

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

Phone Australia

18

Wormald

Street,

Symonston

ACT 2609

6182,

Kingston

2604

Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

www.apvma.gov.au

ABN

19

495

043 447

131126. This material may cause a mild allergic reaction

sensitive individuals on

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

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

eyes, wash out

immediately with water.

Additional

user

safety:

Take care to avoid accidental self-Injection.

the event

self-administration, seek

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

the Medical Practitioner.

Environmental

statements:

Disposal:

Dispose

empty syringes and needles by immediately placing into a designated and

appropriately labelled 'sharps' container.

Storage:

Store between

and 8°C. (Refrigerate.

not freeze). Protect from light.

Name

&

address:

Zoetis Australia Ply

38-42 Wharf Road

West Ryde NSW 2114

AUSTRALIA

The

following

is

for

/JJJVMA

use

only:

APVMA

approval

no.

APVMA

No:

51774/60056

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: Canvac™ BB Vaccine

Page: 1 of 5

This revision issued: January, 2005

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 3519

____________________________________

Pfizer Australia Pty Ltd

A.B.N. 50 008 422 348

Substance:

Bacterial cell extracts and other ingredients in buffered saline suspension.

Trade Name:

Canvac™ BB Vaccine

Other Names:

Bordetella bronchiseptica Vaccine

Pfizer MSDS Code:

0989

Product Use:

For vaccination by injection of dogs against Bordetella bronchiseptica (canine cough).

Creation Date:

May, 2004

Revision Date:

December, 2004

Section 2 - Hazards Identification

Statement of Hazardous Nature

This product is classified as:

Not classified as hazardous according to the criteria of NOHSC Australia.

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

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

Not Hazardous - No criteria found.

SUSDP Classification:

None allocated (Aust), S2 (NZ).

ADG Classification:

None allocated. Not a Dangerous Good.

UN Number:

None allocated.

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Physical Description & colour

: White aqueous suspension.

Odour:

No odour.

Major Health Hazards:

No significant risk factors have been found for this product.

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Inhalation

Short term exposure:

Significant inhalation exposure is considered to be unlikely. Available data indicates that this

product is not harmful. In addition product is unlikely to cause any discomfort or irritation.

Long Term exposure:

No data for health effects associated with long term inhalation.

Skin Contact:

Short term exposure:

Available data indicates that this product is not harmful. It should present no hazards in

normal use. 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

: Exposure via eyes is considered to be unlikely. This product is believed to be not irritating to

eyes.

Long Term exposure

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

Ingestion:

Short term exposure

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

irritation problems in the short or long term.

Long Term exposure

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

Product Name: Canvac™ BB Vaccine

Page: 2 of 5

This revision issued: January, 2005

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

Carcinogen Status:

NOHSC:

No significant ingredient is classified as carcinogenic by NOHSC.

NTP:

No significant ingredient is classified as carcinogenic by NTP.

IARC:

No significant ingredient is classified as carcinogenic by IARC.

Section 3 - Composition/Information on Ingredients

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%

%

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(

(

(

m

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/

/

/

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3

3

3

)

)

)

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(

(

(

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/

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3

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)

)

)

Buffered saline suspension medium

not set

no data

not set

not set

B. bronchiseptica cell extract

not set

no data

not set

not set

Thiomersal

54-64-8

0.01

not set

not set

Other non hazardous ingredients

secret

to 100

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.

Contact or Poisoning:

From the available evidence, this product would appear to offer no significant health hazard

by any exposure route. Consequently, First Aid is not generally required. If in doubt, contact a Poisons Information

Centre or a doctor.

Section 5 - Fire Fighting Measures

Fire and Explosion Hazards

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

involved in a fire.

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

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

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

: 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. 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 above.

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

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

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

and dispose of promptly. Recycle containers wherever possible after careful cleaning. After spills, wash area

preventing runoff from entering drains. If a significant quantity of material enters drains, advise emergency services.

This material may be suitable for approved landfill. Ensure legality of disposal by consulting regulations prior to

disposal. Thoroughly launder protective clothing before storage or re-use. Advise laundry of nature of contamination

when sending contaminated clothing to laundry.

Product Name: Canvac™ BB Vaccine

Page: 3 of 5

This revision issued: January, 2005

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

: As a finished product, this material should be stored at 2-8 degrees Celsius, and not frozen. 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 "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

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.

Exposure Limits

TWA (mg/m

3

)

STEL (mg/m

3

)

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

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

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

Ventilation:

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

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

Eye Protection:

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

wear suitable protective glasses or goggles.

Skin Protection:

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

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

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

Protective Material Types:

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

Respirator:

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

the Australian Standard mentioned above.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

White aqueous suspension.

Odour:

No odour.

Boiling Point:

Approximately 100°C at 100kPa.

Freezing/Melting Point:

Approximately 0°C.

Volatiles:

Water component.

Vapour Pressure:

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

Vapour Density:

No data.

Specific Gravity:

1.01 approx

Water Solubility:

Completely soluble in water.

pH:

Neutral

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water distribution

No data

Autoignition temp:

Not applicable - does not burn.

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 and fats, the following might be expected:

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

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

Product Name: Canvac™ BB Vaccine

Page: 4 of 5

This revision issued: January, 2005

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

compounds. Water. Sodium 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

Target Organs:

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

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Ingredient

Risk Phrases

No ingredient mentioned in the List of Designated Hazardous Substances is present in this product at hazardous

concentrations.

Section 12 - Ecological Information

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

Section 13 - Disposal Considerations

Disposal:

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

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

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

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

dispose into sewers or waterways.

Section 14 - Transport Information

ADG Code:

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

unless required by other regulations.

Section 15 - Regulatory Information

AICS:

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

AICS registration is often not required for ingredients of this type of product as registration occurs under other

schemes. 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

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

NOHSC

National Occupational Health and Safety Commission

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

UN Number

United Nations Number

Contact Points:

Pfizer

(02)9850 3333 (Business hours)

Ask for Environmental Health & Safety Manager

Police and Fire Brigade:

Dial 000

If ineffective:

Dial Poisons Information Centre

(

13 1126 from anywhere in Australia)

Please read all labels carefully before using product.

This MSDS copyright © Kilford & Kilford Pty Ltd, December, 2004.

Product Name: Canvac™ BB Vaccine

Page: 5 of 5

This revision issued: January, 2005

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

Phone (02)9251 4532

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