PROTECH BB BORDETELLA BRONCHISEPTICA KILLED VACCINE

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

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Active ingredient:
BORDETELLA BRONCHISEPTICA KILLED VACCINE
Available from:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
INN (International Name):
vaccine - canine Bordetella(20ug/mL)
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
BORDETELLA BRONCHISEPTICA KILLED VACCINE VACCINE-MICROBIAL Active 0.0 P
Units in package:
25 x 1mL; Syringe
Class:
VM - Veterinary Medicine
Therapeutic group:
DOG | BITCH | CASTRATE | PUPPY
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
BORDETELLA BRONCHISEPTICA | CANINE COUGH SYNDROME | INFECTIOUS TRACHEOBRONCHITIS
Product summary:
Poison schedule: 0; Withholding period: WHP:N/A; Host/pest details: DOG: [BORDETELLA BRONCHISEPTICA]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [BORDETELLA BRONCHISEPTICA]; For the immunisation of dogs against Bordetella bronchiseptica infection, a contributing factor to the canine cough syndrome.For use only by or under the direction of a registered veterinary surgeon. This product should not be used in dogs when they are incubating an infectious disease, seriously debilitated by another infectious disease, parasitic infestation, malnutrition...
Authorization status:
Registered
Authorization number:
54951
Authorization date:
2019-07-01

Protech BB Bordetella bronchiseptica Killed Vaccine

APVMA54951

Page 1 of 5

June 2014

FOR ANIMAL TREATMENT ONLY

PROTECH®BB

Syringe label

Bordetella bronchiseptica

Killed Vaccine

Contents:

1 dose

To be used

under the direction of a registered veterinary surgeon.

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

Contents must be left

outer package until immediately before use.

Shake gently before use.

Store between 2-S"C.

Do not freeze.

Protect from light.

APVMA 54951/62963

Batch No.:

Expiry:

Boehringer

lngelheim

Approved

Protech BB Bordetella bronchiseptica Killed Vaccine

APVMA54951

Page 2

20 June 2014

Tray label -

FOR ANIMAL

TREATMENT

ONLY

PROTECH® BB

Bordetel/a bronchiseptica

Killed Vaccine

Active Constituent:

An inactivated vaccine prepared from a cell-free extract of

Bordetella bronchiseptica

~glmL)

For the immunisation of dogs against

Bordetella bronchiseptica

infection, a contributing factor

the canine cough syndrome.

Contents:

25 single dose syringes

READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

To

be used by,

or

under the direction

of

a registered veterinary surgeon.

Contents must be left

outer package until immediately before use.

Shake gently before use.

Dose: A 1 mL dose (one syringe) is recommended for dogs of all ages.

The vaccine is injected

subcutaneously.

Store between 2-B'C.

Do not freeze.

Protect from light.

APVMA

54951/62963

Batch No.:

Expiry:

Protech®

is a registered trademark of Boehringer lngelheim Vetmedica

Inc.-

used under

license.

Please recycle leaflet, label and tray only.

Boehringer

lngelheim

FOR ANIMAL TREATMENT ONLY

PROTECH®BB

Protech

Bordetella bronchiseptica Killed Vaccine

APVMA

54951

Page 3 of 5

June 2014

Carton label -

Bordetella bronchiseptica

Killed Vaccine

Active Constituent:

inactivated vaccine prepared from a cell-free extract of

Bordeteffa bronchiseptica

~g/mL)

For the immunisation

dogs against

Bordeteffa bronchiseptica

infection, a contributing factor

the canine cough syndrome.

Contents:

25 single dose syringes

READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

To be used

by,

or

under the direction

of

a registered veterinary surgeon.

Contents must

left

outer package until immediately before use.

Shake gently before use.

Dosage and Administration

Dose: A 1 mL dose (one syringe) is recommended for dogs of all ages.

The vaccine is injected

subcutaneously.

REMOVAL OF NEEDLE COVER

not attempt

screw off needle cover.

Ease

by twisting syringe

and fro gently.

First Aid

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

131126.

Disposal

Discarded syringes and needles should immediately be placed

a designated and

appropriately labelled "sharps" container.

Storage

Store between 2-8°C.

Do not freeze. Protect from light.

APVMA No. 54951/62963

Batch No.:

Expiry:

Boehringer lngelheim Pty Limited

Animal Health Division

Waterloo Road

NORTH RYDE NSW 2113

Protech®

a registered trademark

Boehringer lngelheim Vetmedica Inc.

-used

under

license.

Please recycle leaflet and carton only.

Protech BB Bordetella bronchiseptica Killed Vaccine

APVMA54951

Page4

June 2014

Packaging Insert

FOR ANIMAL TREATMENT ONLY

PROTECH®BB

Bordetella

bronchiseptica

Killed Vaccine

Composition

inactivated vaccine prepared from a cell-free extract of

Bordetella bronchiseptica

~g/mL).

aluminium salt

included

enhance the response

vaccination and

increase

duration of immunity. Thiomersal

mg/mL

added

a preservative.

Indication

The vaccine

used for the immunisation of dogs against colonisation of

upper

lower

respiratory tract, nose and throat with

Bordetella bronchiseptica.

DIRECTIONS FOR USE

be used by,

under

direction

a registered

veterinary

surgeon.

Contents must be left

outer package until immediately before use

Shake

gently

before

Precautions

Protech® BB

should

be used in

dogs

when they are:

Incubating

infectious

disease

Seriously

debilitated

another

infectious

disease,

parasitic

infestation

malnutrition;

or

Under

treatment

with

immunosuppressive

drugs.

Side Effects

As Protech® BB

inactivated vaccine, untoward systemic effects are uncommon

vaccine may

used

pregnant bitches.

Careful palpation of the 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 to occur rarely with all vaccines

may require appropriate treatment. Systemic hypersensitivity reactions, mainly characterised

urticaria

facial oedema, have also been reported, particularly

animals receiving a second

injection of Protech® BB 4 to 8 weeks after the first injection.

Premedication with antihistamine

indicated

animals at risk.

Dosage and

Administration

The vaccine is injected subcutaneously. A 1

dose (one syringe) is recommended for dogs

of all ages.

Gentle massage at the site of injection will help

disperse the vaccine.

Protech® BB

adjuvanted vaccine; there may be settling

the adjuvant after storage but

the material is easily resuspended by inversion

the syringe.

REMOVAL

NEEDLE COVER

not attempt to screw off needle cover.

Ease off by twisting syringe to

fro gently.

INDICATIONS FOR USE

Protech BB Bordetella bronchiseptica Killed Vaccine

APVMA54951

Page 5 of 5

June2014

The vaccine

used for the immunisation of dogs against colonization of the upper and lower

respiratory tract and the nose and throat with

Bordetella bronchiseptica.

It may

given alone

or used as a diluent for other vaccines, such

Duramune Adult® C4 vaccine, Protech® C4

vaccine or Protech® Pi2 vaccine.

For optimal effect

the incidence and transmission of

infectious tracheobronchitis (canine cough) vaccination with a multi-component vaccine

containing canine distemper virus, canine parainfluenza virus and canine adenovirus type 2 is

recommended.

Vaccination Programs

For the primary immunisation, puppies and dogs should

given

doses of vaccine with an

interval of 4 weeks between doses.

The epidemiology

each disease, the persistence

maternal antibody and the dog's history

must all be considered when deciding

a vaccination program for a particular animal.

Annual booster vaccinations are recommended

maintain adequate immunity, and a booster is

recommended before exposure to possible sources of infection, such as shows, boarding

kennels or obedience classes, especially if more than six months has elapsed since the last

dose of vaccine was administered.

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

sero-

negative dogs.

This vaccine has been fully tested for sterility and safety before issue but it must be stressed

that the correct vaccination procedure is equally important if secondary infection is

prevented.

First

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

131126.

Additional

User Safety

Take care

avoid self-injection.

the event of self-administration, seek medical attention if you

are concerned

show the package leaflet or the label

the medical practitioner.

Disposal

Discarded syringes and needles should immediately be placed

a designated and

appropriately labelled "sharps" container. Discarded syringes should immediately be placed

designated and appropriately labelled "biologicals" container.

Storage

Store between 2-8°C.

not freeze. Protect from light.

APVMA approval No. 54951162963

Boehringer lngelheim Pty Limited

Animal Health Division

78 Waterloo Road

NORTH RYDE NSW 2113

Protech®

is a registered trademark of Boehringer lngelheim Vetmedica Inc.

-used

under

license.

Please recycle leaflet, label, carton and/or tray only.

CS: 1.7.2

Page:

Material Safety Data Sheet

Infosafe No™

LQ08B

August 2011

ISSUED by BOEHRING

Issue Date :

PROTECH® BB BORDETELLA BRONCHISEPTICA KILLED VACCINE

Product Name :

Not classified as hazardous

1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER

PROTECH® BB BORDETELLA BRONCHISEPTICA KILLED VACCINE

Product Name

Boehringer Ingelheim Pty. Limited

Company Name

78 Waterloo Rd North Ryde

NSW 2113 Australia

Address

1800 038 037

Emergency Tel.

Tel: 1800 038 037

Fax: +61 2 8875 8715

Telephone/Fax

Number

animalhealth.au@boehringer-ingelheim.com

Email

For the immunisation of dogs against Bordetella bronchiseptica (canine cough).

Recommended Use

2. HAZARDS IDENTIFICATION

Not classified as hazardous

NON-HAZARDOUS SUBSTANCE.

NON-DANGEROUS GOODS.

Hazard classification according to the criteria of NOHSC.

Dangerous goods classification according to the Australia Dangerous Goods

Code.

Hazard

Classification

3. COMPOSITION/INFORMATION ON INGREDIENTS

Water suspension of killed Bordetella bronchiseptica

Information on

Composition

Name

CAS

Proportion

Ingredients

Ingredients determined

not to be hazardous

100 %

4. FIRST AID MEASURES

No special precautions required. However, if inhaled, remove affected person

from contaminated area. Keep at rest until recovered. If symptoms persist seek

medical attention.

Inhalation

Do not induce vomiting. Wash out mouth thoroughly with water. If symptoms

develop seek medical attention.

Ingestion

Wash affected area thoroughly with soap and water. If symptoms develop seek

medical attention.

Self-Injection: Accidental self injection may lead to an inflammatory response

and 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.

Skin

If in eyes, hold eyelids apart and flush the eyes continuously with running

water. Continue flushing for several minutes until all contaminants are washed

out completely. If symptoms develop and persist seek medical attention.

Eye

Eyewash and normal washroom facilities.

First Aid Facilities

Treat symptomatically.

Advice to Doctor

For advice in an emergency, contact a Poisons Information Centre (Phone

Australia 13 1126) or a doctor at once.

Other Information

5. FIRE FIGHTING MEASURES

Use appropriate fire extinguisher for surrounding environment.

Suitable

Extinguishing Media

Under fire conditions this product may emit toxic and/or irritating fumes.

Hazards from

Combustion

Products

This product is non-combustible. However, following evaporation of aqueous

component under fire conditions, the non-aqueous component may decompose

Specific Hazards

Print Date: 4/09/2013

CS: 1.7.2

CS: 1.7.2

Page:

Material Safety Data Sheet

Infosafe No™

LQ08B

August 2011

ISSUED by BOEHRING

Issue Date :

PROTECH® BB BORDETELLA BRONCHISEPTICA KILLED VACCINE

Product Name :

Not classified as hazardous

and/or burn.

Fire fighters should wear Self-Contained Breathing Apparatus (SCBA) operated

in positive pressure mode and full protective clothing to prevent exposure to

vapours or fumes. Water spray may be used to cool down heat-exposed

containers.

Precautions in

connection with Fire

6. ACCIDENTAL RELEASE MEASURES

For minor spills: refer to product label for specific instructions. It is good

practice to wear latex gloves when handling vaccines. Avoid inhalation of

fumes, and skin or eye contact. Absorb with an inert material and place in an

appropriate waste disposal container.

In the event of a major spill: Wear appropriate personal protective equipment

and clothing to minimise exposure. Increase ventilation. If possible contain

the spill. Place inert absorbent material onto spillage. Collect the material

and place into a suitable labelled container. Do not dilute material but

contain. Dispose of waste according to the applicable local and national

regulations. If contamination of sewers or waterways occurs inform the local

water and waste management authorities in accordance with local regulations.

Emergency

Procedures

7. HANDLING AND STORAGE

Used as directed on label or package insert. Avoid generating dust/vapours.

Use in a well ventilated area. Exposure without protection should be prevented

in order to lessen the possibility of disorders. It is essential that all who

come into contact with this material maintain high standards of personal

hygiene ie. washing hands prior to eating, drinking, smoking or using toilet

facilities.

Precautions for Safe

Handling

Store in a cool, dry, well-ventilated area, out of direct sunlight and

moisture. Keep containers tightly closed when not in use. Keep only in

original container. Store at 2 to 8°C (Refrigerate. DO NOT FREEZE). Protect

from light. Keep out of reach of children.

Conditions for Safe

Storage

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

No exposure standards have been established for this material, however, the

TWA National Occupational Health And Safety Commission (NOHSC).

National Exposure

Standards

No biological limit allocated.

Biological Limit

Values

Industrial application: Use with good general ventilation. If vapour is

produced local exhaust ventilation should be used.

Engineering

Controls

Industrial application: If engineering controls are not effective in

controlling airborne exposure then an approved respirator with a replaceable

dust/particulate filter should be used. Reference should be made to

Australian/New Zealand Standards AS/NZS 1715, Selection, Use and Maintenance

of Respiratory Protective Devices; and AS/NZS 1716, Respiratory Protective

Devices, in order to make any necessary changes for individual circumstances.

Respiratory

Protection

Industrial application: Safety glasses with side shields or chemical goggles

should be worn. Final choice of appropriate eye/face protection will vary

according to individual circumstances. Eye protection devices should conform

with Australian/New Zealand Standard AS/NZS 1337 - Eye Protectors for

Industrial Applications.

Eye Protection

Wear gloves of impervious material. Final choice of appropriate gloves will

vary according to individual circumstances i.e. methods of handling or

according to risk assessments undertaken. Reference should be made to AS/NZS

2161.1: Occupational protective gloves - Selection, use and maintenance.

Hand Protection

Wear appropriate clothing including chemical resistant apron where clothing is

likely to be contaminated.

Body Protection

9. PHYSICAL AND CHEMICAL PROPERTIES

White liquid suspension in a syringe.

Appearance

Not available

Odour

Approx 0°C

Melting Point

Approx 100°C

Boiling Point

Print Date: 4/09/2013

CS: 1.7.2

CS: 1.7.2

Page:

Material Safety Data Sheet

Infosafe No™

LQ08B

August 2011

ISSUED by BOEHRING

Issue Date :

PROTECH® BB BORDETELLA BRONCHISEPTICA KILLED VACCINE

Product Name :

Not classified as hazardous

Soluble

Solubility in Water

Not available

Specific Gravity

Not available

pH Value

2.37 kPa at 20°C (water vapour pressure)

Vapour Pressure

Not available

Vapour Density

(Air=1)

Not available

Flash Point

Does not burn

Flammability

Not available

Auto-Ignition

Temperature

Not available

Flammable Limits -

Lower

Not available

Flammable Limits -

Upper

10. STABILITY AND REACTIVITY

Stable under normal conditions of storage and handling.

Chemical Stability

Extremes of temperature and direct sunlight.

Conditions to Avoid

None known.

Incompatible

Materials

Thermal decomposition may result in the release of toxic and/or irritating

fumes such as carbon dioxide, 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.

Hazardous

Decomposition

Products

Will not occur

Hazardous

Polymerization

11. TOXICOLOGICAL INFORMATION

No toxicity data available for this product.

Toxicology

Information

Inhalation of product vapour may cause irritation of the nose, throat and

respiratory system.

Inhalation

Ingestion of this product may irritate the gastric tract causing nausea and

vomiting.

Ingestion

May cause redness, itching and irritation.

Skin

May cause eye irritation, tearing, stinging, blurred vision, and redness.

Eye

There is no known chronic effect from this product.

Chronic Effects

12. ECOLOGICAL INFORMATION

No ecological data available for this product.

Ecotoxicity

Not available.

Persistence /

Degradability

Not available.

Mobility

Do not discharge this material into waterways, drains and sewers.

Environ. Protection

13. DISPOSAL CONSIDERATIONS

The disposal of the spilled or waste material and container must be done in

accordance with applicable local and national regulations.

Used needles should be placed in a designated sharps container.

Disposal

Considerations

14. TRANSPORT INFORMATION

Not classified as Dangerous Goods according to the Australian Code for the

Transport of Dangerous Goods by Road and Rail. (7th edition)

Transport

Information

Print Date: 4/09/2013

CS: 1.7.2

CS: 1.7.2

Page:

Material Safety Data Sheet

Infosafe No™

LQ08B

August 2011

ISSUED by BOEHRING

Issue Date :

PROTECH® BB BORDETELLA BRONCHISEPTICA KILLED VACCINE

Product Name :

Not classified as hazardous

15. REGULATORY INFORMATION

Not classified as Hazardous according to criteria of National Occupational

Health & Safety Commission (NOHSC), Australia.

Not classified as a Scheduled Poison according to the Standard for the Uniform

Scheduling of Medicines and Poisons (SUSMP).

This product is subject to the Commonwealth’s Agricultural and Veterinary

Chemicals (Administration) Act 1994 which covers the uniform regulation and

control of agricultural and veterinary chemicals.

Regulatory

Information

Not Scheduled

Poisons Schedule

16. OTHER INFORMATION

MSDS Created: August 2011

Date of preparation

or last revision of

MSDS

...End Of MSDS...

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Print Date: 4/09/2013

CS: 1.7.2

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