PROTECH C3 + 2I

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

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Active ingredient:
CANINE DISTEMPER; LEPTOSPIROSIS - DOG - LEPTOSPIRA ICTEROHAEMORRHAGIAE; HEPATITIS CANINE = CANINE ADENOVIRUS; CORONAVIRUS; PARVOVIRUS - LIVE
Available from:
Boehringer Ingelheim Animal Health Australia Pty. Ltd.
INN (International Name):
canine distemper virus+canine adenovirus+canine parvovirus + others
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
CANINE DISTEMPER VACCINE Active 0.0 U; LEPTOSPIROSIS - DOG - LEPTOSPIRA ICTEROHAEMORRHAGIAE VACCINE Active 0.0 U; HEPATITIS CANINE = CANINE ADENOVIRUS VACCINE-VIRAL Active 0.0 U; CORONAVIRUS VACCINE-VIRAL Active 0.0 U; PARVOVIRUS - LIVE VACCINE-VIRAL Active 0.0 U
Units in package:
#20x1 dose; #C2i; *25x1 dose; *C3
Class:
VM - Veterinary Medicine
Therapeutic group:
DOG - OVER 6 WEEKS OLD
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
CANINE ADENOVIRUS - TYPE 1 | CANINE ADENOVIRUS - TYPE 2 | CANINE CORONAVIRUS | CANINE DISTEMPER | CANINE PARVOVIRUS | LEPTOSPIRA ICTEROHAEMORRHAGIAE | PARVOVIRUS
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - OVER 6 WEEKS OLD: [CANINE ADENOVIRUS - TYPE 1, CANINE ADENOVIRUS - TYPE 2, CANINE CORONAVIRUS, CANINE DISTEMPER, CANINE PARVOVIRUS, LEPTOSPIRA ICTEROHAEMORRHAGIAE]; Live vaccine for the immunisation of healthy dogs, 6 weeks of age or older to protect against disease caused by canine distemper virus, canine adenovirus types 1&2, canine parvovirus and L.interrogans serovar copenhageni and aid in viral shedding (CPV infSee DIRECTIONS FOR USE, PRECAUTIONS and SIDE EFFECTS on label.
Authorization status:
Registered
Authorization number:
51490
Authorization date:
2020-07-01

BOEHRINGER INGELHEIM PTY LIMITED, VETMEDICA DIVISION

PROTECH C3 + 2I

51490/101278

Company Name:

Product Name:

APVMA Approval No:

Label Name:

PROTECH C3 + 2I

Signal Headings:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Constituent

Statements:

Attenuated canine distemper virus (10^2.9 TCID50)

Attenuated canine adenovirus type 2 (10^3.62TCID50)

Attenuated canine parvovirus (CPV-2b strain 10^5.5 TCID50)

Inactivated canine coronavirus (RP

1.62)

Inactivated Bacterins of Leptospira interrogans serovar Copenhageni (RP# 1.0)

Claims:

Live vaccine for the immunisation of healthy dogs, 6 weeks of age or older to protect

against disease caused by canine distemper virus, canine adenovirus type 1, canine

adenovirus type 2, canine parvovirus and Leptospira interrogans serovar Copenhageni

and aid in protection against disease caused by canine coronavirus. This vaccine prevents

viral shedding caused by canine parvovirus infection. Early protection of puppies with final

vaccination at 10 weeks.

Net Contents:

25 x 1 dose Protech C3

25 x 1 dose Protech C2i

Directions for Use:

A new sterile syringe and needle should always be used to administer this vaccine.

Reconstitute the freeze-dried Protech® C3 vaccine with sterile water for injection (1 mL) or

Protech® C2i vaccine.

Inject subcutaneously within 20 minutes of reconstitution.

Do not use chemicals or disinfectants to sterilise the skin, needles or syringes.

Restraints:

Contraindications:

Precautions:

Vaccinate only healthy dogs with normal temperatures.

Dogs under treatment with immunosuppressive drugs should not be vaccinated.

RLP

APPROVED

The use of these vaccines in pregnant bitches is not recommended.

Side Effects:

Some animals may show transient post-vaccination pain, malaise and depression.

Allergic reactions such as anaphylaxis occur rarely and may require parenteral treatment

with an antihistamine, a corticosteroid or adrenalin as appropriate.

Local site reactions after vaccination are rare but transient swelling, pain and subcutaneous

thickening have been reported.

Dosage and

Administration:

This section contains file attachment.

File Name: Protech C3 + 2i dosage and administration.docx

File Size: 19966 bytes

General Directions:

Withholding

Periods:

Trade Advice:

Safety Directions:

First Aid

Instructions:

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

131126.

First Aid Warnings:

Additional User

Safety:

Take care to avoid self-injection. Accidental self-administration may result in local bruising,

pain and swelling. In the event of self-administration, seek medical attention and show the

package leaflet or the label to the Medical Practitioner.

Environmental

Statements:

Disposal:

Discarded syringes and needles should immediately be placed in a designated and

appropriately labelled 'sharps' container. Discarded vials should immediately be placed in a

designated and appropriately labelled 'biologicals' container.

Storage:

Store between 2-8°C. Do not freeze. Protect from light.

DOSAGE AND ADMINISTRATION.

Recommended vaccination programs

In any population of dogs a very small proportion may fail to adequately respond to vaccination due to

concurrent illness, stress, immunosuppression, genetic factors or the presence of maternal

antibodies. The epidemiology of each disease, the likely persistence of maternal antibodies and the

dog's history and environment should be considered when deciding on a suitable vaccination program

for a particular animal.

1.

Primary vaccination programs for pups less than 10 weeks of age.

Vaccination of pups with Protech

®

C3 vaccine at 6, 8 and 10 weeks is highly recommended to

maximise protection. Where pups present for their first vaccination at 8 weeks of age, a second

vaccination at 10 weeks is recommended. Vaccination according to these programs provides 12

months protection against diseases caused by canine distemper virus, canine adenovirus type 1,

canine adenovirus type 2 and canine parvovirus.

2.

Primary vaccination programs for pups and dogs 10 weeks of age or older.

One dose of Protech

®

C3 vaccine.

In previously unvaccinated dogs of 10 weeks of age or older a single dose of Protech

®

C3

vaccine is sufficient to confer 12 months protection against disease caused by canine distemper

virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus. However, to

ensure optimal cover it is highly recommended that a vaccination program be instituted at an

earlier age as described above.

Suggested primary vaccination programs:

Age at 1

st

Vaccination

Vaccination

6 wks

8 wks

10 wks

6 wks

8 wks

10 wks

Continue vaccination program as suggested below under ‘Revaccination’.

Protech

®

C2i may be used as a diluent for Protech

®

C3 vaccine. Two doses 2-4 weeks apart will

protect against Leptospira interrogans serovar Copenhageni and canine coronavirus.

Protech

®

Pi2 reconstituted with Protech

®

BB may be used as a diluent for Protech

®

C3 vaccine.

3.

Revaccination

For protection against canine cough annual revaccination with Protech

®

Bronchi-Shield

®

III is

recommended. Annual revaccination against canine coronavirus and Leptospira interrogans

serovar Copenhageni is recommended using Protech

®

C2i vaccine.

Suggested vaccination programs:

Age

Either

Or

6 wks

Protech C3 + Protech C2i

Protech C4 + Protech C2i

8 wks

Protech C3 + Protech C2i and Protech

Bronchi-Shield III

Protech C4 + Protech C2i and Protech

Bronchi-Shield I

10 wks

Protech C3

Protech C4

Annual

vaccination

Protech C3 + Protech C2i and Protech

Bronchi-Shield III

Protech C4 + Protech C2i and Protech

Bronchi-Shield I

Protech

®

C3 has been assessed as providing at least 12 months protection against canine distemper

virus, canine adenovirus and canine parvovirus. Protech

®

C2i has been assessed as providing at

least 12 months protection against Leptospira interrogans serovar Copenhageni and canine

coronavirus.

Many factors influence the effectiveness of vaccination and the need for revaccination. The

vaccination program for an individual animal should be determined within a veterinarian-client

relationship, taking all these factors into account.

CS: 1.7.2

Page:

Material Safety Data Sheet

Infosafe No™

LQ08G

August 2011

ISSUED by BOEHRING

Issue Date :

PROTECH® C3 +2I

Product Name :

Not classified as hazardous

1. IDENTIFICATION OF THE MATERIAL AND SUPPLIER

PROTECH® C3 +2I

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 healthy dogs against diseases caused by Canine

Distemper, Canine Adenovirus types 1 and 2, Canine Parvovirus, Canine

Coronavirus and Leptospira interrogans serovar Copenhageni.

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

Product contains Canine distemper virus, Canine adenovirus, Canine parvovirus,

Canine coronavirus and Leptospira interrogans serovar Copenhageni.

Information on

Composition

Name

CAS

Proportion

Ingredients

Ingredients determined

not to be hazardous

Balance

Live virus vaccine

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

Print Date: 4/09/2013

CS: 1.7.2

CS: 1.7.2

Page:

Material Safety Data Sheet

Infosafe No™

LQ08G

August 2011

ISSUED by BOEHRING

Issue Date :

PROTECH® C3 +2I

Product Name :

Not classified as hazardous

Non flammable.

Specific Hazards

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

dust/fumes, and skin or eye contact. Sweep up material avoiding dust

generation or dampen spilled material with water to avoid airborne dust, and

then transfer material to a suitable labelled container for subsequent

recycling or disposal.

In the event of a major spill: Increase ventilation. Evacuate all unprotected

personnel. Wear sufficient respiratory protection and full protective clothing

to prevent exposure.

For dry form: Sweep up material avoiding dust generation or dampen spilled

material with water to avoid airborne dust, then transfer material to a

suitable container. Wash surfaces well with soap and water. Seal all wastes in

labelled plastic containers for subsequent recycling or disposal.

For rehydrated solution: Absorb with an inert material and place in an

appropriate waste disposal container.

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.

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) exposure

standards for dust not otherwise specified is 10 mg/m³.

TWA (Time Weighted Average): The average airborne concentration of a

particular substance when calculated over a normal eight-hour working day, for

a five-day week.

National Exposure

Standards

No biological limit allocated.

Biological Limit

Values

Industrial application: Use with good general ventilation. If dust 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

Hand Protection

Print Date: 4/09/2013

CS: 1.7.2

CS: 1.7.2

Page:

Material Safety Data Sheet

Infosafe No™

LQ08G

August 2011

ISSUED by BOEHRING

Issue Date :

PROTECH® C3 +2I

Product Name :

Not classified as hazardous

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

Wear appropriate clothing including chemical resistant apron where clothing is

likely to be contaminated.

Body Protection

9. PHYSICAL AND CHEMICAL PROPERTIES

Off-white freeze dried solid in one vial; turbid liquid in the other.

Appearance

Not available

Odour

0°C Approximately (for Turbid liquid)

Freezing Point

100°C Approximately at 100kPa (for Turbid liquid)

Boiling Point

Soluble

Solubility in Water

Not available

Specific Gravity

No data, expected to be neutral

pH Value

2.37 kPa at 20³C (for Turbid liquid)

Vapour Pressure

Not available

Vapour Density

(Air=1)

Not available

Flash Point

Non flammable in rehydrated state

Flammability

Not applicable

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

Not available.

Hazardous

Decomposition

Products

Will not occur

Hazardous

Polymerization

11. TOXICOLOGICAL INFORMATION

No toxicity data available for this product.

Toxicology

Information

Inhalation of product dusts 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

This product is biodegradable. It will not accumulate in the soil or water or

cause long term problems.

Persistence /

Degradability

Not available.

Mobility

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

Environ. Protection

Print Date: 4/09/2013

CS: 1.7.2

CS: 1.7.2

Page:

Material Safety Data Sheet

Infosafe No™

LQ08G

August 2011

ISSUED by BOEHRING

Issue Date :

PROTECH® C3 +2I

Product Name :

Not classified as hazardous

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

15. REGULATORY INFORMATION

Not classified as Hazardous according to criteria of National Occupational

Health & Safety Commission (NOHSC), Australia.

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

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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