NV COPHOS B INJECTION

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

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Active ingredient:
ETHANOLAMINE PHOSPHATE; CYANOCOBALAMIN
Available from:
CEVA ANIMAL HEALTH PTY LTD
INN (International Name):
cyanocobalamin(50ug/mL)+ethanolamine phos(100mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
ETHANOLAMINE PHOSPHATE AMINE Active 100.0 mg/ml; CYANOCOBALAMIN VITAMIN-B12 Active 50.0 ug/ml
Units in package:
100mL
Class:
VM - Veterinary Medicine
Manufactured by:
CEVA ANIMAL HEALTH
Therapeutic group:
DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT
Therapeutic area:
NUTRITION & METABOLISM
Therapeutic indications:
PHOSPHORUS DEFICIENCY | VITAMIN B12 DEFICIENCY | ANAEMIA | COBALT DEFICIENCY
Product summary:
Poison schedule: 0; Withholding period: WHP: MEAT(Horses): NIL.; Host/pest details: DOG: [PHOSPHORUS DEFICIENCY, VITAMIN B12 DEFICIENCY]; HORSE: [PHOSPHORUS DEFICIENCY, VITAMIN B12 DEFICIENCY]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [PHOSPHORUS DEFICIENCY, VITAMIN B12 DEFICIENCY]; HORSE: [PHOSPHORUS DEFICIENCY, VITAMIN B12 DEFICIENCY]; A phosphorus and vitamin B12 supplement for horses and dogs.
Authorization status:
Registered
Authorization number:
51121
Authorization date:
2019-07-01

DISPOSE of empty container by wrapping

with paper and putting in garbage.

Discarded

needles/sharps

should

immediately

placed in a designated

appropriately

labelled

'sharps'

container.

DIRECTIONS FOR USE:

Administer by intramuscular injection.

Horses:

1mL per 15kg (30mL per 450kg)

bodyweight

Dogs: 1mL per 15kg bodyweight

Administer twice weekly or as directed by

a veterinary surgeon.

MEAT

WITHHOLDING

(HORSES): NIL.

PERIOD

FOR ANIMAL TREATMENT ONLY

COpHOS B

Injection

ACTIVE CONSTITUENTS:

CYANOCOBALAMIN

50J.l9fmL

ETHANOLAMINE

PHOSPHATE

100mgfmL

A phosphorus and vitamIn 812

supplement

horses and dogs.

100mL

STORE below 25°C (Air Conditioning).

Protect from light.

KEEP OUT OF REACH OF

CHILDREN

Batch No.:

Expiry Date:

No,:51121/CSO-a

Nature Vet Pty Limited

11 Moore's Rd

Glenorie NSW 2157

Tel: (61) 2 9652 7000

Fax: (61) 2 9652 7001

www.naturevet.com.au

Product:

CoPhos B Injection

Date; 27/03/2003

Container/Carton Label

Carton has centre panel

repeated on front and back

N.R.A.

APPROVED

LABEL

(TEXT)

Label No:

.5..i.'~I..!C..5.~:>

....

D,ate:

.

.J.,.:fi'l).J

9'2.".

Signature:.

.t?~.:!~.

Creation Date: April 2009

Revision Date: April 2014

Version: 2.0

Next revision due: Apr 2019

Material Safety Data Sheet

NV COpHOS B Injection

Page 1 of 8

COMPANY DETAILS

Company:

Address:

Ceva Animal Health Pty Ltd

11 Moores Road

ABN 54 002 692 426

Glenorie NSW 2157 Australia

Telephone Number:

Facsimile Number:

+61 (02) 9652 7000

+61 (02) 9652 7001

Emergency Telephone Number:

+61 (02) 9652 7000 (Business Hours)

Poisons Information Centre: 131126

SUBSTANCE IDENTIFICATION

Product Name:

NV COpHOS B Injection

Other Names:

Cophos B

Manufacturer’s Product Code:

UN Number:

None allocated

Dangerous Goods Class and Subsidiary Risk:

None allocated

Hazchem Code:

None allocated

SUSDP Poisons Schedule Number:

Not Scheduled

Use:

An injectable energy rich phosphorus supplement with supplementary vitamin B

for use in horses

and dogs. For animal treatment only.

Statement of Hazardous Nature: Not hazardous according to criteria of NOHSC Australia.

Risk Phrases: Not hazardous – no risk phrases identified.

Safety Phrases: Not hazardous – no safety phrases identified.

Section 1 – Identification of Material and Supplier

Section 2 – Hazards Identification

Creation Date: April 2009

Revision Date: April 2014

Version: 2.0

Next revision due: Apr 2019

Material Safety Data Sheet

NV COpHOS B Injection

Page 2 of 8

The substance is a complex mixture, including the following ingredients.

Ingredients:

Chemical Name

CAS Number

Proportion

Dimethylamino Methylphenyl

10% (100 mg/mL)

Phosphinate

Cyanocobalamin

68-19-9

0.005% (50

g/mL)

Sodium Hydroxide

1310-73-2

less than 10%

Benzyl Alcohol

100-51-6

less than 10%

Ingredients determined not to be hazardous

to 100%

Swallowed:

First aid is not generally required.

Eye:

May cause transient eye irritation. If in eyes, hold eyelids open and flush gently with copious

quantities of water until substance is removed (up to 15 minutes).

Skin:

If spilled on skin, remove contaminated clothing and wash skin with soap and water.

Inhaled:

First Aid is not generally required.

First Aid Facilities:

No specific first aid facilities required.

Advice to Doctor:

No specific advice.

Fire/Explosion Hazard:

There is no risk of explosion from this product. The product is not readily combustible.

Flashpoint:

Not determined.

Flammability Limits:

Not determined.

Extinguishing Media:

Use water, foam or powder extinguishing media suited to the environmental materials involved in the

fire.

Section 3 – Composition / Information on Ingredients

Section 4 – First Aid Measures

Section 5 – Fire Fighting Measures

Creation Date: April 2009

Revision Date: April 2014

Version: 2.0

Next revision due: Apr 2019

Material Safety Data Sheet

NV COpHOS B Injection

Page 3 of 8

Special Fire Fighting Procedures:

Wear self-contained breathing apparatus and full protective clothing in accordance with normal fire-

fighting procedures.

Hazchem Code:

None allocated.

Mop up spills promptly.

Emergency Procedures:

None prescribed.

Methods and Materials for Containment and Clean Up Procedures

Mop up spills or absorb with paper. Contaminated absorbent may be disposed of in garbage. Rinse

area well with water.

Precautions for Safe Handling:

Avoid contact with skin and eyes. See Section 8 Exposure Controls and Personal Protection for

details of personal protection measures.

Storage:

Keep outer containers closed and out of reach of children. For quality control, adhere to storage

requirements as listed on label (store below 25°C (air conditioning). Protect from light).

National Exposure Standards:

NOHSC has not listed exposure limits for product ingredients in liquid form (as in this product).

Biological Limit Values:

No BLVs have been established for the ingredients in this product.

BLVs are reference values for the evaluation of potential health risks in the practice of industrial

hygiene. Biological monitoring involves the measurement of substances in biological media (eg blood,

urine, etc.) and the measurement of biological effects induced by the substance.

Engineering Controls:

No engineering controls allocated.

Personal Protective Equipment:

No specific protective clothing required for normal use.

Section 6 – Accidental Release Measures

Section 7 – Handling and Storage

Section 8 – Exposure Controls / Personal Protection

Creation Date: April 2009

Revision Date: April 2014

Version: 2.0

Next revision due: Apr 2019

Material Safety Data Sheet

NV COpHOS B Injection

Page 4 of 8

Appearance:

Cophos B: Clear pink aqueous solution for injection in a labelled 100 mL amber glass vial with a

rubber stopper and aluminium cap, packaged in a labelled outer carton.

Odour:

Not determined.

pH:

5.0 - 6.0

Vapour pressure/density:

Not determined.

Boiling Point:

Not determined.

Freezing / Melting Point:

Not determined.

Solubility:

Miscible in water.

Specific Gravity:

Not determined.

Other Properties:

No other information.

Chemical Stability:

Product is not likely to react or decompose under normal storage conditions. Product colour may

darken and quality of product be adversely affected if exposed to conditions of heat or light for

extended periods.

Conditions to Avoid:

Avoid conditions of extreme heat, and exposure to light.

Incompatible Materials:

No data.

Hazardous Decomposition Products:

Upon thermal decomposition, may emit toxic and irritating gases.

Hazardous Reactions:

No hazardous reactions such as polymerization known.

Section 9 – Physical and Chemical Properties

Section 10 – Stability and Reactivity

Creation Date: April 2009

Revision Date: April 2014

Version: 2.0

Next revision due: Apr 2019

Material Safety Data Sheet

NV COpHOS B Injection

Page 5 of 8

Health Effects:

No known toxic effects at recommended dose rates. Both Vitamin B12 and phosphorus are required

by the human body.

Cyanocobalamin (vitamin B12) is a water-soluble vitamin that functions in the body as a coenzyme in

DNA synthesis and in amino acid and lipid metabolism. Vitamin B12 is present in meats and dairy

products. The usual western diet contains 5 to 20

g of cobalamin per day (0.1 - 0.4 mL of product

would supply this amount of Vit. B12); The minimum daily requirement of cobalamin for adults is about

g per day.

The average daily intake of phosphorus is 800-1400 mg, most of which is absorbed in the gut either

by active or passive transport. The U.S. RDA for phosphorus is 1,200 mg per day for men and women

11 to 18 years of age and 800 mg per day for men and women 18 to 51 years of age. Pregnant and

lactating women have more increased needs.

Acute:

A toxic dose of cyanocobalamin has not been established. Phosphorus, likewise has a large safety

threshold.

Swallowed:

No toxic effects expected following accidental or deliberate ingestion of the product.

Eye:

May cause very slight eye irritation. Avoid contact with eyes.

Skin:

No adverse effects expected following exposure via skin.

Inhaled:

Absorption via inhalation is unlikely.

Chronic:

No chronic health effects expected.

Reproductive Effects:

No reproductive effects expected.

Teratogenic and mutagenic effects:

No teratogenic or mutagenic effects expected.

Carcinogenic Effects:

No carcinogenic effects expected.

Toxicity to Other Domestic Species:

No toxicity to other species expected with normal use.

Section 11 – Toxicological Information

Creation Date: April 2009

Revision Date: April 2014

Version: 2.0

Next revision due: Apr 2019

Material Safety Data Sheet

NV COpHOS B Injection

Page 6 of 8

Ecotoxicity:

No environmental toxicity expected at concentrations of ingredients in this product.

Persistence / Degradability:

Not expected to persist in the environment. Product can be safely disposed of to soil.

Mobility:

No data.

Dispose of empty container by wrapping with paper and putting in garbage. Discarded needles/sharps

(after administration of product) should be immediately placed in a designated and appropriately

labelled “sharps” container for disposal according to Local, State and Federal laws.

UN Number:

None allocated

Dangerous Goods Class and Subsidiary Risk:

None allocated

Hazchem Code:

None allocated

ADG Code: This product is not classified as a Dangerous Good. No special transport conditions are

necessary unless required by other regulations.

SUSDP Poisons Schedule Number:

None allocated

APVMA Approval Number:

51121

This MSDS contains only information related to safety. For other data, see product literature.

Section 12 – Ecological Information

Section 13 – Disposal Considerations

Section 14 – Transport Information

Section 15 – Regulatory Information

Section 16 – Other Information

Creation Date: April 2009

Revision Date: April 2014

Version: 2.0

Next revision due: Apr 2019

Material Safety Data Sheet

NV COpHOS B Injection

Page 7 of 8

Read all labels and package inserts carefully before using this product.

Creation Date: April 2009

Revision Date: April 2014

Version: 2.0

Next revision due: Apr 2019

Material Safety Data Sheet

NV COpHOS B Injection

Page 8 of 8

Glossary and Acronyms:

Acceptable Daily Intake, as listed in the Australian ADI List, August 2003.

CAS Number

Unique number assigned by the Chemical Abstracts Service, Columbus,

Ohio, USA.

Hazchem Code

Emergency action code of numbers and letters giving information to

emergency services.

Lethal dose for 50 % of a group of specified test animals.

MSDS

Material

Safety

Data

Sheet

(also

called

Safety

Data

Sheet

some

countries).

NOEL

No Observable Effect Level, as listed in the Australian ADI List, August 2003.

NOHSC

National Occupational Health and Safety Commission

Risk Phrase

Standard phrase describing the hazard of a substance as provided in the

NOHSC “Approved Criteria for Classifying Hazardous Substances

[NOHSC:1008]”

Safety Phrase

Standard phrase describing the safe handling, storage or use of personal

protective equipment for a material as provided in the NOHSC “Approved

Criteria for Classifying Hazardous Substances [NOHSC:1008]”

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

Time Weighted Average

UN Number

United Nations Number

CONTACT POINT

Ceva Animal Health Regulatory Affairs Manager (02) 9652 7000.

This information has been collated by technical personnel employing data available from the prime

manufacturer of the material. To the best of our knowledge it is true and accurate. It is not intended

to be all inclusive and the manner and conditions of use and handling may involve other or additional

considerations.

END OF MSDS

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