Complying to 91/155/EC, 93/112/EC

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Complying to 91/155/EC, 93/112/EC

Product Safety Data Sheet

Benazecare 5mg and 20mg Tablets

1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

Product Name Benazecare 5, Benazecare 20

Product Code XVD 440, XVD 441

Supplier Animalcare Ltd,

Common Road,

Dunnington,

York, YO19 5RU,

Telephone No. +44 (0) 1904 487687

Fax No. +44 (0) 1904 487611

E-Mail: animalcare@animalcare.co.uk

Emergency Telephone +44 (0) 1904 487687 (daytime)

__________________________________________________________________________

2. HAZARDS IDENTIFICATION

Physical and Chemical Hazards: Unlikely to present a health hazard in normal use

Environmental Hazards: Unlikely to present an environmental hazard in normal use

__________________________________________________________

3. COMPOSITION / INFORMATION ON COMPONENTS

Cas No. FINECS No.

Benazapril Hydrochloride: BG541-74-4

Substance/Preparation: Tablets

Active Ingredients: Benzapril Hydrochloride

Description: Cardiac Therapeutic

Chemical Family: ACE inhibitor

Revision Date: November 2008 Printing Date: 19 December, 2006 Page 1 of 5

Complying to 91/155/EC, 93/112/EC

Product Safety Data Sheet

Benazecare 5mg and 20mg Tablets

4. FIRST AID MEASURES

Inhalation : Remove to fresh air. If anay signs or symptoms occur or persist seek

Medical advice.

Skin Contact : Wash thoroughly with soap and water. Remove contaminated clothing and wash before reuse. Unlikely to arise from broken tablets.

Eye Contact : Immediately flush eyes with copious amounts of water for at least 10 minutes. Immediately obtain medical assistance.

Ingestion : Immediately obtain medical assistance. Subject must be kept warm and at rest.

NOTE TO PHYSICIAN: No empirical data are available for humans. The most significant sign is likely to be marked hypotension. Repeatedly administer medicinal charcoal in a large quantity of water. NOTE; never give anything by mouth to an unconscious person. Do not induce vomiting. The active metabolite, benazeprilat, cannot be eliminated to a significant degree by dialysis. If blood pressure falls severely, administer physiological saline i.v.

5. FIRE FIGHTING MEASURES

Extinguishing Media: The preparation is non-flammable. In the presence of fire, dangerous fumes may be given off .

Extinguishing media

include powder, foam, carbon dioxide or water spray (do

no use direct jet of water). Measures should be taken to

prevent contaminated extinguishing media from seeping

into the ground, contaminating water courses or spreading

uncontrollably.

Protective clothing and breathing apparatus must be worn.

Fire and explosion hazards: None

6. ACCIDENTAL RELEASE MEASURES

Personal Precautions : Wear rubber gloves when handling. Prevent skin and eye contact.

Environmental Precautions: Do not contaminate water courses or sewers.

Revision Date: November 2008 Printing Date: 19 December, 2006 Page 2 of 5

Complying to 91/155/EC, 93/112/EC

Product Safety Data Sheet

Benazecare 5mg and 20mg Tablets

Method for Clean-up : Sweep up and place in a labelles container for safe disposal.

Contact local authority (Environmental Health Department) or

specialist disposal contractor or supplier for information on safe

disposal.

7. HANDLING AND STORAGE

Handling: Avoid contact with eyes, skin or clothing. Avoid inhalation of dust. Wash hands thoroughly after handling.

Storage: Store in closed original containers in a cool, dry, well-ventilated area, below

25

º

C. Store separately from food and feed. Do not re-use containers for any

other purpose. Do not transfer contents to unlabelled containers. Use only with

adequate ventilation. Keep out of reach of children. Unused half tablets should

be returned to the open blister pack, inserted into the cardboard box and

stored safely.

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Occupational Toxicity Risk: Low (tablet form)

Occupational Exposure Standard: Benezepril Hydrochloride 0.02mg/m ะท

(USA value)

General Personal Protective Equipment: Unnecessary for the dosage form

Precautionary measures after work: Wash hands if tablets have been broken manually

9. PHYSICAL AND CHEMICAL PROPERTIES

Form: Scored ovoid tablets

Colour: 5mg Tablets – Light Yellow 20mg Tablets – Pink

Odour: None

Revision Date: November 2008 Printing Date: 19 December, 2006 Page 3 of 5

Complying to 91/155/EC, 93/112/EC

Product Safety Data Sheet

Benazecare 5mg and 20mg Tablets

__________________________________________________________

10. STABILITY AND REACTIVITY

Stability: Stable under normal temperatures and pressures. Thermal decomposition occurs above 180 º C. No hazardous decomposition

products when handled according to the instructions.

Conditions to avoid: Sensitivity to humidity – store in dry place

Materials to avoid: None known

11. TOXICOLOGICAL INFORMATION

Acute oral LD50 rat: > 5000mg/Kg (active ingredient)

12. ECOLOGICAL INFORMATION

Fish toxicity (Zebra Fish) LC50 96h >100mg/1

Daphnia Magna (Water flea) >1000mg/1

Toxicity to bacteria (act water sludge, 3h) IC50 > 100mg/1

Environmental hazard in case of accident (spillage/leakage) - slight

13. DISPOSAL CONSIDERATIONS

Product/Residues: Dispose of using a reputable specialist disposal contractor

Package: Dispose of waste containers using regular disposal methods in

accordance with local and national environmental regulations.

14. TRANSPORT INFORMATION

Transport classification: Not classified as hazardous for transportation

Revision Date: November 2008 Printing Date: 19 December, 2006 Page 4 of 5

Complying to 91/155/EC, 93/112/EC

Product Safety Data Sheet

Benazecare 5mg and 20mg Tablets

15. REGULATORY INFORMATION

Registered as: Veterinary Medicine

Market Authorisation Number: 5mg Vm 10347 / 4021

20mg Vm 10347 / 4022

Legal category: POM-V

16. OTHER INFORMATION

Read label thoroughly before use

The data given here is based on current knowledge and experience. The purpose of this safety datasheet is to describe the products in terms of their safety requirements. The data does not signify any warranty with regards to the products properties.

Revision Date: November 2008 Printing Date: 19 December, 2006 Page 5 of 5

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