SAFETY DATA SHEET - Universal Lab...

SAFETY DATA SHEET

304241 ALIZINE 10ML VBRVersion : 6 First date edition: December 2000

Date actual edition : November 6th, 2006 91/155/CE (3 APT) - ISO 11014-1

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1 IDENTIFICATION OF THE SUBSTANCE / PREPARATION AND THE COMPANY

Identification of the preparation: ALIZINE 10ML VBRUse of the preparation: Veterinary Medicinal Product. FOR VETERINARY USE ONLY

Non aqueous injectable solution containing aglepristone, an antiprogestagen active ingredient belongingto a series of nor-steroids. It is intended to be injected subcutaneously to induce abortion in the bitch –Hormone therapy in dog: cause abortion

Presentation: Containers: vials of 10ml

Code: 304241

Supplier: VIRBAC LaboratoriesB.P. 27F-06511 CarrosFranceTel: +33 (4) 92 08 71 00 / +33 (4) 92 08 72 00Fax : +33 (4) 92 08 71 65

Emergency phone number UK - National Poisons Information Service Phone: 44 / 191 22 5131B - Centre Antipoisons Tel: 070 / 245.245F - NANCY : Tél : 03.83.32.36.36 B - Centre Antipoisons Tél: 070/245.245

2. COMPOSITION / INFORMATION ON INGREDIENTS

Components contributing to the AglepristoneHealth hazard CAS NR: 124478-60-0

Conc. (weight %): 1% < C < 5% - Symbol(s): T - R: 60-61

3. HAZARDS IDENTIFICATION

Most important hazard: - Nor-steroids are used in humans to induce abortion.Accidental self-injection when inject the product subcutaneously to the animal or skin contact withsolution when adjust dose may be a particular hazard to women who are pregnant, intending to becomepregnant, or whose pregnancy status is unknown. Care should be taken by the veterinary surgeon whenhandling the product and the person restraining the animal to AVOID SELF-INJECTION.

May cause harm to the unborn child - May cause alteration of fertility

Specific hazards - This is an oil-based product that may cause prolonged local reactions at the site of injection.AVOID SELF-INJECTION

4. FIRST AID MEASURES

General advice MEDICAL ADVICE SHOULD BE GIVEN IN ANY CASE OF CONTAMINATION.

Inhalation: Remove to fresh air, keep the patient warm and at rest.

Skin contact: The area should be rinsed thoroughly with water and washed with soap.Rinse with plenty of water. Pregnant women, get urgent medical advice.

Eye contact: Contact lenses should be removed. Irrigate copiously with clear water for at least 15 minutes, holding theeyelids apart, and seek medical advice.

Ingestion: If swallowed, get immediate medical attention and show the container or label to the doctor.

In case of accidental injection, immediately seek a medical advice – show the label to the doctor

5. FIRE-FIGHTING MEASURES

Suitable extinguishing media: Carbon dioxide (CO2), water spray, alcohol resistant-foam or polyvalent powder.

Extinguishing media which mustnot be used for safety reasons No information avalaible

Specific methods Keep non-essential personnel and unprotected people away. Do not enter fire area without suitableprotective equipment.If possible and without risk, cool closed containers exposed to fire with water spray.Do not allow run-off from fire fighting to enter drains or watercourses.

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Specific fire hazards: Decomposition products may be a hazard to health. Do not breathe fumes.

Special protective equipment Use a self-contained breathing apparatus and also complete protective equipment.

6. ACCIDENTAL RELEASE MEASURES

Personal precautions Keep non-essential personnel and unprotected people away. Evacuate personnel to a safe area.Avoid any exposure to the product.Use protective equipment according to the quantity of product released: suit, gloves and goggles.

Environmental precautions Any unused product or waste materials should be disposed off in accordancewith national requirements.

Methods for cleaning up: Contain and collect spillage with non-combustible inert absorbent materials.Place in a suitable container for disposal in accordance with the waste regulations.

7. HANDLING AND STORAGE

Handling- Precaution(s): Care should be taken by the veterinary surgeon when handling the product and the person restraining

the animal to AVOID SELF-INJECTION / CONTACT WITH THE PRODUCT. Pregnant women or women at childbearing age should avoid contact with the product. Wear disposable plastic gloves when administering the product. Wash hands after use. In case of self-injection, seek urgent medical advice and show the doctor the insert leaflet warning. Skin contamination must be prevented when bitch is treated.

-See also the label and /or insert leaflet. -See also Section 8.

Storage- Precaution(s): Observe the label / insert leaflet precautions.

Keep out of reach of children.

- Storage conditions: Store in the retailing package tightly closed, protected from lightStore below 25°C

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Measures to be taken in order tominimise worker exposure This is a veterinary medicinal product: consult the recommended precautions of the insert leaflet.

must read carefully the leaflet before use.

Personal protection equipment:- Respiratory protection: Not necessary under normal conditions of use

- Hand protection: Avoid contact with skin - Wear gloves (plastic or PVC)

- Skin and body protection: Not necessary under normal conditions of use - Avoid contact with skin

- Eye protection: Not necessary under normal conditions of use

Hygiene measures: Avoid exposure to the product.Wash hands and exposed skin thoroughly after use.Do not smoke, eat, or drink when handling the product.

9. PHYSICAL AND CHEMICAL PROPERTIES

General informationPhysical state / form: clear oily solutionColour: yellow

10. STABILITY AND REACTIVITY

Stability: stable in normal use and storage

Conditions to avoid Light and temperature above +25°C

Material to avoid: No information available

Dangerous decomposition products: In case of fire may produce hazardous decomposition products.

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11. TOXICOLOGICAL INFORMATION

General information This product is for control to dog reproduction Accidentally self-injections are always dangerous. Womenwho are pregnant, intending to become pregnant, or whose pregnancy status is unknown should use theproduct with caution. Medical advice should be given in any case of contamination.Since no data are available concerning the dermal absorption of aglepristone, skin contamination must

be prevented when bitch is treated.Alizin is an oil-based product that may cause prolonged local reactions at the site of injection

Toxicological information concerning aglepristone:- I.P: DL50/I.P/mouse : 1015 mg/kg

DL50/I.P/rat : 965 mg/kg- Ingestion: DL50/orale/mouse 2415 mg/kg

DL50/orale/rat 3600 mg/kg

12. ECOLOGICAL INFORMATION

General information The risk for the environment is limited to the excretions from the animals receiving the product. Disposalof the unused products or empty containers must be controlled.

13. DISPOSAL CONSIDERATION

Waste / unused products: Any unused product or waste materials should be disposed off in accordance with nationalrequirements.

Contaminated packaging: Any unused product or waste materials should be disposed off in accordance with nationalrequirements.

14.TRANSPORT INFORMATION

General information(s): Transport followed ADR, IMDG, IATA

- ONU N°: No recommended limitations

- Class: ---

15. REGULATORY INFORMATION

Labelling: Labelled according to the labelling regulation in force for veterinary medicinal products

Note: The directive 1999/45/EC concerning the classification, packaging and labelling of dangerous preparations does not apply to the medicinalproducts for human or veterinary use in their finished state, intended for the final user.

Symbol(s) T ToxicContains aglepristone

R-phrase(s) R61 May cause harm to the unborn child –R60 May cause alteration of fertility

S-phrase(s): S 2 Keep out of reach of childrenS36/ 37 Wear suitable gloves and clothesS 45 In case of accident or if you feel unwell, seek medical advice immediately.(show the label where possible)S53 : Avoid exposition, see specific instructions before use

16. OTHER INFORMATION

Important remarks: The information and recommendations given on this data sheet are based on our presentknowledge. This product is a veterinary medicinal product. The user must refer to the relevantproduct label and/or insert leaflet and the product must be used strictly in accordance with theinstructions and recommendations of the product label and/or insert leaflet. The user is alwaysresponsible for ensuring that the requirements of relevant legislation are complied with.

Restrictions: FOR VETERINARY USE ONLYThe product should not be used for others purposes than those recommended.

R-phrase(s) used: R61 May cause harm to the unborn child –R60 May cause alteration of fertility

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History

- First date edition: December 2000

- Date of revision January 2002, October 2003, December 2003, October 2004, November 06th 2006

- Version: 6

- Modifications : V4:Chapter 14 , 15

V5: Paragraph 3: Precision’s on hazard

Paragraph 4: Precision’s on first secures

Paragraph 14: Modifications on transport conditions

V6: Paragraph 2-3-11-15-16

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