SAFETY DATA SHEET - Universal Lab...

SAFETY DATA SHEET

212604 ZOLETIL 50 POUDRE+ SOLVANT VFR

Version: 2 First date edition: december 2003Date of this version : March 2004 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: ZOLETIL 50 POUDRE + SOLVANT VFR

Use of the preparation : FOR VETERINARY USE ONLYInjectable powder and solventAnesthesia and immobilization of domestic cats and dogs.Anesthesia and immobilization of wild and exotic animals.

Description of the preparation Freeze-dried powder + Solvent for injection (flask of 5 ml )

Code 212604

Supplier: VIRBAC LaboratoriesB.P. 27F-06511 CarrosFranceTél: +33 (4) 92 08 71 00

2. COMPOSITION / INFORMATION ON INGREDIENTS

Components contributing to thehealth hazard Tiletamine (chlorhydrate)

CE N°: 238-031-9 - CAS n° : 14176-50-2Conc. (%/weight) : 10 < C <25– Symbol(s) : T – Phrase(s) : R :20/21/22

Zolazepam (chlorhydrate)CE N°: 251-668-7 - CAS n° : 33754-49-3Conc. (%/weight ) : 10< C < 25 – Symbol(s) : Xn – Phrase(s) : R :20/21/22

3. HAZARDS IDENTIFICATION

Most important hazard: Zoletil contains anaesthetic agents : Tiletamine and ZolazepamHarmful by inhalation, contact with skin and ingestion

Specific hazard: May be cause sedative and anxious status, muscular relaxation.Care should be taken by the veterinary surgeon when handling the product and the person restrainingthe animal to AVOID SELF-INJECTION.

4. FIRST AID MEASURES

General advice IN ANY CASE OF ACCIDENT SEEK MEDICAL ADVICE IMMEDIATELY AND SHOW THE LABELTO THE DOCTOR

Inhalation: Move to fresh air in case of accidental inhalationArtificial respiration and / or oxygen if necessary

Skin contact: Remove contaminating clothing. Wash immediately with plenty of water for at least 10 minutes.

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

Ingestion: If swallowed. Get medical attention immediately and show the container or label to the doctor.

5. FIRE-FIGHTING MEASURES

Suitable extinguishing media: Foam, powder, water spray.

Extinguishing media which mustnot be used for safety reasons None known

Specific methods Keep non-essential personnel and unprotected people away. Do not enterfire area without suitable protective equipment. If possible and without risk,cool closed containers exposed to fire with water spray.

Specific fire hazards: Decomposition products may be a hazard to health : toxic fumes may be evolved

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Special protective equipment Self-contained breathing apparatus and complete protective equipment.

6. ACCIDENTAL RELEASE MEASURES

Personal precautions Keep non-essential personnel and unprotected people away.Wear protective clothing, gloves and mask to avoid contact with skin, eyes and inhalation.

Environmental precautions Any unused product or waste materials should be disposed off in accordancewith national requirements. Keep away from drains, surface and ground water and soil

Methods for cleaning up: Take up mechanically (sweeping, shoveling) and collect into suitable container for disposalin accordance with the waste regulations. Clean thoroughly.

7. HANDLING AND STORAGE

Handling- Precaution(s): Avoid exposure. Read carefully the leaflet before use

Handle this product with care to avoid inhalation, contact with eyes and skin and self-injection Do not smoke, eat or drink while handling the product

Technical conditions : Use only in well ventilated areas.

- Safe handling advice : See handling advises on the label and insert leaflet.

Storage- Precaution(s): Keep out of reach of children Keep out of reach of children.

Keep away from food, drink and animal feed.

- Storage conditions: Store in the retailing package tightly closed, away from direct sunlight and high temperatureStore below 25°C, at room temperature (20 +/- 5°C) and protected from more excessive heat

- Conditions to avoid No information

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Measures to be taken in order tominimize worker exposure The person administering the product must read carefully the leaflet before use.

Personal protection equipment:

- Respiratory protection: Avoid inhalation.

- Hand protection : Avoid contact with skin(Protective gloves if there is a likelihood of exposure)

- Skin and body protection: Avoid contact with skin

- Eye protection: Avoid contact with eyes(Protective goggles if there is a likelihood of exposure)

Hygiene measures: Wash hands after use.Do not smoke, eat or drink while handling the product.

9. PHYSICAL AND CHEMICAL PROPERTIES

General information- Appearance: Freeze-dried powder - Color: powder : white to pale yellow- pH : 2 to 4(after reconstituted with adequate solution) - Water solubility: solubleFor solvent:- Appearance: Liquid- Color: colorless- Odor: None

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10. STABILITY AND REACTIVITY

Stability: Stable under normal conditions of use and storage ( see section 7)

Conditions to avoid: Temperature above 25 ° C.Sparks, any source of heat.

Materials to avoid : Oxidizing agents

Dangerous decomposition products: In case of fire, exposure to decomposition products may be dangerous.Do not breathe fumes.

11. TOXICOLOGICAL INFORMATION

General information

Toxicological information concerning ZoletilAcute toxicity

LD50 intraperitoneal route (rat): 134.9 mg/kg

The combined drugs of Zoletil are Tiletamine and Zolazepam.Tiletamine is a dissociative agent, which is pharmacologically similar to ketamineZolazepam is a benzodiazepine pharmacologically similar to Diazepam. It is a sedative and a muscle relaxant, which enhances the tiletaminedepression of the central nervous system.The combination of Tiletamine and Zolazepam does not completely suppress the concomitant effects of tiletamine, but attenuate them and givesan acceptable quality of the cataleptoid anesthesia.

Observations in humans:Neither Tiletamine nor Zolazepam were used in men. Both compounds, however, have similar pharmacokinetics properties to those of ketamineand diazepam respectively.

Toxicological information concerning TiletamineAcute toxicity:

LD50 / oral / mice = 193.5 mg/kg (female) 160.2 mg/kg (male)

Tiletamine produces cataleptic anesthesia also named dissociative anesthesia. The effects on the central nervous system are highly specie anddose related. Tiletamine induces a stimulation of motor activity in rodent and when the doses increase, ataxia appears and progresses toimmobility and coma. Myoclonus may occur in dogs and tongue movements are not uncommon. Salivation is not uncommon in cats at anesthesiadoses but clonic convulsions sign an overdose. Tiletamine given in small doses causes excitation and ataxia in rodents. Given in moderate doses,catalepsy prevails in all species, and in large doses, anesthesia occurs in mice, rat, pigeon, cat and monkeys, while producing only depression inguinea pig and rabbit.

Toxicological information concerning ZolazepamAcute toxicity :

LD50 oral route (rat) : 398.1 mg/kgLD50 oral route (mice) : 512.9 mg/kg

Zolazepam was reported to produce significant anxiolytic effects at doses ranging from 0.63 to 10 mg/kg. The ability of the drug to influenceperformance and to interfere with motor co-ordination and muscle strengths was observed in cats and mice, producing ataxia, anti anxiety andmuscle relaxation.

12. ECOLOGICAL INFORMATION

General information No information available on the product itself

Environmental toxicity Environmental impact should be negligible

13. DISPOSAL CONSIDERATION

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

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

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14.TRANSPORT INFORMATION

General information: Transport of the product according to ADR’s Rules by road, according to RID’s Rules by rail, according toIMDG’s Rules by sea, and according to IATA’s Rules by plane.

ONU number: No classification assigned

Class ***

15. REGULATORY INFORMATION

Labeling: Labeled according to regulation in force for veterinary medicinal products Using the calculation method of 1999/45/EC Directive, classification is as follows :

Symbol(s): Xn – HarmfulContains Tiletamine (chlorhydrate) and Zolazepam (chlorhydrate)

R-phrase(s): R20/21/22 : Harmful by inhalation, contact with skin and ingestion

S-phrase(s): S2 Keep out of reach of childrenS36/37 Wear suitable protective clothing and glovesS45 In case of accident or if you feel unwell, seek medical advice immediately.(show the label where possible)

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

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): R20/21/ 22 Harmful by inhalation, contact with skin and ingestion

History

- First date edition: December 2003

- Date of version : March 2004

- Version: 2

- Modification(s) : paragraph 14 and 15 in accordance with 1999/45/EC Directive

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