HEALTH AND SAFETY DATA SHEET
1.
IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND COMPANY
DECHRA VETERINARY
PRODUCTS,
CARTMEL DRIVE,
HARLESCOTT,
SHREWSBURY,
SHROPSHIRE,
SY1 3TB.
PRODUCT NAME:
DOMIDINE 10 mg/ml
SOLUTION FOR INJECTION
Tel.: +44 (0) 1743 441632
Fax: +44 (0) 1743 462111
PHYSICAL FORM:
Clear, colourless solution
2.
LEGAL CATEGORY:
POM-V
LICENCE NUMBER:
16849/4008
ISSUE DATE:
18/06/2007
PRODUCT TYPE:
Sedative, analgesic, pre-medication for
horses and cattle
CONTAINER:
5 ml, 10 ml and 20 ml glass vials
COMPOSITION/INFORMATION ON ACTIVE INGREDIENTS
NAME
% w/w
Detomidine hydrochloride
Other ingredients and water
1.0
100
3.
HAZARDS IDENTIFICATION:
4.
FIRST-AID MEASURES
HAZARD
EYE CONTACT:
In case of accidental projection of the product into the eyes, rinse
abundantly with fresh water. If irritation persists, seek the advice of a
physician.
DERMAL CONTACT:
In the event of skin contact, wash contaminated area thoroughly. Remove
contaminated clothing. Obtain medical assistance if symptoms occur.
INGESTION/INJECTION:
In the case of accidental oral intake or self-injection, seek medical advice
immediately and show the package leaflet and other product literature to
the physician but do not drive as sedation and changes in blood pressure
may occur.
INHALATION:
Not applicable/no data available.
NOTES TO PHYSICIAN:
Detomidine is an alpha-adrenoreceptor agonist whose toxicity may cause
clinical effects including sedation, respiratory depression and coma,
bradycardia, hypotension and hyperglycaemia.
Ventricular arrhythmias have also been reported. Treatment should be
supportive with appropriate intensive therapy.
ANTIDOTES:
Atipamezole is useful as an antidote in animals. It gives a full recovery
within 15 minutes after injection. No human authorisation exists for this
indication. However, in the case of life threatening symptoms, use of
atipamezole should be considered as a good tolerance has been
demonstrated in human patients.
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5.
FIRE-FIGHTING MEASURES (BULK ACTIVE)
FLAMMABILITY:
Non-flammable.
SUITABLE EXTINGUISHERS:
Water, dry chemical, carbon dioxide or foam as appropriate.
EXPLOSIVE HAZARDS:
None known.
EXTINGUISHERS NOT TO BE USED:
SPECIAL PROTECTIVE EQUIPMENT:
Wear fire-fighting protective equipment and full face-piece
self-contained breathing apparatus.
6.
7.
HAZARDOUS COMBUSTION PRODUCTS:
ACCIDENTAL RELEASE MEASURES
SPILLAGE CLEAN-UP:
No special requirements for spills from a single vial. For large spills, take
precautions to prevent entry into waterways, sewers, or surface drainage
systems. Use protective clothing during clean-up prior to disposal of
spilled material. Use absorbent towels or sand to clean up spills. Collect
absorbed materials into a plastic container and treat as chemical waste.
DECONTAMINATION
PROCEDURES:
Water can be used for clean-up and decontamination operations.
No specific decontamination or detoxification procedures have been
identified for this substance.
HANDLING AND STORAGE
HANDLING:
No special control measures required for the normal handling of this
material. Normal room ventilation is expected to be adequate for routine
handling of this material.
STORAGE:
No storage requirements necessary for occupational hazards.
Follow storage recommendations for the product.
Keep out of the reach and sight of children.
8.
EXPOSURE CONTROLS/PERSONAL PROTECTION:
9.
PHYSICAL AND CHEMICAL PROPERTIES OF ACTIVE
No respiratory or ocular protection required.
Avoid skin contact.
APPEARANCE:
Clear, aqueous solution.
MELTING POINT °C:
SOLUBILITY IN WATER:
Soluble.
BOILING POINT °C:
MOLECULAR FORMULA:
C12H15ClN2
MOLECULAR MASS:
222.7
10. STABILITY AND REACTIVITY:
This material is expected to be stable.
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11. TOXICOLOGICAL INFORMATION
EYE CONTACT:
Product is slightly acidic (pH = 5) and may cause eye irritation.
DERMAL CONTACT:
Irritation, sensitisation, contact dermatitis and systemic effects cannot be
excluded after skin contact.
INGESTION/INJECTION:
Toxic when swallowed. NOEL rats 30 µg/kg – LD50 60 mg/kg.
NOEL and LD50 are 50-75 % lower following self-injection.
INHALATION:
Not applicable/no data available.
OTHER POTENTIAL EFFECTS:
Sedation, respiratory depression and coma, bradycardia, hypotension and
hyperglycaemia.
CHRONIC TOXICTY:
Detomidine has not been found to produce any teratogenic, mutagenic or
carcinogenic potential.
USE DURING PREGNANCY:
If pregnant women handle the product, special caution should be
observed not to self-inject as uterine contractions and decreased foetal
blood pressure may occur after accidental systemic exposure.
12. ECOLOGICAL INFORMATION:
Local regulations and procedures should be consulted prior to
environmental release.
No environmental effects are anticipated.
13. DISPOSAL CONSIDERATIONS:
Any unused veterinary medicinal product or waste material derived from
such veterinary medicinal products should be disposed of in accordance
with local requirements.
14. TRANSPORT INFORMATION:
Transportation and shipping of the material is not restricted. It has no
known significant hazards requiring special packaging or labelling for
air, maritime, US or European ground transport purposes.
15. REGULATORY INFORMATION
European Union classification and labelling: POM-V Prescription Only Medicine – Veterinarian (UK)
VPO Veterinary Practitioner Only (IE)
16. OTHER INFORMATION
Prepared by Dechra Veterinary Products on the basis of the best available data.
No representation is given that the information provided is complete in all respects.
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