Euthatal Solution For Injection 200 Mg In 1 Ml
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1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
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EUTHATAL solution for injection 200mg in 1ml |
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2. |
QUALITATIVE AND QUANTITATIVE COMPOSITION |
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Each ml contains: Active Substance Pentobarbital sodium 200mg Excipients Patent Blue V (E131) 0.01mg For full list of excipients, see section 6.1. |
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3. |
PHARMACEUTICAL FORM |
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Blue aqueous solution for injection. |
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4. |
CLINICAL PARTICULARS |
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4.1 |
Target species |
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Dogs, cats and other small animals. |
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4.2 |
Indications for use specifying the target species |
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Euthanasia in dogs, cats and other small animals. |
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4.3 |
Contra-indications |
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Do not use for anaesthetic purposes. Carcasses of animals, which have been euthanased with the product, must not be used for animal consumption. Do not administer by intramuscular route. |
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4.4 |
Special warnings for each target species |
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In some circumstances the intrathoracic or intracardiac routes of administration may be used, but only as a last resort. The choice of these routes should be made in the light of the attendant difficulties and the unnecessary pain and distress to the animal which could result. When it is anticipated that euthanasia may be problematical (e.g. aggressive patients), premedication with appropriate sedative is recommended. |
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4.5 |
Special precautions for use |
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(i) Special precautions for use in animals. |
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In the event of accidental administration to an animal not presented for euthanasia, measures such as artificial respiration, administration of oxygen, and the use of analeptics are appropriate. |
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(ii) Special precautions to be taken by the person administering the medicinal product to the animals |
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In the case of accidental self-administration, seek urgent medical attention, advising medical service of barbiturate poisoning. Pentobarbital is a potent drug, which is toxic to man. Particular care should be taken to avoid accidental ingestion and self-injection. In the event of an accident the following action should be taken: Skin - Wash immediately with water and then thoroughly with soap and water. Eyes - Wash immediately with cold water and obtain medical attention. Ingestion - Obtain medical attention immediately. Wash out mouth. Keep warm and rest. Accidental self injection - Obtain URGENT medical attention, advising medical services of barbiturate poisoning. Do not leave patient unattended. Advice to Doctor: Maintain airways and give symptomatic and supportive treatment. |
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4.6 |
Adverse reactions (frequency and seriousness) |
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Not applicable. |
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4.7 |
Use during pregnancy, lactation or lay |
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Not applicable. |
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4.8 |
Interaction with other medicinal products and other forms of interaction |
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None known. The product is intended for use alone. |
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4.9 |
Amounts to be administered and administration route |
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The product is primarily intended for, and is most consistently effective when administered by intravenous route. The solution should be administered at the rate of 1ml per 1.4kg (3lb) bodyweight (approximately 150mg/kg bodyweight) as quickly as possible. |
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4.10 |
Overdose (symptoms, emergency procedures, antidotes), if necessary |
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Not applicable. |
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4.11 |
Withdrawal periods |
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Not applicable. Not to be used in animals intended for human consumption. |
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5. |
PHARMACOLOGICAL PROPERTIES |
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ATC Vet Code: |
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QN51AA01 |
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5.1 |
Pharmacodynamic properties |
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The major action of barbiturates is to depress the central nervous system (CNS). All degrees of depression, ranging from mild sedation to general anaesthesia and ultimately death are induced depending upon dosage. The dosage for euthanasia is 140-150 mg/kg, death occurs due to respiratory failure. |
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5.2 |
Pharmacokinetic properties |
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No data available. |
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6. |
PHARMACEUTICAL PARTICULARS |
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6.1 |
List of excipients |
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Propylene Glycol Ethanol Patent Blue V (E131) Water for Injections |
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6.2 |
Major incompatibilities |
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Do not dilute with water or any other fluid. |
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6.3 |
Shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time |
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3 years. Following withdrawal of the first dose, use the product within 28 days. Discard unused material. |
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6.4 |
Special precautions for storage |
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Do not store above 25oC. Protect from light. Discard if any sediment is observed. The product does not contain an antimicrobial preservative. This product is not sterile. |
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6.5 |
Nature and composition of immediate packaging |
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Amber, Type II vials with rubber (6BU) chlorobutyl bung containing 100ml. |
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6.6 |
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate. |
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Any unused product or waste material should be disposed of in accordance with national requirements. UK only: Disposal of this product is controlled by the Misuse of Drugs Regulation 2001 in the UK. |
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7. |
MARKETING AUTHORISATION HOLDER |
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Merial Animal Health Limited PO Box 327 Sandringham House Sandringham Avenue Harlow Business Park Harlow, Essex, CM19 5TG, UK |
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8. |
MARKETING AUTHORISATION NUMBER(S) |
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Vm 08327/4112 (UK) VPA 10857/43/1 (IRELAND) |
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9. |
DATE OF THE FIRST AUTHORISATION OR DATE OF RENEWAL OF THE AUTHORISATION |
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20th September 2003 (UK) 6th March 1998 (Ireland) |
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10. |
DATE OF REVISION OF THE TEXT |
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July 2006 |
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11. |
ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE |
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Not applicable. |