Large Animal Diprevon Solution For Injection
Issued 22/09/2009 – AN 00817/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Large Animal Diprevon Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: mg/ml
(as Diprenorphine hydrochloride 3.26)
Methylthioninium chloride 0.1
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear blue aqueous solution.
4. CLINICAL PARTICULARS
4.1 Target species
Horses and deer.
4.2 Indications for use, specifying the target species
To reverse neuroleptanalgesia induced by etorphine hydrochloride.
Do not use intramuscularly except in the circumstances of an emergency where intravenous injection is not possible.
Do not dilute or mix with any other substances.
Do not use in animals intended for animal consumption.
4.4 Special warnings for each target species
Animals MUST be kept stabled, protected from extremes of temperature and under close supervision for at least 24 hours, particularly for the first 8 hours following administration.
Care must be taken to avoid hypothermia or hyperthermia (see above).
Protect horses eyes from sun or bright light following administration.
4.5 Special precautions for use
i) Special precautions for use in animals
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Spillages should be dealt with AFTER PUTTING ON SUITABLE HEAVY DUTY RUBBER GLOVES, neoprene or nitrile of minimum thickness 0.5 mm, using a copious quantity of water, which can then be flushed down a running sink. Broken glass should be washed and disposed of in a recognised manner.
The product may induce a hallucinatory state after accidental self-administration.
TO AVOID ACCIDENTAL SELF-INJECTION, the following procedure should be adopted:
Use two sterile needles, one to fill the syringe from the vial and one to inject the patient. Once the required dose has been withdrawn from the vial, the syringe should be removed from the needle. A separate sterile needle should be inserted into the injection site and the syringe connected to it. Both needles should be discarded into a closed container.
Wear surgical gloves.
Do not pressurise vial contents.
An eye and skin wash should be readily available for use following any exposure.
Wash off splashes from skin and eyes immediately.
Should accidental self-injection occur, seek medical advice immediately.
Do not drive.
4.6 Adverse reactions (frequency and seriousness)
Signs of tachycardia, hypertension and mild tranquillisation may be seen following remobilisation.
Since the product is used strictly as an antidote, the product literature for the agonist should be referred to.
Recurrence of excitement, ‘walking’ and ‘head-pressing’ six to eight hours after remobilisation. These effects may be reversed by a further half-dose administered subcutaneously.
4.7 Use during pregnancy, lactation or lay
There is no evidence of testing in such situations.
4.8 Interaction with other medicinal products and other forms of interaction
Do not dilute or mix with any other substances (see section 4.3, Contraindications).
4.9 Amounts to be administered and administration route
A volume equal to the total volume of Large Animal Etorphilon Solution for Injection injected previously should be given intravenously as soon as possible after the required period of restraint is complete. Recovery should then take place with minimal disturbance and noise. Animals should be kept under frequent surveillance during recovery.
A further half-dose may be used subcutaneously after the initial intravenous dose if required.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No specific target organ toxicity has been recorded in studies using repeat doses at relatively high dosages.
4.11 Withdrawal period(s)
Must not be administered to animals intended for human or animal consumption.
Not to be used in horses for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antidotes
ATCvet code: QV03AB92
5.1 Pharmacodynamic properties
Diprenorphine hydrochloride is an opioid antagonist used to specifically reverse the neuroleptanalgesic effects of etorphine hydrochloride. Used alone, diprenorphine hydrochloride can act as an agonist and may induce a hallucinatory state.
5.2 Pharmacokinetic particulars
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrochloric acid (dilute), sodium hydroxide (for pH adjustment)
Water for injections
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 1 day.
6.4 Special precautions for storage
Do not store above 25°C. Protect from light.
Following withdrawal of the first dose, use remainder of the product within one day. Discard unused material.
6.5 Nature and composition of immediate packaging
Clear glass (Type II) vials containing 10.5 ml, closed with a chlorobutyl rubber stopper and aluminium crimped seal.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Sherburn Enterprise Park
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
22 September 2009
10 DATE OF REVISION OF THE TEXT
22 September 2009