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Date: Wednesday, May 8, 2024 3:53

Release 4.48
Intra-Epicaine 20 mg/ml Solution for Injection for Horses
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Neurological preparations: Local anaesthetics
Active ingredient: Mepivacaine Hydrochloride
Product:Intra-Epicaine 20 mg/ml Solution for Injection for Horses
Product index: Intra-Epicaine 20 mg/ml Solution for Injection for Horses
Withdrawal notes: Not to be used in horses intended 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.
Incorporating:
Qualitative and quantitative composition
1 ml contains: Active substance:
Mepivacaine hydrochloride 20 mg
Pharmaceutical form
Solution for injection. A clear colourless mobile liquid, practically free from visible particles.
Clinical particulars
Target species
Horses.
Indications for use
Mepivacaine is indicated for infiltration, nerve block, intra-articular and epidural anaesthesia in horses.
Special precautions for use in animals
Care should be taken to avoid intra-vascular injection by aspiration prior to and during administration.
The analgesic effect of mepivacaine, when used as part of a lameness investigation, begins to subside after 45-60 minutes. However, sufficient analgesia may persist to affect gait beyond two hours.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection or skin contact. In the event of accidental self-injection medical advice should be sought. Wash splashes from skin or eyes immediately.
Adverse reactions
Transient, local soft tissue swelling may occur in a small proportion of cases following injection of the product.
Local anaesthetics used in excess can cause systemic toxicity characterised by CNS effects.
If systemic toxicity occurs, as a result of inadvertent intra-vascular injection, the administration of oxygen to treat cardio-respiratory depression and diazepam to control convulsions should be considered.
Use during pregnancy and lactation
Not contraindicated.
Amounts to be administered and administration route
Full aseptic precautions should be observed when injecting the product.
For infiltration: As required, but as a guide 2-5 ml.
For nerve block: 2-10 ml, depending on location.
For intra-articular anaesthesia: 5 ml.
For epidural anaesthesia: 4-10 ml, depending on the depth and extent of anaesthesia required.
In all instances the dosage should be kept to the minimum required to produce the desired effect. The depth and extent of anaesthesia should be determined by pressure with a blunt point, such as a tip of a ball point pen, before commencing manipulations.
The duration of action is about one hour.
It is recommended that the skin should be shaved and thoroughly disinfected prior to the intra-articular or epidural administration.
Overdose
Local anaesthetics used in excess can cause systemic toxicity characterised by CNS effects. If systemic toxicity occurs, as a result of inadvertent intra-vascular injection, the administration of oxygen to treat cardio-respiratory depression and diazepam to control convulsions should be considered.
Withdrawal periods
Not to be used in horses intended 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.
Pharmacological particulars
Mepivacaine hydrochloride is a potent local anaesthetic, with a rapid onset of action. Since it does not cause vasodilation it does not require adrenaline to prolong its effect. Mepivacaine has been employed successfully for all types of local anaesthesia and is recommended for infiltration, nerve block, intra-articular and epidural anaesthesia in the horse.
ATCvet code: QN01BB03
Pharmacodynamic properties
The mechanism of action of mepivacaine is to prevent the generation and conduction of the nerve impulse. Conduction is blocked by decreasing or preventing the large transient increase in the permeability of excitable membranes to Na+ that is produced by a slight depolarisation. This action is due to a direct effect with voltage-sensitive Na+ channels. Mepivacaine exists in both charged and uncharged forms at physiological pH while the intracellular environment favours formation of the active, charged molecule. The onset of action of mepivacaine is, therefore, rapid (2-4 minutes) with an intermediate duration of action (about 1 hour).
Pharmacokinetic properties
Peak venous levels of mepivacaine have been measured in mares following caudal epidural anaesthesia or caudal subarachnoid anaesthesia. The maximum venous concentrations were similar (0.05 µg/ml) and were reached in 51-55 minutes. In a separate study, mepivacaine or its metabolites appeared in the urine within 15 minutes of subcutaneous injection and reached peak levels within 2-6 hours. It was largely cleared from the urine within 24 hours. The major metabolite in horse urine is 3-hydroxymepivacaine.
Pharmaceutical particulars
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
This product does not contain an antimicrobial preservative. Once opened, use immediately. Discard any unused material.
Special precautions for storage
Do not store above 25°C.
Immediate packaging
Clear glass vials containing 10 ml, with a red chlorobutyl stopper and aluminium seals, are available in cartons of six.
Disposal
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 (if different from distributor)
Dechra Limited, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom.
Marketing Authorisation Number
Vm 10434/4016
Significant changes
Date of the first authorisation or date of renewal
20 December 1990
Date of revision of the text
August 2015
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Intra-Epicaine 20 mg/ml Solution for Injection:
GTIN:05701170422030