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Date: Friday, May 3, 2024 14:15

Description: Animalcare_UK_2SpotCol_RGB_vertical_Logo
Release 2.159
Mepidor 20mg/ml Injection
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Neurological preparations: Local anaesthetics
Active ingredient: Mepivacaine Hydrochloride
Product:Mepidor 20mg/ml Injection
Product index: Mepidor 20mg/ml Injection
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.
Not authorised for use in horses producing milk for human consumption.
Incorporating:
Qualitative and quantitative composition
Each ml contains:
Active substance:
Mepivacaine hydrochloride20 mg (equivalent to 17.4 mg Mepivacaine)
For the full list of excipients, see pharmaceutical particulars
Pharmaceutical form
Solution for injection. Clear, colourless to slightly yellow solution.
Clinical particulars
Target species
Horses (non-food producing horses).
Indications for use, specifying the target species
Mepivacaine is indicated for infiltration, nerve block, intra-articular and epidural anaesthesia in non-food producing horses.
Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Aspirate prior to and during administration to avoid intra-vascular injection. 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 effect gait beyond two hours.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to mepivacaine or other local anaesthetics of the amide group should avoid contact with the veterinary medicinal product. This product may be irritant to the skin and eyes. Avoid contact with the skin and eyes. Wash any splashes from skin and eyes immediately with plenty of water. Seek medical advice if irritation persists. Adverse effects on the foetus cannot be excluded. Pregnant women should avoid handling the product. Care should be taken to avoid accidental self-injection. In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use.
Adverse reactions (frequency and seriousness)
Transient, local soft tissue swelling may occur in a small proportion of cases following injection of the product. In case of inadvertent intra-vascular injection or excessive use local anaesthetics can cause systemic toxicity characterised by CNS effects. If systemic toxicity occurs the administration of oxygen to treat cardio-respiratory depression and diazepam to control convulsions should be considered.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Mepivacaine crosses the placenta. There is no evidence that mepivacaine is associated with reproductive toxicity or teratogenic effects. However, there is a potential for anaesthetics of the amide group such as mepivacaine to accumulate in the equine foetus resulting in neonatal depression and interfering with resuscitation efforts. Therefore, use in obstetric anaesthesia only according to the benefit/risk assessment of the responsible veterinarian
Interaction with other medicinal products and other forms of interaction
None known.
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 the tip of a ball point pen, before commencing manipulations. The duration of action is about 1 hour. It is recommended that the skin should be shaved and thoroughly disinfected prior to the intra-articular or epidural administration.
This product does not contain an antimicrobial preservative. Use the vial on one occasion only. Discard any unused material.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Symptoms related to overdose correlate with symptoms occurring after inadvertent intravascular injection as described under adverse reactions.
Withdrawal period(s)
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. Not authorised for use in horses producing milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: local anaesthetics, amides
ATCvet code: QN01BB03
Pharmacodynamic properties
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.
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 particulars
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
List of excipients
Sodium chloride, Sodium hydroxide (for pH adjustment), Hydrochloric acid (for pH adjustment), Water for injections
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
This product does not contain an antimicrobial preservative. Use the vial on one occasion only. Discard any unused material.
Special precautions for storage
Keep the vial in the outer carton in order to protect from light.
This veterinary medicinal product does not require any special temperature storage conditions.
Nature and composition of immediate packaging
Cardboard box with clear glass vials type I, bromobutyl rubber stopper or bromobutyl stopper with a fluorinated polymer coating and aluminium cap
Pack sizes: 10 ml, 5 x 10 ml, 6 x 10 ml.
Not all pack sizes may be marketed.
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 product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Richter Pharma AG, Feldgasse 19, 4600 Wels, Austria
Marketing Authorisation Number
UK (GB) Vm 22080/4008, UK (Northern Ireland) Vm 22080/4008
Significant changes
Date of the first authorisation or date of renewal
04 October 2016
Date of revision of the text
July 2021
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Mepidor 6 x 10ml
GTIN:5055037401943