Mepivacaine

Main information

  • Trade name:
  • Mepivacaine Richter 20 mg/ ml Solution for Injection for Horses
  • Pharmaceutical form:
  • Solution for injection
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Mepivacaine Richter 20 mg/ml Solution for Injection for Horses
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Horses
  • Therapeutic area:
  • Neurological Agent local anaesthetic

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 22080/4011
  • Authorization date:
  • 15-11-2017
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Issued: November 2017

AN: 01470/2016

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Mepivacaine Richter 20 mg/ml solution for injection for horses

(UK)

Mepidor 20 mg/ml solution for injection for horses

(AT, DE, EE, ES, IE, NL)

Mepidor vet. 20 mg/ml solution for injection for horses

(DK, FI, SE)

Mepidor solution for injection for horses

(FR)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Mepivacaine hydrochloride

20 mg

(equivalent to 17.4 mg Mepivacaine)

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless to slightly yellow solution

4.

CLINICAL PARTICULARS

4.1

Target species

Horse

4.2

Indications for use, specifying the target species

Mepivacaine is indicated for intra-articular and epidural anaesthesia in horses.

4.3

Contraindications

Do not use in cases of known hypersensitivity to local anaesthetics belonging to the

amide group, or to any of the excipients.

4.4

Special warnings for each target species

None.

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AN: 01470/2016

4.5

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

affect 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 an 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.

Accidental self-injection may result in cardiorespiratory and/or CNS effects. 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. Do not drive.

Wash hands after use.

4.6

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.

4.7

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.

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4.8

Interaction with other medicinal products and other forms of interaction

Mepivacaine should be used carefully in patients undergoing treatment with other

local anaesthetics of the amide group since the toxic effects are additive.

4.9

Amounts to be administered and administration route

Full aseptic precautions should be observed when injecting the product.

For intra-articular anaesthesia: 60-600mg of mepivacaine hydrochloride (3 to 30 ml

of the medicinal product), dependent on joint size

For epidural use:

0.2 – 0.25 mg/kg (1.0 to 1.25 ml/100 kg), up to10 ml/

horse, 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 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Symptoms related to overdose correlate with symptoms occurring after inadvertent

intravascular injection as described in section 4.6.

4.11 Withdrawal period(s)

Meat and offal:

3 days

Milk:

72 hours

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: local anaesthetics, amides

ATC vet code: QN01BB03

5.1

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. The onset of action of mepivacaine is, therefore, rapid (2-4

minutes) with an intermediate duration of action (about 1 hour).

5.2

Pharmacokinetic particulars

Peak plasma concentrations of mepivacaine have been measured in mares following

caudal epidural anaesthesia or caudal subarachnoid anaesthesia. The maximum

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plasma concentrations were similar (0.05 µg/ml) and were reached in 51-55 minutes.

The major metabolite in horse urine is 3-hydroxymepivacaine.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sodium chloride

Sodium hydroxide (for pH adjustment)

Hydrochloric acid (for pH adjustment)

Water for injections

6.2

Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be

mixed with any other veterinary medicinal products.

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

This product does not contain an antimicrobial preservative. Use the vial on one

occasion only. Discard any unused material.

6.4

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.

6.5

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.

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 product should be disposed of in accordance with local

requirements.

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AN: 01470/2016

7.

MARKETING AUTHORISATION HOLDER

Richter Pharma AG

Feldgasse 19

4600 Wels

AUSTRIA

8.

MARKETING AUTHORISATION NUMBER

Vm 22080/4011

9.

DATE OF FIRST AUTHORISATION

15 November 2017

10.

DATE OF REVISION OF THE TEXT

November 2017

Approved: 15 November 2017

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