Intra-Epicaine 2.0 % w/v Solution for Injection

Introduction

Company name: Dechra Veterinary Products

Address: (A business unit of Dechra Pharmaceuticals PLC)

Cartmel Drive

Harlescott

Shrewsbury SY1 3TB

Telephone: 01743 441632

Fax: 01743 462111

Email: info@dechra-uk.com

Website: www.dechra-uk.com

Presentation

Intra-Epicaine is a sterile, clear, colourless isotonic solution containing:

Mepivacaine Hydrochloride 2.0 % w/v

Sodium Chloride

Water for Injection

Sodium Hydroxide

Uses

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 horses.

Dosage and administration

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 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.

Full aseptic precautions should be observed when injecting the product.

It is recommended that the skin should be shaved and thoroughly disinfected prior to intra-articular or epidural administration.

Care should be taken to avoid intra-vascular injection.

Contra-indications, warnings, etc

Care should be taken to avoid intra-vascular injection by aspiration prior to and during administration.

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.

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.

Transient, local soft tissue swelling may occur in a small proportion of cases following injection of the product.

If you notice any serious effects or other effects not mentioned in this data sheet, please inform your veterinary surgeon.

Operator warnings: 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.

General precautions: For animal treatment only.

Withdrawal period: 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.

Pharmaceutical precautions

Do not store above 25°C. Keep out of the reach and sight of children.

This product does not contain an antimicrobial preservative. Use the vial on one occasion only; any solution remaining in the vial following withdrawal of the required dose should be discarded.

Disposal: Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Glass vials containing 10 ml are available in cartons of six.

Further information

To be supplied only on veterinary prescription.

Veterinary medicinal product authorised for use in UK and Ireland.

Manufactured by: Dales Pharmaceuticals, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, UK.

Marketing authorisation number

Vm 10434/4016.