Mepidor 20 mg/ml Solution for Injection

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Mepivacaine Hydrochloride

Tilgjengelig fra:

Richter Pharma AG

ATC-kode:

QN01BB03

INN (International Name):

Mepivacaine Hydrochloride

Legemiddelform:

Solution for injection

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Horses

Terapeutisk område:

Neurological Agent local anaesthetic

Autorisasjon status:

Authorized

Autorisasjon dato:

2016-10-04

Preparatomtale

Revised: January 2023
AN: 02966/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mepidor 20 mg/ml solution for injection
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
Horses (non-food producing horses)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Mepivacaine is indicated for infiltration, nerve block,
intra-articular and epidural
anaesthesia in non-food producing horses.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Aspirate prior to and during administration to avoid intra-vascular
injection.
Revised: January 2023
AN: 02966/2022
Page 2 of 5
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.
•
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 med