Mepidor 20 mg/ml solution for injection for horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mepivacaine hydrochloride

Available from:

VetViva Richter GmbH

ATC code:

QN01BB03

INN (International Name):

Mepivacaine hydrochloride

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

mepivacaine

Authorization date:

2018-01-05

Summary of Product characteristics

1
_[Version 8.1, 01/2017] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mepidor 20 mg/ml solution for injection for horses
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.
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.
3
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 han