Mepiblock 20 mg/ml solution for injection for horses

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Mepivacaine hydrochloride

Fáanlegur frá:

Dechra Regulatory B.V.

ATC númer:

QN01BB03

INN (Alþjóðlegt nafn):

Mepivacaine hydrochloride

Skammtar:

20 milligram(s)/millilitre

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

mepivacaine

Leyfisstaða:

Authorised

Leyfisdagur:

2017-12-15

Vara einkenni

Health Products Regulatory Authority
07 January 2019
CRN008S6T
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Mepiblock 20 mg/ml solution for injection for horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Mepivacaine (as hydrochloride) 17.42 mg
Equivalent to 20 mg of mepivacaine hydrochloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless solution, practically free from visible particles.
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.
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Health Products Regulatory Authority
07 January 2019
CRN008S6T
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Care should be taken to avoid intra-vascular injection, by aspiration
prior to and
during administration.
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
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.
Adverse effects in the foetus cannot be excluded. Pregnant women
should avoid
handling the veterinary medicinal product.
People with known hypersensitivity to mepivacaine or other local
anaesthetics of the
amide group should avoid contact with the veterinary medicinal
product.
The product may be irritant to the skin and e