INTRA-EPICAINE 20 MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-09-2015
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Active ingredient:
MEPIVACAINE HYDROCHLORIDE
Available from:
Dechra Limited
ATC code:
QN01BB03
INN (International Name):
MEPIVACAINE HYDROCHLORIDE
Dosage:
20 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
VPO-Vet.Practitioner Only
Therapeutic group:
Equine Non Food
Therapeutic area:
Mepivacaine
Therapeutic indications:
Neurological Preparations
Authorization status:
Authorised
Authorization date:
2006-12-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Intra-Epicaine 20 mg/ml solution for injection for horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Mepivacaine hydrochloride
20 mg
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless mobile liquid, practically free from visible particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Mepivacaine is indicated for infiltration, nerve block, intra-articular and epidural anaesthesia in horses.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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 affect 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 or skin contact.
In the event of accidental self-injection medical advice should be sought.
Wash splashes from skin and eyes immediately.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 26/08/2015_
_CRN 7021390_
_page number: 1_
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.
Local anaesthetics used in excess can cause systemic toxicity characterised by CNS
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