Intra-Epicaine 20 mg/ml solution for injection for horses

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Mepivacaine hydrochloride

MAH:

Dechra Regulatory B.V.

ATC_code:

QN01BB03

INN:

Mepivacaine hydrochloride

dosage:

20 milligram(s)/millilitre

pharmaceutical_form:

Solution for injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_area:

mepivacaine

authorization_status:

Authorised

authorization_date:

2006-12-01

SPC

Health Products Regulatory Authority
07 January 2019
CRN008S6T
Page 1 of 5
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.
Health Products Regulatory Authority
07 January 2019
CRN008S6T
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
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.
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
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.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Not cont