BUPRENODALE 0.3 MG/ML SOLUTION FOR INJECTION FOR D
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
BUPRENORPHINE
Available from:
Dechra Ltd
ATC code:
QN02AE01
Dosage:
0.3 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Neurological Preparations
Therapeutic area:
Canine
Authorization date:
2009-02-06
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:10799/011/001
Case No: 7004091
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to:
DECHRA LTD
DECHRA HOUSE, JAMAGE INDUSTRIAL ESTATE, STOKE-ON-TRENT ST7 1XW, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the
Veterinary Medicinal Product:
BUPRENODALE 0.3 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in Part 2 of the said Schedule.
This authorisation,unless previously revoked, shall continue in force from 06/02/2009 to 05/02/2014.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/02/2009_
_CRN 7004091_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Buprenodale 0.3 mg/ml solution for injection for dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains:
ACTIVE SUBSTANCE
Buprenorphine 0.3 mg as buprenorphine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Post-operative analgesia in the cat and dog.
Potentiation of the sedative
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