Hyonate 10 mg/ml solution for injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
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Active ingredient:
hyaluronate sodium
Available from:
Bayer Limited
ATC code:
QM09AX01
Dosage:
10 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Equine - Food
Therapeutic area:
N.S.A.I.D
Authorization status:
Authorised
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
VPA: 10021/033/001
Case No: 7006830
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:
BAYER LIMITED
ANIMAL HEALTH DIVISION, THE ATRIUM, DUBLIN 18, IRELAND
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:
HYONATE 10 MG/ML SOLUTION FOR INJECTION
The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in
the Schedule.
The authorisation,unless revoked, shall continue in force from 16/07/2010.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/07/2010_
_CRN 7006830_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Hyonate 10 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE CONSTITUENTS
Sodium hyaluronate
10 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of lameness in horses due to non-infectious inflammation of joints
4.3 CONTRAINDICATIONS
None known.
4.4 SPECIAL WARNINGS F
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