FRECARDYL SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
HEPTAMINOL HYDROCHLORIDE DIPROPHYLLINE
Available from:
Vetoquinol Ireland Limited
ATC code:
QC01C
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Cardiovascular
Therapeutic area:
Bovine
Authorization date:
1989-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
ANIMAL REMEDIES REGULATIONS, 2005
(S.I. NO. 734 OF 2005)
VPA: 10983/017/001
Case No: 7002050
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) hereby grants to:
VETOQUINOL IRELAND LIMITED
UNIT B, ORANMORE BUSINESS PARK, ORANMORE, GALWAY, 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:
FRECARDYL SOLUTION FOR INJECTION
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 the said Schedule.
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 23/11/2006_
_CRN 7002050_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Frecardyl Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Neo-natal foals, calves, piglets, dogs, cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cardio-respiratory analeptic.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to one of the ingredients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
Active Substances
Heptaminol Hydrochloride
62.6 mg
Diprophylline
50.0 m
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