BIMADINE POWDER FOR ORAL SUSPENSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-06-2024
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Active ingredient:
SULFADIMIDINE
Available from:
Bimeda Chemicals
ATC code:
QJ01EQ03
INN (International Name):
SULFADIMIDINE
Dosage:
25 Grams
Pharmaceutical form:
Powder for Oral Suspension
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Sulfadimidine
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1988-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10126/027/001
Case No: 7004607
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:
BIMEDA CHEMICALS
BROOMHILL ROAD, TALLAGHT, DUBLIN 24., 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:
BIMADINE POWDER FOR ORAL SUSPENSION
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.
The authorisation, unless previously revoked, shall continue in force from 30/09/2008.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/03/2009_
_CRN 7004607_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimadine Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each individual sachet contains :
Active substance:
Sulfadimidine
25 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of diseases in monogastric calves caused by or associated
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