AUROFAC SUIS 100 GRANULAR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-05-2024
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Active ingredient:
CHLORTETRACYCLINE HYDROCHLORIDE
Available from:
Alpharma BVBA
ATC code:
QJ01AA03
Dosage:
100 mg/g
Pharmaceutical form:
Premix for Med.Feedstuffs
Therapeutic group:
Antibacterial
Therapeutic area:
Porcine
Authorization date:
2005-10-28
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007
(S.I. NO. 144 OF 2007)
VPA: 10802/001/002
Case No: 7001163
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 144 of 2007) hereby grants to:
ALPHARMA BVBA
LAARSTRAAT 16, 2600 ANTWERP, BELGIUM
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:
AUROFAC SUIS 100 GRANULAR
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 revoked, shall continue in force from 25/10/2007 until 28/10/2010.
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 04/11/2007_
_CRN 7001163_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
AUROFAC Suis 100 Granular
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see, section 6.1
3 PHARMACEUTICAL FORM
Premix for medicated feed.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an aid in the treatment and control of respiratory and systemic infections in pigs associated with chlortetracycline-
sensitive organisms.
4.3 CONTRAINDICATIONS
Use in adult ruminants is not recommended.
Do not use in animals kno
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