OXYTETRAJECT 200 LA SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
OXYTETRACYCLINE DIHYDRATE
Available from:
Franklin Pharmaceuticals Ltd.
ATC code:
QJ01AA06
Dosage:
200 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Antibacterial
Therapeutic area:
Bovine
Authorization date:
2000-10-27
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10976/016/001
Case No: 7007556
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:
FRANKLIN PHARMACEUTICALS LTD.
ATHBOY ROAD, TRIM, CO. MEATH, 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:
OXYTETRAJECT 200 LA 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.
The authorisation,unless revoked, shall continue in force from 31/03/2010 until .
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 01/04/2010_
_CRN 7007556_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxytetraject 200 LA Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Oxytetracycline
200 mg
(as Oxytetracycline dihydrate)
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Oxytetraject 200 Long Acting is indicated in the treatment and control of diseases caused by or associated with
organisms
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