מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
STREPTOMYCIN SULFATE, DIHYDROSTREPTOMYCIN SULFATE
Norbrook Laboratories Limited
QJ01GA01
STREPTOMYCIN SULFATE, DIHYDROSTREPTOMYCIN SULFATE
Per Cent
Solution for Injection
POM
Bovine, Ovine, Porcine
Streptomycin QJ01GA90 Dihydrostreptomycin
Antibacterial
Authorised
1988-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/028/001A Case No: 7006374 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: NORBROOK LABORATORIES LIMITED STATION WORKS, NEWRY, CO. DOWN BT35 6JP 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: DEVOMYCIN D 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 03/07/2009. 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 04/07/2009_ _CRN 7006374_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Devomycin D 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 Cattle Sheep Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Devomycin D Injection is indicated in the treatment of infections caused by organisms sensitive to Streptomycin and Dihydrostreptomycin in cattle, sheep and pigs. It is also indicated i קרא את המסמך השלם