Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Sulfadimidine as sulfadimidine sodium ph.eur.
Norbrook Laboratories Limited
QJ01EQ03
Sulfadimidine as sulfadimidine sodium ph.eur.
300 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Other Birds, Pigs, Sheep
sulfadimidine
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Intradine 300 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Sulfadimidine 300.0 mg (as Sulfadimidine Sodium) EXCIPIENTS Chlorocresol 1.0 mg 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 and Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Intradine 300 mg/ml Solution for Injection is indicated for the treatment of systemic infections caused by or associated with organisms sensitive to sulfonamides including : _Bordetella bronchiseptica_ _Escherichia coli_ _Pasteurella haemolytica_ _Salmonella dublin_ _Salmonella typhimurium_ Specific indications for Intradine 300 mg/ml Solution for Injection in cattle, sheep and pigs include: - enteritis caused by_ Escherichia coli_,_ Salmonella dublin_ and_ Salmonella thypimurium_ - salmonellosis and septicaemia caused by_ Salmonella dublin_ and_ Salmonella thypimurium_ - pasteurellosis and infections of the respiratory tract caused by_ Pasteurella haemolytica_ - atrophic rhinitis caused by_ Bordetella bronchiseptica_ and_ Pasteurella haemolytica_. Intradine 300 mg/ml Solution for Injection has also been shown to be effective in the treatment of coccidiosis. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _9_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _4_ _6_ _2_ _3_ _p_ _a_ _g Read the complete document