Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
TRIMETHOPRIM, SULFADIAZINE
Vetoquinol Ireland Limited
QJ01EW10
TRIMETHOPRIM, SULFADIAZINE
100 Millilitre
Solution for Injection
POM
Bovine, Canine, Equine - Food, Feline, Porcine
Sulfadiazine and trimethoprim
Antibacterial
Authorised
1994-03-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Septotryl II Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, Cattle, Pigs, Dogs, Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Septotryl II Injection is indicated for the treatment of systemic infections caused by or associated with organisms sensitive to Trimethoprim:Sulphadiazine combination. The spectrum of activity includes both Gram positive and Gram negative organisms including: _Actinobacilli_ _Bordetella _spp_._ _Corynebacteria_ _Escherichia coli_ _Haemophilus _spp_._ _Klebsiella _spp_._ _Pasteurella _spp_._ _Salmonella _spp_._ _Staphylococci_ _Streptococci_ Each ml contains: ACTIVE SUBSTANCES Trimethoprim 40 mg Sulfadiazine 200 mg EXCIPIENTS Chlorocresol 1 mg Sodium Formaldehyde Sulfoxylate 1 mg HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 14/08/2015_ _CRN 7021600_ _page number: 1_ 4.3 CONTRAINDICATIONS Septotryl II Injection should not be given by routes other than those recommended. Do not use in cases of hypersensitivity to the active ingredients. Do not use in animals with severe liver parenchymal damage or blood dyscrasias. Do not use in horses exhibiting drug induced cardiac arrhythmias, such arrhythmias may be associated with the administration of certain anaesthetic and sedative agents. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS Intravenous injections should be administered slowly over as long a period as is reasonably practical in order to a Olvassa el a teljes dokumentumot