Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TRIMETHOPRIM, SULFADIAZINE
Norbrook Laboratories Limited
QJ51E
TRIMETHOPRIM, SULFADIAZINE
40/200 mg/syringe
intramammary Suspension
POM
Bovine
SULFONAMIDES AND TRIMETHOPRIM FOR INTRAMAMMARY USE
Antibacterial
Authorised
1996-10-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Lactatrim MC Lactating Cow Intramammary Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH 8 G SYRINGE CONTAINS: Active substances Trimethoprim 40 mg Sulphadiazine 200 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Intramammary suspension. A white to off-white suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (Lactating) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The veterinary medicinal product is an intramammary suspension for the broad spectrum treatment of clinical mastitis in lactating cattle caused by organisms sensitive to the Trimethoprim/Sulphadiazine combination. Clinically, the veterinary medicinal product has been shown to be effective in the routine treatment of mastitis in lactating cows. The veterinary medicinal product exerts a bactericidal activity at concentrations attained in the udder. _In vitro _the veterinary medicinal product is effective against gram-positive and gram-negative bacteria including _Streptococcus_ _agalactiae_, _Streptococcus_ _dysgalactiae_, _Streptococcus_ _uberis_ and other streptococcal species, staphylococcal spp., _Corynebacterium pyogenes_, _Eschericha coli_, and other gram-negative bacteria. 4.3 CONTRAINDICATIONS Do not use in cattle with known sulphonamide sensitivity, with hepatic damage or with blood dyscrasias. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/09/2013_ _CRN 7015537_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Only for lactating cows, do not administer in dry periods. Whenever possible, the veterinary medicinal product should only be use Read the complete document