מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Trimethoprim; Sulphadiazine
Norbrook Laboratories Limited
QJ51E
Trimethoprim; Sulphadiazine
40/200 mg/syringe
Intramammary suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
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. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _9_ _/_ _0_ _9_ קרא את המסמך השלם