Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
TRIMETHOPRIM, SULFADIAZINE
Norbrook Laboratories Limited
QJ01E
TRIMETHOPRIM, SULFADIAZINE
Per Cent
Oral Paste
POM
Equine - Food
SULFONAMIDES AND TRIMETHOPRIM
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Norodine Equine Oral Paste. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral paste. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Norodine Equine Paste is indicated in the treatment of bacterial infections in horses caused by sensitive micro- organisms including:- _Escherichia coli_ _Staphylococcus spp._ _Streptococcus spp._ 4.3 CONTRAINDICATIONS Contraindicated in horses with known sulphonamide sensitivity and also in animals with hepatic damage or blood dyscrasias. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES No special precautions. Each 4.31g dose contains: Active Substances Trimethoprim 5.80 %w/w Sulfadiazine 28.83 %w/w Excipients Methyl Parahydroxybenzoate (E218) 0.18 %w/w Propyl Parahydroxybenzoate (E216) 0.02 %w/w HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 22/11/2016_ _CRN 7025069_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS Do not use the same syringe to treat more than one animal unless horses are running together or in direct contact with each other on the same premises. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS None. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) No undesirable effects. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Norodine Equine Paste can be safely administered during pregnancy and lactation. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No known interactions. 4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Adjust screw gauge on dial-a-dose plunger to the bodyweight of the Lees het volledige document