Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Trimethoprim; Sulfadiazine
Norbrook Laboratories (Ireland) Limited
QJ01E
Trimethoprim; Sulfadiazine
5.8, 28.83 percent weight/weight
Oral paste
POM: Prescription Only Medicine as defined in relevant national legislation
SULFONAMIDES AND TRIMETHOPRIM
Authorised
1988-10-01
Health Products Regulatory Authority 04 June 2020 CRN009J7W Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Norodine Equine Oral Paste 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 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. 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. Health Products Regulatory Authority 04 June 2020 CRN009J7W Page 2 of 3 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 INTERACTIONS 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 horse. Remove cap from nozzle. Place nozzle in the corner of mouth. Depress plunger depositing paste on upper surface of tongue. The daily dose is 30mg of combined actives per kg bodyweight by oral administration. Treatment should be continued until 2 days afte Preberite celoten dokument