Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Sulfadiazine, Trimethoprim
Norbrook Laboratories Limited
QJ01EW10
Sulfadiazine, Trimethoprim
Coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Antimicrobial
Expired
1987-11-20
Revised 20 November 2008 AN: 02405/2007 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Norodine 20 Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains: Trimethoprim 20mg Sulfadiazine 100 mg. EXCIPIENTS: Titanium dioxide (E171) 0.27mg. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Coated tablet. An off white, sugar coated, unscored, circular tablet. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs Adult Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Alimentary tract infections, respiratory and urogenital infections, skin and wound infections, and eye and ear infections where susceptible organisms are present 4.3 CONTRAINDICATIONS A low incidence of polyarthropathy and Keratoconjunctivitis Sicca (Dry Eye) has been reported in dogs following oral administration of potentiated sulphonamides. If either of these conditions occurs, it is recommended that medication is stopped and that future treatment with similar products is avoided. 4.3 SPECIAL WARNINGS FOR EACH TARGET SPECIES None Revised 20 November 2008 AN: 02405/2007 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The tablets should not be divided. When given to cats the tablets should not be crushed before administration. Maintain adequate fluid intake during treatment. Not to be used in cases of hepatic renal impairment or blood dyscrasia Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Take care to avoid skin contact. Wash hands after use. Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics. Allergic reactions to these substances may occasionall Read the complete document