Țară: Regatul Unit
Limbă: engleză
Sursă: VMD (Veterinary Medicines Directorate)
Sulfadiazine, Trimethoprim
Norbrook Laboratories Limited
QJ01EW10
Sulfadiazine, Trimethoprim
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Cattle, Dogs, Horses, Pigs
Antimicrobial
Authorized
1988-06-01
Revised: July 2023 AN: 00498/2023 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Norodine 24 Solution For Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Trimethoprim 4.00% w/v Sulfadiazine 20.00% w/v EXCIPIENTS: Chlorocresol 0.1% w/w Sodium Formaldehyde Sulphoxylate Dihydrate 0.1% w/w N-methyl pyrrolidone 51.50 % w/v For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution For Injection A sterile clear yellow aqueous solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses Cattle Pigs Dogs Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Norodine 24 Injectable Solution is indicated in the treatment of systemic infections caused by or associated with organisms sensitive to the Trimethoprim:Sulfadiazine combination. The spectrum of activity includes both Gram-positive and Gram-negative organisms including: _Actinobacilli_ _Actinomycae_ _Bordetella_ spp _Brucella_ Corynebacteria _Escherichia coli_ _Haemophilus_ spp _Klebsiella_ spp Revised: July 2023 AN: 00498/2023 Page 2 of 6 _Pasteurella_ spp _Pneumococci_ _Proteus_ _Salmonella_ spp Staphylococci Streptococci _Vibrio_ 4.3 CONTRAINDICATIONS Norodine 24 Injectable Solution should not be given by routes other than those recommended. Not to be administered intraperitoneally, intra-arterially or intrathecally. Do not administer to animals with known sulphonamide sensitivity, severe liver parenchymal damage or blood dyscrasias. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS For intravenous administration the product should be warmed to body temperature and injected slowly over as long a period as is reasonably practical. At the first sign of intolerance the injection should be interrupted and shock treatment initiated. Adequate drinking water should be available during the therapeutic effect of the product. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINA Citiți documentul complet