País: Reino Unido
Idioma: inglés
Fuente: HMA (Heads of Medicines Agencies)
suxibuzone 15 % w/w
Laboratorios Dr. Esteve S.A.
QM01AA90
Granules
Suxibuzone
Horses
2011-05-18
Issued: June 2011 AN: 00389/2010 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Danilon equidos 1.5 g Granules Suxilon 1.5g Granules for top dressing (only for UK) Suxibuzone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 g sachet contains ACTIVE SUBSTANCE: Suxibuzone (microencapsulated) 1.5 g EXCIPIENT(S): Quinoline yellow (E 104) 2.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules Yellow and odourless granules. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses and ponies. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of pain and inflammation associated with musculo-skeletal conditions in the horse _eg_ osteoarthritic conditions, bursitis, laminitis and soft tissue inflammation. 4.3 CONTRAINDICATIONS Do not administer to animals with renal, hepatic or cardiac disorders; where there is the possibility of gastro-intestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia or hypersensitivity to the product. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not administer prior to taking part in a competition. During treatment of very young animals (less than 12 weeks) where development of their hepatic or renal function may be incomplete, or in aged animals which may have these functions impaired, as well as in ponies, additional risk may be involved. In these cases, doses should be accurately calculated and patients monitored closely. Issued: June 2011 AN: 00389/2010 Page Leer el documento completo