Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Selenium
Novartis Animal Health UK Ltd
amended)
Selenium
Expired
Revised: July 2010 (ATC vet code amended) SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Deposel Multidose 50 mg/ml Suspension for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients: Selenium (as barium selenate 175 mg/ml) 50 mg/ml Excipients: Methyl parahydroxybenzoate 2 mg/ml Propyl parahydroxybenzoate 0.5 mg/ml Potassium sorbate 2 mg/ml Disodium edentate 2 mg/ml Ferric oxide, yellow (E172) 3 mg/ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection Smooth, yellow aqueous suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and prevention of selenium deficiency in sheep and cattle for up to 12 months. 4.3. CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not exceed the recommended dosage. Page 1 of 4 Revised: July 2010 (ATC vet code amended) 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Shake pack well before use to ensure resuspension of contents. It is advisable to establish the selenium status of animals prior to treatment. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals Care should be taken to avoid accidental self-injection. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) A nodule is likely to develop at the injection site as a depot of the barium selenate administered. During the clinical studies, indication of transient pain in cattle at the injection site was noted during the first week. 4.7 USE DURING PREGNANCY, LACTATION OR LAY No specific warnings. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known 4.9 A Read the complete document