Země: Velká Británie
Jazyk: angličtina
Zdroj: VMD (Veterinary Medicines Directorate)
Alpha Tocopherol, Cholecalciferol, Retinol
Bela-Pharm GmbH & Co. KG
QA11JA
Alpha Tocopherol, Cholecalciferol, Retinol
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Dogs, Horses, Pigs
Vitamin
Expired
2019-07-12
Revised: December 2021 AN: 01465/2021 & 01466/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Belavit AD 3 E, solution for injection for horses, cattle, pigs, and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: ACTIVE SUBSTANCE: Retinol palmitate 176.47 mg (equivalent to 300,000 I.U. Vitamin A) all-rac alpha tocopheryl acetate 50.00 mg (equivalent to 45.56 mg alpha-tocopherol) (Vitamin E) Oily solution of cholecalciferol 100.00 mg (contains 2.5 mg cholecalciferol; equivalent to 100,000 I.U. Vitamin D 3 ) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, yellow solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses, pigs and dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of combined vitamin A, vitamin D, and vitamin E deficiencies. 4.3 CONTRAINDICATIONS Do not use in food producing animals with adequate vitamin A supply due to the possibility of accumulation in edible tissues. The treatment with Vitamin AD 3 E is contraindicated in case of a hypervitaminosis. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: December 2021 AN: 01465/2021 & 01466/2021 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The recommended dose and duration of treatment should not be exceeded. The use of intramuscular lipid-soluble vitamin products in horses may increase the risk of myositis and myonecrosis. Special precautions to be taken by the person administering the veterinary medicinal product to animals • In case of accidental self-injection, a risk of hypervitaminosis in relation to vitamin A cannot be excluded. Therefore, administration should be performed with great caution. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. • Studies with vi Přečtěte si celý dokument