Country: Կիպրոս
language: հունարեն
source: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες
GRANTED
QA11AA03
SELENIUM 0,15 MG/ML (EQUIV. TO SODIUM SELENITE PENTAHYDRATE 0,5 MG/ML) A-TOCOPHEROL 70 MG/ML (EQUIV. TO A-TOCOPHEROL ACETATE 77
GRANTED
FATRO SpA ITALY
SOLUTION FOR INJECTION
N. A. CHANCE TRADING CO
Withdrawal period: CALVES LAMBS PIGS HORSES; Distributor: MULTIVITAMINS, COMBINATIONS
ΠΑΡΑΡΤΗΜΑ 1:SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SELEVIT, solution for injection for calves, lambs, swine, horses. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCES: selenium ………………………………………………………..0.15 mg equivalent to sodium selenite pentahydrate…………………….0.5 mg -tocopherol …………………………………………..……...70 mg equivalent to -tocopherol acetate………………………...…77 mg cyanocobalamin (vit. B 12 )………………………………………0.1 mg adenosin-5'-monophosphoric acid……………………………...5 mg sorbitol………………………………………………………...50 mg EXCIPIENTS: sodium propyl parahydroxybenzoate…………………………...0.15 mg sodium methyl parahydroxybenzoate…………………………..1.50 mg Other excipients and water for injections q.s. to………….…….1 ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES_ _ Calves, lambs, swine, horses. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES_ _ SELEVIT is indicated in therapy and prophylaxis of muscular dystrophy in calves, lambs, swine; muscle overload; neuritis, myositis, myasthenia; hepatosis dietetica and microangiopathy in swine. 4.3. CONTRAINDICATIONS Do not administer to animals with known hypersensitivity to components of the preparation. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Apply normal aseptic precautions. 1/11 SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS People with known hypersensitivity to the active substances must avoid contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or th read_full_document