SELEVIT, solution for injection for calves, lambs, swine, horses

Country: Կիպրոս

language: հունարեն

source: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες

SPC SPC (SPC)
30-11-2022

active_ingredient:

GRANTED

MAH:

QA11AA03

ATC_code:

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

INN:

GRANTED

pharmaceutical_form:

FATRO SpA ITALY

administration_route:

SOLUTION FOR INJECTION

therapeutic_group:

N. A. CHANCE TRADING CO

leaflet_short:

Withdrawal period: CALVES LAMBS PIGS HORSES; Distributor: MULTIVITAMINS, COMBINATIONS

SPC

                                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.
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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
                                
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