Belavit AD3E, Solution for Injection for Horses, Cattle, Pigs, and Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Alpha Tocopherol, Cholecalciferol, Retinol

Available from:

Bela-Pharm GmbH & Co. KG

ATC code:

QA11JA

INN (International Name):

Alpha Tocopherol, Cholecalciferol, Retinol

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Dogs, Horses, Pigs

Therapeutic area:

Vitamin

Authorization status:

Expired

Authorization date:

2019-07-12

Summary of Product characteristics

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