Belavit AD3E, solution for injection for horses, cattle, pigs, and dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Retinol palmitate ; dl-alpha tocopherol acetate; Colecalciferol concentrate (oily form)

Available from:

Bela-Pharm GmbH & Co. KG

ATC code:

QA11JA

INN (International Name):

Retinol palmitate ; dl-alpha tocopherol acetate; Colecalciferol concentrate (oily form)

Dosage:

176.47,50.00,100.00 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic area:

Combinations of vitamins

Authorization status:

Authorised

Authorization date:

2019-07-26

Summary of Product characteristics

Health Products Regulatory Authority
05 January 2022
CRN00CMKP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Belavit AD3E, solution for injection for horses, cattle, pigs, and
dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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1 ml solution for injection contains
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​
​
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Retinol palmitate
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176.47
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mg
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(equivalent to 300,000 I.U. Vitamin A)
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​
​
all-rac alpha tocopheryl acetate
​
50.00
​
mg
​
(equivalent to 45.56 mg alpha-tocopherol)
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​
​
(Vitamin E)
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​
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Oily solution of cholecalciferol
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100.00
​
mg
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(contains 2.5 mg cholecalciferol; equivalent to 100,000 I.U. Vitamin D
3
)
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​
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For the full list of excipients, see section 6.1.
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​
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.
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 immedia