Carofertin 10 mg/ml Emulsion for injection for cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betacarotene

Available from:

Alvetra u. Werfft GmbH

ATC code:

QA11CA02

INN (International Name):

Betacarotene

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

betacarotene

Therapeutic indications:

Vitamins and minerals

Authorization status:

Authorised

Authorization date:

2016-02-12

Summary of Product characteristics

Health Products Regulatory Authority
07 September 2020
CRN009HCL
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Carofertin 10 mg/ml Emulsion for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
1 ml contains:
​
​
​
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Betacarotene
10.00
​mg
​
​
​
​
EXCIPIENTS:
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​
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Benzyl alcohol (E1519)
​
10.00
​mg
​
Ascorbyl palmitate (E304)
​
0.12
​mg
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All‐rac‐α‐tocopherol
​
0.10
​mg
​
​
​
​
For the full list of excipients, see section 6.1
​
​
3 PHARMACEUTICAL FORM
Emulsion for injection.
Clear, dark red emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (cows/heifers), pig (sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention and treatment of beta‐carotene deficiency and
beta‐carotene deficiency related fertility disorders, which can
arise during phases of insufficient nutritional supply.
4.3 CONTRAINDICATIONS
Do not use in newborn animals because of the presence of benzyl
alcohol. Do not use in known cases of hypersensitivity to
macrogol stearate, or in case 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
None
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Care should be taken to avoid accidental self‐injection.
In case of accidental self‐injection, seek medical advice
immediately and show the package leaflet or the label to the
physician.
People with known hypersensitivity to betacarotene or to any of the
excipients should administer the veterinary medicinal
product with caution.
Wash hands after use.
Health Products Regulatory Authority
07 September 2020
CRN009HCL
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Swelling at the site of the injection occurs very rarely.. This
usually resolves without t