Carofertin 10 mg/ml Emulsion for Injection for Cattle and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

B Carotene

Available from:

VMD NV

ATC code:

QA11CA02

INN (International Name):

B Carotene

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Vitamin

Authorization status:

Authorized

Authorization date:

2016-06-22

Summary of Product characteristics

Revised: January 2021
AN: 01607/2020
Page 1 of 5
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:
Benzyl alcohol (E1519).......10.00 mg
Ascorbyl palmitate (E304).....0.12 mg
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.
Revised: January 2021
AN: 01607/2020
Page 2 of 5
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.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Swelling at the site of the injection occurs very rarely.. This
usually resolves without
the need for treatment.
Due to the content of macrogol-15-hydroxystearate, there is a rare
possibility of
allergy-related or pseudo-allerg