Regumate Equine 2.2 mg/ml Oral Solution for Horses

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Altrenogest

Available from:

MSD Animal Health UK Limited

ATC code:

QG03DX90

INN (International Name):

Altrenogest

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Hormone sex

Authorization status:

Authorized

Authorization date:

2005-04-05

Summary of Product characteristics

Revised: August 2020
AN: 00299/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Regumate Equine 2.2 mg/ml oral solution for horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Altrenogest
2.20 mg
EXCIPIENTS:
Butylhydroxyanisole (E320)
0.07 mg
Butylhydroxytoluene (E321)
0.07 mg
Sorbic acid (E200)
1.50 mg
Benzyl alcohol
10.00 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral Solution.
Clear, light yellow oily solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses (mares).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In
mares
with
significant
follicular
activity
during
the
transitional
period
between seasonal anoestrus and the breeding season (follicles of at
least 20-
25 mm present at the beginning of treatment):
•
Suppression/prevention of oestrus (usually after 1 to 3 days of
treatment)
during the prolonged oestrus periods occurring during this period.
•
Control of the time of initiation of oestrus (approximately 90% of
mares
show signs of oestrus within 5 days following the end of treatment)
and
synchronization of ovulation (60% of mares ovulate between days 11 and
14 following the end of treatment).
4.3
CONTRAINDICATIONS
Do not use in mares where uterine infection has been diagnosed.
Do not use in males.
Revised: August 2020
AN: 00299/2020
Page 2 of 5
4.4
SPECIAL WARNINGS
In order to ensure effective use of the product, the presence of
follicular
activity in mares must be confirmed during the transitional period.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
The medicated feed should be offered to mares being treated as soon as
the
product has been added, and not stored. Part consumed feed must be
safely
destroyed and not given to any other animal.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
- Women who may be, or are pregnant, should not use the product.
Women of chil