Chronogest CR, 20 mg Controlled Release Vaginal Sponge for Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Flugestone Acetate

Available from:

Intervet International BV

ATC code:

QG03D

INN (International Name):

Flugestone Acetate

Pharmaceutical form:

Vaginal sponge

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Sheep

Therapeutic area:

Hormone sex

Authorization status:

Authorized

Authorization date:

2005-06-21

Summary of Product characteristics

Revised: August 2014
AN: 00321/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Chronogest CR, 20 mg controlled release vaginal sponge for sheep.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each polyester polyurethane sponge contains
ACTIVE SUBSTANCE(S)
Flugestone acetate, 20 mg.
LIST OF EXCIPIENTS
Excipients qsp 1 sponge.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Vaginal sponge.
White cylindrical polyester polyurethane foam equipped with string.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep (ewes and ewe-lambs).
4.2
INDICATIONS FOR USE
In ewes and ewe lambs, in combination with PMSG (Pregnant Mare Serum
Gonadotrophin)
-
Induction and synchronization of oestrus and ovulation (non cycling
ewes during
seasonal anoestrus and ewe lambs).
-
Synchronization of oestrus and ovulation (cycling ewes and ewe-lambs).
4.3
CONTRAINDICATIONS
Please refer to section 4.7 and section 4.8.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
-
The repeated treatment with the product combined with PMSG may trigger
the appearance of PMSG antibodies in some ewes. This in turn may
affect
the time of ovulation and result in reduced fertility when combined
with
fixed time artificial insemination at 55h following sponge removal.
Page 1 of 4
Revised: August 2014
AN: 00321/2014
-
The repeated use of sponges within one year has not been studied.
-
The use of a vaginal applicator designed for ewes or ewe lambs is
recommended to correctly insert sponges and to avoid vaginal injuries.
(ii)
Special precautions to be taken by the person administering the
medicinal product to animals
- Direct contact with the skin should be avoided. Personal protective
clothing
(single use gloves) should be worn when handling the product.
If
accidental contact with the skin occurs, wash the affected zone with
soap
and water. Wash hands after treatment and before meals.
-
Human exposure to this product can affect fertility.
- Women who are pregnant, or