Chronogest CR, 20 mg Controlled Release Vaginal Sponge for Sheep

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Flugestone Acetate

Tersedia dari:

MSD Animal Health UK Limited

Kode ATC:

QG03D

INN (Nama Internasional):

Flugestone Acetate

Bentuk farmasi:

Vaginal sponge

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Sheep

Area terapi:

Hormone sex

Status otorisasi:

Authorized

Tanggal Otorisasi:

2005-06-21

Karakteristik produk

Revised: January 2024
AN: 00005/2023
Page 1 of 5
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 sponge contains:
ACTIVE SUBSTANCE:
17.9 mg flugestone equivalent to 20 mg flugestone acetate.
EXCIPIENTS:
Hydroxypropylcellulose
20 mg
Macrogol 4000
20 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White cylindrical polyester polyurethane medicated sponge equipped
with string.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep (ewe and ewe lamb).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In ewes and ewe lambs, in combination with PMSG (Pregnant Mare Serum
Gonadotropin)
-
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
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: January 2024
AN: 00005/2023
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
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.
-
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.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Personal protective equipment consisting of single use gloves should
be worn when
handling the veterinary medicinal product.
The veterinary medicinal product should not be administered by
pregnant women or
women suspected to be pregnant.
Direct contact with the skin should be avoided.
If accidental contac