Chronogest CR, 20 mg Controlled Release Vaginal Sponge for Sheep

Држава: Велика Британија

Језик: Енглески

Извор: VMD (Veterinary Medicines Directorate)

Активни састојак:

Flugestone Acetate

Доступно од:

MSD Animal Health UK Limited

АТЦ код:

QG03D

INN (Међународно име):

Flugestone Acetate

Фармацеутски облик:

Vaginal sponge

Тип рецептора:

POM-V - Prescription Only Medicine – Veterinarian

Терапеутска група:

Sheep

Терапеутска област:

Hormone sex

Статус ауторизације:

Authorized

Датум одобрења:

2005-06-21

Карактеристике производа

Revised: July 2020
AN: 00391/2020
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 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.
Revised: July 2020
AN: 00391/2020
Page 2 of 5
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.
-
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 preg