Chronogest CR 20 mg controlled release vaginal sponge for sheep

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Flugestone acetate

Доступно од:

Intervet Ireland Limited

АТЦ код:

QG03D

INN (Међународно име):

Flugestone acetate

Дозирање:

20 mg/sponge

Фармацеутски облик:

Medicated sponge

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска група:

Sheep

Терапеутска област:

PROGESTOGENS

Терапеутске индикације:

Hormone

Статус ауторизације:

Authorised

Датум одобрења:

1987-10-01

Карактеристике производа

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:
Flugestone acetate 20 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Hydroxypropylcellulose
Macrogol 4000
Water for injections
White sponge with continuous chronolone line forming a ring-like
structure on the round surface of
the sponge (5 - 7 rings per sponge).
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Sheep (ewes, ewe lambs).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
In ewes and ewe lambs, in combination with PMSG (Pregnant Mare Serum
Gonadotrophin)
- Induction and synchronisation of oestrus and ovulation (non-cycling
ewes during seasonal anoestrus
and ewe lambs).
- Synchronisation of oestrus and ovulation (cycling ewes and
ewe-lambs).
3.3
CONTRAINDICATIONS
Do not use in pregnant females.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
The use of a vaginal applicator designed for ewes or ewe lambs is
recommended to correctly insert
sponges and to avoid vaginal injuries.
The repeated treatment with the veterinary medicinal 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 artificial insemination.
The repeated use of sponges within one year has not been studied.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
Direct contact with the skin should be avoided. Personal protective
clothing, consisting of single use
gloves should be worn when handling the veterinary medicinal 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 veterinary medicinal product can affect
fertility.
Women who are pregnant, or suspected to be pregnant, sh