CHRONOGEST CR 20 MG CONTROLLED RELEASE VAGINAL SPONGE FOR SHEEP
Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Résumé des caractéristiques du produit
(SPC)
20-08-2016
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Ingrédients actifs:
FLUGESTONE ACETATE
Disponible depuis:
Intervet Ireland Limited
Code ATC:
QG03D
DCI (Dénomination commune internationale):
FLUGESTONE ACETATE
Dosage:
20 Milligram
forme pharmaceutique:
Sponge
Type d'ordonnance:
POM
Groupe thérapeutique:
Ovine
Domaine thérapeutique:
PROGESTOGENS
indications thérapeutiques:
Hormone
Statut de autorisation:
Authorised
Date de l'autorisation:
1987-10-01
Résumé des caractéristiques du produit
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
3 PHARMACEUTICAL FORM
Vaginal sponge
White sponge with continuous Chronolone line forming a ring-like structure on the round surface of the sponge (5-7
rings per sponge).
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep (ewes, ewe lambs)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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
The use in pregnant females is contraindicated.
4.4 SPECIAL WARNINGS FOR EACH 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.
EACH SPONGE CONTAINS:
_Active substance:_
Flugestone acetate
20 mg
For full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 05/08/2016_
_CRN 7024293_
_page number: 1_
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 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 t
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