DIB 1.0 g Vaginal Delivery System for Cattle

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Progesterone

Commercializzato da:

Syn Vet-Pharma Ireland Limited

Codice ATC:

QG03DA04

INN (Nome Internazionale):

Progesterone

Dosaggio:

1.0 gram(s)

Forma farmaceutica:

Vaginal delivery system

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapeutica:

progesterone

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2021-06-04

Scheda tecnica

Health Products Regulatory Authority
04 June 2021
CRN00CF35
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DIB 1.0 g Vaginal Delivery System for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each vaginal delivery system contains:
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Progesterone
​1.0
g​
​
EXCIPIENTS:
​
​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Vaginal delivery system.
A white winged "V" shape device covered in progesterone-impregnated
silicone, fitted with a green nylon tail to enable
removal.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (cows and heifers).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the control of the oestrous cycle in cycling cows and heifers used
in combination with prostaglandin F2α (PGF2α) or
analogue, including synchronisation of oestrus, e.g. of donor and
recipient animals for embryo transfer.
For induction and synchronisation of oestrus in fixed time artificial
insemination (FTAI) protocols:
- In cycling cows and heifers: used in combination with PGF2α or
analogue.
- In cycling and non-cycling cows and heifers used in combination with
Gonadotropin releasing hormone (GnRH) or analogue
and PGF2α or analogue.
- In non-cycling cows, used in combination with PGF2α or analogue and
equine chorionic gonadotrophin (eCG).
4.3 CONTRAINDICATIONS
Do not use in sexually immature heifers or in females with abnormal
genital tracts e.g. freemartins.
Do not use in animals presenting with infectious or non-infectious
diseases of the genital tract.
Do not use within the first 35 days after calving.
Do not use in pregnant cattle. See section 4.7
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The progesterone treatment alone, according to dosage regimen
proposed, is not sufficient to induce oestrus and ovulation in
all cycling females. Progesterone based breeding protocols are
reproduction management tools and should not replace
adequate feeding and general health management. The