Prid delta 1.55 g vaginal delivery system for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Progesterone

Available from:

Ceva Santé Animale

ATC code:

QG03DA04

INN (International Name):

Progesterone

Dosage:

1.55 gram(s)

Pharmaceutical form:

Vaginal delivery system

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

progesterone

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2010-12-10

Summary of Product characteristics

Health Products Regulatory Authority
05 May 2020
CRN00915T
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Prid delta 1.55 g vaginal delivery system for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivery system contains:
ACTIVE SUBSTANCE:
1.55 g of progesterone
EXCIPIENTS:
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Vaginal delivery system.
Whitish triangular device with a tail.
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 œstrus cycle in cows and heifers including:
- Synchronisation of œstrus including fixed time artificial
insemination (FTAI) protocols.
- Synchronisation of oestrus of donor and recipient animals for embryo
transfer. To be used in combination with a
prostaglandin (PGF2a or analogue)
- Induction and synchronisation of œstrus in cycling and non cycling
cattle including fixed time artificial insemination (FTAI)
protocols.
- In cycling cattle. To be used in combination with prostaglandin
(PGF2α) or analogue.
- In cycling and non-cycling cattle. To be used in combination with
gonadotropin releasing hormone (GnRH) or analogue and
PGF2α or analogue.
- In non-cycling cattle. To be used in combination with PGF2α or
analogue and equine chorionic gonadotrophin (eCG).
4.3 CONTRAINDICATIONS
Do not use in sexually immature heifers or females with abnormal
genital tracts e.g. freemartins.
Do not use before 35 days have passed since previous calving.
Do not use in animals suffering from infectious or non-infectious
disease of the genital tract.
Do not use in pregnant animals. See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The percentage of cows displaying oestrus within a given period
following treatment is usually greater than in untreated cows
and the subsequent luteal phase is of normal duration. However, the
progesterone treatment alone, according to dosage
regimen proposed, is not sufficient to induce oest