DIB 1.0 g Vaginal Delivery System for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Progesterone

Available from:

Syn Vet-Pharma Ireland Limited

ATC code:

QG03DA04

INN (International Name):

Progesterone

Dosage:

1.0 gram(s)

Pharmaceutical form:

Vaginal delivery system

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

progesterone

Authorization status:

Authorised

Authorization date:

2021-06-04

Summary of Product characteristics

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:
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​
​
ACTIVE SUBSTANCE:
​
​
​
Progesterone
​1.0
g​
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EXCIPIENTS:
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​
​
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