PRID E 1.55 g vaginal delivery system for cattle

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Progesterone

Disponibil de la:

LAPROVET

Codul ATC:

QG03DA04

INN (nume internaţional):

Progesterone

Dozare:

1.55 gram(s)

Forma farmaceutică:

Vaginal delivery system

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Cattle

Zonă Terapeutică:

progesterone

Indicații terapeutice:

Hormone

Statutul autorizaţiei:

Authorised

Data de autorizare:

2012-08-24

Caracteristicilor produsului

Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
PRID E 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 a 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 in cycling cattle. To be used in
combination with a prostaglandin (PGF2α).
4.3 CONTRAINDICATIONS
Do not use in sexually immature heifers.
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 progesterone treatment alone, according to dosage regimen
proposed, is not sufficient to induce oestrus and ovulation in
all cycling females.
In order to optimise the protocol, it is advisable to determine
cycling ovarian activity before using the progesterone treatment.
Animals in poor condition, whether from illness, inadequate nutrition,
or other factors, may respond poorly to treatment.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
It is recommended to wait a minimum of 35 days following parturition
before starting the treatment with this product.
Special precautions to be taken by the person administering the
medicinal product to animals
Gloves must be worn when handling the product both during insertion
and removal.
Do not eat or drink when handling the product.
Wash hands after use.
Health Products Regulatory Authority
25 June 2019
CRN0094HY
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
During the course of the s