Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Progesterone
LAPROVET
QG03DA04
Progesterone
1.55 gram(s)
Vaginal delivery system
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
progesterone
Hormone
Authorised
2012-08-24
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 Prečítajte si celý dokument