Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
PROGESTERONE
LAPROVET
QG03DA04
PROGESTERONE
1.55 Grams
Vaginal Delivery System
POM
Bovine
Progesterone
Hormone
Authorised
2012-08-24
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 (PGF2 ). 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _7_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ Lue koko asiakirja