País: Romania
Idioma: anglès
Font: HMA (Heads of Medicines Agencies)
progesterone 1.38 g
Pfizer Limited
QG03DA04
Vaginal device
progesterone
Cattle
2012-01-03
Revised: March 2013 AN: 00091/2012 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CIDR 1.38g (_In AT, BE, BG, CY, CZ, EE, FI, FR, DE, EL, HU, IE, IT, LI, LT, LU, MT, NL, PL, PT, _ _RO, SL, SK, ES, UK_) Relmont Vet (_In DK, IS, NO and SE_) Vaginal Delivery System for Cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE(S): Each device contains Progesterone. 1.38 g. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal delivery system. A “T” shape device consists of progesterone impregnated silicone elastomer skin moulded over an inert nylon spine. 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, including: - Synchronisation of oestrus in groups of animals. - Synchronisation of donor and recipient animals for embryo transfer. To be used in combination with prostaglandin F2 or analogue. Use as recommended normally results in oestrus 48-96 hours after device removal with the majority of animals showing oestrus within 48-72 hours. 4.3 CONTRAINDICATIONS Do not use: - in cows or heifers, with abnormal or immature genital tracts, or with genital infections. - in pregnant cattle. - within the first 35 days after calving. 4.4 SPECIAL WARNINGS Revised: March 2013 AN: 00091/2012 Page 2 of 5 The progesterone treatment alone, according to dosage regimen proposed, is not sufficient to induce oestrus and ovulation in all cycling females. It is advisabl Llegiu el document complet