Država: Italija
Jezik: angleščina
Source: HMA (Heads of Medicines Agencies)
deslorelin acetate 2.1 mg
Arnolds Veterinary Products Limited
QH01CA
Implant
releasing hormones
Horses
2010-02-17
Revised 17/06/2010 – AN 00299/2009 1/5 1. NAME OF VETERINARY MEDICINAL PRODUCT Ovuplant ® 2.1 mg Implantation Tablets for Horses (Mares) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each implantation tablet supplies 2.1 mg Deslorelin (as Deslorelin Acetate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Implantation tablets. Solid cylindrical implant for subcutaneous use. The implant is approximately 2.3 mm in diameter and 3.6 mm in length and is supplied in a preloaded plastic syringe with an attached stainless steel needle. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses (non-pregnant mares) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In mares: zootechnical treatment for the induction of ovulation within 48 hours, during oestrus in normally cycling mares (in sexual season), with an ovarian follicle greater than 30 mm diameter. 4.3 CONTRAINDICATIONS _Cf. Section 4.7_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Mares should be implanted with the veterinary medicinal product when a developing ovarian follicle greater than 30 mm in diameter has been detected by rectal palpation and/or ultrasonography. In larger breeds, it may be necessary to wait until the dominant follicle has progressed to 35 mm in diameter before administration of the veterinary medicinal product. Treated mares should be bred or inseminated within the next 48 hours. The mare should be monitored to ensure that ovulation has occurred and that further breedings are not required. If ovulation does not occur within 48 hours of implantation, continue breeding according to routine management procedures. It has been noted that follicles were s Preberite celoten dokument