SUMMARY OF PRODUCT CHARACTERISTICS. Active Ingredient Buserelin acetate (INN)

Transcription

1 1 (5) SUMMARY OF PRODUCT CHARACTERISTICS 1. Name of the veterinary medicinal product Receptal ad us. vet. 2. Qualitative and quantitative composition 1 ml contains Active Ingredient Buserelin acetate (INN) equivalent to Buserelin 0,0042 mg 0,004 mg Excipients: Benzyl alcohol (Ph. Eur., NF.) Sodium chloride (Ph. Eur., USP) Sodium dihydrogen phosphate 1 H 2 O (USP) Sodium hydroxide (BP, ÖAB, NF ) Water for injection (Ph. Eur., USP ) 3. Pharmaceutical form Injectable solution 4. Pharmacological properties Buserelin is a peptide hormone which is chemically analogous to the releasing hormone (RH) of the luteinising hormone (LH) and follicle stimulating hormone (FSH) thus a gonadotrophine releasing hormone (GnRH) analogue. The mode of action of Receptal corresponds to the physiologicendocrinological action of the naturally occurring gonadotrophin releasing hormone: GnRH leaves the hypothalamus via the hypophyseal portal vessels and enters the anterior lobe of the hypophysis. Here it induces the secretion of the two gonadotrophins FSH and LH into the peripheral blood stream. These then act physiologically to cause maturation of ovarian follicles, ovulation and luteinization in the ovary.

2 2 (5) Buserelin is rapidly eliminated from the plasma after intravenous administration, its initial half-life being minutes in rats and 12 minutes in guinea pigs. It accumulates in liver, kidneys and hypophysis; high concentrations being found in hypophyseal tissue after about 60 minutes. The inactivation of buserelin by enzymatic breakdown (peptidases) can be demonstrated in the hypothalamus and hypophysis and in liver and kidneys. 5. Clinical particulars 5.0 Target species Cows, mares, rabbits and trout 5.1 Indication for use Reduced fertility by ovarian dysfunction, induction of ovulation and improvement of conception rate. Cow: Cystic ovaries with and without symptoms of nymphomania Delayed ovulation Anovulation after artificial insemination and oestrus synchronization Prophylaxis of fertility disorders by early induction of cycle post partum. Mare: Cystic ovarian disorders with and without prolonged or continuous heat Ovulation induction Fixing time of ovulation and service Prolonged or continuous heat Rabbit: Ovulation induction at post partum insemination

3 3 (5) Rainbow trout: Facilitate stripping in rainbow trout in spawning condition. Reduce mortality due to egg binding. 5.2 Contra indications 5.3 Undesirable effects Unknown 5.4 Special precautions for use 5.5 Use during pregnancy and lactation Can be administered to animals at any stage of pregnancy and lactation 5.6 Interactions with other medicaments No interaction known 5.7 Posology and method of application Cows: Cystic ovaries with and without symptoms of nymphomania Delayed ovulation Anovulation after artificial insemination Prophylaxis of fertility disorders by early induction of cycle post partum Mares: Cystic, ovarian disorders Ovulation induction 10 ml 2 times repeated after 24 h 10 ml Rabbit Ovulation induction at post

4 4 (5) partum insemination 0,2 ml 0,2 ml 5.8 Overdose 5.9 Warnings Rainbow trout: - to facilitate stripping in spawning condition ml/kg bw - to reduce mortality due to egg binding ml/kg bw The preferred route of administration for Receptal is intramuscular injection, but it may also be injected intravenously or subcutaneously. No specific overdose reactions known 5.10 Withdrawal period 5.11 Protection of operators 6. Pharmaceutical particulars 6.1 Incompatibilities 6.2 Shelf life 5 years 6.3 Special precautions for storage Store in a cool place below 25 C, protected from light.

5 5 (5) 6.4 Nature and contents of container Colourless multi-dose vials made of glass, sealed with butyl rubber stoppers and aluminium caps. Box with 5 bottles containing 10 ml each 6.5 Name and address of the licence holder Intervet International B.V: Wim de Korverstraat 55 PO Box Boxmeer The Netherlands Name and address of manufacturer Intervet International GmbH Feldstraße 1a D Unterschleißheim Germany 6.6 Special precautions for the disposal of empty containers or waste product