Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
PEFORELIN
Veyx-Pharma GmbH
QH01CA
PEFORELIN
75 Microgram/ML
Solution for Injection
POM
Porcine
Gonadotropin-releasing hormones
Hormone
Authorised
2009-07-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Maprelin 75 microgram/ml solution for injection for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows and gilts) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For zootechnical use and intended for group or herd treatment. Induction of the oestrous cycle in sows after weaning Induction of oestrus in sexually mature gilts following therapy to inhibit the oestrus cycle with progestagens 4.3 CONTRAINDICATIONS Do not use in prepubertal gilts, in case of infertility or general health disorders. Do not use in case of hypersensitivity to the active substance or to any of the excipients_._ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 1 ml solution for injection contains: ACTIVE SUBSTANCE Peforelin 75.00 µg EXCIPIENT(S) Chlorocresol 1.00 mg For a full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/08/2013_ _CRN 7014046_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS The product might induce irritation and sensitization. People with known hypersensitivity to GnRH analogues or any of the excipients should avoid contact with the veterinary medicinal product. The veterinary medicinal product should not be administered by pregnant women, as an accidental self-injection by the user cannot be excluded and because GnRH analogues have been shown to be foetotoxic in laboratory animals. Women of childbearing age Izlasiet visu dokumentu