Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: VMD (Veterinary Medicines Directorate)
Peforelin
VEYX-PHARMA GMBH
QH01CA95
Peforelin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Hormone sex
Authorized
2009-06-24
Revised: March 2014 AN. 01333/2012 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Maprelin 75 µg/ml solution for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: ACTIVE SUBSTANCE: Peforelin 75.00 µg EXCIPIENTS: Chlorocresol 1.00 mg For a full list of excipients, see section 6.1. 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_._ Revised: March 2014 AN. 01333/2012 Page 2 of 5 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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 should administer the product with special caution. In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. In case of accidental contact with the skin, the corresponding area should be thoroughly cleaned with soap and water, as Izlasiet visu dokumentu