Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
peforelin 75 µg/ml
Veyx-Pharma GmbH
QH01CA
Solution for injection
releasing hormones
Pigs
2009-04-24
Veyx Pharma GmbH MAPRELIN ® Part 1 B. 1 SUMMARY OF PRODUCT CHARACTERISTICS 1 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 biotechnical 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 _. _ Veyx Pharma GmbH MAPRELIN ® Part 1 B. 1 SUMMARY OF PRODUCT CHARACTERISTICS 2 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. Persons with a known hypersensitivity to GnRH analogues or any of the excipients should not administer the product. Pregnant women should not administer the produ Read the complete document