Страна: Австрия
Език: английски
Източник: HMA (Heads of Medicines Agencies)
gonadorelin diacetate 50 µg
CEVA Animal Health
QH01CA01
Solution for injection
gonadorelin
Cattle Other
2011-07-07
Revised: August 2012 AN : 01289/2011 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT OVARELIN 50 µg/ml, solution for injection for cattle [AT, BE, DE, HU, IE, LU, NL, NO, PL, PT, UK] OVUGEN 50 µg/ml, solution for injection for cattle [ES] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Composition for 1 ml: _ ACTIVE SUBSTANCE (S):_ _ Gonadorelin (as diacetate tetrahydrate) ........................... 50.0 µg EXCIPIENT Benzyl alcohol ...................................................................... 15.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle: cows, heifers. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of delayed ovulation (repeat breeding). A repeat breeder cow or heifer is generally defined as an animal that has been inseminated at least 2 or often 3 times without becoming pregnant, despite having regular normal œstrus cycles (every 18 -24 days), normal œstrus behaviour and no clinical abnormalities of the reproductive tract. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: August 2012 AN : 01289/2011 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Not applicable. ii. Special precautions to be taken by the person administering the medicinal product to animals Care should be taken when handling the product to avoid self-injection. Acciden Прочетете целия документ