Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
azagly-nafarelin
Intervet International BV
QH01CA
azagly-nafarelin
Dogs; Salmonidae (Salmonid fish)
Pituitary and hypothalamic hormones and analogues
Female salmonid fish such as Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta) and Arctic charr (Salvelinus alpinus)Induction and synchronisation of ovulation for the production of eyed-eggs and fry.Dogs (bitches)Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis.
Revision: 7
Withdrawn
2003-07-20
29/37 B. PACKAGE LEAFLET Medicinal product no longer authorised 30/37 PACKAGE LEAFLET GONAZON CONCENTRATE FOR SOLUTION FOR INJECTION OF FEMALE SALMONID FISH 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Gonazon concentrate for solution for injection of female salmonid fish 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Azagly-nafarelin 1600 g/ml as azagly-nafarelin acetate. Excipient: Benzyl alcohol 4. INDICATION(S) Induction and synchronisation of ovulation for the production of eyed-eggs and fry. 5. CONTRAINDICATIONS Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated naturally. The product should not be used in fish maintained in water temperatures that would normally inhibit ovulation as this can result in a decrease in egg quality. 6. ADVERSE REACTIONS If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Female salmonid fish such as Atlantic salmon (_Salmo salar_), rainbow trout (_Oncorhynchus mykiss_), brown trout (_Salmo trutta_) and Arctic charr (_Salvelinus alpinus_). Medicinal product no longer authorised 31/37 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 9. ADVICE ON CORRECT ADMINISTRATION Inject intraperitoneally along the central line, 1/2 to 1 fin length in front of the pelvic fin base. Fish should be anaesthetised. The dose should be administered in the preferred volume for the particular body weight of fish. The supplied solvent is used to dilute the concentrate to the correct dilution to allow for optimisation of the preferred injection volumes for fish of widely varying body weights. The empty, sterile vial is intended to be used for mixing the concentrate Les hele dokumentet
1/37 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2/37 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Gonazon concentrate for solution for injection of female salmonid fish 2. QUALITATIVE AND QUANTITATIVE COMPOSITION V IAL CONTAINING C ONCENTRATE : ACTIVE SUBSTANCE(S) Azagly-nafarelin 1600 g/ml as azagly-nafarelin acetate. EXCIPIENTS Benzyl alcohol (1%) V IAL CONTAINING S OLVENT : EXCIPIENTS Benzyl alcohol (1%) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Female salmonid fish such as Atlantic salmon (_Salmo salar_), rainbow trout (_Oncorhynchus mykiss_), brown trout (_Salmo trutta_) and Arctic charr (_Salvelinus alpinus_). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Induction and synchronisation of ovulation for the production of eyed-eggs and fry. 4.3 CONTRAINDICATIONS Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated naturally. The product should not be used in fish maintained in water temperatures that would normally inhibit ovulation as this can result in a decrease in egg quality. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin. In some cases this can be related to the use of the compound too early in the spawning season. Medicinal product no longer authorised 3/37 It is recommended to strip fish after injection at intervals of approximately 50-100 degree days. For Arctic charr, injections should be given only if the water temperature is < 8°C. The long term effects of azagly-nafarelin on treated broodstock fish have not been studied. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS High standards of biosecurity must be observed at the time of injection in order to prevent introduction and spread of infectious diseases between broodstock fish. SPECIAL PRECAUTIONS Les hele dokumentet