Země: Velká Británie
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
cloprostenol 75 µg/ml
Laboratorios Syva SA
QG02AD90
Solution for injection
cloprostenol
Cattle Females, Cattle Food, Pigs Females, Pigs Food
2011-08-25
_LUTEOSYL_ _(d)-Cloprostenol _ _0.075 mg/ml Solution for injection _ PART 1 February-2009 OUTHER PACKAGE 1 VIAL OF 2 ML/ 1 VIAL OF 10 ML/ 1 VIAL OF 20 ML/ 5 VIALS OF 20 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT LUTEOSYL 0.075 mg/ml solution for injection for cows and sows. 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES d-Cloprostenol (as d-cloprostenol sodium) 0.075 mg/ml Chlorocresol 1 mg/ml 3. PHARMACEUTICAL FORM Solution for injection. 4. PACKAGE SIZE 1 vial of 2 ml 1 vial of 10 ml 1 vial of 20 ml 5 vials of 20 ml. 5. TARGET SPECIES 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use. Read the package leaflet before use. 8. WITHDRAWAL PERIOD COWS: Meat and offal: 1 day. Milk: 0 hours. SOWS: Meat and offal: 1 day. 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use _LUTEOSYL_ _(d)-Cloprostenol _ _0.075 mg/ml Solution for injection _ PART 1 February-2009 10. EXPIRY DATE EXP {_month/year_} Once opened, use by 28 days. 11. SPECIAL STORAGE CONDITIONS Protect from light. Avoid introduction of contamination. _LUTEOSYL_ _(d)-Cloprostenol _ _0.075 mg/ml Solution for injection _ PART 1 February-2009 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: read package leaflet. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE. For animal treatment only - to be supplied only on veterinary prescription. 14. THE WORDS “KEEP OUT OF Přečtěte si celý dokument
_LUTEOSYL_ _(d)-Cloprostenol _ _0.075 mg/ml Solution for injection _ PART 1 February-2009 _ _ _1B1. SUMMARY OF PRODUCT CHARACTERISTICS _ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT LUTEOSYL 0.075 mg/ml solution for injection for cows and sows (In Poland: LUTEOSYL 0.075 mg/ml solution for injection for cattle and pigs) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: d-Cloprostenol (as d-cloprostenol sodium)..............................0.075 mg/ml EXCIPIENTS: Chlorocresol .............................................................................1 mg/ml For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution, free from particles in suspension. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cows and sows. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES COWS _LUTEOSYL_ _(d)-Cloprostenol _ _0.075 mg/ml Solution for injection _ PART 1 February-2009 INDICATIONS FOR REPRODUCTION: synchronization or induction of oestrus. Induction of parturition. THERAPEUTIC INDICATION: ovarian dysfunction (persistent corpus luteum, luteal cyst), interruption of pregnancy including foetal mummification, endometritis/pyometra, delayed uterine involution. SOWS INDICATIONS FOR REPRODUCTION: Induction of parturition. 4.3 CONTRAINDICATIONS Do not use in gestating animals unless it is desirable to induce parturition or interruption of pregnancy. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS As with parenteral administration of any substance, basic antisep Přečtěte si celý dokument