Land: Portugal
Språk: engelsk
Kilde: HMA (Heads of Medicines Agencies)
chorionic gonadotrophin 200 IU, serum gonadotrophin 400 IU
CEVA Santé Animale
QG03GA01
Powder and solvent for solution for injection
Gonadotropins, combinations
Pigs Females
2012-02-13
1/5 Dokument1 Oct. 10 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2/5 Dokument1 Oct. 10 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Syncrostim 500 IU lyophilisate and solvent for solution for injection for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lyophilisate vials contains: ACTIVE SUBSTANCE: Equine serum Gonadotrophin (eCG, formerly known as PMSG) ............... 500 IU Solvent vial contains: Benzyl alcohol....................................................................................... 16.5 mg /ml Reconstituted solution for 1 dose of 2 ml contains: ACTIVE SUBSTANCES Equine serum Gonadotrophin (eCG, formerly known as PMSG) 500 IU EXCIPIENTS Benzyl alcohol 33.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection Lyophilisate: freeze-dried product in the form of powder agglomerated in cotton-like pellets. Solvent: clear colourless solution. Reconstituted solution: clear colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, Sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In non cycling cattle (cows and heifers) and in ewes and ewe-lambs: Induction and synchronization of oestrus and ovulation. To be used in combination with a progestagen. 4.3 CONTRAINDICATIONS See section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS 3/5 Dokument1 Oct. 10 In case of anaphylactic shock, symptomatic _ _ treatment (e.g. adrenaline or corticoste Les hele dokumentet