Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Chorionic Gonadotrophin, Serum Gonadotrophin
Ceva Animal Health Ltd
Chorionic Gonadotrophin, Serum Gonadotrophin
Powder and solvent for solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Hormone sex
Expired
2010-01-22
Revised: October 2014 AN: 01873/2013 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fertipig HCG 40 IU/ml / PMSG 80 IU/ml lyophilisate and solvent for solution for injection for pigs [AT, DE, DK, IE, UK] Fertipig lyophilisate and solvent for solution for injection for pigs [BE, BG, CY, EL, ES, FR, HU, IT, LU, NL, PL, PT, RO, SK] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lyophilisate vial contains: ACTIVE SUBSTANCES Equine serum gonadotrophin (PMSG) 2 000 IU Gonadotrophin chorionic (HCG) 1 000 IU Solvent vial contains: EXCIPIENTS Benzyl alcohol (E1519) 375 mg One ml of reconstituted solution contains: ACTIVE SUBSTANCES Equine serum gonadotrophin (PMSG) 80 IU Gonadotrophin chorionic (HCG) 40 IU EXCIPIENTS Benzyl alcohol (E1519) 15 mg Reconstituted solution for 1 dose of 5 ml contains: ACTIVE SUBSTANCES Equine serum gonadotrophin (PMSG) 400 IU Gonadotrophin chorionic (HCG) 200 IU EXCIPIENTS Benzyl alcohol (E1519) 75 mg For the full list of excipients, see section 6.1.. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection. Lyophilisate: white to off-white freeze-dried powder. Solvent: clear colourless solution. Reconstituted solution: clear colourless solution. Revised: October 2014 AN: 01873/2013 Page 2 of 6 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES To sows after weaning: • Induction and synchronization of œstrus within 7 days following the treatment. • Reduction of the weaning to oestrus interval in sows with late oestrus. • Treatment of the seasonal anoestrus. 4.3 CONTRAINDICATIONS Do not administer to pregnant animals Do not administer to animals with known hypersensitivity to the active substances or to any of the excipients. Do not administer to sows with follicular cysts. 4.4 SPECIAL WARNINGS Treatment during the primary luteinised phase or in the middle of the cycle may increase the risk of ovarian cysts development. Do not adjust the dose. Increased doses do not incr Read the complete document