Lyophilisate and solvent for solution for injection for cattle and sheep. Equine serum Gonadotrophin.

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Lyophilisate vials contain: 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

INDICATION In non-cycling cattle (cows and heifers) and in ewes and ewe-lambs: Induction and synchronisation of oestrus and ovulation. To be used in combination with a progestagen.

ADVERSE REACTIONS eCG is an exogenous protein for species other than equine. Therefore, antigen-antibody reactions may result. In very rare cases, repeated administrations of eCG can provoke anaphylactic shock (see section Special Warnings).

TARGET SPECIES Cattle, Sheep.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION Intramuscular use. 500 IU of equine serum gonadotrophin (eCG) per animal in one administration corresponding to 2 ml of the reconstituted solution. The product should be administered at the time of the progestagen device withdrawal.

ADVICE ON CORRECT ADMINISTRATION Dissolve the lyophilisate with 2 ml of solvent. Mix until completely dissolved to obtain a homo­genous solution. The reconstituted solution should be used immediately.

WITHDRAWAL PERIOD Meat, offal and milk: zero days

SPECIAL STORAGE PRECAUTIONS Store in a refrigerator (2°C - 8°C). Lyophilisate: protect from light. Shelf-life after first opening the vial of solvent: 28 days. Shelf life after reconstitution according to directions: use immediately. User warnings: Care should be taken when handling the product to avoid self-injection. In case of accidental self-injection, seek medical advice, and show the package leaflet. Pregnant women, those intending to become pregnant, or whose pregnancy status is unknown, should not use the product. Special precautions for use in animals: In case of anaphylactic shock, symptomatic treatment (e.g. adrenaline or corticosteroids) should be administered. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use during pregnancy. Overdose: Administration of higher doses than the recommended doses may increase the risk of twins in cattle and triplets in sheep.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Dispose of any unused product and empty containers in accordance with the guidance from your local waste regulation authority. Pack sizes: Cardboard box containing 5 vials of lyophilisate and one vial of 10 ml solvent. Cardboard box containing 10 vials of lyophilisate and 2 vials of 10 ml solvent. Cardboard box containing 25 vials of lyophilisate and one vial of 50 ml solvent. Not all pack sizes may be marketed. Pharmacodynamic properties: Equine Serum Gonadotrophin (eCG, in the past called PMSG) is a large glycoprotein secreted during pregnancy in the mare and its structure is similar to the endogenous gonadotrophin hormones: FSH and LH. eCG exerts its effects on FSH and LH receptors of the target cells distributed in the gonads: in females, eCG supports the ovarian follicular maturation by stimulating the growth and development of antral follicles. In ovine and in non-cycling bovine females its use is recommended after a treatment for the synchronisation of oestrus with a progestagen: eCG improves follicle maturation and ovulation rate and allows synchronisation of ovulation. POM Prescription Only Medicine