Powder and solvent for solution for injection. Powder: Freeze dried off-white powder. Solvent: Clear, colourless solution. Reconstituted solution: Clear, slightly pink solution.

To induce superovulation in reproductively mature heifers or cows.

For intramuscular administration only.

Dissolve each vial of freeze-dried product with the enclosed solvent. Reconstitution and subsequent withdrawal of product should be performed using strict aseptic technique.

Regimen:

Start injections on day 8 to 10 following observed or induced oestrus. Administer 2.5 ml (87.5 I.U.) of Folltropin intramuscularly, twice daily, for 4 days. In conjunction with the 6th dose of Folltropin, administer prostaglandin F2α or a prostaglandin F2α analogue, at their manufacturer's recommended dose, to cause luteolysis.

Inseminate animals at 12 and 24 hours after the onset of oestrus or 60 and 72 hours after prostaglandin treatment. Additional inseminations may be conducted at 12 hour intervals if indicated.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in males and reproductively immature female cattle.

Do not use in pregnant cattle.

Special precautions for use in animals:

The product should only be used in clinically healthy cows and mature heifers, which are cycling normally. There is a wide range in response to superovulation between animals. There may be a small proportion of non-responders in any group treated.

Collection of embryo is normally started on day 7 following observed oestrus or first breeding. Prior to breeding and the collection of fertilized embryo from these animals, oestrus will have to be induced with prostaglandin F2α or a prostaglandin F2α analogue.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Care should be taken when handling the product to avoid self-injection. Accidental self-injection of FSH may cause biological effects in women and to the unborn child. In case of accidental self- injection in women who are pregnant, or whose pregnancy status is unknown, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness):

Following the administration of the product for three superovulation cycles, ovarian cysts occurred in some cows, but these did not prevent pregnancy. Following superovulation a delayed return to heat is possible.

Laboratory studies with FSH in rats and rabbits have shown evidence of embryotoxicity/foetotoxicity. The safety of the product has not been assessed in pregnant cattle. Do not use in pregnant cattle.

Interaction with other medicinal products and other forms of interaction:

None known.

Overdose (symptoms, emergency procedures, antidotes), if necessary:

Cows were able to respond to the product consistently throughout a series of 3 treatments. No adverse reactions were detected in treated cows after the injection of 400 mg Folltropin as a single dose.

Withdrawal period(s):

Meat and offal: Zero days

Milk: Zero hours

Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.

Freeze dried powder and solvent vials: Do not store above 25ºC.

Reconstituted solution: Store in a refrigerator (2 - 8ºC).

Keep the vials in the outer carton in order to protect from light.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Cardboard box containing one vial of powder and one vial of solvent.

Clear glass 20 ml vial (Type I), with halobutyl rubber stopper (Type I) and red flip-off cap.

Clear glass 20 ml vial (Type I), with halobutyl rubber stopper (Type I) and yellow flip-off cap.

Follicle Stimulating Hormone from an extract of porcine pituitary glands for use in cattle.

Pharmacotherapeutic group: Sex hormones and modulators of the genital system, gonadotrophins.

ATCvet code: QG03GA90

Pharmacodynamic properties: FSH is the initiator of ovarian activity since it directly promotes growth of ovarian follicles. The administration of exogenous FSH to mammals at the time of follicular wave emergence stimulates growth of all follicles over 1.7 mm diameter which would normally be lost to atresia during each oestrus cycle. Multiple growing follicles require FSH stimulation until they are mature enough to respond to LH for the final stages of maturation and ovulation. This usually takes a period of approximately 4 days. In cattle, fertilised ova produced by superovulation with FSH, PMSG and other pharmacological agents containing high concentrations of LH have shown reduced fertilisation. Folltropin contains porcine pituitary extract with FSH activity and low LH activity.

Pharmacokinetic particulars: When administered by intramuscular injection, FSH of porcine origin is rapidly absorbed from the site of injection. It has a half-life of 5 hours and FSH cannot be detected in the blood stream 12 hours after injection. FSH is inactivated by the liver and then excreted by the kidneys.