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.
Use during pregnancy
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
Major incompatibilities:
Do not mix with any other veterinary medicinal product except the solvent supplied for use with the veterinary medicinal product.