Folltropin 700 IU Powder and Solvent for solution for injection 20ml.
To induce superovulation in reproductively mature heifers or cows.
Dosage and administration:
For intramuscular administration only.
Reconstitute Folltropin with Folltropin Solvent. Reconstitution and subsequent withdrawal of product should be performed using strict aseptic technique.
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 F2a or a prostaglandin F2a 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.
Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substance. 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, 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.
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, lactation or lay:
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 cows. Do not use in pregnant cows.
Interaction with other medicinal products and other forms of interaction:
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.
Meat and offal: Zero days
Milk: Zero hours
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 1 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.
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