Folltropin-V (Canada)

Manufacturer: Bioniche Animal Health

Porcine Pituitary Follitropin Extract (PPFE)

Follicle Stimulating Hormone (FSH) for Injection

Sterile

DIN 00867357

Veterinary Use Only

Folltropin-V Indications

For use in reproductively mature heifers or cows to induce a superovulation.

Description

FOLLTROPIN^®-V is a purified follitropin extract obtained from carefully selected porcine pituitary glands. It is lyophilized to maintain potency under normal storage conditions. Each 20 mL vial contains FSH equivalent to 400 mg NIH-FSH-P1*. When reconstituted according to label directions the final solution contains 20 mg/mL. FOLLTROPIN^®-V Diluent is a 20 mL vial of Bacteriostatic Sodium Chloride Injection USP.

Storage

Store FOLLTROPIN^®-V and FOLLTROPIN^®-V Diluent at room temperature (15-30°C). Once reconstituted, FOLLTROPIN^®-V should be stored at 2-7°C (36-45°F) for no longer than 5 days. Discard any unused portion of the reconstituted FOLLTROPIN^®-V solution.

DISCUSSION: It has been previously demonstrated that the ratio of follicle stimulating hormone (FSH) to luteinizing hormone (LH) present in pituitary extracts affects the ability of the ovary to respond to exogenous gonadotropin treatment.^1,2,3 Mean ovulation rates have been shown to decrease when the LH:FSH ratio increases.¹ Previous FSH preparations have been shown to contain large amounts of LH and to vary greatly in the LH:FSH ratio.^1,3-6 Prior to breeding and the collection of fertilized embryo from these animals, estrus will have to be induced with prostaglandin F2α or a prostaglandin F2α analogue.

Dosage and Administration

Reconstitute FOLLTROPIN^®-V with FOLLTROPIN^®-V Diluent. Reconstitution and subsequent withdrawal of product should be performed using strict aseptic technique. Start injections on day 8 to 10 following observed or induced estrus.

Regimen: Administer 2.5 mL (50 mg*) of FOLLTROPIN^®-V intramuscularly, twice daily, for four days. Administer prostaglandin F2α or a prostaglandin F2α analogue, at their manufacturer’s recommended dose to cause luteolysis, in conjunction with the 6th dose of FOLLTROPIN^®-V. Breed animals at normal times following observed estrus or as indicated by the manufacturer of the prostaglandin injection. Collection of embryo is normally started on day 7 following observed estrus or first breeding.

POTENCY AND PURITY: The purification and quality control procedures used in preparing FOLLTROPIN^®-V ensure consistently low LH:FSH ratios.^3,6 Reconstituted FOLLTROPIN^®-V has approximately 20 mg/mL of NIH-FSH-P1 activity.

Warning

Treated animals must not be slaughtered for use in food for at least 10 days after latest treatment with this drug.

CAUTIONS: Do not use this product in swine. In the event of a hypersensitivity reaction, administer epinephrine.

PACKAGING: 20 mL vial of 400 mg* FSH with 20 mL diluent.

* Equivalent to National Institutes of Health (U.S.A.) Reference Standard NIH-FSH-P1.

REFERENCES

1. Chupin, D., Y. Combarnous and R. Procurer (1984). Antagonistic effect of LH on FSH-induced superovulation in cattle. Theriogenology 21:229.

2. Chupin, D., Y. Combarnous and R. Procurer (1985). Different effect of LH on FSH-induced superovulation in two breeds of cattle. Theriogenology 23:184.

3. Armstrong, D.T. and M.A. Opavsky (1986). Biological characterization of a pituitary FSH preparation with reduced LH activity. Theriogenology 25:135.

4. Lindsell, C.E., K. Rajkumar, A.W. Manning, S.K. Emery, R.J. Mapletoft and B.D. Murphy (1986). Variability in FSH:LH ratios among batches of commercially available gonadotropins. Theriogenology 25:167.

5. Murphy, B.D., R.J. Mapletoft, J. Manns and W.D. Humphrey (1984). Variability in gonadotropin preparations as a factor in the superovulatory response. Theriogenology 21:117-125.

6. Vetrepharm Canada Inc (1986-96). Data on file.

BIONICHE ANIMAL HEALTH CANADA INC., P.O. Box 1570, Belleville, Ontario K8N 5J2

02/05

NAC No.: 12150136