Fertinex^TM (urofollitropin for injection, purified) is a preparation of highly purified Follicle Stimulating Hormone (FSH) extracted from the urine of post-menopausal women. Purification is by immunoaffinity chromatography using murine monoclonal antibody to human FSH. The purification process results in a consistent FSH isoform profile, significantly enhanced specific activity (8,500-13, 500 IU FSH/mg protein), and ≥95% purity. Each ampule of Fertinex^TM contains either 75 IU or 150 IU of highly purified FSH and 10 mg lactose in a sterile, lyophilized form. If required, pH is adjusted with 0.1 M hydrochloric acid and/or 0.1 M sodium hydroxide. Fertinex^TM is administered by subcutaneous injection.

Fertinex^TM contains an acidic, water soluble glycoprotein biologically standardized for FSH gonadotropin activity in terms of the Second International Reference Preparation for Human Menopausal Gonadotropins established in September, 1964 by the Expert Committee on Biological Standards of the World Health Organization. Negligible amounts (≤ 0.1 IU LH/1000 IU FSH) of leutinizing hormone (LH) activity are contained in Fertinex^TM.

Therapeutic Class : Infertility.

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