Briogyn

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Drug description

Briogyn (follitropin alfa for injection) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the ?- and ?-subunits. The ?- and ?-subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structure are indistinguishable from those of human follicle stimulating hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile, and a high specific activity. The biological activity of follitropin alfa is determined by measuring the increase in ovary weight in female rats. Briogyn� contains no luteinizing hormone (LH) activity. Briogyn� (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Briogyn� is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.Briogyn � Briogyn� pen device is an easy to use injection pen for use with Briogyn� cartridges( 300 IU and 900 IU) manufactured by CHL. � The pen is for subcutaneous injection only. � The numbers on the Dose Feedback Window is measured in International Units or IUs.� Your doctor will have told you how many IUs to inject each day. � The numbers displayed in the Dose Feedback Window help you to: a. Dial your prescribed dose. b. Verify a complete injection. Give yourself the injection at the same time each day. Your doctor/pharmacist will tell you how many cartridges you need to complete your treatment. In ART for development of multiple follicles in ovulatory patientsVary according to the physician's preference and the patient's response.In general, stimulation of follicular growth is achieved by starting with daily administration of 150 to 225 IU S.C. for a period of 7 days.Thereafter, the dose may be adjusted according to the individual's ovarian response.In responding patients, daily maintenance doses of 75 to 300 IU for 8 to 12 days are usually sufficient, although longer treatment may be necessary.� The maximum individualized daily dose safely used in various clinical studies was 450 IU.Briogyn � is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications.OHSS is a medical event distinct from uncomplicated ovarian enlargement. Severe OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event. It is characterized by an apparent dramatic increase in vascular permeability which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. In such situations immediately cease the use of Briogyn.

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