Bravelle

Drug Description
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BRAVELLE®
(urofollitropin) for Injection, purified

FOR SUBCUTANEOUS OR INTRAMUSCULAR INJECTION

DRUG DESCRIPTION

Bravelle® is a product containing a highly purified preparation of human follicle stimulating hormone (hFSH) extracted from the urine of postmenopausal women. Human FSH consists of two non-covalently linked glycoproteins designated as the α and β subunits. The α subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The β subunit has 111 amino acids of which two are modified by attachment of carbohydrates.

Bravelle® is a sterile, lyophilized powder intended for subcutaneous (SC) or intramuscular (IM) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of Bravelle® contains 82.5 International Units (IU) of Follicle Stimulating Hormone (FSH) activity, 23 mg Lactose Monohydrate, 0.005 mg Polysorbate 20, and Sodium Phosphate buffer (Sodium Phosphate dibasic, Heptahydrate and Phosphoric acid) for pH adjustments, which, when reconstituted with diluent, will deliver 75 IU of FSH. Bravelle® contains up to 2% luteinizing hormone (LH) activity based on bioassay. Human Chorionic Gonadotropin (hCG) is not detected in Bravelle®. When stored at 3° to 25°C, up to 40% of the α-subunits may be oxidized.

The in vivo biological activity of urofollitropin for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle-stimulating hormone, (FSH, Urofollitropin), Urinary, Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995.

FSH is a glycoprotein that is acidic and water-soluble.
Therapeutic class: Infertility.

Last updated on RxList: 11/18/2008


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ENABLEX is a prescription medicine used in adults to treat the following symptoms due to a condition called overactive bladder:

  • · having a strong need to go to the bathroom right away (also called "urgency")
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IMPORTANT SAFETY INFORMATION

You should not take once-daily ENABLEX if you have certain types of stomach problems, glaucoma, or have trouble emptying your bladder. Side effects of ENABLEX include blurred vision, and more commonly dry mouth, constipation, indigestion, and abdominal pain. Use caution when doing certain activities until you know how ENABLEX affects you.


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