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Ovidrel

What is infertility?

Infertility means not being able to get pregnant after one year of trying. Or, six months, if a woman is 35 or older. Women who can get pregnant but are unable to stay pregnant may also be infertile.

Pregnancy is the result of a process that has many steps. To get pregnant:

  • A woman must release an egg from one of her ovaries (ovulation).

  • The egg must go through a Fallopian tube toward the uterus (womb).

  • A man's sperm must join with (fertilize) the egg along the way.

  • The fertilized egg must attach to the inside of the uterus (implantation).

Infertility can happen if there are problems with any of these steps.

Is infertility a common problem?

Yes. About 10 percent of women (6.1 million) in the United States ages 15-44 have difficulty getting pregnant or staying pregnant, according to the Centers for Diseas...

Ovidrel

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OVIDREL®
(choriogonadotropin alfa) Injection Prefilled Syringe

FOR SUBCUTANEOUS USE

DRUG DESCRIPTION

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is a sterile liquid preparation of choriogonadotropin alfa (recombinant human Chorionic Gonadotropin, r-hCG). Choriogonadotropin alfa is a water soluble glycoprotein consisting of two non-covalently linked subunits - designated α and β - consisting of 92 and 145 amino acid residues, respectively, with carbohydrate moieties linked to ASN-52 and ASN-78 (on alpha subunit) and ASN-13, ASN-30, SER-121, SER-127, SER-132 and SER-138 (on beta subunit). The primary structure of the α - chain of r-hCG is identical to that of the α- chain of hCG, FSH and LH. The glycoform pattern of the a - subunit of r-hCG is closely comparable to urinary derived hCG (u-hCG), the differences mainly being due to the branching and sialylation extent of the oligosaccharides. The β - chain has both O- and N glycosylation sites and its structure and glycosylation pattern are also very similar to that of u-hCG.

The production process involves expansion of genetically modified Chinese Hamster Ovary (CHO) cells from an extensively characterized cell bank into large scale cell culture processing. Choriogonadotropin alfa is secreted by the CHO cells directly into the cell culture medium that is then purified using a series of chromatographic steps. This process yields a product with a high level of purity and consistent product characteristics including glycoforms and biological activity. The biological activity of choriogonadotropin alfa is determined using the seminal vesicle weight gain test in male rats described in the “Chorionic Gonadotrophins” monograph of the European Pharmacopoeia. The in vivo biological activity of choriogonadotropin alfa has been calibrated against the third international reference preparation IS75/587 for chorionic gonadotropin.

Ovidrel® (choriogonadotropin alfa injection) PreFilled Syringe is a sterile, liquid intended for subcutaneous (SC) injection. Each Ovidrel® (choriogonadotropin alfa injection) PreFilled Syringe is filled with 0.515 mL containing 257.5 µg of choriogonadotropin alfa, 28.1 mg mannitol, 505 µg 85% O-phosphoric acid, 103 µg L-methionine, 51.5 µg Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 250 µg of choriogonadotropin alfa in 0.5 mL. The pH of the solution is 6.5 to 7.5.

Therapeutic Class: Infertility

What are the precautions when taking choriogonadotropin alfa injection (Ovidrel)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: unusual vaginal bleeding, problems of the uterus, certain type of fertility problem (primary ovarian failure), thyroid problem, adrenal gland problem, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), unexplained ovarian cyst/enlargement.

Tell your doctor your medical history, especially of: liver disease, blood...

Read All Potential Precautions of Ovidrel »

Last reviewed on RxList: 6/25/2010
This monograph has been modified to include the generic and brand name in many instances.

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