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(choriogonadotropin alfa) Injection Prefilled Syringe
FOR SUBCUTANEOUS USE
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 possible side effects of HCG (Novarel, Ovidrel, Pregnyl)?
Stop using HCG and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these signs of a blood clot: pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness, or severe headache.
Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition....
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...
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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