OVIDREL- choriogonadotropin alfa injection, solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

CHORIOGONADOTROPIN ALFA (UNII: 6413W06WR3) (CHORIOGONADOTROPIN ALFA - UNII:6413W06WR3)

MAH:

EMD Serono, Inc.

INN:

CHORIOGONADOTROPIN ALFA

composition:

CHORIOGONADOTROPIN ALFA 250 ug in 0.5 mL

administration_route:

SUBCUTANEOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. - Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Ovidrel® PreFilled Syringe only if enrolled in an in vitro fertilization program. - Primary ovarian failure should be excluded by the determination of gonadotropin levels. - Appropriate evaluation should be performed to exclude pregnancy. - Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Ovidrel® PreFilled Syringe therapy. - Evaluation of the partner's fertility potential should be included in the initial evaluation. Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is contraindicated in women who exhibit: - Prior hypersensitivity to hCG preparations or one of their excipients. - Primary ovarian failure. - Uncontrolled thyroid or adrenal dysfunction. - An uncontrolled organic intracranial lesion such as a pituitary tumor. - Abnormal uterine bleeding of undetermined origin (see "Selection of Patients" ). - Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients" ). - Sex hormone dependent tumors of the reproductive tract and accessory organs. - Pregnancy.

leaflet_short:

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) is supplied in a sterile, liquid single dose pre-filled 1 mL syringe. Each Ovidrel® 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 following package combination is available: The Ovidrel® PreFilled Syringe must be stored refrigerated between 2-8°C (36-46°F) before being dispensed to the patient. Patients should store the pre-filled syringe refrigerated to allow the product to be used until the expiry date shown on the syringe or carton. The Ovidrel® PreFilled Syringe may be stored by the patient for no more than 30 days at room temperature (up to 25°C (77°F) but must be used within those 30 days. Protect from light. Store in original package. Discard unused material.

authorization_status:

Biologic Licensing Application

SPC

OVIDREL - CHORIOGONADOTROPIN ALFA INJECTION, SOLUTION
EMD SERONO, INC.
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OVIDREL PREFILLED SYRINGE
(CHORIOGONADOTROPIN ALFA INJECTION)
FOR SUBCUTANEOUS USE
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 α - 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
PreFilled Syringe is a sterile, liquid in