Source: FDA, National Drug Code (US) Revision Year: 2020
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.
Selection of Patients:
For Subcutaneous Use Only.
Ovidrel PreFilled Syringe 250 µg should be administered one day following the last dose of the follicle stimulating agent. Ovidrel PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Administration should be withheld in situations where there is an excessive ovarian response, as evidenced by clinically significant ovarian enlargement or excessive estradiol production.
Ovidrel PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography.
Ovidrel PreFilled Syringe 250 µg should be administered one day following the last dose of the follicle stimulating agent.
Ovidrel PreFilled Syringe administration should be withheld in situations where there is an excessive ovarian response, as evidenced by multiple follicular development, clinically significant ovarian enlargement or excessive estradiol production.
Ovidrel PreFilled Syringe is intended for a single subcutaneous injection. Any unused material should be discarded.
Ovidrel PreFilled Syringe may be self-administered by the patient. Follow the directions below for injecting Ovidrel PreFilled Syringe.
Step 1: Wash your hands thoroughly with soap and water.
Step 2: Carefully clean the injection site.
Make yourself comfortable by sitting or lying down. Carefully clean the injection site on the stomach with an alcohol wipe and allow it to air-dry.
Step 3: Administer your injection.
Carefully remove the needle cap from the syringe. Do not touch the needle or allow the needle to touch any surface. Inject the prescribed dose as directed by your doctor, nurse or pharmacist.
Step 4: Gently withdraw the needle.
Discard the needle and syringe into your safety container. Place gauze over the injection site. If any bleeding occurs, apply gentle pressure. If bleeding does not stop within a few minutes, place a clean piece of gauze over the injection site and cover it with an adhesive bandage.
Step 5: Storage and clean up.
Remember that your injection materials must be kept sterile and cannot be reused.
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.
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