Ovidrel - Consumer Medicine Information
|Manufacture:||EMD Serono, Inc|
|Condition:||Female Infertility, Hypogonadism, Male, Ovulation Induction, Prepubertal Cryptorchidism|
|Form:||Liquid solution, Subcutaneous (SC)|
|Ingredients:||choriogonadotropin alfa, mannitol, phosphoric acid, methionine, poloxamer 188, sodium hydroxide, water.|
Information for the Patient
Ovidrel (choriogonadotropin alpha) offers the ease of use and convenience available with subcutaneous administration. Please familiarize yourself with the following instructions in order to understand how to self-administer Ovidrel.
Directions for Administration of Ovidrel in Pre-filled Syringe
Ovidrel in pre-filled syringes is intended for a single subcutaneous injection. Any unused material should be discarded. Ask your health care provider on how to dispose of used syringes and medicines no longer required. Ovidrel may be self-administered by the patient.
Follow the Directions Below for injecting Ovidrel
|Step 1: Getting ready|
|On a clean work surface, lay out the items listed below before you begin:
|Step 2: Cleanse|
|Step 3: Prepare Injection Site|
|Step 4: Disposal of used Items|
|Once you have finished your injection, immediately discard the needles and syringe (without recapping the needle) into the disposal container.. Take the container to a clinic or pharmacy for proper disposal.|
Directions for Administration of Ovidrel in Pre-filled Pen
Follow the directions below for injecting Ovidrel
|Step 1: Before you start|
Please note: The scale that can be seen on the reservoir holder is to show how much of the medicine is left in the pen. Do not use it to set the dose
|Step 2: Getting your pen ready|
Caution: Make sure that the needle is securely fixed before starting your injection.
|Step 3: Removing large air bubbles and setting your dose|
Gently turn the dose setting button clockwise. The dose display will show a straight line and you have to keep turning until you can read the number ‘250’. Do not push or pull the dose setting button while you turn it.
|Step 4: Injecting your dose|
|Step 5: After the injection|
Storing the pre-filled pen
- Stability and storage recommendations are provided on page 10.
- Refer to the date indicated on the labels for expiry date. Do not use after expiry date.
- Solutions of pre-filled pens are stored at 2°C - 8°C (in a refrigerator).
- Do not freeze. Protect from light.
- Do not use the Ovidrel® pre-filled pen if the solution contains particles or is not clear.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
About This Medication
What is Ovidrel
Ovidrel is the only recombinant human chorionic gonadotrophin (r-hCG). Its generic name ischoriogonadotropin alpha. It is produced as a solution in a pre-filled syringe or a pre-filled pen that is intended for subcutaneous injection following reconstitution with Sterile Water for Injection, USP/Ph.Eur. Ovidrel ensures that you are receiving the highest purity hCG on the market. Subcutaneous injections offer the advantage of being convenient and easy to self-administer.
What Does Ovidrel Do
Ovidrel is used to trigger ovulation in infertile women with ovarian dysfunction.
What is hCG
Human chorionic gonadotrophin, or hCG, is a hormone that is involved in reproduction in women.
It is found in the urine of pregnant women and is produced by the placenta.
Who Can Take Ovidrel
Ovidrel is indicated for women following the stimulation phase of infertility treatment.
What is the Amount of Ovidrel That Must be Injected
250 µg in a pre-filled pen, 250 µg in 0.5ml for the ready to use solution packaged in a pre-filled
syringe or 250 µg in 1 mL (1 cc) of Sterile Water for Injection for lyophilised product which must be reconstituted.
In case of a drug overdose, contact a health care practicioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
What Are the Side Effects Associated With the Use of Ovidrel
As with other hCG preparations, side effects can occur with the use of Ovidrel: discomfort at the
injection site, stomach pain, nausea, and vomiting have been reported. Ask your fertility team to discuss the possible side effects with you. As with all medications, it is important to report any physical changes and all symptoms to your healthcare professional.
What Risk is There of Developing OHSS While on Ovidrel
Contact your doctor if you experience severe pain or bloating in the stomach or pelvic area, severe
upset stomach, vomiting, or weight gain, as these are symptoms of a medical event called Ovarian Hyperstimulation Syndrome (OHSS). OHSS occurs infrequently (usually less than 3% incidence). However, because OHSS can progress rapidly to a serious medical event, Ovidrel should be stopped at the first signs of OHSS.
Is Ovidrel Associated With Multiple Births
Reports of multiple births have been associated with fertility treatments. You should discuss the
potential risk of multiple births with your doctor before beginning treatment.
Is Ovidrel Associated With Congenital Birth Defects
There is no evidence to establish an association between the administration of Ovidrel to female patients and the occurrence of congenital anomalies in their offspring. The data supporting this position is derived from the conclusions of clinical trials, as well as from post-marketing information where no cases of congenital anomalies have been reported since the introduction of Ovidrel to the market. Moreover, based on large epidemiological studies published in the literature, the rate of major or minor congenital anomalies following assisted reproductive technology procedures is consistent with that found in the unassisted population. It must be noted that these epidemiological studies relate to clinical trials carried out with urinary drugs. There is, however, no ground to suspect that, with regards to this particular risk, the recombinant product would be different from similar drugs of urinary origin.
Can I Take Ovidrel With Other Medications
Please inform your doctor and pharmacist if you are taking or have taken any other medications, even those not requiring a prescription.
While the information contained in the "information for the patient" section provides important information about Ovidrel, it does not contain all the possible uses, actions, precautions, side effects, warnings, contraindications, and interactions of this medication. For more detailed information, please be sure to consult the package insert for this product and to discuss any questions you may have with your physician prior to beginning therapy.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
Fax toll-free to 1-866-678-6789, or
Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.