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Novarel Injection Kit 10,000 Units - 10ml Vial***MFG BACKORDER***NO ESTIMATED RESTOCKING DATE PROVIDED BY MFG***

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Product Summary

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

GONADOTROPINS, CHORIONIC - INTRAMUSCULAR

(GO-nad-oh-TROW-pins, ko-ree-ON-ick)

COMMON BRAND NAME(S): A.P.L., Chorex, Pregnyl, Profasi

USES: This medication is a hormone used in boys (before puberty) to cause the normal dropping of the testicles into the scrotum. It is also used in certain boys to help with normal sexual development. It works by causing the testes to release male sex hormones (e.g., testosterone). This medication is also used in women to treat fertility problems. It is given after finishing another medication (menotropins) to cause the release of an egg (ovulation). It should not be used in women whose ovaries no longer make eggs properly (primary ovarian failure). This medication has not been shown to be effective for weight loss and should not be used for this purpose.

HOW TO USE: This medication is given by injection into a muscle by a health care professional. If you are giving this medication at home, learn all preparation and usage instructions for this product. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If you have any questions about the use of this medication, ask your doctor or pharmacist. The dosage is based on your age, weight, medical condition, and response to treatment. For boys, use this medication usually 3 times a week or as directed by your doctor. For women, use this medication usually for 1 dose after finishing your menotropins treatment. Use this medication regularly to get the most benefit from it. To help you remember, mark the day(s) on the calendar when you need to receive the medication. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.

SIDE EFFECTS: Headache, restlessness, tiredness, or pain at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of the ankles/feet, mental/mood changes (e.g., depression, irritability), signs of early puberty in boys (e.g., facial/pubic hair, voice change, acne), pain/swelling of the breast (in boys). For women, when this medication is used with menotropins to treat infertility, also tell your doctor immediately if this unlikely but serious side effect occurs: abdominal pain/pressure/swelling. For women, when this medication is used with menotropins to treat infertility, seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, slurred speech, weakness on one side of the body, confusion. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, shortness of breath. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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: early puberty (in boys), male sex hormone-dependant cancer (e.g., prostate cancer) in boys. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., congestive heart failure), kidney disease, seizures, asthma, migraine headaches. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. When this medication is used in females with menotropins to treat infertility, it may cause multiple births (e.g., twins, triplets). It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: gonadorelin. This medication may interfere with certain laboratory tests (including luteinizing hormone-LH/follicle stimulating hormone-FSH levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

STORAGE: Store the vials of powder at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Store the mixed medication in the refrigerator between 36-46 degrees F (2-8 degrees C). Write the date when the medication was mixed on the vial. The mixed medication must be used within 1 to 2 months, depending on the product. Check the product package for the storage time for your product. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.

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