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|Pregnyl

Pregnyl

Pregnyl is used for:

Treating fertility problems in certain women who have not gone through menopause. Treating certain testicular development problems and stimulating the development of secondary sexual characteristics in certain patients. It is also used to treat boys 4 to 9 years of age who have testicles that have not moved into the scrotum.

Pregnyl is a hormone. Human chorionic gonadotropin (H CG) stimulates cells in the testicles to produce androgens. Androgens cause the development of male secondary sexual characteristics (eg, hair growth, deepening voice) and may cause the testicles to drop. Human chorionic gonadotropin (HCG) stimulates ovulation (release of an egg) in women.

Do NOT use Pregnyl if:

• you are allergic to any ingredient in Pregnyl
• you have androgen (male sex hormone)-dependent tumors, prostate cancer, an active blood clot(s), brain lesions, an enlarged ovary or ovarian cysts, uterine fibroids, or an enlargement or tumor of the pituitary gland
• you are experiencing abnormally early puberty

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pregnyl :

Some medical conditions may interact with Pregnyl . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have asthma, bleeding in the reproductive or urinary tract, heart or kidney problems, migraine headaches, polycystic ovarian syndrome, or epilepsy

Some MEDICINES MAY INTERACT with Pregnyl . However, no specific interactions with Pregnyl are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pregnyl may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pregnyl :

Use Pregnyl as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pregnyl is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Pregnyl at home, carefully follow the injection procedures taught to you by your health care provider.
• If Pregnyl contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Using the technique described to you by your doctor, add the diluent to the vial that contains the medicine. Mix the solution by gently rotating the vial. DO NOT SHAKE. The solution should be clear and free of particles.
• Wipe the rubber stopper of the vial with an alcohol swab. Insert the needle straight through the center circle of the rubber stopper. Draw up the solution for injection. After drawing up the solution, switch needles. Be sure all air bubbles are tapped out of the syringe.
• Wipe the appropriate injection site (usually the upper thigh or buttocks) with an alcohol swab, then insert the syringe. To be sure that the needle is not in a vein, pull back on the plunger of the syringe while holding the syringe in place. If the syringe begins to fill with blood, the needle is in a vein. If this happens, remove the needle from the skin, throw the syringe away, and start the procedure again using new materials (drugs, syringes, etc.).
• After giving the injection, cover the injection site with a small bandage if necessary.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Pregnyl , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Pregnyl .

Important safety information:

• You must receive a thorough gynecological exam before beginning treatment with Pregnyl .
• Use of Pregnyl can increase your risk of multiple births (eg, twins or triplets), blood clots, enlarged ovaries, and ruptured ovarian cysts. Discuss this risk with your doctor.
• LAB TESTS, including hormone levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Pregnyl is not recommended for use in CHILDREN younger than 4 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Pregnyl during pregnancy. It is unknown if Pregnyl is excreted in breast milk. If you are or will be breast feeding while you are using Pregnyl , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Pregnyl :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Fatigue; headache; irritability; nausea; pain, swelling, bruising, or redness at the injection site; restlessness; tiredness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal breast development; bloating or swelling in the stomach or pelvic area; breast tenderness; chest pain; depression; infrequent urination; irregular heartbeat; leg pain; persistent or severe nausea, vomiting, or diarrhea; stomach or pelvic pain; sudden shortness of breath; swelling of feet or legs; unusual early onset of puberty; weight gain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Pregnyl is usually handled and stored by a health care provider. If you are using Pregnyl at home, store Pregnyl as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pregnyl out of the reach of children and away from pets.

General information:

• If you have any questions about Pregnyl , please talk with your doctor, pharmacist, or other health care provider.
• Pregnyl is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pregnyl . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.