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|Alpha1-Proteinase Inhibitor

Alpha1-Proteinase Inhibitor (Human)

Alpha1-Proteinase Inhibitor (Human) is used for:

Treating emphysema caused by alpha₁-proteinase (A₁-P) deficiency (also known as alpha₁-antitrypsin deficiency).

Alpha1-Proteinase Inhibitor (Human) is an A₁-P inhibitor. It works by blocking an enzyme in the lungs that breaks down lung tissue and sometimes causes emphysema.

Do NOT use Alpha1-Proteinase Inhibitor (Human) if:

• you are allergic to any ingredient in Alpha1-Proteinase Inhibitor (Human)
• you have a selective immunoglobulin A (IgA) deficiency and have antibodies against IgA

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

Before using Alpha1-Proteinase Inhibitor (Human) :

Some medical conditions may interact with Alpha1-Proteinase Inhibitor (Human) . 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 heart or circulatory problems

Some MEDICINES MAY INTERACT with Alpha1-Proteinase Inhibitor (Human) . However, no specific interactions with Alpha1-Proteinase Inhibitor (Human) are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alpha1-Proteinase Inhibitor (Human) 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 Alpha1-Proteinase Inhibitor (Human) :

Use Alpha1-Proteinase Inhibitor (Human) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Alpha1-Proteinase Inhibitor (Human) is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Alpha1-Proteinase Inhibitor (Human) at home, carefully follow the injection procedures taught to you by your health care provider.
• Gently swirl the vial until the powder is completely dissolved. Do not shake.
• If Alpha1-Proteinase Inhibitor (Human) contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Use Alpha1-Proteinase Inhibitor (Human) at room temperature within 3 hours after mixing. Throw away any unused medicine.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. 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.
• Do not miss any doses. If you miss a dose of Alpha1-Proteinase Inhibitor (Human) , contact your doctor.

Ask your health care provider any questions you may have about how to use Alpha1-Proteinase Inhibitor (Human) .

Important safety information:

• Alpha1-Proteinase Inhibitor (Human) may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alpha1-Proteinase Inhibitor (Human) . Using Alpha1-Proteinase Inhibitor (Human) alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Alpha1-Proteinase Inhibitor (Human) CONTAINS ALBUMIN, which comes from human blood. There is an extremely rare risk of developing a viral disease, or a central nervous system disease called Creutzfeldt-Jakob disease. No cases of viral diseases or Creutzfeldt-Jakob disease from albumin have been identified.
• LAB TESTS may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Alpha1-Proteinase Inhibitor (Human) with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is unknown if Alpha1-Proteinase Inhibitor (Human) can cause harm to the fetus. If you become pregnant while taking Alpha1-Proteinase Inhibitor (Human) , discuss with your doctor the benefits and risks of using Alpha1-Proteinase Inhibitor (Human) during pregnancy. It is unknown if Alpha1-Proteinase Inhibitor (Human) is excreted in breast milk. If you are or will be breast-feeding while using Alpha1-Proteinase Inhibitor (Human) , check with your doctor to discuss the risk to your baby.

Possible side effects of Alpha1-Proteinase Inhibitor (Human) :

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:

Dizziness; headache; pain, swelling, or redness at injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); swelling of the ankles or feet; symptoms of infection (eg, fever, chills, muscle aches, sore throat); tingling or numbness of the skin; weakness.

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.

Alpha1-Proteinase Inhibitor (Human) is usually handled and stored by a health care provider. If you are using Alpha1-Proteinase Inhibitor (Human) at home, store Alpha1-Proteinase Inhibitor (Human) as directed by your pharmacist or health care provider. Keep Alpha1-Proteinase Inhibitor (Human) , as well as needles and syringes, out of the reach of children and away from pets

General information:

• If you have any questions about Alpha1-Proteinase Inhibitor (Human) , please talk with your doctor, pharmacist, or other health care provider.
• Alpha1-Proteinase Inhibitor (Human) 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 Alpha1-Proteinase Inhibitor (Human) . 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.