drug-information.ru

|AlphaNine SD

AlphaNine SD

AlphaNine SD is used for:

Controlling and preventing bleeding episodes in patients with hemophilia B.

AlphaNine SD is a clotting factor. It works by correcting defects in patients who have deficiencies of certain clotting factors.

Do NOT use AlphaNine SD if:

• you are allergic to any ingredient in AlphaNine SD
• you are allergic to hamster protein
• you have severe blood clotting problems (eg, fibrinolysis, disseminated intravascular coagulation)

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

Before using AlphaNine SD :

Some medical conditions may interact with AlphaNine SD . 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 liver disease, have a bleeding disorder, are at risk for blood clots, or have recently undergone surgery

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if AlphaNine SD 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 AlphaNine SD :

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

• AlphaNine SD is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using AlphaNine SD at home, carefully follow the injection procedures taught to you by your health care provider.
• Always wash your hands and carefully follow procedures for preparing and giving yourself AlphaNine SD .
• To use AlphaNine SD , warm both vials to room temperature.
• Do not shake vial after adding diluent.
• AlphaNine SD will be given through a vein after it is mixed with sterile water for injection.
• Use AlphaNine SD within 3 hours after the solution is mixed. Do not use leftover medicine or use AlphaNine SD beyond the expiration date on the container.
• If AlphaNine SD contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• 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.
• If you miss a dose of AlphaNine SD , contact your doctor immediately.

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

Important safety information:

• Additional monitoring of your dose or condition may be needed if you are taking drugs that aid blood clotting (eg, tranexamic acid, aminocaproic acid) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, aspirin, ibuprofen).
• LAB TESTS, including blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use AlphaNine SD with extreme caution in NEWBORNS. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking AlphaNine SD , discuss with your doctor the benefits and risks of using AlphaNine SD during pregnancy. It is unknown if AlphaNine SD is excreted in breast milk. If you are or will be breast-feeding while you are using AlphaNine SD , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of AlphaNine SD :

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:

Chills; flushing; headache; nausea; stinging at the injection site; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); arm or leg pain/swelling; chest pain; dark urine; fever; persistent sore throat; unusual fatigue; yellowing of the eyes or skin.

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.

Store AlphaNine SD in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). It may also be stored at room temperature, not to exceed 77 degrees F (25 degrees C), for up to 6 months. Do not freeze. Do not store in the bathroom. Keep AlphaNine SD out of the reach of children and away from pets.

General information:

• If you have any questions about AlphaNine SD , please talk with your doctor, pharmacist, or other health care provider.
• AlphaNine SD 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 AlphaNine SD . 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.