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Coagulation factor XIII a-subunit (recombinant)

Generic Name: coagulation factor xiii a-subunit (recombinant) (koe-AG-yoo-LAY-shun FAK-tor THUR-teen)
Brand Name: Tretten

Coagulation factor XIII a-subunit (recombinant) is used for:

Preventing bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency.

Coagulation factor XIII a-subunit (recombinant) is a clotting factor. It works by increasing the amount of clotting factor XIII in the blood, helping the blood form clots and stop bleeding.

Do NOT use coagulation factor XIII a-subunit (recombinant) if:

  • you are allergic to any ingredient in coagulation factor XIII a-subunit (recombinant)

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

Before using coagulation factor XIII a-subunit (recombinant):

Some medical conditions may interact with coagulation factor XIII a-subunit (recombinant). 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 a history of blood clots

Some MEDICINES MAY INTERACT with coagulation factor XIII a-subunit (recombinant). Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Factor VIIa because the risk of blood clots may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if coagulation factor XIII a-subunit (recombinant) 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 coagulation factor XIII a-subunit (recombinant):

Use coagulation factor XIII a-subunit (recombinant) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with coagulation factor XIII a-subunit (recombinant). Talk to your pharmacist if you have questions about this information.
  • Coagulation factor XIII a-subunit (recombinant) is usually given as an injection at your doctors office, hospital, or clinic. If you will be using coagulation factor XIII a-subunit (recombinant) at home, a health care provider will teach you how to use it. Be sure you understand how to use coagulation factor XIII a-subunit (recombinant). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use coagulation factor XIII a-subunit (recombinant) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • 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. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of coagulation factor XIII a-subunit (recombinant), contact your doctor right away.

Ask your health care provider any questions you may have about how to use coagulation factor XIII a-subunit (recombinant).

Important safety information:

  • Patients receiving clotting factors sometimes develop antibodies or inhibitors to the medicine. This makes coagulation factor XIII a-subunit (recombinant) less effective. If coagulation factor XIII a-subunit (recombinant) stops working or does not work as well as it has before, contact your doctor immediately for instructions.
  • Tell your doctor or dentist that you take coagulation factor XIII a-subunit (recombinant) before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including factor XIII levels, may be performed while you use coagulation factor XIII a-subunit (recombinant). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: It is not known if coagulation factor XIII a-subunit (recombinant) can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using coagulation factor XIII a-subunit (recombinant) while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use coagulation factor XIII a-subunit (recombinant), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of coagulation factor XIII a-subunit (recombinant):

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:

Headache; mild pain in the arms or legs; mild pain at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, swelling, warmth, redness, or lump; chest pain; confusion; coughing up blood; dizziness; fainting; light-headedness; one-sided weakness; shortness of breath; stomach pain or swelling; sudden, severe headache; unusual bruising or bleeding; unusual weakness; vision or speech changes; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of coagulation factor XIII a-subunit (recombinant):

Coagulation factor XIII a-subunit (recombinant) is usually handled and stored by a health care provider. If you are using coagulation factor XIII a-subunit (recombinant) at home, store coagulation factor XIII a-subunit (recombinant) as directed by your pharmacist or health care provider. Keep coagulation factor XIII a-subunit (recombinant) out of the reach of children and away from pets.

General information:

  • If you have any questions about coagulation factor XIII a-subunit (recombinant), please talk with your doctor, pharmacist, or other health care provider.
  • Coagulation factor XIII a-subunit (recombinant) 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take coagulation factor XIII a-subunit (recombinant) or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about coagulation factor XIII a-subunit (recombinant). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to coagulation factor XIII a-subunit (recombinant). This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using coagulation factor XIII a-subunit (recombinant).

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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