Coagulation Factor XIII Concentrate Suspension for injection

What is this medicine?

FACTOR XIII CONCENTRATE (fak tir 13 KON suhn treyt)is used in patients with Factor XIII deficiency to help prevent bleeding.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• history of blood clots

• an unusual or allergic reaction to Factor XIII concentrate, human proteins, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This medicine contains albumin from human blood. It may be possible to pass an infection in this medicine, but no cases have been reported. Talk to your doctor about the risks and benefits of this medicine.

Your condition will be monitored carefully while you are receiving this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or chest tightness

• feeling faint or light-headed, falls

• pain, swelling, warmth in the leg

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• chills

• headache

• joint pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.