Thrombin (Human)

• It is used to treat or prevent bleeding.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using thrombin while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of skin infection like oozing, heat, swelling, redness, or pain.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• Fever.
• A fast heartbeat.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store thrombin at home, talk with your doctor, nurse, or pharmacist about how to store it.

EVITHROM®, Thrombin, Topical (Human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

EVITHROM, Thrombin, Topical (Human), may be used in conjunction with an Absorbable Gelatin Sponge, USP.

EVITHROM is supplied in a 2 ml vial containing 2000 (1600-2400) units of lyophilized human thrombin powder for reconstitution in 2 ml Water for Injection, USP.

Storage and handling

• Store EVITHROM powder vials at 2- 25°C (36-77°F) for up to 2 years.
• Store reconstituted EVITHROM solution at room temperature for up to 8 hours.
• Do not use after the expiration date stated on the vial.
• Do not freeze or refrigerate EVITHROM once it has been reconstituted.
• Vials are for single use only. Discard unused contents.
• Discard if the packaging of EVITHROM is damaged.
• Keep the vials protected from light.

Some viruses such as hepatitis A virus and parvovirus B19 are particularly difficult to remove or inactivate. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include: fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, fatigue and low-grade fever followed by nausea, vomiting and abdominal pain. Dark urine and a yellowed complexion are also common symptoms. Consult your physician if such symptoms appear.

If absorbed systemically EVITHROM could potentially cause blood clotting disorders. Consult your physician for any new or unusual symptoms.

U.S. License No. 1603
Art. No. 80YZ00Z3D0
ETHICON, Inc. 2009
© Omrix Biopharmaceuticals Ltd., 2009

Principal Display Panel
Evithrom 2 mL Vial Label

THROMBIN TOPICAL (HUMAN)

EVITHROM® Lyophilized Powder

NDC-63713-461-02

This bottle contains 2000 (1600-2400) units of lyophilized powder of Thrombin (human), calcium chloride, albumin (human), mannitol and sodium acetate. Store unopened Vial at 2-25°C. Reconstitute in 2mL of Water for Injection, USP to obtain 1000 (800-1200) units/ml. Do not freeze or refrigerate once reconstituted. Vials are for single use only. Discard unused contents. Protect form light. See enclosed instructions.