This material is representative. For complete product information, please see the EZPLAZ^™ Freeze Dried Plasma Full Prescribing Information. EZPLAZ^™ Freeze Dried Plasma is only available for sale in the U.S. Please contact your local representative.

Rx Only.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR EZPLAZ^™ FREEZE DRIED PLASMA

EZPLAZ^™ Freeze Dried Plasma (FDP) is indicated for transfusion in adults when plasma is required and other plasma products are not available. Indications include:

• Management of preoperative or bleeding patients who require replacement of multiple plasma coagulation factors [e.g., liver disease, disseminated intravascular coagulation (DIC)]
• Patients undergoing massive transfusion who have clinically significant coagulation deficiencies
• Patients taking warfarin who are bleeding or need to undergo an invasive procedure before vitamin K could reverse the warfarin effect or who need only transient reversal of warfarin effect

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not use EZPLAZ^™ FDP:

• In patients with history of hypersensitivity to fresh frozen plasma (FFP), liquid plasma or to plasma-derived products including any plasma proteins
• In patients with IgA deficiency

WARNINGS AND PRECAUTIONS

As with other licensed blood products, EZPLAZ^™ FDP may cause adverse events known to be associated with transfusion of blood products. For a complete list and further details not provided below, please refer to the Circular of Information.

Hemolytic Transfusion Reactions
Hemolytic transfusion reactions can occur with ABO blood group mismatches. EZPLAZ^™ FDP is provided in blood group type AB or type A low titer Anti-B (< 1:200 by saline tube method).

Transfusion-Related Acute Lung Injury (TRALI)
To mitigate the risk of TRALI, EZPLAZ^™ FDP is manufactured from FFP donated by male only donors.

Infection Risk from Human Plasma
Because EZPLAZ^™ FDP is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, bacteria, and theoretically the variant Creutzfeldt-Jakob disease (vCJD) agent.

Hypersensitivity Reaction
Hypersensitivity reactions, including anaphylaxis, may occur. Discontinue the transfusion if signs or symptoms of hypersensitivity occur and treat appropriately.

Specific Therapies
EZPLAZ^™ FDP may be less effective in correcting certain coagulopathies when therapies targeting specific coagulation factor deficiencies or anticoagulant effects are available. In such situations, clinicians should consider the use of targeted therapies, when clinically appropriate, including vitamin K for urgent vitamin K antagonist reversal, fibrinogen-containing products for hypofibrinogenemia, specific coagulation factor concentrates, or specific reversal agents for non-vitamin K antagonist anticoagulants. Selection of therapy should be based on the patient's clinical condition, urgency of correction, and availability of alternative treatments.

Volume Expansion
EZPLAZ^™ FDP is not intended for routine volume expansion. When administered in the absence of a documented coagulation factor deficiency or plasma protein deficiency, the expected clinical benefit may be limited, and alternative volume expanders are generally more appropriate. Clinicians should consider alternative therapies based on the patient's clinical needs.

Elevated INR
Transfusion of EZPLAZ^™ FDP may not result in meaningful correction of a minimally elevated international normalized ratio (INR), such as values between 1.5 and 1.7. In these situations, the likelihood of achieving clinically significant hemostatic benefit may be low, and alternative management strategies should be considered based on the patient's overall clinical condition.

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Teleflex at 1-866-246-6990 and FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional Safety Information, please see Full Prescribing Information at www.teleflex.com/EZPLAZPI.