Canine Freeze-Dried Plasma Kit

Canine Freeze-Dried Plasma Kit (cFDP) contains a sterile, non-pyrogenic, single use, 250 mL allogeneic unit of freeze-dried canine plasma within a protective foil overwrap, a 250 mL Sterile Water for Injection (WFI) diluent bag, and a blood administration set. The cFDP contained within this kit is made from pooled canine plasma from either dog erythrocyte antigen (DEA) 1 Negative or DEA 1 Positive dogs. Each kit contains label information stating the blood erythrocyte antigen one status of the pooled plasma, provided as either DEA 1 Negative or DEA 1 Positive.

A freeze-drying process is used to produce cFDP from canine fresh frozen plasma with minimal reduction in labile coagulation factors that remain within normal canine reference ranges during recommended storage conditions. cFDP requires reconstitution with WFI before administration to the patient. After reconstitution with provided WFI, the cFDP unit is equivalent to 250 mL of canine fresh frozen plasma. There are no additives or preservatives in this product.

cFDP is for the treatment of hypovolemia and control of hemorrhage in dogs.

cFDP is provided in a single unit kit containing the freeze-dried canine plasma, Sterile Water for Injection USP necessary for reconstitution, and a sterile blood administration set for dispensing. Needle for administration is NOT included. Each component is individually wrapped in sterile barrier packaging. The kit is bundled into a heat-sealed polyethylene bag and transported in a protective cardboard box.

Kit Contains:
• 1 x unit cFDP from 250 mL pooled canine plasma
• 1 x 250 mL Sterile Water for Injection USP
• 1 x sterile blood administration set with integrated 170-260 µm filter

Requires reconstitution before use. Once reconstituted, the cFDP bag is equivalent to 250 mL canine plasma. Administer reconstituted cFDP via intravenous infusion of 10-20 mL/kg body weight at a rate not to exceed 4-6 mL/minute. Use the supplied administration set with integrated 170-260 µm filter.

After reconstruction, cFDP should be infused immediately but may be stored at room temperature 20-25°C (68-77°F) for up to 180 minutes or stored under refrigeration 1-6°C (34-43°F) for up to 3 days provided cFDP and the kit components are only used one time in a single patient.

Prior to reconstitution, store in a cool, dry area 1-25°C (34-77°F) out of direct sunlight. Excursions permitted up to 38°C (100.4°F) for 72 hours; however, such exposure should be minimized. Following reconstitution may be stored at room temperature 20-25°C (68-77°F) for up to 180 minutes or may be stored under refrigeration 1-6°C (34-43°F) for up to 3 days provided cFDP and the kit components are only used one time in a single patient.

Do not use in patients with a history of hypersensitivity to plasma or plasma-derived products.

For intravenous use in dogs only. Not for use in humans. Keep out of reach of children.

Do not mix or administer with solutions containing divalent cations (e.g., calcium, magnesium, iron) or synthetic colloids (e.g., hydroxyethyl starch). Do not add medications to the plasma bag. Blood products must be administered using a filter; always use the included blood administration set with integrated 170-260 µm filter when administering cFDP. Do not use this product if the plasma bag is leaking or has been damaged in any way.

Increasing oncotic pressure during administration of cFDP may lead to bleeding at sites not evident at lower blood pressures. The patient should be monitored for transfusion reactions. Signs may include: acute or delayed hemolysis, fever, mild to severe anaphylaxis, transfusion-related acute lung injury, transfusion-associated circulatory overload, endotoxemia or sepsis (e.g., bacterial contamination). In all cases of suspected reactions, stop the transfusion, assess the patient, and follow the recommendations of the attending clinician for supportive care and possible resumption of transfusion.

Safety of cFDP has not been evaluated in dogs less than two years of age or dogs that were breeding, pregnant, or lactating.

Donor animals were screened and tested for infectious diseases in accordance with FDA CVM Guidance #254, "Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products". Mantel determined eligibility for each individual donor dog based on historical eligibility criteria, health exams, owner questionnaires, complete blood count, biochemical profile, blood typing, and infectious disease testing. These measures are expected to reduce but not eliminate the risk of transmitting infectious disease agents.