Canine Fresh Frozen Plasma

Company: Animal Blood Resources International

NOTICE TO ALL USERS

The Package Insert is considered an extension of the blood and component container labels as the space on those labels is very limited.

No MSDS is required for these products. The Package Insert is supplied to conform with applicable government regulations. This document should be kept on file and readily available to personnel involved in the use of this product.

Blood and blood components are biologic products and, in the form of cellular products, living canine tissue intended for use in the treatment of canine patients. Professional judgment based on clinical evaluations determines the selection of components, dosage, the rate of administration and decisions in situations not covered in this general statement.

WARNING. In spite of serological testing, the risk of transmitting infectious agents to the patient is present. Careful donor selection, care, and available laboratory tests do not eliminate the hazard. Also, septic and toxic reactions can result from transfusion of bacterially contaminated blood and components. Such reactions are rare, but may be life threatening. In addition, blood components may contain certain immunizing substances other than those indicated on the label. For example, plasma may contain red blood cells and platelets as well as plasma. Therefore, the Package Insert as a whole or in part cannot be considered or interpreted as an expressed or implied warranty of the safety or fitness of the described blood or blood component when used for their intended purpose. Use of specific blood components as indicated by the individual patients clinical condition is needed to prevent inappropriate transfusion. Please note that whole blood is rarely considered an appropriate choice for transfusion.

Autologous transfusion techniques (such as intraoperative salvage and presurgical donation) should be considered whenever feasible in the perioperative setting, to reduce the risks of disease transmission and immune reactions from homologous donations.

GENERAL INFORMATION

DONORS

Blood and components described in the Package Insert have been collected from canine donors which are maintained in isolated, controlled access colonies. The blood type of each donor is indicated on the product label. The colonies receive on site health care, and all animals are current on immunizations to include: Canine Distemper, Adenovirus type 2, Leptospirosis, Parainfluenza, Canine Parvo Virus, and Rabies.

Blood from donors maintained in controlled access colonies generally carries a lower risk of disease transmission than blood from volunteer donors.

Testing of Donor Blood

Testing of the donor’s blood is required before an animal is admitted into the colony as a donor and annually thereafter. All colony donors must test serologically or PCR negative for Canine brucellosis, Ehrlichia canis, Borrelia burgdorferi, Babesia, Anaplasmosis, Rickettsia rickettsia, Hepatozoon, Neorickettsia, Bartonella, hematotropic Mycoplasmas, Leishmania, and Dirofilaria immitis. The label on the container indicates whether the donor is DEA 1 negative, DEA 1 positive, or DEA 4 only.

BLOOD AND COMPONENT LABELING

Labels contain the following information:

1. The Name of the Blood Product.

2. Proper Temperature range for storage.

3. The minimum weight or volume.

4. Company name, address, telephone number and California Biologics registration number (if applicable).

5. The expiration date of the blood component.

6. The donor (serial) identification number.

7. Blood type of the donor.

8. Statement regarding the Package Insert.

GENERAL INSTRUCTIONS FOR WHOLE BLOOD AND ALL COMPONENTS

The following general instructions pertain to Whole Blood and all the components described in the Package Insert.

● The intended recipient must be properly identified before the transfusion is started.

● The plastic blood container must not be vented.

● Blood and blood components must be administered through an appropriate blood filter. A blood administration set with standard (170-260 µ) clot filter is recommended when administering volumes greater than 50 mL. An 18 micron blood filter (HEMO-NATE^® blood filter) is recommended for volumes less than 50 mL. Syringe filters not specifically produced and approved for blood should never be used for any product containing red cells.

● Before use, bags of blood or components should be gently agitated to thoroughly mix contents.

● No medications or solutions may be added to or infused through the same tubing with blood or components except 0.9% Sodium Chloride, Injection (USP).

● Lactated Ringer’s, Injection (USP) or other electrolyte solutions containing calcium should NEVER be added to or administered concurrently with blood or components collected in an anticoagulant containing citrate. All of the products described below contain and are collected into anticoagulants which contain citrate.

● Hemolysis may become evident during the storage of components containing red blood cells. Blood and components should be inspected for bacterial growth. If upon visual inspection the fitness of a component is questioned because of, for example, presence of hemolysis, a significant color change in the contents of the blood bag as compared to the tubing segments, floccular material, cloudy appearance or other problems, the component should not be used. Call Animal Blood Resources at 1-800-243-5759 for further evaluation. A slight pink tinge to the supernatant due to some free hemoglobin may be present and is acceptable for transfusion.

● When thawing frozen products in a water bath, care must be taken to prevent contamination of entry ports. The use of watertight protective plastic over wraps (such as ziplock bags) is recommended.

● Blood and components may be warmed to no more than 37° C during transfusion, if warming is clinically indicated for situations such as hypothermia, blood exchange or massive transfusions.

● Blood components have been prepared by techniques that aid in preserving sterility up to the time of expiration. If the container is entered in a fashion that could contaminate the contents of the container for any reason the component expires 4 hours after entry if maintained at room temperature (20° - 24° C), or 24 hours after entry if refrigerated (1° - 6° C).

● Unless otherwise indicated by the patient’s clinical condition, the rate should be slow, no greater than 0.11 mL / pound of body weight for the first 30 minutes of the transfusion. The patient should be observed during this period since some life threatening reactions occur after the infusion of only a small volume of incompatible blood. If a transfusion reaction occurs, the transfusion should be discontinued immediately and appropriate therapy initiated. The infusion should not be restarted.

● Completion of the transfusion should be prior to component expiration or within 4 hours of warming to room temperature, whichever is sooner. If blood or components cannot be infused in 4 hours, they should be divided into aliquots before reaching 6 degrees C and stored appropriately in the refrigerator until needed.

● A crossmatch should be conducted before every transfusion.

● The blood type of both the donor and the recipient should be known before transfusing whenever possible. When the blood type of the recipient is not known, only blood from type DEA 1 NEGATIVE donors should be given. First time transfusions with donors and recipients of unknown blood types should NEVER be considered safe.

● Blood transfusions should never be considered safe, even under optimum conditions, and should not be given unless there is no other acceptable treatment.

SPECIFIC INSTRUCTIONS FOR FRESH FROZEN PLASMA

PLASMA COMPONENTS

FRESH FROZEN PLASMA

Description

Fresh Frozen Plasma (FFP) is separated and frozen within 8 hours of collection of whole blood. A Unit of Fresh Frozen Plasma contains the labile plasma coagulation Factors V and Vlll (including vWf). Platelets, if present, are not viable. A single unit contains approximately 120 mL to 145 mL ± of Fresh Frozen Plasma. A double unit contains approximately 240 - 265 mL ± of Fresh Frozen Plasma. A mini unit contains approximately 60 mL to 90 mL ± of Fresh Frozen Plasma. These ranges are due to differences in donor PCV’s.

Actions

FFP contains plasma proteins including all coagulation factors both labile and nonlabile.

Canine Fresh Frozen Plasma Indications

Fresh Frozen Plasma is indicated for use in control of bleeding in patients who require replacement of labile plasma coagulation Factors (V and VIII including vWf) when simultaneous blood volume expansion is required. When blood volume expansion is not required, Lyophilized Cryoprecipitate may be used. FFP may also be used in cases where Frozen Plasma is indicated. FFP is indicated for patients with thrombotic thrombocytopenic purpura (TTP) when platelet inactivation is due to an absence of vWF. Fresh Frozen Plasma does not contain platelets.

Contraindications

Do not use FFP when coagulopathy can be corrected more effectively with specific therapy, such as Lyophilized Cryoprecipitate, vitamin K, etc. Do not use FFP when blood volume can be safely and adequately replaced with other volume expanders such as 0.9% Sodium Chloride, Injection (USP) or Lactated Ringer’s Injection (USP).

NOTE: Lyophilized Cryoprecipitate not available in the state of California.

Side Effects and Hazards

As described for Whole Blood, side effects and hazards may include febrile, hemolytic and allergic reactions; circulatory overload; and transmission of infectious diseases. If massive volumes of plasma are used, citrate toxicity, hypothermia and other metabolic problems may occur.

Antibodies in the plasma may react with the recipient’s red cells, causing a positive direct antiglobulin test, possibly hemolysis and, rarely, noncardiogenic pulmonary edema.

Dosage and Administration

A crossmatch should always be performed before plasma is administered. Plasma should be DEA 1 compatible with the recipient’s red cells, from DEA 1 negative donors or produced in a manner that insures no red cell contamination. Plasma produced from whole blood collection cannot be guaranteed free of red cells. Unless labeled otherwise, all ABRI plasma comes from DEA 1 negative donors.

The volume transfused depends on the clinical situations and patient size. Some literature recommends 2 mL to 5 mL per pound of body weight up to 20 mL per pound of body weight.

Dosage should be guided by close patient monitoring. Do not use the Plasma if there is evidence of container breakage or of thawing during storage. Plasma may be thawed at a temperature between 30° and 37° C using gentle agitation. Use a watertight protective plastic overwrap (such as a ziplock bag) if a waterbath is used. Microwaves are not recommended for thawing plasma.

Fresh Frozen plasma thawed in a refrigerator may be refrozen, but should be relabeled as frozen plasma. Plasma thawed and refrozen in this way has an expiration date of five years from the date of collection.

REFERENCES

A reference list is available upon request from Animal Blood Bank Inc.

Animal Blood Resources International, PO Box 1118, Dixon CA 95620

(800) 243-5759

(707) 678-7350 PST and International

(517) 851-8244 EST and International

info@abrint.net

www.abrint.net

Summary Chart of Blood Components

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CPN: 1398014.4