Feline Fresh Frozen Plasma

Company: Animal Blood Resources International

NOTICE TO ALL USERS

The Package Insert is a supplement to 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 inform the user of the product use and conform with applicable government regulations. This document should be kept on file and readily available to personnel involved in the use of these products.

Blood and blood components are biologic products and, in the form of cellular products, living feline tissue intended for use in feline patients at the discretion of the attending veterinarian. 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. This is especially true regarding feline viruses that do not currently have highly successful diagnostic tests and vaccination agents available. 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 patient’s clinical condition is needed to prevent inappropriate transfusion.

Autologous transfusion techniques (such as intraoperative salvage and pre-surgical 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 feline 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 Rabies, Rhinotracheitis, Calici and Panleukopenia. Blood from donors maintained in controlled access colonies generally carries a lower risk of disease transmission than blood from volunteer donors. These risks for feline infectious agents cannot be eliminated under the current state of the art and it must be considered that a risk of disease transmission may be present.

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 negative for FeLV, FIV and are screened for Haemobartonella felis. The label on the container indicates whether the donor is feline blood type A, type B or type AB.

BLOOD AND COMPONENT LABELING

Labels contain the following information:

1. The name of the product.

2. The temperature range in which the component is to be stored.

3. The contents or volume (standard contents, i.e., as prepared according to the Package Insert, is assumed unless otherwise indicated on the label or in Package Insert supplements).

4. ABRI’s name, address, telephone number.

5. California Biologics registration number, if applicable.

6. The expiration date of the blood component.

7. The donor (serial) identification number.

8. Blood type of the donor

9. 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 ABRI Feline Administration set or 18 micron blood filter (HEMO-NATE^® blood filter or equivalent) is recommended for volumes less than 50 mL.

● Before use, bags of blood or components should be gently rocked 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 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. A slight pink tinge to the supernatant due to some free hemoglobin may be present and is acceptable for transfusion. Call Animal Blood Resources International at (800) 243-5759 for further evaluation.

● 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 freezer bags) is recommended.

● 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).

● 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.

● 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, whichever is sooner. If blood or components cannot be infused in 4 hours, they should be divided 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, a crossmatch must be performed. First time transfusions with donors and recipients of unknown blood types are NEVER 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

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 standard unit contains a minimum of 25 mLs of FFP. Ranges are due to differences in donor PCV’s.

Actions

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

Feline Fresh Frozen Plasma Indications

FFP 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 or not a problem. FFP may also be used in cases where Frozen Plasma is indicated. FFP is indicated for patients with thrombotic thrombocytopenic purpura (TTP).

Contraindications

Do not use FFP when coagulopathy can be corrected more effectively with specific therapy, such as vitamin K. 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).

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, non-cardiogenic pulmonary edema.

Dosage and Administration

A minor crossmatch should always be performed before plasma is administered. Plasma should be compatible with the recipient’s red cells.

The volume transfused depends on the clinical situations and patient size. Some literature recommends 2 mL to 5mL 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 freezer bag) if a water bath is used. Microwaves are not recommended for thawing plasma.

FFP should be used as soon as possible but no more than 24 hours after thawing (stored at 1° - 6° C) when administered as a source of labile coagulation factors. Do not refreeze.

REFERENCES

A reference list is available upon request from Animal Blood Re-sources International, or on our website, www.abrint.net

Animal Blood Resources International

www.abrint.net

info@abrint.net

(800) 243-5759

Summary Chart of Blood Components

© Copyright 2013 - Animal Blood Bank, All Rights Reserved

CPN: 1398013.3