DuPont Pharma

Cold Storage Solution

Indications And Clinical Uses: For the flushing and cold storage of organs including kidney, liver and pancreas at the time of their removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.

After precooling the solution to approximately 2 to 6°C in ice, the cold solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation. This solution is to be used for cold storage of the organ and not for continuous machine perfusion. Use of the solution at the recommended temperatures will effectively cool the organ and should reduce its metabolic requirements.

Contra-Indications: There are no known contraindications when used as directed.

Manufacturers’ Warnings In Clinical States: Not for direct injection or i.v. infusion.

Precautions: Before reperfusion is effected in the recipient, the donor organ must be flushed free of the cold storage solution using a physiological solution to prevent occurrence in the recipient of potentially serious cardiovascular complications such as hyperkalemic cardiac arrest or bradyarrythmia. Because of the high concentration of potassium in the solution, precautions must be taken during donor organ retrieval to avoid cardiac arrest.

Viaspan contains variable amounts of visible and subvisible particles (primarily 5 to 100 microns in size) which have been identified as stearate and palmitate fatty acid salts. Stearates and palmitates are used in manufacturing the bags in which Viaspan is distributed (see Dosage, Preparation and Administration for filtration instructions.)

Viaspan includes components (allopurinol and pentafraction) which individually have caused hypersensitivity reactions in patients. Additionally, the additives recommended for use with Viaspan (penicillin, insulin, and dexamethasone) have individually been associated with hypersensitivity reactions in patients. Physicians should consult individual drug labelling and be alert to treat possible reactions.

Adverse Reactions: Cardiovascular complications such as bradyarrhythmia have been reported in cases where the organ has been reflushed with fresh solution within a short period (1 to 3 hours) prior to release of vascular anastomosis clamps in the recipient, or when inadequate flush out of the solution has occurred.

A few anecdotal reports when Viaspan was used in liver graft preservation described clinical problems including hepatic functional changes, poor outcomes including death, and biopsies showing ischemic damage in the liver with or without signs of mild rejection. Any relationship between these clinical problems and Viaspan is unknown.

Dosage And Administration: Preparation and Administration: Cool the solution between 2 and 6°C in ice. Remove overwrap prior to use. Check bags for leaks by squeezing containers firmly. If leaks are found, discard solution containers. With the overwrap removed, perform a visual inspection of the solution for particulate matter and do not use if obvious particulate matter, precipitates, or contamination is evident in the solution. Bags which pass visual inspection must be filtered at the time of use with an in-line Pall Blood Transfusion Filter (No. SQ4OS) as instructed below. Only this filter is recommended for use with Viaspan.

Immediately prior to use, to formulate the final solution, aseptically add the following additives: 1) penicillin G 200 000 units, 2) regular insulin 40 units, 3) dexamethasone 16 mg.

Glutathione, one of the components of Viaspan, oxidizes during storage. If desired an additional 0.922 g/L of glutathione may be added as a freshly prepared solution of reduced glutathione immediately prior to use.

Remove protective cap from outlet port of filter and insert spike from the administration set into port with twisting motion. Open clamp on administration set. Remove twist-off plug from bag port designated “delivery set port.” Hold the administration set vertically above the solution bag, then squeeze solution bag to fill filter and administration set. Close the clamp.

Prior to connection to the organ, the solution container should be suspended from a sufficient height to allow for a steady stream of solution and to produce flow rates of at least 30 mL/min during flushing. Open the clamp to begin flushing. Flushing should be continued until the organ is uniformly pale and the effluent is relatively clear. One filter should be used per bag, and filters must not be reused.

Suggested Minimum Volumes: In situ aortic flush: adults, 2 to 4 L; infants, 50 mL/kg.

Ex vivo infusion: Liver (via portal vein and biliary tree): adults, 1 200 mL; infants, 50 mL/kg. Pancreas or kidney: adults, 300 to 500 mL; infants, 150 to 250 mL.

Additional solution should be dispensed into the container holding the organ. Seal the container aseptically. The organ storage container should be maintained within a well-insulated transport container. Ice should be used to surround the organ storage container, but should not be used within the container, where the ice could come into direct contact with the organ. Donor organs must be flushed free of Viaspan prior to anastomosis (see Precautions). In order to minimize residues of the solution in the liver, just prior to anastomosis, flush 1 L of lactated Ringer’s through the hepatic portal vein.

Availability And Storage: Each L of clear, light yellow, sterile, nonpyrogenic solution for hypothermic flushing and storage of organs contains: pentafraction 50 g, lactobionic acid 35.83 g, potassium phosphate monobasic 3.4 g, magnesium sulfate heptahydrate 1.23 g, raffinose pentahydrate 17.83 g, adenosine 1.34 g, allopurinol 0.136 g, total glutathione 0.922 g, potassium hydroxide 5.61 g, sodium hydroxide and/or hydrochloric acid adjust to pH 7.4, water for injection q.s. The solution has an approximate calculated osmolarity of 320 mOsM, a sodium concentration of 29 mEq/L, and a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at room temperature. Litre bags of 1 000 mL.

Store product at refrigerated temperature (2 to 8°C) until use. Avoid excessive heat. Do not freeze the solution, and do not use if frozen. Do not use if discolored or if obvious particulate matter, precipitates, or contamination is evident in the solution.

VIASPAN™ DuPont Pharma Cold Storage Solution

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