The most common adverse reactions from blood transfusions are allergic and febrile fever—associated reactions, which make up over half of all adverse reactions reported. Rare but serious adverse reactions include infection caused by bacterial contamination of blood products and immune reactions due to problems in blood type matching between donor and recipient. These adverse reactions are not common following blood transfusions but are tracked so that CDC can better understand them and develop interventions to prevent them.
Ms Zafirelis has more than 20 years of multinational regulatory and clinical operations experience. Manufacturing Source of hemoglobin and viral safety Hemopure and Oxyglobin are sourced from bovine red blood cells RBCs.
Our quality management system includes a comprehensive herd management program to ensure the safety of all raw material used in production. All sourced cattle are born in the USA or Canada and obtained from pre-qualified suppliers that maintain comprehensive health and feed histories for each animal.
All collected material is held in quarantine until a post mortem inspection of the cattle is conducted by the onsite USDA veterinarian, and released for human consumption. Manufacturing process Our products are manufactured by an extensive purification procedure.
The purification of hemoglobin involves an automated state-of- the-art process consisting of multiple separation and filtration steps including specific hemoglobin isolation by large-scale, high-pressure ion exchange liquid chromatography.
During the manufacturing process hemoglobin is crosslinked and polymerized by reaction with glutaraldehyde under totally automated procedures. We have recently consolidated all manufacturing activities at our site in Souderton PA, where the facility is undergoing a multimillion dollar expansion to accommodate increased capacity for all production steps from collection of starting materials through aseptic fill finish.
Oxygen is indispensable to the life of all human tissues. Medical conditions such as ischemia or anemia can compromise tissue oxygenation.
Ischemia is a decrease or lack of RBC flow to an organ or body part due to obstructed or constricted blood vessels, as in heart attack, stroke and certain medical procedures.
Anemia is a deficiency of RBCs or hemoglobin associated with blood loss e.
Oxygen deprivation, even for several minutes, can result in cell damage, organ dysfunction and, if prolonged, death. The most critical property of each product is an ability to efficiently transport oxygen. There are two mechanisms by which oxygen transport is enhanced. Promoting both convective and diffusive oxygen delivery; the net result is an increase in oxygen delivery due to both an increase in the oxygen-carrying capacity of the plasma, and changes in the rheology of blood.
HBOC has a viscosity of 1. Addition of HBOC to blood decreases the overall viscosity. The products increase plasma and total hemoglobin concentration and thus increases arterial oxygen content.
Supplied in sterile IV infusion bags, the product is ready to be administered. No reconstitution or other preparation is required. Hemopure also does not need refrigeration and remains stable at room temperature for at least three years.
Normal blood flow Anemic blood flow Published Literature Hemopure and Oxyglobin have to date been the topic of over peer reviewed journal articles, conference proceeding and posters The following reference list includes many of those, but is by no means all inclusive.
The references are date ordered with the most recent first: Drug Deliv Transl Res. Show more Keipert PE.
Adv Exp Med Biol. Epub Mar Epub Feb Bloodless reperfusion with the oxygen carrier HBOC in acute myocardial infarction: J Appl Physiol Epub Feb 9.
Normalization of hemoglobin-based oxygen carrier induced vasoconstriction: Epub Sep Hemoglobin glutamer bovine in South Africa: Epub Apr 6. Artif Cells Nanomed Biotechnol. Epub Mar 2. Determination of methemoglobin and hemoglobin levels in small volume samples.
Absence of developmental toxicity in a canine model after infusion of a hemoglobin-based oxygen carrier: Implications for risk assessment. Epub Jan Developmental toxicity in rats of a hemoglobin-based oxygen carrier results from impeded function of the inverted visceral yolk sac.
Epub Jul Hemoglobin Oxygen Therapeutics LLC (HbO2 Therapeutics) is a leading developer and manufacturer of oxygen carrying solutions, a class of drug products that when administered intravenously can increase the amount of .
Nov 21, · Disseminated intravascular coagulation (DIC) is characterized by systemic activation of blood coagulation, which results in generation and deposition of fibrin, leading to microvascular thrombi in various organs and contributing to multiple organ dysfunction syndrome (MODS).
Consumption and subsequent exhaustion of . The Medical Services Advisory Committee (MSAC) is an independent non-statutory committee established by the Australian Government Minister for Health in The content on the UpToDate website is not intended nor recommended as a substitute for medical advice, diagnosis, or treatment.
Always seek the advice of your own physician or other qualified health care professional regarding any medical questions or conditions. BackgroundRandomized, controlled trials have suggested that the transfusion of blood after prolonged storage does not increase the risk of adverse outcomes among patients, although most of these.
WEEKLY SAFETY MEETING All Euramax Subsidiaries BLOODBORNE PATHOGENS Safety Meeting Contents Meeting Notice Leaders Guide Employee Handout.