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Allergic /Anaphylactic Reactions
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, implement standard medical treatment for shock.
Transmission Of Infectious Agents
BUMINATE 25% is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt- Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin.
All infections thought by a physician possibly to have been transmitted by this product, should be reported by the physician, or other healthcare provider to Baxalta US Inc. at 1-800-423-2090. The physician should discuss the risks and benefits of this product with the patient.
Certain components used in the packaging of this product contain natural rubber latex which may cause allergic reactions.
Closely monitor hemodynamic parameters after administering BUMINATE 25% for evidence of cardiac or respiratory failure, renal failure, or increasing intracranial pressure.
Administer BUMINATE 25% with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk for the patient.Examples include, but are not limited to the following: Heart failure, hypertension, esophageal varices, pulmonary edema, hemorrhagic diathesis, severe anemia, and renal failure.
Adjust the rate of administration according to the solution concentration and the patient's hemodynamic status. Do not exceed 1 mL per min for patients with normal blood volume. More rapid administration can cause circulatory overload and pulmonary edema.14 Discontinue administration at the first clinical signs of cardiovascular overload e.g., headache, dyspnea, jugular venous distention, rales, and abnormal elevations in systemic or central venous blood pressure.
Monitor blood pressure in trauma patients and postoperative surgery patients resuscitated with BUMINATE 25% in order to detect rebleeding secondary to clot disruption.
Pregnancy -Category C
Animal reproduction studies have not been conducted with BUMINATE 25%. It is not known whether BUMINATE 25% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BUMINATE 25% should be given to a pregnant woman only if clearly needed.
It is not known whether BUMINATE 25% is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BUMINATE 25% is administered to a nursing woman.
The safety of albumin solutions has been demonstrated in children provided the dose is appropriate for body weight, however, the safety of BUMINATE 25% has not been evaluated in pediatric patients.
Monitor hemodynamic parameters. Ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets, and erythrocytes) are available if comparatively large volumes are replaced.
Monitor electrolyte status and ensure appropriate steps are taken to restore or maintain the electrolyte balance.
13.Wills MR, Savory J: Aluminum poisoning: dialysis encephalopathy, osteomalacia, and anaemia. Lancet 2:29-34,1983
14.Grocott, Michael P.W., Mythen, Michael G., and Gan, Tong J. Perioperative Fluid Management and Clinical Outcomes in Adults. Anes th Analg. 2005;100:1100
15. Tsao YC, Yu VYH: Albumin in management of neonatal hyperbilirubinaemia. Arch Dis Childhood 47:250-256, 1972This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/21/2016
Additional Buminate 25% Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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