openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
5. WARNINGS AlbuRx ® 5, Albumin (Human) 5% solution is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been extremely reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses through alcohol fractionation and through heat treatment of the product in the final container for 10 hours at 60ºC. Despite these measures, such products can still potentially transmit disease. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for Albumin (Human). There is also the possibility that unknown infectious agents may be present in such products. 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 CSL Behring at 1-800-504-5434. The physician should discuss the risks and benefits of this product with the patient. Turbid solutions must not be used. Do not begin administration more than 4 hours after introduction of the administration set. Partially used bottles must be discarded.
7. ADVERSE REACTIONS Since AlbuRx ® 5, Albumin (Human) 5% solution is sterile when coming from the manufacturer, bacterial contamination with the risk of post-infusion septicemia can only occur if the container has been damaged or following puncture of the rubber cap (see WARNINGS ). Though very rare, non-septic incompatibility reactions including nausea, chills, fever, urticaria, headache and hypotension following the administration of albumin-containing preparations have occasionally been observed. 6,8,9,16 A favorable response to the intravenous administration of 50 to 100 mg of prednisolone was recorded. 9