warnings
IV. Warnings and Cautions Contraindications: None known Precautions for use: • Solutions are NOT INTENDED FOR DIRECT INFUSION. • Do not use if particulate matter is present or if the solution is cloudy. Note: Some opacity of the plastic container due to moisture absorbance by the PVC during the sterilization process may be observed. This is normal and does not affect the quality or the safety of the product. This white, hazy appearance will diminish gradually over time. This advice only applies to the plastic container. Do not use if the solution itself is cloudy or contains particulate matter. • Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Note: The over wrap serves as a moisture barrier. Upon removing the solution bag, small droplets of condensation may be present in the packaging. This is considered normal. After removing the over wrap gently squeeze the inner bag which protects the sterility of the solution. Discard if any leaks are observed or if an excessive amount of solution is noted within the over wrap. • Do not reuse solution. Discard any unused or partially used solutions. • Protect from sharp objects. • Verify that solutions have been appropriately connected to avoid leaks. • The set should be loaded and primed for use within 8 hours of the start of the collection. • Carry out the apheresis procedure in accordance with the detailed instructions of the manufacturer of the apheresis device. Adverse Reactions: Donors being reinfused with citrated blood or blood components may experience side effects due to the presence of citrate. Patients being transfused with the blood components could also experience a reaction to the citrated blood components. The major symptom experienced by donors is paraesthesia. Should this occur the reinfusion should be stopped or the reinfusion rate decreased. In the event of inadvertent bolus of the product administer calcium gluconate. Drug Abuse / Dependence: Both solutions are intended to be used only with automated apheresis devices for collecting human blood and blood components. CP2D is used as an anticoagulant solution and AS-3 is intended for use a nutrient solution. Neither solution is intended for direct infusion; neither solution produces a pharmacological effect. Overdosage: Both solutions are intended to be used only with automated apheresis devices for collecting human blood and blood components. CP2D is used as an anticoagulant solution and AS-3 is intended for use a nutrient solution. Neither solution is intended for direct infusion.