Precautions for Handling: Stability of unopened vial: According to the results of a long-term stability test (25°C±2°C/60% RH±5%RH, 36 months) it was confirmed that Rocuronium Bromide solution for injection/infusion 50 mg/5 mL are stable under normal market circulation for 3 years.
Compatibility with infusion solutions: Compatibility studies with the following infusion fluids have been performed: Rocuronium bromide solution for injection/infusion 50 mg/5 mL has been shown to be compatible with the following when 1 vial is added to 0.9% NaCl (50 mL), 5% glucose (20 mL), Lactated Ringers (250 mL), 5% glucose acetated Ringers (200 mL) solutions. Administration should be begun immediately after mixing. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Use immediately after opening the vial: After dilution with infusion fluids (see Important Precautions under Precautions), chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (below 30°C). From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user/administrator and would normally not be longer than 24 hours.
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