Special precautions for disposal and other handling: Romiplate is a sterile but unpreserved medicinal product and is intended for single use only. Romiplate should be reconstituted in accordance with good aseptic practice.
Romiplate 250μg, Injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL. An additional overfill is included in each vial to ensure that 250 μg of romiplostim can be delivered.
Sterile water for injection only should be used when reconstituting the medicinal product. Sodium chloride solutions or bacteriostatic water should not be used when reconstituting the medicinal product.
Water for injections should be injected into the vial. The vial contents may be swirled gently and inverted during dissolution. The vial should not be shaken or vigorously agitated. Generally, dissolution of Romiplate takes less than 2 minutes. Visually inspect the solution for particulate matter and discolouration before administration. The reconstituted solution should be clear and colourless and should not be administered if particulate matter and/or discolouration are observed.
For the storage condition of the reconstituted product see Shelf life under Storage.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: This medicinal product must not be mixed with other medicinal products, except those previously mentioned in Special precautions for disposal and other handling.