d immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 25°C or 24 hours in a refrigerator (2°C – 8°C), protected from light.
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Store in the original carton in order to protect from light.
For storage conditions of the reconstituted medicinal product, see section 6.3.
6.5 Nature and contents of container
5 ml vial (type 1 clear glass) with a stopper (chlorobutyl rubber), seal (aluminium) and a flip-off cap (polypropylene).
Carton containing 1 or 4 vials of 250 µg of romiplostim.
Carton containing 1 or 4 vials of 500 µg of romiplostim.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Nplate is a sterile but unpreserved product and is intended for single use only. Nplate should be reconstituted in accordance with good aseptic practice.
Nplate 250 micrograms powder for solution for 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.
Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 ml sterile water for injections, yielding a deliverable volume of 1 ml. An additional overfill is included in each vial to ensure that 500 µg of romiplostim can be delivered.
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 Nplate 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 section 6.3.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/08/497/001
EU/1/08/497/003
EU/1/08/497/002
EU/1/08/497/004
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
4 February 2009
10. DATE OF REVISION OF THE TEXT
24 August 2011
Nplate is a registered trademark of Amgen Inc.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
