What Nplate contains
- The active substance is romiplostim.
Each vial of Nplate 250 micrograms powder for solution for injection contains 250 micrograms of romiplostim. After reconstitution, a deliverable volume of 0.5 ml solution contains 250 micrograms of romiplostim (500 micrograms/ml).
Each vial of Nplate 500 micrograms powder for solution for injection contains 500 micrograms of romiplostim. After reconstitution, a deliverable volume of 1 ml solution contains 500 micrograms of romiplostim (500 micrograms/ml).
- The other ingredients are mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
What Nplate looks like and contents of the pack
Nplate is a white powder for solution for injection supplied in a 5 ml glass vial.
Carton containing 1 or 4 vials of either 250 micrograms or 500 micrograms of romiplostim.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien s.a. Amgen n.v. TelTél 32 02 7752711 LuxembourgLuxemburg s.a. Amgen BelgiqueBelgien TelTél 32 02 7752711
359 0 2 805 7020 Magyarország Amgen Kft. Tel. 36 1 35 44 700
eská republika Amgen s.r.o. Tel 420 2 21 773 500 Malta Amgen B.V. The Netherlands Tel 31 076 5732500
Danmark Amgen filial af Amgen AB, Sverige Tlf 45 39617500 Nederland Amgen B.V. Tel 31 076 5732500
Deutschland AMGEN GmbH Tel. 49 89 1490960 Norge Amgen AB Tel 47 23308000
Eesti Amgen Switzerland AG Vilniaus filialas Tel 372 5125 501 Österreich Amgen GmbH Tel 43 01 50 217
Amgen ... . 30 210 3447000 Polska Amgen Sp. z o.o. Tel. 48 22 581 3000
España Amgen S.A. Tel 34 93 600 19 00 Portugal AMGEN Biofarmacêutica, Lda. Tel 351 21 4220550
France Amgen S.A.S Tél 33 01 40 88 27 00 România Amgen România SRL Tel. 4021 527 3000
Slovenija AMGEN zdravila d.o.o. Tel 386 1 585 1767 Ireland Amgen Limited United Kingdom Tel 44 01223 420305
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Amgen Switzerland AG Slovakia Tel 421 33 321 13 22
Italia Amgen Dompé S.p.A. Tel 39 02 6241121 SuomiFinland Amgen AB, sivuliike SuomessaAmgen AB, filial i Finland PuhTel 358 09 54900500
K Papaellinas Co Ltd 357 22741 741 Sverige Amgen AB Tel 46 08 6951100
Latvija Amgen Switzerland AG Rgas filile Tel 371 29284 807 United Kingdom Amgen Limited Tel 44 01223 420305
Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel.: +370 682 28282
This leaflet was last approved in.
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The following information is intended for medical or healthcare professionals only:
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. or
- 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.
From a microbiological point of view, the product should be used immediately. If not used 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.
Any unused product or waste material should be disposed of in accordance with local requirements.