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: Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20. Solvent: water for injections.
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.
Nplate is supplied as a 1 pack or multipack comprising 4 packs. Each pack contains: 1 vial of 250 micrograms or 500 micrograms of romiplostim.
1 pre-filled syringe containing 0.72 or 1.2 ml of water for injections for reconstitution. 1 plunger rod for pre-filled syringe.
1 sterile vial adapter.
1 sterile 1 ml Luer lock syringe.
1 sterile safety needle.
4 alcohol swabs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Amgen Europe B.V.
4817 ZK Breda
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 02 805 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
Amgen Switzerland AG Vilniaus filialas
Tel.: +370 682 28282
This leaflet was last approved in.
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.
1. Remove the plastic cap from Nplate powder vial and clean rubber stopper using the provided alcohol swab. 2. Attach vial adapter to Nplate vial by peeling off paper backing from vial adapter, keeping the vial adapter in its packaging. Keeping the vial on the bench, push the vial adapter down onto the centre of the vial until it is firmly in place. Note To prevent contamination of the product, do not touch the vial adapter spike or Luer lock. 3. Remove and discard vial adapter packaging. 4. Attach plunger rod to the pre-filled syringe of water for injections by twisting the plunger rod clockwise onto the syringe plunger, until you feel a slight resistance.
5. Holding the pre-filled syringe of water for injections with one hand, bend the tip of the white plastic cover downward with your other hand. This will break the seal of the white plastic cover. Once the seal is broken, pull cover off to separate the grey rubber cap from the clear plastic syringe tip. 6. Keeping the vial on the bench, attach the pre-filled syringe of water for injections to vial adapter hold the outer edge of the vial adapter with one hand and twist the syringe tip clockwise onto the adapter with the other hand until you feel a slight resistance. 7. Very slowly and gently expel all water into powder vial. Water should flow slowly onto powder. GENTLY swirl the vial until all of the powder has dissolved and the fluid in the vial is clear and colourless. Do not shake or agitate vial NOTE This may take up to 2 minutes for the powder to completely dissolve. Note From a microbiological point of view, the product must be used immediately after reconstitution. If reconstituted product is not used immediately, the syringe should not be removed from the vial adapter to maintain microbiological integrity. Before continuing Do visually inspect the reconstituted solution for particulate matter andor discoloration. The reconstituted solution should be clear and colourless and should not be administered if particulate matter andor discolouration are observed. Do make sure solution is fully dissolved before removing syringe. 8. Remove the empty pre-filled syringe from the vial adapter. 9. Remove 1 ml administration syringe from package. Attach the 1 ml syringe to vial adapter of reconstituted solution by twisting the syringe tip onto the vial adapter until you feel a slight resistance. 10. Turn assembled syringe-vial unit upside down, so the vial of reconstituted product is above the syringe. Withdraw all of the medicinal product solution into the administration syringe.
11. Ensure the correct amount of solution for the patient dose is in the administration syringe by expelling any excess solution back into the vial. Note Remove all air bubbles from syringe to ensure precise solution amount is in syringe. 12. Twist off administration syringe from vial adapter. Attach safety needle to the filled administration syringe by twisting needle clockwise into syringe Luer lock tip. 13. Prepare injection site with a new alcohol swab. Pull back on the pink safety cover toward the syringe and away from the needle. Remove clear needle shield from prepared needle by holding syringe in one hand and carefully pulling shield straight off with the other hand. 14. Administer subcutaneous injection following local protocols and good aseptic technique. 15. After injecting, activate the pink safety cover by pushing the cover forward using the same hand until you hear andor feel it clicklock. 16. Immediately discard syringe and needle into an approved Sharps Container.