Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
Romiplostim, Quantity: 230 microgram
Amgen Australia Pty Ltd
Injection, powder for
Excipient Ingredients: histidine; sucrose; polysorbate 20; dilute hydrochloric acid; mannitol
Subcutaneous
1
(S4) Prescription Only Medicine
Adults,Nplate is indicated for treatment of thrombocytopenia in adult patients with primary immune thrombocytopenia (ITP) who are:,? non-splenectomised and have had an inadequate response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.,Paediatrics,Nplate is indicated for treatment of thrombocytopenia in paediatric patients aged 1 year and older with primary immune thrombocytopenia ITP for at least 6 months who are:,? non-splenectomised and have had an insufficient response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.
Visual Identification: White powder in 3 mL clear glass with chlorobutyl stopper, aluminium seal and propylene flip-off cap; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2017-10-23
NPLATE ® (ROMIPLOSTIM) PRODUCT INFORMATION PAGE 1 OF 40 NPLATE PRODUCT INFORMATION This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – NPLATE ® (ROMIPLOSTIM) 1. NAME OF THE MEDICINE Romiplostim. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Nplate contains the active ingredient, romiplostim. It is supplied as a sterile, preservative-free, lyophilized white powder in single dose glass vials for reconstitution and subcutaneous (SC) injection. 230 microgram powder for injection Each vial contains 230 micrograms (µg) of romiplostim. After reconstitution, a deliverable volume of 0.25 mL of solution contains 125 µg of romiplostim (500 µg/mL). An overfill is included in each vial to ensure that 125 µg can be drawn from the vial. 375 microgram powder for injection Each vial contains 375 micrograms (µg) of romiplostim. After reconstitution, a deliverable volume of 0.5 mL of solution contains 250 µg of romiplostim (500 µg/mL). An overfill is included in each vial to ensure that 250 µg can be drawn from the vial. 625 microgram powder for injection Each vial contains 625 micrograms (µg) of romiplostim. After reconstitution, a deliverable volume of 1 mL of solution contains 500 µg of romiplostim (500 µg/mL). An overfill is included in each vial to ensure that 500 µg can be drawn from the vial. Excipient(s) with known effect Nplate contains mannitol and sucrose. For the full list of excipients, see section 6.1 List of excipients. NPLATE ® (ROMIPLOSTIM) PRODUCT INFORMATION PAGE 2 OF 40 NPLATE PRODUCT INFORMATION 3. PHARMACEUTICAL FORM Nplate is a sterile, white, preservative-free, lyophilised powder for reconstitution and administration as a subcutaneous (SC) injection. The reconstituted solution should be clear and colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Läs hela dokumentet