NPLATE romiplostim (rbe) 230 microgram powder for injection vial

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Romiplostim, Quantity: 230 microgram

Διαθέσιμο από:

Amgen Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Injection, powder for

Σύνθεση:

Excipient Ingredients: histidine; sucrose; polysorbate 20; dilute hydrochloric acid; mannitol

Οδός χορήγησης:

Subcutaneous

Μονάδες σε πακέτο:

1

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2017-10-23

Αρχείο Π.Χ.Π.

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