NPLATE romiplostim (rbe) 375 microgram powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Romiplostim, Quantity: 375 microgram

Disponível em:

Amgen Australia Pty Ltd

DCI (Denominação Comum Internacional):

Romiplostim

Forma farmacêutica:

Injection, powder for

Composição:

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

Via de administração:

Subcutaneous

Unidades em pacote:

1 x 375 microgram

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

Visual Identification: white powder in 5 mL clear glass vial with chlorobutyl elastomeric stopper, aluminium seal and propylene flip-off cap; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status de autorização:

Registered

Data de autorização:

2008-08-08

Folheto informativo - Bula

NPLATE
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING NPLATE?
Nplate contains the active ingredient romiplostim. Nplate is used to
increase the number of platelets, and to prevent bruising and
bleeding associated with a blood disorder called immune
thrombocytopenia, commonly abbreviated as ITP.
For more information, see Section 1. Why am I using Nplate? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NPLATE?
Do not use if you have ever had an allergic reaction to romiplostim or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Nplate? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Nplate and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NPLATE?
Nplate is injected under the skin (subcutaneous).
More instructions can be found in Section 4. How do I use Nplate? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NPLATE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Nplate.
•
Keep all of your test appointments and doctor appointments so that
your progress can be checked.
•
Tell your doctor immediately if you become pregnant while taking
Nplate.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine unless your doctor tells you. If you
stop taking Nplate, you are at risk of
bleeding.
DRIVING
OR USING
MACHINES
•
Nplate may cause temporary bouts of dizziness in some people and may
impair your ability to safely
drive or use machines

Características técnicas

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