NPLATE romiplostim (rbe) 625 microgram powder for injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

Romiplostim, Quantity: 625 microgram

제공처:

Amgen Australia Pty Ltd

INN (International Name):

Romiplostim

약제 형태:

Injection, powder for

구성:

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

관리 경로:

Subcutaneous

패키지 단위:

1 x 625 microgram

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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.

제품 요약:

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

승인 상태:

Registered

승인 날짜:

2008-08-08

환자 정보 전단

NPLATE
®
N
P
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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

제품 특성 요약

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