Nplate

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

romiplostim

Available from:

Amgen Europe B.V.

ATC code:

B02BX04

INN (International Name):

romiplostim

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Purpura, Thrombocytopenic, Idiopathic

Therapeutic indications:

Adults:Nplate is indicated for the treatment of primary immune thrombocytopenia  (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Paediatrics:Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Product summary:

Revision: 26

Authorization status:

Authorised

Authorization date:

2009-02-04

Patient Information leaflet

77
B. PACKAGE LEAFLET
78
PACKAGE LEAFLET: INFORMATION FOR THE USER
NPLATE 125 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION
NPLATE 250 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION
NPLATE 500 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION
Romiplostim
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nplate is and what it is used for
2.
What you need to know before you use Nplate
3.
How to use Nplate
4.
Possible side effects
5.
How to store Nplate
6.
Contents of the pack and other information
1.
WHAT NPLATE IS AND WHAT IT IS USED FOR
Nplate’s active ingredient is romiplostim, which is a protein used
to treat low platelet counts in
patients with immune primary thrombocytopenia (called ITP). ITP is a
disease in which your body’s
immune system destroys its own platelets. Platelets are the cells in
your blood that help seal cuts and
form blood clots. Very low platelet counts can cause bruising and
serious bleeding.
Nplate is used to treat adult patients with ITP who may or may not
have had their spleen removed and
who have been previously treated with corticosteroids or
immunoglobulins, where these treatments
don’t work. Nplate is also used to treat children aged 1 year and
over with chronic ITP who may or
may not have had their spleen removed and who have been previously
treated with corticosteroids or
immunoglobulins, where these treatments don’t work.
Nplate works by stimulating the bone marrow (part of the bone which
makes blood cells) to produce
more platelets. This should help to

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nplate 125 micrograms powder for solution for injection
Nplate 250 micrograms powder for solution for injection
Nplate 500 micrograms powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nplate 125 micrograms powder for solution for injection
Each vial contains 125 mcg of romiplostim. After reconstitution, a
deliverable volume of 0.25 mL
solution contains 125 mcg of romiplostim (500 mcg/mL). An additional
overfill is included in each
vial to ensure that 125 mcg of romiplostim can be delivered.
Nplate 250 micrograms powder for solution for injection
Each vial contains 250 mcg of romiplostim. After reconstitution, a
deliverable volume of 0.5 mL
solution contains 250 mcg of romiplostim (500 mcg/mL). An additional
overfill is included in each
vial to ensure that 250 mcg of romiplostim can be delivered.
Nplate 500 micrograms powder for solution for injection
Each vial contains 500 mcg of romiplostim. After reconstitution, a
deliverable volume of 1 mL
solution contains 500 mcg of romiplostim (500 mcg/mL). An additional
overfill is included in each
vial to ensure that 500 mcg of romiplostim can be delivered.
Romiplostim is produced by recombinant DNA technology in _Escherichia
coli_ (_E. coli_).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection (powder for injection).
The powder is white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults:
Nplate is indicated for the treatment of primary immune
thrombocytopenia (ITP) in adult patients who
are refractory to other treatments (e.g. corticosteroids,
immunoglobulins) (see sections 4.2 and 5.1).
Paediatrics:
Nplate is indicated for the treatment of chronic primary immune
thrombocytopenia (ITP) in paediatric
patients one year of age and older who are refractory to other
treatments (e.g. corticosteroids,
immunoglobulins) (see sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should rema