Nplate 250microgram powder and solvent for solution for injection pre-filled disposable devices

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Romiplostim

Disponible des:

Amgen Ltd

Codi ATC:

B02BX04

Designació comuna internacional (DCI):

Romiplostim

Dosis:

250microgram

formulario farmacéutico:

Powder and solvent for solution for injection

Vía de administración:

Subcutaneous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: ; GTIN: 8715131004262

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
NPLATE 250 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NPLATE 500 MICROGRAMS POWDER AND SOLVENT 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
7.
Instructions for preparing and giving an injection of Nplate
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 (idiopathic) thrombocytopenic purpura (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 (aged 18 years and over) who
may or may not have had their
spleen removed for chronic ITP 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 prevent bruising and bleeding
associated with ITP.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NPLATE
DO NOT USE NPLATE:

if you are allergic to romiplostim or any of the other ingredients

Fitxa tècnica

OBJECT 1
NPLATE WITH RECONSTITUTION PACK
Summary of Product Characteristics Updated 27-Feb-2018 | Amgen Ltd
1. Name of the medicinal product
Nplate 250 micrograms powder and solvent for solution for injection
Nplate 500 micrograms powder and solvent for solution for injection
2. Qualitative and quantitative composition
Nplate 250 micrograms powder and solvent 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 and solvent 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 and solvent for solution for injection (powder for injection).
The powder is white.
The solvent is a clear colourless liquid.
4. Clinical particulars
4.1 Therapeutic indications
Nplate is indicated for adult chronic immune (idiopathic)
thrombocytopenic purpura (ITP) patients 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 remain under the supervision of a physician who is
experienced in the treatment of
haematological diseases.
Posology
Nplate should be administered once weekly as a subcutaneous injection.
_Initial dose_
The initial dose of romiplostim is 1 mcg/kg based on actual body
weight.
_Dose calculation _
Initial or subsequent
once weekly dose:
Weight* in kg x Dose in mcg/kg = Individual patient dose in mcg
Volume to administer:
Example:
75 kg patient is initiated at 1 mcg/kg of