NeoRecormon 2,000units0.3ml solution for injection pre-filled syringes

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Epoetin beta

Tillgänglig från:

Roche Products Ltd

ATC-kod:

B03XA01

INN (International namn):

Epoetin beta

Dos:

6667unit/1ml

Läkemedelsform:

Solution for injection

Administreringssätt:

Intravenous; Subcutaneous

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 09010300; GTIN: 5000471005424

Bipacksedel

1
uk-ie-mt-pil-neorecormon-clean-180315-pfs
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEORECORMON 500 IU
NEORECORMON 2000 IU
NEORECORMON 3000 IU
NEORECORMON 4000 IU
NEORECORMON 5000 IU
NEORECORMON 6000 IU
NEORECORMON 10,000 IU
NEORECORMON 20,000 IU
NEORECORMON 30,000 IU
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Epoetin beta
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 or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs or illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NeoRecormon is and what it is used for
2.
What you need to know before you use NeoRecormon
3.
How to use NeoRecormon
4.
Possible side effects
5.
How to store NeoRecormon
6.
Content of the pack and other information
1.
WHAT NEORECORMON IS AND WHAT IT IS USED FOR
NeoRecormon is a clear, colourless solution for injection under the
skin _(subcutaneously)_ or into a
vein _(intravenously). _It contains a hormone called _epoetin beta_,
which stimulates the production of red
blood cells. Epoetin beta is produced by a specialised genetic
technology and works in exactly the
same way as the natural hormone erythropoietin.
You must talk to your doctor if you do not feel better or if you feel
worse.
NeoRecormon is indicated for:
•
TREATING SYMPTOMATIC ANAEMIA CAUSED BY CHRONIC KIDNEY DISEASE (renal
anaemia) in patients
on dialysis, or not yet on dialysis.
•
PREVENTING ANAEMIA IN PREMATURE INFANTS (weighing 750 to 1500 g and
born at less than
34 weeks).
•
TREATING ANAEMIA WITH RELATED SYMPTOMS IN ADULT CANCER PATIENTS
RECEIVING CHEMOTHERAPY
•
TREATING PEOPLE DONATING THEIR OWN BLOOD BEFORE SURGERY. The
injections of epoetin

Produktens egenskaper

OBJECT 1
NEORECORMON SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
Summary of Product Characteristics Updated 29-Mar-2018 | Roche
Products Limited
1. Name of the medicinal product
NeoRecormon 500 IU solution for injection in pre-filled syringe.
NeoRecormon 2000 IU solution for injection in pre-filled syringe
NeoRecormon 3000 IU solution for injection in pre-filled syringe
NeoRecormon 4000 IU solution for injection in pre-filled syringe
NeoRecormon 5000 IU solution for injection in pre-filled syringe
NeoRecormon 6000 IU solution for injection in pre-filled syringe
NeoRecormon 10,000 IU solution for injection in pre-filled syringe
NeoRecormon 20,000 IU solution for injection in pre-filled syringe
NeoRecormon 30,000 IU solution for injection in pre-filled syringe
2. Qualitative and quantitative composition
NeoRecormon 500 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains 500
international units (IU)
corresponding to 4.15 micrograms epoetin beta* (recombinant human
erythropoietin).
One ml solution for injection contains 1667 IU epoetin beta.
NeoRecormon 2000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
2000 international units (IU)
corresponding to 16.6 micrograms epoetin beta* (recombinant human
erythropoietin).
One ml solution for injection contains 6667 IU epoetin beta.
NeoRecormon 3000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
3000 international units (IU)
corresponding to 24.9 micrograms epoetin beta* (recombinant human
erythropoietin).
One ml solution for injection contains 10,000 IU epoetin beta.
NeoRecormon 4000 IU solution for injection in pre-filled syringe
One pre-filled syringe with 0.3 ml solution for injection contains
4000 international units (IU)
corresponding to 33.2 micrograms epoetin beta* (recombinant human
erythropoietin).
One ml solution for injection contains 13,333 IU epoetin beta.
NeoRecor