Enbrel 25mg powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Etanercept

Available from:

Pfizer Ltd

ATC code:

L04AB01

INN (International Name):

Etanercept

Dosage:

25mg

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010300; GTIN: 5010981001809

Patient Information leaflet

Page 1 of 15
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENBREL 25 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Etanercept
READ ALL (BOTH SIDES) 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.

Your doctor will also give you a Patient Alert Card, which contains
important safety information
that you need to be aware of before and during treatment with Enbrel.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you or a child in your care. Do
not pass it on to others. It
may harm them, even if their signs of illness are the same as yours or
those of the child you are
caring for.

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
Information in this leaflet is organised under the following 7
sections:
1.
What Enbrel is and what it is used for
2.
What you need to know before you use Enbrel
3.
How to use Enbrel
4.
Possible side effects
5.
How to store Enbrel
6.
Contents of the pack and other information
7.
Instructions for preparing and giving an injection of Enbrel (See
overleaf)
1.
WHAT ENBREL IS AND WHAT IT IS USED FOR
Enbrel is a medicine that is made from two human proteins. It blocks
the activity of another protein in
the body that causes inflammation. Enbrel works by reducing the
inflammation associated with certain
diseases.
In adults (aged 18 and over), Enbrel can be used for moderate or
severe RHEUMATOID ARTHRITIS,
PSORIATIC ARTHRITIS, severe AXIAL SPONDYLOARTHRITIS including
ANKYLOSING SPONDYLITIS, and moderate
or severe PSORIASIS – in each case usually when other widely used
treatments have not worked well
enough or are not suitable for you.
For rheumatoid arthritis, Enbrel is usually used in combination with
methotrexate, although it may
also be used alone if treatment with methotrexate is uns

Summary of Product characteristics

OBJECT 1
ENBREL 25 MG POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 09-May-2018 | Pfizer
Limited
1. Name of the medicinal product
Enbrel 25 mg powder and solvent for solution for injection
2. Qualitative and quantitative composition
Each vial contains 25 mg of etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion
protein produced by recombinant
DNA technology in a Chinese hamster ovary (CHO) mammalian expression
system. Etanercept is a dimer
of a chimeric protein genetically engineered by fusing the
extracellular ligand binding domain of human
tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of
human IgG1. This Fc component
contains the hinge, CH
2
and CH
3
regions, but not the CH
1
region of IgG1. Etanercept contains 934 amino
acids and has an apparent molecular weight of approximately 150
kilodaltons. The specific activity of
etanercept is 1.7 x 10
6
units/mg.
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
Rheumatoid arthritis
Enbrel in combination with methotrexate is indicated for the treatment
of moderate to severe active
rheumatoid arthritis in adults when the response to disease-modifying
antirheumatic drugs, including
methotrexate (unless contraindicated), has been inadequate.
Enbrel can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment
with methotrexate is inappropriate.
Enbrel is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in adults
not previously treated with methotrexate.
Enbrel, alone or in combination with methotrexate, has been shown to
reduce the rate of progression of
joint damage as measured by X-ray and to improve physical function.
Juvenile idiopathic arthritis
Treatment of polyarthritis (rheumatoid factor positive or neg