Enbrel Solution for Injection in a Pre-filled Syringe 50mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ETANERCEPT

Available from:

PFIZER PRIVATE LIMITED

ATC code:

L04AB01

Dosage:

50mg/mL

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

ETANERCEPT 50mg/mL

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Pfizer Manufacturing Belgium NV (Pre-filled Syringe)

Authorization status:

ACTIVE

Authorization date:

2010-07-16

Patient Information leaflet

INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL
_(SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE)_
This section is divided into the following subsections:
Introduction
Step 1: Setting up for an injection
Step 2: Choosing an injection site
Step 3: Injecting the ENBREL solution
Step 4: Disposing of supplies
_Introduction _
The following instructions explain how to prepare and inject ENBREL.
Please read
the instructions carefully and follow them step by step. You will be
instructed by your
doctor or his/her assistant on the techniques of self-injection or on
giving an injection
to a child. Do not attempt to administer an injection until you are
sure that you
understand how to prepare and give the injection.
The etanercept solution should not be mixed with any other medicine
before use.
_Step 1: Setting Up For An Injection _
1.
Select a clean, well-lit, flat working surface.
2.
Take the ENBREL carton containing the pre-filled syringes out of the
refrigerator and place it on the flat work surface. Remove one
pre-filled syringe and
one alcohol swab and place them on the work surface. Do not shake the
pre-filled
syringe of ENBREL. Place the carton containing any remaining
pre-filled syringes
back into the refrigerator (2° to 8° C). If you have any questions
about storage,
contact your doctor, nurse, or pharmacist for further instructions.
3.
Check the expiration date on the pre-filled syringe. If the expiration
date has
passed, do not use the pre-filled syringe and contact your pharmacist
for assistance.
4.
You should allow 15 to 30 minutes for the ENBREL solution in the
syringe to
reach room temperature. DO NOT remove the needle cover while allowing
it to reach
room temperature. Waiting until the solution reaches room temperature
may make the
injection more comfortable for you. Do not warm ENBREL in any other
way (for
example, do not warm it in a microwave or in hot water).
5.
Assemble the additional supplies you will need for your injection.
These
include the alcohol swab from the Enbrel carton, and a cot

Summary of Product characteristics

Page 1 of 36
1.
NAME OF MEDICINAL PRODUCT
ENBREL
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS, ACTIVE MOIETIES
Etanercept (INN)
ENBREL (etanercept) is a human tumour necrosis factor receptor (TNFR)
p75 Fc fusion protein
produced by recombinant DNA technology in a Chinese hamster ovary
(CHO) mammalian cell
expression system. ENBREL 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 the IgG1. ENBREL contains 934 amino acids and has an
apparent molecular weight of
approximately 150 kilodaltons. The potency is determined by measuring
the ability of ENBREL to
neutralise the TNFα-mediated growth inhibition of A375 cells. The
specific activity of ENBREL is
1.7 x 10
6
units/mg.
PHYSICAL CHARACTERISTICS
_Powder and Solvent for Solution for Injection_
Reconstituted ENBREL solution is clear to slightly opalescent and
colourless to slightly yellow or pale
brown, with a pH of 7.4 ± 0.3.
_Solution for Injection in Pre-filled Syringe and Solution of
Injection in Pre-filled Pen_
The solution for injection in the pre-filled syringe and pen is clear
to opalescent, colourless to yellow
or pale brown, and liquid may contain trace levels of translucent to
white amorphous particles, with a
pH of 6.3 ± 0.2.
3.
PHARMACEUTICAL FORM
_POWDER AND SOLVENT FOR SOLUTION FOR INJECTION_
ENBREL is supplied in a carton containing four dose trays. Each dose
tray contains one 25 mg single-
use vial of ENBREL, one syringe (1 mL Sterile Water for Injection),
one stainless steel needle, 1 vial
adaptor, and two alcohol swabs. Clear glass vial (2 mL or 4 mL, type I
glass) with rubber stopper,
aluminium seal, and flip-off plastic cap.
The excipients in ENBREL lyophilised powder are mannitol, nitrogen,
sucrose, trometamol and water
for injections.
_SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE_
ENBREL is sup