Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Sucrose
Sodium chloride
L-Arginine hydrochloride
Sodium dihydrogen phosphate dihydrate
Disodium phosphate dihydrate
Water for injections
6.2     Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4     Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.

Enbrel may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to four weeks after which it should not be refrigerated again. Enbrel should be discarded if not used within four weeks after removal from the refrigeration.

Keep the pre-filled syringes/pens in the outer carton in order to protect from light.

6.5     Nature and contents of container
Pre-filled syringe:
Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger.
25 mg Pre-filled syringe: Cartons contain 4, 8 or 24 pre-filled syringes of Enbrel and 4, 8 or 24 alcohol swabs.
50 mg Pre-filled syringe: Cartons contain 2, 4 or 12 pre-filled syringes of Enbrel with 2, 4 or 12 alcohol swabs. The needle cover contains dry natural rubber (latex) (see section 4.4). Not all pack sizes may be marketed.

Pre-filled pen (MYCLIC)
Pre-filled pen (MYCLIC) containing a pre-filled syringe of Enbrel. The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and plastic plunger. The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex). See section 4.4.

Cartons contain 2, 4 or 12 pre-filled pens of Enbrel with 2, 4 or 12 alcohol swabs. Not all pack sizes may be marketed.


6.6     Special precautions for disposal and other handling
Pre-filled syringe: Before injection, Enbrel single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature. The solution should be clear to slightly opalescent, colourless to pale yellow or pale brown and may contain small translucent or white particles of protein.

Pre-filled pen:
Instructions for use and handling
Before injection, Enbrel single-use pre-filled pens should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cover should not be removed while allowing the pre- filled pen to reach room temperature. By looking though the inspection window, the solution should be clear to slightly opalescent, colourless to pale yellow or pale brown and may contain small translucent or white particles of protein.
Comprehensive instructions for administration are given in this leaflet, section 7, 
Any unused product or waste material should be disposed of in accordance with local requirements.

7. INSTRUCTIONS FOR USE
Using the Pre-Filled Syringe to inject Enbrel

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-injectionor 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 Enbrel 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 a flat work surface. Starting from one of the top corners, pull back the paper cover from the top and sides of the tray. Remove one pre-filled syringe and one alcohol swab and place them on your work surface. Do not shake the pre-filled syringe of Enbrel. Fold the paper cover back over the tray and place the carton containing any remaining pre-filled syringes back into the refrigerator.
Please see section 5 for instructions on how to store Enbrel. If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
3. 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).


4. Assemble the additional supplies you will need for your injection. These include the alcohol swab from the Enbrel carton and a cotton ball or gauze.
5. Wash your hands with soap and warm water.
6. Inspect the solution in the syringe. It should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent particles of protein. This appearance is normal for Enbrel. Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present. If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Step 2: Choosing an injection site
1. Three recommended injection sites for Enbrel using a pre-filled syringe include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 1). If you are self injecting, you should not use the outer area of the upper arms.
Diagram 1



2. A different site should be used for each new injection. Each new injection should be given at least
3 cm from an old site. Do not inject into areas where the skin is tender, bruised, red, or hard.
Avoid areas with scars or stretch marks. (It may be helpful to keep notes on the location of the previous injections.)
3. If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).


Step 3: Injecting the Enbrel solution
1. Wipe the site where Enbrel is to be injected with the alcohol swab, using a circular motion. Do NOT touch this area again before giving the injection.
2. Pick up the pre-filled syringe from the flat work surface. Remove the needle cover by firmly pulling it straight off the syringe (see Diagram 2). Be careful not to bend or twist the cover during removal to avoid damage to the needle.
When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal. Do not touch the needle or allow it to touch any surface. Do not touch or bump the plunger. Doing so could cause the liquid to leak out.



                                               Diagram 2



3. When the cleaned area of skin has dried, pinch and hold it firmly with one hand. With the other hand, hold the syringe like a pencil.
4. With a quick, short motion, push the needle all the way into the skin at an angle between 45° and
90° (see Diagram 3). With experience, you will find the angle that is most comfortable for you or the child. Be careful not to push the needle into the skin too slowly, or with great force.


Diagram 3


5. When the needle is completely inserted into the skin, release the skin that you are holding. With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 4).


Diagram 4


6. When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted. There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site for 10 seconds. Do not rub the injection site. If needed, you may cover the injection site with a bandage.


Step 4: Disposing of supplies

•      The pre-filled syringe is for single-use administration only. The syringe and needle should NEVER be reused. NEVER recap a needle. Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.


Using the MYCLIC pre-filled pen to inject Enbrel
Enbrel 50 mg solution for injection in pre-filled pen
(etanercept)
For subcutaneous injection only

Introduction

•      The instructions below explain how to use the MYCLIC pen to inject Enbrel.
•      Please read the instructions carefully, and follow them step by step.
•      Your healthcare provider will tell you how to inject Enbrel. Do not attempt to administer an injection until you are sure that you understand how to use the MYCLIC pen properly.
•      If you have questions about how to inject, please ask your healthcare provider for help.

The MYCLIC pre-filled pen

Before injection


White needle cap
Green activation button         Expiry date               Clear inspection window

After injection



Filled inspection window                Open end – safety shield
Step 1 Preparing for an Enbrel injection



•      Gather the following items for each injection on a clean, well-lit flat surface: 
        o One MYCLIC pre-filled pen.
o One alcohol swab.
o A suitable sharps container (not included).
o Clean cotton balls or gauze pads (not included).
•   Do not shake the pen.
•   Do not remove the white cap until instructed to do so.
•   For a more comfortable injection, leave your pen at room temperature for 15 to 30 minutes with the white cap in place.
•   Do not warm the pen in any other way.

Step 2 Check label for expiry and dose



•   Check the expiry date (month/year) on the pen label.
•   Make sure the correct dose strength is shown on the pen label.
•   If the expiry date has passed or it is not your prescribed dose, do not use the pen and contact your healthcare provider for assistance.

Step 3 Inspect the medicine



•   Inspect the medicine in the pen by looking through the clear inspection window. The solution should be clear or slightly opalescent, colourless to pale yellow or pale brown, and may contain small white or almost transparent particles of protein. This appearance is normal for Enbrel.
•   Do not use the medicine if it is discoloured, cloudy, or if particles other than those described above are present. If you are concerned with the appearance of the medicine, then contact your healthcare provider for assistance.
•   Note: You may see an air bubble in the window. This is normal.



Step 4 Choose and clean injection site

Abdomen:
Keep at least 5 cm away from your belly button (navel).

Upper thighs
Outer area of upper arms
Caregiver only


•   Choose an injection site in the middle of the front of your upper thighs or stomach area 5 cm away from the belly button (navel). The outer area of the back of the upper arms may also be used by a caregiver.
•   Each injection should be given at least 3 cm from where you last injected. Do not inject into tender, bruised or hard skin. Avoid scars or stretch marks. If you have psoriasis, do not inject directly into any raised, thick, red or scaly skin.
•   Clean the injection site with soap and water, or an alcohol swab if convenient.
•   Allow the site to dry. Do not touch, fan or blow on the cleaned injection site.

Step 5 Remove needle cap



•   Remove the white needle cap by pulling it straight off. Do not bend the cap while removing it.
•   Do not re-attach the cap once it has been removed.
•   After removal of the cap, you will see a purple needle safety shield extending slightly from the end of the pen. Do not push on the end safety shield with your fingers or thumbs.
•   Do not use the pen if it is dropped with the needle cap off.
Note: You may notice a drop of liquid at the needle tip. This is normal.



Step 6 Push pen firmly against skin



•   Push the open end of your pen firmly against the skin at 90 degrees so the purple needle safety shield is pushed completely inside the pen.
Note: You will only be able to press the green button when the needle shield is completely pushed inside the pen.
Pinching or stretching the skin before injection may make the injection site firmer, making it easier to press the injection button.

Step 7 Start your injection

Press button                  Continue to hold

1st                                   2nd click                                 click start                                  Or
10 sec s


•   Press the green button all the way down and you will hear a “click”. The click means the start of the injection.
•   Continue to hold your pen firmly against the skin until you hear a 2nd “click”, or until 10 seconds after the first click (whichever happens first).
Note: If you are unable to start the injection as described, press the pen more firmly against your skin, then press the green button again.



Step 8 Lift off skin



•   Remove your pen from your skin by lifting it straight off the injection site.
•   The purple needle safety shield will automatically extend to cover the needle.

Step 9 Check inspection window



•   Check the pen’s inspection window. It should be completely purple.
•   If the window is not purple, you may not have received a full dose. Contact your healthcare provider for assistance. Do not try to use the pen again. Do not try to use another pen.
•   If you notice a spot of blood at the injection site you should press the cotton ball or gauze over the injection site for 10 seconds. Do not rub the injection site.
Note: The injection button may stay pressed in. This is normal.

Step 10 Dispose



•   Dispose of the used pen as instructed by your healthcare provider. Do not attempt to recap the pen.



•   Do not press on the end of the needle safety shield. If you have any questions, please talk to your healthcare provider.
--End of Instructions for Use—