Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Sodium citrate dihydrate
Sucrose
L-Lysine hydrochloride
Sodium chloride
Citric acid anhydrous
Sodium hydroxide
Hydrochloric acid
Water for injection


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. Keep in the outer carton in order to protect from light.
After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the syringe to reach room temperature. Do not warm in any other way. Immediate use is then recommended.

Erelzi may be stored 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. Erelzi should be discarded if not used within four weeks after removal from the refrigeration.

6.5     Nature and contents of container

Erelzi solution for injection in pre-filled syringe
Clear type I glass syringe with a stainless steel 27 gauge ½ inch needle with a needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.5 ml or 1.0 ml of solution.

Erelzi 50 mg solution for injection in pre-filled pen
Erelzi is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady pen). The syringe inside the pen is made from clear type I glass with a stainless steel 27 gauge ½ inch needle and an inner rubber needle cap, containing 1.0 ml of solution.

Cartons contain 1, 2 or 4 pre-filled syringes or pre-filled pens of Erelzi. Multipacks contain 12 (3 packs of 4) 25 mg or 50 mg pre-filled syringes or pre-filled pens or 8 (2 packs of 4) or 24 (6 packs of 4) 25 mg pre-filled syringes of Erelzi. Not all pack sizes may be marketed.

6.6     Special precautions for disposal and other handling

Instructions for use and handling of the Erelzi pre-filled syringe
Before injection, Erelzi single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cap should not be removed while allowing the pre-filled syringe to reach room temperature. The solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.

Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe".

Instructions for use and handling of the Erelzi pre-filled SensoReady pen Before injection, Erelzi single-use pre-filled pens should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cap should not be removed while allowing the pre-filled pen to reach room temperature. By looking through the viewing window, the solution should be clear to slightly opalescent, colourless to slightly yellowish and may contain small translucent or white particles of protein.

Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi SensoReady pen".
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7. Instructions for preparing and administration of Erelzi injection

7.1    Instructions for use of Erelzi pre-filled syringe

It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist. The box contains Erelzi pre-filled syringe(s) individually sealed in a plastic blister.

DO NOT USE                       In this configuration the needle guard is ACTIVATED – DO NOT USE the pre-filled syringe



READY TO BE USED
In this configuration the needle guard is NOT
ACTIVATED and the pre-filled syringe is ready for use



Your Erelzi pre-filled syringe with needle guard and add-on finger flange 


After the medicine has been injected, the needle guard will be activated to cover the needle. This is intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed medicines and individuals who assist self-injecting patients from accidental needle stick injuries.

What you additionally need for your injection:
• Alcohol wipe
• Cotton ball or gauze
• Sharps disposal container
Important safety information

Caution: Keep the syringe out of the sight and reach of children.
1. Do not open the outer box until you are ready to use this medicine.
2. Do not use this medicine if the seal of the blister is broken, as it may not be safe for you to use.
3. Do not shake the syringe.
4. Never leave the syringe lying around where others might tamper with it.
5. The pre-filled syringe has a needle guard that will be activated to cover the needle after the injection is finished. The needle guard will help to prevent needle stick injuries to anyone who handles the pre-filled syringe.
Be careful not to touch the needle guard wings before use. By touching them, the needle guard may be activated too early.
6. Do not remove the needle cap until just before you give the injection.
7. The syringe cannot be re-used. Dispose of the used syringe immediately after use in a sharps container.
8. Do not use if the syringe has been dropped onto a hard surface or dropped after removing the needle cap.


Storage of the Erelzi pre-filled syringe
1. Store this medicine sealed in its outer box to protect it from light. Store in the refrigerator between 2 °C to 8 °C. DO NOT FREEZE.
2. Remember to take the blister out of the refrigerator and allow it to reach room temperature before preparing it for injection (15–30 minutes).
3. Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”. If it has expired, return the entire pack to the pharmacy.

The injection site
The injection site is the place on the body where you are going to use the pre-filled syringe.
• The recommended site is the front of your thighs. You may also use the lower abdomen, but not the area 5 centimeters around the navel
(belly button).
• Choose a different site each time you give yourself an injection.
• Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.
If you have psoriasis, you should NOT inject directly into any raised, thick, red, or scaly skin patches or lesions (“psoriasis skin lesions”).
If a caregiver is giving you the injection, the outer upper arms may also be used.



Preparing the Erelzi pre-filled syringe

1. Take the blister out of the refrigerator and leave it unopened for about 15–30 minutes so that it reaches room temperature.
2. When you are ready to use the syringe, open the blister and wash your hands thoroughly with soap and water.
3. Clean the injection site with an alcohol swab.
4. Take the syringe out of the blister.
5. Inspect the syringe. The liquid should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein. This appearance is normal for Erelzi. Do not use if the liquid is cloudy, discoloured, or has large lumps, flakes, or coloured particles. Do not use if the syringe is broken or the needle guard is activated. In all these cases, return the entire product pack to the pharmacy.

How to use the Erelzi pre-filled syringe

Carefully remove the needle cap from the syringe. Discard the needle cap. You may see a drop of liquid at the end of the needle. This is normal.


Gently pinch the skin at the injection site and insert the needle as shown. Push the needle all the way in to ensure that the medicine can be fully administered.



Hold the syringe finger flange as shown. Slowly press the plunger as far as it will go, so that the plunger head is completely between the needle guard wings.
Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.



Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.


Slowly release the plunger and allow the needle guard to automatically cover the exposed needle.
There may be a small amount of blood at the injection site.
You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.
Disposal instructions
Dispose of the used syringe in a sharps container (closable, puncture- resistant container). For the safety and health of you and others,
needles and used syringes must never be re-used.



If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Erelzi.

7.2       Instructions for use of Erelzi SensoReady pen

Read ALL the way through these instructions before injecting.

These instructions are to help you to inject correctly using the Erelzi SensoReady pen.
It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.


Your Erelzi SensoReady pen:

Store your boxed pen in a refrigerator, between 2 °C to 8
°C and out of the sight and reach of children.
• Do not freeze the pen.
• Do not shake the pen.
• Do not use the pen if it has been dropped with the cap removed.
For a more comfortable
Erelzi SensoReady pen shown with the cap removed.              injection, take the pen out of Do not remove the cap until you are ready to inject.           the refrigerator 15-30 minutes before injecting to allow it to reach room temperature.

What you need for your injection:

Included in the carton:                                      Not included in the carton: 
A new and unused Erelzi SensoReady                           • Alcohol wipe pen.                                                         • Cotton ball or gauze • Sharps disposal container
Before your injection:


1. Important safety checks before you inject:
The solution should be clear or slightly opalescent, colourless to slightly yellowish, and may contain small white or almost translucent particles of protein. This appearance is normal for
Erelzi.
Do not use if the liquid is cloudy, discoloured, or has large lumps, flakes, or coloured particles.
Do not use the pen if the expiry date has passed.
Do not use if the safety seal has been broken.
Contact your pharmacist if the pen fails any of these checks.
2a. Choose your injection site:
• The recommended site is the front of the thighs. You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
• Choose a different site each time you give yourself an injection.
• Do not inject into areas where the skin is tender, bruised, red,
scaly or hard. Avoid areas with scars or stretch marks. If you have psoriasis, you should NOT inject directly into any raised,
thick, red, or scaly skin patches or lesions (“psoriasis skin lesions”).
2b. Caregivers and healthcare professionals only:
• If a caregiver or healthcare professional is giving you your injection, they may also inject into your outer upper arm.



3. Cleaning your injection site:
• Wash your hands with soap and hot water.
• Using a circular motion, clean the injection site with the alcohol swab. Leave it to dry before injecting.
• Do not touch the cleaned area again before injecting.



Your injection:
   4. Removing the cap:
• Only remove the cap when you are ready to use the pen.
• Twist off the cap in the direction of the arrows.
• Once removed, throw away the cap. Do not try to re-attach the cap.
• Use the pen within 5 minutes of removing the cap.

5. Holding your pen:
• Hold the pen at 90 degrees to the cleaned injection site



Correct         Incorrect
YOU MUST READ THIS BEFORE INJECTING.

During the injection you will hear 2 loud clicks.

The 1st click indicates that the injection has started. Several seconds later a 2nd click will indicate that the injection is almost finished.

You must keep holding the pen firmly against your skin until you see a green indicator fill the window and stop moving.

6. Starting your injection:
• Press the pen firmly against the skin to start the injection.
• The 1st click indicates the injection has started.
• Keep holding the pen firmly against your skin.
• The green indicator shows the progress of the injection.


7. Completing your injection:
• Listen for the 2nd click. This indicates the injection is almost complete.
• Check the green indicator fills the window and has stopped moving.
• The pen can now be removed.


After your injection:
8. Check the green indicator fills the window:
• This means the medicine has been delivered. Contact your doctor if the green indicator is not visible.
• There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.
9. Disposing of your Erelzi pen:
• Dispose of the used pen in a sharps disposal container (i.e. a puncture-resistant closable container, or similar).
• Never try to re-use your pen.



If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Erelzi.