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AstraZeneca

Relistor
methylnaltrexone bromide

Package leaflet: Information for the user


Relistor 12 mg/0.6 mL solution for injection

Methylnaltrexone bromide


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What Relistor looks like and contents of the pack


Relistor is a solution for injection. It is clear, colourless to pale yellow, and does not contain flakes or particles.


Each vial contains 0.6 mL of solution.


Packs of more than one vial contain inner cartons consisting of: one vial, one 1 mL injection syringe with retractable injection needle, and two alcohol swabs.


The following packs are available: Single vial

Pack containing 2 vials, 2 injection syringes with retractable injection needle, and 4 alcohol swabs (i.e. 2 inner cartons).


Pack containing 7 vials, 7 injection syringes with retractable injection needle, and 14 alcohol swabs

(i.e. 7 inner cartons).


Not all pack sizes may be marketed.


Marketing Authorisation Holder

Bausch Health Ireland Limited 3013 Lake Drive

Citywest Business Campus Dublin 24, D24PPT3 Ireland


Manufacturer


Bausch Health Ireland Limited 3013 Lake Drive

Citywest Business Campus Dublin 24, D24PPT3 Ireland


Przedsiębiorstwo Farmaceutyczne Jelfa SA ul. Wincentego Pola 21

58-500 Jelenia Góra,

Poland


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This leaflet was last revised in 11/2020


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PATIENT CHECKLIST


This section contains important questions that you will need to answer before you take Relistor, and during treatment with Relistor.


If you answer No to any of the following questions during the course of treatment with your medicine, please contact your doctor, nurse or pharmacist.


  1. Are you receiving opioid therapy (for example morphine or codeine) for your illness?

  2. Has it been 48 hours or longer since your last bowel movement?

  3. Are you familiar with the technique of self injection or have you discussed this with your doctor (or nurse or pharmacist)?

  4. Are you mobile enough to reach the toilet, or do you have a caregiver looking after you who can help?

  5. Do you have a contact number for your community nurse or the health centre?


    INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR

    This section is divided into the following subsections: Introduction

    Step 1: Setting up for an injection

    Step 2: Preparing the injection syringe

    Step 3: Choosing and preparing an injection site

    Step 4a: Injecting Relistor using a pack containing injection syringe with retractable injection needle Step 4b: Injecting Relistor using a standard injection syringe and injection needle

    Step 5 Disposing of supplies


    Introduction


    The following instructions explain how to inject Relistor. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor, nurse or pharmacist on the techniques of self-administration. Do not attempt to administer an injection until you are sure that you understand how to give the injection. This injection should not be mixed in the same syringe with any other medicine.


    You may receive either a pack containing an inner carton with everything needed for the injection, or a single vial only. If you receive only the vial, you will need to obtain alcohol swabs and an injection syringe.


    Step 1: Setting up for an injection


    1. Select a flat, clean, well-lit working surface where you can lay out the contents of your Relistor carton. Make sure you have set aside a proper amount of time to complete the injection.


    2. Wash your hands thoroughly with soap and warm water.


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    3. Assemble the supplies you will need for your injection. These include the Relistor vial, a 1 mL injection syringe (with or without retractable needle), 2 alcohol swabs, and a cotton ball or gauze.


    4. Make sure the solution in the vial is clear and colourless to pale yellow, and does not contain flakes or particles. If it is not, do not use the solution. Contact your pharmacist, nurse or doctor for assistance.


Step 2: Preparing the injection syringe


  1. Remove the protective plastic cap from the vial.


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  2. Wipe the vial’s rubber stopper with an alcohol swab and place it on your flat work surface.

    Make sure not to touch the rubber stopper again.


  3. Pick up the syringe from your work surface. Hold the barrel of the syringe with one hand and pull the needle cover straight off. Place the needle cover back on the work surface. DO NOT touch the needle or allow it to come into contact with any other surface.

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    Carefully pull back the plunger on the syringe to either the 0.4 mL mark for 8 mg of Relistor or the

    0.6 mL mark for 12 mg Relistor. Your doctor, nurse or pharmacist will have advised you which dose they have prescribed for you and how often you need to take it. For patients receiving supportive care for advanced illness, the usual doses are given in the table below. The dose is normally given every 48 hours (every two days) as an injection under the skin.


    Patient weight in kg Fill syringe to mL level (dose) Less than 38 kg 0.15 mg/kg

    38-61 kg 0.4 mL (8 mg)

    62-114 kg 0.6 mL (12 mg)

    More than 114 kg 0.15 mg/kg


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    For patients with long-term pain (except patients receiving supportive care for advanced illness), fill the syringe to the 0.6 mL mark for 12 mg of Relistor.


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    Carefully pull back the plunger to correct level on syringe (e.g. 0.4 mL if you have been prescribed 8 mg)


  4. Insert the needle straight down into the centre of the vial stopper. Do not insert it at an angle as the needle may bend or break. Hold the vial on the work surface with the other hand so that it can not slip off. You will feel a slight resistance as the needle passes through the stopper. Look for the needle tip inside the vial.


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  5. In order to get the air out of the syringe, gently push the plunger down to inject the air into the vial.


  6. If you are using the supplied injection syringe with retractable injection needle, DO NOT PUSH THE PLUNGER DOWN COMPLETELY. Make sure you stop pushing the plunger when you feel resistance. If you push the plunger completely, you will hear a ‘click’ sound. This will mean that the safety mechanism has been activated, and the needle will disappear

    into the syringe. If this happens, discard the product and start again using another vial and syringe.


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    With the needle still in the vial, turn the vial upside-down. Hold the syringe at eye level so that you can see the dosing marks and make sure the tip of the needle is in the fluid all of the time. Slowly pull the plunger down to the 0.4 mL or 0.6 mL mark on the syringe or as advised, depending on the dose prescribed by your doctor, nurse or pharmacist. You may see some fluid or bubbles inside the vial when the syringe is properly filled. This is normal.


  7. With the needle still inserted in the upside down vial, check for air bubbles in the syringe.

    Gently tap the syringe to make any air bubbles rise to the top of the syringe; be sure that you still hold onto the vial and syringe. Slowly push the plunger up until all air bubbles are removed. If you push solution back into the vial, slowly pull back the plunger to draw the correct amount of solution back into the syringe. Due to the safety design of the syringe, a small air bubble may be resistant to removal. There is no need to worry about this as it will not

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    affect the accuracy of the dose or pose any risk to your health.


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    Tap the upside down syringe and push out any air bubbles with the plunger


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  8. Always make sure you have the correct dose in the syringe. If unsure, please contact your doctor, nurse or pharmacist.


    Ensure you have the correct dose level in the syringe (e.g.

    0.4 mL if you have been

    prescribed 8 mg)


  9. Remove the syringe and needle from the vial. Keep the needle attached to the syringe. Do not touch the needle or allow the needle to touch any surface. Once you have drawn the medicine into the syringe, it must be used within 24 hours because Relistor is affected by light and may not work properly if it is left in the syringe for longer than 24 hours.

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Step 3: Choosing and preparing an injection site


  1. The three areas of the body recommended for injection of Relistor are: (1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (only if injecting another person).


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  2. It is recommended to move to a different site each time an injection is given. Avoid repeated injections at the exact same spot previously used. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.


  3. To prepare the area of skin where Relistor is to be injected, wipe the injection site with an alcohol swab. DO NOT TOUCH THIS AREA AGAIN BEFORE GIVING THE INJECTION.

Allow the injection site to air-dry before injecting.


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Step 4a: Injecting Relistor using a pack containing injection syringe with retractable injection needle


  1. Holding the filled syringe with the needle pointing up, recheck the syringe for air bubbles. If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe.


  2. Hold the syringe in one hand like a pencil. Use the other hand to gently pinch the cleaned area of skin and hold it firmly.


  3. Push the full length of the needle into the skin at a slight angle (45 degrees) with a quick, short motion.

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  4. After the needle is inserted, let go of the skin and slowly push the plunger all the way down until the syringe is empty and you hear a click to inject Relistor.


  5. When you hear a click sound that means the entire contents were injected. The needle will automatically retract from the skin and be capped. There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site. Do not rub the injection site. If needed, you may cover the injection site with a plaster.


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Step 4b: Injecting Relistor using a standard injection syringe and injection needle


  1. Holding the filled syringe with the needle pointing up, recheck the syringe for air bubbles. If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe.


  2. Hold the syringe in one hand like a pencil. Use the other hand to gently pinch the cleaned area of skin and hold it firmly.


  3. Push the full length of the needle into the skin at a slight angle (45 degrees) with a quick, short motion.


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  4. After the needle is inserted, let go of the skin and slowly push the plunger all the way down to inject Relistor.


  5. When the syringe is empty, quickly 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. Do not rub the injection site. If needed, you may cover the injection site with a plaster.


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Step 5: Disposing of supplies


The capped syringe or syringe and needle should NEVER be reused. NEVER recap the needle. Dispose of the capped syringe or needle and syringe in a closable puncture-resistant container as instructed by your doctor, nurse or pharmacist.