How to administer your Relistor injection ®

How to administer your Relistor ® injection
This leaflet contains instructions to help you administer your Relistor injection. Your healthcare professional will give you full training in how to administer
the injection. Do not attempt to administer an injection until you are sure that you understand how to do this.
In addition to this leaflet, you will also find a Patient Information Leaflet (PIL) inside your carton and it is advised that you read this carefully before beginning
your treatment. Please re-read the PIL each time you get a new carton. There may be new information.
If you have any further questions about your treatment, please contact your healthcare professional.
Preparing yourself for your injection
1 Find a quiet place with 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.
C
2 Relistor may work within a few minutes to a few hours of the injection; therefore, it is important to be
near toilet facilities with assistance available if necessary soon after receiving your dose.
3 Remove the patient information leaflet from the carton and read it carefully. Familiarise yourself
with the contents of the tray, which contains A 2 alcohol wipes, B an empty syringe with
a retractable needle and C a vial containing the Relistor injection solution. You may also need
a cotton wool ball or some gauze, and a plaster.
B
A
Preparing the injection
1
1 Wash your hands thoroughly with soap and
warm water.
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2 Make sure the solution in the vial is clear, colourless
to pale yellow, and does not contain flakes or
particles. If not, do not use the solution and contact
your healthcare professional for assistance.
2
3 Remove the pink plastic cap from the
Relistor vial.
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4 Place the vial on your flat work surface and clean
the rubber stopper with one of the alcohol wipes.
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4
5
6
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5 Hold the syringe firmly in one hand and carefully
pull the needle cap straight off. DO NOT touch the
needle or allow it to come into contact with any
other surface.
6 Pull back the plunger on the syringe to either the
0.4ml mark for 8mg of Relistor or the 0.6ml mark
for 12mg of Relistor. Your healthcare professional
will have advised you which dose they have
prescribed for you and how often you need to take
it. 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 Less than 38kg
38-61kg
62-114kg
More than 114kg
Fill syringe to
ml level (dose)
0.15mg/kg
0.4ml (8mg)
0.6ml (12mg)
0.15mg/kg
7 Insert the needle straight down into the rubber
stopper of the vial. DO NOT insert it at an angle as
the needle may bend or break. You will feel a slight
resistance as the needle passes through the
stopper and you should then be able to see the
needle tip inside the vial.
8 Gently push on the plunger until you feel some
resistance. This forces air out of the syringe and
into the vial. DO NOT PUSH THE PLUNGER DOWN
COMPLETELY as this will activate the self-retracting
needle. If you hear a click, discard the needle safely
and start again using another vial and syringe.
9 Turn the vial and syringe upside down and hold
the syringe at eye level so that you can see the
dosing marks.
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10 Making sure the tip of the needle is in the fluid all
of the time, slowly pull back the plunger to the 0.4ml
or 0.6ml mark or as advised, depending on the dose
prescribed by your healthcare professional.
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11 With the needle still in the vial, gently tap the side of
the syringe to make any air bubbles rise to the top.
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 affect the
accuracy of the dose or pose any risk to your health.
12 Always make sure you have the correct dose
in the syringe. If you are unsure, please contact
your healthcare professional.
12
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13 Slowly withdraw the needle from the vial, again
being careful not to touch it or allow it to come
into contact with any other surface.
14 Choose an injection site. You can inject yourself
in your abdomen or thigh. If somebody else is giving
you the injection the upper arm can also be used.
You should try to use a different injection site each
time, to avoid giving yourself repeated injections
in exactly the same spot. DO NOT inject into tender,
bruised, red or hard skin and avoid any scars or
stretch marks.
14
If you have any additional questions about Relistor or the injection procedure, please refer to your patient information leaflet,
which can be found inside your carton. Further assistance can also be provided by your healthcare professional or by calling
the TMC Pharma Services Ltd. Medical Information department on +44(0)1252 842255. For further information, please visit
www.myrelistor.co.uk.
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Injecting yourself
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1 Clean the injection site with an alcohol wipe and
allow to dry. Do not touch this area again before
giving the injection.
2
3
2 Hold the filled syringe with the needle pointing
upwards and recheck for air bubbles. If there are
bubbles, gently tap the syringe with your finger until
the bubbles rise to the top of the syringe and then
slowly push the plunger up to force the air out of
the syringe.
3 Hold the syringe in one hand like a pencil. Use the
other hand to gently pinch the cleaned area of skin
around the injection site and hold it firmly. Insert the
full length of the needle into your skin at a 45°
angle with a quick short motion.
5
6
4 Let go of your skin and slowly push the plunger
down until the syringe is empty and you hear a
click. The click sound tells you that the entire
contents of the syringe have been injected. It also
means that the needle safety mechanism has been
activated which automatically retracts the needle
from your skin and back into the barrel of the syringe.
5 There may be a little bleeding at the injection site.
You can press a ball of cotton wool or gauze over
the site to stop the bleeding and cover with a
plaster if necessary. Do not rub the injection site.
6 Dispose of your syringe safely in a closed,
puncture-resistant container such as a sharps bin.
NEVER reuse your syringe or needle and NEVER
recap the used needle.
If you have any additional questions about Relistor or the injection procedure, please refer to your patient information leaflet, which can be found inside your
carton. Your healthcare professional will be able to answer any of your queries. For further information, you can also visit www.myrelistor.co.uk.
Frequently asked questions
Why have I been prescribed Relistor?
Relistor treats constipation that is caused by medicines
used to manage pain and other symptoms called opioids (for
example morphine, codeine). Opioids are prescribed by your
healthcare professional. Relistor is used together with
laxatives.
Relistor is for use in adults (aged 18 and over).
How does it work?
Relistor blocks the constipating effects of opioids in a different
way to laxatives. It will not stop the effect of your painkillers.
How should I use Relistor?
Relistor is administered by an injection just under the skin.
Your healthcare professional will have chosen the right dose
for you.
Always use Relistor exactly as your healthcare professional
has told you. You should check with your healthcare
professional if you are not sure.
Full details about where and how the injection is administered
can be found in the patient information leaflet which is in the
carton with your medicine. However, you should ask your
healthcare professional if you are unsure about anything.
How quickly does it work?
Relistor may work within a few minutes to a few hours
of the injection. Therefore, it is important to be near toilet
facilities soon after receiving your dose with assistance
available if necessary.
What are the possible side-effects?
As with all medicines, some patients may experience side
effects, although not everybody will get them. The most
common side effects (more than 1 in 10 patients) which
have been reported are stomach pain, feeling sick, wind
and diarrhoea.
Common side effects (more than 1 in 100 patients - but less
than 1 in 10 patients) are dizziness and reactions at the site
of injection.
Relistor may cause dizziness, and this may have an effect on
driving and use of machines.
If any of the side effects gets serious, or if you notice any side
effects not listed here or in the patient information leaflet
enclosed with your medicine, please tell your healthcare
professional. If severe diarrhoea occurs during treatment,
you should stop taking Relistor and contact your healthcare
professional immediately.
Will my painkillers stop working?
No, Relistor has been shown to have no effect on the
painkilling effect of opioids.
Do I need to stop taking laxatives?
Do not stop taking laxatives unless your healthcare
professional tells you to.
What if I am taking other medicines?
Please tell your healthcare professional if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription. Your healthcare professional
may allow you to take other medicines, including those used
for constipation.
How often do I need to take it?
Your healthcare professional will have decided on how much
you should take and how often you should take it. Always use
Relistor exactly as your healthcare professional has told
you. You should check with your healthcare professional if
you are not sure.
How should I store it?
This medicine should be stored below 30ºC, in its carton
to protect it from light. It should not be used after the expiry
date shown on the carton and vial. As with all medicines,
it must be kept safely out of the reach and sight of children.
Only use it if the solution is clear, colourless to pale yellow,
and does not contain flakes or particles.
What do I need to do if my injection does not work?
Patients respond differently and some patients may not
respond to every dose. It is important to continue to keep
your healthcare professional informed of your response.
Is it suitable for me?
There are some instances where Relistor should only be used
with special care. For instance, if you have severe liver or
kidney disease, if you have a colostomy, peritoneal catheter,
diverticular disease, or faecal impaction.
Ask your healthcare professional for advice before taking
Relistor, or any medicine, if you are pregnant, think you might
be pregnant or you are breast feeding.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours. If you have any further questions, ask your
healthcare professional.
When should I not use Relistor?
Do not use:
• If you are allergic (hypersensitive) to methylnaltrexone
bromide or any of the other ingredients, or
• If you or your healthcare professional know that your
bowels are blocked by something other than constipation.
What should I do if I use more than I should?
If you have administered more Relistor than you should have
done, (either by injecting too much on a single occasion or by
using more than one injection in 24 hours), you must contact
your healthcare professional immediately and always have
the outer carton with you even if it is empty.
What should I do if I forget to take my Relistor?
If you forget a dose, do not worry. Talk to your healthcare
professional.
How should I dispose of my injection supplies?
The vial and needle/syringe should not be re-used. Do not
re-cap the needle. Once you have finished with the needle
and syringe, they should both be placed in a sealable,
puncture-resistant container, such as a dedicated ‘sharps
bin’ (e.g. yellow biohazard container), hard plastic container
(e.g. detergent bottle), or metal container (e.g. an empty drink
can). Ask your healthcare professional for instructions on
how to properly dispose of the container after use if you are
at all unsure.
General information
What does my medicine look like?
It is a solution for injection. It is clear, colourless
to pale yellow, and does not contain flakes or particles.
Each vial contains 0.6ml of solution.
Cartons of more than one vial contain trays which have a
1ml injection syringe with retractable injection needle and
two alcohol swabs.
What are the ingredients?
The active substance is methylnaltrexone bromide. Each
vial of 0.6ml contains 12mg methylnaltrexone bromide.
The other ingredients are sodium chloride, sodium calcium
edetate, glycine hydrochloride, water for injections,
hydrochloric acid (to adjust pH) and sodium hydroxide
(to adjust pH).
Any other questions
THIS LEAFLET HAS BEEN DESIGNED TO HELP YOU
TO UNDERSTAND THE MEDICATION YOU HAVE BEEN
PRESCRIBED. IT IS NOT A REPLACEMENT FOR THE
DETAILED PATIENT INFORMATION LEAFLET (PIL)
PROVIDED WITHIN THE MEDICINE CARTON WHICH
YOU SHOULD ALSO READ.
If you have any further questions, you should ask your
healthcare professional. For more information, please visit
www.myrelistor.co.uk.
For any information about this medicine, please contact the
Marketing Authorisation Holder;
Marketing Authorisation Holder:
TMC Pharma Services Ltd, Lodge Farm Barn,
Elvetham Park Estate, Fleet Road, Hartley Wintney,
Hampshire, RG27 8AS, United Kingdom
Tel: +44(0)1252 842255,
Fax: +44(0)1252 842277,
Email: Medical.Dept@TMCPharma.com
Manufacturer: Wyeth Lederle S.p.A., Via Franco Gorgone,
Zona Industriale, 95100 Catania, Italy
REL001 Date of preparation: September 2011