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THYMOGLOBULINE 25MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): RABBIT ANTI-HUMAN THYMOCYTE IMMUNOGLOBULIN

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Genzyme UK (Suffolk)

Measure bar should be 150mm at 100% scale

Customer

50 gsm
Process Black

Colours Used

Keyline (does not print)

Any unused medicine or waste material should be disposed of in
accordance with local requirements.
For additional information about the medicine, please consult the SmPC or
contact the local representative.

THYMO 5MG/ML Leaflet

624236

Description

If you have any further questions on the use of this medicine, ask your
doctor.

624236

GI266305

If you are given more Thymoglobuline than you should have
It is unlikely you will be given more Thymoglobuline than you should,
as you will be closely checked by your doctor or nurse during your
treatment. If this does happen you may get a lower than normal platelet
cell count (thrombocytopenia) or lower than normal white cell count
(leucopenia). This can cause fever, chills, sore throat, mouth ulcers and
bleeding or bruising more easily than normal.

Item Code



Preparation of Thymoglobuline Infusion (Use Aseptic
Technique)
Withdraw the required volume of the reconstituted solution from
the Thymoglobuline vials. Add the daily dose to an infusion solution
(0.9% sodium chloride or 5% glucose solution) so as to obtain a total
infusion volume of 50 to 500 ml (usually 50 ml/vial).
The medicine should be administered on the same day. The use of a
0.22 µm in–line filter is recommended.

Profile

Depending on the daily dose, reconstitution of several vials
of Thymoglobuline powder might be needed. Determine the number of
vials to be used and round up to the nearest vial.
Using aseptic technique, reconstitute the powder with 5 ml of sterile
water for injections to obtain a solution containing 5 mg protein per ml.

Other medicines your doctor may give you
Your doctor may give you some other medicines before, or at the same
time as Thymoglobuline. These medicines are used to prevent, or treat
possible side effects and could include:
• Antipyretics (like paracetamol) to reduce fever
• Corticosteroids (e.g. hydrocortisone) to prevent organ rejection and
prevent side effects
• Antihistamines (e.g. cetirizine) to prevent an allergic response
• Heparin to reduce the risk of blood clots

Folded: 102x30mm

It is strongly recommended that every time you administer a dose
of Thymoglobuline, the name and batch number of the medicine are
recorded in order to maintain a record of the batches used.

266x305mm

Each vial of Thymoglobuline is intended for single use only.

The solution should be clear or slightly opalescent. Reconstituted
medicine should be inspected visually for particulate matter and
discolouration. Do not use vials exhibiting particles or discolouration.
Immediate use of reconstituted medicine is recommended.

Size

medical

8.5pt

for

Min. Point Size

intended

UK/ROI/MT

The following information is
or healthcare professionals only:

Market

You should not be given Thymoglobuline
• if you are allergic to anti–human thymocyte globulin, rabbits or any
of the other ingredients of this medicine (listed in section 6).
• if you have a severe infection because Thymoglobuline decreases your
body’s ability to fight infections.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine. This is because Thymoglobuline should not be given
to pregnant women unless it is absolutely necessary as the effects are
unknown.
Do not breastfeed while you are being given Thymoglobuline.
This is because it may get into your breast milk and may affect the baby.

English

given

louise.heel

are

Language

you

Proof By

before

2

know

Thymoglobuline with food and drink and alcohol
It is unlikely that eating and drinking will affect your medicine.

Proof No.

to

Vaccinations
Do not have any vaccination during or soon after treatment with
Thymoglobuline without first discussing it with your doctor as it may cause
side effects or may not work because your immune system cannot respond
to it.

The dose of Thymoglobuline may be changed by your doctor if you have
any side effects.

N/A

2. What you need
Thymoglobuline

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines or any other anti-rejection medicine
(immunosuppressants), such as azathioprine or corticosteroids.
This is because, if the body’s defense system is reduced too much, severe
infections may occur. It may also increase the risk of developing cancer
in the future.

Your doctor or nurse will check you regularly while you receive your
first dose because this is when you are more likely to get side effects.
They will check for rashes, check your pulse, blood pressure and breathing.
From time to time your doctor may also want you to have a blood test to
monitor your blood cell count. If your white blood cell count is low, your
doctor may also administer medicines to prevent or treat infections; if your
platelet counts are low, your doctor may give you a platelet transfusion.

Pharma
Code

Kidney and Heart Transplantation
Thymoglobuline is used in patients who have had a kidney or heart
transplant, to prevent the rejection of a kidney or a heart transplant.
It is also used to treat the rejection of a kidney transplant in patients who
are resistant to treatment with corticosteroids. Thymoglobuline is a type of
drug known as an immunosuppressant (anti-rejection drug) and is usually
used in combination with other immunosuppressants. When a patient
receives an organ, the body’s natural defence system will try to get rid of
it (reject it). Thymoglobuline modifies the body’s defence mechanism and
helps it accept the transplanted organ.

Other medicines and Thymoglobuline

To treat kidney rejection in patients resistant to corticosteroids:
The recommended dose is 1.5 mg of Thymoglobuline for every kilogram
of weight every day for 7 to 14 days.
There are no data in children for rejection of kidney transplantation.

18/01/2016

Thymoglobuline is made by injecting human thymus cells into rabbits.
It contains immunoglobulins (antibodies) which attach to and destroy some
of the cells of your immune system in your body. These cells play a role in
the rejection of transplanted organs or carry out other unwanted immune
reactions.

The measures taken are considered effective for enveloped viruses such
as human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus
and for the non-enveloped Hepatitis A and parvovirus B19 viruses.

To prevent heart rejection:
The recommended dose is between 1 and 2.5 mg of Thymoglobuline for
every kilogram of weight for 3 to 5 days.

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Thymoglobuline belongs to a group of medicines called
immunosuppressants (anti–rejection medicines). These medicines can
help prevent the rejection of transplanted organs. They can also be
used to treat other unwanted immune reactions.

To prevent kidney rejection:
The recommended dose is between 1 and 1.5 mg of Thymoglobuline for
every kilogram of weight every day for 3 to 9 days.

Date

1. What Thymoglobuline is and what it is used for

Human blood components are used in the manufacturing process for
Thymoglobuline. When medicines are made from human blood or
plasma, certain measures are put in place to prevent infections being
passed on to patients. These include careful selection of blood and plasma
donors to make sure those at risk of carrying infections are excluded,
and the testing of each donation and pools of plasma for signs of
virus/infections. Also during manufacturer of Thymoglobuline, steps
have been included during processing of the blood that can inactivate
or remove the viruses. Despite these measures, when medicines prepared
from human blood components are administered, the possibility of passing
on infection cannot be totally excluded.
This also applies to any unknown or emerging viruses or other types
of infections.

Artwork No.

What is in this leaflet
1. What Thymoglobuline® is and what it is used for
2. What you need to know before you are given Thymoglobuline
3. How Thymoglobuline is given
4. Possible side effects
5. How to store Thymoglobuline
6. Contents of the pack and other information

During treatment with Thymoglobuline, your doctor will carry out regular
blood tests and other tests to monitor your health. Because of the way this
medicine works, it could affect your blood and other organs.

The dose you will be given will depend on your weight (unless you are
obese when it will depend on your ideal weight), which medical problem
you are being treated for, and if you are being given any other medicines
at the same time.

artwork.leicester@multipkg.com

Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• This medicine will be given to you by a doctor or nurse in hospital.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this leaflet.
See section 4.

Your medicine will be given to you by a doctor or nurse in a hospital.
Thymoglobuline is given through a plastic tube (catheter) directly into your
blood stream (intravenous infusion) over a period of at least 6 hours.
The first dose may be given over a longer period of time.

Clearly mark any amendments on one proof and return to MPS

Rabbit anti-human thymocyte immunoglobulin

3. How Thymoglobuline is given

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

solution for infusion

Driving and using machines
Do not drive or operate with machinery while being treated with
Thymoglobuline.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Thymoglobuline® 25 mg powder for

Warnings and precautions
Tell your doctor or pharmacist or nurse if any of these apply to you.
Thymoglobuline may not be suitable for you:
• if you have ever had an allergic reaction to animals or other medicines.
Your doctor will monitor you closely and stop treatment if there are any
signs of an allergic reaction to Thymoglobuline.
• if you have any blood disorders, such as lower than normal platelets
in your blood (thrombocytopenia) or lower than normal white cells in
your blood (leucopenia).The dose you will be given will depend on the
number of white blood cells or platelets in your blood which will be
checked before, during and after treatment.



Package leaflet: Information for the user

4. Possible side effects

Customer

THYMO 5MG/ML Leaflet

Genzyme UK (Suffolk)

Folded: 102x30mm

50 gsm

Malta: Thymoglobuline 25 mg, powder for solution for infusion

Other sources of information
For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder.
624236

Process Black

This leaflet was last revised in 01/2016

Colours Used

UK: Thymoglobuline 25 mg powder for solution for infusion

Keyline (does not print)

Slovenia: Thymoglobuline 25 mg, powder for solution for infusion

Measure bar should be 150mm at 100% scale

Description

GI266305

624236

Profile

266x305mm

Item Code

Size

Ireland: Thymoglobuline 25 mg powder for solution for infusion

8.5pt



These side effects may be mild and go away on treatment with
other medicines. They may also be reduced by changing the dose
of Thymoglobuline or increasing the period of time over which it is given.

This medicinal product is authorised in the Member States
of the EEA under the following names:

Min. Point Size

What Thymoglobuline looks like and contents of the pack
Thymoglobuline is supplied in a glass vial containing a white powder.
Before it is used it is mixed with 5 millilitres (ml) of sterile water to make
a liquid. Each millilitre (ml) contains 5 mg of rabbit anti-human thymocyte
immunoglobulin. This liquid is then mixed with a sodium chloride or glucose
solution so that it can be given slowly (infused) into your bloodstream
through a plastic tube (catheter) in a large vein.

Marketing Authorisation numbers:
UK: PL 12375/0021
Ireland: PA 611/3/1
Malta: MA 596/00201

UK/ROI/MT

What Thymoglobuline contains
The active substance is: 25 mg of rabbit anti-human thymocyte
immunoglobulin.
The other ingredients are: mannitol, glycine, sodium chloride (salt).
Thymoglobuline may also contain residues of polysorbate, from the
manufacturing process.

N/A

Uncommon side effects (may affect more than 1 in 1,000 people):
• Liver injury (liver failure)

6. Contents of the pack and other information

Pharma
Code

Common side effects (may affect more than 1 in 100 people):
• Diarrhoea, difficulty swallowing, nausea, vomiting
• Shivering
• Serum sickness, which is an illness caused by antibodies against
Thymoglobuline causing rash, itching, urticaria (itchy, red welts), joint
pains, kidney problems and swollen lymph nodes and which develops
within 6-21 days. Serum sickness is usually mild and goes away
without treatment or with a short course of corticosteroids
• Muscle pain
• Growths (including cancerous and non-cancerous)
• Shortness of breath
• Itchiness, rash
• Low blood pressure
• Increase in some liver enzymes in your blood

The doctor or nurse will check that the medicine has not passed its expiry
date before preparation.

Malta
Sanofi Malta Ltd
3rd Floor, Avantech Building,
St. Julian’s Rd.,
San Gwann SGN 2805, Malta
Tel: +356 21493022
email: PharmacovigilanceMalta@sanofi.com

Market

The unopened vials of Thymoglobuline will be stored in a refrigerator
(2 – 8 °C).

English

Your medicine will be stored in a hospital by a doctor or nurse, out of the
sight and reach of children.

louise.heel

5. How to store Thymoglobuline

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI,
Citywest Business Campus,
Dublin 24, Ireland.
Tel: 01 4035600
email: IEmedinfo@sanofi.com

Language

By reporting side effects you can help provide more information on the
safety of this medicine.

Proof By

Reporting

2

ADR

Proof No.

via

United Kingdom
Sanofi, One Onslow Street
Guildford, Surrey
GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

18/01/2016

Very common side effects (may affect more than 1 in 10 people):
• Low white blood cell count; low platelet count
• Fever
• Infection

Malta
You can also report side effects directly
www.medicinesauthority.gov.mt/adrportal

Local representative:

Date

The side effects listed below were recorded during a clinical study. This
does not necessarily mean that all were caused by Thymoglobuline.

Ireland
You can also report side effects directly via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

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During or after treatment with Thymoglobuline, some patients experience
a temporary increase in certain liver function tests (laboratory tests which
indicate how well your liver is functioning). Generally, there are no
symptoms and the liver function tests return to normal without treatment.

United Kingdom
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

The product is manufactured by:
Genzyme Polyclonals S.A.S.
23 boulevard Chambaud de la Bruyère
69007 Lyon
France
Tel: +33 4 37 28 16 00
Fax: +33 4 37 28 16 79

Artwork No.

Sometimes, receiving a Thymoglobuline infusion may cause the following
additional side effects. You should tell your doctor as soon as
possible if you have any of the following:
• Difficulty breathing, wheezing or coughing
• Feeling or being sick
• Dizzy or feeling faint
• Tiredness
• Joint pain
• Headache
• Bleeding or bruising more easily than normal
• Irregular or fast heartbeat
• Symptoms of infection such as fever, chills, sore throat, mouth ulcers

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.

artwork.leicester@multipkg.com

Talk to your doctor if you are concerned about any of these side effects or
if there is anything you do not understand.

Clearly mark any amendments on one proof and return to MPS

If you are receiving Thymoglobuline with other medicines which suppress
your immune system, you may be more susceptible to infections.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Genzyme Europe B.V.
Gooimeer 10
1411 DD Naarden
The Netherlands
Tel: +31 35 699 1200
Fax: +31 35 699 1444

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Tell your doctor immediately if you notice:
• A raised itchy rash
• Difficulty in breathing
• Stomach pain
• Swelling of the face, tongue or throat

Sometimes the effects of Thymoglobuline may not occur until months
after it is used. These delayed effects may include an increased risk of
infections and of certain types of cancer. These events have sometimes
been associated with a fatal outcome.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Like all medicines, this medicine can cause side effects, although not
everybody gets them. Some side effects, such as fever, rash and headache,
and others affecting your pulse rate, blood pressure and breathing,
as well as some allergic reactions, are more likely to occur with your first
or second dose of Thymoglobuline than with later doses.



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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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