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CYMEVENE POWDER FOR INFUSION

Active substance(s): GANCICLOVIR SODIUM

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Genisys-No.
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10177066
Pantone Black
148x840 mm
148x210 mm

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Creator

Date

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Kaczmarczyk

30.06.16

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10 pt
NP9345
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11.08.10

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97.4.3525
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Package leaflet: Information for the user

Cymevene® 500 mg
powder for concentrate for solution for infusion
ganciclovir

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

Other medicines and Cymevene

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

● Keep this leaflet. You may need to read it
again.
● If you have any further questions, ask your
doctor, pharmacist or nurse.
● This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
● If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.

In particular, tell your doctor or pharmacist if
you are taking any of the following medicines:
● imipenem/cilastatin – used for bacterial
infections,
● pentamidine – used for parasite or lung
infections,
● flucytosine, amphotericin B – used for
fungal infections,
● trimethoprim, trimethoprim/
sulfamethoxazole, dapsone – used for
bacterial infections,
● probenecid – used for gout,
● mycophenolate mofetil – used after an
organ transplant,
● vincristine, vinblastine, doxorubicin – used
for cancer,
● hydroxyurea – used for a problem called
polycythemia, sickle cell disease and cancer,
● didanosine, stavudine, zidovudine or any
other medicines used for HIV.
If any of the above apply to you (or you are
not sure), talk to your doctor or pharmacist
before using Cymevene.

What is in this leaflet

1. What Cymevene is and what it is used for
2. What you need to know before you use
Cymevene
3. How to use Cymevene
4. Possible side effects
5. How to store Cymevene
6. Contents of the pack and other information

1. What Cymevene is and what
it is used for

Pregnancy, breast-feeding and fertility

What Cymevene is

Pregnancy

Cymevene contains the active substance
ganciclovir. This belongs to a group called
anti‑viral medicines.

Cymevene should not be used by pregnant
women unless the benefits to the mother
outweigh the possible risks to the unborn baby.
If you are pregnant or think you might be
pregnant, do not use this medicine unless your
doctor tells you to. This is because Cymevene
may harm the unborn baby.

What Cymevene is used for

Cymevene is used to treat diseases caused by a
virus called cytomegalovirus (CMV) in patients
who have a weak immune system. It is also
used to prevent CMV infection after an organ
transplant or during chemotherapy. It is used
in adults and adolescents 12 years and older.
● The virus can affect any part of the body.
This includes the retina at the back of the
eye – this means the virus can cause
problems with eye sight.
● The virus can affect
anyone, but it is a
particular problem in
people with a weak
immune system. In
these people the CMV
virus can lead to a
serious disease. A weak
immune system may be
caused by other diseases
(such as AIDS) or by
medicines (such as
chemotherapy or
immunosuppressants).

Contraception
You should not become pregnant while using
this medicine. This is because it may affect the
unborn baby.
Women
If you are a woman who
could get pregnant – use
contraception while you
are using Cymevene. Also
do this for at least 30 days
after Cymevene has been
stopped.
Men
If you are a man whose female partner could
get pregnant – use a barrier method of
contraception (such as condoms) while you are
using Cymevene. Also do this for at least
90 days after Cymevene has been stopped.
If you or your partner becomes pregnant while
using Cymevene, talk to your doctor straight
away.

2. What you need to know
before you use Cymevene

Breast-feeding
Do not use Cymevene if you are breast-feeding.
If your doctor wants you to start using
Cymevene you must stop breast-feeding
before you start using the medicine. This is
because Cymevene may pass into breast milk.

Do not use Cymevene if:

● you are allergic to ganciclovir, valganciclovir
or any of the other ingredients of this
medicine (listed in section 6)
● you are breast-feeding (see Breast-feeding
subsection).
Do not use Cymevene if any of the above apply
to you. If you are not sure, talk to your doctor,
pharmacist or nurse before using Cymevene.

Fertility
Cymevene may affect fertility. Cymevene may
temporarily or permanently stop men from
producing sperm. If you are planning to have a
baby, talk to your doctor or pharmacist before
using Cymevene.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before
using Cymevene if:
● you are allergic to aciclovir, valaciclovir,
penciclovir or famciclovir – these are other
medicines used for viral infections
● you have low white blood cell, red blood
cell or platelet counts – your doctor will do
blood tests before you start and during your
treatment
● you have had problems with your blood cell
counts caused by medicines in the past
● you have kidney problems – your doctor
will need to give you a lower dose and
check your blood cell counts more often
during treatment
● you are having radiotherapy.
If any of the above apply to you (or you are
not sure), talk to your doctor, pharmacist or
nurse before using Cymevene.

Driving and using machines

You may feel sleepy, dizzy, confused or shaky,
or you may lose your balance or have fits
while using Cymevene. If this happens, do not
drive or use any tools or machines.

Cymevene contains sodium

Cymevene contains 43 mg of sodium in each
500 mg dose. This should be taken into
consideration by patients on a controlled
sodium diet.

3. How to use Cymevene
Always use this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

Look out for side effects
Cymevene can cause some serious side effects
that you need to tell your doctor about straight
away. Look out for these while you are taking
Cymevene – your doctor may tell you to stop
taking Cymevene and you may need urgent
medical treatment:
● low white blood cell counts – with signs of
infection such as sore throat, mouth ulcers
or a fever
● low red blood cell counts – signs include
feeling short of breath or tired, palpitations
or pale skin
● low level of platelets – signs include
bleeding or bruising more easily than usual,
blood in urine or stools or bleeding from
gums, the bleeding could be severe
● allergic reaction – the signs may include red
itchy skin, swelling of the throat, face, lips
or mouth, difficulty swallowing or
breathing.
Tell your doctor straight away if you notice
any of the serious side effects above. See
Serious side effects at the top of section 4 for
more information.

Using this medicine
Cymevene will be given to you by a doctor or
nurse. It will be given through a tube into your
vein. This is called an intravenous infusionand
it will usually take one hour.
The dose of Cymevene varies from one patient
to another. Your doctor will work out how
much you need. It will depend on:
● your weight
● your age
● how well your kidneys are working
● your blood counts
● what you are using the medicine for.
How often you will have Cymevene and how
long you keep using it will also vary.
● You will usually start by having one or
two infusions every day.
● If you have two infusions a day, this will
continue for up to 21 days.
● After that the doctor may prescribe the
infusion once a day.
People with kidney or blood problems
If you have any kidney or blood problems
your doctor might suggest a smaller dose of
Cymevene and check your blood cell counts
more often during treatment.

Tests and checks
While you are using Cymevene your doctor
will do regular blood tests. This is to check the
dose you are having is right for you. For the
first 2 weeks these blood tests will be done
often. After that the tests will be done less often.

If you use more Cymevene than you
should

Children and adolescents

If you think you have been given too much
Cymevene talk to your doctor or go to hospital
straight away. You may get the following
symptoms if you have too much:

There is limited information on how safe or
effective Cymevene is in children under
12 years.

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The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR USE AND HANDLING
Please refer to the Summary of Product Characteristics for full prescribing information.
Method of administration

Preparation of final diluted solution for
infusion

Caution:
Ganciclovir must be administered by
intravenous infusion over 1 hour at a
concentration not exceeding 10 mg/mL.
Do not administer by rapid or bolus intravenous
injection because the resulting excessive
plasma levels may increase the toxicity of
ganciclovir.

Based on patient weight the appropriate volume
should be removed with a syringe from the vial
and further diluted into an appropriate infusion
solution. Add a volume of 100 mL of diluent
to the reconstituted solution. Infusion
concentrations greater than 10 mg/mL are not
recommended.
Sodium chloride, dextrose 5%, Ringer’s or
lactated Ringer’s solutions are determined
chemically or physically compatible with
Cymevene.

Do not administer by intramuscular or
subcutaneous injection because this may result
in severe tissue irritation due to the
high pH (~11) of ganciclovir solutions.

Cymevene should not be mixed with other
intravenous products.

The recommended dosage, frequency and
infusion rates should not be exceeded.

The diluted solution should then be infused
intravenously over 1 hour as directed in section
4.2. Do not administer by intramuscular or
subcutaneous injection because this may result
in severe tissue irritation due to the high pH
(~11) of ganciclovir solution.

Cymevene is a powder for solution for infusion.
After reconstitution Cymevene is a colourless
to slightly yellowish solution, practically free
from visible particles.
The infusion should be given into a vein with
adequate blood flow, preferably via a plastic
cannula.

Disposal
For single use only. Any unused medicinal
product or waste material should be disposed
of in accordance with local requirements.

Caution should be exercised in the
handling of Cymevene.

Since Cymevene is considered a potential
teratogen and carcinogen in humans, caution
should be observed in its handling. Avoid
inhalation or direct contact of the powder
contained in the vials or direct contact of the
reconstituted solution with the skin or mucous
membranes. Cymevene solutions are alkaline
(pH ~11). If such contact occurs, wash
thoroughly with soap and water, rinse eyes
thoroughly with plain water.
Preparation of the reconstituted concentrate
Aseptic technique should be used throughout
to reconstitute lyophilised Cymevene.
1. The flip-off cap should be removed to
expose the central portions of the rubber
stopper. Draw 10 mL of water for injection
into a syringe, then slowly inject through the
centre of the rubber stopper into the vial
pointing the needle towards the wall of the
vial. Do not use bacteriostatic water for
injection containing parabens (parahydroxybenzoates), since these are
incompatible with Cymevene.
2. The vial should be gently swirled in order to
ensure complete wetting of the product.
3. The vial should be gently rotated/ swirled for
some minutes to obtain a clear reconstituted
solution.
4. The reconstituted solution should be checked
carefully to ensure that the product is in solution
and practically free from visible particles prior
to dilution with compatible solvent.
Reconstituted solutions of Cymevene range in
colour from colourless to light yellow.

1

Please turn over 
10177066 GB

10177066_NP9345.indd 1

30.06.2016 11:15:22

Genisys-No.
Printing Colour:
Format:
Folding Format:

10177066
Pantone Black
148x840 mm
148x210 mm

Type Size
Drawing Norm
make-up code

Creator

Date

Version

Kaczmarczyk

30.06.16

1

Signature

10 pt
NP9345
GB

Proofreader

11.08.10

Date

● stomach pain, diarrohea or being sick
● shaking or fits
● blood in your urine
● kidney or liver problems
● changes in blood cell counts.

United Kingdom

If you stop using Cymevene

5. How to store Cymevene

97.4.3525
Signature

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Do not stop using Cymevene without talking
to your doctor.

Keep this medicine out of the sight and reach
of children.

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

Powder: Does not require any special storage
conditions. It should not be used after the expiry
date which is stated on the carton. The expiry
date refers to the last day of that month.

4. Possible side effects

After reconstitution:
Chemical and physical in-use stability has
been demonstrated for the reconstituted
product for 12 hours at 25°C after dissolving
with water for injections. Do not refrigerate or
freeze.
From a microbiological point of view, the
reconstituted solution should be used
immediately. If not used immediately, in-use
storage times and conditions prior to use are
the responsibility of the user.

Like all medicines, this medicine can cause
side effects, although not everybody gets them.
The following side effects may happen with
this medicine:

Serious side effects

Tell your doctor straight away if you notice
any of the following serious side effects – your
doctor may tell you to stop taking Cymevene
and you may need urgent medical treatment:

After dilution in infusion solutions (sodium
chloride 0.9%, dextrose 5%, Ringer’s or
lactated Ringer’s solution for injection) :
Chemical and physical in-use stability has
been demonstrated for 24 hours at 2 – 8°C
(do not freeze).

Very common: may affect more than
1 in 10 people
● low white blood cell counts – with signs of
infection such as sore throat, mouth ulcers
or a fever
● low red blood cell counts – signs include
feeling short of breath or tired, palpitations
or pale skin.

From a microbiological point of view, the
Cymevene infusion solution should be used
immediately. If not used immediately, in-use
storage times and conditions prior to use are
the responsibility of the user and should not be
longer than 24 hours at 2°C to 8°C, unless
reconstitution and dilution have taken place in
controlled and validated aseptic conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help
protect the environment.

Common: may affect up to 1 in 10 people
● low level of platelets – signs include
bleeding or bruising more easily than usual,
blood in urine or stools or bleeding from
gums, the bleeding could be severe.
Uncommon: may affect up to 1 in
100 people
● allergic reaction – the signs may include,
red itchy skin, swelling of the throat, face,
lips or mouth, difficulty swallowing or
breathing.

6. Contents of the pack and
other information

Tell your doctor straight away if you notice
any of the side effects above.

Other side effects

What Cymevene contains

Tell your doctor,
pharmacist or nurse if you
notice any of the following
side effects:
Very common: may affect
more than 1 in 10 people
● diarrhoea
● feeling short of breath.

● The active substance is
ganciclovir. Each glass
vial contains 500 mg
ganciclovir as
ganciclovir sodium.
Following
reconstitution of the
powder, 1ml solution contains 50 mg
ganciclovir.
● The other ingredients are sodium hydroxide
and hydrochloric acid.

Common: may affect up to 1 in 10 people
● headache
● trouble sleeping
● fever, chills or night sweats
● feeling tired, dizzy, weak or generally
unwell
● feeling depressed, anxious, confused or
having abnormal thoughts
● pain
● ear pain
● hands or feet feeling weak or numb, which
may affect your balance
● muscle pain or spasms
● back, chest or joint pain
● sight problems or eye pain
● eczema, skin problems, itching
● changes to your sense of touch, tingling,
tickling, pricking or burning feeling
● fits
● cough
● feeling or being sick
● problems swallowing
● changes to the way things taste
● loss of appetite, anorexia or weight loss
● stomach pain, constipation, wind,
indigestion
● urine infection – signs include fever,
passing urine more often, pain when
passing urine
● thrush and oral thrush
● bacterial skin infection – signs include red,
painful or swollen skin
● blood poisoning (sepsis)
● changes in blood cell counts
● liver and kidney problems shown in tests
● a skin reaction where the medicine was
injected – such as inflammation, pain and
swelling.

What Cymevene looks like and contents
of the pack

Cymevene is a white to off white powder for
concentrate for solution for infusion, supplied
in a single-dose glass vial, with a rubber
stopper and aluminium closure with flip-off
cap. Reconstituted solutions of Cymevene
range in colour from colourless to light yellow.
Vials of Cymevene are supplied in packs of
1 or 5. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom.

Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany

This medicinal product is authorised in
the Member States of the EEA under
the following names:
Cymevene: Austria, Belgium, Bulgaria,
Croatia, Czech Republic, Denmark, Estonia,
Finland, Greece, Hungary, Iceland, Ireland,
Lithuania, Luxembourg, The Netherlands,
Norway, Poland, Portugal, Romania, Slovak
Republic, Spain, Sweden, United Kingdom.

Uncommon: may affect up to 1 in 100 people
● hair loss
● deafness
● mouth ulcers
● hives, dry skin
● feeling agitated or nervous
● eye infection (conjunctivitis)
● abnormal thoughts or feelings, losing
contact with reality
● blood in urine
● tremor, shaking
● swollen stomach
● uneven heartbeat
● low blood pressure, which may make you
feel dizzy or faint
● serious kidney problems shown in tests
● low red blood cell counts shown in tests
● infertility in men – see ‘Fertility’ section
● pancreatitis – signs are severe stomach pain
which spreads into your back.

Cymeven i.v.: Germany
Cymevan: France
Citovirax: Italy
This leaflet was last revised in July 2016.

Other sources of information
Detailed information on this medicine is
available on the European Medicines Agency
(EMA) web site: http://www.ema.europa.eu

Rare: may affect up to 1 in 1,000 people
● rash
● hallucinations – hearing or seeing things
that are not real.

Side effects in children and adolescents
The following side effects are more likely in
children:
● fever
● stomach pain
● low white blood cell counts.

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly (see details
below). By reporting side effects you can help
provide more information on the safety of this
medicine.
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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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