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Active substance: GANCICLOVIR SODIUM

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Patient Information Leaflet

powder for infusion 500 mg

Please read all of this leaflet carefully
before you start having this medicine.
● Keep this leaflet. You may need to read
it again.
● If you have any further questions, ask
your doctor or nurse.
● If any of the side effects become serious
or troublesome, or if you notice any
side effects not listed in this leaflet,
please tell your doctor or nurse.

Taking other medicines
Please tell your doctor or nurse if you are
taking or have recently taken any other
medicines. This includes medicines that
you buy without a prescription and herbal
medicines. This is because Cymevene can
affect the way some medicines work.
Also some medicines can affect the way
Cymevene works.
In particular, tell your doctor or nurse if
you are taking any of the following
● Probenecid (used to treat gout).
● Mycophenolate mofetil (used after an
organ transplant).
● Zidovudine, didanosine, cidofovir or
foscarnet (used to treat HIV).
● Imipenem-cilastatin, trimethoprim,
pentamidine, flucytosine, amphotericin
B or dapsone (antibiotics used to treat
● Doxorubicin, vincristine, vinblastine or
hydroxyurea (used to treat cancer).

In this leaflet:
1 What Cymevene is and what it is used
2 Before you are given Cymevene
3 How Cymevene will be given
4 Possible side effects
5 How Cymevene is stored
6 Further information

1. What Cymevene is and what
it is used for
Cymevene contains a medicine called
ganciclovir. This belongs to a group of
medicines called ‘anti-virals’.

Pregnancy and breast-feeding
You must not have Cymevene if you are
pregnant or breast-feeding. Cymevene
will damage an unborn baby.
● If you are a man and your partner is at
an age where she could get pregnant,
you must use condoms during your
treatment with Cymevene and for
90 days after the end of treatment.
● If you are a woman at an age where you
could get pregnant, you must use
contraception (birth control) during
your treatment.

Cymevene is used to treat infections
caused by a virus called cytomegalovirus
● The virus can infect any part of the
body. This includes the retina of the
eye where it causes problems with eye
● The virus can infect
anyone. However, in
people who have a
poor immune system
because of other
diseases or medicines
(people who are
‘immunocompromised’), it can
lead to serious

If you are not sure if
you are protected (have
adequate contraception),
talk to your doctor or
nurse before having
Driving and using machines
Ganciclovir can make you feel dizzy,
sleepy or confused. It can also cause fits
and loss of co-ordination. If any of these
happen to you, do not drive or use any
tools or machines.

Cymevene is also used to prevent
cytomegalovirus (CMV) infection after an
organ transplant.

2. Before you are given

3. How Cymevene will be given

You must not be given Cymevene if:
● You are allergic (hypersensitive) to
ganciclovir (the only ingredient in
● You are allergic to similar medicines
called ‘anti-virals’. These include
valganciclovir, aciclovir and
● You are pregnant or breast-feeding a
baby. See the section on ‘Pregnancy
and breast-feeding’.
You must not be given Cymevene if any
of the above apply to you. If you are not
sure, talk to your doctor or nurse before
having Cymevene.

Cymevene will be given to you by a
doctor or nurse. It will be given to you
through a small tube into one of your
veins (called an ‘intravenous infusion’). It
usually takes one hour for the medicine to
be given.
● The dose of Cymevene varies from one
patient to another. It depends on your
age, weight, how well your kidneys are
working and what you need the
medicine for. The doctor will work out
how much to give you.
● How often you have Cymevene and
how long you keep having it for also
varies from one patient to another. You
will usually start by having one infusion
every 12 hours for up to 21 days. After
that you may have one infusion a day.
● Your doctor will see how you respond
to this medicine, you may need to have
regular blood tests. If necessary your
dose might be changed or your
treatment stopped.

Take special care with Cymevene
Check with your doctor or nurse before
having Cymevene if:
● You have low numbers of white blood
cells, red blood cells or platelets in your
● You have had blood problems in the
past that have been caused by
● You are having radiotherapy, or have
recently had it.
● You have kidney problems.
● You or your partner might become
pregnant during treatment. See the
section on ‘Pregnancy and breastfeeding’.
If any of the above apply to you, or if you
are not sure, talk to your doctor or nurse
before you have Cymevene.

If you are given more Cymevene than
you should
● If you are given too much Cymevene
you may get changes to your blood,
problems with your liver or kidneys,
stomach pain, being sick, diarrhoea, fits
and shaking.
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This information is intended for medical or healthcare professionals only:
Cymevene® powder for infusion 500 mg
Please refer to the Summary of Product Characteristics for full prescribing information.
Posology and method of administration

Paediatric patients
There has been limited clinical experience
in treating patients under the age of
12 years. Reported adverse events were
similar to those seen in adults.

For intravenous infusion following
reconstitution with 10ml Water for
Injections BP. Based on patient weight
the appropriate calculated dose volume
should be removed from the vial
(ganciclovir concentration 50mg/ml) and
added to an acceptable infusion fluid
(typically 100ml) for delivery over the
course of 1 hour. Infusion concentrations
greater than 10mg/ml are not
recommended. (For further information
see Instructions for use/handling and

However, the use of Cymevene in
children warrants extreme caution due to
the potential for long-term
carcinogenicity and reproductive toxicity.
The benefits of treatment should
outweigh the risks. Cymevene is not
indicated for the treatment of congenital
or neonatal CMV infections.
Dosage reductions
For less severe neutropenia or other
cytopenias a reduction in the total daily
dose should be considered. Cell counts
usually normalise within 3 to 7 days after
discontinuing the drug or decreasing the
dose. As evidence of marrow recovery
becomes apparent gradual increases in
dose, with careful monitoring of white
blood cell counts, may be appropriate.

Treatment of CMV infection
Initial (induction) treatment: 5mg/kg
infused at a constant rate over 1 hour
every 12 hours (10mg/kg/day) for 14 to
21 days.
Long-term (maintenance) treatment: For
immunocompromised patients at risk of
relapse of CMV retinitis a course of
maintenance therapy may be given.
Intravenous infusion of 6mg/kg once daily
5 days per week, or 5mg/kg once daily
7 days per week is recommended.

Patients with severe leucopenia,
neutropenia, anaemia, thrombocytopenia
and pancytopenia
Severe leucopenia, neutropenia, anaemia,
thrombocytopenia, pancytopenia, bone
marrow depression and aplastic anaemia
have been observed in patients treated
with Cymevene. Therapy should not be
initiated if the absolute neutrophil count is
less than 500 cells/µL, or the platelet
count is less than 25000/µL, or the
haemoglobin level is less than 8g/dL.

Treatment of disease progression:
Indefinite treatment may be required in
patients with AIDS, but even with
continued maintenance treatment, patients
may have progression of retinitis. Any
patient in whom the retinitis progresses,
either while on maintenance treatment or
because treatment with Cymevene has
been withdrawn, may be re-treated using
the induction treatment regimen.

Cymevene should be used with caution in
patients with pre-existing haematological
cytopenia or a history of drug-related
haematological cytopenia and in patients
receiving radiotherapy.

Prevention of CMV disease
Induction regimen: 5mg/kg infused every
12 hours (10mg/kg/day) for 7 to 14 days.

If there is a significant deterioration of
blood cell counts during therapy with
Cymevene, treatment with haematopoetic
growth factors and/or dose interruption
should be considered.

Maintenance regimen: Intravenous
infusion of 6mg/kg once daily 5 days per
week, or 5mg/kg once daily 7 days per
week is recommended.
Special dosage instructions

Method of administration
Cymevene is a powder for solution for
intravenous infusion. For directions on
the preparation of the infusion solution,
see Instructions for use/handling, and

Patients with renal impairment:
Serum creatinine levels or creatinine
clearance should be monitored carefully.
Dosage adjustment is required according
to creatinine clearance as shown in the
table below.

Cymevene must only be given by
intravenous infusion, preferably via a
plastic cannula, into a vein with adequate
blood flow.

An estimated creatinine clearance
(ml/min) can be related to serum
creatinine by the following formulae:

Caution - do not administer by rapid or
bolus i.v. injection! The toxicity of
Cymevene may be increased as a result of
excessive plasma levels.

(140 – age [years])
For males = x (body weight [kg])

(72) x (0.011 x serum

creatinine [micromol/L])

Caution - i.m. or s.c. injection may result
in severe tissue irritation due to the high
pH (~11) of ganciclovir solutions.
The recommended dosage, frequency, or
infusion rates should not be exceeded.

For females = 0.85 x male value

Induction dose
of ganciclovir

≥  70 ml/min

5.0mg/kg every
12 hours
2.5mg/kg every
12 hours
after haemodialysis

50 – 69 ml/min
25 – 49 ml/min
10 – 24 ml/min
< 10 ml/min

Instructions for use/handling and
Caution should be exercised in the
handling of Cymevene.
Since Cymevene is considered a potential
teratogen and carcinogen in humans,
caution should be exercised 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 approximately
11). If such contact occurs, wash
thoroughly with soap and water, rinse eyes
thoroughly with sterile water, or plain
water if sterile water is unavailable.

Elderly patients
No studies on the efficacy or safety of
Cymevene in elderly patients have been
conducted. Since elderly individuals often
have reduced renal function, Cymevene
should be administered to elderly patients
with special consideration for their renal
status (see above).

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Uncommon (affect less than 1 in
100 people)
● Changes to your bone marrow (which
may affect how your body produces
some blood cells).
● Disturbances of the mind, including
feeling agitated and losing contact with
● Shaking or trembling that you cannot
● Infection of the eye (conjunctivitis).
● Deafness.
● Uneven heart beat.
● Low blood pressure. The signs include
feeling dizzy or light-headed.
● Mouth ulcers, swelling of the abdomen
(tummy) and pancreatitis. The signs of
pancreatitis include severe pain in the
stomach which spreads to your back.
● Loss of hair and dry skin.
● Serious kidney disease.
● Blood in your urine (water).
● Infertility in men. Cymevene may stop
men from producing sperm. This can
be temporary or permanent.

● If you think you have been given too
much Cymevene, tell your doctor or
If you have any further questions on the
use of this medicine, ask your doctor or

4. Possible side effects
Like all medicines, Cymevene can cause
side effects, although not everyone will
get them.
Allergic reactions (uncommon, affect less
than 1 in 100 people)
If you have an allergic reaction, tell a
doctor straight away.
The signs may include:
● A raised itchy skin rash (hives).
● Difficulty breathing or swallowing
caused by sudden swelling of the throat,
face, lips and mouth.
● Sudden swelling of the hands, feet and

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. 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.

Other possible side effects:
Very common (affect more than 1 in
10 people)
● Low numbers of one type of white
blood cell (called neutrophils). The
signs include infections of the mouth,
gums, throat and lungs. Your doctor
may want you to have blood tests.
● Low numbers of red blood cells
(anaemia). The signs include feeling
tired, pale skin, palpitations (a fluttering
sensation in the heart) and being short
of breath.
● Difficulty breathing.
● Diarrhoea.

United Kingdom
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5. How Cymevene is stored
● Your doctor or pharmacist are
responsible for storing Cymevene.
They are also responsible for disposing
of any unused Cymevene correctly.
● Keep out of the reach and sight of
● Do not store
Cymevene above
● Do not use Cymevene
after the expiry date
printed on the pack.

Common (affect less than 1 in
10 people)
● Infections of the
blood, skin, urinary
tract and mouth. The
signs include high
temperature (fever),
chills, feeling tired,
redness and swelling
of the skin, pain on
passing water and
creamy white spots in
the mouth.
● Low numbers of all types of white
blood cells. The signs include
infections of the mouth, gums, throat
and lungs.
● Low numbers of platelets in your blood.
The signs include bruising easily and
nose bleeds.
● Low numbers of all the types of cells in
your blood. The signs include feeling
tired, bruising easily, being short of
breath and nose bleeds.
● Loss of appetite.
● Depression, anxiety, feelings of
confusion and abnormal thinking.
● Headache.
● Difficulty in sleeping.
● Changes to the way things taste.
● Dizziness.
● Fits (‘convulsions’).
● Changes in your skin sensitivity (such
as numbness, pins and needles, burning
● Changes to your eye-sight (vision), loss
of vision or eye pain.
● Pain in your ears.
● A cough.
● Feeling or being sick, pain in your
stomach, constipation, wind and
difficulty swallowing.
● Problems with your liver, shown in a
blood test.
● Skin rashes (including inflammation,
redness and blistering), itchiness and
sweating at night.
● Pain in your back, joints, muscles or
chest or muscle cramps.
● Problems with your kidneys. This may
affect the amount of water (urine) that
you pass.
● Feeling tired, unwell or weak, high
temperature (fever), shivering, weight
● A reaction where Cymevene was given
into your vein.

6. Further information
What Cymevene contains
The active substance in Cymevene powder
for infusion is ganciclovir. Each glass vial
contains 500 mg (milligrams) ganciclovir
as ganciclovir sodium 543 mg. Sodium
content per vial is 43 mg.
There are no other ingredients in
What Cymevene looks like and contents
of the pack
Cymevene is a powder, supplied in a glass
vial. Before it is given, Cymevene is
made into a solution by adding sterile
water to the vial. The correct dose is then
taken out of the vial and added to the bag
of infusion solution to be given to the
Vials of Cymevene are supplied in packs
of 5 or 25. Not all packs may be
Marketing Authorisation Holder and
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom.
This leaflet was last revised in
April 2015


Method of Preparation of Cymevene
1. Lyophilized Cymevene should be
reconstituted by injecting 10ml of
sterile Water for Injections into the
vial. Do not use bacteriostatic
water for injection containing
parabens (para-hydroxybenzoates),
since these are incompatible with
Cymevene sterile powder and may
cause precipitation.
2. The vial should be shaken to dissolve
the drug.
3. Reconstituted solution should be
inspected for particulate matter prior
to proceeding with the admixture
4. Reconstituted solution in the vial is
stable at room temperature for
12 hours. It should not be
Preparation and administration of
infusion solution
Based on patient weight the appropriate
calculated dose volume should be
removed from the Cymevene vial
(concentration 50mg/ml) and added to
an acceptable infusion fluid. Normal
saline, dextrose 5% in water, Ringer’s or
lactated Ringer’s solution are
determined chemically or physically
compatible with Cymevene. Infusion
concentrations greater than 10mg/ml are
not recommended.
Cymevene should not be mixed with
other iv products.
Because Cymevene is reconstituted with
nonbacteriostatic sterile water, the
infusion solution should be used as soon
as possible and within 24 hours of
dilution in order to reduce the risk of
bacterial contamination.
The infusion solution should be
refrigerated. Freezing is not
Any unused product or waste material
should be disposed of in accordance
with local requirements.
This leaflet was last revised in
April 2015

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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.