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GANCICLOVIR 500 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): GANCICLOVIR / GANCICLOVIR / GANCICLOVIR

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Package leaflet: Information for the user
Ganciclovir 500 mg powder for solution for infusion
ganciclovir
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
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.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Ganciclovir is and what it is used for
What you need to know before you use Ganciclovir
How to use Ganciclovir
Possible side effects
How to store Ganciclovir
Contents of the pack and other information
1. What Ganciclovir is and what it is used for

What ganciclovir is
Ganciclovir contains the active substance ganciclovir. This belongs to a group called ‘anti-viral’ medicines.
What ganciclovir isused for
Ganciclovir 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 where it causes 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).
2.

What you need to know before you use Ganciclovir

Do not use Ganciclovir if:
you are allergic to ganciclovir, vilganciclovir or any of the other ingredients of this medicine (listed in
section 6).
you are breast-feeding (see Breast-feeding subsection).
Do not use ganciclovir if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist
opr murse before using ganciclovir.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ganciclovir 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.
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• 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
Ganciclovir.
Look out for side effects
Ganciclovir can cause some serious side effects that you need to tell your doctor about straight away. Look
out for these while you are taking ganciclovir – your doctor may tell you to stop taking ganciclovir 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.
Tests and checks
While you are using ganciclovir 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.
Children and adolescents
There is limited information on how safe or effective ganciclovir is in children under 12 years.
Other medicines and Ganciclovir
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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
Ganciclovir.
Pregnancy, breast-feeding and fertility
Pregnancy
Gancicilovir 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 Gancicilovir may harm the unborn baby.
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 Gancicilovir.
Also do this for at least 30 days after Gancicilovir has been stopped.
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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 Gancicilovir. Also do this for at least 90 days after
Gancicilovir has been stopped.
If you or your partner becomes pregnant while using Gancicilovir talk to your doctor straight away.
Breast-feeding
Do not use Gancicilovir if you are breast-feeding. If your doctor wants you to start using Gancicilovir you
must stop breast-feeding before you start using the medicine. This is because Gancicilovir may pass into
breast milk.
Fertility
Gancicilovir may affect fertility. Gancicilovir 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 Gancicilovir.
Driving and using machines
You may feel dizzy, confused or shaky, or you may lose your balance or have fits while using Gancicilovir.
If this happen to you, do not drive or use any tools or machines.
Gancicilovir contains sodium
Gancicilovir contains 1.96 mmol sodium (45.057mg) of sodium in each 500 mg dose. This should be taken
into consideration by patients on a controlled sodium diet.
3.

How to use Ganciclovir

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Using this medicine
Gancicilovir 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 infusion and it will usually take one hour.
The dose of Ganciclovir 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 Ganciclovir 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 Ganciclovir and
check your blood cell counts more often during treatment.
If you use more Ganciclovir than you should
If you think you have been given too much Ganciclovir talk to your doctor or go to hospital straight
away. You may get the following symptoms if you have too much:
• stomach pain, diarrohea or being sick
• shaking or fits
• blood in your urine
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kidney or liver problems
changes in blood cell counts.

If you stop using Ganciclovir:
Do not stop using Ganciclovir wihtout talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.

Possible side effects

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 Ganciclovir and you may need urgent medical treatment:
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.
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.
Tell your doctor straight away if you notice any of the side effects above.
Other side effects:
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.
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
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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.

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.
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 via the Yellow Card Scheme at: www.
mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5.

How to store Ganciclovir

Keep this medicine out of the sight and reach of children.
Powder: Does not require any special storage conditions. It should not be used after the expiry date which is
stated on the label after EXP. The expiry date refers to the last day of that month.
Undiluted vials: This medicinal product does not require any special storage condition.
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.
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.
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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 25°C and 2 – 8°C (do not
freeze). From a microbiological point of view, the ganciclovir should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user and would
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.
6.

Contents of the pack and other information

What Ganciclovir contains
The active substance is ganciclovir. Each glass vial contains 500 mg ganciclovir as ganciclovir
Following reconstitution of the powder, 1ml solution contains 50 mg ganciclovir.
The other ingredients are sodium hydroxide and water for injections.
What Ganciclovir looks like and contents of the pack
Ganciclovir is a white to off white lyophilized cake or powder, supplied in a 10 ml glass vial (type I, clear
glass) with dark grey Bromobutyl rubber closure and flip off aluminium seals. Reconstituted solutions of
Ganciclovir is a clear colorless solution.
Vials of Ganciclovir are supplied in packs of 1, 5 or 25. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan
Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Agila Specialities Polska Sp. z. o. o.
10, Daniszewska Str., 03-230 Warsaw
Poland.
This leaflet was last revised in 27/07/2016
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency (EMA) web
site: http://www.ema.europa.eu
-----------------------------------------------------------------------------------------------------------------------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.

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Method of administration
Caution;
Ganciclovir must be administered by intravenous infusion over 1hour 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. .
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.
The recommended dosage, frequency and infusion rates should not be exceeded.
Ganciclovir is a powder for solution for infusion. After reconstitution Ganciclovir is a solution practically
free from visible particles.
The infusion should be given into a vein with adequate blood flow, preferably via a plastic cannula.
Instructions for use/handling and disposal
Caution should be exercised in the handling of Ganciclovir.
Since Ganciclovir 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. Ganciclovir 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 Ganciclovir.
1. The flip off aluminium seal 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 (para-hydroxybenzoates), since these are incompatible
with Ganciclovir.
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 Ganciclovir are a clear colourless solution.

Preparation of final diluted solution for infusion
Based on patient weight the appropriate volume should be removed with a syringe from the Ganciclovir vial
(concentration 50 mg/ml) and further dilated into an appropriate infusion solution. Add a volume of 100ml of
diluent to the reconstituted solution. Infusion concentrations greater than 10mg/mL are not recommended.
Sodium chloride, dextrose 5%, Ringer's or lactated Ringer's solutions are determined chemically or
physically compatible with Ganciclovir.
Ganciclovir should not be mixed with other intravenous products.
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.

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

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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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