Patient leaflet - Ganciclovir 500 mg powder for concentrate for solution for infusion
1. WHAT GANCICLOVIR IS AND WHAT IT IS USED FOR
What Ganciclovir is
Ganciclovir 500mg powder for concentrate for solution for infusion contains the active substance ganciclovir. This belongs to a group called antiviral medicines.
What Ganciclovir is used for
Ganciclovir is used to treat diseases caused by a virus called cytomegalovirus (CMV) in adults and adolescent patients 12 years and older who have a weak immune system. It is also used to prevent CMV infection after an organ transplant or during chemotherapy in adults and children from birth.
- 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).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GANCICLOVIR
Do not use Ganciclovir
- if you are allergic to ganciclovir, valganciclovir or any of the other ingredients of this medicine (listed in section 6).
- if you are breastfeeding (see breastfeeding subsection).
Do not use Ganciclovir if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse 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.
- 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 the serious side effects listed in Section 4 and tell your doctor if you notice any of these while you are taking Ganciclovir - your doctor may tell you to stop taking Ganciclovir and you may need urgent medical treatment.
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 as a treatment for CMV disease in children under 12 years. Babies and infants given Ganciclovir for prevention of CMV disease, will undergo regular blood tests
Other medicines and Ganciclovir
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use 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, ciclosporin, tacrolimus – 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, tenofovir or any other medicines used for HIV,
- adefovir or any other medicines used to treat Hepatitis B.
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
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 using this medicine.
Pregnancy
Ganciclovir 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 Ganciclovir may harm the unborn baby.
If you or your partner becomes pregnant while you are using Ganciclovir, talk to your doctor straight away.
Contraception - Women
You should not become pregnant while using this medicine. This is because it may affect the unborn baby. If you are a woman who could get pregnant – use contraception while you are using Ganciclovir. Also do this for at least 28 weeks after Ganciclovir has been stopped.
Contraception - Men
If you are a man whose female partner could get pregnant – use condoms plus an additional contraceptive method while you are using Ganciclovir. Also do this for at least 95 days after Ganciclovir has been stopped.
Breastfeeding
Do not use Ganciclovir if you are breastfeeding. If your doctor wants you to start using Ganciclovir you must stop breastfeeding before you start using the medicine. This is because Ganciclovir may pass into breast milk.
Fertility
Ganciclovir may affect fertility. Ganciclovir 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 Ganciclovir.
Driving and using machines
You may feel sleepy, dizzy, confused or shaky, or you may lose your balance or have fits while using Ganciclovir. If this happens, do not drive or use any tools or machines.
Ganciclovir contains sodium
This medicine contains approximatly 43 mg sodium (main component of cooking/table salt) in each 500 mg vial. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.
3. HOW TO USE GANCICLOVIR
Using this medicine
Ganciclovir 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 (in children their height may also be taken into account),
- your age,
- how well your kidneys are working,
- your blood counts,
- what you are using the medicine for.
How often you will have to use Ganciclovir and for how long you will need to 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, diarrhoea or being sick
- shaking or fits
- blood in your urine
- kidney or liver problems
- changes in blood cell counts.
If you stop using Ganciclovir
Do not stop using Ganciclovir without talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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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 more information.
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 handling of Ganciclovir. 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.
Method of administration
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.
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.
The infusion should be given into a vein with adequate blood flow, preferably via a plastic cannula. Package leaflet: Information for the user
Ganciclovir 500 mg powder for concentrate for solution for infusion
ganciclovir
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
- blood infection (sepsis) – signs include fever, chills, palpitations, confusion and slurred speech
- 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
- severely low blood cell count
- pancreatitis – signs are severe stomach pain which spreads into your back
- fits.
Uncommon: may affect up to 1 in 100 people
- failure of the bone marrow to produce blood cells
- hallucinations – hearing or seeing things that are not real
- abnormal thoughts or feelings, losing contact with reality
- failure of kidney function.
Rare: may affect up to 1 in 1,000 people
- 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 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
- thrush and oral thrush
- upper respiratory tract infection (e.g. sinusitis, tonsillitis)
- loss of appetite
- headache
- cough
- feeling short of breath
- diarrhoea
- feeling or being sick
- abdominal pain
- eczema
- feeling tired
- fever.
Common: may affect up to 1 in 10 people
- influenza
- urine infection – signs include fever, passing urine more often, pain when passing urine
- infection of the skin and the tissues under the skin
- mild allergic reaction – the signs may include red, itchy skin
- weight loss
- feeling depressed, anxious or confused
- trouble sleeping
- hands or feet feeling weak or numb, which may affect your balance
- changes to your sense of touch, tingling, tickling, pricking or burning feeling
- changes to the way things taste
- chills
- eye inflammation (conjunctivitis), eye pain or sight problems
- ear pain
- low blood pressure, which may make you feel dizzy or faint
- problems swallowing
- constipation, wind, indigestion, stomach pain, swelling of the abdomen
- mouth ulcers
- abnormal results of liver and kidney laboratory tests
- night sweats
- itching, rash
- hair loss
- back pain, muscle or joint pain, muscle spasms
- feeling dizzy, weak or generally unwell
- a skin reaction where the medicine was injected – such as inflammation, pain and swelling.
Uncommon: may affect up to 1 in 100 people
- feeling agitated
- tremor, shaking
- deafness
- uneven heartbeat
- hives, dry skin
- blood in urine
- infertility in men – see ‘Fertility’ section
- chest pain.
Side effects in children and adolescents
Low blood cell counts are more likely in children, especially babies and infants.
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects 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.
Do not use this medicine after the expiry date, which is stated on the vial label and carton after “EXP”. The expiry date refers to the last day of that month.
Powder:
Does not require any special storage conditions.
After reconstitution:
Do not refrigerate or freeze.
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.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the reconstituted product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
After dilution:
Do not freeze.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2–8°C.
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not throw away any medicines via wastewater. 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 vial contains 500 mg ganciclovir (as ganciclovir sodium). After reconstitution with 10 mL of water for injection, each mL contains 50 mg of ganciclovir.
- The other excipients are: sodium hydroxide and/or hydrochloric acid for pH-adjustment
What Ganciclovir looks like and contents of the pack
Ganciclovir is a white to off white powder for concentrate for solution for infusion, supplied in a single-dose glass vial, closed with a rubber stopper and a flip-off seal.
Reconstituted solutions of Ganciclovir range in colour from colourless to pale yellow.
Vials of Ganciclovir are supplied in packs of 1 or 5.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó 8, 8A e 8B
Fervença
2705-906 Terrugem SNT
Portugal
Manufacturer
Thymoorgan Pharmazie GmbH
Schiffgraben 23
38690 Goslar
Germany
This leaflet was last revised in July 2024
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Preparation of the reconstituted concentrate
Aseptic technique should be used throughout to reconstitute lyophilised Ganciclovir.
- 1. The flip-off 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 range in colour from colourless to pale yellow.
Preparation of final diluted solution for infusion
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 Ganciclovir. Ganciclovir should not be mixed with other intravenous products.
Disposal
For single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Reverse 160 mm