Ganciclovir accord

Package leaflet: Information for the user

Ganciclovir Accord, 500 mg, powder for concentrate for solution for infusion
Ganciclovir
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet; you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Ganciclovir Accord is and what it is used for
2. Important information before using Ganciclovir Accord
3. How to use Ganciclovir Accord
4. Possible side effects
5. How to store Ganciclovir Accord
6. Contents of the pack and other information

1. What Ganciclovir Accord is and what it is used for

What Ganciclovir Accord is
The active substance in Ganciclovir Accord is ganciclovir. It belongs to a group of medicines called antiviral agents.

What Ganciclovir Accord is used for
Ganciclovir Accord is used to treat cytomegalovirus (CMV) infections in adults and adolescents aged 12 years and older who have a weakened immune system. It is also used to prevent CMV infections after organ transplantation or during chemotherapy in adults and children from birth onwards.

• CMV infection can affect any part of the body, including the retina of the eye – this means the virus can cause vision problems.
• The virus can cause disease in anyone, but it is particularly problematic in people with weakened immune systems. In such individuals, CMV may cause serious illness. Immune system weakness may result from other diseases (e.g. AIDS) or from medications (e.g. chemotherapy or immunosuppressive drugs).

2. Important information before using Ganciclovir Accord

When not to use Ganciclovir Accord:

• if the patient is allergic to ganciclovir, valganciclovir, or to any of the other ingredients of this medicine (listed in section 6);
• during breastfeeding (see section “Breastfeeding”).

Do not use Ganciclovir Accord if any of the above apply to the patient. If in doubt, speak with a doctor, pharmacist, or nurse before taking Ganciclovir Accord.

Warnings and precautions

Talk to a doctor, pharmacist, or nurse before starting treatment with Ganciclovir Accord if:

• the patient is allergic to acyclovir, valacyclovir, penciclovir, or famciclovir – medicines used to treat viral infections;
• the patient has low levels of white blood cells, red blood cells, or platelets – the doctor will perform blood tests before and during treatment;
• the patient has previously experienced blood cell count problems due to taking medicines;
• the patient has impaired kidney function – a lower dose of the medicine may be required and blood cell counts will need to be monitored more frequently during treatment;
• the patient is undergoing radiotherapy.

If any of the above apply to the patient (or if in doubt), speak with a doctor, pharmacist, or nurse before taking Ganciclovir Accord.

Be aware of adverse reactions

Ganciclovir Accord may cause certain serious adverse reactions, which should be reported to a doctor immediately. Pay attention to the serious adverse reactions listed in section 4 and inform the treating doctor if any of these occur during treatment with Ganciclovir Accord – the doctor may advise stopping the medicine and the patient may require urgent medical treatment.

Laboratory tests

While taking Ganciclovir Accord, the doctor will carry out regular blood tests. These are performed to ensure the dose of medicine is appropriate for the patient. Blood tests will be frequent during the first 2 weeks of treatment, and less frequently thereafter.

Children and adolescents

There is limited information on the safety and efficacy of Ganciclovir Accord in children under 12 years of age. Newborns and infants receiving Ganciclovir Accord for prevention of CMV disease will undergo regular blood testing.

Ganciclovir Accord and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• imipenem with cilastatin – used to treat bacterial infections;
• pentamidine – used to treat parasitic infections or lung infections;
• flucytosine, amphotericin B – used to treat fungal infections;
• trimethoprim, trimethoprim with sulfamethoxazole, dapsone – used to treat bacterial infections;
• probenecid – used to treat gout;
• mycophenolate mofetil, cyclosporine, tacrolimus – used after organ transplantation;
• vincristine, vinblastine, doxorubicin – used in cancer treatment;
• hydroxyurea – used to treat excessive red blood cells (polycythaemia), sickle cell anaemia, and cancers;
• didanosine, stavudine, zidovudine, tenofovir, or other medicines used in HIV infection;
• adefovir or other medicines used to treat hepatitis B.

If any of the above apply to the patient (or if in doubt), speak with a doctor or pharmacist before taking Ganciclovir Accord.

Pregnancy, breastfeeding, and fertility

Pregnancy

Women who are pregnant should not take Ganciclovir Accord unless the therapeutic benefits to the mother outweigh the potential risks to the unborn child.

If the patient is pregnant or suspects she may be pregnant, she should not take this medicine unless advised otherwise by a doctor. Ganciclovir Accord may harm the unborn child.

Contraception

Women must not become pregnant while taking this medicine. The medicine may harm the unborn child.

Women

Women of childbearing potential should use effective contraception during treatment with Ganciclovir Accord. Contraception should also be continued for at least 30 days after stopping Ganciclovir Accord.

Men

Men whose partners may become pregnant should use mechanical contraception (e.g. condoms) during treatment with Ganciclovir Accord. Mechanical contraception should also be used for at least 90 days after stopping Ganciclovir Accord.

If a patient taking Ganciclovir Accord becomes pregnant, or if a partner of a male patient taking Ganciclovir Accord becomes pregnant, contact a doctor immediately.

Breastfeeding

Women who are breastfeeding should not take Ganciclovir Accord. Breastfeeding should be discontinued if the doctor considers it necessary to start treatment with Ganciclovir Accord. Ganciclovir Accord may pass into breast milk.

Fertility

Ganciclovir Accord may have harmful effects on fertility. Ganciclovir Accord may cause reversible or permanent suppression of sperm production. Patients planning to have children should discuss this with their doctor or pharmacist before starting treatment with Ganciclovir Accord.

Driving and using machines

During treatment with Ganciclovir Accord, drowsiness, dizziness, confusion, tremors, loss of balance, or seizures may occur. Patients experiencing these symptoms should refrain from driving or operating machinery.

Ganciclovir Accord contains sodium

Ganciclovir Accord contains 43 mg of sodium (the main component of table salt) per 500 mg vial. This corresponds to 2.15% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Ganciclovir Accord

This medicine should always be used exactly as directed by the doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
How to use Ganciclovir Accord
Ganciclovir Accord is administered by a doctor or nurse. The medicine is given through a tube
inserted into a vein. This method of administration is called an "intravenous infusion" and usually
lasts one hour.
The dose of Ganciclovir Accord varies depending on the patient. Your doctor will determine the
appropriate dose. The dose depends on:

• the patient's body weight (in children, height may also be considered)
• age
• kidney function
• blood counts
• the indication for which the medicine is being used.

The frequency of Ganciclovir Accord administration and the duration of treatment will also vary.

• Treatment usually starts with one or two infusions per day.
• If two infusions are given daily, treatment will last up to 21 days at most.
• Afterwards, the doctor may prescribe one infusion per day.

Patients with impaired kidney function or blood disorders
If the patient has impaired kidney function or blood disorders, the doctor may recommend a lower
dose of Ganciclovir Accord and more frequent monitoring of blood cell counts during treatment.
Administration of a higher than recommended dose of Ganciclovir Accord
If an overdose of Ganciclovir Accord is suspected, contact your doctor immediately or go to the
hospital. If a higher than recommended dose is administered, the following symptoms may occur:

• abdominal pain, diarrhoea or vomiting,
• tremor or convulsions,
• blood in the urine,
• impaired kidney or liver function,
• changes in blood counts.

Stopping treatment with Ganciclovir Accord
Do not stop using Ganciclovir Accord without first consulting your doctor.
If you have any further questions about the use of this medicine, please consult 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 occur during treatment with this medicine:
Serious side effects
Contact your doctor immediately if any of the following serious side effects occur – your doctor may advise you to stop taking Ganciclovir Accord and you may require urgent medical treatment:
Very common: may affect more than 1 in 10 people

• low number of white blood cells – symptoms include signs of infection such as sore throat, mouth ulcers or fever
• low number of red blood cells – symptoms include shortness of breath or tiredness, palpitations or pale skin.

Common: may affect up to 1 in 10 people

• blood infection (sepsis) – symptoms include fever, chills, palpitations, confusion and slurred speech
• low number of platelets – symptoms include bleeding or bruising more easily than normal, blood in urine or stools, or bleeding from gums; bleeding may be severe
• very low number of blood cells
• inflammation of the pancreas – symptoms include severe abdominal pain radiating to the back
• seizures.

Uncommon: may affect up to 1 in 100 people

• failure of bone marrow to produce blood cells
• hallucinations – seeing or hearing things that are not there
• disturbances in thinking and feeling, loss of contact with reality
• kidney function disorders.

Rare: may affect up to 1 in 1000 people

• severe allergic reaction – symptoms may include redness, itching of the skin, swelling of the throat, face, lips or mouth, difficulty swallowing or breathing.

Inform your doctor immediately if any of the above side effects occur.
Other side effects
Tell your doctor, pharmacist or nurse if any of the following side effects occur:
Very common: may affect more than 1 in 10 people
Oral thrush or oral candidiasis

• upper respiratory tract infection (e.g. sinusitis, tonsillitis)
• loss of appetite
• headache
• cough
• shortness of breath
• diarrhoea
• nausea or vomiting
• abdominal pain
• rash
• feeling tired
• fever.

Common: may affect up to 1 in 10 people

• influenza
• urinary tract infection – symptoms include fever, more frequent urination, pain during urination
• skin and subcutaneous tissue infections
• mild allergic reaction – symptoms may include redness, itching of the skin
• weight loss
• feeling depressed, anxious or confused
• difficulty falling asleep
• feeling of weakness or numbness in hands or feet, which may lead to balance problems
• disturbances in touch sensation, tingling, itching, prickling or burning sensations
• changes in taste sensation
• chills
• eye inflammation (conjunctivitis), eye pain and vision problems
• ear pain
• low blood pressure, which may cause dizziness or fainting
• difficulty swallowing
• constipation, flatulence, indigestion, stomach pain, abdominal bloating
• mouth ulcers
• abnormal laboratory test results for liver and kidney function
• night sweats
• itching, skin rash
• hair loss
• back pain, muscle or joint pain, muscle cramps
• dizziness, weakness or general malaise
• skin reaction at the injection site – e.g. inflammation, pain and swelling.

Uncommon: may affect up to 1 in 100 people

• feeling of restlessness
• tremor, shaking
• deafness
• irregular heartbeat
• urticaria, dry skin
• blood in urine
• infertility in men – see section “Effect on fertility”
• chest pain.

Side effects in children and adolescents
Low blood cell counts are more likely in children, especially newborns and infants.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49-21-301, fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ganciclovir Accord

Keep this medicine out of the sight and reach of children.
Powder: no special requirements for storage of the medicinal product.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
After preparation:
Chemical and physical in-use stability has been demonstrated for 12 hours at room temperature (below 25°C) after reconstitution with water for injections. Do not store in a refrigerator and do not freeze.
From a microbiological point of view, the prepared solution should be used immediately. If the product is not used immediately, the responsibility for storage conditions and duration of storage prior to use lies with the user.
After dilution in infusion solutions (0.9% sodium chloride solution, 5% dextrose solution, Ringer's solution, or Ringer's lactate solution):
Chemical and physical stability of the solution has been demonstrated for 24 hours at a temperature of 2°C to 8°C (do not freeze).
From a microbiological point of view, the prepared infusion solution of Ganciclovir Accord should be used immediately. If it is not used immediately, the determination of storage time and conditions before use is the responsibility of the person administering the medicine and must not exceed 24 hours at 2–8°C, unless the solution has been prepared and diluted under controlled, validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ganciclovir Accord contains

• The active substance is ganciclovir. Each glass vial contains 500 mg of ganciclovir (as ganciclovir sodium). After reconstitution, 1 ml of solution contains 50 mg of ganciclovir.

What Ganciclovir Accord looks like and contents of the pack
Ganciclovir Accord is a sterile, white lyophilisate in the form of a powder for preparing a concentrate
for infusion solution, available in a 10 mL Type I glass vial containing a single dose, closed with a
chlorobutyl rubber stopper, sealed with an aluminium cap and a PP flip-off cap. The vial is
packaged in a cardboard box. After dissolution in water for injections, Ganciclovir Accord forms
a colourless solution.
Vials of Ganciclovir Accord are available in packs containing 1, 5 or 25 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw, Poland
Tel: +48 22 577 28 00

Manufacturer
Laboratorio Reig Jofré, S.A.
Grand Capitán 10
08970 Sant Joan Despí, Spain
Laboratori Fundació DAU
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona, Spain

This medicinal product is authorised in the following names in the European Economic Area countries:
Spain: Ganciclovir Accord 500 mg powder for concentrate for solution for perfusion
Germany: Ganciclovir Accord 500 mg powder for concentrate for infusion solution
Portugal: Ganciclovir Accord
Italy: Ganciclovir Accord

The following information is intended for healthcare professionals only.
INSTRUCTIONS FOR PREPARATION, ADMINISTRATION AND HANDLING
OF THE MEDICINAL PRODUCT
Before prescribing, refer to the Summary of Product Characteristics.

Directions for administration
Warning:
Ganciclovir must be administered as an intravenous infusion over 1 hour at a concentration not exceeding 10 mg/ml. The medicinal product must not be given as a rapid intravenous injection or bolus, as excessively high serum concentrations resulting from such administration may increase the toxicity of ganciclovir.
The medicinal product must not be administered by intramuscular or subcutaneous injection, as the high pH (~11) of the ganciclovir solution may cause severe tissue irritation.

Doses higher than recommended, increased frequency of dosing or increased infusion rate must not be used.

Ganciclovir Accord is a powder for solution for infusion. After reconstitution, Ganciclovir Accord forms a clear solution practically free from visible particles.

The intravenous infusion should be administered into a vein with adequate blood flow, preferably via a plastic catheter.

Ganciclovir Accord must be handled with care.
Due to the potential teratogenic and carcinogenic effects of Ganciclovir Accord in humans, precautions must be taken during the preparation and administration of Ganciclovir Accord solutions. Avoid inhalation and direct contact with the powder in the vials or direct contact of the solution with skin or mucous membranes. Ganciclovir Accord solutions are alkaline (pH ~11). In case of direct contact, the affected area should be thoroughly washed with soap and water; in case of eye contact, rinse immediately with running water.

Preparation of the concentrate solution
Aseptic techniques must be used when preparing the lyophilised medicinal product Ganciclovir Accord.

1. Remove the flip-off cap and expose the central part of the rubber stopper. Using a syringe, withdraw 10 ml of water for injections and insert the needle through the centre of the rubber stopper. Slowly inject the water into the vial, directing the needle towards the vial wall. Do not use water for injections containing bacteriostatic agents with parabens (parahydroxybenzoates), as they are incompatible with Ganciclovir Accord.
2. Gently swirl the vial to ensure complete wetting of the medicinal product.
3. Gently rotate or shake the vial for several minutes until a clear concentrate solution is obtained.
4. Before dilution with a compatible diluent, inspect the prepared concentrate solution visually to confirm complete dissolution and absence of particulate matter. The prepared solution of Ganciclovir Accord is colourless.

Preparation of the diluted infusion solution
Using a syringe, withdraw the dose appropriate for the patient's body weight from the vial containing the concentrate of Ganciclovir Accord and add it to the appropriate infusion solution. Add 100 ml of diluent to the prepared solution. Infusion solutions with a concentration exceeding 10 mg/ml are not recommended.

Sodium chloride solution, 5% glucose solution, Ringer's solution, or Ringer's lactate solution have been shown to be chemically and physically compatible with Ganciclovir Accord.

Ganciclovir Accord must not be mixed with other medicinal products intended for intravenous administration.

The diluted solution should then be administered as an intravenous infusion over 1 hour, as described in section 4.2. The medicinal product must not be administered by intramuscular or subcutaneous injection, as the high pH (~11) of the ganciclovir solution may cause severe tissue irritation.

Disposal
This product is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local regulations.