Ganciclovir Accord

Leaflet accompanying the packaging: information for the user

Ganciclovir Accord, 500 mg, powder for concentrate for solution for infusion

Ganciclovir

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please 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 of Ganciclovir Accord is ganciclovir. It belongs to a group of antiviral medicines.

What Ganciclovir Accord is used for

Ganciclovir Accord is used to treat diseases caused by cytomegalovirus (CMV) in adult patients and adolescents from 12 years of age with weakened immune systems. The medicine is also used to prevent CMV infections after organ transplantation or during chemotherapy in adults and children from birth.

• CMV infection can affect any part of the body, including the retina of the eye - this means that the virus can cause vision problems.
• The virus can cause disease in anyone, but it is a particular problem for people with weakened immune systems. In people with weakened immune systems, CMV can cause serious diseases. Weakened immune systems can be caused by other diseases (e.g., AIDS) or medications (e.g., chemotherapy or immunosuppressive drugs).

2. Important information before using Ganciclovir Accord

When not to use Ganciclovir Accord:

• 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").

Do not use Ganciclovir Accord if you are affected by any of the above points. If you are unsure before taking Ganciclovir Accord, talk to your doctor, pharmacist, or nurse.

Warnings and precautions

Before starting treatment with Ganciclovir Accord, discuss it with your doctor, pharmacist, or nurse if:

• you are allergic to acyclovir, valacyclovir, penciclovir, or famciclovir - medicines used to treat viral infections;
• you have a low number of white blood cells, red blood cells, or platelets - before starting treatment and during treatment, your doctor will perform blood tests;
• you have had problems with blood cell counts due to medication use in the past;
• you have kidney problems - it may be necessary to reduce the dose of the medicine and monitor your blood cell count more frequently during treatment;
• you are undergoing radiation therapy.

If you are affected by any of the above points (or if you are unsure), talk to your doctor, pharmacist, or nurse before taking Ganciclovir Accord.

Be aware of side effects

Ganciclovir Accord may cause certain serious side effects, which you should report to your doctor immediately. Be aware of serious side effects listed in section 4 and inform your doctor if you experience any of them while taking Ganciclovir Accord - your doctor may advise you to stop taking Ganciclovir Accord and you may need urgent treatment.

Lab tests

While taking Ganciclovir Accord, your doctor will perform regular blood tests. This is to check if the dose of the medicine is suitable for you. During the first 2 weeks, blood tests will be performed frequently. Then, blood tests will be performed less frequently.

Children and adolescents

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

Ganciclovir Accord and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

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

If you are affected by any of the above points (or if you are unsure), talk to your doctor or pharmacist before taking Ganciclovir Accord.

Pregnancy, breastfeeding, and fertility

Pregnancy

Pregnant women should not take Ganciclovir Accord unless the therapeutic benefits to the mother outweigh the potential risks to the unborn child. If you are pregnant or think you may be pregnant, do not take this medicine unless your doctor advises you to. Ganciclovir Accord may harm the unborn child. ContraceptionWomen should not become pregnant while taking this medicine. The medicine may harm the unborn child. WomenWomen of childbearing age should use contraception while taking Ganciclovir Accord. Contraception should also be used for at least 30 days after stopping Ganciclovir Accord. MenMen whose partners may become pregnant should use mechanical contraception (e.g., condoms) while taking Ganciclovir Accord. Mechanical contraception should also be used for at least 90 days after stopping Ganciclovir Accord. If you become pregnant or your partner becomes pregnant while taking Ganciclovir Accord, contact your doctor immediately. BreastfeedingBreastfeeding women should not take Ganciclovir Accord. You should stop breastfeeding if your doctor thinks it is necessary to start taking Ganciclovir Accord. Ganciclovir Accord may pass into breast milk. FertilityGanciclovir Accord may have a harmful effect on fertility. Ganciclovir Accord may cause temporary or permanent inhibition of sperm production. Patients planning to have children should discuss this with their doctor or pharmacist before starting Ganciclovir Accord.

Driving and using machines

During treatment with Ganciclovir Accord, drowsiness, dizziness, confusion, or tremors may occur. Patients who experience these symptoms should avoid driving and using machines.

Ganciclovir Accord contains sodium

Ganciclovir Accord contains 46 mg of sodium (a major component of common salt) per 500 mg vial. This corresponds to 2.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ganciclovir Accord

Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. How to use the medicineGanciclovir Accord is given by a doctor or nurse. The medicine is given through a tube inserted into a vein. This method of administration is called "intravenous infusion" and usually takes one hour. The dose of Ganciclovir Accord varies depending on the patient. Your doctor will determine the dose to be used. The dose of the medicine depends on:

• the patient's body weight (in children, their height may also be taken into account)
• age
• kidney function
• blood cell count
• the indication for which the medicine is used.

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

• Treatment usually starts with one or two infusions per day.
• If two infusions are given per day, the duration of treatment will be up to 21 days.
• Then, your doctor may prescribe one infusion per day.

Patients with kidney problems or blood disordersIf you have kidney problems or blood disorders, your doctor may prescribe a lower dose of Ganciclovir Accord and monitor your blood cell count more frequently during treatment.

Using more Ganciclovir Accord than prescribed

If you think you have used more Ganciclovir Accord than prescribed, contact your doctor or go to the hospital immediately. If more Ganciclovir Accord is used than prescribed, the following symptoms may occur:

• abdominal pain, diarrhea, or vomiting,
• tremors or seizures,
• blood in the urine,
• kidney or liver problems,
• changes in blood cell count.

Stopping Ganciclovir Accord

Do not stop taking Ganciclovir Accord without consulting your doctor first. If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ganciclovir Accord can cause side effects, although not everybody gets them. The following side effects may occur while taking this medicine:

Serious side effects

Contact your doctor immediately if you experience any of the following serious side effects - your doctor may advise you to stop taking Ganciclovir Accord and you may need urgent treatment:
Very common:may affect more than 1 in 10 people

• low white blood cell count - with symptoms of infection, such as sore throat, mouth ulcers, or fever
• low red blood cell count - symptoms include shortness of breath, 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 platelet count - symptoms include bleeding or bruising more easily than usual, blood in the urine or stool, or bleeding from the gums; bleeding may be severe;
• very low blood cell count
• pancreatitis - symptoms include severe abdominal pain radiating to the back
• seizures.

Uncommon:may affect up to 1 in 100 people

• bone marrow failure
• hallucinations - seeing or hearing things that are not there
• thought and perception disorders, loss of contact with reality
• kidney problems.

Rare:may affect up to 1 in 1000 people

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

Tell your doctor immediately if you experience any of the above side effects.

Other side effects

Tell your doctor, pharmacist, or nurse if you experience any of the following side effects:
Very common:may affect more than 1 in 10 people

• thrush or oral thrush
• upper respiratory tract infection (e.g., sinusitis, tonsillitis)
• loss of appetite
• headache
• cough
• shortness of breath
• diarrhea
• nausea or vomiting
• abdominal pain
• rash
• fatigue
• fever.

Common:may affect up to 1 in 10 people

• flu
• urinary tract infection - symptoms include fever, frequent urination, pain while urinating
• skin and subcutaneous tissue infections
• mild allergic reaction - symptoms may include redness, itching of the skin
• weight loss
• feeling depressed, anxious, or confused
• difficulty sleeping
• feeling weak or numb in the hands or feet, which may lead to balance problems
• disorders of touch, tingling, itching, burning, or stinging
• taste changes
• chills
• eye inflammation (conjunctivitis), eye pain, and vision problems
• ear pain
• low blood pressure, which may cause dizziness or fainting
• swallowing problems
• constipation, gas, indigestion, stomach pain, bloating
• mouth ulcers
• abnormal liver and kidney test results
• night sweats
• itching, rash
• hair loss
• back pain, muscle or joint pain, muscle spasms
• feeling dizzy, weak, or unwell
• skin reaction at the injection site - e.g., inflammation, pain, and swelling.

Uncommon:may affect up to 1 in 100 people

• feeling agitated
• tremors, shakiness
• deafness
• irregular heartbeat
• hives, dry skin
• blood in the urine
• infertility in men - see "Fertility"
• chest pain.

Side effects in children and adolescents

Low blood cell count is more likely to occur in children, especially newborns and infants.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 authorization holder. By reporting side effects, you can help 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: There are no special precautions 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 month stated. After preparation:

• Chemical and physical stability of the reconstituted solution has been demonstrated for 12 hours at room temperature (below 25°C) after reconstitution in water for injection. Do not store in the refrigerator and do not freeze.

From a microbiological point of view, the reconstituted solution should be used immediately. If the product is not used immediately, the in-use storage times and conditions are the responsibility of the user. After dilution in infusion solutions (0.9% sodium chloride solution, 5% glucose solution, Ringer's solution, or Ringer's solution with lactate):

• 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 reconstituted infusion solution of Ganciclovir Accord should be used immediately. If it is not used immediately, the in-use storage times and conditions before administration are the responsibility of the healthcare professional and should 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 how to dispose of 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 lyophilized powder for concentrate for solution for infusion, available in a 10 mL Type I glass vial, containing one dose, with a chlorobutyl rubber stopper, an aluminum seal, and a PP flip-off cap. The whole is in a cardboard box. After reconstitution in water for injection, Ganciclovir Accord is a clear solution. Vials containing Ganciclovir Accord are available in packs of 1, 5, or 25 vials. Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o. ul. Taśmowa 7 02-677 Warsaw 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 authorized in the Member States of the European Economic Area under the following names:

Spain Ganciclovir Accord 500 mg polvo para concentrado para solución para perfusión Germany Ganciclovir Accord 500 Pulver für ein Konzentrat zur Herstellung einer Infusionslösung Portugal Ganciclovir Accord Italy Ganciclovir Accord

Date of last revision of the leaflet: March 2023

The following information is intended for healthcare professionals only.

INSTRUCTIONS FOR PREPARATION AND HANDLING OF THE MEDICINAL PRODUCT Before prescribing, read the Summary of Product Characteristics. Method of administration Note: Ganciclovir must be administered by intravenous infusion over 1 hour at a concentration not greater than 10 mg/ml. The product should not be administered by rapid intravenous injection (bolus) as this may increase the toxicity of ganciclovir. The product should not be administered by intramuscular or subcutaneous injection as the high pH (~11) of the ganciclovir solution may cause tissue irritation. Preparation of the concentrate

• 1. Remove the flip-off cap and expose the central part of the rubber stopper. Using a syringe, draw up 10 ml of water for injection, insert the needle through the center of the rubber stopper, and slowly inject the water into the vial, directing the needle towards the side of the vial. Do not use water for injection containing preservatives with parabens (parahydroxybenzoates), as they are incompatible with Ganciclovir Accord.

• 2. Gently swirl the vial to completely wet the product.
• 3. Gently rotate/shake the vial for a few minutes to obtain a clear concentrate solution.
• 4. Before dilution using a compatible solvent, inspect the reconstituted solution carefully to ensure that the product has dissolved and that it does not contain visible particles. The reconstituted solution of Ganciclovir Accord is a clear solution.

Preparation of the diluted infusion solution From the vial of reconstituted Ganciclovir Accord concentrate, using a syringe, withdraw the dose appropriate to the patient's body weight and add it to an appropriate infusion solution. Add the reconstituted solution to 100 ml of diluent. It is not recommended to administer the infusion solution at a concentration greater than 10 mg/ml. Compatibility of Ganciclovir Accord has been demonstrated with sodium chloride 0.9% solution, glucose 5% solution, Ringer's solution, or Ringer's solution with lactate. Ganciclovir Accord should not be mixed with other products for intravenous administration. The diluted solution should then be administered by intravenous infusion over 1 hour, as described in section 4.2. The product should not be administered by intramuscular or subcutaneous injection, as the high pH (~11) of the ganciclovir solution may cause tissue irritation. Disposal The product is for single use only. Any unused solution or waste material should be disposed of in accordance with local requirements.