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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Sodium ganciclovir

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ganciclovir Accord is and what it is used for
2. What you need to know 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

Ganciclovir Accord contains the active substance ganciclovir. It belongs to a group of medicines called antivirals.

What Ganciclovir Accord is used for

Ganciclovir is used to treat diseases caused by a virus called cytomegalovirus (CMV) in adult and adolescent patients aged 12 years and older with a weakened immune system. It is also used to prevent CMV infection after organ transplantation or during chemotherapy in adults and children from birth.

• The virus can affect any part of the body, including the retina at the back of the eye – meaning the virus can cause vision problems.
• The virus can affect anyone, but it is particularly problematic in people with a weakened immune system. In these individuals, CMV can cause serious illness. A weakened immune system may be caused by other diseases (such as AIDS) or by medications (such as chemotherapy or immunosuppressants).

2. What you need to know before using Ganciclovir Accord

Do not 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 subsection “Breastfeeding”).

Do not use ganciclovir if any of the above applies to you. If you are unsure, consult your doctor, pharmacist, or nurse before using ganciclovir.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting ganciclovir if:

• you are allergic to aciclovir, valaciclovir, penciclovir, or famciclovir – these are other medicines used to treat viral infections
• you have low levels of white blood cells, red blood cells, or platelets in your blood – your doctor will perform blood tests before starting and during your treatment
• you have previously had blood cell count problems due to medications
• you have kidney problems – your doctor may prescribe a lower dose and you may need more frequent blood tests during treatment
• you are receiving radiotherapy.

If any of the above applies to you (or you are unsure), consult your doctor, pharmacist, or nurse before using ganciclovir.

Monitor for adverse effects

Ganciclovir may cause serious adverse effects that you must report to your doctor immediately. Watch for the serious adverse effects listed in Section 4, and if you experience any of them while using ganciclovir, inform your doctor right away – your doctor may instruct you to stop taking ganciclovir and you may require urgent medical treatment.

Tests and monitoring

Your doctor will perform regular blood tests during treatment with ganciclovir. This is to ensure that the dose you are taking is appropriate for you. During the first 2 weeks, blood tests will be performed frequently. Afterwards, they will be performed less often.

Children and adolescents

There is limited information on the safety and efficacy of ganciclovir in treating CMV disease in children under 12 years of age. Periodic blood tests will be performed in newborns and infants treated with ganciclovir for prevention of CMV disease.

Other medicines and Ganciclovir Accord

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• imipenem/cilastatin – used for bacterial infections

• pentamidine – used for parasitic or lung infections

• flucytosine, amphotericin B – used for fungal infections

• trimethoprim, trimethoprim/sulfamethoxazole, dapsone – used for bacterial infections

• probenecid – used for gout

• mycophenolate mofetil, cyclosporine, tacrolimus – used after organ transplantation

• vincristine, vinblastine, doxorubicin – used for cancer

• hydroxyurea – used for a condition called ‘polycythaemia’, sickle cell disease, and cancer

• didanosine, stavudine, zidovudine, tenofovir, or other medicines used for HIV

• adefovir or any other medicine used to treat Hepatitis B

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before using ganciclovir.

Pregnancy, breastfeeding, and fertility

Pregnancy

Ganciclovir must not be used during pregnancy unless the benefits to the mother outweigh the potential risks to the fetus.

If you are pregnant or think you might be pregnant, do not take this medicine unless instructed by your doctor. This is because ganciclovir may harm the unborn baby.

Contraception

You must not become pregnant while using this medicine. This is because it may harm the unborn baby.

Women

If you are a woman of childbearing age – you must use an effective method of contraception while taking ganciclovir. You must also continue using it for at least 30 days after stopping treatment with ganciclovir.

Men

If you are a man whose partner may become pregnant, you must use a barrier method of contraception (e.g. condoms) while taking ganciclovir. Continue using it for at least 90 days after stopping treatment with ganciclovir.

If your partner becomes pregnant while you are taking ganciclovir, consult your doctor immediately.

Breastfeeding

Do not use ganciclovir if you are breastfeeding. If your doctor intends to start treatment with ganciclovir, you must stop breastfeeding before starting this medicine. This is because ganciclovir may pass into breast milk.

Fertility

Ganciclovir may affect fertility. Ganciclovir may temporarily or permanently stop sperm production in men. If you plan to have a child, consult your doctor or pharmacist before using ganciclovir.

Driving and using machines

You may feel drowsy, dizzy, confused, agitated, lose your balance, or have seizures while using ganciclovir. If this happens, do not drive or operate tools or machinery.

Ganciclovir Accord contains sodium

This medicine contains 46 mg of sodium (the main component of table/cooking salt) in each 500 mg vial. This is equivalent to 2.3% of the maximum recommended daily intake of sodium for an adult.

3. How to use Ganciclovir Accord

Follow exactly the instructions given by your doctor or pharmacist for administering this medicine. If you are unsure, consult your doctor or pharmacist again.

Use of this medicine

Your doctor or nurse will administer ganciclovir to you. It will be given through a tube inserted into your vein. This is called an "intravenous infusion" and will last approximately one hour.

The dose of ganciclovir varies from person to person. Your doctor will calculate the dose you need. This dose will depend on:

• your body weight (in children, height must also be taken into account),
• your age,
• proper kidney function,
• your blood cell count,
• the reason for which you are receiving the medicine.

The frequency with which ganciclovir is administered and the duration of treatment may also vary.

• Typically, you will start by receiving one or two infusions per day.
• If you receive two infusions per day, this will continue for 21 days.
• Afterwards, your doctor may prescribe the infusion once daily.

Patients with kidney or blood problems

If you have any kidney or blood problems, your doctor may recommend a lower dose of ganciclovir and monitor your blood cell count more frequently during treatment.

If you use more Ganciclovir Accord than you should

If you think you have been given too much ganciclovir, consult your doctor or go to the hospital immediately. In case of overdose or accidental ingestion, you may also contact the Toxicology Information Service, Telephone: 91 562 04 20, stating the name of the medicine and the amount received.

You may experience the following symptoms:

• stomach pain, diarrhea, or nausea
• tremors or seizures
• blood in your urine
• liver or kidney problems
• changes in blood cell count.

If you stop treatment with Ganciclovir Accord

Do not stop using ganciclovir without consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine:

Serious adverse effects

Contact your doctor immediately if you experience any of the following serious adverse effects – your doctor may tell you to stop taking ganciclovir and that you require urgent medical treatment:

Very common: may affect more than 1 in 10 people

• decrease in the number of white blood cells – signs of infection such as sore throat, mouth ulcers or fever
• decrease in the number of red blood cells – symptoms 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 difficulty speaking
• decrease in the number of platelets – symptoms include bleeding and bruising more easily than normal, blood in urine or stools or bleeding gums; these bleedings may be severe
• severe decrease in blood cells
• pancreatitis with signs such as severe stomach pain spreading to the back
• seizures.

Uncommon: may affect up to 1 in 100 people

• failure of the bone marrow to produce blood cells
• hallucinations – seeing or hearing things that are not real
• disturbed thoughts or feelings, loss of contact with reality
• kidney function failure.

Rare: may affect up to 1 in 1,000 people

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

Contact your doctor immediately if you notice any of the above-mentioned adverse effects.

Other adverse effects

If you experience any of the following adverse effects, inform your doctor, pharmacist or nurse:

Very common: may affect more than 1 in 10 people

• candidiasis and oral candidiasis
• upper respiratory tract infection (e.g. sinusitis, tonsillitis)
• loss of appetite
• headache
• cough
• feeling short of breath
• diarrhoea
• nausea and vomiting
• abdominal pain
• eczema
• fatigue
• fever.

Common: may affect up to 1 in 10 people

• influenza (flu)
• urinary tract infection, with signs including fever, more frequent urination, pain when urinating
• skin and subcutaneous tissue infection
• mild allergic reactions, with signs including redness and swelling of the skin
• weight loss
• feeling depressed, anxious or confused
• difficulty sleeping
• numbness or weakness in hands and feet, which may affect your balance
• changes in sense of touch, tingling, pins and needles, burning sensation
• changes in taste
• chills
• eye inflammation (conjunctivitis), eye pain or vision problems
• ear pain
• low blood pressure, which may make you feel dizzy or cause blurred vision
• difficulty swallowing
• constipation, gas, indigestion, stomach pain, abdominal bloating
• mouth ulcers
• abnormal results in liver and kidney laboratory tests
• night sweats
• itching, rash
• hair loss
• back, muscle or joint pain, muscle spasms
• dizziness, weakness or general malaise
• skin reaction at the injection site – such as inflammation, pain and swelling.

Uncommon: may affect up to 1 in 100 people

• restlessness
• tremors
• deafness
• irregular heartbeat
• urticaria, dry skin
• blood in the urine
• male infertility – see section “Fertility”
• chest pain

Other adverse effects in children and adolescents

A decrease in blood cell counts is more likely in children, especially in babies and infants.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ganciclovir Accord

Keep this medicine out of the sight and reach of children.

Powder: No special storage conditions required. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

After reconstitution:

Chemical and physical in-use stability has been demonstrated for the reconstituted product for 12 hours at room temperature (below 25 °C) after dissolution with water for injections. Do not refrigerate or freeze.

From a microbiological standpoint, the reconstituted solution should be used immediately. If not used immediately, the time and conditions of storage prior to use are the responsibility of the user.

After dilution in infusion solutions (0.9% sodium chloride, 5% dextrose, Ringer's solution or Ringer lactate solution for injection):

Chemical and physical in-use stability has been demonstrated for 24 hours at 2–8 °C (do not freeze).

From a microbiological standpoint, the ganciclovir infusion solution should be used immediately. If not used immediately, the time and conditions of storage prior to use are the responsibility of the user and must not exceed 24 hours at a temperature of 2 °C to 8 °C, unless reconstitution and dilution have been carried out in a controlled environment and under 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. Package contents and other information

Composition of Ganciclovir Accord

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

Nature of the product and package contents

Ganciclovir is a sterile, lyophilized white powder for concentrate for solution for infusion, supplied in a single-dose glass vial with a chlorobutyl rubber stopper and an aluminium seal with a plastic cap. The reconstituted ganciclovir solution is clear.

Ganciclovir vials are available in pack sizes of 1 vial, 5 vials or 25 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Centes

c/Moll de Barcelona s/n

Ed. Est, 6th floor

08039 Barcelona

Spain

Manufacturer

Reig Jofre, S.A.

Gran Capitan 10

08970 Sant Joan Despí

Barcelona, 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:

Germany: Ganciclovir Accord 500 mg Powder for a concentrate for solution for infusion

Italy: Ganciclovir Accord

Poland: Ganciclovir Accord

Portugal: Ganciclovir Accord

Date of the most recent review of this summary of product characteristics: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only:

INSTRUCTIONS FOR USE AND HANDLING

Please refer to the product's summary of characteristics or package leaflet for complete prescribing information.

Method of administration

Warning:

Ganciclovir must be administered by intravenous infusion over 1 hour, at a concentration not exceeding 10 mg/ml. It must not be administered as a bolus or rapid intravenous injection, as excessively high plasma levels may increase ganciclovir toxicity.

Do not administer by intramuscular or subcutaneous injection, as this may cause severe tissue irritation due to the high pH (~11) of the ganciclovir solution.

The recommended dose, frequency, and infusion rate must not be exceeded.

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

Infusion should be administered into veins with adequate blood flow, preferably via a plastic cannula.

Precautions to be taken when handling Ganciclovir Accord:

Since ganciclovir is considered potentially teratogenic and carcinogenic in humans, caution must be exercised during handling. Avoid inhalation or direct contact with the powder in vials, or direct contact of the reconstituted solution with skin or mucous membranes. Ganciclovir solutions are alkaline (pH ~11). If contact occurs, wash the affected area thoroughly with soap and water, and rinse eyes thoroughly with copious amounts of water.

Preparation of the reconstituted concentrate

Aseptic technique must be used during reconstitution of lyophilized ganciclovir.

1. Remove the flip-off cap to expose the central portion of the rubber stopper. Withdraw 10 ml of water for injections using a syringe, then slowly inject it through the center of the rubber stopper into the vial, directing the needle toward the vial wall. Do not use bacteriostatic water for injections containing parabens (para-hydroxybenzoates), as these are incompatible with ganciclovir.

2. Gently rotate the vial to ensure complete wetting of the product.

3. Gently rotate or swirl the vial for several minutes until a clear reconstituted solution is obtained.

4. The reconstituted solution must be carefully inspected to confirm complete dissolution and to ensure it is practically free from visible particles before proceeding to dilution with a compatible diluent. The reconstituted ganciclovir solution is clear.

Preparation of the final diluted solution for infusion

Depending on the patient's body weight, withdraw the required volume from the vial using a syringe, and then dilute it in an appropriate infusion fluid. Add 100 ml of diluent to the reconstituted solution. Infusion concentrations higher than 10 mg/ml are not recommended. Solutions of sodium chloride, 5% dextrose, Ringer's injection, and Ringer's lactate injection have been shown to be chemically and physically compatible with ganciclovir.

Ganciclovir must not be mixed with other intravenous products.

The diluted solution must be administered by intravenous infusion over 1 hour, as indicated in section 4.2. Do not administer by intramuscular or subcutaneous injection, as this may cause severe tissue irritation due to the high pH (~11) of the ganciclovir solution.

Disposal

For single use only. Any unused medicine and waste material must be disposed of in accordance with local regulations.