Leaflet: information for the user

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

Ganciclovir sodium

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Ganciclovir Accord

3. How to use Ganciclovir Accord

4. Possible side effects

5. Storage of Ganciclovir Accord

6. Contents of the pack and additional information

What is Ganciclovir Accord

Ganciclovir contains ganciclovir as its active ingredient. It belongs to a group of medicines called antivirals.

What is Ganciclovir Accord used for

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

• The virus can affect any part of the body. Including the retina at the back of the eye – which means the virus can cause vision problems.
• The virus can affect anyone, but it is a particular problem in people with a weakened immune system. In these people, the CMV virus can cause serious disease. A weakened immune system can be caused by other diseases (such as AIDS) or by medicines (such as chemotherapy or immunosuppressants).

Do not use Ganciclovir Accord:

• If you are allergic to ganciclovir, valganciclovir, or any of the other components of this medication (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 to use ganciclovir if:

• You are allergic to aciclovir, valaciclovir, penciclovir, or famciclovir - these are other medications used for the treatment of viral infections
• You have a low number 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 had problems with blood cell counts due to medications in the past
• You have kidney problems - your doctor may prescribe a lower dose and may need to perform blood tests more frequently during your treatment.
• You are receiving radiation therapy.

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

Monitor side effects

Ganciclovir may cause severe side effects that you must report to your doctor immediately. Monitor the severe side effects listed in Section 4 and if you experience any while using ganciclovir, tell your doctor - your doctor may instruct you to stop taking ganciclovir and may need to provide urgent medical treatment.

Tests and controls

Your doctor will perform regular blood tests during ganciclovir treatment. This is to check that the dose you are taking is suitable for you. During the first two weeks, these blood tests will be performed frequently. After that, the tests will be performed less frequently.

Children and adolescents

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

Other medications and Ganciclovir Accord

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

• Imipenem/cilastatina – 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 ‘polycythemia’, sickle cell disease, and cancer,
• Didanosine, stavudine, zidovudine, tenofovir, or other medications used for HIV.

• Adefovir or any other medication used for hepatitis B treatment.

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 should not be used by pregnant women unless the benefits for the mother outweigh the potential risks to the fetus.

If you are pregnant or think you may be pregnant, do not take this medication unless your doctor tells you to. This is because ganciclovir may cause harm to the fetus.

Contraception

You should not become pregnant while using this medication. This is because it may affect the fetus.

Women

If you are a woman of childbearing age – you should use a contraceptive method while using ganciclovir. You should also use it for at least 30 days after completing ganciclovir treatment.

Men

If you are a man, whose partner may become pregnant, you should use a barrier contraceptive method (such as condoms) while taking ganciclovir. Continue using it for at least 90 days after completing ganciclovir treatment.

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 wants to start treating you with ganciclovir, you should stop breastfeeding before starting this medication. 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 operating machinery

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

Ganciclovir Accord contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use of this medication

Your doctor or nurse will administer ganciclovir. It will be administered through a tube in your vein. This is called "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 weight (in children, your height will also be taken into account),
• your age,
• the correct functioning of your kidneys,
• the number of blood cells,
• how long you will be using the medication

The frequency with which ganciclovir will be administered to you and the time you will need to use it may also vary.

• Usually, you will start receiving one or two infusions per day.
• If you receive two infusions per day, you will continue this way for 21 days.
• After that, your doctor may prescribe the infusion once a day.

People with kidney or blood problems

If you have any kidney or blood problems, your doctor may recommend a smaller 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 can also contact the Toxicological Information Service, Phone: 91 562 04 20, indicating the medication and the amount received.

You may experience the following symptoms:

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

If you interrupt treatment with Ganciclovir Accord

Do not stop using ganciclovir without consulting your doctor.

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

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

Severe side effects

Inform your doctor immediately if you experience any of the following severe side effects – your doctor may tell you to stop taking ganciclovir and that you need urgent medical treatment:

Very common: may affect more than 1 in 10 people

• Decrease in the number of white blood cells – with 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) – with signs that include fever, chills, palpitations, confusion and difficulty speaking
• Decrease in the number of platelets – symptoms include bleeding and the appearance of bruises more easily than normal, blood in urine or stool or bleeding gums, these bleeding may be severe
• Intense decrease in the number of blood cells
• Pancreatitis with signs such as severe stomach pain that extends 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 thinking or feelings, loss of contact with reality
• Failure of kidney function.

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

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

Inform your doctor immediately if you notice any of the side effects mentioned above.

Other side effects

If you experience any of the following side 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
• Shortness of breath
• Diarhea
• Nausea and vomiting
• Abdominal pain
• Eczema
• Tiredness
• Fever.

Common:may affect up to 1 in 10 people

• Flu
• Urinary tract infection, with signs that include fever, frequent urination, pain while urinating
• Skin and subcutaneous tissue infection
• Mild allergic reactions, with signs that include redness and swelling of the skin
• Weight loss
• Sensation of depression, anxiety or confusion
• Difficulty sleeping
• Numbness or weakness in hands and feet, which may affect your balance
• Changes in the sense of touch, tingling, pins and needles or 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 have blurred vision
• Difficulty swallowing
• Constipation, gas, indigestion, stomach pain, abdominal distension
• Mouth ulcers
• Abnormal results in liver and kidney function tests
• Nocturnal sweating
• Itching, rash
• Hair loss
• Back, muscle or joint pain, muscle spasms
• Sensation of dizziness, weakness or general malaise
• Reaction at the injection site – such as inflammation, pain and swelling.

Uncommon:may affect up to 1 in 100 people

• Agitation
• Tremors
• Deafness
• Irregular heart rhythm
• Hives, dry skin
• Blood in the urine
• Infertility in men – see section “Fertility”
• Chest pain

Other side effects in children and adolescents

A decrease in the number of blood cells is more likely in children, especially in babies and infants.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Powder: No special storage conditions are required. Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

After reconstitution:

Chemical and physical stability during handling has been demonstrated for the reconstituted product for 12 hours at room temperature (below 25 °C) after dissolving it with water for injectable preparations. Do not refrigerate or freeze.

From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, the time and storage conditions before use are the responsibility of the user.

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

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

From a microbiological point of view, the ganciclovir infusion solution should be used immediately. If not used immediately, the time and storage conditions before use are the responsibility of the user and should not exceed 24 hours at a temperature of 2 °C to 8 °C, unless reconstitution and dilution are made in a validated controlled and aseptic site.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Ganciclovir Accord

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

Appearance of the product and contents of the pack

Ganciclovir is a sterile and lyophilized powder for concentrate for solution for infusion of white color that comes in a glass vial monodose, with a chlorobutyl rubber stopper and an aluminum seal with a plastic cap. The reconstituted solution of ganciclovir is transparent.

The ganciclovir vials are presented in a pack of 1 vial, 5 vials or 25 vials.

Only some 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 with the following names:

Germany:Ganciclovir Accord 500 mg Powder for a Concentrate for the Preparation of an Infusion Solution

Infusionslösung

Italy:Ganciclovir Accord

Poland:Ganciclovir Accord

Portugal:Ganciclovir Accord

Last review date of this leaflet:March 2023

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/

This information is intended solely for healthcare professionals:

INSTRUCTIONS FOR USE AND HANDLING

Please consult the technical data sheet or product characteristics summary for complete prescription information.

Administration form

Warning:

Ganciclovir must be administered by intravenous infusion over 1 hour, with a concentration not exceeding 10 mg/ml. Do not administer in bolus or rapid intravenous injection because excessive plasma levels resulting from this may increase the toxicity of ganciclovir.

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

Do not exceed the recommended dose, frequency, and infusion rate.

Ganciclovir is a powder for infusion solution. After reconstitution, ganciclovir is a transparent solution, practically free of visible particles.

The infusion should be performed in veins with adequate blood flow, preferably through a plastic cannula.

Precautions to be taken in the handling of Ganciclovir Accord:

Since ganciclovir is considered potentially teratogenic and carcinogenic in humans, caution should be exercised in its handling. Avoid inhaling or coming into direct contact with the powder contained in the vials or with the reconstituted solution with the skin or mucous membranes. Ganciclovir solutions are alkaline (pH ~ 11). If contact occurs, wash the area thoroughly and extensively with water and soap and rinse the eyes thoroughly with plenty of water.

Preparation of the reconstituted concentrate

Aseptic technique should be used during the reconstitution of lyophilized ganciclovir.

1. Remove the flip-off stopper to expose the central part of the rubber stopper. Extract 10 ml of water for injectable preparations with a syringe, then inject it slowly through the center of the rubber stopper into the vial with the needle pointing towards the vial wall.Do not use bacteriostatic water for injectable preparations that contains parabens (para-hydroxybenzoates), as these are incompatible with ganciclovir.

1. Gently rotate the vial to ensure complete humidification of the product.

1. The vial should be rotated/gently shaken for a few minutes to obtain a transparent reconstituted solution.

1. The reconstituted solution should be carefully checked to ensure the dissolution of the product and that it is practically free of visible particles before proceeding to dilution with a compatible solvent. The reconstituted ganciclovir solution is transparent.

Preparation of the final diluted solution for infusion

Depending on the patient's weight, extract the necessary volume from the vial with a syringe and then dilute it in an appropriate infusion liquid. Add 100 ml of the solvent to the reconstituted solution. Concentrations of infusion exceeding 10 mg/ml are not recommended. Solutions of sodium chloride, dextrose 5%, Ringer for injection, and Ringer with lactate for injection have been shown to be compatible chemically or physically with ganciclovir.

Ganciclovir should not be mixed with other intravenous products.

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

Elimination

For single use only. The elimination of unused medication and any residue will be carried out in accordance with local regulations.