GANCICLOVIR HIKMA 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Ganciclovir Hikma

Do not use Ganciclovir Hikma:

? if you are allergic to ganciclovir, valganciclovir, or any of the other ingredients of this medicine (listed in section 6).

? if you are breast-feeding (see sub-section “Breast-feeding”).

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

Warnings and precautions

Tell your doctor, pharmacist, or nurse before starting to use ganciclovir if:

? you are allergic to aciclovir, valaciclovir, penciclovir, or famciclovir - these are other medicines used to treat 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 your blood cell count in the past due to medicines

? 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 radiotherapy.

If any of the above applies to you (or you are not sure), consult your doctor, pharmacist, or nurse before using ganciclovir.

Monitor for side effects

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

Tests and checks

Your doctor will perform regular blood tests during treatment with ganciclovir. This is to check that the dose being used is right 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 of age. Periodic blood tests will be performed on newborns and infants treated with ganciclovir for the prevention of CMV disease.

Other medicines and Ganciclovir Hikma

Tell your doctor or pharmacist if you are using, have recently used, or might 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 infections caused by parasites or in the lungs,

? 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 medicines used for HIV,

? adefovir or any other medicine used for the treatment of Hepatitis B.

If any of the above applies to you (or you are not sure), consult 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 potential risks to the fetus. If you are pregnant or think you may be pregnant, do not take this medicine unless your doctor tells you to. This is because ganciclovir may harm the fetus.

If you or your partner become pregnant while using ganciclovir, talk to your doctor immediately.

Contraception - Women

You must not become pregnant while using this medicine. This is because it may affect the fetus. If you are a woman of childbearing age, you must use a contraceptive method while using ganciclovir. You must also use it for at least 28 days after finishing treatment with ganciclovir.

Contraception - Men

If you are a man, whose female partner could become pregnant, use condoms plus an additional contraceptive method while using ganciclovir. Continue to use it for at least 95 days after finishing treatment with ganciclovir.

Breast-feeding

Do not use ganciclovir if you are breast-feeding. If your doctor wants to start treating you with ganciclovir, you must stop breast-feeding before starting to use 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 are planning to have a child, consult your doctor or pharmacist before using ganciclovir.

Driving and using machines

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

Ganciclovir Hikma contains sodium

This medicine contains 43 mg of sodium (the main component of cooking/table salt) in each 500 mg vial. This is equivalent to 2% of the maximum recommended daily intake of sodium for an adult.

3. How to use Ganciclovir Hikma

Use of this medicine

Your doctor or nurse will give you ganciclovir. It will be given to you through a tube in your vein. This is called “intravenous infusion” and will take about 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, height is also taken into account),

? your age,

? how well your kidneys are working,

? your blood cell count,

? what you are using the medicine for.

The frequency at which you will be given ganciclovir and the length of time you will need to use it may also vary.

? You will usually start by receiving one or two infusions a day.

? If you receive two infusions a day, you will continue like this for 21 days.

? After that, your doctor may prescribe one infusion a day.

People with kidney or blood problems

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

If you use more Ganciclovir Hikma than you should

If you think you have been given too much ganciclovir, talk to your doctor or go to the hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

You may have the following symptoms if you use too much:

? stomach pain, diarrhea, or nausea

? tremors or seizures

? blood in your urine

? liver or kidney problems

? changes in your blood cell count.

If you stop using Ganciclovir Hikma

Do not stop using ganciclovir without talking to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you get any of the following serious side effects - your doctor may tell you to stop using ganciclovir and may 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 bruising more easily than normal, blood in urine or stools, or bleeding gums, these bleeding events can be serious

? severe decrease in the number of blood cells

? pancreatitis with signs such as severe stomach pain that radiates to the back

? seizures.

Uncommon:may affect up to 1 in 100 people

? inability 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

? kidney failure.

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

? severe allergic reaction - symptoms can include redness and itching of the skin, swelling of the throat, face, lips, or mouth, difficulty swallowing or breathing.

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

Other side effects

If you get any of the following side effects, tell 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

? diarrhea

? nausea and vomiting

? abdominal pain

? eczema

? fatigue

? fever.

Common:may affect up to 1 in 10 people

? flu

• urinary tract infection, with signs that include fever, frequent urination, pain when urinating
• skin and subcutaneous tissue infections
• mild allergic reactions, with signs that include redness and swelling of the skin
• weight loss
• feeling depressed, anxious, or confused

? difficulty sleeping

• numbness or weakness in hands and feet, which can affect your balance
• changes in sense of touch, tingling, prickling, or burning sensations
• changes in taste
• chills
• eye inflammation (conjunctivitis), eye pain, or vision problems
• ear pain
• low blood pressure, which can make you feel dizzy or have blurred vision
• difficulty swallowing
• constipation, gas, indigestion, stomach pain, abdominal distension
• mouth ulcers
• abnormal liver and kidney laboratory 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 - such as inflammation, pain, and swelling.

Uncommon:may affect up to 1 in 100 people

? agitation

• tremors

? deafness

• irregular heartbeat

? 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 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ganciclovir Hikma

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 carton after EXP. The expiry date refers to the last day of the month shown.

Powder:

No special storage conditions are required.

After reconstitution:

Do not refrigerate or freeze.

The chemical and physical stability during handling has been demonstrated for the reconstituted product for 12 hours at 25 ºC after dissolving with water for injection.

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

After dilution:

Do not freeze.

The chemical and physical stability during use has been demonstrated for 24 hours at 2 – 8 ºC.

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

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. Container Contents and Additional Information

Composition ofGanciclovir Hikma

The active ingredient is ganciclovir. Each glass vial contains 500 mg of ganciclovir (as ganciclovir sodium). After reconstitution of the powder with 10 mL, each mL of solution contains 50 mg of ganciclovir.

The other components (excipients) are sodium hydroxide and hydrochloric acid for pH adjustment.

Appearance of the Product and Container Contents

Ganciclovir Hikma is a white to off-white powder for concentrate for solution for infusion, packaged in a single-dose glass vial with a rubber stopper and flip-off cap. The color of the reconstituted Ganciclovir Hikma solution ranges from colorless to light yellow.

The vials of Ganciclovir Hikma are presented in packs of 1 or 5 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Ganciclovir Hikma 500 mg Powder for concentrate for solution for infusion

Austria: Ganciclovir Hikma 500 mg Powder for concentrate for solution for infusion

France: Ganciclovir Hikma 500 mg, powder for solution for infusion

Italy: Ganciclovir Hikma

Spain: Ganciclovir Hikma 500 mg powder for concentrate for solution for infusion EFG

Portugal: Ganciclovir Hikma

Date of the last revision of thisleaflet: January 2024

Other sources of information

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

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This information is intended only for healthcare professionals:

INSTRUCTIONS FOR USE AND HANDLING

Please consult the product's technical sheet for complete prescribing information.

Precautionsto be takenwhen handlingGanciclovir Hikma:

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

Method of administration

Warning: Ganciclovir must be administered by intravenous infusion over 1 hour, with a concentration that should not exceed 10 mg/mL. It should not be administered as a bolus or rapid intravenous injection because the resulting high plasma levels 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.

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

Preparation of the reconstituted concentrate

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

1. Remove the flip-off cap to expose the central part of the rubber stopper. Withdraw 10 mL of water for injection with a syringe and then slowly inject it through the center of the rubber stopper into the vial with the needle directed towards the vial wall. Do not use bacteriostatic water for injection that contains parabens (para-hydroxybenzoates), as they are incompatible with ganciclovir. Rotate the vial slightly to ensure complete wetting of the product.
2. Rotate the vial slightly for a few minutes until a clear reconstituted solution is obtained.
3. 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 color of the reconstituted ganciclovir solution ranges from colorless to light yellow.

Preparation of the final diluted solution for infusion

Based on the patient's body weight, withdraw the necessary volume from the vial with a syringe and then dilute it in a suitable infusion liquid. Add a volume of 100 mL of the solvent to the reconstituted solution. Concentrations of infusion greater than 10 mg/mL are not recommended.

Sodium chloride, 5% dextrose, Ringer's, and Ringer's lactate solutions for injection have been shown to be chemically or physically compatible with Ganciclovir. Ganciclovir should not be mixed with other intravenous products.

Disposal

It is for single use. The disposal of unused medicinal products and any waste materials should be carried out in accordance with local regulations.