How to use CYMEVENE 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Cymevene 500 mg powder for concentrate for solution for infusion
ganciclovir
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
? 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 signs of illness are the same as yours.
? If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Cymevene and what is it used for
- What you need to know before you use Cymevene
- How to use Cymevene
- Possible side effects
- Storage of Cymevene
- Contents of the pack and other information
1. What is Cymevene and what is it used for
What is Cymevene
Cymevene contains the active substance ganciclovir. It belongs to a group of medicines called antivirals.
What is Cymevene used for
Cymevene is used to treat diseases caused by a virus called cytomegalovirus (CMV) in adult patients and adolescents from 12 years of age 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 for people with a weakened immune system. In these people, the CMV virus can cause serious illness. A weakened immune system can be caused by other diseases (such as AIDS) or by medicines (such as chemotherapy or immunosuppressants).
2. What you need to know before you use Cymevene
Do not use Cymevene:
? 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 Cymevene if any of the above applies to you. If you are not sure, consult your doctor, pharmacist, or nurse before using Cymevene.
Warnings and precautions
Tell your doctor, pharmacist, or nurse before you start using Cymevene 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 do blood tests before you start 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 do blood tests more frequently during your treatment
? you are having radiotherapy.
If any of the above applies to you (or if you are not sure), consult your doctor, pharmacist, or nurse before using Cymevene.
Monitor for side effects
Cymevene can cause serious side effects that you need to tell your doctor about immediately. Monitor the serious side effects listed in Section 4 and if you experience any while using Cymevene, tell your doctor - your doctor may tell you to stop taking Cymevene and may need urgent medical treatment.
Tests and checks
Your doctor will do regular blood tests during your treatment with Cymevene. This is to check that the dose you are taking is right for you. During the first two weeks, these blood tests will be done frequently. After that, the tests will be done less frequently.
Children and adolescents
There is limited information on the safety and efficacy of Cymevene in the treatment of CMV disease in children under 12 years of age. Blood tests will be done regularly in newborns and infants treated with Cymevene for the prevention of CMV disease.
Other medicines and Cymevene
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, cyclosporin, tacrolimus - used after an organ transplant
? 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 if you are not sure), consult your doctor or pharmacist before using Cymevene.
Pregnancy, breast-feeding, and fertility
Pregnancy
Cymevene 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 Cymevene may harm the fetus.
Contraception
You must not become pregnant while using this medicine. This is because it may affect the fetus.
Women
If you are a woman of childbearing age, you must use a contraceptive method while using Cymevene. You must also use it for at least 30 days after finishing treatment with Cymevene.
Men
If you are a man whose partner could become pregnant, you must use a barrier contraceptive method (e.g., condoms) while taking Cymevene. Continue to use it for at least 90 days after finishing treatment with Cymevene.
If your partner becomes pregnant while you are taking Cymevene, consult your doctor immediately.
Breast-feeding
Do not use Cymevene if you are breast-feeding. If your doctor wants to start treating you with Cymevene, you must stop breast-feeding before starting to take this medicine. This is because Cymevene may pass into breast milk.
Fertility
Cymevene may affect fertility. Cymevene may temporarily or permanently stop sperm production in men. If you plan to have a child, consult your doctor or pharmacist before using Cymevene.
Driving and using machines
You may feel drowsy, dizzy, confused, or agitated, or you may lose your balance or have seizures while using Cymevene. If this happens, do not drive or use tools or machinery.
Cymevene 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 Cymevene
Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.
Use of this medicine
Your doctor or nurse will give you Cymevene. It will be given to you through a tube in your vein. This is called “intravenous infusion” and will take about an hour.
The dose of Cymevene varies from person to person. Your doctor will calculate the dose you need. This dose will depend on:
? your weight (in children, height must also be taken into account)
? your age
? how well your kidneys are working
? your blood cell count
? what you are using the medicine for
The frequency with which you will be given Cymevene and the 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 Cymevene and check your blood cell count more frequently during treatment.
If you use more Cymevene than you should
If you think you have been given too much Cymevene, consult your doctor or go to the hospital immediately. In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service (Telephone: 91 5620420).
You may have the following symptoms:
? 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 Cymevene
Do not stop using Cymevene without consulting your doctor.
If you have any other questions about the use of this medicine, ask 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 with this medicine:
Serious side effects
Tell your doctor immediately if you experience any of the following serious side effects – your doctor may tell you to stop taking Cymevene 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 bleeds can be serious
? severe decrease in the number of blood cells
? pancreatitis with signs such as severe stomach pain that spreads 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 experience 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 sensation
- 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 experience 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 Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Cymevene
Keep this medicine out of the sight and reach of children.
Powder: No special storage conditions are required. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.
After reconstitution:
The chemical and physical stability during handling has been demonstrated for the reconstituted product for 12 hours at 25°C after dissolving with water for injection. 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 solution for injection):
The 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 Cymevene 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 2-8°C, unless the reconstitution and dilution are performed in a controlled and validated aseptic environment.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Container contents and additional information
Composition ofCymevene
? The active ingredient 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.
? The other components are sodium hydroxide and hydrochloric acid.
Appearance of the product and container contents
Cymevene is a white to off-white powder for concentrate for solution for infusion, which comes in a single-dose glass vial with a rubber stopper and aluminum seal. The color of the reconstituted Cymevene solution ranges from colorless to light yellow.
The Cymevene vials are presented in packs of 1 or 5 vials.
Only some pack sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany
Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH
Lindigstrasse 6
63801 Kleinostheim
Germany
Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH
Borsigstrasse 2
63755 Alzenau
Germany
Further information on this medicinal product can be obtained from the local representative of the marketing authorization holder:
Laboratorios Rubió, S.A.
Industria, 29 - Pol. Ind. Comte de Sert
08755 Castellbisbal (Barcelona)
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Cymevene:Austria, Belgium, Croatia, Czech Republic, Denmark, Finland, Hungary, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom.
Cymevene i.v.:Germany
Cymevan:France
Citovirax:Italy
Date of last revision of thisleaflet: April 2020
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 summary of product characteristics or package insert for complete prescribing information.
Method of administration
Warning:
Ganciclovir should be administered by intravenous infusion over 1 hour, with a concentration that should not exceed 10 mg/ml. It should not be administered by 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.
Cymevene is a powder for solution for infusion. After reconstitution, Cymevene is a colorless to slightly yellowish solution, practically free from visible particles.
Infusion should be performed in veins with adequate blood flow, preferably through a plastic cannula.
Precautionsto be takenwhen handlingCymevene:
Since Cymevene is considered potentially teratogenic and carcinogenic in humans, caution should be exercised when handling it. Avoid inhalation or direct contact with the powder in the vials or direct contact with the reconstituted solution with skin or mucous membranes. Cymevene solutions are alkaline (pH ~11). If this occurs, wash the area carefully and thoroughly with soap and water and rinse the eyes thoroughly with plenty of water.
Preparation of the reconstituted concentrate
Aseptic technique should be used during the reconstitution of Cymevene lyophilized powder.
- The aluminum seal should be removed 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 containing parabens (para-hydroxybenzoates), as they are incompatible with Cymevene.
- Gently rotate the vial to ensure complete wetting of the product.
- The vial should be rotated/gently shaken for a few minutes until a clear reconstituted solution is obtained.
- The reconstituted solution should be carefully checked to ensure dissolution of the product and that it is practically free from visible particles before proceeding to dilution with a compatible solvent. The color of the reconstituted Cymevene 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 100 ml of the solvent to the reconstituted solution. Concentrations of infusion greater than 10 mg/ml are not recommended.
Sodium chloride solutions, 5% dextrose, Ringer's injection, and Ringer's lactate injection have been shown to be chemically or physically compatible with Cymevene.
Cymevene should not be mixed with other intravenous products.
The diluted solution should be administered by intravenous infusion over 1 hour. 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.
Disposal
It is for single use. Disposal of unused medicinal products and any waste material should be in accordance with local regulations.
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- Country of registration
- Dosage formINJECTABLE PERFUSION, 500 mg sodium ganciclovir
- ATC codeJ05AB06
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to CYMEVENE 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTIONDosage form: INJECTABLE PERFUSION, 500 mgActive substance: ganciclovirManufacturer: Accord Healthcare S.L.U.Prescription requiredDosage form: INJECTABLE PERFUSION, 500 mgActive substance: ganciclovirManufacturer: Hikma Farmaceutica (Portugal) S.A.Prescription requiredDosage form: INJECTABLE PERFUSION, 25 mg/mlActive substance: aciclovirManufacturer: Accord Healthcare S.L.U.Prescription required
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Frequently Asked Questions
CYMEVENE 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in CYMEVENE 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION is ganciclovir. This information helps identify medicines with the same composition but different brand names.
CYMEVENE 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION is manufactured by Cheplapharm Arzneimittel Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CYMEVENE 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy CYMEVENE 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (ganciclovir) include GANCICLOVIR ACCORD 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION, GANCICLOVIR HIKMA 500 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION, ACICLOVIR ACCORD 25 mg/ml CONCENTRATE FOR INFUSION SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
