Ganciclovir
The active substance of Cymevene is ganciclovir. It belongs to a group of antiviral medicines.
Cymevene is used to treat diseases caused by cytomegalovirus (CMV) in adult patients and adolescents aged 12 years and older with impaired immune system function. The medicine is also used to prevent CMV infections after organ transplantation or during chemotherapy in adults and children from birth.
Before starting treatment with Cymevene, the patient should discuss it with their doctor, pharmacist, or nurse if:
Cymevene can cause certain serious side effects, which should be reported to the doctor immediately. The patient should pay attention to serious side effects listed in section 4 and inform their doctor if they experience any of these side effects while taking Cymevene - the doctor may recommend stopping Cymevene and the patient may require urgent treatment.
While taking Cymevene, the doctor will perform regular blood tests. This is to check if the dose of the medicine is suitable for the patient. During the first 2 weeks, blood tests will be performed frequently. Then, blood tests will be performed less frequently.
There is limited information on the safety and efficacy of Cymevene in the treatment of CMV disease in children under 12 years of age. Newborns and infants receiving Cymevene for the prevention of CMV disease will undergo regular blood tests.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:
Pregnancy
Pregnant women should not take Cymevene unless the therapeutic benefits to the mother outweigh the potential risks to the unborn child.
If the patient is pregnant or thinks they may be pregnant, they should not take this medicine unless their doctor recommends it. Cymevene may harm the unborn child.
Contraception
Women should not become pregnant while taking this medicine. The medicine may harm the unborn child.
Women
Women of childbearing age should use contraception while taking Cymevene. Contraception should also be used for at least 30 days after stopping Cymevene.
Men
Men whose partners may become pregnant should use mechanical contraception (e.g., condoms) while taking Cymevene. Mechanical contraception should also be used for at least 90 days after stopping Cymevene.
If the patient's partner becomes pregnant while taking Cymevene, they should contact their doctor immediately.
Breastfeeding
Breastfeeding women should not take Cymevene. Breastfeeding should be stopped if the doctor decides that it is necessary to start taking Cymevene. Cymevene may pass into breast milk.
Fertility
Cymevene may have a harmful effect on fertility. Cymevene may cause temporary or permanent inhibition of sperm production. Patients planning to have children should discuss this with their doctor or pharmacist before starting Cymevene.
During treatment with Cymevene, drowsiness, dizziness, confusion, or tremors may occur. Patients who experience these symptoms should avoid driving vehicles and operating machines.
Cymevene contains 43 mg of sodium (the main component of common salt) in a 500 mg vial. This corresponds to 2% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult a doctor or pharmacist.
How to take the medicine
Cymevene is administered by a doctor or nurse. The medicine is administered through a tube inserted into a vein. This method of administration is called "intravenous infusion" and usually takes one hour.
The dose of Cymevene varies depending on the patient. The doctor will determine the size of the dose.
The dose of the medicine depends on:
The frequency of taking Cymevene and the duration of treatment will also vary.
Patients with kidney function disorders or blood disorders
If the patient has kidney function disorders or blood disorders, the doctor may recommend a lower dose of Cymevene and more frequent monitoring of the blood cell count during treatment.
In case of suspected overdose of Cymevene, the patient should contact their doctor or go to the hospital immediately. If a higher dose of the medicine is used, the following symptoms may occur:
The patient should not stop taking Cymevene without consulting their doctor first.
In case of any further doubts about taking this medicine, the patient should consult a doctor, pharmacist, or nurse.
Like all medicines, Cymevene can cause side effects, although not everybody gets them.
The following side effects may occur while taking this medicine:
The patient should contact their doctor immediately if they experience any of the following severe side effects - the doctor may recommend stopping Cymevene and the patient may require urgent treatment:
Very common:may occur in more than 1 in 10 patients
Common:may occur in up to 1 in 10 patients
Uncommon:may occur in up to 1 in 100 patients
Rare:may occur in up to 1 in 1000 patients
The patient should inform their doctor immediately if they experience any of the above side effects.
The patient should inform their doctor, pharmacist, or nurse if they experience any of the following side effects:
Very common:may occur in more than 1 in 10 patients
Common:may occur in up to 1 in 10 patients
Uncommon:may occur in up to 1 in 100 patients
Low blood cell count is more likely to occur in children, especially newborns and infants.
If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
phone: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.
The medicine should be stored out of sight and reach of children.
Powder: no special storage precautions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
After preparation:
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Cymevene is a white or off-white powder for concentrate for solution for infusion, available in a 10 ml glass vial containing one dose, closed with a flip-off cap made of laminated/siliconized rubber and an aluminum cap, in a cardboard box.
The prepared solution of Cymevene has a color from colorless to light yellow.
The vials of Cymevene are available in packs containing 1 vial.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 42/138/91-C
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
[Information about the trademark]
INSTRUCTIONS FOR PREPARATION AND HANDLING OF THE MEDICINE
Before prescribing the medicine, the patient should 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 medicine should not be administered by rapid intravenous infusion or rapid injection (bolus), as the resulting high concentrations in the blood may increase the toxicity of ganciclovir.
The medicine should not be administered by intramuscular or subcutaneous injection, as the high pH (~11) of the ganciclovir solution may cause severe tissue irritation.
Do not administer doses greater than recommended, increase the frequency of subsequent doses, or increase the infusion rate.
Cymevene is a powder for concentrate for solution for infusion. After preparation, Cymevene is a colorless or slightly yellowish solution, practically free from visible particles.
Intravenous infusion should be administered into a vein with adequate blood flow, preferably through a plastic catheter.
Due to the potential teratogenic and carcinogenic effects of Cymevene in humans, caution should be exercised when handling and preparing Cymevene solutions. Avoid inhaling the powder in the vials or direct contact of the solution with the skin or mucous membranes. Cymevene solutions have an alkaline pH (~11). In case of direct contact, the exposed area should be thoroughly washed with soap and water, and the eyes should be rinsed with running water.
Preparation of the concentrate
Preparation of the diluted solution for infusion
From the vial with the Cymevene concentrate, draw up the dose suitable for the patient's body weight using a syringe and add it to the appropriate infusion solution. Add 100 ml of the diluent to the prepared solution. It is not recommended to administer the solution at a concentration greater than 10 mg/ml.
It has been shown that sodium chloride solution, 5% glucose solution, Ringer's solution, or Ringer's solution with lactate are chemically and physically compatible with Cymevene.
Cymevene should not be mixed with other medicines intended for intravenous administration.
The diluted solution should then be administered by intravenous infusion over 1 hour. The medicine should not be administered by intramuscular or subcutaneous injection, as the high pH (~11) of the ganciclovir solution may cause severe tissue irritation.
Disposal
The medicine is intended for single use only. Any unused remainder of the medicine or its waste should be disposed of in accordance with local regulations.
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