500 mg powder for concentrate for infusion solution
ganciclovir
1. What Cymevene is and what it is used for
What Cymevene is
Cymene contains the active substance ganciclovir. It belongs to a group of medicines called antiviral medicines.
What Cymevene is used for
Cymevene is used to treat diseases caused by a virus called cytomegalovirus ( CMV ) in adults and adolescents 12 years of age and older who have a weakened immune system. It is also used to prevent CMV – infection after organ transplantation or during treatment with chemotherapy in adults and children from birth.
- The virus can affect all parts of the body. It includes the retina at the back of the eye – this means that 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 can CMV – Virus et lead to a serious illness. A weakened immune system can be caused by other diseases (such as AIDS ) or by drugs (such as chemotherapy or drugs that affect the immune system).
2. What you need to know before you use Cymevene
Do not use Cymevene if:
- you are allergic to ganciclovir or any of the other ingredients of this medicine (listed in section 6).
- you are breastfeeding (see section Breastfeeding below). Do not use Cymevene if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before using Cymevene.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Cymevene about:
- 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 – your doctor will take blood samples before you start your treatment and during treatment
- you have previously had problems with the number of blood cells caused by drugs
- you have impaired kidney function – your doctor will give you a lower dose and check your blood levels more often during treatment
- you undergo radiation therapy.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Cymevene.
Be alert to signs of side effects that are
Cymene can cause some serious side effects that you must tell your doctor immediately. Be aware of the serious side effects listed in section 4 and tell your doctor immediately if you notice any of these while you are being treated with Cymevene – your doctor may tell you to stop taking Cymevene and you may need urgent medical attention. care.
Samples and controls
While you are taking Cymevene, your doctor will take regular blood tests. This is to make sure that the dose you receive is right for you. During the first two weeks, these blood samples will be taken frequently. After that, the samples will be taken less frequently.
Children and young people
There is limited information on the safety and efficacy of Cymevene in the treatment of CMV in children under 12 years of age. Toddlers and infants receiving Cymevene to prevent CMV disease will have regular blood tests.
Other medicines and Cymevene
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- imipenem/cilastatin – used against bacterial infections,
- pentamidine – used to treat parasitic or lung infections,
- flucytosine, amphotericin B – used against fungal infections,
- trimethoprim, trimethoprim/sulfamethoxazole, dapsone – used against bacterial infections,
- probenecid – used for gout,
- mycophenolate mofetil, ciclosporin, tacrolimus – used after organ transplantation,
- vincristine, vinblastine, doxorubicin – used against cancer,
- hydroxyurea – used against a disease called polycythemia, sickle cell disease, and cancer,
- didanosine, stavudine, zidovudine, tenofovir, or any other medicine used to treat HIV
- adefovir or any other medicine used to treat hepatitis B.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Cymevene.
Pregnancy, breastfeeding, and fertility
Pregnancy
Cymene should not be used by pregnant women unless the benefits to the mother outweigh the potential risks to the unborn baby.
If you are pregnant or think you may be pregnant, do not use this medicine unless your doctor tells you to. This is because Cymevene can harm your unborn baby.
Use of contraceptives
You should not get pregnant while using this medicine. This is because it can harm your unborn baby.
- women you are a woman who may become pregnant – use contraception while using Cymevene. Also, do this for at least 30 days after stopping treatment with Cymevene.
- if you are a man and have a female partner who may become pregnant – use condoms as contraception while using Cymevene. Also, do this for at least 90 days after stopping treatment with Cymevene.
If you or your partner become pregnant while taking Cymevene, tell your doctor immediately.
Breast-feeding
Do not use Cymevene if you are breast-feeding. If your doctor wants you to start taking Cymevene, you must stop breast-feeding before you start taking this medicine. This is because Cymevene can pass into breast milk.
Fertility
Cymene may affect fertility. Cymevene can cause men to temporarily or permanently stop producing sperm. If you are planning to have children, talk to your doctor or pharmacist before using Cymevene.
Driving and using machines
You may feel drowsy, dizzy, confused, or shaky, or you may lose your balance or have cramps while using Cymevene. If this happens, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Cymevene contains sodium
This medicine contains 43 mg of sodium (the main ingredient in common salt/table salt) in each 500 mg vial. This corresponds to 2% of the maximum recommended daily sodium intake for adults.
3. How to use Cymevene
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Using this medicine
Cymevene will be given to you by a doctor or nurse. It will be given into a vein through a tube. It is called an intravenous infusion and it usually takes an hour.
Dosage one of Cymevene varies from patient to patient. Your doctor will calculate how much you need. It depends on:
- your weight (in children the length can also be taken into account)
- your age
- how well your kidneys are working
- your blood levels
- what you are using the medicine for.
How often you should receive Cymevene and how long you should continue to use it also varies.
- You will usually start by getting one or two infusions each day.
- If you receive two infusions per day, it will continue for up to 21 days.
- Thereafter, the doctor may prescribe an infusion once a day.
People who have kidney or blood problems
If you have any kidney or blood problems, your doctor may suggest a lower dose of Cymevene and check your blood counts more often during treatment.
If you use more Cymevene then you should
If you think you have been given too much Cymevene, talk to your doctor or go to the hospital immediately. You may get any of the following symptoms if you have had too much:
- abdominal pain, diarrhea, or nausea
- tremors or convulsions
- blood in the urine
- kidney or liver problems
- altered blood levels.
If you stop using Cymevene
Do not stop using Cymevene without talking to your doctor first.
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. The following side effects may occur with this medicine:
Serious side effects are
Tell your doctor immediately if you notice any of the following serious side effects – your doctor may tell you to stop taking Cymevene and you may need urgent medical attention:
Very common: may affect more than 1 user in 10
- low white blood cell count – with signs of infection such as sore throat, cold sores, or fever
- low red blood cell count – signs include shortness of breath or fatigue, palpitations, or pale skin
Common: may affect up to 1 in 10 users
- blood poisoning ( sepsis ) – signs include fever, chills, palpitations, confusion, and slurred speech
- low platelet count – signs include bleeding or you are more likely to get bruises, blood in urine or feces, or bleeding from the gums, the bleeding can be severe
- severely low blood levels
- pancreatitis – sign is severe abdominal pain that spreads to the back
- cramps
Uncommon: may affect up to 1 in 100 people
- failure of bone marrow to produce blood s
- hallucinations – hearing or seeing things that are not real
- abnormal thoughts or feelings, lose touch with reality
- renal impairment
Rare: may affect up to 1 in 1,000 people
- severe allergic reaction – signs may include red itchy skin, swelling of the throat, face, lips, or mouth, difficulty swallowing or breathing.
Contact a doctor immediately if you notice any of the above side effects.
Other side effects ar
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
Very common: may affect more than 1 user in 10
- cod or cod in the mouth
- upper respiratory infections (e.g. sinusitis, inflammation of the tonsils)
- loss of appetite
- headache
- cough
- shortness of breath
- diarrhea
- nausea or vomiting
- abdominal pain
- eczema
- fatigue
- fever.
Common: may affect up to 1 in 10 users
- influenza
- urinary tract infection – signs include fever, urination more often than usual, pain when urinating
- infection of the skin and the tissues under the skin
- mild allergic reaction – signs may include red and itchy skin
- weight loss
- feeling depressed, anxious, or confused
- difficulty sleeping
- hands or feet feel weak and numb, which can affect balance
- feeling changes, tingling, tickling, stinging, or burning sensation
- taste changes
- overindulge
- eye inflammation ( conjunctivitis ), pain in the eyes, or problems with vision
- earache
- low blood pressure, which can make you feel dizzy or faint
- difficulty swallowing
- constipation, gas tension, indigestion, abdominal pain, swollen abdomen
- cold sores
- abnormal results on liver and kidney tests
- night sweats
- itching, rash
- hair loss
- back pain, pain in muscles or joints, muscle cramps
- feeling dizzy, feeling weak, or feeling sick
- a skin reaction at the site of injection – such as inflammation, pain, and swelling.
Uncommon: may affect up to 1 in 100 people
- feel upset
- tremors, tremors
- deafness
- irregular heartbeat
- hives, dry skin
- blood in the urine
- infertility in men – see section “Fertility”
- chest pain.
Side effects are in children and adolescents
Low blood levels are more common in children, especially in toddlers and infants.
5. How to store Cymevene
Keep this medicine out of the sight and reach of children.
Powder: No special storage instructions. Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
After preparation:
Chemical and physical in-use stability has been demonstrated for the reconstituted product for 12 hours at 25 ° C after reconstitution with water for injections. Do not store in the refrigerator or freezer.
From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user.
After dilution in infusion solution (sodium chloride 0.9%, glucose 5%, Ringer 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 point of view, Cymevene infusion solution should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user and should not be longer than 24 hours at 2 to 8 ° C, unless reconstitution and dilution have taken place under controlled and 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. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is ganciclovir. Each vial contains 500 mg of ganciclovir as ganciclovir sodium. After reconstitution of the powder, 1 ml of concentrate contains 50 mg of ganciclovir.
- The other ingredients are sodium hydroxide and hydrochloric acid.
What the medicine looks like and the contents of the pack
Cymevene is a white to off-white powder for concentrate for solution for infusion, supplied in single-dose vials of glass with a rubber stopper and an aluminum closure with a snap cap. Prepared Cymevene solution varies in color from colorless to light yellow.
Cymevene is supplied in packs of 1 or 5 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany
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