CYMEVENE Injection
ganciclovir 500mg injection
What is in this leaflet
This leaflet answers some common questions about CYMEVENE injection. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of your being given CYMEVENE injection against the benefits expected for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What CYMEVENE is used for
The name of your medicine is CYMEVENE, also known as ganciclovir or DHPG.
CYMEVENE acts against cytomegalovirus or CMV (a type of herpes virus). CMV causes infections mainly in people with poor immunity. There are several reasons for poor immunity. These include the special medicines taken after receiving an organ transplant or having HIV/AIDS.
CYMEVENE injection is used in severe CMV eye infections which can cause blindness. Unfortunately it is not a cure for CMV eye infections.
CYMEVENE may also be used for CMV infections in other parts of the body.
CYMEVENE is not effective against the virus that causes AIDS.
Your doctor may have prescribed CYMEVENE for another reason. Ask your doctor if you have any questions why CYMEVENE has been prescribed for you.
This medicine is available only with a doctor's prescription.
Before you are given CYMEVENE
Animal and other laboratory studies have shown CYMEVENE has caused infertility, birth defects and cancer. It is possible that these effects may also occur in humans.
When you must not be given CYMEVENE
Do not use CYMEVENE if
you have allergies to CYMEVENE, or a medicine from the same family called acyclovir (Zovirax®) or any ingredients listed in the Ingredients section of this leaflet
you are pregnant
you are breastfeeding
you have very low blood counts for platelets (which help clotting) or neutrophils (a type of white blood cell which defends against infections)
If you are not sure if you should be receiving CYMEVENE, talk to your doctor.
Use in Children
There is very little information available on the use of CYMEVENE in children less than 12 years. When children who have been given CYMEVENE become adults, they may have an increased risk of cancer and may find it difficult to have children of their own. Therefore CYMEVENE should only be used if these risks are outweighed by the benefits of treatment.
Before you are given CYMEVENE
Your doctor must know about the following before you are given CYMEVENE.
You must tell your doctor if:
you are pregnant or intend to become pregnant
you are breastfeeding or plan to breastfeed
you have had an allergic reaction to any medicine which you have taken previously to treat your current condition
you have a history of low blood counts for platelets or neutrophils
you have or previously have had poor kidney function
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or healthfood shop.
Some medicines may interfere with CYMEVENE. These medicines include:
probenecid (Benemid)
zidovudine (AZT or Retrovir)
didanosine (ddI or Videx)
mycophenolate mofetil (CellCept)
medicines for the treatment of cancer
imipenim-cilastin (Primaxin)
other medicines for the treatment of HIV or HIV-related infections.
These medicines may be affected by CYMEVENE or may affect how well CYMEVENE works.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. Your doctor or pharmacist can advise you of the medicines you should not take while taking CYMEVENE.
If you have not told your doctor about any of the above, tell them before you are given CYMEVENE.
How CYMEVENE is given
CYMEVENE injection is added to an infusion bag and given as a 'drip' into a vein, usually over a period of one hour. It is usually repeated every 12 hours for 14 to 21 days. The dose may be given once daily thereafter.
Your doctor will decide what dose of CYMEVENE you will receive. This depends on how serious your infection is and your kidney function.
While you are using CYMEVENE
Things you must do
Make sure that all doctors, dentists and pharmacists who are treating you know that you are being given CYMEVENE.
See your doctor regularly so that your CMV disease, blood cell counts and any other potential side effects may be monitored carefully. If blood cell counts are low then this may reduce your ability to fight infection, or for your blood to clot efficiently. If left undetected these effects on blood cells may contribute to death or serious illness.
If you have a CMV eye infection, you must also see your doctor regularly to monitor the condition of your retina.
If there is a possibility of your partner becoming pregnant, a barrier contraceptive should be used while you are receiving CYMEVENE and for 90 days after stopping.
Things to be careful of
Be careful driving or operating machinery until you know how CYMEVENE affects you. CYMEVENE however, usually does not affect these activities.
Things you must not do
You must not take any other medication, unless your doctor is aware of it.
Storage
CYMEVENE powder for injection must be kept in a cool dry place where the temperature stays below 30°C.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well after you have been given CYMEVENE.
CYMEVENE helps most people with CMV infections but it may have unwanted side effects in some people.
All medicines can have side effects. You may need medical treatment or a change of therapy if you get some of these side effects.
If you notice any of the following you should see your doctor immediately
a deterioration or worsening of your eye sight even if you are using CYMEVENE
bruising or purple spots on your body
any sign of infection such as fever, chills, sore throat or mouth ulcers
rapid heartbeat or sudden fevers
tiredness
skin rash
Unwanted effects may be due to CYMEVENE, other medications or any disease or condition you may also have.
Tell your doctor if you notice any of the following and they are worrying you
weight loss
itching
pain
hair loss
diarrhoea
producing more saliva than usual
pain or swelling at the site of injection
loss of feeling or tingling
Other side effects reported with CYMEVENE are
More common
low white blood cell counts
Less common
anaemia
low blood platelet count
Rare or very rare, but may be serious
severe allergic reactions
gastrointestinal inflammation
haemorrhage (bleeding)
liver inflammation
pancreas inflammation
seizures
kidney failure
heart arrhythmias
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist to answer any questions you may have.
Product Description
What CYMEVENE looks like
CYMEVENE is available as a freeze dried powder in clear glass vials. It will be made up into an infusion bag before being given to you.
Ingredients
CYMEVENE does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
Active ingredient
Each 10 mL CYMEVENE vial contains:
546 mg of ganciclovir sodium equivalent to 500 mg of ganciclovir
There are no other ingredients in CYMEVENE vials.