What Gavomeg^® is

Gavomeg^® contains the active substance ganciclovir. 

This belongs to a group called antiviral medicines.

What Gavomeg^® is used for

Gavomeg^® is used to treat diseases caused by a virus called cytomegalovirus (CMV) in adults and adolescent patients 12 years and older who have a weak immune system. It is also used to prevent CMV infection after an organ transplant or during chemotherapy in adults and adolescent patients 12 years and older.

• The virus can affect any part of the body. This includes the retina at the back of the eye – this means the virus can cause problems with eye sight.

• The virus can affect anyone, but it is a particular problem in people with a weak immune system. In these people the CMV virus can lead to a serious disease. A weak immune system may be caused by other diseases (such as AIDS) or by medicines (such as chemotherapy or immunosuppressants).

Do not use Gavomeg^® if:

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

• you are breastfeeding (see Breastfeeding subsection).

Do not use Gavomeg^® if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before using Gavomeg^®.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Gavomeg^® if:

• you are allergic to aciclovir, valaciclovir, penciclovir or famciclovir – these are other medicines used for viral infections.

• you have low white blood cell, red blood cell or platelet counts – your doctor will do blood tests before you start and during your treatment.

• you have had problems with your blood cell counts caused by medicines in the past.

• you have kidney problems – your doctor will need to give you a lower dose and check your blood cell counts more often during treatment.

• you are having radiotherapy.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Gavomeg^®.

Look out for side effects

Gavomeg^® can cause some serious side effects that you need to tell your doctor about straight away.

Look out for the serious side effects listed in Section 4 and tell your doctor if you notice any of these while you are taking Gavomeg^® - your doctor may tell you to stop taking Gavomeg^® and you may need urgent medical treatment.

Tests and checks

While you are using Gavomeg^® your doctor will do regular blood tests. This is to check the dose you are having is right for you. For the first 2 weeks these blood tests will be done often. After that the tests will be done less often.

Children and adolescents

There is limited information on how safe or effective ganciclovir is as a treatment for CMV disease in children under 12 years. 

Other medicines and Gavomeg^®

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 for bacterial infections,

• pentamidine – used for parasite or lung infections,

• flucytosine, amphotericin B – used for fungal infections,

• trimethoprim, trimethoprim/sulfamethoxazole, dapsone – used for bacterial infections,

• probenecid – used for gout,

• mycophenolate mofetil, ciclosporin, tacrolimus – used after an organ transplant,

• vincristine, vinblastine, doxorubicin – used for cancer,

• hydroxyurea – used for a problem called polycythemia, sickle cell disease and cancer,

• didanosine, stavudine, zidovudine, tenofovir or any other medicines used for HIV,

• adefovir or any other medicines 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 Gavomeg^®.

Pregnancy, breastfeeding, and fertility

Pregnancy

Gavomeg^® should not be used by pregnant women unless the benefits to the mother outweigh the possible risks to the unborn baby.

If you are pregnant or think you might be pregnant, do not use this medicine unless your doctor tells you to. This is because ganciclovir may harm the unborn baby.

Contraception

You should not become pregnant while using this medicine. This is because it may affect the unborn baby.

Women

If you are a woman who could get pregnant – use contraception while you are using Gavomeg^®.

Also do this for at least 30 days after Gavomeg^® has been stopped.

Men

If you are a man whose female partner could get pregnant – use a barrier method of

contraception (such as condoms) while you are using Gavomeg^®. Also do this for at least 90 days after Gavomeg^® has been stopped.

If you or your partner becomes pregnant while using Gavomeg^®, talk to your doctor straight away.

Breastfeeding

Do not use Gavomeg^® if you are breastfeeding. If your doctor wants you to start using Gavomeg^® you must stop breastfeeding before you start using the medicine. This is because Gavomeg^® may pass into breast milk.

Fertility

Gavomeg^® may affect fertility. Gavomeg^® may temporarily or permanently stop men from producing sperm. If you are planning to have a baby, talk to your doctor or pharmacist before using Gavomeg^®.

Driving and using machines

You may feel sleepy, dizzy, confused or shaky, or you may lose your balance or have fits while using Gavomeg^®. If this happens, do not drive or use any tools or machines.

Gavomeg^® contains sodium

This medicine contains 43 mg sodium (main component of cooking/table salt) in each 500 mg vial.

This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Using this medicine

Gavomeg^® will be given to you by a doctor or nurse. It will be given through a tube into your vein.

This is called an intravenous infusion and it will usually take one hour.

The dose of Gavomeg^® varies from one patient to another. Your doctor will work out how much you need. It will depend on:

• your weight (in children their height may also be taken into account),

• your age,

• how well your kidneys are working,

• your blood counts,

• what you are using the medicine for.

• How often you will have Gavomeg^® and how long you keep using it will also vary.

• You will usually start by having one or two infusions every day.

• If you have two infusions a day, this will continue for up to 21 days.

• After that the doctor may prescribe the infusion once a day.

People with kidney or blood problems

If you have any kidney or blood problems your doctor might suggest a smaller dose of Gavomeg^® and check your blood cell counts more often during treatment.

If you use more Gavomeg^® than you should

If you think you have been given too much Gavomeg^® talk to your doctor or go to hospital straight away. You may get the following symptoms if you have too much:

• stomach pain, diarrhoea or being sick

• shaking or fits

• blood in your urine

• kidney or liver problems

• changes in blood cell counts.

If you stop using Gavomeg^®

Do not stop using Gavomeg^® without talking to your doctor.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Serious side effects

Tell your doctor straight away if you notice any of the following serious side effects – your doctor may tell you to stop taking Gavomeg^® and you may need urgent medical treatment:

Very common: may affect more than 1 in 10 people

• low white blood cell counts – with signs of infection such as sore throat, mouth ulcers or a Fever.

• low red blood cell counts – signs include feeling short of breath or tired, palpitations or pale skin.

Common: may affect up to 1 in 10 people

• blood infection (sepsis) – signs include fever, chills, palpitations, confusion and slurred speech.

• low level of platelets – signs include bleeding or bruising more easily than usual, blood in urine or stools or bleeding from gums, the bleeding could be severe.

• severely low blood cell count.

• pancreatitis – signs are severe stomach pain which spreads into your back

• fits.

Uncommon: may affect up to 1 in 100 people

• failure of the bone marrow to produce blood cells

• hallucinations – hearing or seeing things that are not real

• abnormal thoughts or feelings, losing contact with reality

• failure of kidney function.

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

• severe allergic reaction – the signs may include, red itchy skin, swelling of the throat, face, lips or mouth, difficulty swallowing or breathing.

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

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

• thrush and oral thrush

• upper respiratory tract infection (e.g., sinusitis, tonsillitis)

• loss of appetite

• headache

• cough

• feeling short of breath

• diarrhoea

• feeling or being sick

• abdominal pain

• eczema

• feeling tired

• fever.

Common: may affect up to 1 in 10 people

• influenza

• urine infection – signs include fever, passing urine more often, pain when passing urine

• infection of the skin and the tissues under the skin

• mild allergic reaction – the signs may include red, itchy skin

• weight loss

• feeling depressed, anxious or confused

• trouble sleeping

• hands or feet feeling weak or numb, which may affect your balance

• changes to your sense of touch, tingling, tickling, pricking or burning feeling

• changes to the way things taste

• chills

• eye inflammation (conjunctivitis), eye pain or sight problems

• ear pain

• low blood pressure, which may make you feel dizzy or faint

• problems swallowing

• constipation, wind, indigestion, stomach pain, swelling of the abdomen

• mouth ulcers

• abnormal results of liver and kidney laboratory tests

• night sweats

• itching, rash

• hair loss

• back pain, muscle or joint pain, muscle spasms

• feeling dizzy, weak or generally unwell

• a skin reaction where the medicine was injected – such as inflammation, pain and swelling.

Uncommon: may affect up to 1 in 100 people

• feeling agitated

• tremor, shaking

• deafness

• uneven heartbeat

• hives, dry skin

• blood in urine

• infertility in men – see ‘Fertility’ section

• chest pain.

Side effects in children and adolescents

• Low blood cell counts are more likely in children, especially 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 (see details below). By reporting side affects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

The dry powder: Store below 30°C. 

It should not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

After reconstitution:

Chemical and physical in-use stability has been demonstrated for the reconstituted product for 12 hours at 30°C after dissolving with water for injections. Do not refrigerate or freeze.

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

After dilution in infusion solutions (sodium chloride 0.9%, dextrose 5%, Ringer’s or lactated Ringer’s 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, the Gavomeg^® infusion solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.