Meroza contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections.

Meroza is used to treat the following in adults and children aged 3 months and older:

·       Infection affecting the lungs (pneumonia).

·       Lung and bronchial infections in patients suffering from cystic fibrosis.

·       Complicated urinary tract infections.

·       Complicated infections in the abdomen.

·       Infections that you can catch during or after the delivery.

·       Complicated skin and soft tissues infections.

·       Acute bacterial infection of the brain (meningitis).

Meroza may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

Meroza may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.

Do not use Meroza

·       If you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meroza (listed in Section 6).

·       If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Meroza:

●    if you have health problems, such as liver or kidney problems.

●    if you have had severe diarrhoea after taking other antibiotics.

You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meroza.

Other medicines and Meroza

Tell your doctor, pharmacist or nurse if you are taking or have recently taken or might take any other medicines. This is because Meroza can affect the way some medicines work and some medicines can have an effect on Meroza

In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines: 

●    Probenecid (used to treat gout).

●    Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Meroza should not be used because it may decrease the effect of sodium valproate.

●    Oral anti-coagulant agent (used to treat or prevent blood clots).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. It is preferable to avoid the use of meropenem during pregnancy.

Your doctor will decide whether you should use Meroza.

It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving meropenem. Small amounts of this medicine may pass into the breast milk. Therefore, your doctor will decide whether you should use Meroza while breast-feeding.

Driving and using machines

No studies on the effect on the ability to drive and use machines have been performed.

Meropenem has been associated with headache and tingling or pricking skin (paraesthesia). Any of these side effects could affect your ability to drive or operate machines.

Meroza may cause involuntary muscle movements which may cause the person's body to shake rapidly and uncontrollably (convulsions). This is usually accompanied with a loss of consciousness. Do not drive or use machines if you experience this side effect.

Meroza contains sodium.

Meroza 500 mg: This medicine contains approximately 45 mg of sodium (main component of cooking/table salt) in each 500 mg dose. This is equivalent to 2.25 % of the recommended maximum daily dietary intake of sodium for an adult.

Meroza 1 g: This medicine contains approximately 90 mg of sodium (main component of cooking/table salt) in each 1.0 g dose. This is equivalent to 4.5 % of the recommended maximum daily dietary intake of sodium for an adult.

If you have a condition which requires you to monitor your sodium intake, please inform your doctor, pharmacist or nurse.

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

Use in adults

●    The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will decide on the dose that you need.

●    The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). You will usually receive a dose every 8 hours. However, you may receive a dose less often, if your kidneys do not work very well.

Use in children and adolescents

●    The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meroza for each kilogram (kg) that the child weighs. A dose is usually given every 8 hours. Children who weigh over 50 kg will be given an adult dose.

How to USE MEROZA

●    Meroza will be given to you as an injection or infusion into a large vein.

●    Your doctor or nurse will normally give Meroza to you.

●    However, some patients, parents and carers are trained to give Meroza at home. Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for giving Meroza to yourself or someone else at home’). Always use Meroza exactly as your doctor has told you. You should check with your doctor if you are not sure.

●    Your injection should not be mixed with or added to solutions that contain other medicines.

●    The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meroza.

●    You should normally have your injections at the same times each day.

If you use more Meroza than you should

If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.

If you forget to use Meroza

If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection.

Do not take a double dose (two injections at the same time) to make up for a forgotten dose.

If you stop using Meropenem

Do not stop having Meroza until your doctor tells you to.

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

Like all medicines, Meroza can cause side effects, although not everybody gets them.

Severe allergic reactions

If you have a severe allergic reaction, stop having Meroza and see a doctor straight away. You may need urgent medical treatment. The signs may include a sudden onset of:

●    Severe rash, itching or hives on the skin.

●    Swelling of the face, lips, tongue or other parts of the body.

●    Shortness of breath, wheezing or trouble breathing.

Damage to red blood cells (not known)

The signs include:

●    Being breathless when you do not expect it.

●    Red or brown urine.

If you notice any of the above, see a doctor straight away.

Other possible side effects:

Common (may affect up to 1 in 10 people)

●    Abdominal (stomach) pain.

●    Feeling sick (nausea).

●    Being sick (vomiting).

●    Diarrhoea.

●    Headache.

●    Skin rash, itchy skin.

●    Pain and inflammation.

●    Increased numbers of platelets in your blood (shown in a blood test).

●    Changes in blood tests, including tests that show how well your liver is working.

Uncommon (may affect up to 1 in 100 people)

●    Changes in your blood. These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called ‘bilirubin’. Your doctor may do blood tests from time to time.

●    Changes in blood tests, including tests that show how well your kidney is working.

●    A tingling feeling (pins and needles).

●    Infections of the mouth or the vagina that are caused by a fungus (thrush).

●    Inflammation of the bowel with diarrhoea.

●    Sore veins where Meroza is injected.

●    Other changes in your blood. The symptoms include frequent infections, high temperature and sore throat. Your doctor may do blood tests from time to time.

●    Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains.

Rare (may affect up to 1 in 1,000 people)

●    Fits (convulsions).

Frequency not known (cannot be estimated from available data)

●    Serious hypersensitivity reactions involving fever, skin rash, and changes in the blood tests that check how the liver is working (increased levels of liver enzymes) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome.

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 via The National Pharmacovigilance and Drug Safety Centre (NPC). By reporting side affects you can help provide more information on the safety of this medicine.

-       Do not store above 30°C.

-       Keep out of the reach and sight of children.

-       Do not use Meroza after the expiry date which is stated on the carton and the vial after “EXP”. The expiry date refers to the last day of that month.

-       After reconstitution: The reconstituted solutions for intravenous injection or infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection or infusion should not exceed one hour.

-       From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.

-       If not used immediately in-use storage times and conditions are the responsibility of the user.

-       Do not freeze the reconstituted solution.

-       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.