Meronem
Meronem IV 500 mg and 1 g
Powder for solution for injection or infusion
meropenem
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same
as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
1. What Meronem is and what it is used for
2. Before you use Meronem
3. How to use Meronem
4. Possible side effects
5. How to store Meronem
6. Further information
What Meronem is and what it is used for
Meronem belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections.
- 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).
Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Before you use Meronem
Do not use Meronem
- If you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meronem (listed in Section 6 Further information).
- If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem.
Take special care with Meronem
Check with your doctor before using Meronem:
- 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 Meronem.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. This is because Meronem can affect the way some medicines work and some medicines can have an effect on Meronem.
In particular, tell your doctor or nurse if you are taking any of the following medicines:
- Probenecid (used to treat gout).
- Sodium valproate (used to treat epilepsy). Meronem should not be used because it may decrease the effect of sodium valproate.
Pregnancy and breast-feeding
It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving meropenem. It is preferable to avoid the use of meropenem during pregnancy.
Your doctor will decide whether you should use meropenem.
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 and it may affect the baby. Therefore, your doctor will decide whether you should use meropenem while breast-feeding.
Ask your doctor for advice before taking any medicine.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
Important information about some of the ingredients of Meronem
Meronem contains sodium.
Meronem 500 mg: This medicinal product contains approximately 2.0 mEq of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.
Meronem 1 g: This medicinal product contains approximately 4.0 mEq of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.
If you have a condition which requires you to monitor your sodium intake please inform your doctor or nurse.
How to use Meronem
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.
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 Meronem 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.
- Meronem will be given to you as an injection or infusion into a large vein.
- Your doctor or nurse will normally give Meronem to you.
- However, some patients, parents and carers are trained to give Meronem at home. Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for giving Meronem to yourself or someone else at home’). Always use Meronem 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 Meronem.
- You should normally have your injections at the same times each day.
If you use more Meronem 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 Meronem
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 Meronem until your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, Meronem can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
- Very common (affects more than 1 user in 10).
- Common (affects 1 to 10 users in 100).
- Uncommon (affects 1 to 10 users in 1,000).
- Rare (affects 1 to 10 users in 10,000).
- Very rare (affects less than 1 user in 10,000).
- Not known (frequency cannot be estimated from the available data but this is rare or very rare).
Severe allergic reactions
If you have a severe allergic reaction, stop having Meronem 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
- 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
- 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 kidneys are working.
- A tingling feeling (pins and needles).
- Infections of the mouth or the vagina that are caused by a fungus (thrush).
Rare
- Fits (convulsions).
Other possible side effects of unknown frequency
- Inflammation of the bowel with diarrhoea.
- Sore veins where Meronem 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
How to store Meronem
Keep out of the reach and sight of children.
Do not use Meronem after the expiry date which is stated on the container. The expiry date refers to the last day of that month.
Do not store above 30°C.
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.
Do not freeze the reconstituted solution.
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.
Further information
What Meronem contains
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
The other ingredient is anhydrous sodium carbonate.
What Meronem looks like and contents of the pack
- Meronem is a white to light yellow powder for solution for injection or infusion in a vial. Pack sizes of 1 or 10 vials.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Meronem are held by
Meronem is manufactured by
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Optinem
Belgium: Meronem IV
Bulgaria: Meronem
Cyprus: MERONEM
Czech Republic: MERONEM
Denmark: MERONEM
Estonia: Meronem
Finland: Meronem
France: MERONEM
Germany: Meronem
Greece: Meronem
Hungary: Meronem
Iceland: Meronem
Ireland: Meronem IV
Italy: MERREM
Latvia: Meronem
Lithuania: Meronem IV
Luxembourg: Meronem IV
Malta: Meronem IV
Netherlands: Meronem i.v.
Norway: Meronem
Poland: Meronem
Portugal: Meronem
Romania: Meronem i.v.
Slovak Republic: Meronem 500mg i.v.
Slovenia: Meronem
Spain: Meronem I.V.
Sweden: Meronem
United Kingdom: Meronem IV
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Reference number
Meronem IV 500 mg 17901/0029
Meronem IV 1 g 17901/0030
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Advice/medical education
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons.
Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.
1. It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read
the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.
2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to
yours.
4. You should not give antibiotics that were prescribed for you to other people.
5. If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.
This leaflet was last updated in October 2009.
© AstraZeneca 2009
Meronem is a trade mark of the AstraZeneca group of companies.
INF 09 0019
330014 F.46
ref.: D300.049
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