Meropenem 500 mg powder for solution for injection or infusion – patient leaflet, side effects, dosage

1. What Meropenem is and what it is used for

Meropenem belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections.

Meropenem 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)

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

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

2. What you need to know before you use Meropenem

Do not use Meropenem

• if you are allergic (hypersensitive) to Meropenem or any of

  the other ingredients of this medicine (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 or nurse before using Meropenem:

• if you have health problems, such as liver or kidney problems.
• if you have had severe diarrhoea after taking other antibiotics.

Liver problems

If you notice yellowing of the skin and eyes, itchy skin, dark-coloured urine or light-coloured stool tell your doctor. This may

be a sign of liver problems which your doctor needs to check. 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.

You may develop signs and symptoms of severe skin reactions (see section 4). If this happens talk to your doctor or nurse immediately so that they can treat the symptoms.

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

If you notice unexplained muscle pain, tenderness or weakness and/or dark coloured urine tell your doctor immediately. This may be a sign of muscle breakdown (called rhabdomyolysis) which may lead to kidney problems.

Other medicines and Meropenem

Tell your doctor if you are taking, have recently taken or might take any other medicines.

This is because Meropenem can affect the way some medicines work and some medicines can have an effect on Meropenem.

In particular, tell your doctor 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). Meropenem 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 and fertility

If you are pregnant or breast-feeding, think you may be pregnant or 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 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. Therefore, your doctor will decide whether you should use Meropenem while breast-feeding.

Driving and using machines

No studies on the effect on the ability to drive and use machines have been performed. However, Meropenem has been associated with headache; tingling or pricking skin(paraesthesiae); and involuntary muscle movements, leading the person’s body to shake rapidly and uncontrollably (convulsions), that are usually accompanied with a loss of consciousness, and any of these could affect your ability to drive or operate machines. Do not drive or use machines if you experience this side effect.

Meropenem contains sodium.

Meropenem 500 mg: This medicine contains 45.13 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 2.3% of the recommended maximum daily dietary intake of sodium for an adult.

Meropenem 1000 mg: This medicine contains 90.25 mg sodium (main component of cooking/table salt) in each vial. 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 or nurse.

3. How to use Meropenem

Always use this medicine exactly as your doctor has told you. Check with your doctor 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 11 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meropenem 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 Meropenem

• Meropenem will be given to you as an injection or infusion into a large vein.

• Your doctor or nurse will normally give Meropenem to

  you.

• However, some patients, parents and carers are trained to give Meropenem at home. Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for giving Meropenem to yourself or someone else at home’). Always use Meropenem 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 Meropenem.
• You should normally have your injections at the same times each day.

If you use more Meropenem 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 Meropenem

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 Meropenem until your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

Severe allergic reactions

If you have a severe allergic reaction, stop having Meropenem and see a doctor straight away. You may need urgent medical treatment. The signs and symptoms 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.
• Serious skin reactions which include

• 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.

  • Severe red scaly rash, skin bumps that contain pus, blisters or peeling of skin, which may be associated with a high fever and joint pains.
  • Severe skin rashes that can appear as reddish circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis). Damage to red blood cells (frequency 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.

Muscle breakdown

Unexplained muscle pain, tenderness or weakness, and/or dark coloured urine.

If you notice these signs or symptoms, 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.

The following information is intended for healthcare professionals only:

Instructions for giving Meropenem to yourself or someone else at home

Some patients, parents and carers are trained to give Meropenem at home.

Warning – You should only give this medicine to yourself or someone else at home after a doctor or nurse has trained you.

How to prepare this medicine

• The medicine must be mixed with another liquid (the diluent). Your doctor will tell you how much of the diluent to use.

• Use the medicine straight after preparing it. Do not freeze it.

  1. 1. Wash your hands and dry them very well. Prepare a clean working area.
  2. 2. Remove the Meropenem bottle (vial) from the packaging. Check the vial and the expiry date. Check that the vial is intact and has not been damaged.
  3. 3. Remove the coloured cap and clean the rubber stopper with an alcohol wipe. Allow the rubber stopper to dry.
  4. 4. Connect a new sterile needle to a new sterile syringe, without touching the ends.
  5. 5.

     Draw up the recommended amount of sterile ‘Water for Injections’ into the syringe. The amount of liquid that you need is shown in the table below:

     Dose of Meropenem Amount of ‘Water for Injections’ needed for dilution 500 mg (milligrams) 10 ml (milliliters) 1 g (gram) 20 ml

     1.5 g 30 ml

     2 g 40 ml

     Please note: If your prescribed dose of Meropenem is more than 1g, you will need to use more than 1 vial of Meropenem. You can then draw the liquid in the vials into the one syringe.

     1. 6. Put the needle of the syringe through the centre of the rubber stopper and inject the recommended amount of Water for Injections into the vial or vials of Meropenem.
     2. 7. Remove the needle from the vial and shake the vial well for about 5 seconds, or until all the powder has dissolved. Clean the rubber stopper once more with a new alcohol wipe and allow the rubber stopper to dry.
     3. 8. With the plunger of the syringe pushed fully into the syringe, put the needle back through the rubber stopper. You must then hold both the syringe and the vial and turn the vial upside down.
     4. 9. Keeping the end of the needle in the liquid, pull back the plunger and draw all the liquid in the vial into the syringe.
     5. 10.

        Remove the needle and syringe from the vial and throw the empty vial away in a safe place.

        Meropenem 500 mg powder for solution for injection or infusion

        Meropenem 1 g powder for solution for injection or infusion

        Meropenem

        Meropenem 500 mg

        powder for solution for injection or infusion

        Meropenem 1 g

        powder for solution for injection or infusion

        Meropenem xxx V014

        ACSI079F02 ACSI079F01

BACK

• Changes in blood tests, including tests that show how well your kidney is working.
• Reduced levels of potassium in your blood (which can cause weakness, muscle cramps, tingling and heart rhythm disturbances).
• Liver problems. Yellowing of the skin and eyes, itchy skin, dark-coloured urine or light-coloured stool. If you notice these signs or symptoms, see a doctor straight away.
• 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 Meropenem 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.

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

• Fits (convulsions)
• Acute disorientation and confusion (delirium)

Sudden chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome has been noted with other medicines of the same type. If this happens talk to a doctor or nurse immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Meropenem

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

Do not use this medicine after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of that month.

Do not store above 30 °C.

Do not freeze.

Injection

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

• 3 hours when stored at up to 25 °C;
• 12 hours when stored under refrigerated conditions (2-8 °C)..

Infusion

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

• 6 hours when stored at up to 25 °C when Meropenem is

  dissolved in 0.9% sodium chloride;

• 24 hours when stored under refrigerated conditions (2-8 °C)

  when Meropenem is dissolved in 0.9% sodium chloride;

• 1 hour when stored at up to 25 °C when Meropenem is

  dissolved in 5% dextrose solution;

  • 8 hours when stored under refrigerated conditions (2-8 °C)

    when Meropenem is dissolved in 5% dextrose solution; 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.

6. Contents of the pack and other information

What Meropenem contains

• The active substance is meropenem trihydrate. Each 20 ml

  vial/100 ml bottle contains 500 mg Meropenem. Each 20 ml vial, 50/100 ml bottle contains 1000 mg Meropenem. The other ingredient is sodium carbonate.

What Meropenem looks like and contents of the pack

Meropenem is a white or light yellow powder for solution for injection or infusion in vial or bottle.

Meropenem 500 mg powder for solution for injection or infusion is available in 20 ml glass vials and 100 ml glass bottles. Meropenem 1 g powder for solution for injection or infusion is available in 20 ml glass vials, 50 ml and 100 ml glass bottles.

Pack sizes of 1 or 10 vials or bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

For UK

Fresenius Kabi Ltd

Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1NT

UK

For Ireland

Fresenius Kabi Deutschland GmbH

Else-Kroener-Strasse 1,

61352 Bad Homburg v.d.H.,

Germany

Manufacturer(s) responsible for batch release

ACS Dobfar S.p.A.

Nucleo Industriale S. Atto, S. Nicolò a Tordino, 64100 Teramo Italy

and

LABESFAL – Laboratórios Almiro S.A. (Fresenius Kabi Group) Lagedo, 3465-157 Santiago de Besteiros

Portugal

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Meropenem Kabi 500 mg Pulver zur Herstellung einer Injektions- bzw. Infusionslösung

Meropenem Kabi 1 g Pulver zur Herstellung einer Injektions- bzw. Infusionslösung

Belgium Meropenem Fresenius Kabi 500 mg poeder voor oplossing voor injectie of infusie / poudre pour solution injectable ou pour perfusion / Pulver zur Herstellung einer Injektionslösung oder Infusionslösung Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie / poudre pour solution injectable ou pour perfusion / Pulver zur Herstellung einer Injektionslösung oder Infusionslösung

Bulgaria Meropenem Kabi 1 g

Cyprus Meropenem Kabi 500 mg, κόνις για ενέσιμο διάλυμα ή διάλυμα για έγχυση Meropenem Kabi 1000 mg, κόνις για ενέσιμο διάλυμα ή διάλυμα για έγχυση

Czech Meropenem Kabi

Republic

Denmark Meropenem Fresenius Kabi

Estonia Meropenem Kabi 1000 mg

Germany Meropenem Kabi 500 mg Pulver zur Herstellung einer Injektions- bzw. Infusionslösung

Meropenem Kabi 1 g Pulver zur Herstellung einer Injektions- bzw. Infusionslösung

Greece Meropenem/Kabi 500 mg, κόνις για διάλυμαπρος ένεση ή έγχυση

Meropenem/Kabi 1g, κόνις για διάλυμαπρος ένεση ή έγχυση

Hungary Meropenem Kabi 500 mg

Meropenem Kabi 1 g

Ireland Meropenem 500 mg powder for solution for injection or infusion

Meropenem 1 g powder for solution for injection or infusion

Latvia Meropenem Kabi 1000 mg pulveris injekciju vai infūziju šķīduma pagatavošanai

Lithuania Meropenem Kabi 500 mg milteliai injekciniam arba infuziniam tirpalui Meropenem Kabi 1000 mg milteliai injekciniam arba infuziniam tirpalui

Luxemburg Meropenem Kabi 500 mg Pulver zur Herstellung einer Injektionslösung oder Infusionslösung

Meropenem Kabi 1 g Pulver zur Herstellung einer Injektionslösung oder Infusionslösung

Netherlands Meropenem Fresenius Kabi 500 mg poeder voor oplossing voor injectie of infusie Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie

Norway Meropenem Fresenius Kabi 500 mg, pulver til injeksjonsvæske/ infusjonsvæske, oppløsning

Meropenem Fresenius Kabi 1 g, pulver til injeksjonsvæske/ infusjonsvæske, oppløsning

Poland Meropenem Kabi

Portugal Meropenem Kabi

Romania Meropenem Kabi 500 mg pulbere pentru soluţie injectabilă sau perfuzabilă Meropenem Kabi 1 g pulbere pentru soluţie injectabilă sau perfuzabilă

Spain Meropenem Kabi 500 mg polvo para solución inyectable o para perfusión Meropenem Kabi 1 g polvo para solución inyectable o para perfusión

Sweden Meropenem Fresenius Kabi 500 mg, pulver till injektionsvätska eller infusionsvätska, lösning

Meropenem Fresenius Kabi 1 g, pulver till injektionsvätska eller infusionsvätska, lösning

Slovenia Meropenem Kabi 500 mg prašek za raztopino za injiciranje ali infundiranje Meropenem Kabi 1 g prašek za raztopino za injiciranje ali infundiranje

Slovakia Meropenem Kabi 500 mg

Meropenem Kabi 1 g

United Meropenem 500 mg powder for solution for Kingdom injection or infusion

Meropenem 1 g powder for solution for injection or infusion

This leaflet was last revised in March 2026.

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. 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. 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. 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. 4. You should not give antibiotics that were prescribed for you to other people.
5. 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.

   xxx V014

BACK

1. 11. Hold the syringe upright, with the needle pointing upwards. Tap the syringe so that any bubbles in the liquid rise to the top of the syringe.
2. 12. Remove any air in the syringe by gently pushing the plunger until all the air has gone.
3. 13. If you are using Meropenem at home, dispose of any needles and infusion lines that you have used in an appropriate way. If your doctor decides to stop your treatment, dispose of any unused Meropenem in an appropriate way.

Giving the injection

You can either give this medicine through a short cannula or venflon, or through a port or central line.

Giving Meropenem through a short cannula or venflon

1. 1. Remove the needle from the syringe and throw the needle away carefully in your sharps bin.
2. 2. Wipe the end of the short cannula or venflon with an alcohol wipe and allow it to dry. Open the cap on your cannula and connect the syringe.
3. 3. Slowly push the plunger of the syringe to give the antibiotic steadily over about 5 minutes.
4. 4. Once you have finished giving the antibiotic and the syringe is empty, remove the syringe and use a flush as recommended by your doctor or nurse.
5. 5.

   Close the cap of your cannula and carefully throw the syringe away in your sharps bin.

   Giving Meropenem through a port or central line

   1. 1. Remove the cap on the port or line, clean the end of the line with an alcohol wipe and allow it to dry.
   2. 2. Connect the syringe and slowly push the plunger on the syringe to give the antibiotic steadily over about 5 minutes.
   3. 3. Once you have finished giving the antibiotic, remove the syringe and use a flush as recommended by your doctor or nurse.
   4. 4.

      Place a new clean cap on your central line and carefully throw the syringe away in your sharps bin.

      ACSI079F02