Meropenem Kabi 500 mg powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Meropenem Kabi 500 mg powder for solution for injection and for infusion EFG

Meropenem

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Meropenem Kabi 500 mg is and what it is used for
2. What you need to know before using Meropenem Kabi 500 mg
3. How to use Meropenem Kabi 500 mg
4. Possible side effects
5. How to store Meropenem Kabi 500 mg
6. Contents of the pack and other information

1. What Meropenem Kabi 500 mg is and what it is used for

Meropenem Kabi belongs to a group of medicines called carbapenem antibiotics. It works by destroying bacteria that can cause serious infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Meropenem is used to treat the following infections in adults and children from 3 months of age:

• Infection affecting the lungs (pneumonia)
• Bronchial and lung infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated abdominal infections
• Infections you may acquire during or after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial infection of the brain (meningitis)

Meropenem Kabi may be used in the treatment of febrile neutropenic patients in whom a bacterial infection is suspected.

Meropenem can be used to treat bacterial blood infection (bacteraemia) that may be associated with one of the types of infection mentioned above.

2. What you need to know before using Meropenem Kabi 500 mg

Do not use Meropenem Kabi

• If you are allergic (hypersensitive) to meropenem or to 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 Kabi.

Warnings and precautions

Talk to your doctor or nurse before starting Meropenem Kabi:

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

Liver problems

Inform your doctor if you notice yellowing of the skin or eyes, itching of the skin, dark-coloured urine, or pale-coloured stools. These may be signs of liver problems that your doctor should investigate.

You may develop a positive reaction in a test (Coombs test), indicating the presence of antibodies that could destroy red blood cells. Your doctor will discuss this with you.

You may develop signs and symptoms of serious skin reactions (see section 4). If this occurs, inform your doctor or nurse immediately so that symptoms can be treated.

If you are in any of these situations, or if you have any doubts, consult your doctor or nurse before using Meropenem Kabi.

Use of Meropenem Kabi with other medicines

Tell your doctor about any medicines you are taking, have recently taken, or might need to take.

Meropenem Kabi may affect how some medicines work, and some of these medicines may affect Meropenem Kabi.

In particular, inform 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 Kabi should not be used, as it may reduce the effect of sodium valproate.
• Oral anticoagulants (used to treat or prevent blood clots).

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. It is preferable to avoid using meropenem during pregnancy.

Your doctor will decide whether you should use meropenem.

It is important to inform your doctor if you are breastfeeding or plan to breastfeed before receiving meropenem treatment. A small amount of this medicine may pass into breast milk. Therefore, your doctor will decide whether you should use meropenem during breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive or use machines. However, Meropenem Kabi has been associated with headache, tingling or prickling sensations of the skin (paraesthesia), and involuntary muscle movements leading to rapid, uncontrolled body agitation (convulsions), usually accompanied by loss of consciousness. Any of these effects could impair your ability to drive or use machines. Do not drive or operate machinery if you experience these adverse effects.

Meropenem Kabi contains sodium.

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

If you have a condition that requires you to control your sodium intake, inform your doctor or nurse.

3. How to use Meropenem Kabi 500 mg

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults

• The dose depends on the type of infection you have, its location in the body, and its severity. Your doctor will decide the appropriate dose for you.
• The usual dose in adults ranges from 500 mg (milligrams) to 2 g (grams). Normally, a dose is administered every 8 hours. However, if your kidneys are not functioning properly, you may receive the dose less frequently.

Use in children and adolescents

• The dose for children over 3 months and up to 12 years of age is determined based on the child's age and body weight. The usual dose ranges from 10 mg to 40 mg of Meropenem Kabi per kilogram (kg) of body weight. Doses are normally administered every 8 hours. Children weighing more than 50 kg will receive an adult dose.

How to use Meropenem Kabi

• Meropenem Kabi will be administered to you as an injection or intravenous infusion into a large vein.
• Meropenem Kabi is normally administered by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer Meropenem Kabi at home. Instructions for this purpose are provided in this leaflet (in the section titled “Instructions for administering Meropenem Kabi to yourself or another person at home”). Follow exactly the administration instructions for Meropenem Kabi as given by your doctor. Consult your doctor if you have any doubts.
• Your injection must not be mixed with or added to solutions containing other medicines.
• The injection may last approximately 5 minutes or between 15 and 30 minutes. Your doctor will inform you how Meropenem Kabi is to be administered.
• Injections should normally be given at the same time each day.

If you use more Meropenem Kabi than you should

If you accidentally use more than the prescribed dose, contact your doctor or go to the nearest hospital immediately.

If you forget to use Meropenem Kabi

If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled dose, do not take the missed dose.

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

If you stop using Meropenem Kabi

Do not stop Meropenem Kabi unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Severe allergic reactions

If you experience a severe allergic reaction, stop treatment with Meropenem Kabi and seek medical attention immediately. You may require urgent medical treatment. Symptoms may include 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 difficulty breathing.
• Severe skin reactions including:
  • Severe hypersensitivity reactions with fever, skin rashes and changes in blood test results monitoring liver function (increased levels of liver enzymes), increase in a type of white blood cells (eosinophilia), and enlargement of lymph nodes. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
  • Severe red, scaly rash, skin bumps containing pus, blisters or peeling of the skin, which may be associated with high fever and joint pain.
  • Severe skin reactions that may appear as red, circular spots, often with central blisters on the trunk, skin peeling, and ulcers in the mouth, throat, nose, genitals and eyes, possibly 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)

Symptoms include:

• Unexpected shortness of breath.
• Red or brown urine.

If you notice any of the above, seek medical attention immediately.

Other possible adverse effects:

Common (may affect up to 1 in 10 people)

• Abdominal (stomach) pain.
• Nausea.
• Vomiting.
• Diarrhea.
• Headache.
• Skin rash, itching.
• Pain and inflammation.
• Increased number of platelets in the blood (detected in a blood test).
• Changes in blood tests, including tests showing how well your liver is functioning.

Uncommon (may affect up to 1 in 100 people)

• Changes in your blood. These include a decrease in the number of platelets (which may make you bruise more easily), increase in certain white blood cells, decrease in other white blood cells, and increase in a substance called "bilirubin". Your doctor may perform periodic blood tests.
• Changes in blood tests, including tests showing how well your kidneys are functioning.
• Decreased levels of potassium in the blood (which may cause weakness, muscle cramps, tingling sensations, and changes in heart rhythm).
• Liver problems. Yellowing of the skin and eyes, skin itching, dark urine or pale stools. If you notice these signs or symptoms, consult a doctor immediately.
• Tingling sensation (paresthesia).
• Mouth or vaginal fungal infections (thrush).
• Inflammation of the intestine with diarrhea.
• Pain in the veins where Meropenem Kabi is injected.
• Other changes in your blood. Symptoms include frequent infections, fever and sore throat. Your doctor may perform periodic blood tests.

Rare (may affect up to 1 in 1000 people)

• Seizures (convulsions).
• Acute disorientation and confusion (delirium).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem Kabi 500 mg

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Injection

After reconstitution: Reconstituted solutions for injection must be used immediately. The time interval between the start of reconstitution and the end of injection must not exceed:

• 3 hours if stored at a temperature up to 25°C;

• 12 hours if stored under refrigerated conditions (2–8°C).

Infusion

After reconstitution: Reconstituted solutions for infusion must be used immediately. The time interval between the start of reconstitution and the end of infusion must not exceed:

• 6 hours if stored at a temperature up to 25°C when Meropenem Kabi is dissolved in 0.9% sodium chloride;

• 24 hours if stored under refrigerated conditions (2–8°C) when Meropenem Kabi is dissolved in 0.9% sodium chloride;

• 1 hour if stored at a temperature up to 25°C when Meropenem Kabi is dissolved in 5% dextrose solution;

• 8 hours if stored under refrigerated conditions (2–8°C) when Meropenem Kabi is dissolved in 5% dextrose solution.

From a microbiological standpoint, unless the method of opening/reconstitution/dilution eliminates the risk of microbial contamination, the product should be used immediately.

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

Do not freeze the reconstituted solution.

Medicines must not be disposed of via wastewater or household waste. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Meropenem Kabi

• The active substance is meropenem (trihydrate). Each 20 ml vial or 100 ml bottle contains 500 mg of meropenem (anhydrous).
• The other component is sodium carbonate.

Presentation of the product and contents of the container

Meropenem Kabi is a white or pale yellow powder for injectable solution or infusion in a vial.

It is available in 20 ml glass vials and 100 ml glass bottles.

Pack sizes of 1 or 10 vials/bottles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.

Marina 16-18, 08005 – Barcelona

Spain

Manufacturer

ACS Dobfar S.p.A.

Nucleo Industriale S. Atto, S. Nicolò a Tordino, 64020 Teramo

Italy

or

LABESFAL – Laboratórios Almiro S.A. (Fresenius Kabi Group)

Lagedo, 3465-157 Santiago de Besteiros

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Meropenem Kabi 500 mg Powder for solution for injection or

Austria infusion

Meropenem Fresenius Kabi 500 mg powder for solution for injection or

Belgium infusion / poudre pour solution injectable ou pour perfusion / Pulver zur Herstellung einer Injektions- bzw. Infusionslösung

Bulgaria Meropenem Kabi 500 mg

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

Czech Republic Meropenem Kabi

Denmark Meropenem Fresenius Kabi

Estonia Meropenem Kabi 500 mg

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

Germany

Meropenem Kabi 500 mg, κόνις για διάλυμα προς ένεση ή έγχυση

Greece

Hungary Meropenem Kabi 500 mg

Ireland Meropenem 500 mg powder for solution for injection or infusion

Latvia Meropenem Kabi 500 mg pulveris injekciju vai infūziju šķīduma pagatavošanai

Lithuania Meropenem Kabi 500 mg milteliai injekciniam arba infuziniam tirpalui

Meropenem Kabi 500 mg Pulver zur Herstellung einer Injektionslösung oder Infusionslösung

Luxembourg	Infusion solution
	Meropenem Fresenius Kabi 500 mg powder for solution for injection or
Netherlands	infusion

Meropenem Fresenius Kabi 500 mg, powder for injection solution or infusion solution,

Norway solution

Poland Meropenem Kabi

Portugal Meropenem Kabi 500 mg Powder for injectable solution or for perfusion

Romania Meropenem Kabi 500 mg powder for injectable or perfusable solution

Spain Meropenem Kabi 500 mg powder for injectable solution or for perfusion

Meropenem Fresenius Kabi 500 mg, powder for injection solution or

Sweden infusion solution, solution

Meropenem Kabi 500 mg powder for injection or infusion solution

Slovenia

Meropenem Kabi 500 mg

Slovakia

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

This leaflet has been reviewed in August 2025.

Health advice/education

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.

Sometimes a bacterial infection does not respond to treatment with an antibiotic. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means they can survive and even multiply despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics cautiously can help reduce the chances of bacteria becoming resistant to them.

When your doctor prescribes you an antibiotic, it is intended only for your current illness. Following the advice below will help prevent the development of resistant bacteria that could stop the antibiotic from working.

1. It is very important to receive the correct dose of the antibiotic at the right times and for the correct number of days. Read the labelling instructions carefully and, if you do not understand something, ask your doctor or pharmacist.
2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection it was prescribed for.
3. You should not take antibiotics that have been prescribed for other people, even if they had an infection similar to yours.
4. You should not give other people antibiotics that were prescribed for you.
5. If you have leftover antibiotics after completing your treatment as directed by your doctor, return them to a pharmacy for proper disposal.

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Instructions for administering Meropenem Kabi to yourself or another person at home

Some patients, parents, and caregivers are trained to administer Meropenem Kabi at home.

Warning – You should only administer this medicine to yourself or another person at home after being trained by a doctor or nurse.

How to prepare this medicine

• The medicine must be mixed with another liquid (the diluent). Your doctor will tell you how much diluent to use.
• Use the medicine immediately after preparation. Do not freeze it.

1. Wash your hands thoroughly and dry them well. Prepare a clean workspace.
2. Remove the Meropenem Kabi vial from its packaging. Check the vial and the expiration date. Ensure the vial is intact and undamaged.
3. Remove the colored cap and clean the rubber stopper with an alcohol-impregnated cotton swab. Allow the rubber stopper to dry.
4. Attach a new sterile needle to a new sterile syringe, without touching the ends.
5. Draw up the recommended amount of sterile “Water for Injection” into the syringe. The amount of liquid required is shown in the following table:

Meropenem Kabi dose Amount of ‘Water for

Injection’ needed for

dilution

500 mg (milligrams) 10 ml (millilitres)

1 g (gram) 20 ml

1.5 g 30 ml

2 g 40 ml

Note that: If the prescribed dose of Meropenem Kabi is greater than 1 g, you will need to use more than one vial of Meropenem Kabi. You may then draw the liquid from multiple vials into a single syringe.

6. Insert the syringe needle into the center of the rubber stopper and inject the recommended amount of “Water for Injection” into the Meropenem Kabi vial(s).
7. Remove the needle from the vial and shake it well for about 5 seconds, or until all the powder has dissolved. Clean the rubber stopper once again with a new alcohol-impregnated cotton swab and allow it to dry.
8. With the plunger fully depressed, reinsert the needle through the rubber stopper. Hold the syringe and vial together and invert the vial up and down.
9. Keeping the needle tip submerged in the liquid, pull back the plunger to withdraw all the liquid from the vial into the syringe.
10. Remove the syringe and needle from the vial and dispose of the empty vial in an appropriate container.
11. Hold the syringe vertically with the needle pointing upwards. Gently tap the syringe to allow any air bubbles to rise to the top.
12. Expel air from the syringe by gently pushing the plunger until all air has been removed.
13. If you are using Meropenem Kabi at home, properly dispose of used needles and infusion lines. If your doctor decides to discontinue your treatment, properly dispose of any unused Meropenem Kabi.

Administration of the injection

You may administer this medicine through a peripheral intravenous catheter, or via a port or central line.

Administration of Meropenem Kabi via peripheral intravenous catheter

1. Remove the needle from the syringe and carefully dispose of it in an authorized sharps container.
2. Clean the end of the peripheral intravenous catheter with an alcohol-impregnated cotton swab and allow it to dry. Open the cannula cap and attach the syringe.
3. Slowly push the syringe plunger to administer the antibiotic steadily over approximately 5 minutes.
4. Once the antibiotic has been administered and the syringe is empty, remove it and flush the line as recommended by your doctor or nurse.
5. Close the cannula cap and carefully dispose of the syringe in an authorized sharps container.

Administration of Meropenem Kabi via port or central line

1. Remove the cap from the port or line, clean the end with an alcohol-impregnated cotton swab, and allow it to dry.

2. Attach the syringe and slowly push the plunger to administer the antibiotic steadily over approximately 5 minutes.

3. After completing administration of the antibiotic, remove the syringe and flush the line as recommended by your doctor or nurse.

4. Attach a new clean cap to the central line and carefully dispose of the syringe in an authorized sharps container.