MEROPENEM KABI 500 mg POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

PATIENT INFORMATION LEAFLET

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

Meropenem

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Meropenem Kabi 500 mg is and what it is used for
2. What you need to know before you use Meropenem Kabi 500 mg
3. How to use Meropenem Kabi 500 mg
4. Possible side effects
5. Storage of 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 killing bacteria that can cause serious infections.

Antibiotics are used to treat bacterial infections and will not work for infections caused by viruses, such as the common cold or flu.

It is important that you follow the instructions for the dose, administration interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines 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 infections in the abdomen
• Infections that you can acquire during or after childbirth
• Complicated skin and soft tissue infections
• Bacterial infection of the brain (meningitis)

Meropenem Kabi may be used to treat patients with neutropenia who have fever that is suspected to be due to a bacterial infection.

Meropenem can be used to treat bacterial infection of the blood that may be associated with one of the aforementioned infections.

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

Do not use Meropenem Kabi

• 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 starting Meropenem Kabi:

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

You may develop a positive reaction to a test (Coombs test), which indicates the presence of antibodies that can 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, inform your doctor or nurse immediately so that they can treat the symptoms.

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

Using Meropenem Kabi with other medicines

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

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may 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 that you inform your doctor if you are breastfeeding or plan to breastfeed before receiving treatment with meropenem. 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 and use machines. However, Meropenem Kabi has been associated with headache, tingling or numbness of the skin (paresthesia), and involuntary muscle movements, leading to rapid and uncontrolled body movements (convulsions), which are usually accompanied by loss of consciousness. Any of these effects could affect your ability to drive or use machines. Do not drive or use machines if you experience this side effect.

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 the instructions for administration of this medicine as indicated 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, the area of the body affected, and its severity. Your doctor will decide what dose you need.
• The normal dose in adults is between 500 mg (milligrams) and 2 g (grams). You will usually be given a dose every 8 hours. However, if your kidneys do not work well, you may receive the dose less frequently.

Use in children and adolescents

• The dose for children over 3 months and up to 12 years is decided based on the child's age and weight. The normal dose is between 10 mg and 40 mg of Meropenem Kabi per kilogram (kg) of the child's weight. You will usually be given a dose every 8 hours. Children who weigh more than 50 kg will be given an adult dose.

How to use Meropenem Kabi

• Meropenem Kabi will be administered to you as an injection or infusion into a large vein.
• Meropenem Kabi will usually be administered by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer Meropenem Kabi at home. The instructions for this are found in this leaflet (in the section called "Instructions for administering Meropenem Kabi to yourself or another person at home"). Follow the instructions for administration of Meropenem Kabi as indicated by your doctor. Consult your doctor if you have doubts.
• Your injection should not be mixed with or added to solutions that contain other medicines.
• The injection may take approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how Meropenem Kabi is administered.
• Injections should usually be administered at the same time every 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 injection, do not receive the missed one.

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

If you stop using Meropenem Kabi

Do not stop using Meropenem Kabi 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 using Meropenem Kabi and see a doctor immediately. You may need urgent medical treatment. The symptoms can include:

• Sudden onset of severe rash, itching, or hives.
• 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, rash, and changes in blood test results that check liver function (increased liver enzyme levels), increased eosinophils, and enlarged lymph nodes. These can be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
  • Severe scaly red rash, bumps on the skin that contain pus, blisters, or peeling of the skin, which can be associated with high fever and joint pain.
  • Severe skin reactions that can appear as circular red patches often with central blisters on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, and which 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 symptoms include:

• Shortness of breath when you do not expect it.
• Red or brown urine.

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

Other possible side effects:

Common(may affect up to 1 in 10 people)

• Abdominal pain (stomach pain).
• Nausea.
• Vomiting.
• Diarrhea.
• Headache.
• Rash, itching of the skin.
• Pain and inflammation.
• Increased platelet count in the blood (checked 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 a decrease in platelet count (which can make you bruise more easily), increased white blood cells, decreased white blood cells, and increased bilirubin. Your doctor may perform periodic blood tests.
• Changes in blood tests, including tests that show how well your kidneys are working.
• Tingling sensation (paresthesia).
• Mouth or vaginal infections caused by a fungus (thrush).
• Inflammation of the intestine with diarrhea.
• Pain in the veins where Meropenem Kabi is injected.
• Other changes in your blood. The 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).
• Sudden confusion and disorientation (delirium).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem Kabi 500 mg

Keep out of sight and reach of children.

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

Do not store above 30°C.

Injection

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

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

• 12 hours when stored under refrigeration (2-8°C).

Infusion

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

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

• 24 hours if stored under refrigeration (2-8°C) when Meropenem Kabi is dissolved in sodium chloride 0.9%;
• 1 hour if stored at a temperature up to 25°C when Meropenem Kabi is dissolved in dextrose 5% solution;
• 8 hours if stored under refrigeration (2-8°C) when Meropenem Kabi is dissolved in dextrose 5% solution.

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

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

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. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Meropenem Kabi

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

Appearance of the Product and Container Contents

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

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

Container sizes of 1 or 10 vials/bottles.

Only some container 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 infusion

Austria

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

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

Bulgaria

Meropenem Kabi 500 mg

Cyprus

Meropenem Kabi 500 mg, σκόνη για ενδοφλέβια διαλύματα ή διαλύματα 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, σκόνη για διαλύματα προς ένεση ή έγχυση

Greece

Hungary

Meropenem Kabi 50 mg

Ireland

Meropenem 500 mg powder for solution for injection or infusion

Latvia

Meropenem Kabi 500 mg pulveris injekciju vai infuziju šķīduma pagatavošanai

Lithuania

Meropenem Kabi 500 mg milteliai injekciniam arba infuziniam tirpalui

Meropenem Kabi 500 mg Pulver zur Herstellung einer Injektionslösung oder Infusionslösung

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

Norway

Poland

Meropenem Kabi

Portugal

Meropenem Kabi 500 mg Pó para solução injectável ou para perfusão

Romania

Meropenem Kabi 500 mg pulbere pentru solutie injectabila sau perfuzabila

Spain

Meropenem Kabi 500 mg polvo para solución inyectable o para perfusión

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

Sweden

Meropenem Kabi 500 mg prašek za raztopino za injiciranje ali infundiranje

Slovenia

Meropenem Kabi 500 mg

Slovakia

United Kingdom

Meropenem 500 mg powder for solution for injection or infusion

This leaflet was last revised in May 2022.

Health Advice/Education

Antibiotics are used to treat infections caused by bacteria. They have no effect on 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 taken. This means they can survive and even multiply, despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics with caution can help reduce the opportunities for bacteria to become resistant to them.

When your doctor prescribes you antibiotic treatment, it is to treat only your current illness. Paying attention to the following tips will help prevent the emergence of resistant bacteria that could stop the antibiotic from working.

2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people, even if they have had a similar infection to yours.
4. You should not give antibiotics that were prescribed for you to other people.
5. If you have any antibiotic left over after completing your treatment as directed by your doctor, you should take it to the pharmacy for proper disposal.

Detailed and up-to-date information on this medicinal product 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 only for healthcare professionals:

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 a doctor or nurse has trained you.

How to Prepare this Medicinal Product

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

2. Remove the Meropenem Kabi vial (or bottle) from the packaging. Check the vial and expiration date. Check that the vial is intact and has not been damaged.
3. Remove the colored cap and clean the rubber stopper with an alcohol-impregnated cotton swab. Let the rubber stopper dry.
4. Insert a new sterile needle into a new sterile syringe, without touching the ends.
5. Draw up the recommended amount of sterile "Water for Injection" with the syringe. The amount of liquid you need is shown in the following table:

Dose of Meropenem Kabi Amount of 'Water for Injection' needed for dilution

500 mg (milligrams) 10 ml (milliliters)

1 g (gram) 20 ml

1.5 g 30 ml

2 g 40 ml

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

1. Puncture the center of the rubber stopper with the syringe needle and inject the recommended amount of "Water for Injection" into the Meropenem Kabi vial(s).
2. 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 again with a new alcohol-impregnated cotton swab and let it dry.
3. With the syringe plunger fully pushed into the syringe, puncture the rubber stopper again with the needle. You should then hold the syringe and vial and turn the vial upside down.
4. Keeping the needle tip in the liquid, pull the plunger and draw up all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and discard the empty vial in an appropriate container.
6. Hold the syringe vertically, with the needle facing upwards. Gently tap the syringe to make any bubbles in the liquid rise to the top of the syringe.
7. Remove the air from the syringe by gently pushing the plunger until the air has been expelled.
8. If you are using Meropenem Kabi at home, dispose of the needles and infusion lines you have used properly. If your doctor decides to interrupt your treatment, dispose of any unused Meropenem Kabi properly.

Administration of the Injection

You can administer this medicinal product through a peripheral intravenous catheter or through a central port or line.

Administration of Meropenem Kabi through a Peripheral Intravenous Catheter

1. Remove the needle from the syringe and discard it carefully in authorized containers for sharp objects.
2. Clean the end of the peripheral intravenous catheter with an alcohol-impregnated cotton swab and let it dry. Open the cannula cap and connect the syringe.
3. Slowly press the syringe plunger to administer the antibiotic constantly over about 5 minutes.
4. Once you have finished administering the antibiotic and the syringe is empty, remove it and flush the line as recommended by your doctor or nurse.
5. Close the cannula cap and discard the syringe carefully in authorized containers for sharp objects.

Administration of Meropenem Kabi through a Central Port or Line

1. Remove the cap from the port or line, clean the end of the line with an alcohol-impregnated cotton swab, and let it dry.
2. Connect the syringe and slowly press the plunger to administer the antibiotic constantly over about 5 minutes.
3. Once you have finished administering the antibiotic, remove the syringe and flush the line as recommended by your doctor or nurse.

1. Place a new clean cap on the central line and discard the syringe carefully in authorized containers for sharp objects.