Meropenem Kern Pharma 500 mg powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Meropenem Kern Pharma 500 mg powder for solution for injection and infusion EFG

Meropenem Kern Pharma 1000 mg powder for solution for injection and infusion EFG

Read all of this 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, pharmacist 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 pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

The name of this medicine is one of the following:

• Meropenem Kern Pharma 500 mg powder for solution for injection and infusion
• Meropenem Kern Pharma 1000 mg powder for solution for injection and infusion

In the remainder of this leaflet, the medicine is referred to as Meropenem Kern Pharma

Contents of this leaflet:

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

1. What Meropenem Kern Pharma is and what it is used for

Meropenem contains the active substance meropenem and 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 influenza or the common cold.

It is important that you follow your doctor's instructions regarding dose, frequency, and duration of treatment.

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.

This medicine is used to treat the following conditions 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 that may occur during and after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial infection of the brain (meningitis)

Meropenem may be used to treat patients who are neutropenic and have fever suspected to be due to a bacterial infection.

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

2. What you need to know before using Meropenem Kern Pharma

Do not use Meropenem Kern Pharma if:

• You are allergic to meropenem or to any of the other ingredients of this medicine (listed in section 6).
• You are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems, as you may also be allergic to meropenem.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before starting Meropenem Kern Pharma if:

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

You may develop a positive result in a test (Coombs test) indicating the presence of antibodies that can 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, contact 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 Kern Pharma.

Using Meropenem with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is because meropenem may affect how some medicines work, and some of these medicines may affect meropenem.

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

• Probenecid (used to treat gout).
• Sodium valproate (used to treat epilepsy). Meropenem should not be used, as it may reduce the effect of sodium valproate.
• Anticoagulant agents (used to treat or prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 meropenem should be used.

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 meropenem should be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

Meropenem has been associated with headache and tingling or prickling sensations in the skin (paresthesia). Any of these side effects could affect your ability to drive or use machines.

Meropenem may cause involuntary muscle movements, which may result in rapid, uncontrolled body movements (seizures). This is usually accompanied by loss of consciousness.

Do not drive or operate machinery if you experience this adverse effect.

Meropenem Kern Pharma contains sodium

Meropenem Kern Pharma 500 mg: This medicine contains approximately 45 mg of sodium per 500 mg dose. This is equivalent to 2.25% of the maximum recommended daily sodium intake for an adult.
Meropenem Kern Pharma 1000 mg: This medicine contains 90 mg of sodium per 1.0 g dose. This is equivalent to 4.5% of the maximum recommended daily sodium intake for an adult.

If you have a medical condition requiring you to control your sodium intake, inform your doctor, pharmacist, or nurse.

3. How to use Meropenem Kern Pharma

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

Use in adults

• The dose depends on the type of infection you have, the part of the body affected, and its severity. Your doctor will decide the dose you need.
• The dose in adults ranges from 500 mg (milligrams) to 2 g (grams). Normally, you will be given a dose 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 of age up to 12 years is determined based on the child's age and weight. The usual dose is between 10 mg and 40 mg of meropenem per kilogram (kg) of the child's body weight. Normally, a dose is administered every 8 hours. Children weighing more than 50 kg will receive an adult dose.

How to use Meropenem

• Meropenem will be administered to you as an injection or intravenous infusion into a large vein.
• Usually, meropenem will be given by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer meropenem at home. Instructions for this are included in this leaflet (in the section titled “Instructions for administering Meropenem Kern Pharma to yourself or another person at home”). Follow exactly the administration instructions for meropenem 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 is administered.
• Injections should normally be given at the same time each day.

If you use more Meropenem Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Meropenem Kern Pharma

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 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 treatment with Meropenem Kern Pharma

Do not stop meropenem unless instructed by your doctor.

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

4. Possible adverse effects

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

Severe allergic reactions

If you experience any of the following signs or symptoms, contact your doctor or nurse 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 liver enzyme levels), increase in a type of white blood cells (eosinophilia), and enlargement of the lymph nodes. These may be signs of a multi-organ hypersensitivity disorder known as DRESS syndrome.
• Severe red, scaly rash, skin lesions containing pus, blisters or skin peeling, 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, ulcers in the mouth, throat, nose, genitals and eyes, and which may 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)

Symptoms include:

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

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

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

• Abdominal (stomach) pain
• Feeling unwell (nausea)
• Malaise (vomiting)
• Diarrhea
• Headache
• Skin rash, itching of the skin
• Pain and inflammation
• Increased number of platelets in the blood (detected in a blood test)
• Changes in blood tests, including tests showing how 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 increased levels of a substance called “bilirubin”. Your doctor may perform periodic blood tests.
• Changes in blood tests, including tests showing how your kidneys are functioning.
• Tingling sensation (pins and needles).
• Mouth or vaginal fungal infections (thrush).
• Inflammation of the intestine with diarrhea.
• Pain in the veins where Meropenem Kern Pharma 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 1,000 people)

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

Sudden chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome with other medicines of the same type. If this occurs, consult a doctor or nurse immediately.

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem Kern Pharma

Keep this medicine 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.

Injection

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

• 3 hours when stored at a temperature up to 25°C.
• 12 hours when stored under refrigerated conditions (2°C - 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 when stored at a temperature up to 25°C, when Meropenem Kern Pharma is dissolved in sodium chloride.
• 24 hours when stored under refrigerated conditions (2°C - 8°C), when Meropenem Kern Pharma is dissolved in sodium chloride.
• When Meropenem Kern Pharma is dissolved in glucose, the solution must be used immediately.

From a microbiological standpoint, 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 of use are the responsibility of the user.

Do not refrigerate or freeze the reconstituted solution.

Medicines should not be disposed of via wastewater or household waste. 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 Kern Pharma

• The active substance is meropenem.
• The other component is anhydrous sodium carbonate.

Meropenem Kern Pharma 500 mg: each vial contains meropenem trihydrate equivalent to 500 mg of anhydrous meropenem.

Meropenem Kern Pharma 1000 mg: each vial contains meropenem trihydrate equivalent to 1000 mg of anhydrous meropenem.

Appearance of the product and contents of the container

Meropenem Kern Pharma is a white to pale yellow crystalline powder for solution for injection or infusion in a glass vial sealed with a rubber stopper and an aluminum flip-off cap. It is available in packs of 1 or 10 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa (Barcelona)
Spain

Manufacturer

DEMO S.A.
21st km National Road Athens-Lamia,
14568 Krioneri, Athens
Greece

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria: Meropenem Noridem 500 mg Powder for solution for injection/infusion, Meropenem Noridem 1 g Powder for solution for injection/infusion
Germany: Meropenem Noridem 500 mg Powder for solution for injection/infusion, Meropenem Noridem 1 g Powder for solution for injection/infusion
Greece: MEROPENEM/NORIDEM 500 mg κόνις για ενέσιμο διάλυμα /διάλυμα προς έγχυση
Ireland: Meropenem 500 mg Powder for solution for injection/infusion, Meropenem 1 g Powder for solution for injection/infusion
Poland: Meropenem Noridem 500 mg proszek do wstrzykiwania / do infuzji, Meropenem Noridem 1 g proszek do sporządzania roztworu do wstrzykiwania / do infuzji

Date of the most recent revision of this leaflet: 03/2025.

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

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 antibiotic treatment. 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 presence of the antibiotic.

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

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

1. It is very important that you receive the correct dose of the antibiotic, at the right times, and for the correct number of days. Read the instructions in the leaflet carefully, and if anything is unclear, consult your doctor or pharmacist for clarification.
2. Do not use an antibiotic unless it has been specifically prescribed for you, and use it only to treat the infection for which it was prescribed.
3. Do not use antibiotics prescribed for other people, even if they had a similar infection to yours.
4. Do not give your prescribed antibiotics to other people.
5. If you have leftover antibiotics after completing your treatment as directed by your doctor, return them to a pharmacy for proper disposal.

Instructions for administering Meropenem Kern Pharma to yourself or another person at home

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

Warning – You must 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.

1. Wash your hands thoroughly and dry them well. Prepare a clean work area.
2. Remove the vial of Meropenem Kern Pharma from the pack. 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 Injections” into the syringe. The amount of liquid required is shown in the table below:

Please note: If the amount of meropenem prescribed for you is greater than 1000 mg, you will need to use more than one vial of Meropenem Kern Pharma. You may then withdraw the liquid from the vials using a single syringe.

1. Pierce the center of the grey rubber stopper with the syringe needle and inject the recommended amount of “Water for Injections” into the Meropenem Kern Pharma vial(s).
2. Remove the needle from the vial and shake the vial well for about 5 seconds, or until all the powder has dissolved. Clean the grey rubber stopper again with a fresh alcohol-impregnated cotton swab and allow it to dry.
3. With the syringe plunger fully depressed, pierce the grey rubber stopper again with the needle. Hold the syringe and vial together and turn the vial upside down.
4. Keeping the tip of the needle in the liquid, pull back on the plunger and withdraw all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and dispose of the empty vial safely.
6. Hold the syringe vertically with the needle pointing upwards. Gently tap the syringe so that any air bubbles rise to the top.
7. Expel the air from the syringe by gently pushing the plunger until the air has been completely removed.
8. If you are using Meropenem Kern Pharma at home, properly dispose of the needles and infusion sets you have used. If your doctor decides to discontinue your treatment, properly dispose of any unused Meropenem Kern Pharma.

Administration of the injection

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

Administration of Meropenem Kern Pharma through a peripheral intravenous catheter

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

Administration of Meropenem Kern Pharma through a port or central line

1. Remove the cap from the port or line, clean the end of the line with an alcohol-impregnated cotton swab, and allow it to dry.
2. Attach the syringe and slowly push the plunger to administer the antibiotic at a steady rate over approximately 5 minutes.
3. Once the antibiotic administration is complete, 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 your sharps container.