MEROPENEM KERN PHARMA 1000 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist 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 pharmacist. This includes any possible side 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 rest of this leaflet, the medicine will be called Meropenem Kern Pharma

Contents of the pack:

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

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

Meropenem contains the active substance meropenem and 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 do not work for viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, administration, and duration of treatment given by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

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

Meropenem 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 Kern Pharma

Do not use Meropenem Kern Pharma if:

• You are allergic to meropenem or 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 had severe diarrhea after taking other antibiotics.

You may develop a positive test result (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 severe skin reactions (see section 4). If this occurs, consult your doctor or nurse immediately so that they can treat the symptoms.

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

Using Meropenem with other medicines

Tell your doctor or pharmacist that you are using or have recently used or may need to use any other medicines.

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

In particular, tell 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 decrease the effect of sodium valproate.
• Anticoagulant agent (used to treat or prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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.

Meropenem has been associated with headache and tingling or numbness 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 can cause rapid and uncontrolled body agitation (convulsions). This is usually accompanied by loss of consciousness.

Do not drive or use machines if you experience this side effect.

Meropenem Kern Pharma contains sodium

Meropenem Kern Pharma 500 mg: This medicine contains approximately 45 mg of sodiumper 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 condition that requires controlling your sodium intake, inform your doctor, pharmacist, or nurse.

3. How to use Meropenem Kern Pharma

Follow the instructions for administration of this medicine 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 area of the body where it is located, and its severity. Your doctor will decide what dose you need.
• The 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 using 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 weight. You will usually be given a dose 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.
• Meropenem will usually be given to you by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer meropenem at home. The instructions for this are found in this leaflet (in the section called "Instructions for administering Meropenem Kern Pharma to yourself or another person at home"). Follow the instructions for administration of meropenem given 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 is administered.
• Injections should usually 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 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 Kern Pharma

Do not stop meropenem until your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, 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 experience any of the following symptoms, tell your doctor or nurse immediately. You may need urgent medical treatment. The symptoms can 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 difficulty breathing.
• Severe skin reactions that include:
• Severe hypersensitivity reactions with fever, skin rash, and changes in blood test results that check liver function (increased liver enzyme levels), increased eosinophils, and swollen lymph nodes. These can be signs of a condition 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 (unknown frequency)

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)
• Feeling sick (nausea)
• Being sick (vomiting)
• Diarrhea
• Headache
• Skin rash, itching
• Pain and inflammation
• Increased platelet count in the blood (checked by a blood test)
• Changes in blood tests, including tests that show how 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 blood tests periodically.
• Changes in blood tests, including tests that show how your kidneys are working.
• Tingling sensation (numbness).
• Mouth or vaginal infections caused by a fungus (thrush).

• Inflammation of the intestine with diarrhea.
• Pain in the veins where Meropenem Kern Pharma is injected.
• Other changes in your blood. The symptoms include frequent infections, fever, and sore throat. Your doctor may perform blood tests periodically.

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

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

Sudden chest pain, which can 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 side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

Injection

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

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

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 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 no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Meropenem Kern Pharma

• The active ingredient 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 Container Content

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

Only some 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 Member States of the European Economic Area under the following names:

Austria: Meropenem Noridem 500 mg Pulver zur Herstellung einer Injektions-/Infusionslösung Meropenem Noridem 1 mg Pulver zur Herstellung einer Injektions-/Infusionslösung

Germany: Meropenem Noridem 500mg Pulver zur Herstellung einer Injektions-/Infusionslösung Meropenem Noridem 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung

Greece: MEROPENEM/NORIDEM 500 mg κ?νις για εν?σιμο δι?λυμα /δι?λυμα προς ?γχυση

Ireland: Meropenem 500mg Powder for solution for injection/infusion

Meropenem 1 g Powder for solution for injection/infusion

Poland: Meropenem Noridem 500mg proszek do wstrzykiwan / do infuzji Meropenem Noridem 1g proszek do sporzadzania roztworu do wstrzykiwan / do infuzji

Date of the Last Revision of this Leaflet: 03/2025.

Detailed 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/

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 to happen 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 opportunity 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 advice will help prevent the appearance of resistant bacteria that could stop the antibiotic from working.

2. You must not use an antibiotic unless it has been specifically prescribed for you, and you must use it only to treat the infection for which it was prescribed.
3. You must not use antibiotics that have been prescribed for other people, even if they have had a similar infection to yours.
4. You must not give antibiotics that were prescribed for you to other people.
5. If you have any antibiotic left over after receiving the treatment as indicated by your doctor, you must take it to the pharmacy so that it can be disposed of properly.

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 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 what amount of diluent to use.
• Use the medicinal product immediately after preparation. Do not freeze it.

2. Remove the Meropenem Kern Pharma vial from the packaging. Check the vial and the expiration date. Check that the vial is intact and has not been damaged.
3. Remove the colored cap and clean the rubber stopper with a cotton swab impregnated with alcohol. Let the rubber stopper dry.
4. Connect a new sterile needle to a new sterile syringe, without touching the ends.
5. Draw up the recommended amount of sterile "Water for injections" with the syringe. The amount of liquid you need is shown in the table below:

Note that:If the amount of meropenem prescribed for you is more than 1000 mg, you will need to use more than one Meropenem Kern Pharma vial. You can then draw up the liquid from the vials with a single syringe.

1. Pierce the center of the gray 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 it well for about 5 seconds, or until all the powder has dissolved. Clean the gray rubber stopper again with a new cotton swab impregnated with alcohol and let it dry.
3. With the syringe plunger fully pushed into the syringe, pierce the gray rubber stopper again with the needle. You must then hold the syringe and the vial and turn the vial upside down.
4. Keeping the needle tip in the liquid, pull the plunger and draw all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and discard the empty vial in a safe place.
6. Hold the syringe vertically, with the needle facing up. 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 come out.
8. If you are using Meropenem Kern Pharma at home, dispose of the needles and infusion lines you have used properly. If your doctor decides to interrupt your treatment, dispose of the unused Meropenem Kern Pharma 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 Kern Pharma through a Peripheral Intravenous Catheter

1. Remove the needle from the syringe and discard it carefully in your sharps container.
2. Clean the end of the catheter with a cotton swab impregnated with alcohol and let it dry. Open the catheter 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 your doctor or nurse has recommended.
5. Close the catheter cap and discard the syringe carefully in your sharps container.

Administration of Meropenem Kern Pharma through a Central Port or Line

1. Remove the cap from the port or line, clean the end of the line with a cotton swab impregnated with alcohol, 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 your doctor or nurse has recommended.
4. Place a new clean cap on the central line and discard the syringe carefully in your sharps container.