Meropenem Hikma 1 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Meropenem Hikma 1 g powder for solution for injection and for 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 questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Meropenem Hikma is and what it is used for

2. What you need to know before using Meropenem Hikma

3. How to use Meropenem Hikma

4. Possible side effects

5. How to store Meropenem Hikma

6. Contents of the pack and other information

1. What Meropenem Hikma is and what it is used for

Meropenem Hikma 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 are not effective against viral infections such as flu or colds.

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 after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

• 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 with neutropenia who have fever suspected to be due to a bacterial infection.

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

2. What you need to know before using Meropenem Hikma

Do not use Meropenem Hikma:

• if you are allergic to meropenem or to any of the other ingredients of this medicine (listed in section 6, “Contents of the pack and other information”).
• if you are allergic 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 Hikma:

• if you have any health problems, such as liver or kidney problems.
• if 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.

Liver problems

Inform your doctor if you notice yellowing of the skin or eyes, itching of the skin, dark-colored urine, or pale-colored stools. These may be signs of liver problems that your doctor needs to check.

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

Using Meropenem Hikma with other medicines

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

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

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 Hikma should not be used, as it may reduce the effect of sodium valproate.

• Oral anticoagulant (used to treat or prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid the use of meropenem during pregnancy.

It is very 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 Hikma while breastfeeding.

Driving and using machines

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

However, meropenem has been associated with headache and tingling or prickling sensations in the skin (paresthesia), as well as involuntary muscle movements that may cause the body to shake rapidly and uncontrollably (seizures), which are usually accompanied by loss of consciousness, and this could affect your ability to drive or use machines.

Meropenem Hikma contains sodium

Meropenem Hikma 1 g: This medicine contains 90 mg of sodium (the main component of table/cooking salt) in each 1 g dose. This corresponds to 4.5% of the maximum recommended daily intake of sodium 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 Hikma

Follow exactly the instructions given by your doctor or nurse for administering this medicine. If you are unsure, consult your doctor 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 appropriate dose for you.
• The usual dose in adults is between 500 mg (milligrams) and 2 g (grams). Normally, a dose is given every 8 hours. However, if your kidneys are not functioning properly, the dose may be given less frequently.

Use in children and adolescents

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

How to use Meropenem Hikma

• Meropenem Hikma will be administered to you as an injection or infusion into a large vein.
• Usually, Meropenem Hikma will be administered by your doctor or nurse.

However, some patients, parents, or caregivers are trained to administer Meropenem Hikma at home. Instructions for this are provided in this leaflet (in the section entitled “Instructions for administering Meropenem Hikma to yourself or another person at home”). Follow exactly the administration instructions for Meropenem Hikma given by your doctor. Consult your doctor if you have any doubts.

• Your injection must not be mixed 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 Hikma is administered.
• Injections should normally be given at the same time each day.

If you use more Meropenem Hikma than you should

If you accidentally use more than the prescribed dose, contact your doctor, go immediately to the nearest hospital, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount received.

If you forget to use Meropenem Hikma

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

Do not use a double dose (two injections at once) to make up for forgotten doses.

If you stop treatment with Meropenem Hikma

Do not stop Meropenem Hikma until your doctor tells you to do so.

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 everybody will experience them.

Severe allergic reactions

If you experience a severe allergic reaction, stop taking Meropenem Hikma and see a doctor immediately. You may require urgent medical treatment. Signs and symptoms may include sudden onset of:

• Severe hives, itching, and blistering of the skin.
• Swelling of the face, lips, tongue, or other parts of the body.
• Shortness of breath, wheezing, or difficulty breathing.

Damage to red blood cells (frequency unknown)

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:

Common (may affect up to 1 in 10 people)

• Abdominal (stomach) pain.
• Nausea.
• Vomiting.
• Diarrhoea.
• Headache.
• Skin rash, itching.
• Pain and inflammation.
• Increase in the 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 increase in a substance called "bilirubin". Your doctor may carry out periodic blood tests.

• Changes in blood tests, including tests showing how your kidneys are functioning.

• Tingling sensation (pins and needles).

• Fungal infections of the mouth or vagina (thrush).

• Inflammation of the intestine with diarrhoea.

• Pain in the veins where Meropenem Hikma is injected.

• Other changes in your blood. Symptoms include frequent infections, fever, and sore throat. Your doctor may carry out periodic blood tests.

• Sudden onset of severe rash, blistering, or peeling of the skin. These may be associated with high fever and joint pain.

• Decrease in potassium levels in the blood (which may cause weakness, muscle cramps, tingling, and irregular heartbeat).

• Liver problems. Yellowing of the skin and eyes, itching, dark urine, or pale stools. If you notice these signs or symptoms, consult a doctor immediately.

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

• Seizures (fits).

Unknown frequency (cannot be estimated from available data)

• 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 the lymph nodes. These may be signs of a multiorgan hypersensitivity disorder known as DRESS syndrome.

Reporting of adverse effects

If you experience any 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 Hikma

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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

Injectable

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

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

Infusion

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

• 3 hours when stored up to 25°C, when meropenem is dissolved in sodium chloride;
• 24 hours when stored under refrigerated conditions (2–8°C), when meropenem is dissolved in sodium chloride;
• when meropenem is dissolved in dextrose, 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 freeze the reconstituted solution.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Meropenem Hikma

Each vial contains meropenem trihydrate equivalent to 1 g of anhydrous meropenem.

The other component is anhydrous sodium carbonate.

Appearance of the product and contents of the container

Meropenem Hikma is a white to pale yellow powder for injectable or infusion solution in a glass vial with a rubber stopper and flip-off aluminum cap.

Pack sizes of 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Hikma Farmacêutica (Portugal) S.A.

Estrada do Rio da Mó, nº8, 8A and 8B, Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer responsible

ACS Dobfar S.p.A Nucleo Industriale S. Atto

• Nicolò a Tordino

64100 TERAMO

Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

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

Austria: Meropenem Hikma 1g Pulver zur Herstellung einer Injektions-/Infusionslösung

Ireland: Meropenem 1g Powder for solution for injection/infusion

Italy: Meropenem Hikma 1g Polvere per soluzione iniettabile o infusione

Germany: Meropenem Hikma 1g Pulver zur Herstellung einer Injektions-/Infusionslösung

Portugal: Meropenem Hikma 1g P? para solução injetável ou para perfusão

Netherlands: Meropenem Hikma 1000 mg Poeder voor oplossing injectie voor infusie

United Kingdom: Meropenem 1g Powder for solution for injection/infusion

France: Meropenem Hikma 1mg Poudre pour solution injectable/pour perfusion

Date of the most recent review of this package leaflet: August 2025

Other sources of information:

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

Medical advice/health 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 taken. 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 chance of bacteria becoming resistant to them. When your doctor prescribes an antibiotic treatment, it is intended only for your current illness. Following the advice below will help prevent the emergence of resistant bacteria that could stop the antibiotic from working. 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 package leaflet, and if you do not understand something, consult your doctor or pharmacist for clarification. You should not use an antibiotic unless it has been specifically prescribed for you, and you should use it only to treat the infection for which it was prescribed. You should not use antibiotics that have been prescribed for other people, even if they had an infection similar to yours. You should not give other people antibiotics that were prescribed for you. If you have leftover antibiotics after completing your treatment as directed by your doctor, you should return them to the pharmacy for proper disposal.

This information is intended for healthcare professionals only:

The following sections contain practical information regarding the preparation and administration of the product. When assessing the suitability of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics. See also section 3, “How to use Meropenem,” in this leaflet.

Instructions for self-administering Meropenem Hikma or administering it to another person at home

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

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

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

How to prepare this medicine

1. Wash your hands thoroughly and dry them. Prepare a clean workspace.
2. Remove the Meropenem Hikma 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 grey 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, taking care not to touch the ends.
5. Draw into the syringe the recommended volume of sterile “Water for Injections.” The volume of liquid required is shown in the table below:

Meropenem Hikma dose	Amount of “Water for Injections” required for dilution
500 mg (milligrams)	10 ml (millilitres)
1 g (gram)	20 ml
1.5 g	30 ml
2 g	40 ml

Please note: If the amount of Meropenem Hikma prescribed to you is greater than 1 g, you will need to use more than one vial of Meropenem Hikma. You may then withdraw the liquid from the vials into a syringe.

1. Insert the needle of the syringe through the centre of the grey rubber stopper and inject the recommended amount of Water for Injections into the vial(s) of Meropenem Hikma.
2. Remove the needle from the vial and shake 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, reinsert the needle through the grey rubber stopper. Then hold the syringe and vial together and invert the vial up and down.
4. Keeping the tip of the needle in the liquid, pull back 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 in an appropriate container.
6. Hold the syringe vertically with the needle pointing upwards. Gently tap the syringe to allow any air bubbles in the liquid to rise to the top.
7. Expel the air from the syringe by gently pushing the plunger until the air has been removed.
8. If you are using Meropenem Hikma at home, properly dispose of used needles and infusion sets. If your doctor decides to discontinue your treatment, properly dispose of any unused Meropenem Hikma.

Administration of the injection

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

Administration of Meropenem Hikma via peripheral intravenous catheter

1. Remove the needle from the syringe and carefully dispose of it in your authorized sharps container.
2. Clean the end of the peripheral intravenous catheter with an alcohol-impregnated cotton swab and allow it to dry. Remove the cannula 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 instructed by your doctor or nurse.
5. Replace the cannula cap and carefully dispose of the syringe in your authorized sharps container.

Administration of Meropenem Hikma via 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 depress the plunger to administer the antibiotic at a steady rate over approximately 5 minutes.
3. After completing administration of the antibiotic, remove the syringe and flush the line as instructed by your doctor or nurse.
4. Place a new clean cap on the central line and carefully dispose of the syringe in your authorized sharps container.

Administration of Meropenem Hikma by intravenous infusion

Meropenem may be administered by intravenous infusion over approximately 15–30 minutes. For intravenous infusion, Meropenem Hikma vials may be reconstituted directly to a final concentration of 1 to 20 mg/ml with 0.9% sodium chloride or 5% glucose infusion solution.

The solution should be shaken before use.

The vials are for single use only.