Meropenem Aurovit 1000 mg powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Meropenem Aurovit 1,000 mg powder for solution for injection and infusion EFG

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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must 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, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Meropenem Aurovit 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 are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, 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. Do not dispose of 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 may occur during and after childbirth.
• Complicated skin and soft tissue infections.
• Acute bacterial infection of the brain (meningitis).

Meropenem can be used to treat febrile neutropenic patients suspected of having a bacterial infection.

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 Aurovit

Do not use Meropenem Aurovit

• if you are allergic to meropenem or to any of the other ingredients of this medicine (listed in section 6).
• 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 pharmacist before starting Meropenem Aurovit:

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

Liver problems

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

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, inform your doctor or nurse immediately so that symptoms can be treated.

If you experience unexplained muscle pain, tenderness or weakness, and/or dark urine, inform your doctor immediately. This may be a sign of muscle breakdown (called rhabdomyolysis), which can lead to kidney problems.

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

Other medicines and Meropenem Aurovit

Inform your doctor, pharmacist, or nurse 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 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 should not be used, as it may reduce the effect of valproic acid/sodium valproate/valpromide.
• Oral anticoagulant agent (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 the use of 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 intend to breastfeed before receiving meropenem. Small amounts of this medicine pass into breast milk. Therefore, your doctor will decide whether you should use meropenem while 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). Either of these effects could affect your ability to drive or use machines.

Meropenem may cause involuntary muscle movements, leading to rapid, uncontrolled shaking of the body (seizures). This is usually accompanied by loss of consciousness. Do not drive or use machines if you experience this adverse effect.

Meropenem Aurovit contains sodium

This medicine contains approximately 90 mg of sodium (a main component of table/cooking salt) per vial.

The recommended maximum daily dose of this medicine contains 540 mg of sodium. This corresponds to 27% of the maximum recommended daily sodium intake for an adult.

Consult your doctor or pharmacist if you need 4 or more vials per day for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to use Meropenem Aurovit

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

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, you will receive 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 and up to 12 years is determined based on the child's age and weight. The usual dose ranges from 10 mg to 40 mg of meropenem per kilogram (kg) of the child’s body weight. A dose is normally administered every 8 hours. Children weighing more than 50 kg will receive an adult dose.

• Meropenem will be administered to you as an injection or intravenous infusion into a large vein.
• Meropenem is normally 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 Aurovit to yourself or another person at home”). Follow exactly the administration instructions provided 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 Aurovit than you should

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

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

If you forget to use Meropenem Aurovit

If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled 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 using Meropenem Aurovit

Do not discontinue meropenem 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 may cause adverse effects, although not everyone gets them.

Severe allergic reactions

If you experience any of the following signs and symptoms, contact your doctor immediately. You may require urgent medical treatment. Signs and 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 enlarged lymph nodes. These may be signs of a multiorgan 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 rashes that may appear as red, circular spots, often with central blisters on the trunk, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals and eyes, 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 (unknown frequency)

Symptoms include:

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

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

Muscle breakdown

• Muscle pain without apparent cause, tenderness or weakness and/or dark-colored urine.

If you notice these signs or symptoms, seek immediate medical attention.

Other possible adverse effects:

Frequent (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 by blood test).
• Changes in blood tests, including tests showing how your liver is functioning.

Uncommon (may affect up to 1 in 100 people)

• Blood changes. 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 your kidneys are functioning.
• Decreased potassium levels in the blood (which may cause weakness, muscle cramps, tingling sensations, and irregular heart rhythms).
• Liver problems. Yellowing of the skin and eyes, itching, dark urine or pale stools. If you notice these signs or symptoms, contact a doctor immediately.
• Tingling sensation (pins and needles).
• Mouth (thrush) or vaginal fungal infections.
• Inflammation of the intestine with diarrhea.
• Pain in the veins where meropenem 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.
• Acute disorientation and confusion (delirium).

With other medicines of the same type, sudden chest pain has been observed, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. If this occurs, contact a doctor or nurse immediately.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem Aurovit

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.

No special storage conditions are required.

Injection:

After reconstitution: Reconstituted solutions for intravenous 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 up to 25°C.
• 12 hours when stored in the refrigerator (2–8°C). In this case, if the prepared solution is stored in the refrigerator (i.e., at 2–8°C), it must be used within 1 hour after removal from the refrigerator.

Infusion:

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

• 3 hours when stored at up to 25°C, if meropenem is dissolved in sodium chloride.
• 24 hours when stored in the refrigerator (2–8°C), if meropenem is dissolved in sodium chloride.
• The reconstituted meropenem solution in 5% glucose (dextrose) solution must be used immediately. The time interval between the start of reconstitution and the end of intravenous injection or infusion must not exceed one hour.

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. 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 Aurovit

Each vial contains meropenem trihydrate equivalent to 1,000 mg of anhydrous meropenem.

The other component is sodium carbonate.

Presentation of the product and contents of the pack

Meropenem Aurovit is presented as a powder for injectable solution and for infusion.

It must be dissolved before use and administered either as a direct injection or by infusion.

The medicine is supplied in glass vials containing a white or slightly yellow powder, in pack sizes of 1 vial or 10 vials.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

ACS Dobfar S.p.A.

Nucleo Industriale S. Atto, S. Nicolò a Tordino

64100 Teramo

Italy

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

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Date of the most recent review of this leaflet: October 2025

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 carefully may help reduce the chance of bacteria becoming resistant.

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

1. It is very important to receive the correct dose of the antibiotic, at the correct times, and for the correct number of days. Read the instructions in this leaflet, and if you do not understand something, consult your doctor or pharmacist for clarification.
2. Do not take 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 take 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 antibiotic after completing your treatment as directed by your doctor, return it to the pharmacy for proper disposal.

This information is intended solely for doctors or healthcare professionals:

Instructions for administering Meropenem Aurovit 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.

• 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.

How to prepare this medicine

1. Wash your hands thoroughly and dry them well. Prepare a clean work area.
2. Remove the vial of Meropenem Aurovit from its packaging. Check the vial and the expiry date. Ensure the vial is intact and has not been damaged.
3. Remove the coloured cap and clean the grey rubber stopper with an alcohol-impregnated cotton swab. Allow the rubber stopper to dry.
4. Insert a new sterile needle into a new sterile syringe, taking care not to touch 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 table below:

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

1. Pierce the center of the grey rubber stopper with the needle of the syringe and inject the recommended amount of “Water for Injection” into the Meropenem Aurovit vial(s).
2. Remove the needle from the vial. Shake well for about 15 seconds and observe for 1 minute. If the powder is not completely dissolved, shake again for 15 seconds. This may be repeated once more, if necessary. Clean the grey rubber stopper again with a new alcohol-impregnated cotton swab and allow it to dry.
3. With the plunger of the syringe fully pushed in, pierce the grey rubber stopper again with the needle. Then hold the syringe and vial together and invert the vial.
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 so that any air bubbles rise to the upper part of the syringe.
7. Expel the air from the syringe by gently pushing the plunger until all the air has been removed.
8. If you are using Meropenem Aurovit at home, properly dispose of the needles and infusion lines you have used. If your doctor decides to discontinue your treatment, properly dispose of any unused Meropenem Aurovit.

Administration of the injection

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

Administration of Meropenem Aurovit 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 Aurovit 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 push the plunger to administer the antibiotic at a steady rate over approximately 5 minutes.
3. After completing the antibiotic administration, 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.