Meropenem Aurovit 2.000 mg powder for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Meropenem Aurovit 2,000 mg powder for solution for infusion

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, 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, 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 belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that may 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 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. Medicines should not be disposed of via wastewater or household waste.

Meropenem is used to treat the following infections in adults and children aged 3 months and older:

• 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 febrile neutropenic patients with suspected bacterial infection.

Meropenem may also 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 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, pharmacist, or nurse before starting to use Meropenem Aurovit.

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

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 should investigate.

You may develop a positive result on 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-colored 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 or nurse 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 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 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 very important that you inform your doctor if you are breastfeeding or planning 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 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 of the skin (paresthesia). Either of these effects could affect your ability to drive or use machines.

Meropenem may cause involuntary muscle movements, which may result in rapid and uncontrolled shaking of the body (convulsions). This is usually accompanied by loss of consciousness. Do not drive or operate machinery if you experience this adverse effect.

Meropenem Aurovit contains sodium

This medicine contains approximately 180 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 9% of the maximum daily sodium intake recommended for an adult.

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

Consult your doctor or pharmacist if you need 3 or more vials per day for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

3. How to use Meropenem Aurovit

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

Use in adults

• The dose depends on the type of infection you have, its location in the body, and its severity. Your doctor will decide the dose you need.
• The usual dose in adults is between 500 mg (milligrams) and 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 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 body weight. Doses are normally administered every 8 hours. Children weighing more than 50 kg will receive an adult dose.

How to use Meropenem Aurovit

• Meropenem will be administered to you as an intravenous infusion into a large vein.
• Usually, meropenem will be administered by your doctor or nurse.
• Your injection must not be mixed with or added to solutions containing other medicines.
• The infusion may last 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, it should be administered 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 a forgotten dose.

If you stop using Meropenem Aurovit

Do not stop meropenem treatment unless instructed to do so 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 will experience them.

Severe allergic reactions

If you experience any of the following signs and symptoms, inform your doctor or nurse 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 indicating liver function (elevated liver enzyme levels), increase in a type of white blood cells (eosinophilia), and enlarged lymph nodes. These may be signs of a multi-organ hypersensitivity disorder known as DRESS syndrome.
  • Severe red, scaly rash, pus-filled bumps on the skin, blisters or skin peeling, which may be associated with high fever and joint pain.
  • Severe skin reactions that may appear as circular red spots, often with central blisters on the trunk, skin peeling, and ulcers in the mouth, throat, nose, genitals and eyes, possibly 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 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 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 blood counts, including a decrease in platelets (which may cause you to 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 and inflammation at the site where meropenem was injected.
• Other changes in your blood. Symptoms include frequent infections, fever, and sore throat. Your doctor may perform periodic blood tests.
• Decreased potassium levels in the blood (which may cause weakness, muscle cramps, tingling, and irregular heart rhythms).
• Liver problems: yellowing of the skin and eyes (jaundice), 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).
• 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, consult 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 carton and vial after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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 refrigerated (2–8°C), if meropenem is dissolved in sodium chloride.
• The solution of meropenem reconstituted in 5% glucose (dextrose) solution must be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion must not exceed one hour.

From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and must not exceed the times indicated above for chemical and physical stability during use, whichever is shorter.

Do not freeze the reconstituted solution.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Meropenem Aurovit

• The active substance is meropenem. Each vial contains meropenem trihydrate equivalent to 2,000 mg of anhydrous meropenem.
• The other component is: sodium carbonate.

Appearance of the product and contents of the pack

Meropenem Aurovit is a white to pale yellow powder for infusion.

It must be dissolved before use and administered directly by infusion.

The medicine is available in packs of 6 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

Further information on this medicine is available from the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

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

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

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 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 likelihood of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, the aim is to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could impair the effectiveness of antibiotics.

• It is very important to take the correct dose of the antibiotic, at the correct times and for the correct number of days. Read the instructions in the leaflet carefully, and if you do not understand something, consult your doctor or pharmacist.
• You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it to treat the infection for which it was prescribed.
• You should not take antibiotics that have been prescribed for other people, even if they had an infection similar to yours.
• You should not give your prescribed antibiotics to other people.
• If you have leftover antibiotics after completing your prescribed treatment, you should return the remaining medicine to a pharmacy for proper disposal.