MEROPENEM AUROVIT 2.000 mg POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you use Meropenem Aurovit

Do not use Meropenem Aurovit

• If you are allergic to meropenem or 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

Consult 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 had severe diarrhea after taking other antibiotics.

Liver problems

Tell your doctor if you notice yellowing of the skin and eyes, itching of the skin, dark-colored urine, or light-colored stools. It may be a sign of liver problems that your doctor should check.

You may develop a positive response to a test (Coombs test) that indicates 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 happens, inform your doctor or nurse immediately so that they can treat the symptoms.

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

Other medicines and Meropenem Aurovit

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

This is because meropenem may affect the way some medicines work, and some of these may have an effect on meropenem.

In particular, tell 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 decrease the effect of sodium valproate.
• 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 plan 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 if you should use meropenem.

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 if 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). Either of these effects could affect your ability to drive or use machines.

Meropenem may cause involuntary muscle movements, which can cause the person's body to shake rapidly and uncontrollably (convulsions). This is usually accompanied by a loss of consciousness. Do not drive or use machines if you experience this adverse effect.

Meropenem Aurovit contains sodium

This medicine contains approximately 180 mg of sodium (main component of table salt/cooking salt) per vial.

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

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

3. How to use Meropenem Aurovit

Follow exactly the administration instructions of this medicine indicated by your doctor or nurse. If in doubt, consult your doctor 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 normal 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 normal 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 Aurovit

• Meropenem will be administered to you as an infusion into a large vein.
• Meropenem will usually be administered by your doctor or nurse.
• Your injection should not be mixed with or added to solutions that contain other medicines.
• The injection may last between 15 and 30 minutes. Your doctor will tell you how meropenem is administered.
• Injections are usually given at the same time every day.

If you use more Meropenem Aurovit than you should

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

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 Aurovit

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 Aurovit

Do not stop meropenem until your doctor tells you to.

If you have any other questions about 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 these signs and symptoms, tell your doctor or nurse immediately. You may need urgent medical treatment. The signs and 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 control liver function (increase in liver enzyme levels), increase in a type of white blood cell (eosinophilia), and enlargement of lymph nodes. These can be signs of a multi-organ sensitivity disorder 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 can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Damaged red blood cells (frequency not known)

The symptoms include:

• Shortness of breath when you do not expect it.
• Red or brown urine.

If you notice any of the above, go to a doctor immediately.

Other possible side effects:

Frequent (may affect up to 1 in 10 people)

• Abdominal pain (stomach).
• Nausea.
• Vomiting.
• Diarrhea.
• Headache.
• Rash, itching of the skin.
• Pain and inflammation.
• Increased platelet count in the blood (checked in 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 the blood. These include a decrease in the number of platelets (which can make you bruise more easily), an increase in some white blood cells, a decrease in other white blood cells, and an increase in the amount of a substance called "bilirubin". Your doctor may perform periodic blood tests.
• 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 is injected.
• Other changes in your blood. The symptoms include frequent infections, fever, and sore throat. Your doctor may perform periodic blood tests.
• Decrease in potassium levels in the blood (which can cause weakness, muscle cramps, numbness, and changes in heart rhythm).
• Liver problems. Yellowing of the skin and eyes, itching of the skin, dark-colored urine, or light-colored stools. If you notice these signs or symptoms, consult a doctor immediately.

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

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

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Meropenem Aurovit

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the vial after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

After reconstitution:

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

• 3 hours when stored 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 should be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion should not exceed one hour.

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

Do not freeze the reconstituted solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. 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: anhydrous sodium carbonate.

Appearance of the product and contents of the pack

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

It should 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Date of the last revision of this leaflet: June 2025

Detailed information about this medicine 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 antibiotics. One of the most common reasons for this to happen is that the bacteria that cause 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 possibility of bacteria becoming resistant to them.

When your doctor prescribes antibiotic treatment, their goal is to treat only your current illness. Paying attention to the following tips will help prevent the appearance of resistant bacteria that could prevent the antibiotic from working.