MEROPENEM AUROVITAS 500 mg POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Meropenem Aurovitas 500 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 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

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

Meropenem 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 interval, and treatment duration as indicated 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 medicines down the drain or into the trash.

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 you can acquire during or 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 Aurovitas

Do not use Meropenem Aurovitas

• 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 Aurovitas.

• 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 urine, or light-colored stools. This may be a sign of liver problems that your doctor should check.

You may develop a positive reaction 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 before using meropenem.

Other medicines and Meropenem Aurovitas

Tell your doctor, pharmacist, or nurse 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, breastfeeding, and fertility

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 important that you inform your doctor if you are breastfeeding or plan to breastfeed before receiving 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 performed on the effects on the ability to drive and use machines.

Meropenem has been associated with headache, tingling, or numbness of 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 the 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 side effect.

Meropenem Aurovitas contains sodium

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

Consult your doctor if you need 9 or more vials per day for a prolonged period, especially if you have been advised to follow a low-salt diet (sodium).

3. How to use Meropenem Aurovitas

Follow the instructions for administration of this medicine exactly as 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 Aurovitas

• Meropenem will be administered to you as an injection or infusion into a large vein.
• Meropenem will usually be administered 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 Aurovitas to yourself or another person at home"). Follow the instructions for administration of meropenem exactly as indicated 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 every day.

If you use more Meropenem Aurovitas 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, 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 Aurovitas

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 Aurovitas

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 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 have a severe allergic reaction, stop using meropenem and see a doctor immediately. You may need urgent medical treatment. The symptoms can include:

• Sudden onset of a severe rash, itching, or hives.
• 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, 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 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 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 (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, see a doctor immediately.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abdominal pain (stomach pain).
• 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), 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.
• 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 blood tests periodically.
• Decreased potassium levels in the blood (which can cause weakness, muscle cramps, tingling, and changes in heart rhythm).
• Liver problems. Yellowing of the skin and eyes, itching of the skin, dark 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 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 Aurovitas

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 label of the vial and the carton after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Injection:

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

• 2 hours if stored at controlled room temperature (15-25°C);
• 8 hours if stored in the refrigerator (2-8°C).

Infusion:

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

• 6 hours when stored at controlled room temperature (15-25°C), if meropenem is dissolved in sodium chloride.
• 12 hours when stored at 2-8°C, if meropenem is dissolved in sodium chloride. In this case, if the prepared solution is stored in the refrigerator (i.e., at 2-8°C), it should be used within 1 hour after removal from the refrigerator.
• 30 minutes when meropenem is dissolved in glucose (dextrose).

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 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 Contents and Additional Information

Composition of Meropenem Aurovitas

• The active ingredient is meropenem. Each vial contains meropenem (trihydrate) equivalent to 500 mg of meropenem (anhydrous).
• The other component is anhydrous sodium carbonate.

Appearance of the Product and Container Contents

Meropenem Aurovitas is a white or light yellow crystalline powder for solution for injection and infusion, in a vial. The reconstituted solution is a clear to yellowish solution.

A 30 ml glass vial of type I transparent glass with a bromobutyl rubber stopper and an aluminum cap with a blue polypropylene disc, containing 674.78 mg of powder.

The medicine is available in packs of 1 or 10 vials.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

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

Date of the last revision of this leaflet:September 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/).

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This information is intended only for healthcare professionals:

Instructions for administering Meropenem Aurovitas to yourself or another person at home

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

Caution – You should only administer this medicine to yourself or another person at home after a doctor or nurse has trained you.

Instructions for inserting the needle into the rubber stopper

To avoid the rubber stopper coming off when inserting the needle into the rubber stopper, it is recommended to use a needle with a diameter of 21 gauge or smaller for reconstitution of the medicine.

The needle should only be inserted into the center of the rubber stopper, vertically.

How to prepare this medicine

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

1. Wash your hands and dry them very well. Prepare a clean work area.
2. Remove the Meropenem Aurovitas 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. Insert a new sterile needle into 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:

1. Pierce the center of the rubber stopper with the syringe needle and inject the recommended amount of "Water for injections" into the Meropenem Aurovitas 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 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 should 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 withdraw all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and discard the empty vial in an appropriate container.
6. Hold the syringe vertically, with the needle facing up. Gently tap the syringe to make any air 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 Aurovitas at home, dispose of the needles and infusion lines you have used properly. If your doctor decides to interrupt your treatment, dispose of any unused Meropenem Aurovitas properly.

Administration of the injection

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

Administration of Meropenem Aurovitas through a peripheral intravenous catheter

1. Remove the needle from the syringe and dispose of it carefully in authorized containers for sharp objects.
2. Clean the end of the peripheral intravenous catheter with a cotton swab impregnated with alcohol and let it dry. Open the cannula 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 cannula cap and dispose of the syringe carefully in authorized containers for sharp objects.

Administration of Meropenem Aurovitas through a port or central 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 dispose of the syringe carefully in authorized containers for sharp objects.