MEROPENEM AUROVIT 1000 mg POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

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

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, pharmacist, 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

1. What Meropenem Aurovit is and what it is used for
2. What you need to know before you use Meropenem Aurovit
3. How to use Meropenem Aurovit
4. Possible side effects
5. Storage of 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 will not work for viral infections such as the common cold or flu.

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 in 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 and after childbirth.
• Complicated skin and soft tissue infections.
• Acute bacterial infection of the brain (meningitis).

Meropenem can 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 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 or pharmacist 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. 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 Aurovit

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

This is because meropenem can 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 can decrease 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 have a baby, ask your doctor or pharmacist for advice 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. Small amounts of this medicine pass into breast milk. Therefore, your doctor will decide if you should use meropenem during breastfeeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, meropenem has been associated with headache; tingling or numbness in the skin (paresthesia); and involuntary muscle movements, leading to rapid and uncontrolled body movements (convulsions), which are usually accompanied by loss of consciousness. Any of these effects could affect your ability to drive or use machines.

Meropenem Aurovit contains sodium

This medicine contains approximately 90 mg of sodium (the main component of table/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 intake of sodium for an adult.

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

3. How to use Meropenem Aurovit

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

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. A dose is usually given every 8 hours. Children who weigh more than 50 kg will be given an adult dose.

• Meropenem will be given to you as an injection or infusion into a large vein.
• Meropenem will usually be given to you 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 Aurovit 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 can 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 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 forget 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 further questions on 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 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 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 check liver function (increased liver enzyme levels), increased white blood cell count (eosinophilia), 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 skin peeling, which can be associated with high fever and joint pain.
• Severe skin reactions that can appear as circular red patches, often with blisters in the center, on the trunk, skin peeling, 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 (unknown frequency)

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 blood, including a decrease in platelet count (which can make you bruise more easily), increased white blood cell count, decreased white blood cell count, and increased bilirubin levels. Your doctor may perform blood tests periodically.
• Changes in blood tests, including tests that show how your kidneys are working.
• Decreased potassium levels in the blood (which can cause weakness, muscle cramps, tingling, and heart rhythm disturbances).
• 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.
• Tingling sensation (paresthesia).
• 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.

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 that the side effects are 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 Aurovit

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 carton after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Injection:

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

• 3 hours when stored up to 25°C.
• 12 hours when stored in a refrigerator (2-8°C). In this case, if the prepared solution is stored in a refrigerator (i.e., at 2-8°C), it should be used within 1 hour after removal from the refrigerator.

Infusion:

After reconstitution: The reconstituted solutions for intravenous infusion should be used immediately. The time 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 a 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 between the start of reconstitution and the end of injection or infusion should not exceed 1 hour.

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. Contents of the container and additional information

Composition of Meropenem Aurovit

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

The other component is anhydrous sodium carbonate.

Appearance of the product and contents of the container

Meropenem Aurovit is presented in the form of powder for injectable solution and for infusion.

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

The medication is presented in glass vials containing a white or slightly yellow powder, in packages with 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

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

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Date of the last revision of this prospectus: September 2025

This information is intended only for 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 should only administer this medication to yourself or another person at home after a doctor or nurse has trained you.

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

How to prepare this medication

1. Wash your hands and dry them very well. Prepare a clean work area.
2. Remove the Meropenem Aurovit vial from the package. Check the vial and expiration date. Check that the vial is intact and has not been damaged.
3. Remove the colored cap and clean the gray rubber stopper with a cotton swab soaked in 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 Injection" with the syringe. The amount of liquid you need is shown in the table below:

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

1. Pierce the center of the gray rubber stopper with the syringe needle 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 can be repeated once more if necessary. Clean the gray rubber stopper again with a new cotton swab soaked in 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 vial and turn the vial upside down.
4. Keeping the needle tip in the liquid, pull the plunger and draw up 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 pointing up. Gently tap the syringe to make any 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 Aurovit at home, dispose of the needles and infusion lines you have used in an appropriate manner. If your doctor decides to interrupt your treatment, dispose of the unused Meropenem Aurovit in an appropriate manner.

Administration of the injection

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

Administration of Meropenem Aurovit through a peripheral intravenous catheter

1. Remove the needle from the syringe and discard it carefully in authorized containers for sharp objects.
2. Clean the end of the peripheral intravenous catheter with a cotton swab soaked in alcohol and let it dry. Open the cap of the cannula and connect the syringe.
3. Slowly press the syringe plunger to administer the antibiotic at a constant rate over about 5 minutes.
4. Once you have finished administering the antibiotic and the syringe is empty, remove it and flush the line as recommended by your doctor or nurse.
5. Close the cap of the cannula and discard the syringe carefully in authorized containers for sharp objects.

Administration of Meropenem Aurovit through a central port or line

1. Remove the cap from the port or line, clean the end of the line with a cotton swab soaked in alcohol, and let it dry.
2. Connect the syringe and slowly press the plunger to administer the antibiotic at a constant rate over about 5 minutes.
3. Once you have finished administering the antibiotic, remove the syringe and flush the line as recommended by your doctor or nurse.
4. Place a new clean cap on the central line and discard the syringe carefully in authorized containers for sharp objects.

Composition of Meropenem Aurovit

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

The other component is anhydrous sodium carbonate.

Appearance of the product and contents of the container

Meropenem Aurovit is presented in the form of powder for injectable solution and for infusion.

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

The medication is presented in glass vials containing a white or slightly yellow powder, in packages with 1 vial or 10 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

ACS Dobfar S.p.A.

Nucleo Industriale S. Atto, S. Nicolò a Tordino

64100 Teramo

Italy

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

Date of the last revision of this prospectus: September 2020

This information is intended only for 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 should only administer this medication to yourself or another person at home after a doctor or nurse has trained you.

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

How to prepare this medication

1. Wash your hands and dry them very well. Prepare a clean work area.
2. Remove the Meropenem Aurovit vial from the package. Check the vial and expiration date. Check that the vial is intact and has not been damaged.
3. Remove the colored cap and clean the gray rubber stopper with a cotton swab soaked in 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 Injection" with the syringe. The amount of liquid you need is shown in the table below:

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

1. Pierce the center of the gray rubber stopper with the syringe needle 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 can be repeated once more if necessary. Clean the gray rubber stopper again with a new cotton swab soaked in 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 vial and turn the vial upside down.
4. Keeping the needle tip in the liquid, pull the plunger and draw up 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 pointing up. Gently tap the syringe to make any 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 Aurovit at home, dispose of the needles and infusion lines you have used in an appropriate manner. If your doctor decides to interrupt your treatment, dispose of the unused Meropenem Aurovit in an appropriate manner.

Administration of the injection

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

Administration of Meropenem Aurovit through a peripheral intravenous catheter

1. Remove the needle from the syringe and discard it carefully in authorized containers for sharp objects.
2. Clean the end of the peripheral intravenous catheter with a cotton swab soaked in alcohol and let it dry. Open the cap of the cannula and connect the syringe.
3. Slowly press the syringe plunger to administer the antibiotic at a constant rate over about 5 minutes.
4. Once you have finished administering the antibiotic and the syringe is empty, remove it and flush the line as recommended by your doctor or nurse.
5. Close the cap of the cannula and discard the syringe carefully in authorized containers for sharp objects.

Administration of Meropenem Aurovit through a central port or line

1. Remove the cap from the port or line, clean the end of the line with a cotton swab soaked in alcohol, and let it dry.
2. Connect the syringe and slowly press the plunger to administer the antibiotic at a constant rate over about 5 minutes.
3. Once you have finished administering the antibiotic, remove the syringe and flush the line as recommended by your doctor or nurse.
4. Place a new clean cap on the central line and discard the syringe carefully in authorized containers for sharp objects.