Prospecto: Information for the User

Meropenem Aurovitas 500mg powder for injectable solution and for EFG infusion

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or nurse.

-This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section 4.

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

2.What you need to know before starting to use Meropenem Aurovitas

3.How to use Meropenem Aurovitas

4.Possible adverse effects

5.Storage of Meropenem Aurovitas

6.Contents of the package and additional information

Meropenem belongs to a group of medications known as carbapenem antibiotics. It works by destroying bacteria, which can cause severe infections.

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

•Lung infection (pneumonia)

•Respiratory and lung infections in patients with cystic fibrosis

•Complicated urinary tract infections

•Complicated abdominal infections

•Infections you may acquire during or after delivery

•Complicated skin and soft tissue infections

•Acute bacterial meningitis

Meropenem may be used to treat neutropenic patients with fever suspected to be due to bacterial infection.

Meropenem can be used to treat bacterial blood infections that may be associated with one of the aforementioned infections.

No use Meropenem Aurovitas

•If you are allergic to meropenem or any of the other components of this medication (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.

You may develop a positive response to 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 severe skin reactions (see section 4). If this occurs, 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 Medications and Meropenem Aurovitas

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

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

In particular, inform your doctor or nurse if you are taking any of the following medications:

•Probenecid (used to treat gout).

•Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Do not use meropenem, as it may decrease the effect of sodium valproate.

•Oral anticoagulant (used to treat or prevent blood clots).

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. It is preferable to avoid using meropenem during pregnancy. Your doctor will decide if you should use meropenem.

It is essential to inform your doctor if you are breastfeeding or plan to breastfeed before receiving meropenem. A small amount of this medication may pass into breast milk. Therefore, your doctor will decide if you should use meropenem during breastfeeding.

Driving and Operating Machines

No studies have been conducted on the effects on the ability to drive and operate machines.

Meropenem has been associated with headaches, tingling, or pins and needles (paresthesia). Any of these adverse effects could affect your ability to drive or operate 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 operate machines if you experience this adverse effect.

Meropenem Aurovitas contains sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or nurse. In case of doubt, consult your doctor or nurse again.

Use in adults

•The dose depends on the type of infection you present, 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 normally be given a dose every 8 hours. However, if your kidneys do not function 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 normally be given a dose every 8 hours. Children weighing 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 in a large-caliber vein.

•Meropenem will normally 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 exactly the administration instructions for meropenem as indicated by your doctor. Consult your doctor if you have any doubts.

•Your injection should not be mixed with or added to solutions that contain other medications.

•The injection may take approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to administer meropenem.

•Injections are normally given at the same time every day.

If you use more Meropenem Aurovitas 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Meropenem Aurovitas

If you forget an injection, you should receive it as soon as possible. However, if it is almost time to administer the next injection, do not receive the missed one. Do not use a double dose (two injections at once) to compensate for a missed dose.

If you interrupt treatment with Meropenem Aurovitas

Do not stop meropenem until your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe allergic reactions

If you experience a severe allergic reaction,stop taking meropenem and seek medical attention immediately. You may need urgent medical treatment. Symptoms can include a sudden onset of:

•Severe skin 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, skin rash, and changes in blood test results that control liver function (elevated liver enzymes), increased eosinophils, and lymph node enlargement. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome.

-Severe scaly red rash, skin bumps containing pus, blisters, or skin peeling, which may be associated with high fever and joint pain.

-Severe skin reactions that may appear as circular red patches often with central blisters on the trunk, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Blood cell damage(unknown frequency)

Symptoms include:

•Shortness of breath when not expected.

•Red or brown urine.

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

Other possible side effects:

Frequent (may affect up to 1 in 10 people)

•Abdominal pain.

•Nausea.

•Vomiting.

•Diarrhea.

•Headache.

•Skin rash, itching.

•Pain and inflammation.

•Increased platelet count in the blood (checked in a blood test).

•Changes in blood test results, including liver function tests.

Less frequent (may affect up to 1 in 100 people)

•Changes in blood. These include a decrease in platelet count (which may make you bruise more easily), increased some white blood cells, decreased other white blood cells, and increased bilirubin levels. Your doctor may perform blood tests periodically.

•Changes in blood test results, including kidney function tests.

•Tickling sensation (tingling).

•Fungal infections of the mouth or vagina.

•Intestinal inflammation 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 blood tests periodically.

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

•Seizures.

•Acute disorientation and confusion (delirium).

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

No special storage conditions are required.

Injection:

After reconstitution:Solutions forintravenous injectionreconstituted must be used immediately.The time interval 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 a refrigerator (2-8°C).

Infusion:

After reconstitution:Solutions forintravenous infusionreconstituted must be used immediately.The time interval 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 a refrigerator (i.e., at 2-8°C), it must 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 opening/reconstitution/dilution method eliminates the risk of microbiological contamination, the product must be used immediately.

If not used immediately, the storage times and usage conditions are the responsibility of the user.

Do not freeze the reconstituted solution.

Medicines should not be disposed of through the drains or trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

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 contents of the container

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

30 ml glass vial type I transparent with bromobutyl rubber stopper and aluminum capsule with a blue polypropylene disc, containing674.78 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 responsible manufacturer

Marketing authorization holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For more information about this medicine, please contact 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 with the following names:

Last review date of this leaflet:February 2024

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely 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.

Attention – 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 prevent the stopper from coming off when inserting the needle into the rubber stopper, it is recommended to use a needle with a diameter of caliber 21 or less for reconstituting 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 how much diluent to use.

•Use the medicine just after preparing it. Do not freeze it.

1.Wash your hands and dry them thoroughly. Prepare a clean work area.

2.Remove the vial (vial) of Meropenem Aurovitas from the pack. Check the vial and expiration date. Check that the vial is intact and not damaged.

3.Remove the colored cap and clean the rubber stopper with an alcohol-soaked cotton swab. Let the rubber stopper dry.

4.Insert a new sterile needle into a new sterile syringe, without touching the ends.

5.Draw out the recommended amount of "Sterile Water for Injection" with the syringe. The amount of liquid needed is shown in the table below:

6.Pass through the center of the rubber stopper with the needle of the syringe and inject the recommended amount of "Sterile Water for Injection" into the vial(s) of Meropenem Aurovitas.

7.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 alcohol-soaked cotton swab and let it dry.

8.With the plunger of the syringe pushed all the way in, pass through the gray stopper again with the needle. You should then hold the syringe and vial and turn the vial upside down.

9.Keeping the end of the needle in the liquid, pull the plunger and draw out all the liquid from the vial into the syringe.

10.Remove the needle and syringe from the vial and dispose of the empty vial in an appropriate container.

11.Hold the syringe vertically, with the needle pointing up. Give gentle taps to the syringe to allow any bubbles in the liquid to rise to the top of the syringe.

12.Remove air from the syringe by gently pushing the plunger until the air has come out.

13.If you are using Meropenem Aurovitas at home, dispose of the needles and infusion sets you have used properly. If your doctor decides to stop your treatment, dispose of the unused Meropenem Aurovitas properly.

Administration of the injection

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

Administration ofMeropenem Aurovitasthrough a peripheral intravenous catheter

1.Remove the needle from the syringe and dispose of it properly in your authorized sharp containers.

2.Clean the end of the peripheral intravenous catheter with an alcohol-soaked cotton swab and let it dry. Open the cap of the cannula and connect the syringe.

3.Slowly push the plunger of the syringe to administer the antibiotic continuously for about 5 minutes.

4.Once you have finished administering the antibiotic and the syringe is empty, remove it and clean the line as recommended by your doctor or nurse.

5.Close the cap of the cannula and dispose of the syringe properly in your authorized sharp containers.

Administration ofMeropenem Aurovitasthrough a central port or line

1.Remove the cap from the central port or line, clean the end of the line with an alcohol-soaked cotton swab and let it dry.

2.Connect the syringe and slowly push the plunger to administer the antibiotic continuously for about 5 minutes.

3.Once you have finished administering the antibiotic, remove the syringe and clean the line as recommended by your doctor or nurse.

4.Place a new clean cap on the central line and dispose of the syringe properly in your authorized sharp containers.