Prospect: information for the user

Meropenem Aurovit 500 mg powder for injectable solution and for infusionEFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

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

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

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

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

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

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

3.How to use Meropenem Aurovit

4.Possible adverse effects

5.Storage of Meropenem Aurovit

6.Contents of the package and additional information

Meropenem Aurovit contains the active ingredient meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by destroying bacteria that can cause serious 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 that you may acquire during and after childbirth.

-Complicated skin and soft tissue infections.

-Acute bacterial meningitis.

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

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

No use Meropenem Aurovit

-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 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.

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 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 Aurovit

Inform your doctor or pharmacist 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). Meropenem should not be used, as it may reduce the effect of valproic acid/sodium valproate/valpromide.

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or 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. Small amounts of this medication 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. However, meropenem has been associated with headaches; tingling or pins and needles in the skin (paresthesia); and involuntary muscle movements, leading to rapid and uncontrolled body agitation (convulsions), which is usually accompanied by loss of consciousness. Any of these effects may affect your ability to drive or operate machines.

Meropenem Aurovit contains sodium

This medication contains approximately 45 mg of sodium (main component of table salt/for cooking) in each vial.

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

Consult your doctor or pharmacist if you need 8 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 of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 usually 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 determined 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 weighing over 50 kg will be given an adult dose.

-Meropenem will be administered to you as an injection or infusion in a large-caliber 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 Aurovit to yourself or another person at home"). Follow exactly the administration instructions of meropenem indicated by your doctor. Consult your doctor if you have any doubts.

-Your injection should not be mixed with or added to solutions containing 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 should usually be administered 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Meropenem Aurovit

If you forget a dose, you should receive it as soon as possible. However, if it is almost time to administer the next dose, do not receive the forgotten one.

Do not use a double dose (two injections at once) to compensate for a missed dose.

If you interrupt the treatment with Meropenem Aurovit

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, pharmacist, 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 levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes. 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)

Symptoms include:

-Shortness of breath when not expected.

-Red or brown urine.

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

Other possible side effects:

Common(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 tests that show how well the liver is functioning.

Uncommon(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 levels of some white blood cells, decreased levels of other white blood cells, and increased levels of a substance called "bilirubin". Your doctor may perform blood tests periodically.

-Changes in blood test results, including tests that show how well the kidneys are functioning.

-Tickling sensation (tingling).

-Fungal infections of the mouth (aphthous ulcers) 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, pharmacistor 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 the 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 sight and out of reach of children.

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

No special storage conditions are required.

Injection:

After reconstitution: The reconstituted solutions for intravenous injection must be used immediately. The time interval 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.

Perfusion:

After reconstitution: The reconstituted solutions for intravenous perfusion must be used immediately. The time interval between the start of reconstitution and the end of intravenous perfusion 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 meropenem reconstituted solution in 5% dextrose solution should be used immediately. The time interval between the start of reconstitution and the end of intravenous injection or perfusion should not exceed 1 hour.

From a microbiological point of view, unless the opening/reconstitution/dilution method eliminates the risk of microbiological contamination, the product should 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 drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Meropenem Aurovit

Each vial contains meropenem trihydrate equivalent to 500 mg of anhydrous meropenem.

The other component is anhydrous sodium carbonate.

Appearance of the product and contents of the pack

Meropenem Aurovit is presented as a powder for injection and infusion.

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

The product is presented in glass vials containing a white or slightly yellowish powder, in packs containing 1 vial or 10 vials.

Marketing Authorization Holder and Responsible Person for Manufacturing

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible Person for Manufacturing:

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Last review date of this leaflet: October 2020

This information is intended solely 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.

Attention – 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 just after preparing it. Do not freeze it.

How to prepare this medication

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

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

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

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

5.Extract the recommended amount of "Intravenous Water" sterile with the syringe. The amount of liquid needed is shown in the table below:

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

6.Pierce the center of the grey rubber stopper with the needle of the syringe and inject the recommended amount of "Intravenous Water" into the Meropenem Aurovit vial(s).

7.Remove the needle from the vial. Shake well for 15 seconds and observe for 1 minute.If the powder is not completely dissolved, shake again for 15 seconds. This can be repeated again, if necessary.Clean the grey 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, pierce the grey rubber 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 extract 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 upwards. Gently tap 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 been removed.

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

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 dispose of it carefully in your authorized sharp objects container.

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

3.Slowly push the syringe plunger to administer the antibiotic continuously for 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 cannula cap and dispose of the syringe carefully in your authorized sharp objects container.

Administration of Meropenem Aurovit through 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 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 dispose of the syringe carefully in your authorized sharp objects container.