MEROPENEM STERISCIENCE 500 mg POWDER FOR INJECTION AND INFUSION SOLUTION

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

Do not use Meropenem Steriscience:

• if you are allergic to meropenem or any of the other components of this medicine (listed in section 6);
• if you are allergic (hypersensitive) to other antibiotics, such as penicillins, cephalosporins, or carbapenems, as you may also be allergic to meropenem.

Warnings and precautions

Consult your doctor or nurse before starting to use this medicine if:

• you have health problems, such as liver or kidney problems;
• you have had severe diarrhea after taking other antibiotics.

You may test positive for 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 experience 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 unsure whether you are in any of these situations, consult your doctor or nurse before using this medicine.

Children

This medicine is not recommended for use in children under 3 months of age, as the safety and efficacy of meropenem have not been established in children of these ages.

Other medicines and Meropenem Steriscience

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or may need to use any other medicine.

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, pharmacist, 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

Pregnancy

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 using meropenem during pregnancy. Your doctor will decide whether you should use meropenem.

Breastfeeding

It is very important that, before receiving treatment with meropenem, you inform your doctor if you are breastfeeding or plan to breastfeed. A small amount of this medicine may pass into breast milk. Therefore, your doctor will decide whether 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.

This medicine has been associated with headache and tingling or numbness in the skin (paresthesia). Any of these side effects could affect your ability to drive or use machines.

This medicine 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 side effect.

Meropenem Steriscience contains sodium

Meropenem Steriscience 500 mg: This medicine contains 45 mg of sodium (main component of table salt/cooking salt) per 500 mg dose. This is equivalent to 2.25% of the maximum daily sodium intake recommended for an adult.

Meropenem Steriscience 1000 mg: This medicine contains 90 mg of sodium (main component of table salt/cooking salt) per 1000 mg dose. This is equivalent to 4.5% of the maximum daily sodium intake recommended for an adult.

3. How to use Meropenem Steriscience

Follow the administration instructions for this medicine exactly as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, 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 2000 mg (milligrams). You will usually be given a dose every 8 hours. However, if your kidneys do not function properly, 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 who weigh over 50 kg will be given an adult dose.

How to use Meropenem Steriscience

• 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 receive training to administer meropenem at home. The instructions for this are found in this leaflet (in the section called "Instructions for administering meropenem to yourself or to another person at home"). Follow the administration instructions for meropenem exactly as indicated by your doctor. Consult your doctor if you have doubts.
• The injection should not be mixed with solutions containing other medicines, nor should it be added to these.
• The injection can last approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how meropenem is administered.
• The injections should usually be administered at the same time every day.

If you use more Meropenem Steriscience 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 Steriscience

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 missed doses.

If you stop using Meropenem Steriscience

Do not stop using meropenem until your doctor tells you to.

If you have any other doubts about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe allergic reactions

If you experience any of the following signs and symptoms, inform your doctor or nurse immediately. You may need urgent medical treatment. The signs and symptoms can include a sudden onset of any of the following:

• 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, including:
• • Severe hypersensitivity reactions with fever, skin rash, and changes in blood test results showing liver activity (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 containing 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 central blisters — on the trunk, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes, 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, go to a doctor immediately.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abdominal pain (stomach 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 tests, including those that show liver activity.

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 cells, decreased white blood cells, and increased bilirubin. Your doctor may perform periodic blood tests.
• Changes in blood tests, including those that show kidney activity.
• Tingling sensation (paresthesia).
• 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 blood. The symptoms include frequent infections, fever, and sore throat. Your doctor may perform periodic blood tests.

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

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

Reporting side effects

It is essential to report suspected side effects to the medicine after authorization. This allows for continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals are invited to report suspected side effects to the Spanish Medicines Monitoring System: www.notificaRAM.es.

5. Storage of Meropenem Steriscience

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

Do not use this medicine after the expiration date shown on the packaging and on the label of the vials after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Injection

After reconstitution:

The reconstituted solutions for intravenous solution should be used immediately.

Chemical and physical stability in use of the solutions prepared for intravenous injection has been demonstrated for the following periods:

• 3 hours at a maximum of 25 °C;
• 6 hours under refrigeration (2 °C to 8 °C).

Infusion

After reconstitution:

The reconstituted solutions for intravenous solution should be used immediately.

When meropenem is dissolved in sodium chloride 0.9% (9 mg/ml), chemical and physical stability in use of the solutions prepared for infusion has been demonstrated for the following periods:

• 3 hours stored at a maximum of 25 °C;
• 24 hours stored under refrigeration (2 °C to 8 °C).

When meropenem is dissolved in glucose (dextrose) 5% (50 mg/ml), the solution should be used immediately.

From a microbiological point of view, unless the reconstitution method rules out 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 thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Meropenem Steriscience

The active ingredient is meropenem.

Each vial contains meropenem trihydrate equivalent to 500 mg or 1000 mg of meropenem.

The other component is sodium carbonate.

Appearance of the product and packaging content

Meropenem Steriscience is a powder of a color that ranges from white to pale yellow for injectable solution and for infusion in a vial.

Meropenem Steriscience 500 mg powder for injectable solution and for infusion

Transparent glass vial with a bromobutyl rubber stopper sealed with an easy-to-open aluminum cap and sky blue in color.

Meropenem Steriscience 1000 mg powder for injectable solution and for infusion

Transparent glass vial with a bromobutyl rubber stopper sealed with an easy-to-open aluminum cap and red in color.

The product is available in packaging sizes of 1 or 10 vials. Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Steriscience B.V.

Kranenburgweg 135-A

2583 ER The Hague

Netherlands

Manufacturer

Pharma Pack Hungary Kft.

H-2040, Budaörs, Vasút út 13

Hungary

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

Date of last revision of this leaflet:01 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended only for healthcare professionals:

To consult all the information on administration guidelines, warnings, and precautions, instructions for reconstitution of the medicinal product before administration, etc., see the technical data sheet.

Instructions for administering meropenem to yourself or administering it to another person at home

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

Warning: This medicinal product should only be administered to yourself or to another person at home after a doctor or nurse has trained you.

How to prepare this medicinal product

• The medicinal product must be mixed with another liquid (the diluent). Your doctor will tell you what amount of diluent to use.
• Use the medicinal product 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 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 gray 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 injectable preparations" with the syringe. The amount of liquid you need is shown in the table below:

Note:If the amount of meropenem prescribed for you is more than 1 g, you will need to use more than one meropenem 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 injectable preparations" into the meropenem 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 gray rubber stopper again with a new cotton swab impregnated with alcohol and let it dry. Before administration, the solution must be visually inspected for particles or color change. Use the solution only if it is transparent and colorless or yellowish and does not contain particles.
3. With the syringe plunger fully pushed into the syringe, pierce the gray rubber stopper again with the needle. You must 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 facing 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 all the air has come out.
8. If you are using meropenem at home, dispose of the needles and infusion lines you have used properly. If your doctor decides to interrupt your treatment, dispose of the unused meropenem properly.

Administration of the injection

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

Administration of meropenem 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 impregnated with 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 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 cap of the cannula and discard the syringe carefully in authorized containers for sharp objects.

Administration of meropenem 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 discard the syringe carefully in authorized containers for sharp objects.

Each vial is for single use.

The solution must be shaken before use. Before administration, it must be visually inspected for particles or color change. Use the solution only if it is transparent and colorless or yellowish and does not contain particles.

For the storage conditions after reconstitution/dilution of the medicinal product, see section 5.

The disposal of unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations.