Meropenem LDP Laboratorios Torlan 1 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Meropenem LDP-Laboratorios Torlan 1g powder for solution for injection and for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist or nurse.

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

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

Contents of the leaflet

1. What Meropenem LDP-Laboratorios Torlan is and what it is used for
2. What you need to know before using Meropenem LDP-Laboratorios Torlan
3. How to use Meropenem LDP-Laboratorios Torlan
4. Possible side effects
5. How to store Meropenem LDP-Laboratorios Torlan
6. Contents of the pack and other information

1. What Meropenem LDP-Laboratorios Torlan is and what it is used for

Meropenem LDP-Laboratorios Torlan 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 are not effective against viral infections such as influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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

? Infection affecting the lungs (pneumonia)

? Bronchial and lung infections in patients with cystic fibrosis

? Complicated urinary tract infections

? Complicated abdominal infections

? Infections that may occur during and after childbirth

? Complicated skin and soft tissue infections

? Acute bacterial infection of the brain (meningitis)

Meropenem LDP-Laboratorios Torlan may be used to treat febrile neutropenic patients (patients with low levels of white blood cells called neutrophils) in whom a bacterial infection is suspected.

Meropenem LDP-Laboratorios Torlan can be used to treat bacterial blood infection (bacteraemia) that may be associated with one of the types of infection mentioned above.

2. What you need to know before using Meropenem LDP-Laboratorios Torlan

Do not use Meropenem LDP-Laboratorios Torlan

• if you are allergic to meropenem or to 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

Talk to your doctor, pharmacist, or nurse before starting to use Meropenem LDP-Laboratorios Torlan:

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

You may develop a positive result in 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 serious skin reactions (see section 4). If this occurs, inform your doctor or nurse immediately so that symptoms can be treated.

Liver problems

Tell your doctor if you notice yellowing of the skin or eyes, dark-colored urine, or pale-colored stools. These may be signs of liver problems that your doctor should evaluate.

If you are in any of these situations, or if you have any doubts, consult your doctor before using meropenem.

Other medicines and Meropenem LDP-Laboratorios Torlan

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take or use any other medicines.

This is because meropenem may affect how some medicines work, and some of these medicines may affect meropenem.

In particular, inform 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 reduce the effect of valproic acid/sodium valproate/valpromide.
• 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 are planning 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 whether you should use Meropenem LDP-Laboratorios Torlan.

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

Driving and using machines

Studies on the effects on the ability to drive and use machines have not been conducted. Meropenem LDP-Laboratorios Torlan has been associated with headache and tingling or pricking sensations of the skin (paresthesia). Any of these adverse effects could affect your ability to drive or use machines. Meropenem LDP-Laboratorios Torlan may cause involuntary muscle movements, which may result in rapid and uncontrollable shaking of the body (convulsions). This is usually accompanied by loss of consciousness. Do not drive or operate machinery if you experience this adverse effect.

Meropenem LDP-Laboratorios Torlan contains sodium

Meropenem LDP-Laboratorios Torlan 1g contains approximately 90 mg of sodium (the main component of table/cooking salt) per vial. This is equivalent to 4.50% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Meropenem LDP-Laboratorios Torlan

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

Use in adults

? The dose depends on the type of infection you have, its location in the body, and its severity. Your doctor will decide the appropriate dose for you.

? The usual dose in adults ranges from 500 mg (milligrams) to 2 g (grams). Normally, a dose is administered every 8 hours. However, if your kidneys are not functioning properly, the dose may be given less frequently.

Use in children and adolescents

? The dose for children over 3 months of age up to 12 years is determined based on the child's age and weight. The usual dose is between 10 mg and 40 mg of Meropenem LDP-Laboratorios Torlan per kilogram (kg) of body weight. Doses are normally administered every 8 hours. Children weighing more than 50 kg will receive an adult dose.

How to use Meropenem LDP-Laboratorios Torlan

? Meropenem LDP-Laboratorios Torlan will be administered to you as an intravenous injection or infusion into a large vein.

? Usually, Meropenem LDP-Laboratorios Torlan will be administered by your doctor or nurse.

? However, some patients, parents, or caregivers are trained to administer Meropenem LDP-Laboratorios Torlan at home. Instructions for this are included in this leaflet (in the section titled “Instructions for administering Meropenem LDP-Laboratorios Torlan to yourself or another person at home”). Follow exactly the administration instructions provided by your doctor. Consult your doctor if you have any doubts.

? Your injection must not be mixed with or added to solutions containing other medicines.

? The injection may last approximately 5 minutes or between 15 and 30 minutes. Your doctor will inform you how Meropenem LDP-Laboratorios Torlan is to be administered.

? Injections should normally be given at the same time each day.

If you use more Meropenem LDP-Laboratorios Torlan than you should

If you accidentally use more than the prescribed dose, contact your doctor, go immediately to the nearest hospital, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Meropenem LDP-Laboratorios Torlan

If you miss an injection, it should be administered as soon as possible. However, if it is almost time for your next dose, do not take the missed dose.

Do not use a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Meropenem LDP-Laboratorios Torlan

Do not stop Meropenem LDP-Laboratorios Torlan unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Severe allergic reactions

If you experience a severe allergic reaction, stop treatment with Meropenem LDP-Laboratorios Torlan and seek medical attention immediately. You may require urgent medical treatment. Symptoms may include sudden onset of:

? 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.

Damage to red blood cells (frequency not known)

Symptoms include:

? Unexpected shortness of breath.

? Red or brown urine.

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

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

? Abdominal (stomach) pain.

? Nausea.

? Vomiting.

? Diarrhea.

? Headache.

? Skin rash, itching.

? Pain and inflammation.

? Increase in the number of platelets in the blood (detected in a blood test).

? Changes in blood tests, including tests showing how your liver is functioning.

Uncommon (may affect up to 1 in 100 people)

? Changes in your blood. These include a decrease in the number of platelets (which may make you bruise more easily), increase in certain white blood cells, decrease in other white blood cells, and increase in a substance called "bilirubin." Your doctor may perform periodic blood tests.

? Changes in blood tests, including tests showing how your kidneys are functioning.

? Tingling sensation (pins and needles).

? Mouth or vaginal fungal infections (thrush).

? Inflammation of the intestine 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 periodic blood tests.

? Sudden onset of severe skin rash, blistering, or skin peeling. This may be associated with high fever and joint pain.

• Decreased potassium levels in the blood (may cause weakness, muscle cramps, tingling, and irregular heartbeat)
• Liver problems. Yellowing of the skin or eyes, itching, dark-colored urine, or pale stools. If you notice these signs or symptoms, consult your doctor immediately.

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

? Seizures (fits).

• Acute disorientation and confusion (delirium).

Frequency not known (cannot be estimated from available data)

? Severe hypersensitivity reactions with fever, skin rashes, and changes in blood tests indicating liver function (increased liver enzyme values), increase in a type of white blood cell (eosinophilia), and enlarged lymph nodes. These may be symptoms of a multiorgan hypersensitivity disorder known as DRESS syndrome.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem LDP-Laboratorios Torlan

Keep this medicine out of the sight and reach of children. Store below 30 °C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Injection

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

• 3 hours when stored at a temperature up to 25°C;
• 12 hours when stored under refrigerated conditions (2–8°C).

Infusion

After reconstitution: reconstituted solutions for infusion must be used immediately.

The time interval between the start of reconstitution and the end of infusion must not exceed:

• 3 hours when stored at a temperature up to 25°C if the medicine is dissolved in sodium chloride;
• 24 hours when stored under refrigerated conditions (2–8°C) if the medicine is dissolved in sodium chloride;
• when the medicine is dissolved in dextrose, the solution must be used immediately.

From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and must not exceed the times indicated above for chemical and physical stability during use, whichever is shorter.

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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Meropenem LDP-Laboratorios Torlan

• The active substance is meropenem. Each vial contains meropenem trihydrate equivalent to 1 g of anhydrous meropenem.
• The other component is sodium carbonate.

Appearance of the product and contents of the container

White to pale yellow powder.

Type III glass vial.

This medicine is supplied in packs containing 10 vials.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LDP LABORATORIOS TORLAN, S.A.

Ctra. Barcelona 135

08290 Cerdanyola del Vallès (Barcelona)

Spain

Manufacturer

ACS DOBFAR S.p.A.

Nucleo Industriale S. Atto

• Nicolò a Tordino

64100 Teramo

Italy

Local Representative

Laphysan, SAU

C/ Anabel Segura nº11. Edificio A Planta 4. Puerta D.

28108 Alcobendas (Madrid)

Spain

Date of the most recent review of this leaflet: June 2025

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

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This information is intended for healthcare professionals only:

Instructions for self-administering Meropenem LDP-Laboratorios Torlana or administering it to another person at home

Some patients, parents, and caregivers are trained to administer Meropenem LDP-Laboratorios Torlana at home.

Warning – You must only administer this medicine to yourself or another person at home after being trained by a doctor or nurse.

How to prepare this medicine

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

1. Wash your hands thoroughly and dry them well. Prepare a clean work area.
2. Remove the vial of Meropenem LDP-Laboratorios Torlana from its packaging. Check the vial and the expiration date. Ensure the vial is intact and undamaged.
3. Remove the coloured cap and clean the rubber stopper with an alcohol-impregnated cotton pad. Allow the rubber stopper to dry completely.
4. Attach a new sterile needle to a new sterile syringe, taking care not to touch the ends.
5. Draw up the recommended amount of sterile “Water for Injections” into the syringe.

The amount of liquid required is shown in the table below:

Dose of Meropenem LDP-Laboratorios Torlan	Amount of “Water for Injection” required for dilution
500 mg (milligrams)	10 ml (milliliters)
1 g (gram)	20 ml

1. Pierce the center of the rubber stopper with the syringe needle and inject the recommended amount of “Water for Injections” into the Meropenem LDP-Laboratorios Torlan vial(s).
2. Remove the needle from the vial and shake the vial well for about 5 seconds, or until all the powder has dissolved. Clean the rubber stopper again with a fresh alcohol-impregnated cotton swab and allow it to dry.
3. With the syringe plunger fully pushed into the syringe, pierce the grey rubber stopper again with the needle. Then hold the syringe and vial securely and invert the vial.
4. Keeping the tip of the needle in the liquid, pull back the plunger to withdraw all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and dispose of the empty vial in an appropriate container.
6. Hold the syringe vertically with the needle pointing upward. Gently tap the syringe to allow any air bubbles in the liquid to rise to the upper part of the syringe.
7. Expel the air from the syringe by gently pushing the plunger until the air is completely removed.
8. If you are using Meropenem LDP-Laboratorios Torlan at home, properly dispose of the used needles and infusion devices. If your doctor decides to discontinue your treatment, properly dispose of any unused Meropenem LDP-Laboratorios Torlan.

Administration of the Injection

You may administer this medication through a peripheral intravenous catheter, or via a port or central line.

Administration of Meropenem LDP-Laboratorios Torlan via Peripheral Intravenous Catheter

1. Remove the needle from the syringe and carefully dispose of it in your authorized sharps container.
2. Clean the end of the peripheral intravenous catheter with an alcohol-impregnated cotton swab and allow it to dry. Remove the cannula cap and attach the syringe.
3. Slowly push the syringe plunger to administer the antibiotic steadily over approximately 5 minutes.
4. Once the antibiotic has been fully administered and the syringe is empty, remove it and flush the line as instructed by your doctor or nurse.
5. Replace the cannula cap and carefully dispose of the syringe in your authorized sharps container.

Administration of Meropenem LDP-Laboratorios Torlan via Port or Central Line

1. Remove the cap from the port or line, clean the end of the line with an alcohol-impregnated cotton swab, and allow it to dry.
2. Attach the syringe and slowly push the plunger to administer the antibiotic steadily over approximately 5 minutes.
3. After completing the antibiotic administration, remove the syringe and flush the line as directed by your doctor or nurse.
4. Attach a new clean cap to the central line and carefully dispose of the syringe in your authorized sharps container.