MEROPENEM LDP LABORATORIOS TORLAN 500 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Patient Information Leaflet

Meropenem LDP-Laboratorios Torlan 500 mg powder for solution for injection and infusion EFG

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 LDP-Laboratorios Torlan is and what it is used for
2. What you need to know before you use Meropenem LDP-Laboratorios Torlan
3. How to use Meropenem LDP-Laboratorios Torlan
4. Possible side effects
5. Storage of 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.

Meropenem LDP-Laboratorios Torlan 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 LDP-Laboratorios Torlan may be used to treat patients with low white blood cell counts (neutropenia) who have fever that is suspected to be due to a bacterial infection.

Meropenem LDP-Laboratorios Torlan 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 LDP-Laboratorios Torlan

Do not use Meropenem LDP-Laboratorios Torlan

• 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

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

• 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) 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.

Liver problems

Tell your doctor or pharmacist 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.

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

Other medicines and Meropenem LDP-Laboratorios Torlan

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

This is because meropenem may affect the way some medicines work, and some of these may affect 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 may decrease 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 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 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

No studies have been conducted on the effects on the ability to drive and use machines. Meropenem LDP-Laboratorios Torlan 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. Meropenem LDP-Laboratorios Torlan may cause involuntary muscle movements, which can cause the 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 LDP-Laboratorios Torlan contains sodium

Meropenem LDP-Laboratorios Torlan 500 mg contains approximately 45 mg of sodium (main component of table/cooking salt) in each vial. This is equivalent to 2.25% of the maximum recommended daily dietary intake of sodium for an adult.

3. How to use Meropenem LDP-Laboratorios Torlan

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist 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 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 LDP-Laboratorios Torlan 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 LDP-Laboratorios Torlan

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

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

? However, some patients, parents, or caregivers are trained to administer Meropenem LDP-Laboratorios Torlan at home. The instructions for this are found in this leaflet (in the section called "Instructions for administering Meropenem LDP-Laboratorios Torlan to yourself or another person at home"). Follow the instructions for administration of Meropenem LDP-Laboratorios Torlan 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 last approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how Meropenem LDP-Laboratorios Torlan is administered.

? Injections should usually be administered at the same time every day.

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

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

If you forget to use Meropenem LDP-Laboratorios Torlan

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 LDP-Laboratorios Torlan

Do not stop using Meropenem LDP-Laboratorios Torlan until your doctor tells you to.

If you have any other questions about 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 LDP-Laboratorios Torlan and go to a doctor immediately. You may need urgent medical treatment. The symptoms can include:

? 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)

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 of the skin.

? Pain and inflammation.

? Increased platelet count in the blood (found 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 your blood. These include a decrease in the number of platelets (which can make you bruise more easily), an increase in some white blood cells, a decrease in other white blood cells, and an increase in the amount of a substance called "bilirubin". Your doctor may perform blood tests periodically.

? Changes in blood tests, including tests that show how your kidneys are working.

? Tingling sensation (numbness).

? Infections of the mouth or vagina caused by a fungus (thrush).

? 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.

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

• Decrease in potassium levels in the blood (can cause weakness, muscle cramps, tingling, and changes in heart rhythm)
• 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 your doctor immediately.

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

? Seizures (convulsions).

• Acute disorientation and confusion (delirium).

Frequency not known(cannot be estimated from the available data)

? Severe hypersensitivity reactions with fever, skin rash, and changes in blood tests that control liver function (increase in liver enzyme values) and increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be symptoms of a multi-organ sensitivity disorder known as DRESS syndrome.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https//www.notificaram.es. By reporting side 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 ºC.

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

Injection

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

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

Infusion

After reconstitution: The reconstituted solutions for infusion should be used immediately.

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

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

.

From a microbiological point of view, 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 before use are the responsibility of the user and should 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. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Container Content and Additional Information

The active ingredient is meropenem. Each vial contains meropenem trihydrate equivalent to 500 mg of anhydrous meropenem

• The other component is sodium carbonate.

Appearance of the Product and Container Content

White to light yellow powder.

Type III glass vial

This medication is supplied in packages of 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 Last Revision of this Prospectus:June 2025

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

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This information is intended only for healthcare professionals:

Instructions for Administering Meropenem LDP-Laboratorios Torlan to Yourself or Another Person at Home

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

Warning – You should only administer this medication to yourself or another person at home after a doctor or nurse has trained you.

How to Prepare this Medication

• 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.

1. Wash your hands and dry them very well. Prepare a clean work area.
2. Remove the Meropenem LDP-Laboratorios Torlan 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 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:

1. Pierce the center of the rubber stopper with the syringe needle and inject the recommended amount of "Water for Injectable Preparations" into the Meropenem LDP-Laboratorios Torlan 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 rubber stopper again with a new cotton swab impregnated with alcohol and let it dry.
3. With the syringe plunger fully pushed into the syringe, pierce the gray rubber stopper with the needle again. You should then hold the syringe and vial and turn the vial upside down.
4. Keeping the needle end 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 the air has come out.
8. If you are using Meropenem LDP-Laboratorios Torlan at home, properly dispose of the needles and infusion lines you have used. If your doctor decides to interrupt your treatment, properly dispose of the unused Meropenem LDP-Laboratorios Torlan.

Administration of the Injection

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

Administration of Meropenem LDP-Laboratorios Torlan through a Peripheral Intravenous Catheter

1. Remove the needle from the syringe and carefully discard it 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 cannula cap 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 cannula cap and carefully discard the syringe in authorized containers for sharp objects.

Administration of Meropenem LDP-Laboratorios Torlan 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 carefully discard the syringe in authorized containers for sharp objects.