Label: information for the patient

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

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

- This medication has been prescribed only to you, and you should 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 label. See section 4.

Meropenem LDP-Laboratorios Torlan belongs to a group of medications called carbapenem antibiotics. It acts by destroying bacteria, which can cause severe infections.

Meropenem LDP-Laboratorios Torlan 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 and after childbirth

? Complicated skin and soft tissue infections

? Acute bacterial meningitis

Meropenem LDP-Laboratorios Torlan may be used to treat neutropenic patients (patients with low levels of white blood cells called neutrophils) who have fever suspected to be due to a bacterial infection.

Meropenem LDP-Laboratorios Torlan can be used to treat bacterial blood infections that may be associated with one of the previously mentioned infections.

Do not use Meropenem LDP-Laboratorios Torlan

• 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 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) 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 LDP-Laboratorios Torlan

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take or use 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,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 whether to use MeropenemLDP-Laboratorios Torlan

It is very important to inform your doctor if you are breastfeeding or plan to be, before receiving treatment with meropenem. A small amount of this medication may pass into breast milk. Therefore, your doctor will decide whether to use MeropenemLDP-Laboratorios Torlan

during breastfeeding.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. MeropenemLDP-Laboratorios Torlanhas been associated with headaches and tingling or prickling sensations in the skin (paresthesia). Any of these adverse effects could affect your ability to drive or operate machinery. 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 operate machinery if you experience this adverse effect.

MeropenemLDP-Laboratorios Torlan contains sodium

MeropenemLDP-Laboratorios Torlan500 mg contains approximately 45 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 2.25% of the maximum daily recommended dietary intake of sodium for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist 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 MeropenemLDP-Laboratories Torlanper 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 LDP-Laboratories Torlan

?MeropenemLDP-Laboratories Torlanwill be administered as an injection or infusion in a large-caliber vein.

?MeropenemLDP-Laboratories Torlanwill normally be administered by your doctor or nurse.

?However, some patients, parents, or caregivers are trained to administer MeropenemLDP-Laboratories Torlanat home. The instructions for this are found in this leaflet (in the section called “Instructions for administering Meropenem LDP-Laboratories Torlan

to yourself or another person at home”). Follow exactly the administration instructions of MeropenemLDP-Laboratories Torlanindicated 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 MeropenemLDP-Laboratories Torlanis administered.

?Injections should normally be administered at the same time every day

If you use more MeropenemLDP-Laboratories Torlanthan you should

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

If you forget to use Meropenem LDP-Laboratories Torlan

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 the missed doses.

If you interrupt the treatment with Meropenem LDP-Laboratories Torlan

Do not stop MeropenemLDP-Laboratories Torlanuntil 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 LDP-Laboratorios Torlan and seek medical attention immediately. You may need urgent medical treatment. Symptoms may 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.

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:

Common(may affect up to 1 in 10 people)

?Abdominal pain (stomach pain).

?Nausea.

?Vomiting.

?Diarrhea.

?Headache.

?Skin rash, itching skin.

?Pain and inflammation.

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

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

Uncommon(may affect up to 1 in 100 people)

?Changes in your blood. These include a decrease in platelet count (which may make you bruise more easily), an increase in some white blood cells, a decrease in other white blood cells, and an increase in a substance called “bilirubin”. Your doctor may perform blood tests periodically.

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

?Tickling sensation (tingling).

?Fungal infections of the mouth or vagina (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 blood tests periodically.

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

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

?Seizures.

• Acute disorientation and confusion (delirium).

Unknown frequency(cannot be estimated from available data)

?Severe hypersensitivity reactions with fever, skin rash, and changes in blood tests that control liver function (elevated liver enzyme levels) and an 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 type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https//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. Store below 30°C.

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.

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 of 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 of up to 25°C when the medication is dissolved in sodium chloride; -

- 24 hours when stored under refrigerated conditions (2-8°C) when the medication is dissolved in sodium chloride;

- when the medication is dissolved in dextrose, the solution must be used immediately.

.

From a microbiological point of view, unless the opening/reconstitution/dilution method excludes the risk of microbial contamination, the product must be used immediately. If not used immediately, storage times and previous use conditions are the responsibility of the user and must not be greater than the times indicated above for chemical and physical stability during use, the shorter of the two. .

Do not freeze the reconstituted solution.

Medicines must not be thrown down the drain or in the trash. In case of doubt ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

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 contents of the container

White to light yellow powder.

Type III glass vial

This medicine is supplied in containers of 10 vials

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LDP LABORATORIOS TORLAN, S.A.

Ctra. Barcelona 135

08290 Cerdanyola del Vallès (Barcelona)

Spain

Responsible for manufacturing

ACS DOBFAR S.p.A.

Nucleo Industriale S. Atto

S. Nicolò a Tordino

64100 Teramo

Italy

Local Representative

Laphysan, SAU

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

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet:May 2024

The detailed information of this medicine is available on 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 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.

Attention – You must only administer this medicine to yourself or another person at home after a doctor or nurse has trained you.

How to prepare this medicine

• The medicine must be mixed with another liquid (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 LDP-Laboratorios Torlan from the container. 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. Extract the recommended amount of "Sterile Water for Injection" with the syringe.

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

6. Pierce the center of the rubber stopper with the needle of the syringe and inject the recommended amount of "Sterile Water for Injection" into the/each vial of Meropenem LDP-Laboratorios Torlan.

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, re-pierce the gray rubber stopper 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 up. Give gentle taps to the syringe to allow any bubbles that may be 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 LDP-Laboratorios Torlan at home, dispose of the needles and infusion sets you have used in an appropriate manner. If your doctor decides to stop your treatment, dispose of the unused Meropenem LDP-Laboratorios Torlan in an appropriate manner.

Administration of the injection

You can administer this medicine 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 dispose of it carefully in your authorized sharp objects 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. Press the plunger of the syringe slowly 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 site as your doctor or nurse has recommended.

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

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 an alcohol-soaked cotton swab and let it dry.

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

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

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