Meropenem Qilu 1 g powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Meropenem Qilu 1 g powder for solution for injection and infusion EFG

Read this 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, ask 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 reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Meropenem Qilu contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by destroying bacteria that can cause serious infections.

Meropenem Qilu 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 (an inherited disease in which the lungs and digestive system can become blocked by thick, sticky mucus)
• Complicated urinary tract infections
• Complicated abdominal (stomach) infections
• Infections that you may acquire during and after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial infection of the brain (meningitis)

This medicine may be used to treat patients who are neutropenic (with a weakened immune system) and who have fever suspected to be due to a bacterial infection.

Meropenem Qilu may be used to treat bacterial blood infection (bacteraemia) that could be associated with one of the types of infection mentioned above.

2. What you need to know before using Meropenem Qilu

Do not use Meropenem Qilu

• 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 or pharmacist before starting to use Meropenem Qilu

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

Blood tests

You may develop a positive reaction in a test (Coombs test) indicating the presence of antibodies that could destroy red blood cells.

Your doctor will discuss this with you.

Skin reactions

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, itching, dark-coloured urine, or pale stools. These may be signs of liver problems that your doctor needs to check.

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

Other medicines and Meropenem Qilu

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Meropenem Qilu may affect how some medicines work, and some of these medicines may affect Meropenem Qilu.

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 Qilu should not be used, as it may reduce the effect of sodium valproate.
• Oral anticoagulant agent (used to treat or prevent blood clots).

Pregnancy and breastfeeding

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 Qilu.

It is important that you inform your doctor if you are breastfeeding or plan to breastfeed before receiving Meropenem Qilu. Small amounts of this medicine 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.

However, meropenem has been associated with headache and tingling or prickling sensations in the skin (paraesthesia). Any of these effects could affect your ability to drive or use machines.

This medicine may cause involuntary muscle movements, leading to rapid and uncontrolled body movements (seizures), which are usually accompanied by loss of consciousness. Do not drive or operate machinery if you experience this side effect.

Meropenem Qilu contains sodium

This medicine contains 90 mg of sodium (main component of table/cooking salt) in each 1 g dose. This corresponds to 4.5% of the maximum daily intake of sodium recommended for an adult.

If you have a condition that requires you to control your sodium intake, inform your doctor, pharmacist, or nurse.

3. How to use Meropenem Qilu

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse.

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 to 2 g. Normally, a dose is administered every 8 hours. However, if your kidneys are not functioning properly, you may receive the dose less frequently.

Use in children and adolescents

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

How to use Meropenem Qilu

• Meropenem Qilu will be administered to you as an injection or infusion into a large vein.
• Usually, Meropenem Qilu is given by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer Meropenem Qilu at home. Instructions for this are provided in this leaflet (in the section entitled «Instructions for administering Meropenem Qilu to yourself or another person at home»). Follow exactly the administration instructions given 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 Qilu is to be administered.
• Injections should normally be given at the same time each day.

If you use more Meropenem Qilu than you should

If you accidentally use more than prescribed, contact your doctor or go to the nearest hospital immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Meropenem Qilu

If you miss an injection, you should receive it 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 forgotten dose.

If you stop treatment with Meropenem Qilu

Do not stop Meropenem Qilu 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 any of the following symptoms, inform your doctor or nurse immediately. You may require urgent medical treatment. Symptoms may include a 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.

• Severe skin reactions including:

• Severe hypersensitivity reactions with fever, skin rashes and changes in blood test results monitoring liver function (increased levels of liver enzymes), increase in a type of white blood cells (eosinophilia) and enlargement of lymph nodes. These may be signs of a multi-organ hypersensitivity disorder known as DRESS syndrome.

• Severe red, scaly rash, skin lesions containing pus, blisters or skin peeling, which may be associated with high fever and joint pain.

• Severe skin reactions that may appear as red, circular spots often with central blisters on the trunk, skin peeling, mouth ulcers, and ulcers in the throat, nose, genitals and eyes, possibly preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Damage to red blood cells

Symptoms include:

• Unexpected shortness of breath
• Red or brown urine

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

Possible adverse effects

Common (may affect up to 1 in 10 people)

• Abdominal (stomach) pain.
• Feeling unwell (nausea).
• Vomiting.
• Diarrhea.
• Headache.
• Skin rash, itching of the skin.
• Pain and inflammation (swelling at the injection site).
• 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 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 (thrush) or vaginal fungal infections.
• Inflammation of the intestine with diarrhea.
• Pain in the veins where Meropenem Qilu is injected.
• Other changes in your blood. Symptoms include frequent infections, fever and sore throat. Your doctor may perform periodic blood tests. Your doctor may perform periodic blood tests.
• Decreased potassium levels in the blood (which may cause weakness, muscle cramps, tingling and irregular heart rhythm).
• Liver problems. Yellowing of the skin and eyes, itching of the skin, dark urine or pale stools. If you notice these signs or symptoms, consult a doctor immediately.

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

• Seizures.
• Acute disorientation and confusion (delirium).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if these are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem Qilu

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

Do not use this medicine after the expiry date stated on the carton and label of the vial after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After reconstitution/dilution:

Intravenous bolus injection administration

A solution for bolus injection is prepared by dissolving the medicine in water for injection, to a final concentration of 50 mg/ml.

The reconstituted solution of the medicinal product in water for injection must be used immediately.

Intravenous infusion administration

A solution for infusion is prepared by dissolving the medicine in an infusion solution of 9 mg/ml sodium chloride (0.9%), or in an infusion solution of 50 mg/ml dextrose (5%), to a final concentration of 1 to 20 mg/ml.

The reconstituted solution of the medicinal product in 9 mg/ml sodium chloride (0.9%) infusion solution must be used immediately. The maximum time between the start of reconstitution and the end of infusion must not exceed one hour.

The reconstituted solution of the medicinal product in 50 mg/ml dextrose (5%) solution must be used immediately.

Do not freeze the reconstituted solution.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Meropenem Qilu

The active substance is meropenem.

Each vial contains 1 g of meropenem (as meropenem trihydrate).

The other component is sodium carbonate.

Appearance of Meropenem Qilu and contents of the pack

Meropenem Qilu is presented in vials containing a white or slightly yellowish powder for injectable solution or for infusion.

Pack sizes of 1 or 10 vials (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40, 8th floor,

28046 Madrid,

Spain

Manufacturers

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès,

08290 Barcelona,

Spain

Eurofins Analytical Services Hungary Kft.

Anonymus utca 6, Budapest

H-1045,

Hungary

LLC “UNIFARMA”

Vangazu street 23,

Riga, LV-1024,

Latvia

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 – Barcelona

Spain

Tel.: +34 93 342 7890

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

Date of the most recent review of this leaflet: 10/2025

Other sources of information:

Detailed 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/