MEROPENEM QILU 500 mg POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Meropenem Qilu 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 Package Leaflet

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

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

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

Meropenem Qilu is used to treat the following infections in adults and children from 3 months of age:

• Infection that affects the lungs (pneumonia)
• Bronchial and lung infections in patients with cystic fibrosis (a hereditary disease in which the lungs and digestive system can become clogged with thick, sticky mucus)
• Complicated urinary tract infections
• Complicated infections in the abdomen (stomach)
• Infections that you can acquire during and after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial infection of the brain (meningitis)

This medicine can be used to treat patients with weakened immune systems (neutropenic patients) who have fever that is suspected to be due to a bacterial infection.

Meropenem Qilu can be used to treat bacterial infection of the blood that may be associated with one of the aforementioned types of infection

2. What you need to know before you use Meropenem Qilu

Do not use Meropenem Qilu

• 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 or pharmacist before you start using Meropenem Qilu

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

Blood tests

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.

Skin reactions

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.

If you are in any of these situations, or if you have 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 take any other medicines. This is because Meropenem Qilu can affect the way some medicines work, and some of these may have an effect on Meropenem Qilu.

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 Qilu should not be used, as it can decrease 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 have a baby, ask your doctor or pharmacist for advice 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 on the effects on the ability to drive and use machines have been performed.

However, meropenem has been associated with headache and tingling or numbness in the skin (paresthesia). Either 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 agitation (convulsions), which is usually accompanied by loss of consciousness. Do not drive or use machines if you experience this side effect.

Meropenem Qilu contains sodium

This medicine contains 45 mg of sodium (a major component of table salt/cooking salt) in each 500 mg dose. This is equivalent to 2.25% 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 administration of this medicine given by your doctor or pharmacist. If you are in doubt, ask your doctor, pharmacist, or nurse.

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 and 2 g. 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 per kilogram (kg) of the child's weight. You will usually be given a dose every 8 hours. Children who weigh more than 50 kg will be given an adult dose.

How to use Meropenem Qilu

• Meropenem Qilu will be administered to you as an injection or infusion into a large vein.
• Meropenem Qilu will usually be administered by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer Meropenem Qilu at home. The instructions for this are found in this package leaflet (in the section called "Instructions for administering Meropenem Qilu to yourself or another person at home"). Follow exactly the instructions for administration of Meropenem Qilu given by your doctor. If you have doubts, ask your doctor.
• Your injection should not be mixed with or added to solutions that contain other medicines.
• The injection may take approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how Meropenem Qilu is administered.
• Injections should usually be given at the same time every day.

If you use more Meropenem Qilu than you should

If you accidentally use more doses than prescribed, 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 Toxicological Information Service, telephone 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 injection, do not receive the missed one. Do not use a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Meropenem Qilu

Do not stop using Meropenem Qilu until your doctor tells you to.

If you have any further questions on 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 get any of these symptoms, tell your doctor or nurse immediately. You may need urgent medical treatment. The symptoms can 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 that include:

• Severe hypersensitivity reactions with fever, skin rash, and changes in blood test results that check liver function (increase in liver enzyme levels), increase in a type of white blood cell (eosinophilia), and swelling of the lymph nodes. These can be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
• Severe scaly red rash, bumps on the skin that contain pus, blisters, or peeling of the skin, 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, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, and which can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Damaged red blood cells

The symptoms include:

• Shortness of breath when you do not expect it
• Brown or red urine

If you notice any of the above, go to a doctor immediately.

Possible side effects

Common (may affect up to 1 in 10 people)

• Abdominal pain (stomach pain).
• Feeling sick (nausea).
• Vomiting.
• Diarrhea.
• Headache.
• Skin rash, itching.
• Pain and inflammation (swelling at the injection site).
• Increased number of platelets in the blood (checked 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 the 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).
• Mouth or vaginal infections caused by a fungus.
• Inflammation of the intestine with diarrhea.
• Pain in the veins where Meropenem Qilu is injected.
• Other changes in your blood. The symptoms include frequent infections, fever, and sore throat. Your doctor may perform blood tests periodically.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines Agency: www.notificaRAM.es. By reporting side 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 which is stated on the carton and vial label after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

After reconstitution/dilution:

Administration of intravenous bolus injection

A solution for 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.

Administration by intravenous infusion

A solution for infusion is prepared by dissolving the medicine in a 9 mg/ml sodium chloride (0.9%) infusion solution or in a 50 mg/ml dextrose (5%) infusion solution, 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 that should elapse between the start of reconstitution and the end of infusion should not exceed one hour.

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

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 no longer required. 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 500 mg of meropenem (as meropenem trihydrate).

The other ingredient is sodium carbonate.

Appearance of Meropenem Qilu and contents of the pack

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

Package sizes: 1 vial or 10 vials (clinical pack).

Not all 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

Manufacturer

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this package leaflet: 12/2023

Other sources of information:

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