Meronem

Patient Information Leaflet: User Information

Meronem, 500 mg, powder for solution for injection or infusion

Meronem, 1 g, powder for solution for injection or infusion

Meropenem

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

Important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Meronem and what is it used for
• 2. Important information before using Meronem
• 3. How to use Meronem
• 4. Possible side effects
• 5. How to store Meronem
• 6. Contents of the pack and other information

1. What is Meronem and what is it used for

Meronem belongs to a group of medicines called carbapenem antibiotics. Its action is to destroy bacteria that can cause severe infections.
Meronem is used to treat the following infections in adults and children over 3 months:

• Lung infection (pneumonia).
• Chronic bronchitis and lung infection in patients with cystic fibrosis.
• Complicated urinary tract infections.
• Complicated intra-abdominal infections.
• Postpartum and postpartum infections (that can develop during or after childbirth).
• Complicated skin and soft tissue infections.
• Acute bacterial meningitis (meningococcal).

Meronem may be used to treat febrile neutropenic patients who are suspected of having a bacterial infection.
Meronem may be used to treat bacterial infections of the blood that may be associated with the infections listed above.

2. Important information before using Meronem

When not to use Meronem

• If the patient is allergic to meropenem or any of the other ingredients of this medicine (listed in section 6).
• If the patient has been diagnosed with an allergy to other antibiotics, such as penicillins, cephalosporins, or carbapenems, as the patient may also be allergic to meropenem.

Warnings and precautions

Before using Meronem, the patient should inform their doctor, pharmacist, or nurse:

• if they have liver or kidney disease;
• if they have had severe diarrhea after using other antibiotics.

During treatment, the patient may experience a positive Coombs test, which indicates the presence of antibodies that can destroy red blood cells. The doctor will discuss this with the patient.
The patient may experience objective and subjective symptoms of severe skin reactions (see section 4). If the patient experiences such symptoms, they should contact their doctor or nurse immediately to start treatment for these symptoms.
If the patient experiences unexplained muscle pain, tenderness, or weakness, and/or dark urine, they should inform their doctor immediately. These may be symptoms of muscle breakdown (called rhabdomyolysis), which can lead to kidney problems.
If the patient is unsure whether any of the above situations apply to them, they should tell their doctor.

Meronem and other medicines

The patient should tell their doctor, pharmacist, or nurse about all the medicines they have taken recently and any they plan to take, as Meronem may affect the action of some medicines and other medicines may affect the action of Meronem.
In particular, the patient should tell their doctor if they are taking:

• Probenecid (used to treat gout).
• Valproic acid, sodium valproate, or valpromide (used to treat epilepsy). Meronem should not be used, as it may reduce the effect of sodium valproate.
• Oral anticoagulants (used to treat or prevent the formation of blood clots in blood vessels).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. It is recommended to avoid giving meropenem to pregnant women.
The doctor will decide whether the patient should take Meronem.
If the patient is breastfeeding or plans to breastfeed, it is very important that they inform their doctor before using Meronem. Small amounts of this medicine pass into breast milk.
The doctor will decide whether the patient should take Meronem while breastfeeding.

Driving and using machines

No studies have been conducted on the effects of Meronem on the ability to drive and use machines.
Meronem has been associated with headaches, tingling, and numbness (paresthesia).
Any of these side effects may affect the ability to drive or use machines.
Meronem may cause involuntary muscle contractions that cause rapid and uncontrolled shaking of the whole body (seizures). This is usually accompanied by loss of consciousness. If the patient experiences this side effect, they should not drive or use machines.

Meronem contains sodium

Meronem 500 mg: this medicine contains 45 mg of sodium (a major component of common salt) per 500 mg dose of meropenem. This corresponds to 2.25% of the recommended maximum daily intake of sodium in the diet for adults.
Meronem 1 g: this medicine contains 90 mg of sodium (a major component of common salt) per 1 g dose of meropenem. This corresponds to 4.5% of the recommended maximum daily intake of sodium in the diet for adults.
If the patient's health condition requires monitoring of sodium intake, they should inform their doctor, pharmacist, or nurse.

3. How to use Meronem

This medicine should always be used exactly as prescribed by the doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

Use in adults

• The dose of the medicine depends on the type of infection, the site of infection in the body, and the severity of the infection. The doctor will decide on the dose needed by the patient.
• The usual dose for adults is 500 mg (milligrams) to 2 g (grams). The medicine is usually given every 8 hours. However, in patients with kidney damage, doses may be given less frequently.

Use in children and adolescents

• The dose of the medicine for children over 3 months to 11 years depends on the child's age and weight. The usual dose is 10 mg to 40 mg of Meronem per kilogram (kg) of body weight. The medicine is usually given every 8 hours. Children with a body weight over 50 kg should be given the adult dose.

How to use Meronem

• Meronem will be given to the patient by injection or infusion into a large vein.
• Meronem will be given by a doctor or nurse.
• Sometimes, some patients, parents, and caregivers may be trained to administer Meronem at home. The administration instructions are included in this leaflet (in the section "Instructions for self-administration of Meronem at home"). Self-administration of the medicine to oneself or another person at home is only allowed after prior training by a doctor or nurse. The patient should always use Meronem exactly as prescribed by their doctor. In case of doubts, the patient should consult their doctor.
• The medicine should not be given after mixing with another medicine or added to solutions containing other medicines.
• Administration may take 5 minutes or 15 to 30 minutes. The doctor will decide how long the administration should take for the patient.
• The medicine should usually be given at the same times of the day.

Using more Meronem than prescribed

In case of accidental administration of a dose higher than prescribed by the doctor, the patient should contact their doctor or go to the nearest hospital immediately.

Missing a dose of Meronem

If a dose is missed, it should be given as soon as possible. If the time to the next dose is short, the missed dose should be skipped.
A double dose should not be given to make up for a missed dose.

Stopping Meronem treatment

The patient should not stop using Meronem unless their doctor tells them to.
In case of doubts about the use of the medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Meronem can cause side effects, although not everybody gets them.

Severe allergic reactions

If any of these symptoms occur, the patient should contact their doctor or nurse immediately. The patient may need urgent medical attention. Symptoms may include:

• severe rash, itching, or hives on the skin;
• swelling of the face, lips, tongue, or other parts of the body;
• difficulty breathing, wheezing, or shortness of breath;
• severe skin reactions, including: severe hypersensitivity reactions, including fever, skin rash, changes in blood test results indicating liver function (increased liver enzyme activity) and increased white blood cell count (eosinophils), as well as swollen lymph nodes. These may be symptoms of a multi-organ hypersensitivity reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). severe, red, scaly rash, skin nodules containing pus, blisters, or peeling of the skin, which may be associated with fever and joint pain. severe skin reactions, which may appear as red, round patches on the torso, often with blisters in the center, peeling of the skin, ulcers of the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms [toxic epidermal necrolysis (Lyell's syndrome) or Stevens-Johnson syndrome].

Destruction of red blood cells (frequency not known)

Symptoms may include:

• unexplained shortness of breath;
• red or brown urine. If any of these symptoms occur, the patient should contact their doctor immediately.

Muscle breakdown

• Muscle pain of unknown cause, tenderness, or weakness, and/or dark urine. If the patient experiences these symptoms, they should contact their doctor immediately.

Other possible side effects

Common (may affect up to 1 in 10 people)

• Abdominal pain.
• Nausea.
• Vomiting.
• Diarrhea.
• Headache.
• Rash, itching of the skin.
• Inflammation and pain.
• Increased platelet count (in blood tests).
• Changes in liver function test results.

Uncommon (may affect up to 1 in 100 people)

• Changes in blood tests, including decreased platelet count (which may cause easy bruising), increased white blood cell count, decreased white blood cell count, and increased bilirubin levels in the blood. The doctor may recommend regular blood tests.
• Changes in blood test results, including kidney function tests.
• Numbness or tingling (pins and needles).
• Fungal infections of the mouth or vagina (thrush).
• Colitis with diarrhea.
• Pain in the veins at the injection site.
• Other changes in blood tests. Symptoms may include frequent infections, fever, and sore throat. The doctor may recommend regular blood tests from time to time.

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

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

During the use of other medicines of the same type, cases of sudden chest painhave been observed, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome. If the patient experiences this side effect, they should tell their doctor or nurse immediately.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Meronem

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a temperature not exceeding 30°C.

Injection

After reconstitution: the solution for intravenous injection should be administered immediately after preparation.
The reconstituted solution should not be stored for more than:

• 3 hours at a temperature not exceeding 25°C;
• 12 hours in a refrigerated state (2-8°C).

Infusion (intravenous infusion)

After reconstitution: the solution for intravenous infusion should be administered immediately after preparation.
The reconstituted solution should not be stored for more than:

• 3 hours at a temperature not exceeding 25°C, if Meronem is reconstituted with sodium chloride solution;
• 24 hours in a refrigerated state (2-8°C), if Meronem is reconstituted with sodium chloride solution;
• if Meronem is reconstituted with dextrose solution, the reconstituted solution should be administered immediately.

From a microbiological point of view, the solution should be administered immediately, unless the method of opening, reconstitution, and dilution precludes the risk of microbiological contamination.
If the solution is not administered immediately, the user is responsible for the storage time and conditions.
Do not freeze the reconstituted solution.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Meronem contains

Meronem 500 mg: the active substance is meropenem. Each vial contains 500 mg of anhydrous meropenem in the form of meropenem trihydrate.
Meronem 1 g: the active substance is meropenem. Each vial contains 1 g of anhydrous meropenem in the form of meropenem trihydrate.
The other ingredient is anhydrous sodium carbonate.

What Meronem looks like and contents of the pack

Meronem is a white to light yellow powder in a vial, for solution for injection or infusion. The pack contains 1 or 10 vials in a cardboard box.

Marketing authorization holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Pfizer Service Company BV
10 Hoge Wei
1930 Zaventem
Belgium
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
Phone: +48 22 335 61 00

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium: Meronem IV
Cyprus: MERONEM
Czech Republic: MERONEM
Finland: Meronem
France: MERONEM
Greece: Meronem
Italy: MERREM
Luxembourg: Meronem IV
Poland: Meronem
Sweden: Meronem
United Kingdom (Northern Ireland): Meronem IV

Date of last revision of the leaflet: 11/2024

Advice - medical information
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
Bacterial infections that do not respond to antibiotics can occur. One of the most common causes of such cases is the resistance of bacteria to the antibiotic used. This means that despite the use of antibiotics, some bacteria may survive or multiply.
There may be many reasons for bacterial resistance. Careful use of antibiotics can help reduce the possibility of developing resistance.
If the doctor has prescribed an antibiotic, it means that the patient needs it only because of their current illness. By following the instructions below, the patient can help prevent bacterial resistance that makes the antibiotic ineffective.

• 1. It is very important to use the antibiotic in the correct dose, at the correct time, and for the correct number of days. The patient should read the instructions in the patient information leaflet, and if they have any doubts, they should consult their doctor or pharmacist for clarification.
• 2. The patient should not use an antibiotic unless it has been prescribed by a doctor and should only use it to treat the infection for which it was prescribed.
• 3. The patient should not use an antibiotic prescribed for another person, even if they had similar symptoms.
• 4. The patient should not pass on an antibiotic prescribed for them to other people.
• 5. Any unused antibiotic prescribed by a doctor should be taken to a pharmacy for proper disposal.

Information intended for healthcare professionals only:

Instructions for self-administration of Meronem at home

Some patients, parents, and caregivers may be trained to administer Meronem at home.

Warning. The medicine can only be self-administered at home after prior training by a doctor or nurse.

How to prepare the medicine

• This medicine must be mixed with another liquid (solvent). The doctor will instruct how much solvent to use.
• The medicine should be administered immediately after preparation. Do not freeze the prepared medicine.
• 1. Wash and dry hands. Prepare a clean workspace.
• 2. Remove the Meronem vial from the packaging. Check the vial and expiration date. Check if the packaging of the medicine is damaged.
• 3. Remove the colored cap and wipe the gray rubber stopper with an alcohol swab. Wait until the stopper is dry.
• 4. Connect a new sterile needle to a new sterile syringe, without touching the ends.
• 5. Draw the prescribed amount of water for injection into the syringe. The required amount of water is listed in the table below:

Note:If the prescribed dose of Meronem is more than 1 g, more than one vial of Meronem will be needed. The solution from multiple vials can then be drawn into one syringe.

• 6. Insert the syringe needle into the center of the rubber stopper, inject, and add the water for injection from the syringe to the vial or vials of Meronem.
• 7. Remove the needle from the vial and shake the vial well for about 5 seconds or until the powder is dissolved. Wipe the rubber stopper again with a new alcohol swab and wait until it is dry.
• 8. Make sure the syringe plunger is fully pressed, then reinsert the needle through the gray rubber stopper. Hold the syringe and vial, then turn the vial upside down.
• 9. Holding the needle end in the solution, pull the syringe plunger and draw the solution from the vial into the syringe.
• 10. Remove the needle from the vial and set the empty vial aside in a safe place.
• 11. Hold the syringe vertically, with the needle end facing up. Gently tap the syringe to make the air bubbles rise to the top.

• 12. Remove all air from the syringe by gently pressing the plunger until all air is removed.
• 13. If Meronem is used at home, the used needles and infusion lines should be disposed of properly. If the doctor decides to discontinue treatment, any unused medicine should be disposed of in accordance with local regulations.

Administering the medicine

The medicine can be administered through a short cannula or venflon or through a port or central line.

Administering Meronem through a short cannula or venflon

• 1. Remove the needle from the syringe and carefully dispose of it in a sharps container.
• 2. Clean the end of the cannula or venflon with an alcohol swab and wait until it is dry. Remove the cannula cap and connect the syringe.
• 3. Slowly press the syringe plunger to administer the antibiotic evenly over about 5 minutes.
• 4. After completing the administration of the antibiotic and emptying the syringe, disconnect the syringe and flush the cannula according to the doctor's or nurse's instructions.
• 5. Close the cannula and carefully dispose of the syringe in a sharps container.

Administering Meronem through a port or central line

• 1. Remove the cap from the port or central line, clean the end of the line with an alcohol swab, and wait until it is dry.
• 2. Connect the syringe and slowly press the plunger to administer the antibiotic evenly over about 5 minutes.
• 3. After completing the administration of the antibiotic, disconnect the syringe and flush the line according to the doctor's or nurse's instructions.
• 4. Put a new cap on the central line and carefully dispose of the syringe in a sharps container.