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

Please read carefully the contents of this leaflet before using the medicine, as it contains

important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Contents of the Leaflet

• 1. What Meronem is and what it is 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 Meronem is and what it is 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 from 3 months of age and older:

• Lung infection (pneumonia).
• Inflammation of the bronchi and lungs in cystic fibrosis.
• Complicated urinary tract infections.
• Complicated infections within the abdominal cavity.
• Infections occurring during or after childbirth (puerperal infections).
• Complicated skin and soft tissue infections.
• Acute bacterial meningitis (meningococcal).

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

2. Important information before using Meronem

When not to use Meronem

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

When to be cautious using Meronem

Before using Meronem, inform your doctor, pharmacist, or nurse:

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

During treatment, you may experience a positive Coombs test, which indicates the presence of antibodies that can destroy red blood cells. Your doctor will discuss this with you.
You may experience objective and subjective symptoms of severe skin reactions (see section 4). If you experience such symptoms, you should immediately contact your doctor or nurse so that treatment for these symptoms can be started.
If you are unsure whether any of the above situations apply to you, you should inform your doctor.

Meronem and other medicines

Tell your doctor, pharmacist, or nurse about all the medicines you have taken recently or are taking, as Meronem may change the effect of some medicines, and other medicines may affect the effect of Meronem.
In particular, tell your doctor if you are using:

• 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 blood clots in blood vessels).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine. It is recommended to avoid giving meropenem to pregnant women.
Your doctor will decide whether you should use Meronem.
If you are breastfeeding or plan to breastfeed, it is very important to inform your doctor before using Meronem. Small amounts of this medicine pass into human milk.
Therefore, the use of Meronem in breastfeeding women will be decided by your doctor.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.
The use of Meronem has been associated with headaches, a feeling of tingling, and numbness (paresthesia).
Any of these side effects may affect your ability to drive or use machines.
Meronem may cause involuntary muscle contractions leading to rapid and uncontrolled shaking of the whole body (seizures). This is usually accompanied by loss of consciousness. If you experience this side effect, you 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 your health condition requires monitoring of sodium intake, you should inform your doctor, pharmacist, or nurse.

3. How to use Meronem

Always use this medicine exactly as your doctor, pharmacist, or nurse has told you. If you are unsure, check with your doctor, pharmacist, or nurse.

Use in adults

• The dose of the medicine depends on the type of infection you have, the site of infection in your body, and the severity of the infection. Your doctor will decide the dose you need.
• The usual dose for adults is from 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 12 years of age depends on the child's age and weight. The usual dose is from 10 mg to 40 mg of Meronem per kilogram (kg) of the child's weight. The medicine is usually given every 8 hours. Children with a weight over 50 kg should be given the adult dose.

How to use Meronem

• Meronem will be given to you by injection or infusion into a large vein.
• Meronem will be given by your doctor or nurse.
• Sometimes, some patients, parents, and caregivers may be trained to give Meronem at home. The instructions for administration are included in this leaflet (in the section "Instructions for self-administration of Meronem at home"). Self-administration of the medicine to yourself or another person at home is only allowed after prior training by a doctor or nurse. Always use Meronem strictly according to your doctor's instructions. If you are unsure, ask your 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 from 15 to 30 minutes. Your doctor will decide how long the administration should take.
• The medicine should usually be given at the same times each day.

Using more Meronem than prescribed

If you have accidentally used a dose of Meronem higher than prescribed by your doctor, you should immediately contact your doctor or go to the nearest hospital.

Missing a dose of Meronem

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

Stopping Meronem treatment

Do not stop using Meronem unless your doctor tells you to.
If you have any doubts about using the medicine, ask your 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 you experience any of these symptoms, you should immediately contact your doctor or nurse. You 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 lymph node enlargement. These may be symptoms of a multi-organ hypersensitivity reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). severe, red, blistering, peeling skin rash, which may be associated with fever and joint pain. severe skin rash, which may appear as red, round patches on the trunk, 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 include:

• unexpected shortness of breath;
• red or brown urine color. If you experience any of these symptoms, you should immediately contact your doctor.

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

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 you experience this side effect, you should immediately inform your doctor or nurse.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Meronem

Keep this 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 that 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 up to 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 up to 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;

From a microbiological point of view, the solution should be administered immediately, unless the method of opening, reconstitution, and dilution precludes the risk of microbial contamination.
If the solution is not administered immediately, the responsibility for the storage time and conditions lies with the user.
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

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, please 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: 04/2024

Advice - medical information
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
Bacterial infections can occur that do not respond to antibiotics. 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 your doctor has prescribed an antibiotic, it means you need it only because of your current illness. By following the instructions below, you can help prevent bacterial resistance, which causes the antibiotic to stop working.

• 1. It is very important to use the antibiotic in the correct dose, at the correct time, and for the correct number of days. You should read the instructions in the patient information leaflet, and if you have any doubts, ask your doctor or pharmacist to explain.
• 2. You should not use an antibiotic unless it has been prescribed by a doctor and only use it to treat the infection for which it was prescribed.
• 3. You should not use an antibiotic prescribed for another person, even if they had similar symptoms.
• 4. You should not give an antibiotic prescribed for you to other people.
• 5. Any leftover antibiotic prescribed by a doctor should be returned to the pharmacy for proper disposal.

The following information is intended for medical personnel or 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). Your doctor will instruct you on how much solvent to use.
• The medicine should be administered immediately after preparation. Do not freeze the prepared medicine.
• 1. Wash and dry your 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 up the prescribed amount of water for injection into the syringe. The required amount of water is shown 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 up into one syringe.

• 6. Place the needle of the syringe into the center of the rubber stopper, insert it, 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. Again, wipe the rubber stopper with a new alcohol swab and wait until it is dry.
• 8. Make sure the syringe plunger is pushed all the way in, then reinsert the needle through the rubber stopper. Hold the syringe and vial, then turn the vial upside down.
• 9. Holding the tip of the needle 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 put the empty vial in a safe place.

• 11. Hold the syringe vertically, with the needle end up. Gently tap the syringe to make any 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, used needles and infusion lines should be disposed of properly. If your doctor decides to stop treatment, any unused medicine should be disposed of in accordance with local regulations.

Administration of the medicine

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

Administration of 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 cap from the cannula 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 your doctor's or nurse's instructions.
• 5. Close the cannula and carefully dispose of the syringe in a sharps container.

Administration of 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 your 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.