Meropenem

Meronem, 500 mg, powder for solution for injection or infusion
Meronem, 1 g, powder for solution for injection or infusion
meropenem
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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. It works by killing bacteria that may cause serious infections.
Meronem is used to treat the following infections in adults and children aged 3 months and older:

• Lung infection (pneumonia).
• Bronchitis and lung infection in cystic fibrosis.
• Complicated urinary tract infections.
• Complicated intra-abdominal infections.
• Infections occurring during or after childbirth (puerperal infections).
• Complicated skin and soft tissue infections.
• Acute bacterial meningitis.

Meronem may also be used to treat febrile patients with neutropenia in whom a bacterial infection is suspected.
Meronem may also be used to treat bacterial bloodstream infections that may be associated with the infections listed above.

2. Information before using Meronem

When not to use Meronem

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

Warnings and precautions
Before using Meronem, inform your doctor, pharmacist or nurse:

• if the patient has liver or kidney disease;
• if the patient has previously experienced severe diarrhoea after taking other antibiotics.

During treatment, the patient may develop a positive Coombs test, indicating the presence of antibodies that may destroy red blood cells. The doctor will discuss this with the patient.
The patient may experience signs and symptoms of serious skin reactions (see section 4). If such symptoms occur, the patient should contact a doctor or nurse immediately so that treatment for these symptoms can be started.
If the patient experiences unexplained muscle pain, tenderness or weakness and/or dark-coloured urine, medical advice should be sought immediately. These may be symptoms of muscle breakdown (called rhabdomyolysis), which can lead to kidney problems.

Liver function disturbances
If the patient develops yellowing of the skin or the whites of the eyes, itching of the skin, dark-coloured urine or pale-coloured stools, inform the doctor. These may be signs of liver function disturbances, which the doctor should investigate.
If the patient is unsure whether any of the above situations apply, they should inform their doctor.

Meronem and other medicines
Tell your doctor, pharmacist or nurse about any medicines the patient has recently taken, or plans to take, because Meronem may alter the effect of certain medicines and other medicines may influence the effect of Meronem.
In particular, inform the doctor if the patient is taking:

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Administration of meropenem during pregnancy is not recommended.
The decision on whether the patient should take Meronem will be made by the doctor.
If the patient is breastfeeding or intends to breastfeed, it is very important to inform the doctor before using Meronem. Small amounts of this medicine pass into human milk. Therefore, the decision on using Meronem during breastfeeding will be made by the doctor.

Driving and using machines
Studies on the effect on the ability to drive and use machines have not been conducted.
Use of Meronem has been associated with headache, and sensations of pricking or tingling (paraesthesia).
Any of these adverse effects may affect the ability to drive or operate machinery.
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 this adverse effect occurs, the patient should not drive or operate machinery.

Meronem contains sodium
Meronem 500 mg: this medicine contains 45 mg of sodium (the main component of table salt) in each dose containing 500 mg of meropenem. This corresponds to 2.25% of the recommended maximum daily intake of sodium in the adult diet.
Meronem 1 g: this medicine contains 90 mg of sodium (the main component of table salt) in each dose containing 1 g of meropenem. This corresponds to 4.5% of the recommended maximum daily intake of sodium in the adult diet.
If the patient's medical condition requires monitoring of sodium intake, this should be discussed with the doctor, pharmacist or nurse.

3. How to use Meronem

This medicine should always be used exactly as prescribed by your doctor, pharmacist, or nurse.
If in doubt, consult your doctor, pharmacist, or nurse.

Use in adults

• The dose of this medicine depends on the type of infection, its location in the body, and the severity of the infection. Your doctor will decide the appropriate dose for you.
• The usual dose in adults ranges from 500 mg (milligrams) to 2 g (grams). The medicine is usually administered every 8 hours. However, if you have kidney impairment, doses may be given less frequently.

Use in children and adolescents

• The dose of Meronem in children older than 3 months up to 11 years of age depends on the child's age and body 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 body weight above 50 kg should receive the adult dose.

How to use Meronem

• Meronem will be administered to you as an injection or infusion into a large vein.
• Meronem will be given by a doctor or nurse.
• In some cases, certain patients, parents, or caregivers may be trained to administer Meronem at home. Instructions for self-administration are provided in this leaflet (in the section “Instructions for self-administration of Meronem at home”). Self-administration of the medicine at home, either to yourself or another person, is permitted only after proper training by a doctor or nurse. Always use Meronem strictly according to your doctor’s instructions. If in doubt, consult your doctor.
• This medicine must not be mixed with another medicine or added to solutions containing other drugs.
• Administration may last 5 minutes or between 15 and 30 minutes. Your doctor will decide how long the infusion should last for you.
• The medicine should usually be given at the same times each day.

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

If you miss a dose of Meronem
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
Do not administer a double dose to make up for a missed dose.

Stopping Meronem
Do not stop using Meronem unless instructed by your doctor.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Severe allergic reactions
If any of the following subjective or objective symptoms occur, seek immediate medical advice from a doctor or nurse. The patient may urgently require medical assistance. Subjective and objective symptoms may include rapidly occurring:

• 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 such as fever, skin rash, changes in blood test results used to assess liver function (increased liver enzyme activity), and increased number of a certain type of white blood cells (eosinophils), as well as enlarged lymph nodes. These may be symptoms of a multi-organ disorder due to hypersensitivity, known as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
• severe, red, peeling rash, skin lesions containing pus, blisters or skin peeling, which may be associated with fever and joint pain.
• severe skin rashes, which may appear as red, round spots on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes, and may be preceded by fever and flu-like symptoms [bullous erythema multiforme (Stevens-Johnson syndrome)] or in more severe cases [toxic epidermal necrolysis (Lyell's syndrome)].

Damage to red blood cells (frequency unknown)
Symptoms include:

• sudden onset of shortness of breath;
• red or brown discoloration of urine. If any of the above symptoms occur, seek immediate medical advice from a doctor.

Muscle breakdown

• Unexplained muscle pain, tenderness or weakness and (or) dark discoloration of urine.

If any of these objective or subjective symptoms occur, seek immediate medical advice from a doctor.
Liver function disorders (not common)

• Yellowing of the skin and whites of the eyes, itching of the skin, dark urine or pale stools. If the patient experiences any of these objective or subjective symptoms, seek immediate medical advice from a doctor.

Other possible adverse reactions
Common (may occur in 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 diagnostic test results indicating liver function.

Uncommon (may occur in up to 1 in 100 people)

• Changes in blood tests, including decreased platelet count (may cause easy bruising), increased number of certain white blood cells, decreased number of other white blood cells, increased blood bilirubin levels. The doctor may recommend regular blood tests.
• Changes in blood test results, including tests indicating kidney function.
• Decreased potassium levels in the patient's blood (which may cause weakness, muscle cramps, tingling and heart rhythm disturbances).
• Tingling sensation (pins and needles).
• Fungal infections of the mouth or vagina (thrush).
• Inflammation of the intestine with diarrhea.
• Vein pain at the site of Meronem administration.
• Other changes in blood. Symptoms include frequent infections, fever and sore throat. Occasionally, the doctor may recommend regular blood tests.

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

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

During the use of other medicines of the same type, cases of sudden chest pain have been observed, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. If this adverse reaction occurs, inform the doctor or nurse immediately.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps 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 stated month.
Store below 30°C.

Injection
After reconstitution: the intravenous injection solution should be administered immediately after preparation.
The prepared solution should not be stored for longer than:

• 3 hours at a temperature not exceeding 25°C;
• 12 hours under refrigerated conditions (2–8°C).

Infusion (intravenous infusion)
After reconstitution: the intravenous infusion solution should be administered immediately after preparation.
The prepared solution should not be stored for longer than:

• 3 hours at a temperature not exceeding 25°C, if Meronem was reconstituted with sodium chloride solution;
• 24 hours under refrigerated conditions (2–8°C), if Meronem was reconstituted with sodium chloride solution;
• if Meronem was reconstituted with dextrose solution, the prepared solution must be administered immediately.

From a microbiological point of view, the solution should be used immediately, unless the method of opening, reconstitution and dilution excludes the risk of microbiological contamination.
If the solution is not administered immediately, the responsibility for the duration and conditions of storage lies with the user.
Do not freeze the prepared solution.
Medicines must 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 pale yellow powder in a vial, intended for the preparation of a solution for injection or infusion. The pack contains 1 or 10 vials in a cardboard box.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer
Pfizer Service Company BV
10 Hoge Wei
1930 Zaventem
Belgium

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Pfizer Polska Sp. z o.o.
Tel. +48 22 335 61 00

This medicinal product is authorised 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

Advice – Medical education
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
There are bacterial infections that do not respond to antibiotic treatment. One of the most common reasons for such cases is bacterial resistance to the antibiotic used. This means that despite antibiotic treatment, some bacteria may survive or multiply.

There may be many causes of bacterial resistance. Prudent use of antibiotics may help reduce the development of resistance.

If your doctor has prescribed an antibiotic, it means you need it specifically for your current illness. By following the advice below, you can help prevent the development of bacterial resistance, which causes antibiotics to stop working.

1. It is very important to take the antibiotic at the correct dose, at the correct time, and for the correct number of days. Please read the instructions in the patient leaflet, and if you have any doubts, consult your doctor or pharmacist for clarification.
2. Do not use an antibiotic unless it has been prescribed by a doctor, and use it only to treat the infection for which it was prescribed.
3. Do not use an antibiotic prescribed for another person, even if their symptoms were similar.
4. Do not give away an antibiotic prescribed for you to other people.
5. Return any unused antibiotic prescribed for you to a pharmacy for proper disposal.

Information intended exclusively for healthcare professionals:

Instructions for self-administration of Meronem at home
Some patients, parents, and caregivers may be trained to administer the Meronem medication at home.
Warning: Self-administration of the medication at home is permitted only after proper training by a physician or nurse.
How to prepare the medication

• This medication must be mixed with another liquid (diluent). Your doctor will instruct you on the exact volume of diluent to use.
• The medication should be administered immediately after preparation. Do not freeze the prepared solution.
  1. Wash your hands thoroughly and dry them. Prepare a clean work area.
  2. Remove the Meronem vial from its packaging. Check the vial and the expiration date. Inspect for any signs of damage to the medication packaging.
  3. Remove the colored cap and wipe the grey rubber stopper with an alcohol swab. Wait for the stopper to dry completely.
  4. Attach a new sterile needle to a new sterile syringe, taking care not to touch the tips.
  5. Draw up the recommended volume of water for injections into the syringe. The required amount of water is given in the table below:

Note: If the prescribed dose of Meronem is greater than 1 g, more than one vial of Meronem will be required. In such cases, the solution from multiple vials can be drawn into a single syringe.

6. Insert the syringe needle into the center of the rubber stopper, pierce it, and inject the water for injection from the syringe into the vial or vials containing Meronem.
7. Remove the needle from the vial and shake the vial vigorously for about 5 seconds or until the powder is completely dissolved. Wipe the rubber stopper again with a new alcohol-soaked swab and wait for it to dry.
8. Ensure the syringe plunger is fully depressed. Then, reinsert the needle through the gray rubber stopper. Hold both the syringe and the vial, and then invert the vial.
9. Keeping the tip of the needle submerged in the solution, pull back the plunger to 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 in an upright, vertical position with the needle tip pointing upward. Gently tap the syringe to allow any air bubbles to rise to the top.
12. Carefully expel all air from the syringe by gently pressing the plunger until all air is removed.
13. If Meronem is being used at home, used needles and infusion lines must be disposed of properly. If the physician decides to discontinue treatment, any unused medication should be disposed of according to local regulations.

Administration of the Medicinal Product
The medicinal product may be administered through a short cannula or venflon, or via a port or central line.

Administration of Meronem via 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-soaked swab and wait for it to dry. Remove the cannula cap and connect the syringe.
3. Slowly depress the syringe plunger to administer the antibiotic evenly over approximately 5 minutes.
4. After completing the antibiotic administration and emptying the syringe, disconnect the syringe and flush the cannula as directed by the physician or nurse.
5. Cap the cannula and carefully dispose of the syringe in a sharps container.

Administration of Meronem via a port or central line

1. Remove the cap from the port or central line, clean the end of the line with an alcohol-soaked swab, and wait for it to dry.
2. Connect the syringe and slowly depress the plunger to administer the antibiotic evenly over approximately 5 minutes.
3. After completing the antibiotic administration, disconnect the syringe and flush the line as directed by the physician or nurse.
4. Attach a new cap to the central line and carefully dispose of the syringe in a sharps container.