Meropenem aptapharma

Patient Information Leaflet

Meropenem AptaPharma, 2000 mg, powder for solution for infusion
M e r o p e n e m
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• 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 Meropenem AptaPharma is and what it is used for
2. Important information before receiving Meropenem AptaPharma
3. How to use Meropenem AptaPharma
4. Possible side effects
5. How to store Meropenem AptaPharma
6. Contents of the pack and other information

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

Meropenem AptaPharma contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that may cause serious infections.
Meropenem AptaPharma is used to treat the following infections in adults and children aged 3 months and older:

• Lung infection (pneumonia);
• Bronchial and lung infection in cystic fibrosis;
• Complicated urinary tract infections;
• Complicated intra-abdominal infections;
• Puerperal and postpartum infections;
• Complicated skin and soft tissue infections;
• Acute bacterial meningitis (infection of the membranes surrounding the brain and spinal cord).

Meropenem AptaPharma can be used to treat febrile patients with neutropenia in whom a bacterial infection is suspected.
Meropenem AptaPharma can be used to treat bacterial blood infections that may be associated with the types of infections listed above.

2. Important Information Before Administering Meropenem AptaPharma

When not to use Meropenem AptaPharma

• if the patient has a known allergy to meropenem or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has a known allergy to other antibiotics such as penicillins, cephalosporins, or carbapenems, because such patients may also be allergic to meropenem.

Warnings and precautions
Before using Meropenem AptaPharma, inform the doctor, pharmacist, or nurse:

• if the patient has any health problems such as liver or kidney disease;
• if the patient has previously experienced severe diarrhea after taking other antibiotics.

Liver-related disorders
If the patient develops yellowing of the skin or whites of the eyes, itching, dark urine, or pale stools, inform the doctor immediately. These may be symptoms of impaired liver function, which the doctor should evaluate.
During treatment, the patient may have a positive test result (the so-called 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 objective and subjective symptoms of severe skin reactions (see section 4). If such symptoms occur, contact the doctor or nurse immediately so that appropriate treatment can be initiated.
If the patient has any doubts whether any of the above situations apply, consult the doctor before administering Meropenem AptaPharma.

Children
Meropenem AptaPharm is not recommended for use in children under 3 months of age, as the safety and efficacy of meropenem have not been established in children under 3 months of age.

Meropenem AptaPharma and other medicines
Inform the doctor, pharmacist, or nurse about all medicines currently used or recently taken, as well as any medicines the patient plans to take. Meropenem AptaPharma may alter the effect of certain medicines, and other medicines may affect the action of Meropenem AptaPharma.
In particular, inform the doctor or nurse if the patient is taking any of the following medicines:

• probenecid (used in the treatment of gout);
• valproic acid and/or sodium valproate and/or valpromide (used in the treatment of epilepsy). Meropenem AptaPharma should not be used, as it may reduce the effectiveness of sodium valproate;
• oral anticoagulants (used in the treatment or prevention of blood clots).

Pregnancy, breastfeeding, and fertility
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 use meropenem will be made by the doctor.
If the patient is breastfeeding or intends to breastfeed, it is important to inform the doctor before taking meropenem. Small amounts of this medicine pass into human milk. Therefore, the decision on using meropenem during breastfeeding will be made by the doctor.

Driving and operating machinery
Studies on the effect on the ability to drive vehicles or operate machinery have not been conducted. However, meropenem has been associated with headache and sensations of pricking and numbness (paresthesia), which may affect the ability to drive or operate machinery.
Meropenem may also cause involuntary muscle movements leading to rapid, uncontrolled shaking of the entire body (seizures). This is usually accompanied by loss of consciousness.
If the patient experiences this adverse effect, he or she should not drive or operate machinery.

Meropenem AptaPharma contains sodium
This medicine contains 180 mg of sodium (the main component of table salt) in each vial. This corresponds to 9% of the maximum recommended daily intake of sodium in the diet of adults.
Consult the doctor or pharmacist if the patient requires 3 or more vials per day for an extended period, especially if the patient has been advised to follow a low-salt (low-sodium) diet.

3. How to use Meropenem AptaPharma

This medicine will be prepared and administered to the patient by a doctor or another qualified healthcare professional. The doctor will decide how much Meropenem AptaPharma the patient should receive.

Use in adults

• The dose depends on the type of infection the patient has, the location of the infection in the body, and the severity of the infection. The doctor will determine the dose required by the patient.
• The usual dose in adults ranges from 500 mg (milligrams) to 2000 mg (2 grams). The medicine is usually administered every 8 hours. However, the patient may receive the dose less frequently if their kidneys are not functioning properly.

Use in children and adolescents

• The dose of the medicine for children aged over 3 months up to 12 years depends on the child's age and body weight. The usual dose is between 10 mg and 40 mg of Meropenem AptaPharma per kilogram (kg) of the child's body weight. The medicine is usually administered every 8 hours. Children with a body weight above 50 kg will receive the adult dose.

Other strengths of the medicinal product Meropenem AptaPharma and/or other medicinal products containing meropenem may be available on the market and may be more suitable for dosing in children with body weight below 50 kg and in adults with impaired kidney function.

How to use Meropenem AptaPharma

• Meropenem AptaPharma will be administered to the patient as an intravenous infusion into a large vein.
• Meropenem AptaPharma will be administered by a doctor or nurse.
• The infusion solution must not be mixed or combined with solutions containing other medicines.
• The infusion may last approximately 15–30 minutes.
• The infusion should usually be administered at the same time each day.

Accidental overdose of Meropenem AptaPharma
If the patient thinks they may have accidentally received more medicine than prescribed by the doctor, they should contact their doctor or nurse immediately.

Missed dose of Meropenem AptaPharma
If an infusion has been missed, it should be administered to the patient as soon as possible. However, if the time for the next infusion is approaching, the missed infusion should be skipped.
Do not administer a double dose (two infusions at the same time) to make up for a missed dose.

Stopping treatment with Meropenem AptaPharma
Do not stop using Meropenem AptaPharma unless instructed to do so by the doctor.
If you have any further questions about the use of this medicine, please consult your doctor or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Severe allergic reactions
If any of the following symptoms occur, contact your doctor or nurse immediately. The patient may urgently require medical attention.
Symptoms may include rapidly developing:

• 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 indicating liver function (increased liver enzyme activity), and increased number of certain white blood cells (eosinophils), as well as enlarged lymph nodes. These may be symptoms of a multi-organ hypersensitivity disorder known as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome);
  • severe red, peeling rash, skin nodules 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, and ulcers in the mouth, throat, nose, genital organs and eyes, possibly preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or in a more severe form (toxic epidermal necrolysis).

Sudden chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome, has been observed during treatment with other medicines of the same class. In such a case, contact your doctor or nurse immediately.

Damage to red blood cells (hemolytic anemia) (not common (may occur in up to 1 in 100 people))
Symptoms include:

• sudden onset of shortness of breath;
• red or brown discoloration of urine.

If any of the above symptoms occur, contact your doctor immediately.

Other possible side effects:

Common (may occur in up to 1 in 10 people)

• abdominal pain,
• nausea,
• vomiting,
• diarrhoea,
• headache,
• rash, itching of the skin,
• inflammation and pain,
• increased platelet count (seen in blood tests),
• changes in laboratory test results indicating liver function.

Not common (may occur in up to 1 in 100 people)

• blood changes, including decreased platelet count (which may cause easy bruising), increased number of certain white blood cells, decreased number of other white blood cells, increased blood bilirubin levels. Symptoms may include frequent infections, fever and sore throat. Your doctor may occasionally recommend regular blood tests.
• changes in blood test results, including those indicating kidney function,
• tingling sensation (pins and needles),
• fungal infections of the mouth or vagina (candidiasis),
• inflammation of the intestine with diarrhoea,
• pain at the injection site, redness of the skin and inflammation (thrombophlebitis),
• low blood potassium levels (which may cause weakness, muscle cramps, tingling and heart rhythm disturbances),
• liver-related disorders. 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 symptoms, contact the doctor immediately.

Rare (may occur in up to 1 in 1000 people)

• seizures,
• acute disorientation and confusion (delirium).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Meropenem AptaPharma

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and
the outer carton after EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Infusion
After reconstitution: the solution for intravenous infusion should be administered immediately after preparation.
The time interval between the start of reconstitution and the end of intravenous infusion must not exceed:

• 3 hours at temperatures up to 25°C if meropenem has been dissolved in 9 mg/mL (0.9%) sodium chloride infusion solution;
• 24 hours under refrigerated conditions (2-8°C) if meropenem has been dissolved in 9 mg/mL (0.9%) sodium chloride infusion solution;
• if meropenem has been dissolved in glucose (dextrose) 50 mg/mL (5%) infusion solution, the prepared solution should be administered immediately.

From a microbiological point of view, unless the method of opening and/or reconstitution excludes the risk of microbiological contamination, the product should be used immediately.
If the product is not used immediately, the responsibility for storage duration and conditions during use lies with the user. Do not freeze the reconstituted solution.
Do not use this medicine if particulate matter is observed or if there is a change in colour. Only use solutions that are colourless to yellow and free from particulate matter.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Meropenem AptaPharma contains
The active substance is meropenem.
Each vial contains meropenem trihydrate equivalent to 2000 mg of meropenem.

• Other ingredients: sodium carbonate.

What Meropenem AptaPharma looks like and contents of the pack
Meropenem AptaPharma is a white to pale yellow crystalline powder for solution for infusion, in glass vials.
After reconstitution, the product is a clear, colourless or yellow solution.
The product is packed in a 50 mL vial made of colourless glass of type I, with a bromobutyl rubber stopper of type I and a green aluminium flip-off cap with a PP overseal.
The pack contains 6 vials.

Marketing Authorisation Holder
Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Lubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]

Manufacturer/Importer
ACS Dobfar S.p.A.
Nucleo Industriale S. Atto
San Nicolò A Tordino
64100 Teramo
Italy

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

Date of the latest update of the leaflet: August 2025
Advice / Medical education
Antibiotics are used to treat bacterial infections. They are ineffective against
viral infections.
There are cases of 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 the use of an antibiotic, some bacteria may survive or multiply.
There are many causes of bacterial resistance. Proper use of antibiotics may
reduce the likelihood of bacteria developing resistance.
When a doctor prescribes an antibiotic, it is intended solely for the treatment of the illness currently affecting the patient. By following the advice below, you can help prevent bacterial resistance, which causes antibiotics to stop working.

1. It is very important to take the antibiotic at the correct dose, at the correct times, and for the correct number of days. Read the instructions in the patient leaflet, and if in doubt, consult your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been prescribed for you by a doctor, and use it only to treat the infection for which it was prescribed.
3. Do not take an antibiotic prescribed for another person, even if they have similar symptoms.
4. Do not give an antibiotic prescribed for you to other people.
5. Any unused antibiotic prescribed for you should be returned to a pharmacy, which will dispose of it properly.

The following information is intended exclusively for healthcare professionals or medical personnel.
To review complete information regarding dosage, warnings, and precautions, please refer to the Product Characteristics Summary.
P reparation of the infusion
Meropenem AptaPharma 2000 mg is intended for intravenous infusion only.
To prepare the intravenous infusion solution, dissolve the contents of the vial of meropenem in:

• 9 mg/mL (0.9%) sodium chloride infusion solution, or
• 50 mg/mL (5%) glucose (dextrose) infusion solution, to obtain a final concentration of 1 to 20 mg/mL.

Standard aseptic conditions must be maintained during preparation and administration of the solution.
Shake the solution before use. The solution should be visually inspected prior to administration for the presence of particulate matter or discoloration. Only clear, colorless to yellow solutions free from particulate matter should be used.
For storage conditions of the product after reconstitution, see section 5.