MEROPENEM 500 mg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Meropenem AptaPharma, 500 mg, powder for solution for injection/infusion
3. Meropenem AptaPharma, 1000 mg, powder for solution for injection/infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Meropenem AptaPharma and what is it used for
5. Important information before using Meropenem AptaPharma
   1. When not to use Meropenem AptaPharma
   2. Warnings and precautions
   3. Children
   4. Meropenem AptaPharma and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Meropenem AptaPharma contains sodium
6. How to use Meropenem AptaPharma
   1. Use in adults
   2. Use in children and adolescents
   3. How to use Meropenem AptaPharma
   4. Using a higher dose of Meropenem AptaPharma than recommended
   5. Missing a dose of Meropenem AptaPharma
   6. Stopping the use of Meropenem AptaPharma
7. Possible side effects
   1. Severe allergic reactions
   2. Destruction of red blood cells (frequency not known - cannot be estimated from available data)
   3. Other possible side effects
   4. Common (may occur in up to 1 in 10 people)
   5. Uncommon (may occur in up to 1 in 100 people)
   6. Rare (may occur in up to 1 in 1000 people)
   7. Reporting side effects
8. How to store Meropenem AptaPharma
9. Contents of the packaging and other information
   1. What Meropenem AptaPharma contains
   2. What Meropenem AptaPharma looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: April 2021
   7. Medical advice/information
   8. The following information is intended for healthcare professionals only
   9. Instructions for self-administration of Meropenem AptaPharma at home
   10. Warning. The medicine can be administered at home only after prior training by a doctor or nurse.
   11. How to prepare the medicine
   12. Administering the medicine
   13. Administering Meropenem AptaPharma through a short cannula or venflon
   14. Administering Meropenem AptaPharma through a port or central line

Leaflet accompanying the packaging: patient information

Meropenem AptaPharma, 500 mg, powder for solution for injection/infusion

Meropenem AptaPharma, 1000 mg, powder for solution for injection/infusion

Meropenem

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• 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 side effects 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 Meropenem AptaPharma and what is it used for
• 2. Important information before using Meropenem AptaPharma
• 3. How to use Meropenem AptaPharma
• 4. Possible side effects
• 5. How to store Meropenem AptaPharma
• 6. Contents of the packaging and other information

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

Meropenem AptaPharma contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. Its action involves destroying bacteria that can cause severe infections.
Meropenem AptaPharma is used to treat the following infections in adults and children over 3 months of age:

• lung infection (pneumonia);
• bronchitis and pneumonia in patients with cystic fibrosis;
• complicated urinary tract infections;
• complicated infections within the abdominal cavity.
• intrauterine and postpartum infections (that can develop during or after childbirth);
• complicated skin and soft tissue infections;
• acute bacterial meningitis.

Meropenem AptaPharma can be used to treat febrile neutropenic patients who are suspected of having a bacterial infection.
Meropenem AptaPharma can be used to treat bacterial infections of the blood that may be associated with the above-mentioned infections.

2. Important information before using Meropenem AptaPharma

When not to use Meropenem AptaPharma

• if the patient has been diagnosed with an allergy to meropenem or any other component 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 Meropenem AptaPharma, inform the doctor, pharmacist, or nurse:

• if the patient has health problems such as liver or kidney disease;
• if the patient has had severe diarrhea after using other antibiotics.

During treatment, the patient may have a positive result in a certain test (so-called Coombs test) indicating the presence of antibodies that can destroy red blood cells. The doctor will discuss this with the patient.
The patient may experience symptoms of severe skin reactions (see section 4).
If the patient experiences such symptoms, they should immediately contact their doctor or nurse so that treatment for these symptoms can be started.
If the patient is unsure whether any of the above situations apply to them, they should tell their doctor before taking Meropenem AptaPharma.

Children

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

Meropenem AptaPharma and other medicines

Tell the doctor, pharmacist, or nurse about all medicines being taken currently or recently and about any medicines the patient plans to take. Meropenem AptaPharma may change the action of some medicines, and other medicines may affect the action of Meropenem AptaPharma.
In particular, tell the doctor or nurse if the patient is taking:

• probenecid (used to treat gout);
• valproic acid, sodium valproate, or valpromide (used to treat epilepsy). Do not use Meropenem AptaPharma, 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, breastfeeding, and fertility

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 administering meropenem during pregnancy.
The doctor will decide whether to administer meropenem to the patient.
If the patient is breastfeeding or plans to breastfeed, it is very important to inform the doctor before using meropenem. Small amounts of this medicine pass into breast milk.
The doctor will decide whether to administer meropenem to a breastfeeding woman.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.
Taking meropenem has been associated with headaches, a feeling of tingling and numbness (paresthesia), which may affect the ability to drive or use machines. Meropenem can also cause involuntary muscle movements causing 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.

Meropenem AptaPharma contains sodium

Meropenem AptaPharma 500 mg: this medicine contains 45 mg of sodium (the main component of table salt) in each vial. This corresponds to 2.3% of the recommended maximum daily sodium intake in the diet for adults.
Meropenem AptaPharma 1000 mg: this medicine contains 90 mg of sodium (the main component of table salt) in each vial. This corresponds to 4.5% of the recommended maximum daily sodium intake 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 Meropenem AptaPharma

This medicine should always be used as directed by the doctor or nurse. In case of doubts, consult the doctor or nurse.

Use in adults

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

Use in children and adolescents

• The dose of the medicine in 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 Meropenem AptaPharma per kilogram (kg) of the child's weight. The medicine is usually administered every 8 hours. Children with a weight over 50 kg are given a dose as for adults.

How to use Meropenem AptaPharma

• Meropenem AptaPharma will be administered to the patient by injection or infusion into a large vein.
• Meropenem AptaPharma will be administered by a doctor or nurse.
• However, sometimes, some patients, parents, or caregivers may be trained to administer Meropenem AptaPharma at home. The administration instructions are included in this leaflet (in the section "Instructions for self-administration of Meropenem AptaPharma at home"). Always use Meropenem AptaPharma strictly according to the doctor's instructions. In case of doubts, consult the doctor.
• The solution for injection should not be mixed or added to solutions containing other medicines.
• Administration may take 5 minutes or from 15 to 30 minutes. The doctor will decide how long the administration of the medicine should take for the patient.
• The medicine should usually be administered at the same times of the day.

Using a higher dose of Meropenem AptaPharma than recommended

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

Missing a dose of Meropenem AptaPharma

If a dose of the medicine is missed, it should be administered as soon as possible. However, if the time to the next dose is short, the missed dose should be skipped.
Do not administer a double dose to make up for the missed dose.

Stopping the use of Meropenem AptaPharma

Do not stop using Meropenem AptaPharma unless the doctor recommends it.
In case of doubts related to the use of the medicine, consult the 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 any of these symptoms occur, immediately contact a doctor or nurse. The patient may urgently need medical attention.
The symptoms may include:

• severe rash, itching, or skin lesions;
• swelling of the face, lips, tongue, or other parts of the body;
• difficulty breathing, wheezing, or breathing problems;
• severe skin reactions, including: severe hypersensitivity reactions, including fever, skin rash, changes in liver function test results, and an increased number of a certain type of white blood cell (eosinophils), as well as lymph node enlargement. These may be symptoms of a multi-organ hypersensitivity disorder known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); severe, red, flaky skin rash, skin lesions containing pus, blisters, or skin peeling, which may be associated with fever and joint pain; severe skin lesions, which may appear as red, round spots on the torso, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye lesions, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or in a more severe form [toxic epidermal necrolysis (Lyell's syndrome)].

Destruction of red blood cells (frequency not known - cannot be estimated from available data)

Symptoms may include:

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

If any of these symptoms occur, immediately contact a doctor.

Other possible side effects

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

• abdominal pain
• nausea
• vomiting
• diarrhea
• headache
• rash, skin itching
• inflammation and pain
• increased platelet count (in blood tests)
• changes in liver function test results

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

• blood changes, including decreased platelet count (may cause easy bruising), increased count of certain white blood cells, decreased count of other white blood cells, increased bilirubin levels in the blood. The doctor may recommend regular blood tests.
• changes in blood test results, including kidney function tests
• tingling sensation
• fungal infections of the mouth or vagina (thrush)
• inflammation of the colon with diarrhea
• vein pain at the injection site
• other blood changes. Symptoms include frequent infections, fever, and sore throat. From time to time, the doctor may recommend regular blood tests.
• sudden severe rash or blistering or peeling of the skin. This may be accompanied by fever and joint pain.

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

• seizures
• sudden confusion and disorientation (delirium).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell the doctor or pharmacist.
Side effects can be reported directly to the
Department of Medicinal Product Monitoring
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 will help gather more information on the safety of this medicine.

5. How to store Meropenem AptaPharma

Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and carton after "EXP". The expiry date refers to the last day of the month.
Store at a temperature below 30°C.
Injection
After reconstitution: the solution for intravenous injection should be administered immediately after preparation.
The prepared 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
After reconstitution: the solution for intravenous infusion should be administered immediately after preparation.
The prepared solution should not be stored for more than:

• 6 hours at a temperature up to 25°C, if meropenem is dissolved in a 9 mg/ml (0.9%) sodium chloride solution for infusion;
• 24 hours in a refrigerated state (2-8°C), if meropenem is dissolved in a 9 mg/ml (0.9%) sodium chloride solution for infusion;
• if meropenem is dissolved in a 50 mg/ml (5%) glucose solution for infusion, the prepared 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 microbial contamination.
If the solution is not administered immediately, the user is responsible for the storage time and conditions.
Do not freeze the prepared solution.
The solution should be visually inspected before administration to check for particulate matter or color change.
Only use the solution if it is colorless to yellow and free of visible particles.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Meropenem AptaPharma contains

The active substance of the medicine is meropenem.
Meropenem AptaPharma 500 mg:
Each vial contains 570 mg of meropenem trihydrate, equivalent to 500 mg of meropenem.
Meropenem AptaPharma 1000 mg:
Each vial contains 1140 mg of meropenem trihydrate, equivalent to 1000 mg of meropenem.
The other ingredients are sodium carbonate.

What Meropenem AptaPharma looks like and contents of the pack

Meropenem AptaPharma is a white to light yellow crystalline powder for solution for injection/infusion, in glass vials.
The reconstituted product is a clear solution, colorless to yellow.
Meropenem AptaPharma 500 mg: a 20 mL vial made of type III colorless glass with a bromobutyl rubber stopper, a purple aluminum cap, and a PP flip-off cap, in a carton.
Meropenem AptaPharma 1000 mg: a 20 mL vial made of type III colorless glass with a bromobutyl rubber stopper, a gray aluminum cap, and a PP flip-off cap, in a carton.
The pack contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder

Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Ljubljana
Slovenia

Manufacturer/Importer

ACS Dobfar S.p.A.
Nucleo Industriale S. Atto, S. Nicolò a Tordino
64100 Teramo
Italy

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

Date of last revision of the leaflet: April 2021

Medical advice/information

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 causes of such cases is the resistance of bacteria to the antibiotic used.
This means that despite the use of an antibiotic, some bacteria may survive or multiply.
There are many reasons for bacterial resistance. Proper use of antibiotics can reduce the likelihood of bacteria developing resistance.
When a doctor prescribes an antibiotic, it is intended to treat the patient's current illness only. By following the guidelines below, you 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 times, and for the correct number of days. Read the instructions in the patient information leaflet, and if in doubt, ask the doctor or pharmacist to explain.
• 2. Do not use 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 use an antibiotic prescribed for someone else, even if they have similar symptoms.
• 4. Do not pass on an antibiotic prescribed for you to other people.
• 5. Return any unused antibiotic prescribed by a doctor to a pharmacy for proper disposal.

The following information is intended for healthcare professionals only

Instructions for self-administration of Meropenem AptaPharma at home

Some patients, parents, or caregivers may be trained to administer Meropenem AptaPharma at home.

Warning. The medicine can be administered at home only 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 your hands. Prepare a clean workspace.
• 2. Remove the Meropenem AptaPharma vial from the packaging. Check the vial and expiration date. Check for signs of damage to the medicine packaging.
• 3. Remove the colored cap and wipe the gray rubber stopper with an alcohol swab. Wait until the stopper is dry.
• 4. Attach a new, sterile needle to a new, sterile syringe, without touching the tips.
• 5. Draw the prescribed amount of water for injection into the syringe. The required amount of water is listed in the table below:
• 6. Insert the needle of the syringe into the center of the gray rubber stopper and inject the water for injection from the syringe into the vial or vials of Meropenem AptaPharma.

• 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 rubber stopper. Hold both the syringe and the vial, and turn the vial upside down.
• 9. Holding the tip of the needle submerged in the solution, pull the syringe plunger and draw the solution from the vial into the syringe.
• 10. Disconnect the needle and syringe 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 collect air bubbles at the top.
• 12. Remove all air from the syringe by gently pressing the plunger until all the air is out.
• 13. If Meropenem AptaPharma is used at home, 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 Meropenem AptaPharma 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 Meropenem AptaPharma 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. Replace the cap on the central line and carefully dispose of the syringe in a sharps container.