Meropenem Kabi

Leaflet accompanying the packaging: information for the user

Meropenem Kabi, 500 mg, powder for solution for injection or infusion

Meropenem Kabi, 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.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for one person. 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 or nurse. See section 4.

Table of contents of the leaflet

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

1.

What is Meropenem Kabi and what is it used for

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

• pneumonia (lung infection);
• lung and bronchial infections in patients with cystic fibrosis;
• complicated urinary tract infections;
• complicated abdominal infections;
• intrauterine and postpartum infections;
• complicated skin and soft tissue infections;
• severe bacterial infection of the brain (meningitis).

Meropenem Kabi can be used to treat patients with neutropenia and fever if a bacterial infection is suspected.
Meropenem Kabi can be used to treat bacterial blood infections that may be associated with the above-mentioned infections.

2. Important information before using Meropenem Kabi

When not to use Meropenem Kabi

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

Warnings and precautions

Before starting treatment with Meropenem Kabi, consult a doctor or nurse:

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

The result of the Coombs test performed during treatment may be positive, indicating 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 immediately contact a doctor or nurse to start treatment for these symptoms.
In case of doubt as to whether any of the above situations apply to the patient, they should inform their doctor or nurse before using Meropenem Kabi.

Meropenem Kabi and other medicines

Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Meropenem Kabi may affect the action of some medicines, and some medicines may affect the action of Meropenem Kabi.
Particularly inform the doctor or nurse if the patient is taking:

• probenecid (used to treat gout);
• valproic acid, sodium valproate, valpromide (used to treat epilepsy); Meropenem Kabi should not be used as it may reduce the effectiveness of these medicines;
• oral anticoagulants (used to treat or prevent 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 a doctor or pharmacist before using this medicine. Meropenem should be avoided in pregnant women.
The doctor will decide whether the patient should receive meropenem.
It is essential that before starting meropenem, the patient informs their doctor if they are breastfeeding or plan to breastfeed. Small amounts of this medicine pass into breast milk. The doctor will decide whether the patient should use meropenem while breastfeeding.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. However, using Meropenem Kabi may cause headache, tingling, and numbness of the skin (paresthesia), uncontrolled muscle contractions leading to sudden and uncontrolled body tremors (seizures), usually associated with loss of consciousness. These are side effects that can affect the ability to drive and use machines. Do not drive or operate machines if these side effects occur.

Meropenem Kabi contains sodium

Meropenem Kabi, 500 mg:
This medicine contains 45.13 mg of sodium (the main component of table salt) per vial/bottle.
This corresponds to 2.3% of the maximum recommended daily sodium intake in the diet for adults.
Meropenem Kabi, 1 g:
This medicine contains 90.25 mg of sodium (the main component of table salt) per vial/bottle.
This corresponds to 4.5% of the maximum recommended daily sodium intake in the diet for adults.
If the patient's health condition requires controlling the amount of sodium they consume, they should inform their doctor or nurse.

3. How to use Meropenem Kabi

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

Adult patients

• 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 determine the appropriate dose for the patient.
• The dose for adult patients is usually between 500 mg (milligrams) and 2 g (grams). The medicine is usually administered every 8 hours. However, if the patient has kidney problems, the medicine may be administered less frequently.

Children and adolescents

• The dose for children over 3 months and up to 12 years depends on the child's age and weight. The usual dose is between 10 mg and 40 mg of Meropenem Kabi per kilogram (kg) of body weight. The dose is usually administered every 8 hours. Children over 50 kg are given the same dose as adult patients.

How to use Meropenem Kabi

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

Using a higher dose of Meropenem Kabi than recommended

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

Missing a dose of Meropenem Kabi

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 (two injections at the same time) to make up for the missed dose.

Stopping treatment with Meropenem Kabi

Do not stop treatment with Meropenem Kabi unless the doctor recommends it.
In case of any further doubts related to the use of this medicine, consult a doctor or nurse.

4. Possible side effects

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

Severe allergic reactions

If the patient experiences a severe allergic reaction, stop using Meropenem Kabi and contact a doctor immediately. The patient may need urgent medical attention. Symptoms of a severe allergic reaction may occur suddenly and 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 used to assess liver function (increased liver enzyme activity) and an increase in the number of a certain type of white blood cell (eosinophilia), 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.
• severe, red, flaking rash, skin lesions containing pus, blisters, or skin peeling, which may be associated with high fever and joint pain.
• severe skin rashes that may appear as red, round spots on the torso, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye inflammation, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or in a more severe form (toxic epidermal necrolysis).

Red blood cell damage (frequency not known)

Symptoms include:

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

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

Other possible side effects

Common side effects (less than 1 in 10 patients):

• abdominal pain (stomach);
• nausea;
• vomiting;
• diarrhea;
• headache;
• rash, itching of the skin;
• pain and inflammation;
• increased platelet count (in blood test results);
• changes in blood test results, including those used to assess liver function.

Uncommon side effects (less than 1 in 100 patients):

• changes in blood, including decreased platelet count (may cause easy bruising), increased white blood cell count, decreased white blood cell count, increased bilirubin levels; the doctor may recommend regular blood tests;
• changes in blood test results, including those used to assess kidney function;
• tingling sensation (pins and needles);
• fungal infections of the mouth or vagina (thrush);
• inflammation of the intestine with diarrhea;
• pain in the veins at the injection site of Meropenem Kabi;
• other changes in blood; symptoms include frequent infections, high fever, and sore throat; the doctor may recommend regular blood tests.

Rare side effects (less than 1 in 1,000 patients):

• seizures (epileptic fits);
• acute confusion and disorientation (delirium).

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell a 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
tel.: +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 the medicine.

5. How to store Meropenem Kabi

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Do not store above 30°C. Do not freeze.
Injection
After reconstitution: the solution for intravenous injection should be used immediately. The time between the start of reconstitution and the end of intravenous injection should not exceed:

• 3 hours at a temperature of 25°C;
• 12 hours during storage in a refrigerator (2-8°C).

Infusion
After reconstitution: the solution for intravenous infusion should be used immediately. The time between the start of reconstitution and the end of intravenous infusion should not exceed:

• 6 hours at a temperature of 25°C, if Meropenem Kabi was reconstituted in 0.9% sodium chloride solution;
• 24 hours during storage in a refrigerator (2-8°C), if Meropenem Kabi was reconstituted in 0.9% sodium chloride solution;
• 1 hour at a temperature of 25°C, if Meropenem Kabi was reconstituted in 5% glucose solution;
• 8 hours during storage in a refrigerator (2-8°C), if Meropenem Kabi was reconstituted in 5% glucose solution.

From a microbiological point of view, the medicine should be used immediately, unless the opening and/or reconstitution and/or dilution took place in aseptic conditions.
If the medicine is not used immediately, the user is responsible for the storage time and conditions before use.
Do not freeze the prepared solution.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Meropenem Kabi contains

• The active substance of the medicine is meropenem trihydrate.

Meropenem Kabi, 500 mg
Each 20 ml vial or 100 ml bottle contains 500 mg of meropenem in the form of meropenem trihydrate.
Meropenem Kabi, 1 g
Each 20 ml vial or 50 ml and 100 ml bottle contains 1.0 g of meropenem in the form of meropenem trihydrate.

• The other ingredient is sodium carbonate.

What Meropenem Kabi looks like and contents of the packaging

Meropenem Kabi is a white or light yellow powder for solution for injection or infusion.
Meropenem Kabi, 500 mg, powder for solution for injection or infusion is available in 20 ml glass vials and 100 ml bottles.
Meropenem Kabi, 1 g, powder for solution for injection or infusion is available in 20 ml glass vials and 50 ml and 100 ml bottles.
The packaging contains 1 vial (bottle) or 10 vials (bottles).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

ACS Dobfar S.p.A.
Nucleo Industriale S. Atto, S. Nicolò a Tordino, 64100 Teramo
Italy
LABESFAL - Laboratórios Almiro S.A. (Fresenius Kabi Group)
Lagedo, 3465-157 Santiago de Besteiros
Portugal
To obtain detailed information, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

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

Austria

Meropenem Kabi 500 mg/1 g Pulver zur Herstellung einer Injektions- bzw. Infusionslösung

Belgium

Meropenem Fresenius Kabi 500 mg/1 g poeder voor oplossing voor injectie of infusie / poudre pour solution injectable ou pour perfusion / Pulver zur Herstellung einer Injektionslösung oder Infusionslösung

Bulgaria

Meropenem Kabi 500 mg/1 g

Cyprus

Meropenem Kabi 500 mg/1000 mg, κόνις για ενέσιμο διάλυμα ή διάλυμα για έγχυση

Czech Republic

Meropenem Kabi

Denmark

Meropenem Fresenius Kabi

Estonia

Meropenem Kabi 500 mg/1000 mg

Greece

Meropenem Kabi 500 mg/1 g, κόνις για διάλυμα προς ένεση ή έγχυση

Spain

Meropenem Kabi 500 mg/1 g polvo para solución inyectable o para perfusión

Netherlands

Meropenem Fresenius Kabi 500 mg/1 g poeder voor oplossing voor injectie of infusie

Ireland

Meropenem 500 mg/1 g powder for solution for injection or infusion

Lithuania

Meropenem Kabi 500 mg/1 g milteliai injekciniam arba infuziniam tirpalui

Luxembourg

Meropenem Kabi 500 mg/1 g Pulver zur Herstellung einer Injektionslösung oder Infusionslösung

Latvia

Meropenem Kabi 500 mg/1000 mg pulveris injekciju vai infūziju šķīduma pagatavošanai

Germany

Meropenem Kabi 500 mg/1 g Pulver zur Herstellung einer Injektions- bzw. Infusionslösung

Norway

Meropenem Fresenius Kabi 500 mg, pulver til injeksjonsvæske/infusjonsvæske, oppløsning
Meropenem Fresenius Kabi 1 g, pulver til injeksjonsvæske/infusjonsvæske, oppløsning

Poland

Meropenem Kabi

Portugal

Meropenem Kabi

Romania

Meropenem Kabi 500 mg/1 g pulbere pentru soluţie injectabilă sau perfuzabilă

Slovakia

Meropenem Kabi 500 mg/1 g

Slovenia

Meropenem Kabi 500 mg/1 g prašek za raztopino za injiciranje ali infundiranje

Sweden

Meropenem Fresenius Kabi 500 mg/1 g, pulver till injektionsvätska eller infusionsvätska, lösning

Hungary

Meropenem Kabi 500 mg/1 g

United Kingdom

Meropenem 500 mg/1 g powder for solution for injection or infusion
Date of last revision of the leaflet:17.11.2023

Medical education

Antibiotics are used to treat infections caused by bacteria. They are ineffective in treating viral infections.
Sometimes bacterial infections do not respond to antibiotic treatment. One of the most common reasons is the resistance of bacteria causing the infection to the used antibiotic. This means that bacteria can survive the treatment cycle and even multiply, despite the use of an antibiotic.
Bacterial resistance to antibiotics can be caused by various factors, and the risk of developing such resistance can be reduced by the responsible use of antibiotics.
The antibiotic prescribed by the doctor is intended solely for the treatment of the current illness. Following the recommendations below will help prevent the development of resistant bacteria, which could render the antibiotic ineffective.

• 1. It is very important to use the antibiotic in the correct dose, at the right time, and for the right number of days. Read the instructions in the leaflet and, in case of doubts, ask the doctor or pharmacist for clarification.
• 2. The patient should not use an antibiotic that was not prescribed specifically for them. They should use it only to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not use antibiotics prescribed for another person, even if they had a similar infection.
• 4. Do not pass on antibiotics prescribed for one patient to other people.
• 5. If the prescribed antibiotic cycle is completed, any remaining antibiotic should be taken to a pharmacy for proper disposal.

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Information intended only for healthcare professionals:

Instructions for self-administration of Meropenem Kabi at home

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

Warning. The medicine can only be 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 solution.
• 1. Wash and dry your hands thoroughly. Prepare a clean workspace.
• 2. Remove the Meropenem Kabi vial (bottle) from the packaging. Check the vial and expiration date. Check if the vial is damaged or shows signs of tampering.
• 3. Remove the colored cap and wipe the rubber stopper with an alcohol swab. Wait until it dries.
• 4. Connect a new, sterile needle to a new, sterile syringe without touching the ends.
• 5. Draw the prescribed volume of sterile water for injection into the syringe. The required volume of water is found in the table below:

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

• 6. Insert the needle of the syringe through the center of the rubber stopper and add the prescribed volume of water for injection to the vial or vials of Meropenem Kabi.
• 7. Remove the needle from the vial and shake the vial for about 5 seconds or until the powder is dissolved. Again, wipe the rubber stopper with a new alcohol swab and wait until it dries.
• 8. With the syringe plunger fully pressed, carefully insert the needle back through the rubber stopper. Hold the syringe and vial, then turn the vial upside down.
• 9. Holding the needle end submerged in the solution, slowly pull back the syringe plunger to draw the entire solution from the vial into the syringe.
• 10. Remove 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 up. Gently tap the syringe to make any air bubbles rise to the top.
• 12. Remove the air from the syringe by gently pressing the plunger until all the air is removed.
• 13. If Meropenem Kabi is used at home, the used needles and infusion set should be disposed of properly. If the doctor decides to stop 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 access.

Administering Meropenem Kabi 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 dries. 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 the doctor's or nurse's instructions.
• 5. Close the cannula and carefully dispose of the syringe in a sharps container.

Administering Meropenem Kabi through a port or central access

• 1. Remove the cap from the port or central line, clean the end of the line with an alcohol swab, and wait until it dries.
• 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.