Meropenem Kabi

Package Leaflet: 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 all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1.

What Meropenem Kabi is and what it is used for

Meropenem Kabi belongs to a group of medicines called carbapenem antibiotics.
It works by killing bacteria that can cause serious infections.
Meropenem Kabi is used to treat the following infections in adults and children over 3 months of age:

• pneumonia (infection of the lungs);
• lung and bronchial infections in patients with cystic fibrosis;
• complicated urinary tract infections;
• complicated abdominal infections;
• intra-abdominal 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 infections of the blood, which may be associated with the infections listed above.

2. What you need to know before you use Meropenem Kabi

When not to use Meropenem Kabi

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

Warnings and precautions

Before taking Meropenem Kabi, tell your doctor or pharmacist:

• if you have any health problems, such as liver or kidney problems;
• if you have ever had severe diarrhea after taking 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. Your doctor will discuss this with you.
You may experience signs of severe skin reactions (see section 4). If you experience such signs, you should contact your doctor or pharmacist immediately to start treatment for these signs.
If you are unsure whether any of the above situations apply to you, tell your doctor or pharmacist before taking Meropenem Kabi.

Meropenem Kabi with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Meropenem Kabi may affect the way some medicines work, and some medicines may affect the way Meropenem Kabi works.
In particular, tell your doctor or pharmacist if you are 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 effect of these medicines;
• oral anticoagulants (used to treat or prevent blood clots in blood vessels).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Meropenem should be avoided during pregnancy.
Your doctor will decide whether you should be given meropenem.
It is important that you inform your doctor if you are breastfeeding or planning to breastfeed before taking meropenem. Small amounts of this medicine pass into breast milk. Your doctor will decide whether you should take meropenem while breastfeeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, Meropenem Kabi may cause headache, tingling, or numbness of the skin, uncontrolled muscle contractions leading to sudden and uncontrolled body jerks (seizures), usually associated with loss of consciousness. These are side effects that can affect your ability to drive and use machines. Do not drive or operate machinery if you experience these side effects.

Meropenem Kabi contains sodium

Meropenem Kabi, 500 mg:
This medicine contains 45.13 mg of sodium (the main component of common salt) per vial/bottle.
This corresponds to 2.3% of the maximum recommended daily intake of sodium in the diet for adults.
Meropenem Kabi, 1 g:
This medicine contains 90.25 mg of sodium (the main component of common salt) per vial/bottle.
This corresponds to 4.5% of the maximum recommended daily intake of sodium in the diet for adults.
If you need to control your sodium intake due to a medical condition, tell your doctor or pharmacist.

3. How to use Meropenem Kabi

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.

Adult patients

• The dose of Meropenem Kabi depends on the type of infection, the site of infection in the body, and the severity of the infection. Your doctor will determine the appropriate dose for you.
• The dose for adults is usually between 500 mg (milligrams) and 2 g (grams). The medicine is usually given every 8 hours. However, if you have kidney problems, the medicine may be given less frequently.

Children and adolescents

• The dose for children over 3 months and up to 12 years of age 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 given every 8 hours. Children weighing over 50 kg should be given the adult dose.

How to use Meropenem Kabi

• Meropenem Kabi is given to you into a large vein by injection or infusion.
• Meropenem Kabi is usually given by a doctor or nurse.
• Some patients, parents, and caregivers are trained to administer Meropenem Kabi at home. The instructions for administration are included in this leaflet (in the section "Instructions for self-administration of Meropenem Kabi at home"). Always use Meropenem Kabi exactly as your doctor has told you. If you are not sure, check with your doctor.
• The medicine must 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. Your doctor will inform you how to administer Meropenem Kabi.
• The medicine is usually given at the same time every day.

Overdose of Meropenem Kabi

If you have accidentally taken more than the prescribed dose of Meropenem Kabi, contact your doctor or go to the nearest hospital immediately.

Missed dose of Meropenem Kabi

If you miss a dose, take it as soon as possible. However, if the time to the next dose is near, skip the missed dose.
Do not take a double dose (two injections at the same time) to make up for a missed dose.

Stopping treatment with Meropenem Kabi

Do not stop using Meropenem Kabi unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Severe allergic reactions

If you experience a severe allergic reaction, stop using Meropenem Kabi and contact your doctor immediately. You may need urgent medical attention. Symptoms of a severe allergic reaction can 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 that check liver function (increased liver enzyme activity) and increased levels of a certain type of white blood cell (eosinophilia), as well as enlarged lymph nodes. These may be symptoms of a multi-organ hypersensitivity reaction known as drug reaction with eosinophilia and systemic symptoms.
• severe, red, flaky rash, skin lesions containing pus, blisters, or peeling of the skin, which may be associated with high fever and joint pain.
• severe skin reactions, which may appear as red, round patches on the torso, often with blisters in the center, peeling of the skin, 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).

Hemolysis (frequency not known)

Symptoms include:

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

If you experience any of these symptoms, contact your doctor immediately.

Other possible side effects

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

• abdominal pain (stomach pain);
• 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 liver function tests.

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

• changes in blood tests, including decreased platelet count (which may cause easy bruising), increased levels of certain white blood cells, decreased levels of other white blood cells, increased levels of a substance called bilirubin; your doctor may recommend regular blood tests;
• changes in blood test results, including kidney function tests;
• tingling sensation (pins and needles);
• fungal infections of the mouth or vagina (thrush);
• inflammation of the colon with diarrhea;
• vein pain at the injection site;
• other changes in blood tests; symptoms include frequent infections, high fever, and sore throat; your doctor may recommend regular blood tests.

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

• seizures (fits);
• severe confusion and disorientation (delirium).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported to the national reporting system listed below.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Meropenem Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
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 administration should not exceed:

• 3 hours when stored at 25°C;
• 12 hours when stored 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 when stored at 25°C, if Meropenem Kabi was reconstituted in 0.9% sodium chloride solution;
• 24 hours when stored in a refrigerator (2-8°C), if Meropenem Kabi was reconstituted in 0.9% sodium chloride solution;
• 1 hour when stored at 25°C, if Meropenem Kabi was reconstituted in 5% glucose solution;
• 8 hours when stored in a refrigerator (2-8°C), if Meropenem Kabi was reconstituted in 5% glucose solution.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Meropenem Kabi contains

• The active substance is meropenem trihydrate.

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

• The other ingredient is sodium carbonate.

What Meropenem Kabi looks like and contents of the pack

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 pack 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 Warszawa

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
For further information, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warszawa
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

France

Meropenem Kabi 500 mg/1 g poudre pour solution injectable ou pour perfusion

Germany

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

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

Netherlands

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

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

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 bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. One of the most common reasons is the resistance of the bacteria causing the infection to the antibiotic used. This means that the bacteria can survive the treatment cycle and even multiply, despite the use of the 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.
Paying attention to the following recommendations will help prevent the development of resistant bacteria, which could make 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, if in doubt, ask your doctor or pharmacist for clarification.
• 2. You should not use an antibiotic that has not been prescribed specifically for you. Use it only to treat the infection for which the antibiotic was prescribed.
• 3. You should not use antibiotics prescribed for someone else, even if they had a similar infection.
• 4. Do not give antibiotics prescribed for you to other people.
• 5. If you have finished the prescribed treatment cycle and there are any remaining antibiotics, take them to a pharmacy for proper disposal.

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Information intended for healthcare professionals only:

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 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 reconstituted solution.
• 1. Wash and dry your hands thoroughly. Prepare a clean workspace.
• 2. Remove the vial (bottle) of Meropenem Kabi 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 for it to dry.
• 4. Connect a new, sterile needle to a new, sterile syringe, without touching the ends.
• 5. Draw up the prescribed volume of sterile water for injection into the syringe. The required volume of water is listed 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. You can then draw up the solution from multiple vials 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. Wipe the rubber stopper with a new alcohol swab and wait for it to dry.
• 8. With the syringe plunger fully depressed, carefully insert the needle through the rubber stopper again. 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 and draw up the entire solution from the vial.
• 10. Remove the needle and syringe from the vial and set the empty vial aside in a safe place.
• 11. Hold the syringe upright, 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.

Administration of the medicine

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

Administration of 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 for it to 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 the doctor's or nurse's instructions.
• 5. Close the cannula and carefully dispose of the syringe in a sharps container.

Administration of 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 for it to dry.
• 2. Connect the syringe and slowly press the syringe 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.