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
Meropenemum
Please read all of this leaflet carefully before this medicine is administered, 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 nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of the leaflet

1. What Meropenem Kabi is and what it is 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 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 may cause serious infections.
Meropenem Kabi is used to treat the following infections in adults and children aged 3 months and older:

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

Meropenem Kabi may be used to treat patients with neutropenia and fever when a bacterial infection is suspected.
Meropenem Kabi may also be used to treat bacterial bloodstream infections that may be associated with the infections listed above.

2. Important information before using Meropenem Kabi

When not to use Meropenem Kabi

• If you are allergic (hypersensitive) to meropenem or to 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 starting treatment with Meropenem Kabi, consult your doctor or nurse:

• if you have any health problems such as liver or kidney function disorders;
• if you have previously experienced severe diarrhoea after taking other antibiotics.

The Coombs test, performed during treatment, may yield a positive result, indicating the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.
You may experience signs and symptoms of severe skin reactions (see section 4). If you develop such symptoms, contact your doctor or nurse immediately so that appropriate treatment can be initiated.
If you are unsure whether any of the above situations apply to you, inform your doctor or nurse before receiving Meropenem Kabi.

Meropenem Kabi and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Meropenem Kabi may affect the action of certain medicines, and certain medicines may affect the action of Meropenem Kabi.
You must especially inform your doctor or nurse if you are taking:

• probenecid (used in the treatment of gout);
• valproic acid, sodium valproate, valpromide (used in the treatment of epilepsy); Meropenem Kabi should not be used, as it may reduce the effectiveness of these medicines;
• oral anticoagulants (used in the treatment or prevention of 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 child, consult your doctor or pharmacist before using this medicine. Administration of meropenem to pregnant women should be avoided.
Your doctor will decide whether you should receive meropenem.
It is important that before starting meropenem treatment, you inform your doctor whether you are breastfeeding or intend to breastfeed. Small amounts of this medicine pass into human milk. Therefore, your doctor will decide whether you should use meropenem during breastfeeding.

Driving and using machines
Studies on the effect of this medicine on the ability to drive and operate machinery have not been conducted. However, treatment with Meropenem Kabi may cause headache, tingling and pricking sensations of the skin (paraesthesia), uncontrolled muscle contractions leading to sudden and uncontrolled body jerks (seizures), which are usually associated with loss of consciousness. These are side effects that may affect the ability to drive and operate machinery. 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 table salt) per vial/bottle.
This corresponds to 2.3% of the maximum recommended daily dietary sodium intake 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 dietary sodium intake for adults.
If you need to control your sodium intake due to your medical condition, inform your doctor or nurse.

3. How to use Meropenem Kabi

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your 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. Your doctor will determine the appropriate dose for you.
• The usual dose in adult patients ranges from 500 mg (milligrams) to 2 g (grams). The medicine is usually administered every 8 hours. However, if the patient has impaired kidney function, the medicine may be given less frequently.

Children and adolescents

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

How to use Meropenem Kabi

• Meropenem Kabi is administered 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. Instructions for self-administration are included in this leaflet (under the section "Instructions for self-administration of Meropenem Kabi at home"). Always use Meropenem Kabi strictly according to your doctor's instructions. If in doubt, consult your doctor.
• Do not mix or add this medicine to solutions containing other medicines.
• Administration of the medicine may take approximately 5 minutes or from 15 to 30 minutes. Your doctor will inform you how Meropenem Kabi should be administered.
• The medicine is usually given at the same time each day.

Use of more Meropenem Kabi than prescribed
If you accidentally use more medicine than prescribed by your doctor, contact your doctor immediately or go to the nearest hospital.

Missed dose of Meropenem Kabi
If you miss an injection, administer it as soon as possible. However, if the time until the next scheduled dose is short, skip the missed dose.
Do not administer 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 advises you to do so.
If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Severe allergic reactions
If a patient experiences a severe allergic reaction, treatment with Meropenem Kabi must be discontinued immediately and the doctor should be contacted urgently. The patient may require immediate medical assistance. 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;
• shortness of breath, wheezing or difficulty breathing;
• 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 increased levels of a certain type of white blood cells (eosinophilia), as well as swollen lymph nodes. These may be symptoms of a multi-organ hypersensitivity disorder known as drug reaction with eosinophilia and systemic symptoms (DRESS).
  • severe red, peeling rash, skin lesions containing pus, blisters or skin peeling, which may be associated with high fever and joint pain.
  • severe skin rashes, which may appear as reddish, round spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs and eyes, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or in a more severe form (toxic epidermal necrolysis).

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

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

If any of the above symptoms occur, seek immediate medical advice.
Other possible adverse reactions
Common adverse reactions (less than 1 in 10 patients):

• abdominal (stomach) pain;
• nausea;
• vomiting;
• diarrhoea;
• headache;
• skin rash, itching;
• pain and inflammation;
• increased platelet count (in blood test results);
• changes in blood test results, including tests assessing liver function.

Uncommon adverse reactions (less than 1 in 100 patients):

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

Rare adverse reactions (less than 1 in 1,000 patients):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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
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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Meropenem Kabi

Keep the medicine out of the 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 stated 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 injection must 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 must not exceed:

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

From a microbiological point of view, the medicine should be used immediately unless reconstitution and/or dilution has taken place under aseptic conditions.
If the medicine is not used immediately, responsibility for the storage duration and conditions prior to use lies with the user.
Do not freeze the prepared solution.

Medicines must not be disposed of via the sewage system 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 Meropenem Kabi contains

• The active substance is meropenem trihydrate.

Meropenem Kabi, 500 mg
Each 20 ml vial or 100 ml bottle contains 500 mg meropenem as meropenem trihydrate.
Meropenem Kabi, 1 g
Each 20 ml vial or 50 ml and 100 ml bottle contains 1.0 g 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 pale 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.
Pack sizes contain 1 vial (bottle) or 10 vials (bottles).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

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 Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Meropenem Kabi 500 mg/1 g Powder for solution for injection or infusion
Belgium Meropenem Fresenius Kabi 500 mg/1 g powder for injection or infusion solution / 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 powder for solution for injection or infusion
Netherlands Meropenem Fresenius Kabi 500 mg/1 g powder for solution for injection or infusion
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, powder for injection/infusion solution
Meropenem Fresenius Kabi 1 g, powder for injection/infusion solution
Poland Meropenem Kabi
Portugal Meropenem Kabi
Romania Meropenem Kabi 500 mg/1 g powder for injectable or perfusable solution
Slovakia Meropenem Kabi 500 mg/1 g
Slovenia Meropenem Kabi 500 mg/1 g powder for solution for injection or infusion
Sweden Meropenem Fresenius Kabi 500 mg/1 g, powder for injection or infusion solution
Hungary Meropenem Kabi 500 mg/1 g
United Kingdom Meropenem 500 mg/1 g powder for solution for injection or infusion

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 bacterial resistance to the antibiotic used. This means that bacteria may survive or even multiply despite antibiotic treatment.
Bacterial resistance to antibiotics may be caused by various factors, and the risk of developing such resistance can be reduced by prudent use of antibiotics.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following recommendations will help prevent the development of resistant bacteria, which could make antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the correct time, and for the correct number of days. Read the instructions in the leaflet carefully and ask your doctor or pharmacist for clarification if you have any doubts.
2. The patient should not use an antibiotic that was not specifically prescribed for them. It should be used only to treat the infection for which it was prescribed.
3. The patient should not use antibiotics prescribed for another person, even if that person had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any antibiotic remains after completing the prescribed course of treatment, return it to a pharmacy for proper disposal.

Information intended exclusively 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 drug may only be self-administered at home after prior training by a physician or nurse.
How to prepare the drug

• This drug must be mixed with another fluid (diluent). Your doctor will instruct you on the volume of diluent to use.
• The drug should be administered immediately after preparation. Do not freeze the prepared solution.
  1. Wash and thoroughly dry your hands. Prepare a clean work area.
  2. Remove the vial (bottle) of Meropenem Kabi from its packaging. Check the vial and the expiration date. Ensure the vial is intact and shows no signs of damage.
  3. Remove the colored cap and wipe the rubber stopper with an alcohol swab. Wait for the stopper to dry.
  4. Attach a new sterile needle to a new sterile syringe, taking care not to touch the ends.
  5. Draw into the syringe the recommended volume of sterile water for injection. The required volume of water is listed in the table below:

Caution. If the prescribed dose of Meropenem Kabi exceeds 1 g, more than one vial of this medicine will be required. The solution from multiple vials may then be drawn into a single syringe.

6. Insert the syringe needle through the center of the rubber stopper and add the recommended volume of water for injections to the vial or vials containing Meropenem Kabi.
7. Remove the needle from the vial and shake the vial for approximately 5 seconds or until the powder is completely dissolved. Wipe the rubber stopper again with a new alcohol-impregnated swab and wait for the stopper to dry.
8. With the syringe plunger fully depressed, reinsert the needle through the rubber stopper. Hold both the syringe and the vial, then invert the vial.
9. Keeping the tip of the needle submerged in the solution, pull back the syringe plunger to draw all the solution from the vial into the syringe.
10. Remove the needle with the syringe 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 pointing upward. Gently tap the syringe to allow any air bubbles to rise to the top.
12. Expel air from the syringe by gently pressing the plunger until all air is removed.
13. If Meropenem Kabi is being used at home, used needles and infusion administration sets should be disposed of properly. If the physician decides to discontinue treatment, unused medication must be discarded according to local regulations.

Administration of the medicine
The medicine may be administered via a short cannula or venflon, or through a port or central line.
Administration of Meropenem Kabi 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-impregnated swab and wait for it to dry. Remove the cap from the cannula and attach 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 Meropenem Kabi 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-impregnated swab, and wait for it to dry.
2. Attach 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.