Meropenem Noridem

Leaflet accompanying the packaging: information for the user

Meropenem Noridem, 500 mg and 1 g, powder for solution for injection/infusion

for infusion
Meropenem

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed specifically for you; do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, you should tell your doctor, pharmacist, or nurse. This also applies to any possible side effects not listed in the leaflet. See section 4.

The medicine is available under one of the following names:

• Meropenem Noridem, 500 mg, powder for solution for injection/infusion
• Meropenem Noridem, 1 g, powder for solution for injection/infusion

In the rest of the leaflet, the medicine will be referred to as Meropenem Noridem.
_________________________________________________________________

Table of contents of the leaflet:

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

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

Meropenem Noridem contains the active substance meropenem. It belongs to a group of medicines called carbapenem antibiotics. Its action involves destroying bacteria that can cause severe infections.
Meropenem Noridem is used to treat the following infections in adults and children from

• 3 months of age:
• Lung infections (pneumonia)
• Lung and bronchial infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated abdominal cavity infections
• Postpartum infections
• Complicated skin and soft tissue infections
• Acute bacterial infection of the brain (meningitis)

Meropenem Noridem may be used to treat patients with neutropenia and fever if a bacterial infection is suspected.
Meropenem may be used to treat a bacterial infection of the blood that may be associated with the above types of infections.

2. Important information before using Meropenem Noridem

When not to use Meropenem Noridem:

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

Warnings and precautions

Before using Meropenem Noridem, you should consult a doctor, pharmacist, or nurse:

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

The Coombs test result 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 signs and symptoms of severe skin reactions (see section 4). If these occur, you should immediately consult a doctor or nurse for appropriate treatment.
In case of doubt as to whether any of the above situations apply to the patient, you should inform the doctor or nurse before using Meropenem Noridem.

Other medicines and Meropenem Noridem

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Meropenem Noridem may affect the action of some medicines, and some medicines may affect the action of Meropenem Noridem.
You should especially inform your doctor or nurse if you are taking:

• probenecid (used to treat gout);
• valproic acid/sodium valproate/valpromide (used to treat epilepsy). Meropenem Noridem should not be used, as it may reduce the effect of sodium valproate.
• oral anticoagulant (used to prevent blood clot formation).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine. It is recommended to avoid using meropenem during pregnancy. The doctor will decide whether you should use meropenem.
If you are breastfeeding or plan to breastfeed, you should inform your doctor before using meropenem. Small amounts of the medicine may pass into breast milk. Therefore, the doctor will decide whether you should use the medicine 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.
Meropenem may cause headache and a feeling of tingling or numbness of the skin (paresthesia). Any such side effect may impair the ability to drive and use machines.
Meropenem may cause involuntary muscle movements that cause rapid and uncontrolled body movements (seizures). These are usually accompanied by loss of consciousness.
In the event of such a side effect, you should not drive or operate machines.

Meropenem Noridem contains sodium

Meropenem Noridem 500 mg: the medicine contains 45 mg of sodium (a major component of table salt) per 500 mg dose. This corresponds to 2.25% of the recommended maximum daily sodium intake for an adult.
Meropenem Noridem, 1 g: the medicine contains approximately 90 mg of sodium per 1 g dose. This corresponds to 4.5% of the recommended maximum daily sodium intake for an adult.
If the patient's health condition requires controlling the amount of sodium consumed, you should inform the doctor, pharmacist, or nurse.

3. How to use Meropenem Noridem

This medicine should always be used as directed by a doctor, pharmacist, or nurse. In case of doubt, you should consult a doctor, pharmacist, or nurse.

Use in adults

• 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, in the case of kidney function disorders, the medicine may be administered less frequently.

Use in 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 Noridem per kilogram (kg) of the child's weight. The doses are usually administered every 8 hours. Children with a weight over 50 kg are given the adult dose.

How to use Meropenem Noridem

• How to take Meropenem Noridem will be administered to the patient into a large vein by injection or infusion.
• Meropenem Noridem will be administered by a doctor or nurse.
• Some patients, parents, and caregivers are trained to administer Meropenem Noridem at home. The administration instructions are included in this leaflet (in the section "Instructions for self-administration of Meropenem Noridem at home"). Meropenem Noridem should always be used as directed by a doctor. In case of doubt, you should 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 Noridem.
• The medicine is usually administered at the same time every day.

Using a higher dose of Meropenem Noridem than recommended

If a higher dose of the medicine than recommended by the doctor is used, you should immediately contact a doctor or go to the nearest hospital.

Missing a dose of Meropenem Noridem

If an injection 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 injection should be skipped. A double dose (two injections at the same time) should not be administered to make up for the missed dose.

Stopping the use of Meropenem Noridem

You should not stop using Meropenem Noridem unless the doctor recommends it.
In case of any doubts related to the use of this medicine, you should consult a 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 the patient experiences the following signs and symptoms, you should immediately contact a
doctor or nurse. The patient may need urgent medical attention. Signs and symptoms of a severe allergic reaction may include sudden:

• severe rash, itching, or hives on the skin;
• swelling of the face, lips, tongue, or other parts of the body;
• difficulty breathing, wheezing, or breathing problems.
• Serious skin reactions, which include: o serious hypersensitivity reactions with fever, rash, and changes in blood tests checking liver function (increased liver enzyme values) and an increased number of white blood cells (eosinophilia) and enlarged lymph nodes. The above symptoms may also indicate the occurrence of a multi-organ hypersensitivity syndrome known as DRESS syndrome. o Severe red, blistering, peeling skin rash, skin nodules with pus, blisters, or peeling of the skin, which may be accompanied by high fever and joint pain. o Severe skin reactions, which may appear as red, round patches, often with central blisters on the torso, peeling of the skin, ulcers of the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Blood cell damage (frequency not known)

Symptoms include:

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

If any of the above symptoms occur, you should immediately contact a
doctor.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• stomach pain (abdominal pain).
• Nausea.
• vomiting.
• diarrhea.
• headache.
• rash, itching of the skin.
• pain and inflammation.
• increased platelet count (in laboratory tests).
• changes in blood test results, including those checking liver function.

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 1 in 1000 people)

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

Sudden chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome, has been reported with other medicines of the same type. In such a case, you should immediately contact a doctor or nurse.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301; fax: +48 22 49 21 309; e-
mail: ndl@urpl.gov.pl.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Meropenem Noridem

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vials after "Expiry date". The expiry date refers to the last day of that month.

Injection

After reconstitution: the prepared injection solutions should be used immediately. The time from the start of preparation of the solution to the end of its administration by intravenous injection should not exceed one hour.

Infusion

After reconstitution: the prepared infusion solutions should be used immediately. The time from the start of preparation of the solution to the end of its administration by intravenous infusion should not exceed one hour.
From a microbiological point of view, provided that the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
If the solution is not used immediately, the person administering the medicine is responsible for its storage and conditions until use.
The prepared solution should not be refrigerated or frozen.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Noridem contains

The active substance of the medicine is meropenem.
Meropenem Noridem 500 mg: each vial contains meropenem trihydrate equivalent to 500 mg of anhydrous meropenem.
Meropenem Noridem 1 g: each vial contains meropenem trihydrate equivalent to 1 g of anhydrous meropenem.
The other ingredients are: anhydrous sodium carbonate.

What Meropenem Noridem looks like and contents of the pack

Meropenem is a white to light yellow crystalline powder for solution for injection or infusion, in a glass vial with a gray rubber stopper and an aluminum cap.
Pack size: 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:Noridem Enterprises Ltd, Evagorou and Makariou Mitsi Building 3,
Office 115, 1065 Nicosia, Cyprus.
Manufacturer:DEMO S.A., 21 km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.

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

Ireland:
Meropenem 500 mg and 1 g Powder for solution for injection/infusion
Austria:
Meropenem Noridem 500 mg und 1 g Pulver zur Herstellung einer Injektions-
/Infusionslösung
Germany:
Meropenem Noridem 500 mg und 1 g Pulver zur Herstellung einer Injektions-
/Infusionslösung
Greece:
MEROPENEM/NORIDEM 500 mg και 1 g Κόνις για ενέσιμο διάλυμα/ διάλυμα
προς έγχυση
Spain:
Meropenem Kern Pharma 500 mg y 1 g polvo para solución inyectable y para
perfusión EFG
Poland:
Meropenem Noridem 500 mg i 1g proszek do sporządzania roztworu do
wstrzykiwań / do infuzji
Date of last revision of the leaflet:11/2024

Advice/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 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 prudent use of antibiotics.
The antibiotic prescribed by the doctor is intended solely for the treatment of the current illness. Paying attention to the following recommendations will help prevent the development of resistant bacteria, which would render the antibiotic ineffective.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. You should read the instructions in the leaflet and, in case of doubt, ask your 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 for the treatment of the infection for which the antibiotic was prescribed.
• 3. The patient should not take antibiotics prescribed for another person, even if they had a similar infection.
• 4. You should not pass on antibiotics prescribed for a given patient to other people.
• 5. If any antibiotic remains after completing the prescribed treatment cycle, you should take it to a pharmacy for proper disposal.

Instructions for self-administration of Meropenem Noridem at home

Some patients, parents, and caregivers may be trained to administer Meropenem Noridem 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 (diluent). The doctor will instruct you on how much diluent to use.
• The medicine should be administered immediately after preparation. Do not freeze it.
• 1. You should wash and dry your hands thoroughly. Prepare a clean workspace.
• 2. Remove the Meropenem Noridem vial 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 gray rubber stopper with an alcohol swab. Wait until the stopper is dry.
• 4. Connect a new, sterile needle to a new, sterile syringe, without touching their ends.
• 5. Draw the prescribed volume of sterile water for injection into the syringe. The required volume of water is shown in the table below:

Note:If the prescribed dose of Meropenem Noridem is more than 1 g, more than one vial of the medicine will be needed. In this case, the solution from multiple vials can 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 Meropenem Noridem vial or vials.
• 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 is dry.
• 8. With the syringe plunger fully pressed, 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 the syringe plunger to draw the entire solution from the vial into the syringe.
• 10. Remove the needle and syringe from the vial and place the empty vial in a safe location.
• 11. You should hold the syringe vertically, with the needle facing 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 Noridem is used at home, the used needles and infusion set 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 tube (short cannula or venflon) or through a port or central access.

Administering Meropenem Noridem through a tube (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 tube with an alcohol swab and wait until it is dry. Remove the tube 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 tube and carefully dispose of the syringe in a sharps container.

Administering Meropenem Noridem 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 is 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. Put a new cap on the central line and carefully dispose of the syringe in a sharps container.