Meropenem Noridem

Package Leaflet: Information for the User

Meropenem Noridem, 500 mg and 1 g, Powder for Solution for Injection/Infusion

for infusion
Meropenem

Read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this 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 this leaflet, the medicine will be called Meropenem Noridem.
_________________________________________________________________

Contents of the pack and other information:

• 1. What Meropenem Noridem is and what it is 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 pack and other information

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

Meropenem Noridem contains the active substance meropenem. It belongs to a group of medicines called carbapenem antibiotics. Its action is to kill bacteria that can cause serious infections.
Meropenem Noridem is used to treat the following infections in adults and children from 3 months of age:

• 3. months of age:
• Lung infections (pneumonia)
• Lung and bronchial infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated abdominal 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, which may be associated with the above-mentioned 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, tell your doctor, pharmacist, or nurse:

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

The result of the Coombs test 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, the patient should immediately see a doctor or nurse for appropriate treatment.
In case of doubt, whether any of the above situations apply to the patient, the patient should inform the doctor or nurse before using Meropenem Noridem.

Other medicines and Meropenem Noridem

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Meropenem Noridem may affect the way some medicines work and some medicines may affect the way Meropenem Noridem works.
Particularly, tell 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 clots).

Pregnancy and breastfeeding

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 using this medicine. It is better to avoid using meropenem during pregnancy. The doctor will decide whether you should use meropenem.
If you are breastfeeding or plan to breastfeed, 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 meropenem while breastfeeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.
Meropenem may cause headache and a feeling of tingling or numbness of the skin (paresthesia). Any such side effect may affect the ability to drive and use machines.
Meropenem may cause involuntary muscle movements causing rapid and uncontrolled movements of the body (seizures). This is usually accompanied by loss of consciousness.
In case of such a side effect, do not drive or operate machinery.

Meropenem Noridem contains sodium

Meropenem Noridem 500 mg: the medicine contains 45 mg of sodium (a major component of common salt) per 500 mg dose. This corresponds to 2.25% of the recommended maximum daily intake of sodium 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 intake of sodium for an adult.
If the patient's health condition requires monitoring of sodium intake, inform the doctor, pharmacist, or nurse.

3. How to use Meropenem Noridem

This medicine should always be used as directed by your doctor, pharmacist, or nurse. If you are unsure, ask your 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 patients with kidney problems, 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 body weight. The doses are usually administered every 8 hours. Children with a body 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 the doctor. In case of doubt, ask the 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 more Meropenem Noridem than prescribed

If a larger dose of the medicine than prescribed by the doctor is accidentally used, contact the doctor or go to the nearest hospital immediately.

Missing a dose of Meropenem Noridem

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 Meropenem Noridem treatment

Do not stop using Meropenem Noridem unless the doctor tells you to.
In case of any doubts about using this medicine, ask your 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 any of the following signs and symptoms, contact a doctor or nurse immediately.
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 shortness of breath.
• 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 increased white blood cell count (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, sometimes with mouth sores, and often with fever and joint aches. o Severe skin rash, which may start as red, itchy, flat patches on the skin, often on the trunk, and may progress to widespread peeling of the skin, sometimes with fever and changes in blood tests (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Destruction of red blood cells (frequency not known)

Symptoms include:

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

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

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 liver function tests.

Uncommon (may affect up to 1 in 100 people)

• changes in blood, including decreased platelet count (which may cause easy bruising), increased white blood cell count, decreased white blood cell count, increased bilirubin levels; the doctor may occasionally recommend blood tests.
• changes in blood test results, including kidney function tests.
• 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 1,000 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, contact a doctor or nurse immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. Side effects can be reported to the national reporting system listed below:
Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw, Poland, Phone: +48 22 49 21 301; fax: +48 22 49 21 309; e-mail: ndl@urpl.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Meropenem Noridem

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 and vials after "Expiry Date". The expiry date refers to the last day of that month.

Injection

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

Infusion

After reconstitution: the prepared solution for infusion should be used immediately. The time from the start of reconstitution to the end of administration should not exceed one hour.
From a microbiological point of view, unless 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 responsibility for the storage conditions and the storage time before use lies with the user.
Do not refrigerate or 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 Noridem contains

The active substance 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/Education

Antibiotics are used to treat infections caused by bacteria. 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 antibiotics.
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 could 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. 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. Do not pass on antibiotics prescribed for you to other people.
• 5. If there are any leftover antibiotics after completing the prescribed treatment cycle, take them 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 how much diluent to use.
• The medicine should be administered immediately after preparation. Do not freeze it.
• 1. 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 not damaged and has no signs of tampering.
• 3. Remove the color 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 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 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 up 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 Noridem.
• 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 again with a new alcohol swab and wait until it is dry.
• 8. With the syringe plunger fully pressed, reinsert the needle through the rubber stopper. Hold the syringe and vial, then turn the vial upside down.
• 9. Holding the needle end submerged in the solution, 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 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.

Administration of the medicine

The medicine can be administered through a tube (short cannula or venflon) or through a port or central access.

Administration of 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.

Administration of 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 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.