Meropenem noridem

Package leaflet: Information for the user

Meropenem Noridem, 500 mg and 1 g, powder for solution for injection / infusion
Meropenem
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Speak to your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, tell your doctor, pharmacist, or nurse. This includes any possible adverse reactions not listed in this leaflet. See section 4.

This 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 remainder of this leaflet, the medicine will be referred to as Meropenem Noridem.
_________________________________________________________________
Leaflet contents:

1. What Meropenem Noridem is and what it is used for
2. What you need to know 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 a substance called meropenem. It belongs to a group of medicines known as carbapenem antibiotics. It works by killing bacteria that can cause serious 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 intra-abdominal infections
• Postpartum infections
• Complicated skin and soft tissue infections
• Acute bacterial meningitis (infection of the membranes surrounding the brain and spinal cord)

Meropenem Noridem may be used to treat patients with neutropenia and fever when a bacterial infection is suspected.
Meropenem may also be used to treat bacterial blood infections (bacteraemia) that may be associated with the types of infections listed above.

2. Important information before using Meropenem Noridem

When not to use Meropenem Noridem:

• if the patient is allergic to meropenem or to 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, consult a doctor, pharmacist or nurse:

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

The Coombs test result may be positive, indicating the presence of antibodies that may 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 seek medical advice from a doctor or nurse for appropriate treatment.
If in doubt whether any of the above situations apply to the patient, this should be discussed with the doctor or nurse before administering Meropenem Noridem.

Other medicines and Meropenem Noridem
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Meropenem Noridem may affect the action of certain medicines, and certain medicines may affect the action of Meropenem Noridem.
In particular, inform the doctor or nurse if the patient is taking:

• probenecid (used in the treatment of gout);
• valproic acid/sodium valproate/valpromide (used in the treatment of epilepsy). Meropenem Noridem should not be used, as it may reduce the effectiveness of sodium valproate.
• an oral anticoagulant (used to prevent blood clots).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. It is preferable to avoid using meropenem during pregnancy. The doctor will decide whether the patient should use meropenem.
If the patient is breastfeeding or plans to breastfeed, she should inform her doctor before using meropenem. Small amounts of the drug may pass into breast milk. Therefore, the doctor will decide whether the patient should use the medicine during breastfeeding.

Driving and operating machinery
Studies on the effect of the medicine on the ability to drive and operate machinery have not been conducted.
Meropenem may cause headache and tingling or pricking sensations of the skin (paraesthesiae). Any such adverse reaction may impair the ability to drive and operate machinery.
Meropenem may cause involuntary muscle movements resulting in rapid and uncontrolled body movements (seizures). These are usually accompanied by loss of consciousness.
If this adverse reaction occurs, the patient should not drive or operate machinery.

Meropenem Noridem contains sodium
Meropenem Noridem 500 mg: the medicine contains 45 mg of sodium (the main component of table salt) in each 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 in each 1 g dose. This corresponds to 4.5% of the recommended maximum daily sodium intake for an adult.
If the patient's medical condition requires sodium intake to be controlled, this should be discussed with the doctor, pharmacist or nurse.

3. How to use Meropenem Noridem

This medicine should always be used exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Use in adults

• The dose of this medicine depends on the type of infection, its location in the body, and the severity of the infection. Your doctor will determine the appropriate dose for you.
• The usual dose for adult patients ranges from 500 mg (milligrams) to 2 g (grams). The medicine is usually administered every 8 hours. However, if you have impaired kidney function, the medicine may be given less frequently.

Use in 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 Noridem per kilogram (kg) of body weight. Doses are usually given every 8 hours. Children with a body weight above 50 kg should receive the adult dose.

How to use Meropenem Noridem

• How to administer the medicine: Meropenem Noridem will be given to the patient by intravenous injection or infusion into a large vein.
• Meropenem Noridem will be administered by a doctor or nurse.
• Some patients, parents, and caregivers are trained to administer Meropenem Noridem at home. Instructions for self-administration are provided in this leaflet (in section “Instructions for self-administration of Meropenem Noridem at home”). Meropenem Noridem should always be used exactly as prescribed by your doctor. If you have any doubts, 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 between 15 and 30 minutes. Your doctor will inform you how Meropenem Noridem should be administered.
• The medicine is usually given at the same time each day.

Use of a higher than recommended dose of Meropenem Noridem
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 Noridem
If you miss an injection, administer it as soon as possible. However, if the time until the next dose is short, skip the missed dose. Do not administer a double dose (two injections at the same time) to make up for the missed dose.

Stopping treatment with Meropenem Noridem
Do not stop using Meropenem Noridem unless your doctor advises you to do so.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, 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 the patient experiences any of the symptoms listed below, seek immediate contact with a
doctor or nurse. The patient may urgently require medical assistance. Signs and symptoms of a severe allergic reaction may include sudden onset of:

• 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, including:

• serious hypersensitivity reactions with fever, rash, and changes in blood tests assessing liver function (elevated liver enzymes), increased white blood cell count (eosinophilia), and enlarged lymph nodes. These symptoms may also indicate the occurrence of a multi-organ hypersensitivity syndrome known as DRESS syndrome.
• severe red, peeling rash, skin nodules with pus, blisters, or skin peeling, which may be accompanied by high fever and joint pain.
• severe skin rashes that may appear as reddish, round spots often with central blisters on the trunk, skin peeling, and ulceration of the mouth, throat, nose, genital organs, and eyes, possibly preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

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

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

If any of the above symptoms occur, seek immediate medical advice from a doctor.

Other possible adverse reactions:
Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

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

Rare (may affect up to 1 in 1000 patients)

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

Sudden chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome, has been reported with other medicines of the same class. In such a case, immediate contact with a doctor or nurse is required.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C PL-02 222 Warsaw, Tel.: + 48 22 49 21 301; fax: + 48 22 49 21 309; e-
mail: [email protected] .
Reporting adverse reactions helps to provide 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 stated on the cardboard box and
vials under "Expiry date". The expiry date refers to the last day of the specified month.

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

• 3 hours when stored at a temperature up to 25 °C.
• 12 hours when stored in a refrigerator (2 °C - 8 °C).

Infusion
After reconstitution: prepared infusion solutions should be used immediately. The time from
the beginning of solution preparation to the end of its administration by intravenous infusion
should not exceed:

• 6 hours when stored at a temperature up to 25 °C, when Meropenem Noridem is dissolved in sodium chloride.
• 24 hours when stored in a refrigerator (2 °C - 8 °C), when Meropenem Noridem is dissolved in sodium chloride.
• when Meropenem Noridem is dissolved in glucose, the solution should be used immediately.

From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes
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 the storage duration and conditions prior to use.
Do not cool or freeze the prepared solution.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to
dispose of medicines no longer in use. This 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 ingredient is: anhydrous sodium carbonate.

What Meropenem Noridem looks like and contents of the pack
Meropenem is a white to pale yellow crystalline powder for solution for injection or infusion, contained in a glass vial sealed with a rubber stopper and an aluminium cap.
Pack size: 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in 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

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 bacterial resistance to the antibiotic used. This means that bacteria can survive or even multiply despite antibiotic therapy.
Bacterial resistance to antibiotics may be caused by various factors, and the risk of developing such resistance can be reduced by using antibiotics responsibly.
The antibiotic prescribed by your doctor is intended solely for treating the 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 specified times, and for the prescribed number of days. Please read the instructions in this leaflet and, if in doubt, ask your doctor or pharmacist for clarification.
2. Patients should not use an antibiotic that has not been specifically prescribed for them. Antibiotics should be used only to treat the infection for which they were prescribed.
3. Patients should not take 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.

Instructions for self-administration of Meropenem Noridem at home
Some patients, parents, and caregivers may be trained to administer Meropenem Noridem at home.
Warning: This medicine may be self-administered at home only after proper training by a doctor or nurse.

How to prepare the medicine

• This medicine must be mixed with another liquid (diluent). Your doctor will instruct you on the amount of diluent to use.
• The medicine should be administered immediately after preparation. Do not freeze.
  1. Wash and thoroughly dry your hands. Prepare a clean working area.
  2. Remove the Meropenem Noridem vial from its packaging. Check the vial and the expiry date. Ensure the vial is intact and shows no signs of damage.
  3. Remove the coloured cap and wipe the grey rubber stopper with an alcohol-impregnated swab. Wait for the stopper to dry.
  4. Attach a new sterile needle to a new sterile syringe, taking care not to touch the tips.
  5. Draw into the syringe the recommended volume of sterile water for injections. The required volume of water is shown in the table below:

Note: If the prescribed dose of Meropenem Noridem is greater than 1 g,
more than one vial of the medicine will be required. In this case, the solution from multiple vials can be drawn into one syringe.

6. Insert the syringe needle through the center of the rubber stopper and add the recommended volume of water for injection into the vial or vials containing Meropenem Noridem.
7. Remove the needle from the vial and shake the vial for about 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, insert the needle again through the grey rubber stopper. Hold both the syringe and the vial, then turn the vial upside down.
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 upwards. Gently tap the syringe to allow any air bubbles to rise to the top.
12. Remove air from the syringe by gently pressing the plunger until all air has been expelled.
13. If Meropenem Noridem is being used at home, used needles and infusion sets must be disposed of properly. If the doctor decides to discontinue treatment, any unused medicine should be disposed of according to local regulations.

Administration of the medicine
The medicine can be administered through a cannula (short cannula or venflon) or through a port or central access.
Administration of Meropenem Noridem through a cannula (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 with an alcohol-impregnated swab and wait for it to dry. Remove the cannula cap 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 instructed by the doctor or nurse.
5. Cap the cannula 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-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 instructed by the doctor or nurse.
4. Apply a new cap to the central line and carefully dispose of the syringe in a sharps container.