Nableran

Leaflet accompanying the packaging: information for the user

Nableran

500 mg, powder for solution for injection or infusion
1 g, powder for solution for injection or infusion
Meropenem

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1.

What is Nableran and what is it used for

Nableran contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that cause severe infections.
Nableran is used to treat the following infections in adults and children over 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)

Nableran may be used to treat patients with neutropenia and fever if a bacterial infection is suspected.
Nableran may be used to treat bacterial blood infections that may be associated with the above-mentioned infections.

2. Important information before using Nableran

When not to use Nableran

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

Warnings and precautions

Before starting to use Nableran, the patient should discuss with their doctor, pharmacist, or nurse if:
they have liver or kidney problems;
they have experienced severe diarrhea after using other antibiotics.
During treatment, the Coombs test result may be positive. This indicates the presence of antibodies that can destroy red blood cells. The doctor will discuss this with the patient.
The patient may experience objective and subjective symptoms of severe skin reactions (see section 4). If the patient experiences such symptoms, they should contact their doctor or nurse immediately to start treatment for these symptoms.

• If the patient experiences any of the above situations, they should tell their doctor or nurse before using Nableran.

In case of doubt, whether any of the above situations apply to the patient, they should inform their doctor or nurse before using Nableran.

Nableran and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Nableran may affect the action of some medicines, and some medicines may affect the action of Nableran.
In particular, the patient should inform their doctor, pharmacist, or nurse if they are taking:

• probenecid (used to treat gout);
• valproic acid, sodium valproate, or valpromide (used to treat epilepsy); Nableran should not be used, as it may reduce the effect of sodium valproate;
• oral anticoagulants (used to treat or prevent blood clots in blood vessels).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should tell their doctor before receiving meropenem. It is recommended to avoid using meropenem during pregnancy.
The doctor will decide whether the patient should receive meropenem.
It is essential for the patient to inform their doctor if they are breastfeeding or plan to breastfeed before starting meropenem. Small amounts of this medicine pass into breast milk. The doctor will decide whether the patient should use meropenem 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.
However, using meropenem may cause headache and tingling or numbness of the skin (paresthesia). Either of these side effects may affect the ability to drive or use machines. Nableran may cause uncontrolled muscle contractions, leading to sudden and uncontrolled body jerks (seizures), which are usually associated with loss of consciousness. If the patient experiences this side effect, they should not drive or use machines.

Nableran contains sodium

Nableran, 1 g: contains approximately 90 mg of sodium (a major component of common salt) per 1 g dose.
This corresponds to 4.5% of the maximum recommended daily intake of sodium in the diet for adults.
If the patient's health condition requires controlling the amount of sodium consumed, they should inform their doctor or nurse.

3. How to use Nableran

This medicine should always be used exactly as prescribed by the doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor or pharmacist.

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 and 2 g. 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 Nableran per kilogram of body weight. The doses are usually administered every 8 hours. Children with a body weight over 50 kg should receive the adult dose.

Method of administration

• Nableran will be administered to the patient into a large vein by injection or infusion.
• Nableran will usually be administered by a doctor or nurse.
• However, some patients, parents, or caregivers may be trained to administer Nableran at home. The administration instructions are included in this leaflet (in the section "Instructions for self-administration of Nableran at home"). The patient should always use Nableran exactly as prescribed by their doctor. In case of doubt, the patient should consult their doctor.
• The medicine should not be mixed or added to solutions containing other medicines.
• The injection may take about 5 minutes or 15-30 minutes. The doctor will inform the patient how to administer Nableran.
• The medicine is usually administered at the same time every day.

Using a higher dose of Nableran than recommended

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

Missing a dose of Nableran

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.
The patient should not take a double dose (two injections at the same time) to make up for the missed dose.

Stopping the use of Nableran

The patient should not stop using Nableran unless their doctor advises them to do so.
In case of any further doubts about using this medicine, the patient should consult their doctor 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 these symptoms, they should contact their doctor or nurse immediately. The patient may need urgent medical attention. The symptoms may include:
severe rash, itching, or hives;
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 for liver function (increased liver enzyme activity), and increased levels of a certain type of white blood cell (eosinophils), as well as enlarged lymph nodes. These may be symptoms of a multi-organ hypersensitivity disorder known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
severe red, blistering, peeling skin rash, skin nodules containing pus, blisters, or peeling skin, which may be associated with fever and joint pain;
severe skin rash, which may appear as red, round patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome] or in a more severe form [toxic epidermal necrolysis].

Destruction of red blood cells (frequency unknown)

Symptoms may include:
sudden shortness of breath;
red or brown urine color.
If any of these symptoms occur, the patient should contact their doctor immediately.

Other possible side effects

Common (occurring in less than 1 in 10 people):

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

Uncommon (occurring in less than 1 in 100 people):

changes in blood, 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; the doctor may recommend regular blood tests;
changes in blood test results, including kidney function tests;
tingling sensation (numbness and prickling);
fungal infections of the mouth (thrush) or vagina;
inflammation of the intestines with diarrhea;
pain in the veins at the injection site of Nableran;
other changes in blood with symptoms including frequent infections, high fever, and sore throat; the doctor may recommend regular blood tests;

Rare (occurring in less than 1 in 1000 people):

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

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309 Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Nableran

Store the medicine out of sight and reach of children.
Do not use Nableran after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store above 25°C.
After reconstitution: the solution for injection or intravenous infusion should be used immediately after preparation; the time from the start of reconstitution to the end of administration of the solution in intravenous injection or infusion should not exceed one hour.
Do not freeze the reconstituted solution.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Nableran contains

The active substance of the medicine is meropenem.
Nableran, 500 mg
Each vial contains 500 mg of meropenem in the form of meropenem trihydrate.
Nableran, 1 g
Each vial contains 1 g of meropenem in the form of meropenem trihydrate.
The other ingredient of the medicine is anhydrous sodium carbonate.

What Nableran looks like and contents of the pack

Nableran is a powder for solution for injection or infusion.
Nableran is a white to light yellow crystalline powder.
Nableran is supplied in single packs containing 1 vial or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw

Manufacturer

Terapia S.A.
124 Fabricii Street
400 632 Cluj Napoca
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp,
Netherlands
Date of last revision of the leaflet:01.06.2023

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 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. The patient should read the instructions in the leaflet and, in case of doubt, ask their doctor or pharmacist for clarification.
• 2. The patient should not use an antibiotic that was not prescribed specifically for them. The antibiotic should only be used to treat the infection for which it was prescribed.

• 3. The patient should not take antibiotics prescribed for another person, even if they had a similar infection.
• 4. The patient should not pass on antibiotics prescribed for them to other people.
• 5. If any antibiotic remains after completing the recommended treatment cycle, the patient should take it to a pharmacy for proper disposal.

Information intended for healthcare professionals only

Instructions for self-administration of Nableran at home

Some patients, parents, or caregivers may be trained to administer Nableran at home.

Warning. The medicine can only be self-administered at home after prior training by a doctor or nurse.

This medicine must be mixed with another liquid (diluent). The doctor will instruct on how much diluent to use.
The medicine should be administered immediately after preparation. Do not freeze it.

Administering Nableran by injection

To administer Nableran by rapid intravenous injection (bolus), the powder should be reconstituted with sterile water for injection to achieve a final concentration of 50 mg/ml.

How to prepare the medicine

• 1. Wash and dry hands thoroughly. Prepare a clean workspace.
• 2. Remove the Nableran vial from the packaging. Check the vial and expiry 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 for the stopper to dry.
• 4. Attach a new, sterile needle to a new, sterile syringe, without touching the ends.
• 5. Draw up the recommended volume of sterile water for injection into the syringe. The following table shows the volume of water needed to reconstitute the dose of Nableran.

Note.If the prescribed dose of Nableran is more than 1 g, more than one vial of the medicine will be needed. The solution from several vials can then be drawn up into one syringe.

• 6. Insert the needle of the syringe through the center of the rubber stopper and add the recommended volume of water for injection to the vial or vials of Nableran.
• 7. Remove the needle from the vial and shake the vial held in the handfor one minute. Wait for a moment. Shake the vial again for another minute, then check the clarity of the solution. If necessary, shake for another minute or until the powder is completely dissolved.

Wipe the rubber stopper again with a new alcohol swab and wait for it to dry.

• 8. Push the syringe plunger to the end and reinsert the needle through the rubber stopper. Hold the syringe and vial together, then turn the vial upside down.
• 9. Holding the tip of the needle in the solution, pull the syringe plunger to draw up the entire solution from the vial.
• 10. Remove the needle and syringe from the vial and put the empty vial in a safe place.
• 11. Hold the syringe upright, 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 Nableran 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 short cannula or venflon, or through a port or central access.

Administering Nableran 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 cannula cap and attach 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, detach 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.

Administering Nableran through a central venous access port or central catheter

• 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. Attach the syringe and slowly press the plunger to administer the antibiotic evenly over about 5 minutes.
• 3. After completing the administration of the antibiotic, detach 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.

Administering Nableran by intravenous infusion

Nableran can be administered by intravenous infusion over about 15-30 minutes. For intravenous infusion, Nableran can be reconstituted directly in a solution of sodium chloride for infusion at a concentration of 9 mg/ml (0.9%) or glucose solution for infusion at a concentration of 50 mg/ml (5%) to achieve a concentration of meropenem of 1-20 mg/ml.
The solution should be shaken before use.