Nableran

Package Leaflet: 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 package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 package 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 serious infections.
Nableran is used to treat the following infections in adults and children from 3 months of age and older:

• 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)

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

2. Important information before using Nableran

When not to use Nableran

If you are allergic (hypersensitive) to meropenem or 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 Nableran, tell your doctor, pharmacist, or nurse if you have:
liver or kidney problems;
experienced severe diarrhea after taking other antibiotics.
During treatment, the Coombs test result may be positive. This indicates the presence of antibodies that can destroy red blood cells. Your doctor will discuss this with you.
You may experience objective and subjective symptoms of severe skin reactions (see section 4). If you experience such symptoms, you should contact your doctor or nurse immediately to start treatment for these symptoms.

• If you are unsure whether any of the above situations apply to you, tell your doctor or nurse before using Nableran.

In case of doubt, whether any of the above situations apply to you, tell your doctor or nurse before using Nableran.

Nableran and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking, have recently taken, or might take.
Nableran may affect the way some medicines work, and some medicines may affect the way Nableran works.
Particularly, tell your doctor, pharmacist, or nurse if you 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 you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is recommended to avoid using meropenem during pregnancy.
Your doctor will decide whether you should be given meropenem.
It is important that before taking meropenem, you inform your doctor if you are breastfeeding or planning to breastfeed. Small amounts of this medicine may pass into breast milk. Your doctor will decide whether you should be given meropenem while breastfeeding.

Driving and using machines

No studies on the effects of this medicine on the ability to drive and use machines have been performed.
However, meropenem may cause headache and tingling or numbness of the skin (paresthesia). Each 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 you experience this side effect, you 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 your health condition requires controlling the amount of sodium you consume, you should tell your doctor or nurse.

3. How to use Nableran

This medicine should always be used exactly as your doctor, pharmacist, or nurse has told you.
If you are unsure, ask your doctor or pharmacist.

Use in adults

• The dose of Nableran 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 dose for adults is usually between 500 mg and 2 g. The medicine is usually given every 8 hours. However, in patients with kidney problems, the medicine may be given 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 given every 8 hours. Children with a body weight over 50 kg should be given the adult dose.

Method of administration

• Nableran will be given to you into a large vein by injection or infusion.
• Nableran will usually be given to you 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 package leaflet (in the section "Instructions for self-administration of Nableran at home"). You should always use Nableran exactly as your doctor has told you. If you are unsure, ask your doctor.
• The medicine must not be mixed or added to solutions containing other medicines.
• The injection may take about 5 minutes or from 15 to 30 minutes. Your doctor will tell you how to administer Nableran.
• The medicine is usually given at the same time every day.

Using more Nableran than prescribed

If you have accidentally used a dose of Nableran higher than prescribed by your doctor, contact your doctor or go to the nearest hospital immediately.

Missing a dose of Nableran

If you miss an injection, you should do it as soon as possible. However, if the time to the next dose is short, you should skip the missed injection.
Do not give a double dose (two injections at the same time) to make up for the missed dose.

Stopping treatment with Nableran

Do not stop using Nableran until your doctor tells you to.
If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Nableran can cause side effects, although not everybody gets them.

Severe allergic reactions

If you experience any of these symptoms, contact your doctor or nurse immediately. You 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, scaly rash, skin lesions containing pus, blisters, or peeling of the skin, which may be associated with fever and joint pain;
severe skin reactions, which may appear as red, round patches on the torso, often with blisters in the center, peeling of the 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 not known)

Symptoms may include:
sudden shortness of breath;
red or brown urine.
If you experience any of these symptoms, contact your doctor immediately.

Other possible side effects

Common (affecting less than 1 in 10 people):

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

Uncommon (affecting less than 1 in 100 people):

changes in blood tests, 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; your 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;
other changes in blood tests with symptoms including frequent infections, high fever, and sore throat; your doctor may recommend regular blood tests;

Rare (affecting less than 1 in 1000 people):

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

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nableran

Keep this medicine out of the 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 infusion should be used immediately; the time from the start of reconstitution to the end of administration should not exceed one hour.
Do not 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. This will help protect the environment.

6. Contents of the package and other information

What Nableran contains

The active substance 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 is anhydrous sodium carbonate.

What Nableran looks like and contents of the package

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.
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 package leaflet:01.06.2023

Medical education

Antibiotics are used to treat infections caused by bacteria. They are ineffective 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 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 your doctor is intended only to treat the current illness. Paying attention to the following recommendations will help prevent the development of resistant bacteria, which could make 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 package leaflet and, if in doubt, ask your doctor or pharmacist for clarification.
• 2. You should not use an antibiotic that was not prescribed specifically for you. The antibiotic should only be used to treat the infection for which it was prescribed.

• 3. You should not take antibiotics prescribed for someone else, even if they had a similar infection.
• 4. Do not give your antibiotics to other people.
• 5. If you have any leftover antibiotic after completing the prescribed treatment cycle, 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, and 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). Your doctor will instruct you 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 dissolved in sterile water for injection, to a final concentration of 50 mg/ml.

How to prepare the medicine

• 1. Wash and dry your hands thoroughly. Prepare a clean workspace.
• 2. Remove the Nableran 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. Attach a new, sterile needle to a new, sterile syringe, without touching the ends.
• 5. Draw the prescribed volume of sterile water for injection into the syringe. The following table shows the volume of water needed to dissolve 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. You can then draw the solution from several vials 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 Nableran.
• 7. Remove the needle from the vial and shake the vial held in your 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 all the powder is dissolved.

Wipe the rubber stopper again with a new alcohol swab and wait until it is dry.

• 8. Push the syringe plunger to the end and reinsert the needle through the gray 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 and draw the entire solution from the vial into the syringe.
• 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, the 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 until it is 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, disconnect 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 catheter

• 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. 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, 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.

Administering Nableran by intravenous infusion

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