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
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Nableran is and what it is 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 pack and other information

1. What Nableran is and what it is 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 aged 3 months and older:

• 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)

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

2. Important information before using Nableran

When not to use Nableran
Do not use Nableran if you are allergic (hypersensitive) to meropenem or to any of the other ingredients of this medicine (listed in section 6).
Do not use Nableran if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins or other carbapenems, as you may also be allergic to meropenem.

Warnings and precautions
Before starting Nableran, talk to your doctor, pharmacist or nurse if:

• you have liver or kidney problems;
• you have previously experienced severe diarrhoea after taking other antibiotics.

During treatment, the Coombs test may become positive. This indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.
You may experience signs and symptoms of severe skin reactions (see section 4). If you develop such symptoms, contact your doctor or nurse immediately so that treatment for these symptoms can be started.
If you experience unexplained muscle pain, tenderness or weakness and/or dark-coloured urine, inform your doctor immediately. These may be symptoms of muscle breakdown (called rhabdomyolysis), which can lead to kidney problems.

Liver problems
If you develop yellowing of the skin or the whites of the eyes, itching, dark-coloured urine or pale-coloured stools, tell your doctor.
These may be signs of liver problems, which your doctor should investigate.
If you are unsure whether any of the above situations apply to you, tell your doctor or nurse before receiving Nableran.

Nableran and other medicines
Tell your doctor, pharmacist or nurse about all medicines you are currently taking, have recently taken or plan to take.
Nableran may affect the action of certain medicines and some medicines may affect the action of Nableran.
In particular, inform your doctor, pharmacist or nurse if you are taking:

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

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine. The use of meropenem during pregnancy is not recommended.
Your doctor will decide whether you should be given meropenem.
It is important that you inform your doctor whether you are breastfeeding or intend to breastfeed before starting meropenem. Small amounts of this medicine pass into breast milk. Therefore, your doctor will decide whether you should use meropenem while breastfeeding.

Driving and using machines
The effect of this medicine on the ability to drive or operate machinery has not been studied.
However, meropenem may cause headache and tingling or prickling sensations of the skin (paraesthesiae). Any of these side effects may affect your ability to drive or operate machinery.
Nableran may cause uncontrolled muscle spasms leading to sudden and uncontrollable body jerks (seizures), which are usually associated with loss of consciousness. If you experience this side effect, you must not drive or operate machinery.

Nableran contains sodium
Nableran 500 mg: contains approximately 45 mg of sodium (the main component of table salt) per 500 mg dose.
This corresponds to 2.25% of the maximum recommended daily dietary intake of sodium for adults.
Nableran 1 g: contains approximately 90 mg of sodium (the main component of table salt) per 1 g dose.
This corresponds to 4.5% of the maximum recommended daily dietary intake of sodium for adults.
If your medical condition requires you to control your sodium intake, inform your doctor or nurse.

3. How to use Nableran

This medicine should always be used exactly as recommended by the doctor, pharmacist, or nurse.
If in doubt, consult the 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 individual patient.
• The usual dose for adult patients ranges from 500 mg to 2 g. The medicine is usually administered every 8 hours. However, in patients with impaired kidney function, the medicine may be given less frequently.

Use in children and adolescents

• The dose for children aged over 3 months and up to 12 years depends on the child's age and body weight. The usual dose is 10 mg to 40 mg of Nableran per kilogram of body weight. Doses are usually administered every 8 hours. Children with a body weight greater than 50 kg should receive the adult dose.

Method of administration

• Nableran will be administered into a large vein by injection or infusion.
• Nableran is usually administered by a doctor or nurse.
• However, some patients, parents, or caregivers may be trained to administer Nableran at home. Instructions for self-administration are included in this leaflet (in the section "Instructions for self-administration of Nableran at home"). Nableran should always be used strictly according to the doctor's recommendations. If in doubt, consult the doctor.
• This 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. The doctor will inform the patient how Nableran should be administered.
• The medicine is usually given at the same time each day.

Use of a higher than recommended dose of Nableran
If a dose higher than recommended by the doctor has been accidentally administered, contact the doctor immediately or go to the nearest hospital.
Missed dose of Nableran
If a dose has been missed, it should be administered as soon as possible. However, if the time until 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 a missed dose.
Stopping treatment with Nableran
Do not stop using Nableran unless instructed to do so by the doctor.
If there are any further doubts regarding the use of this medicine, consult the doctor 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 following objective or subjective symptoms, immediate contact
should be made with a doctor or nurse. The patient may urgently require medical assistance.
Objective and subjective symptoms may include rapidly occurring:
severe rash, itching or hives;
swelling of the face, lips, tongue or other parts of the body;
shortness of breath, wheezing or difficulty breathing;
severe skin reactions including:
severe hypersensitivity reactions such as fever, skin rash, changes in blood test results used to assess liver function (increased liver enzyme activity), and increased number of a certain type of white blood cells (eosinophils), as well as enlarged lymph nodes. These may be symptoms of a multi-organ disorder due to hypersensitivity, known as drug reaction with eosinophilia and systemic symptoms (DRESS).
severe, red, peeling rash, skin lesions containing pus, blisters or skin peeling, which may be associated with fever and joint pain;
severe skin rashes that may appear as red, round spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms [bullous erythema multiforme (Stevens-Johnson syndrome)] or in a more severe form (toxic epidermal necrolysis).
Damage to red blood cells (frequency unknown)
Symptoms include:
sudden onset of shortness of breath;
red or brown discoloration of urine.
If any of the above symptoms occur, immediate contact should be made with a doctor.
Muscle breakdown
Unexplained muscle pain, tenderness or weakness and (or) dark discoloration of urine.
If these objective or subjective symptoms occur, immediate contact should be made with a doctor.
Other possible adverse reactions
Common (affects less than 1 in 10 people):
abdominal (stomach) pain;
nausea;
vomiting;
diarrhea;
headache;
rash, skin itching;
pain and inflammation;
increased platelet count (in laboratory tests);
changes in blood laboratory test results, including tests assessing liver function.
Uncommon (affects less than 1 in 100 people):
blood changes, including decreased platelet count (which may cause easy bruising), increased number of certain white blood cells, decreased number of other white blood cells, increased levels of a substance called bilirubin; the doctor may recommend periodic blood tests;
changes in blood test results, including tests assessing kidney function;
tingling sensation (numbness and prickling);
fungal infections of the mouth (oral thrush) or vagina;
intestinal inflammation with diarrhea;
vein pain at the site of Nableran injection;
other blood changes with symptoms including frequent infections, high fever and sore throat;
the doctor may recommend periodic blood tests.
decreased potassium levels in the blood (which may cause weakness, muscle cramps, tingling and heart rhythm disturbances);
liver-related disorders. Yellowing of the skin and whites of the eyes, skin itching, dark urine or pale stools. If the patient experiences these symptoms, immediate contact should be made with a doctor.
Rare (affects less than 1 in 1000 people):
seizures (epileptic fits);
acute disorientation and confusion (delirium).
During the use of other medicines of the same type, cases of sudden chest pain have been observed, which may be a symptom of a potentially severe allergic reaction known as Kounis syndrome. If this adverse reaction occurs, immediate information should be provided to a doctor or nurse.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information regarding the safety of the medicine can be collected.

5. How to store Nableran

Keep Nableran 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 indicated.
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 by intravenous injection or infusion should not exceed one hour.
Do not freeze the prepared solution.
Medicines must 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 Nableran contains
The active substance in Nableran is meropenem.
Nableran, 500 mg
Each vial contains 500 mg of meropenem as meropenem trihydrate.
Nableran, 1 g
Each vial contains 1 g of meropenem as meropenem trihydrate.
Another 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 pale yellow crystalline powder.
Nableran is supplied in single packs containing 1 vial or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
Poland

Manufacturer
Terapia S.A.
124 Fabricii Street
400 632 Cluj Napoca
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp,
The Netherlands

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 the course of treatment, and even multiply, despite the use of the antibiotic.
Bacterial resistance to antibiotics may be caused by various factors, and the risk of developing such resistance can be reduced by prudent use of antibiotics.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Paying attention to 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 time, and for the correct number of days. Please read the instructions in this leaflet and, if in doubt, ask your doctor or pharmacist for clarification.
2. The patient 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. The patient 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 the pharmacy for proper disposal.

Information intended exclusively for healthcare professionals

Instructions for self-administration of Nableran at home
Some patients, parents, and caregivers may be trained to administer Nableran at home.
Warning: This medicine may only be self-administered at home after proper training by a physician or nurse.
This medicine must be mixed with another liquid (diluent). Your doctor will instruct you how much diluent to use.
The medicine should be administered immediately after preparation. Do not freeze.

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

How to prepare this medicine

1. Wash your hands thoroughly and dry them completely. Prepare a clean work area.
2. Remove the Nableran vial from its packaging. Check the vial and the expiration date. Ensure the vial is intact and shows no signs of damage.
3. Remove the colored 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 table below indicates the volume of water required to dissolve the dose of medicine.

Note. If the prescribed dose of Nableran is greater than 1 g, more than one
vial of the medication will be required. In such case, the solution from multiple vials may be drawn into a single syringe.

6. Insert the syringe needle through the center of the rubber stopper and add the recommended volume of water for injections into the vial or vials containing Nableran.
7. Remove the needle from the vial and shake the vial held in hand for one minute. Allow it to rest briefly. Shake again for another minute, then check the clarity of the solution. If necessary, continue shaking for an additional minute or until all the powder has completely dissolved. Wipe the rubber stopper again with a new alcohol-soaked swab and wait until the stopper is dry.
8. Fully depress the syringe plunger and reinsert the needle through the gray rubber stopper. Hold both the syringe and the vial securely, then invert the vial.
9. Keeping the needle tip submerged in the solution, slowly 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 place the empty vial in a safe location.
11. Hold the syringe vertically with the needle pointing upward. 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 is expelled.
13. If Nableran is administered at home, used needles and infusion sets must be disposed of properly. If the physician decides to discontinue treatment, any unused medication should be discarded according to local regulations.

Administration of the medication
The drug may be administered through a short cannula or venflon, or via a port or central line.
Administration of 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-soaked swab and wait until it dries. 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 directed by the physician or nurse.
5. Cap the cannula and carefully dispose of the syringe in a sharps container.

Administration of Nableran through a central venous port or central catheter

1. Remove the cap from the port or central line, clean the line end with an alcohol-soaked swab, and wait until it dries.
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 directed by the physician or nurse.
4. Attach a new cap to the central line and carefully dispose of the syringe in a sharps container.

Administration of Nableran by intravenous infusion
Nableran may be administered as an intravenous infusion lasting approximately 15–30 minutes. For intravenous infusion, Nableran may be dissolved directly in 0.9% sodium chloride infusion solution (9 mg/ml) or 5% glucose infusion solution (50 mg/ml) to achieve a final meropenem concentration of 1 to 20 mg/ml.
The solution should be shaken before use.