MEROPENEM AUROBINDO

Package leaflet: Information for the user

Meropenem Aurobindo 500 mg powder for solution for injection/infusion, 1 g powder for solution for injection/infusion

Equivalent medicinal product
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Meropenem Aurobindo is and what it is used for
2. What you need to know before taking Meropenem Aurobindo
3. How to take Meropenem Aurobindo
4. Possible side effects
5. How to store Meropenem Aurobindo
6. Contents of the pack and other information

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

Meropenem Aurobindo belongs to a group of medicines called carbapenem antibiotics. It works
by killing bacteria that can cause serious infections.
Meropenem Aurobindo is used to treat the following infections in adults and children from 3
months of age and older:

• Infections affecting the lungs (pneumonia)
• Lung and bronchial infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated abdominal infections
• Infections that may occur during or after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial infections of the brain (meningitis).

Meropenem Aurobindo may be used to treat febrile neutropenic patients when a bacterial
infection is suspected.
Meropenem Aurobindo may be used to treat bacterial bloodstream infections that may be
associated with any of the infections listed above.

2. What you need to know before taking Meropenem Aurobindo

Do not take Meropenem Aurobindo

• if you are allergic to meropenem or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems, because you may also be allergic to meropenem.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Meropenem Aurobindo

• if you have any health problems, such as liver or kidney problems;
• if you have had severe diarrhoea after taking other antibiotics.

Liver problems
Inform your doctor if you notice yellowing of the skin or eyes, skin itching, dark-coloured urine or pale-coloured stools. These could be signs of a liver problem, which your doctor will need to check.
You may test positive in a test (the Coombs test) indicating the presence of antibodies that can destroy red blood cells. Your doctor will discuss this issue with you.
You may develop signs and symptoms of severe skin reactions (see section 4). If this happens, speak immediately with your doctor or nurse so they can treat the symptoms.
If you are unsure whether any of these conditions apply to you, talk to your doctor or nurse before taking Meropenem Aurobindo.
Other medicines and Meropenem Aurobindo
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
This is because Meropenem Aurobindo can affect how some medicines work, and some medicines can affect Meropenem Aurobindo.
In particular, inform your doctor or nurse if you are taking any of the following medicines:

• Probenecid (used to treat gout).
• Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Meropenem Aurobindo must not be used because it may reduce the effect of sodium valproate.
• Oral anticoagulant agents (used to treat or prevent blood clots).

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. It is preferable to avoid using Meropenem Aurobindo during pregnancy. Your doctor will decide whether you should take Meropenem Aurobindo.
Before taking meropenem, it is important that you inform your doctor if you are breast-feeding or plan to breast-feed.
Small amounts of this medicine may pass into breast milk. Therefore, your doctor will decide whether you should take meropenem while breast-feeding.
Driving and using machines
Studies on the ability to drive or operate machinery have not been conducted. Meropenem has been associated with headache and skin tingling (paraesthesia). Either of these effects may affect your ability to drive or use machinery.
Meropenem may cause involuntary muscle movements, leading to rapid and uncontrolled shaking of the body (convulsions). This is usually accompanied by loss of consciousness. Do not drive or operate machinery if this side effect occurs.
The maximum daily dose of this medicine contains 540 mg of sodium (the main component of table salt). This corresponds to 27% of the maximum recommended daily dietary intake of sodium for an adult.
Meropenem Aurobindo 500 mg
Talk to your doctor or pharmacist if you need 9 or more vials per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
Meropenem Aurobindo 1 g
Talk to your doctor or pharmacist if you need 5 or more vials per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take Meropenem Aurobindo

Take this medicine exactly as instructed by your doctor or nurse. If you have
any doubts, consult your doctor or nurse.
Use in adults

• The dose depends on the type of infection you have, the location of the infection, and the severity of the infection. Your doctor will decide the dose you need.
• The usual dose for adults is between 500 mg (milligrams) and 2 g (grams). You will usually receive a dose every 8 hours. However, you may receive a dose less frequently if your kidneys are not working properly.

Use in children and adolescents

• The dose for children and adolescents over 3 months of age and up to 12 years of age is determined based on the child's age and body weight. The usual dose is between 10 mg and 40 mg of Meropenem Aurobindo per kilogram (kg) of patient weight. The dose is usually given every 8 hours. Children weighing more than 50 kg will receive the adult dose.

How to use Meropenem Aurobindo

• Meropenem Aurobindo will be administered to you as an injection or infusion into a large vein.
• Usually, Meropenem Aurobindo will be given by a doctor or nurse.
• However, some patients, parents, or caregivers may be trained to administer Meropenem Aurobindo at home. Instructions for this are provided in this leaflet (in the section “Instructions for administering Meropenem Aurobindo to yourself or others at home”). Always use Meropenem Aurobindo exactly as prescribed by your doctor. Ask your doctor if you are unsure.
• The injection must not be mixed or added to solutions containing other medicines.
• The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how Meropenem Aurobindo should be administered.
• Injections should normally be given at the same time each day.

If you take more Meropenem Aurobindo than you should
If you have accidentally used more than the prescribed dose, contact your doctor or go
immediately to the nearest hospital.
If you forget to take Meropenem Aurobindo
If an injection has been missed, it should be given as soon as possible. However, if it is almost time for the next injection, the missed dose should be skipped. Never take a double dose (two
injections at the same time) to make up for a missed dose.
If you stop treatment with Meropenem Aurobindo
Do not stop taking Meropenem Aurobindo unless told to do so by your doctor.
If you have any questions about the use of this medicine, ask your 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 a severe allergic reaction occurs, you must stop taking Meropenem Aurobindo and contact a doctor immediately. You may require urgent medical treatment. Symptoms of an allergic reaction may include sudden onset of:

• severe skin rash, itching or hives,
• swelling of the face, lips, tongue or other parts of the body;
• difficulty breathing, wheezing or breathing problems;
• severe skin reactions including: or severe hypersensitivity reactions including fever, rash and changes in blood tests showing how the liver is functioning (increased liver enzyme levels) and an increase in a type of white blood cells (eosinophilia), as well as swollen lymph nodes. These may be signs of a multi-organ hypersensitivity disorder known as DRESS syndrome; or severe red, scaly skin rash, skin lesions containing pus, blisters or skin peeling, which may be associated with high fever and joint pain; or serious skin reactions that may appear as red circular patches, often with central blisters on the trunk, skin exfoliation, mouth, throat, nose, genital or eye ulcers, which may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).

Damage to red blood cells (frequency not known)
These symptoms include:

• shortness of breath when not expected
• red or brown urine

If you notice any of these symptoms, you must contact a doctor immediately.
Other possible side effects:
Common (may affect up to 1 in 10 people)

• Abdominal pain (stomach)
• Feeling unwell (nausea)
• Feeling unwell (vomiting)
• Diarrhoea
• Headache
• Rash, itching
• Pain and inflammation
• Increase in the number of platelets in the blood (shown by a blood test)
• Changes in laboratory tests, including tests showing liver function.

Uncommon (may affect up to 1 in 100 people)

• Blood disorders. These include: reduced number of platelets (which may cause bruising more easily), increase in certain types of white blood cells, decrease in other white blood cells, and increased levels of a substance called bilirubin. Your doctor may occasionally prescribe blood tests
• Changes in blood tests, including those showing kidney function
• Tingling sensation
• Fungal infections of the mouth or vagina (thrush)
• Inflammation of the intestine with diarrhoea
• Inflammation of the vein where Meropenem Aurobindo was injected
• Other blood disorders. Symptoms include frequent infections, fever and sore throat. Your doctor may occasionally prescribe blood tests
• Decreased potassium levels in the blood (which may cause weakness, muscle cramps, tingling and heart rhythm disturbances)
• Liver problems. Yellowing of the skin and eyes, itchy skin, dark-coloured urine or pale-coloured stools. If you notice any of these signs or symptoms, consult a doctor immediately.

Rare (may affect up to 1 in 1,000 people)

• Seizures
• Acute disorientation and confusion (delirium).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Meropenem Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following SCAD.
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.

Injection
After reconstitution: reconstituted solutions for intravenous injection must be used immediately. The time interval between the start of reconstitution and the end of intravenous injection must not exceed:

• 3 hours if stored at controlled room temperature (15–25°C);
• 8 hours if stored under refrigeration (2–8°C).

Do not freeze the reconstituted solution.

Infusion
After reconstitution: reconstituted solutions for intravenous infusion must be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion must not exceed:

• 6 hours if stored at controlled room temperature (15–25°C), when meropenem is dissolved in sodium chloride solution;
• 12 hours if stored at 2–8°C when meropenem is dissolved in sodium chloride. In this case, if the prepared solution is stored under refrigeration (2–8°C), it must be used within 1 hour after removal from the refrigerator;
• 30 minutes when meropenem is dissolved in glucose (dextrose).

From a microbiological standpoint, the product should be used immediately unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination.
If not used immediately, the duration and conditions of storage during use are the responsibility of the user.
Do not freeze the reconstituted solution.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Meropenem Aurobindo contains

• The active substance is meropenem. Each vial contains meropenem trihydrate equivalent to 500 mg of anhydrous meropenem. Each vial contains meropenem trihydrate equivalent to 1 g of anhydrous meropenem.
• The other ingredient is anhydrous sodium carbonate.

Description of the appearance of Meropenem Aurobindo and contents of the pack
Meropenem Aurobindo is a crystalline powder, white to pale yellow, for injectable/infusion solution in a vial.
After reconstitution, the product is a clear solution, colourless to yellow.
Meropenem Aurobindo 500 mg:
674.78 mg of powder in a 30 ml clear glass vial, tubular shape, type I, with a stopper (bromobutyl rubber stopper with aluminium seals and a blue polypropylene disc).
Meropenem Aurobindo 1 g:
1349.56 mg of powder in a 40 ml clear glass vial, tubular shape, type I, with a stopper (bromobutyl rubber stopper with aluminium seals and a white polypropylene disc).
The medicine is supplied in packs of 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2,
Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturer
APL Swift Services (Malta) Limited - HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000 - Malta

This medicine is authorised in the European Economic Area member states under the following names:
Belgium: Meropenem Eugia 500 mg/1 g powder for solution for injection/infusion
Germany: Meropenem PUREN 500 mg/1 g Powder zur Herstellung einer Injektions-/Infusionslösung
Ireland: Meropenem Aurobindo 500 mg/1 g powder for solution for injection or infusion
Italy: Meropenem Aurobindo
Portugal: Meropenem Aurovitas
Romania: Meropenem Aurobindo 500 mg pulbere pentru solutie injectabila/perfuzabila
Meropenem Aurobindo 1 g pulbere pentru solutie injectabila/perfuzabila
Spain: Meropenem Aurovitas 500 mg/1 g polvo para solución inyectable o para perfusión EFG

Advice/health education
Antibiotics are used to treat infections caused by bacteria. They have no effect on infections caused by viruses.
Sometimes a bacterial infection does not respond to a course of antibiotics. One of the most common reasons is bacterial resistance to the antibiotic being administered. This means that bacteria can survive and even multiply despite the antibiotic treatment.
Bacteria can become resistant to antibiotics for various reasons. Using antibiotics carefully can help reduce the likelihood of bacteria becoming resistant.
When your doctor prescribes a course of antibiotics, it is intended to treat only the current illness. By following the advice below, you can help prevent the development of antibiotic-resistant bacteria.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the correct number of days. Read the instructions on the label and, if you do not understand something, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only to treat the infection for which it was prescribed.
3. Do not take antibiotics that were prescribed for someone else, even if they had an infection similar to yours.
4. Do not give your prescribed antibiotics to other people.
5. If you have leftover antibiotic after completing the prescribed course, return the unused portion to the pharmacy for proper disposal.

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for self-administration or administration by others of Meropenem Aurobindo at home
Some patients, parents, or caregivers may be instructed to administer Meropenem Aurobindo at home.
Warning – You must administer this medicine to yourself or others at home only after being trained by a doctor or nurse.
Instructions for inserting the needle into the rubber stopper:
To avoid coring of the stopper, when inserting the needle into the rubber stopper, it is recommended to use a needle with a diameter of 21 gauge or smaller for reconstitution of the product.
The needle must be inserted only into the centre of the rubber stopper, vertically.

How to prepare this medicine

• This medicine must be mixed with another liquid (diluent). Your doctor will tell you how much diluent to use.
• Use the medicine immediately after preparation. Do not freeze.
  1. Wash and thoroughly dry your hands. Prepare a clean work area.
  2. Remove the Meropenem Aurobindo vial from its packaging. Check the vial and the expiry date. Ensure it is intact and has not been damaged.
  3. Remove the coloured cap and clean the grey rubber stopper with alcohol, then allow it to dry.
  4. Attach a new, sterile needle to a new sterile syringe, taking care not to touch the tip.
  5. Draw into the syringe the correct amount of “water for injections”. The amount of liquid required is shown in the table below:

6. Insert the needle of the syringe through the centre of the grey rubber stopper and inject the recommended amount of water for injections into the vial or vials of Meropenem Aurobindo.
7. Remove the needle from the vial and shake the vial well for about 5 seconds or until all the powder has dissolved. Clean the grey rubber stopper again with alcohol and allow it to dry.
8. With the plunger of the syringe fully pushed into the syringe, reinsert the needle through the grey rubber stopper. Hold both the syringe and the vial, keeping the vial inverted.
9. Keeping the tip of the needle in the liquid, pull back the plunger and draw all the liquid from the vial into the syringe.
10. Remove the needle and syringe from the vial and dispose of the empty vial in a safe manner.
11. Hold the syringe vertically with the needle pointing upwards. Tap the syringe gently so that any air bubbles rise to the top of the syringe.
12. Remove air from the syringe by gently pushing the plunger until all the air has been expelled.
13. If you are using Meropenem Aurobindo at home, dispose of needles and infusion waste appropriately. If your doctor decides that you should stop treatment, dispose of any unused medicine appropriately.

How to administer the injection
The medicine can be administered via a needle-cannula or "Venflon", or via a partially or totally implanted central venous catheter (Port-type).

Administration of Meropenem Aurobindo via needle-cannula or "Venflon"

1. Remove the needle from the syringe and carefully dispose of it in a sharps container.
2. Clean the tip of the needle-cannula or Venflon with alcohol and allow it to dry. Remove the cap from the cannula and connect it to the syringe.
3. Slowly push the syringe plunger to administer the antibiotic evenly over approximately 5 minutes.
4. Once the antibiotic has been administered and the syringe is empty, remove the syringe and flush as recommended by your doctor or nurse.
5. Close the opening of the needle-cannula and carefully dispose of the syringe in the waste container.

Administration of Meropenem Aurobindo via partially or totally implanted central venous catheter (Port-type)

1. Remove the cap from the partially or totally implanted catheter, clean the catheter tip with alcohol and allow it to dry.
2. Attach the syringe and slowly push the plunger to administer the antibiotic evenly over approximately 5 minutes.
3. Once the antibiotic has been administered and the syringe is empty, remove the syringe and flush as recommended by your doctor or nurse.
4. Place a new clean cap onto the central catheter and carefully dispose of the syringe in the waste container.