Luxomer

Package leaflet: Information for the user

LUXOMER 500 mg powder for solution for injection/infusion, 1 g powder for solution for injection/infusion

Meropenem
Generic medicine
Please read all of this leaflet carefully before you start using 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, pharmacist, 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 effects, including those not listed in this leaflet, tell your
doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet

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

1. What LUXOMER is and what it is used for

LUXOMER contains the active substance meropenem, which belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that can cause serious infections.
LUXOMER 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 intra-abdominal infections
Infections that may occur during or after childbirth
Complicated skin and soft tissue infections
Acute bacterial infections of the brain (meningitis).
LUXOMER may be used to treat bacterial bloodstream infections that may be associated with one of the infections listed above.
LUXOMER may be used to treat febrile neutropenic patients (patients with low levels of white blood cells called neutrophils) in whom a bacterial infection is suspected.

2. What you need to know before using LUXOMER

Do not use LUXOMER
if you are allergic (hypersensitive) to meropenem or to 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,
because you may also be allergic to meropenem.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using LUXOMER if:
you have health problems, such as liver or kidney problems
you have previously experienced episodes of diarrhoea after taking other antibiotics.

You may develop a positive result 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 occurs, speak to your
doctor or nurse immediately so that they can treat the symptoms.

If you are unsure whether any of these conditions apply to you, talk to your doctor or nurse before using
LUXOMER.

Other medicines and LUXOMER
Tell your doctor if you are taking, have recently taken, or might take any other
medicines.

This is because LUXOMER may affect how some medicines work, and some
medicines may affect LUXOMER.

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). LUXOMER must not be used because it may reduce the effect of sodium valproate.
Oral anticoagulant agents (used to treat or prevent blood clots).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before using this medicine.

Pregnancy
It is preferable to avoid using LUXOMER during pregnancy. Your doctor will decide whether you should use
LUXOMER.

Breastfeeding
Before using meropenem, it is important that you inform your doctor if you are breastfeeding or plan to breastfeed.
Small amounts of this medicine pass into breast milk and may affect the baby.
Therefore, your doctor will decide whether you should use meropenem while breastfeeding.

Driving and using machines
No studies on the ability to drive vehicles or use machines have been performed.
However, meropenem has been associated with headache and skin tingling (paraesthesia). Any of these adverse effects could affect your ability to drive or use machines.
Meropenem may cause involuntary muscle movements, which may lead to rapid and uncontrollable shaking of the body (seizures). This is usually accompanied by loss of consciousness. Do not drive or use machines if you experience these effects.

LUXOMER contains sodium
LUXOMER 500 mg contains 45 mg of sodium (the main component of table/cooking salt) in
each vial. This corresponds to 2.25% of the maximum daily recommended sodium intake for an adult.
LUXOMER 1 g contains 90 mg of sodium (the main component of table/cooking salt) in
each vial. This corresponds to 4.5% of the maximum daily recommended sodium intake for an adult.
If you have a condition that requires sodium intake to be controlled, inform your doctor or
nurse.

3. How to use LUXOMER

Use 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 recommended dose for adults is generally between 500 mg (milligrams) and 2 g (grams), depending
on the type of infection you have.
The dose will be administered every 8 hours.
However, if your kidneys are not functioning properly, the dose will be administered less frequently (depending
on the severity of renal impairment, the dose may be given every 12 hours or every 24
hours).
Use in children and adolescents
The recommended dose for children and adolescents aged over 3 months up to 12 years
is determined based on the child's age and weight. The recommended dose is between 10 mg and 40 mg of
LUXOMER per kilogram (kg) of patient's body weight.
A dose should be administered every 8 hours.
Children weighing more than 50 kg will receive the adult dose.
Instructions for the use of LUXOMER

LUXOMER will be administered to you as an injection or infusion into a large vein.

Normally, LUXOMER will be administered by your doctor or nurse.
However, some patients, relatives or caregivers may be trained on how to administer
LUXOMER at home. Instructions for this are provided at the end of this leaflet (in the
section titled “Instructions for home administration of LUXOMER to yourself or others”).
Always use LUXOMER exactly as instructed by your doctor. If you have any doubts, consult your doctor.
The injection must not be mixed or added to solutions containing other medicines.
The injection may take approximately 5 minutes or between 15 and 30 minutes. Your doctor will inform you how LUXOMER should be administered.
The injection must be given every day at the same time.
If you use more LUXOMER than you should
If you accidentally use more than the prescribed dose, contact your doctor or go immediately to the nearest hospital.
If you forget to use LUXOMER
If you forget to give an injection, it should be administered as soon as possible. However, if it is almost time for the next injection, the missed dose should be skipped. Do not use a double dose (two injections at the same time) to make up for a forgotten dose.
If you stop using LUXOMER
Do not stop using LUXOMER unless your doctor tells you to do so.
If you have any questions about the use of this medicine, consult 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, stop taking LUXOMER and consult 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
Shortness of breath, wheezing or difficulty breathing.
Severe skin reactions including:
Severe hypersensitivity reactions including fever, rash, and changes in blood tests indicating how the liver is functioning (increased levels of liver enzymes) 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.
Severe red, scaly skin rash, pus-filled pimples, blisters or skin peeling, which may be associated with high fever and joint pain.
Severe 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, and 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)
Signs include:
Sudden shortness of breath
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 of illness (vomiting).
Diarrhoea.
Headache.
Skin rash, itchy skin.
Pain and inflammation.
Increased number of platelets in the blood (detected by a blood test).
Changes in blood tests, including tests showing liver function.
Uncommon (may affect up to 1 in 100 people)
Blood abnormalities. These include reduced number of platelets (which may cause easier bruising), increased levels of certain types of white blood cells, decreased number of 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 indicating kidney function.
Tingling sensation (pins and needles).
Fungal infections of the mouth or vagina (thrush).
Inflammation of the intestine with diarrhoea.
Inflammation of the vein where LUXOMER was injected.
Rare (may affect up to 1 in 1,000 people)
Seizures.
Delirium.
Reporting of side effects
If you experience any side effect, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at the following website:
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 LUXOMER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.

Bolus injection (administered as a single dose)
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:
3 hours if stored at controlled room temperature (15–25°C), when meropenem is dissolved in a sodium chloride solution;
24 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 required. This will help protect the environment.

6. Package contents and other information

What LUXOMER contains
The active substance is meropenem.
Each vial contains 570 mg of meropenem trihydrate equivalent to 500 mg of anhydrous meropenem.
Each vial contains 1140 mg of meropenem trihydrate equivalent to 1 g of anhydrous meropenem.
The other component is sodium carbonate.

Description of the appearance of LUXOMER and contents of the pack
LUXOMER 500 mg:
674 mg of powder in a 20 ml clear glass vial.
LUXOMER 1 g:
1348 mg of powder in a 20 ml clear glass vial.
The medicine is supplied in packs of 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sintesy Pharma S.r.l.
Via G. Mazzini, 20
20123 - Milano (Italy)

Manufacturer
ACS DOBFAR S.p.A.
Nucleo Industriale S.Atto
S. Nicolò a Tordino
64100 Teramo (Italy)

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.
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 an antibiotic course, it is intended to treat only your current illness. By following the advice below, you can help prevent the emergence of resistant bacteria that could block the effectiveness of antibiotics.

1. It is very important that you take the antibiotic at the correct dose, at the correct 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. You should not use an antibiotic unless it has been specifically prescribed for you, and you should use it only to treat the infection for which it was prescribed.
3. You should not use antibiotics that were prescribed for other people, even if they had an infection similar to yours.
4. You should not give to others antibiotics that have been prescribed for you.
5. If any antibiotic remains after you have completed the prescribed course, you should return the unused medicine to a pharmacy for proper disposal.

Instructions for healthcare professionals or for home administration of LUXOMER by the patient himself or by another person
Some patients, relatives or caregivers are trained to administer LUXOMER at home.
Warning – You must administer this medicine to yourself or to another person at home only after being trained by a doctor or nurse.

Injection
Meropenem for intravenous bolus injection must be reconstituted with sterile water for injectable preparations to a final concentration of 50 mg/ml.

Infusion
Meropenem vials for intravenous infusion must be reconstituted directly with sodium chloride 9 mg/ml (0.9%) or glucose injectable solutions 50 mg/ml (5%) to a final concentration of 1 to 20 mg/ml.

How to prepare this medicine
The medicine must be mixed with another liquid (the solvent). Your doctor will tell you how much solvent 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 LUXOMER from its packaging. Check the vial and the expiration date. Ensure the vial is intact and shows no signs of damage.
3. Remove the cap and clean the rubber stopper with alcohol. Allow the rubber stopper to dry.
4. Insert a new sterile needle into a new sterile syringe, without touching the tips.
5. Draw up the recommended amount of sterile "Water for Injections" and transfer it into the syringe. The amount of liquid required is indicated in the table below:

Note: If the prescribed dose of LUXOMER is greater than 1 g, you will need to use more than one vial of LUXOMER. You may then withdraw the liquid from the vials using a syringe.

6. Insert the syringe needle into the centre of the rubber stopper of the vial and inject the recommended amount of “Water for Injections” into the LUXOMER vial or vials.
7. Remove the needle from the vial and shake the vial well for about 5 seconds, or until the powder is completely dissolved. Clean the rubber stopper again with alcohol and allow it to dry.
8. With the plunger fully inserted into the barrel of the syringe, reattach the needle to the top of the rubber stopper. Hold the syringe and vial together and invert the vial.
9. Keeping the tip of the needle immersed in the liquid, pull back the plunger of the syringe to withdraw 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 place.
11. Hold the syringe upright with the needle tip pointing upwards. Tap the syringe gently to allow any air bubbles to rise to the surface.
12. Remove any air present in the syringe by gently pushing the plunger until all air is expelled. If you are using LUXOMER at home, dispose of used needles and infusion lines appropriately. If your doctor decides to discontinue treatment, dispose of any unused LUXOMER appropriately.

How to administer the injection
This medicine may also be administered via a cannula needle (“Venflon”) or through a Port-type catheter or central infusion line.

Administration of LUXOMER via a cannula needle or “Venflon”

1. Remove the needle from the syringe and carefully dispose of the needle in a sharps container.
2. Wipe the tip of the small cannula needle or “Venflon” with alcohol and allow it to dry. Open the cannula cap and connect it to the syringe.
3. Slowly push the syringe plunger to administer the antibiotic steadily over approximately 5 minutes.
4. Once the antibiotic has been fully administered and the syringe is empty, remove the syringe and proceed with flushing, as recommended by your doctor or nurse.
5. Replace the cap on the cannula and carefully dispose of the syringe in a sharps container.

Administration of LUXOMER via a Port-type catheter or central infusion line

1. Remove the cap from the Port or infusion line, clean the end of the line with alcohol, and allow it to dry.
2. Attach the syringe and gently push the plunger to administer the antibiotic steadily over approximately 5 minutes.
3. After completing administration of the antibiotic, remove the syringe and flush the line as recommended by your doctor or nurse.
4. Attach a new clean cap to the central infusion line and carefully dispose of the syringe in a sharps container.

Any remaining antibiotic solution and all materials used for administration must be disposed of in accordance with local regulations.