LUXOMER 500 mg Порошок Для Инъекционного/Инфузионного Раствора

Содержание инструкции

1. LUXOMER 500 mg powder for injectable solution/for infusion, 1 g powder for injectable solution/for infusion
   1. What is LUXOMER and what is it 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

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

Meropenem
Generic medicine

Read this leaflet carefully before you use this medicine as 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 pharmacist or nurse.
This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or 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 you use 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 is LUXOMER and what is it 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:
Infections affecting the lungs (pneumonia)
Lung and bronchial infections in patients suffering from cystic fibrosis
Complicated urinary tract infections
Complicated abdominal infections
Infections that can be contracted during or after childbirth
Complicated skin and soft tissue infections
Acute bacterial infections of the brain (meningitis).
LUXOMER can be used in the treatment of bacterial blood infections that may be
associated with one of the infections listed above.
LUXOMER can be used in the treatment of neutropenic patients (patients with reduced levels of
white blood cells called neutrophils) with fever that is suspected to be due to a bacterial
infection.

2. What you need to know before using LUXOMER

Do not use LUXOMER
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,
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 had episodes of diarrhoea after taking other antibiotics.
You may develop a positive test (the Coombs test) which indicates the presence of antibodies that can
destroy red blood cells. Your doctor will discuss this with you.
You may develop signs and symptoms of severe skin reactions (see section 4). If this happens, tell your
doctor or nurse immediately so they can treat the symptoms.
If you are not sure if 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 can affect the way some medicines work and some
medicines can have effects on LUXOMER.
In particular, tell 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 should not
be used because it may decrease the effect of sodium valproate.
Oral anticoagulants (used to treat or prevent blood clots).

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

Pregnancy
It is preferable to avoid the use of LUXOMER during pregnancy. The doctor will decide if you should use
LUXOMER.

Breastfeeding
Before using meropenem it is important that you tell your doctor if you are breastfeeding or if you plan to do so.
Small amounts of this medicine pass into breast milk and may have effects on the baby.
Therefore, the doctor will decide if you should use meropenem during breastfeeding.

Driving and operating machinery
No studies have been performed on the ability to drive vehicles and operate machinery.
However, meropenem has been associated with headache, tingling of the skin (paresthesia). Any
of these adverse effects may affect your ability to drive or operate machinery.
Meropenem can cause involuntary muscle movements, which can cause rapid and
uncontrolled shaking of the body (convulsions). This is usually accompanied by loss of consciousness. Do
not drive or operate machinery if you experience these effects.

LUXOMER contains sodium
LUXOMER 500 mg contains 45 mg of sodium (the main component of table salt) in
each vial. This is equivalent to 2.25% of the maximum recommended daily intake of sodium
for an adult.
LUXOMER 1 g contains 90 mg of sodium (the main component of table salt) in
each vial. This is equivalent to 4.5% of the maximum recommended daily intake of sodium
for an adult.
If you suffer from a condition that requires you to control your sodium intake, tell your doctor or
nurse.

3. How to use LUXOMER

Use this medicine following the instructions of your doctor or nurse exactly. If you have any doubts, ask 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 given to you every 8 hours.
However, if your kidneys do not function well, the dose will be given to you less frequently (depending on the severity of kidney impairment, the dose will be given to you every 12 hours or every 24 hours).

Use in children and adolescents
The recommended dose for children and adolescents over 3 months of age and up to 12 years, is decided based on the child's age and weight. The recommended dose is between 10 mg and 40 mg of LUXOMER per kilogram (kg) of the patient's weight.
A dose must be given every 8 hours.
Children weighing more than 50 kg will receive the adult dose.

Instructions for use of LUXOMER
LUXOMER will be given to you as an injection or infusion into a large vein.
Normally, LUXOMER will be given to you by your doctor or nurse.
However, some patients, relatives, or caregivers may be instructed on how to administer LUXOMER at home. The instructions for doing so are at the end of this leaflet (in the section called “Instructions for administering LUXOMER at home to yourself or to other people”). Use LUXOMER following the instructions of your doctor exactly. If you have any doubts, ask your doctor.
The injection should not be mixed or added to solutions containing other medicines.
The injection may take about 5 minutes or 15 to 30 minutes. Your doctor will tell you how to administer LUXOMER.
The injection should be given at the same time each day.

If you use more LUXOMER than you should
If you accidentally used a higher dose than prescribed, 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 given as soon as possible. However, if it is almost time for the next injection, the forgotten injection should be skipped. Do not use a double dose (two injections at the same time) to make up for the forgotten dose.

If you stop using LUXOMER
Do not stop using LUXOMER until your doctor tells you to.
If you have any doubts about using 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.

Serious allergic reactions
If you get a serious allergic reaction, stop taking LUXOMERand tell your
doctor immediately. You may need urgent medical treatment. Symptoms of an
allergic reaction can include the sudden appearance 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. •
Serious skin reactions that include:
Serious hypersensitivity reactions including fever, rash, and changes
in blood tests that check how your liver is functioning (increased levels
of liver enzymes) and an increase in a type of white blood cells (eosinophilia) and
swollen lymph nodes. These can be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
Severe, reddish scaly skin rash, skin blisters containing pus, blisters or
skin peeling, which may be associated with high fever and joint pain.
Serious skin reactions that may appear as circular red patches often with blisters
in the center on the trunk, skin exfoliation, ulcers of the mouth, throat, nose, genitals and
eyes 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)
The signs include:

Becoming unexpectedly short of breath
Red or brown urine.
If you notice any of these symptoms you should contact your doctor immediately.

Other possible side effects:
Common (may affect up to 1 in 10 people)
Abdominal pain (stomach).
Feeling unwell (nausea).
Feeling sick (vomiting).
Diarrhoea.
Headache.
Skin rash, itchy skin.
Pain and inflammation.
Increased number of platelets in the blood (determined with a blood test).
Changes in blood tests, including tests showing how your liver is functioning.

Uncommon (may affect up to 1 in 100 people)
Changes in blood. These include a reduction in the number of platelets (which can
cause you to bruise more easily), an increase in some types of white blood cells, a decrease in the number of
other white blood cells and an increase in a substance called bilirubin. Your doctor may occasionally prescribe
blood tests.
Changes in blood tests, including those showing how your kidneys are functioning.
Feeling of pins and needles.
Infections of the mouth or vagina caused by fungi (thrush).
Inflammation of the bowel with diarrhoea.
Inflammation of the vein where LUXOMER is injected.

Rare (may affect up to 1 in 1,000)
Convulsions
Delirium.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly through 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 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 the package after
EXP. The expiry date refers to the last day of that month.
Do not store at temperatures above 25°C.

Bolus injection (injected in a single dose)
After reconstitution: the 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 conditions (2-8°C);
Do not freeze the reconstituted solution.

Infusion
After reconstitution: the 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 conditions (2 - 8°C) it must
be used within 1 hour after removing it from the refrigerator;
30 minutes when meropenem is dissolved in glucose (dextrose).
From a microbiological point of view, the product must be used immediately, unless the
opening/reconstitution/dilution method precludes the risk of microbiological contamination.
If not used immediately, the storage times and conditions during use are
the responsibility of the user.
Do not freeze the reconstituted solution.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LUXOMER contains
The active ingredient 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 - Milan (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 an infection caused by bacteria does not respond to a course of antibiotics. One of the most common
reasons is the resistance of the bacteria causing the infection to the antibiotic being administered.
This means that the bacteria can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for various reasons. Using antibiotics with
caution can help reduce the likelihood that bacteria become resistant.
When the doctor prescribes a course of antibiotics, it is intended to treat only the current illness. By paying
attention to the following advice, you will help prevent the emergence of resistant bacteria that could
block the activity of the antibiotic.

• 1. It is very important that you use 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. You must not use an antibiotic unless it has been specifically prescribed for you and you must use it only to treat the infection for which it has been prescribed.
• 3. You must not use antibiotics that had been prescribed to other people, even if they had an infection similar to yours.
• 4. You must not give antibiotics prescribed for you to other people.

• 5. If any antibiotic remains after you have finished the course as prescribed by your doctor, you must take the remainder to the pharmacy for correct disposal.

Instructions for healthcare professionals or for self-administration of LUXOMER at home
to yourself or others
Some patients, relatives or caregivers are instructed to administer LUXOMER at home.

Warning – You must administer this medicine to yourself or others, at
home, only after being instructed by a doctor or nurse.
Injection
Meropenem for use for intravenous bolus injection must be reconstituted with sterile water for
injections 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 50 mg/ml (5%) injectable glucose solutions 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). The doctor will tell you how much
solvent to use.
Use the medicine immediately after preparation. Do not freeze.

• 1. Wash and dry your hands thoroughly. Prepare a clean work area.
• 2. Remove LUXOMER from its packaging. Check the vial and expiry date. Verify that 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 ends.
• 5. Draw up the recommended amount of sterile “Water for Injections” and transfer it to 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 1 vial of
LUXOMER. You can then draw up the liquid from the vials with a syringe.

• 6. Insert the needle of the syringe into the centre of the rubber stopper of the vial and inject the recommended amount of “Water for Injections” into the vial or vials of LUXOMER.

• 7. Remove the needle from the vial and shake the vial well for about 5 seconds, or until the powder is dissolved. Clean the rubber stopper again with alcohol and allow the rubber stopper to dry.
• 8. With the syringe plunger fully inside the syringe body, put the needle back on top of the rubber stopper. You must hold the syringe and the vial at the same time, and turn the vial upside down.
• 9. Keeping the needle tip immersed in the liquid, pull back the syringe plunger and draw all the liquid from the vial into the syringe.
• 10. Remove the needle and syringe from the vial and discard the empty vial in a safe place.
• 11. Hold the syringe upright, with the needle tip pointing upwards. Tap the syringe to make any air bubbles rise to the surface.
• 12. Eliminate any air in the syringe by gently pushing the plunger until all the air is removed. If you are using LUXOMER at home, dispose of the used needles and infusion lines appropriately. If the doctor decides to stop treatment, dispose of any unused LUXOMER appropriately.

How to administer the injection
This medicine can also be administered via an indwelling needle or “Venflon”, or via a
Port-type catheter or a central infusion line.

Administration of LUXOMER via an indwelling 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 indwelling needle or “Venflon” with alcohol and allow to dry. Open the cap of the cannula and connect it to the syringe.
• 3. Slowly push the syringe plunger to administer the antibiotic steadily for about 5 minutes.
• 4. Once the antibiotic administration is finished and the syringe is empty, remove the syringe and proceed with flushing, as recommended by the doctor or nurse.
• 5. Close the cannula cap and carefully dispose of the syringe in a sharps container.

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

• 1. Remove the cap from the Port or line, clean the end of the line with alcohol and allow to dry.
• 2. Connect the syringe and gently push the syringe plunger to administer the antibiotic steadily for about 5 minutes.
• 3. Once the antibiotic administration is finished, remove the syringe and proceed with flushing as recommended by the doctor or nurse.
• 4. Insert a new clean cap onto the central infusion line and carefully dispose of the syringe in a sharps container.

The residual antibiotic solution, as well as all materials used for administration, must
be disposed of in accordance with local regulations.