MEROPENEM 500 mg Порошок Для Инъекционного Раствора

Содержание инструкции

1. Meropenem Aurobindo 500 mg powder for injectable solution/for infusion, 1 g powder for injectable solution/for infusion
   1. What is Meropenem Aurobindo and what it is used for
   2. What you need to know before you take 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

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

Generic medicine

Read this leaflet carefully before you start to 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 nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you are given Meropenem Aurobindo
• 3. How Meropenem Aurobindo is given
• 4. Possible side effects
• 5. How to store Meropenem Aurobindo
• 6. Contents of the pack and other information

1. What is Meropenem Aurobindo 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 for the treatment of the following infections in adults and children from 3 months
of age and older:

• Infections that affect 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).

Meropenem Aurobindo can be used in the treatment of neutropenic patients with fever who are suspected
to be due to a bacterial infection.
Meropenem Aurobindo can be used in the treatment of bacterial blood infections that may be
associated with one of the infections listed above.

2. What you need to know before you take Meropenem Aurobindo

Do not take Meropenem Aurobindo

• if you are allergic to meropenem or 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 health problems, such as problems with your liver or kidneys;
• if you have had severe diarrhoea after taking other antibiotics.

You may test positive on a test (the Coombs test) which indicates the presence of antibodies that can destroy your
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
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 the way that some medicines work and some
medicines can have an effect on Meropenem Aurobindo.
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). Meropenem Aurobindo 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 or pharmacist for advice before using this medicine. It is preferable to avoid
the use of Meropenem Aurobindo during pregnancy. Your doctor will decide if you should take Meropenem
Aurobindo.
Before taking meropenem it is important that you inform your doctor if you are breastfeeding or if you plan to do so.
Small amounts of this medicine may pass into breast milk. Therefore, your doctor will decide if you should
take meropenem during breastfeeding.

Driving and using machines
No studies have been conducted on the ability to drive vehicles or operate machinery. Meropenem has been
associated with headache and tingling of the skin (paresthesia). Each of these effects may affect the
ability to drive vehicles and use machinery.
Meropenem can cause involuntary muscle movements, which can cause the body to shake rapidly
and uncontrollably (convulsions). This is usually accompanied by loss of consciousness. Do not drive vehicles and do not use
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 is equivalent to 27% of the maximum recommended daily intake of sodium with the diet of an
adult.
Meropenem Aurobindo 500 mg
Talk to your doctor or pharmacist if you need 9 or more vials a 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 a 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 following exactly the instructions of 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 dose for adults is usually 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 well.

Use in children and adolescents

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

How to use Meropenem Aurobindo

• Meropenem Aurobindo will be given to you as an injection or infusion into a large vein.
• Normally Meropenem Aurobindo will be given to you by a doctor or nurse.
• However, some patients, parents or people assisting the patient, are instructed to administer Meropenem Aurobindo at home. Instructions for doing so 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 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 Meropenem Aurobindo.
• Normally injections should be given at the same time each day.

If you take more Meropenem Aurobindo 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 take Meropenem Aurobindo
If an injection is forgotten, it should be given as soon as possible. However, if it is almost time
for the next injection, the forgotten injection should be skipped. Never take a double dose (two
injections at the same time) to make up for the missed one.

If you stop taking Meropenem Aurobindo
Do not stop taking Meropenem Aurobindo until your doctor tells you to.
If you have any doubts 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.
manifest.

Serious allergic reactions
If you get a serious allergic reaction, you must stop taking Meropenem Aurobindo
and see a doctor immediately. You may need urgent medical treatment. Symptoms of
an allergic reaction can include the sudden appearance of:

• a 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 that include: o severe hypersensitivity reactions including fever, rash and changes in blood tests checking how your liver is functioning (increased liver enzyme levels) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These can be signs of a multi-organ sensitivity disorder known as DRESS syndrome; o a severe, reddish, scaly skin rash, skin blisters containing pus, blisters or peeling skin, which may be associated with high fever and joint pain; o severe skin reactions that can appear as circular red patches, often with central blisters 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)
These symptoms include:

• shortness of breath when you don't expect it
• red or brown urine

If you notice any of these symptoms you mustcontact a 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, itching
• Pain and inflammation
• Increased number of platelets in the blood (shown by a blood test)
• Changes in laboratory tests, including tests showing how your liver is functioning.

Uncommon(may affect up to 1 in 100 people)

• Changes in blood. These include: reduction in the number of platelets (which can cause easier bruising), increase in some types of white blood cells, decrease in the number of other white blood cells and 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
• Fungal infections of the mouth or vagina (thrush)
• Inflammation of the intestine with diarrhoea
• Inflammation of the vein where Meropenem Aurobindo is injected
• Other changes in the blood. Symptoms include frequent infections, fever and sore throat. Your doctor may occasionally prescribe blood tests.

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

• Convulsions
• Acute disorientation and confusion (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 Meropenem Aurobindo

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 packaging box after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.

Injection
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:

• 6 hours if stored at controlled room temperature (15-25°C), when meropenem is dissolved in a 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 conditions (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 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 wastewater 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 Meropenem Aurobindo contains

• The active ingredient 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 component is anhydrous sodium carbonate.

Description of the appearance of Meropenem Aurobindo and contents of the pack
Meropenem Aurobindo is a white to pale yellow crystalline powder for solution for injection/infusion
in a vial.
After reconstitution, the product is a clear solution from colourless to yellow.
Meropenem Aurobindo 500 mg:
674.78 mg of powder in a 30 ml clear glass tubular vial, type I, with a stopper
(bromobutyl rubber with aluminium seals and a blue polypropylene disc).
Meropenem Aurobindo 1 g:
1349.56 mg of powder in a 40 ml clear glass tubular vial, type I, with a stopper
(bromobutyl rubber with aluminium seals and a white polypropylene disc).
The medicinal product 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
Milpharm Limited - Ares Block, Odyssey Business Park, West End Road - Ruislip HA4 6QD – United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium: Meropenem AB 500 mg/1 g powder for solution for injection/infusion
Germany: Meropenem PUREN 500 mg/1 g powder for the preparation of an
injection -/infusion solution
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 powder for injectable solution/infusion
Meropenem Aurobindo 1 g powder for injectable solution/infusion
Spain: Meropenem Aurovitas 500 mg/1 g powder for injectable solution or for
perfusion EFG
United Kingdom: Meropenem 500 mg/1 g powder for solution for injection or infusion
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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 carefully can
help reduce the likelihood that bacteria will become resistant.
When your 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 take the antibiotic at the correct dose, at the right time and for the right 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 take an antibiotic unless it has been specifically prescribed for you and you should only use it to treat the infection for which it has been prescribed.
• 3. You should not take antibiotics that were prescribed to other people, even if they had an infection similar to yours.
• 4. You should not give antibiotics that were prescribed for you to other people.
• 5. If any antibiotic remains after you have finished the course as prescribed by your doctor, you should take the remainder to the pharmacy for proper disposal.

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for administering Meropenem Aurobindo at home to yourself or others
Some patients, parents or caregivers are instructed to administer
Meropenem Aurobindo at home.

Warning – You must only administer this medicine to yourself or others, at home, after
being instructed by a doctor or nurse.
How to prepare this medicine

• The 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 it.
• 1. Wash and dry your hands thoroughly. Prepare a clean work area.
• 2. Remove the vial of Meropenem Aurobindo from the packaging. Check the vial and the expiry date. Check that it is intact and has not been damaged.
• 3. Remove the coloured cap and clean the grey rubber stopper with alcohol and let it dry.
• 4. Insert a new, sterile needle onto a new sterile syringe, without touching the ends.

• 5. Draw the correct amount of “water for injections” into the syringe. The amount of liquid needed is shown in the following table:

• 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 let it dry.
• 8. With the syringe plunger fully depressed, insert the needle through the rubber stopper again. Hold both the syringe and the vial and keep the vial upside down.
• 9. Keeping the needle tip 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 place.
• 11. Hold the syringe vertically, with the needle pointing upwards. Tap the syringe so that any bubbles in the liquid rise to the end of the syringe.
• 12. Remove the 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 the needles and infusion residues appropriately. If the doctor decides that you should stop treatment, dispose of the unused medicine appropriately.

How to administer the injection
The medicine can be administered via an indwelling needle or cannula (“Venflon”) or via a central venous catheter with partial or total implant (Port type).

Administration of Meropenem Aurobindo via an indwelling needle or cannula (“Venflon”)

• 1. Remove the needle from the syringe and carefully dispose of it in a sharps container.
• 2. Clean the end of the indwelling needle or cannula with alcohol and let it dry. Open the cap of the cannula and connect it to the syringe.
• 3. Slowly push the syringe plunger to administer the antibiotic evenly over about 5 minutes.
• 4. When you have finished administering the antibiotic and the syringe is empty, remove the syringe and flush as recommended by your doctor or nurse.
• 5. Close the opening of the indwelling needle and carefully dispose of the syringe in the waste bin.

Administration of Meropenem Aurobindo via a central venous catheter with partial or total implant
(Port type)

• 1. Remove the cap from the implantable catheter, clean the end of the catheter with alcohol and let it dry.
• 2. Connect the syringe and slowly push the syringe plunger to administer the antibiotic evenly over about 5 minutes.
• 3. When you have finished administering the antibiotic and the syringe is empty, remove the syringe and flush as recommended by your doctor or nurse.
• 4. Place a new clean cap on the central catheter and carefully dispose of the syringe in the waste bin.