500 mg and 1 g powder for solution for injection or infusion
Meropenem

What Meropenem Fresenius Kabi is and what it is used for

Meropenem Fresenius Kabi belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that can cause serious infections.

Meropenem Fresenius Kabi is used to treat the following conditions in adults and children aged 3 months and older:

  • Lung infection ( pneumonia )
  • Infection in the lungs and bronchus in patients with cystic fibrosis
  • Complicated urinary tract infections
  • Complicated abdominal infections
  • Infection you that can occur during or after childbirth
  • Complicated infection is in the skin or soft tissues
  • Acute bacterial infections in the brain ( meningitis )

Meropenem Fresenius Kabi can be used to treat neutropenic patients with a fever suspected of being a bacterial infection.

Meropenem can be used to treat bacterial infections in the blood that may be associated with any of the infections mentioned above.

Meropenem contained in Meropenem Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this leaflet. If you have any further questions, ask your doctor, pharmacist, or other healthcare professional and always follow their instructions.

What you need to know before you use Meropenem Fresenius Kabi

Do not use Meropenem Fresenius Kabi

  • 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, you may also be allergic to Meropenem.

Warnings and cautions

Talk to your doctor or nurse before using Meropenem Fresenius Kabi:

  • If you have health problems, such as liver or kidney disease.
  • If you get severe diarrhea after taking other antibiotics .

You can get a positive result on a blood test (Coombs test) which indicates the presence of antibodies that can destroy your red blood cells. Your doctor will talk to you about this.

You may experience signs and symptoms of severe skin reactions (see section 4). If this happens, talk to your doctor or nurse immediately so they can treat your symptoms.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before receiving Meropenem Fresenius Kabi.

Other medicines and Meropenem Fresenius Kabi

Tell your doctor if you are taking, have recently taken, or might take any other medicines.
This is because some medicines may affect or be affected by treatment with Meropenem Fresenius Kabi.

In particular, tell your doctor or nurse if you are taking the following medicines:

  • Probenecid (medicine for gout )
  • Valproic acid / sodium valproate / valpromide (antiepileptic medicine ) . Meropenem Fresenius Kabi should not be used as it may impair the effect of sodium valproate.
  • Blood thinners taken by mouth (used to treat or prevent blood clots).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is desirable to avoid meropenem during pregnancy. Your doctor will decide if you should get meropenem.

You must tell your doctor if you are breastfeeding or planning to start breastfeeding before getting meropenem. Small amounts of this medicine may pass into breast milk. Your doctor will therefore decide if you should use meropenem while breastfeeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

However, Meropenem Fresenius Kabi has been associated with headaches, tingling and tingling in the skin ( paresthesia ), and involuntary muscle movements, which cause the body to shake rapidly and uncontrollably (cramps) and which are usually accompanied by loss of consciousness. All of these side effects can affect your ability to drive and use machines. Do not drive or use machines if you get this type of side effect.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Meropenem Fresenius Kabi contains sodium

Meropenem 500 mg: This medicine contains 45.13 mg of sodium (contained in table salt) in each vial. This is equivalent to 2.3% of the recommended daily intake of sodium for adults.

Meropenem 1 g: This medicine contains 90.25 mg of sodium (contained in table salt) in each vial. This is equivalent to 4.5% of the recommended daily intake of sodium for adults.

If you have a health problem that requires you to control your sodium intake, tell your doctor or nurse.

How to use Meropenem Fresenius Kabi

Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Use for adults

  • Dose one depends on the type of infection you have, where in the body infection one is sitting and how serious it is. Your doctor will determine the dose you need
  • One dose for adults is usually between 500 mg (milligrams) and 2 g (grams). You are usually given one dose every 8 hours. But you get a dose less often if your kidneys do not work really well.

Use in children and adolescents

  • Dose one for children over 3 months and up to 12 years depends on the child’s age and weight. The usual dose is between 10 mg and 40 mg of Meropenem Fresenius Kabi for each kilogram (kg) that the child weighs. One dose is usually given every 8 hours. Children weighing over 50 kg will receive an adult dose.

How to use Meropenem Fresenius Kabi

  • Meropenem Fresenius Kabi will be given to you as an injection or infusion into a large vein
  • Your doctor or nurse will normally give you Meropenem Fresenius Kabi
  • Some patients, parents or caregivers are sometimes trained to give Meropenem Fresenius Kabi at home. Instructions for doing this can be found in this leaflet (in the section: Instructions for giving Meropenem Fresenius Kabi to yourself or someone else in the home). Always use Meropenem Fresenius Kabi exactly as your doctor has told you. If you are not sure, talk to your doctor.
  • Your injection should not be mixed with or added to solutions containing other medicines
  • Injection one can take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meropenem Fresenius Kabi
  • You should normally get your injections at the same time each day

If you use more Meropenem Fresenius Kabi than you should 

If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital immediately.

If you forget to use Meropenem Fresenius Kabi

If you miss an injection, take it as soon as possible. But if it’s almost time for the next injection, skip the missed injection.
You should not be given a double dose (two injections at the same time) to compensate for a missed dose.

If you stop using Meropenem Fresenius Kabi

Do not stop using Meropenem Fresenius Kabi until your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergic reactions
If you have a severe allergic reaction, stop using Meropenem Fresenius Kabi and contact a doctor immediately. You may need urgent medical attention. Symptoms may appear suddenly:

  • Severe rash, itching or hives on the skin
  • 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 reaction with fever, rash and changes in blood tests to check liver function (elevated levels of liver enzymes) and an increase in a type of white blood cell ( eosinophilia ) and enlarged lymph nodes . These can be signs of a hypersensitivity reaction in several organs called DRESS syndrome.
    • Severe red rash, skin rashes that contain var, blisters or flaky skin. This can be associated with high fever and joint pain.
    • Severe rash that may appear as red round spots on the torso, often with blisters in the middle, flaky skin, sores in the mouth, throat, nose, genitals and eyes that may be preceded by fever and flu-like symptoms (Steven-Johnson syndrome) or a more severe form ( toxic epidermal necrolysis ).

Damage to red blood cells (no known frequency)

Symptoms that may occur:

  • Shortness of breath when you do not expect it
  • Red or brown urine

If you notice any of the above symptoms, contact a doctor immediately.

Other possible side effects:

Common (may affect up to 1 in 10 people)

  • Magont
  • Nausea
  • Vomiting
  • Diarrhea
  • Headache
  • Skin rash, itching
  • Pain and inflammation
  • Increased platelet count in the blood (measured in a blood test)
  • Changes in blood tests, including tests that show how well your liver is working

Uncommon (may affect up to 1 in 100 people)

  • Changes in the blood. These include decreased platelet count (which makes it easier for you to get bruises), increased number of certain white blood cells , decreased number of other white blood cells and increased amounts of a substance called ‘bilirubin’. Your doctor may take blood samples from time to time
  • Changes in values ​​from blood tests, including tests that show how well your kidneys are working
  • Tingling and tingling
  • Fungal infections of the mouth or abdomen
  • Inflammation of the intestine with diarrhea
  • Tenderness in the vein where Meropenem Fresenius Kabi is injected
  • Other changes in the blood. Symptoms may include frequent infections , high fever and sore throat. Your doctor may take blood samples from time to time

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

  • Cramps

How to store Meropenem Fresenius Kabi

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 carton after EXP. The expiration date is the last day of the specified month.


Do not store above 30 ° C.

Do not freeze.


Injection

After reconstitution: Reconstituted solutions for intravenous injection should be used immediately. The time between the start of dilution and the end of intravenous injection should not exceed:

  • 3 hours when stored at up to 25 ° C)
  • 12 hours when stored in a refrigerator (2‑8 ° C)

Infusion

After reconstitution: Prepared intravenous infusion solutions should be used immediately. The time between the start of reconstitution and the end of intravenous infusion should not exceed:

  • 3 hours when stored at up to 25 ° C if Meropenem Fresenius Kabi has been dissolved in 0.9% sodium chloride;
  • 24 hours when stored in a refrigerator (2‑8 ° C) if Meropenem Fresenius Kabi has been dissolved in 0.9% sodium chloride;
  • 1 hour when stored at up to 25 ° C if Meropenem Fresenius Kabi has been dissolved in glucose solution
  • 8 hours when stored in a refrigerator (2‑8 ° C) if Meropenem Fresenius Kabi has been dissolved in glucose solution

From a microbiological point of view, the product should be used immediately, unless the method of opening/preparation/dilution excludes the risk of microbial contamination.

If the product is not used immediately, the storage times and conditions of use are the user’s responsibility.


The prepared solution must not be frozen.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is meropenem trihydrate.
Meropenem Fresenius Kabi 500 mg: 20 ml vial or 100 ml vial contains 500 mg meropenem.
Meropenem Fresenius Kabi 1 g: 20 ml vial, 50 ml or 100 ml vial contains 1000 mg meropenem.

The other ingredient is anhydrous sodium carbonate.

What the medicine looks like and contents of the pack

Meropenem Fresenius Kabi is a white or light yellow powder for solution for injection or infusion, vial/vial.
Meropenem Fresenius Kabi 500 mg powder for solution for injection or infusion is supplied in a 20 ml vial or 100 ml glass vial.
Meropenem Fresenius Kabi 1 g powder for solution for injection or infusion is supplied in a 20 ml vial, 50 ml, or 100 ml glass vial.

There are 1 or 10 vials/bottles per pack.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Fresenius Kabi AB
751 74 Uppsala

Manufacturer responsible for product release

ACS Dobfar SpA
Nucleo Industriale S. Atto S. Nicolò a Tordino
64100 Teramo
Italien

and

Fresenius Kabi Deutschland GmbH
61346 Bad Homburg vdH Germany

Address for release:
Pfingstweide 53, 61169 Friedberg

and

LABESFAL – Laboratórios Almiro SA (Fresenius Kabi Group)
Lagedo, 3465-157 Santiago de Besteiros
Portugal

Advice / medical instruction
Antibiotics are used to treat infections caused by bacteria. They have no effect against infection caused by viruses.
Sometimes a bacterial infection does not respond to a course of antibiotics. One of the most common reasons for this is that the bacteria have become resistant (resistant) to the antibiotic prescribed. This means that they can survive and even grow despite antibiotic treatment.
Bacteria can become resistant to antibiotics for several reasons. Careful use of antibiotics can help reduce the risk of bacteria becoming resistant to them.
Once your doctor has prescribed antibiotic treatment, the intention is to treat only your current illness. By following the advice below, you will help prevent the development of resistant bacteria that can cause antibiotics to stop working. You must take your antibiotic in the right dose, at the right time, and in the right number of days. Read the instructions on the label and if there is anything you do not understand, ask your doctor or pharmacist to explain. Do not take antibiotics unless it has been prescribed specifically for you and you should only take them for the infection for which it has been prescribed. Do not take antibiotics that have been prescribed to others even if they have had an infection similar to yours. Never give antibiotics prescribed to you to anyone else. If you have antibiotics left after completing a course according to your doctor’s prescription, return the remaining medicine to the pharmacy so that it is destroyed correctly.

Muhammad Nadeem

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