500 mg & 1 g powder for solution for injection or infusion,
meropenem solution

What Meropenem STADA is and what it is used for

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

  • 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 Stada can be used to treat neutropenic patients with a fever suspected of being caused by a bacterial infection.

Meropenem contained in Meropenem Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Meropenem STADA

Do not use Meropenem STADA

  • 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, you may also be allergic to meropenem.

Warnings and cautions

Talk to your doctor or pharmacist before receiving Meropenem Stada:

  • 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.

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

Other medicines and Meropenem STADA

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 Stada.

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

  • probenecid (anti- gout medicine )
  • sodium valproate ( antiepileptic medicine ). Meropenem Stada should not be used as it may impair the effect of sodium valproate.
  • warfarin (a medicine that prevents blood clots). Blood samples may need to be taken more often.

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 and may affect the baby. Therefore, your doctor will decide if you should be given meropenem while you are breastfeeding.

Driving and using machines

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

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 STADA contains sodium

Meropenem Stada 500 mg: This medicine contains approximately 45 mg sodium (the main ingredient in common salt/table salt) per 500 mg vial. This corresponds to 2.3% of the highest recommended daily intake of sodium for adults.

Meropenem Stada 1 g: This medicine contains approximately 90 mg sodium (the main ingredient in table salt/table salt) per 1 g vial. This corresponds to 4.5% of the highest recommended daily intake of sodium for adults.

How to use Meropenem STADA

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 for 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 Stada 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.
  • Meropenem Stada will be given to you as an injection or infusion into a large vein.
  • Your doctor or nurse will normally give you Meropenem Stada.
  • Some patients, parents or caregivers are sometimes trained to give Meropenem Stada at home. Instructions for doing this can be found in this leaflet (in the section: Instructions for giving Meropenem Stada to yourself or someone else in the home). Always use Meropenem Stada 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 Stada.
  • You should normally get your injections at the same time each day.

Possible side effects

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

Severe allergic reactions

If you get a severe allergic reaction, stop using Meropenem Stada 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.

Damage to red blood cells (has been reported)

Symptoms that may occur:

  • shortness of breath when one does not expect it
  • red or brown urine.

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

DRES’s syndrome (reported)

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.

Other possible side effects:

Common (may affect up to 1 in 10 people)

  • magont
  • nausea
  • vomiting
  • diarrhea
  • headache
  • rash, itching
  • pain and inflammation
  • increased number of platelets 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.

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

  • cramps.

Has been reported (occurs in an unknown number of users)

  • inflammation of the intestine with diarrhea
  • tenderness in the vein where Meropenem Stada 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
  • sudden severe rash and blisters or flaky skin. This can be associated with high fever and joint pain.

How to store Meropenem STADA

Before reconstitution or dilution: No special precautions for storage.

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

After reconstitution: The reconstituted solution for intravenous injection or infusion should be used immediately. The time between initiation of dilution and completion of intravenous injection or infusion should not exceed 1 hour.

The prepared solution must not be frozen.

The solutions should be inspected visually for particulate matter before administration. The only clear pale yellow solution, free from visible particles should be used.

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

Each vial of Meropenem Stada 500 mg powder for solution for injection or infusion contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.

Each vial of Meropenem Stada 1 g powder for solution for injection or infusion contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.

The other ingredient is sodium carbonate.

What the medicine looks like and contents of the pack

Meropenem Stada is a white or light yellow powder for solution for injection or infusion in a vial. There are 1 or 10 vials per pack.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Other manufacturers

Pharmathen SA

6, Dervenakion Str., 153 51 Pallini, Attikis

Greece

STADAPHARM GmbH

Feodor-Lynen-Straße 35, 30625 Hanover

Germany

Clonmel Healthcare Ltd

Waterford Road, Clonmel, Co. Tipperary

Ireland

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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