1 g Powder for solution for injection/infusion
Meropenem

What Meropenem Bradex is and what it is used for

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

Meropenem Bradex is used to treat the following conditions in adults and children aged three 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 Bradex can be used to treat neutropenic patients with a fever suspected of being a bacterial infection.

Meropenem Bradex can be used to treat an infection in the bloodstream that occurs in connection with or is suspected to be associated with, any of the above infections.

Meropenem contained in Meropenem Bradex may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Bradex 

Do not use Meropenem Bradex 

  • If you are allergic (hypersensitive) to meropenem or to any of the other ingredients of this medicine (see 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, pharmacist, or nurse before using Meropenem Bradex:

– If you have health problems, such as liver or kidney disease.

– If you have 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 Bradex.

Other medicines and Meropenem Bradex 

Tell your doctor, pharmacist, or nurse 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 Bradex.

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 Bradex should not be used as it may impair the effect of sodium valproate.
  • Blood-thinning medicines 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. 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. Meropenem Bradex has been associated with headaches and tingling or tingling in the skin ( paresthesias ). Any of these side effects may affect your ability to drive or use machines. Meropenem Bradex can cause involuntary muscle movements that can cause the body to shake quickly and uncontrollably (cramps). This is usually accompanied by loss of consciousness. 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 Bradex contains excipients

This medicine contains approximately 4.0 meq of sodium per 1 g dose, which should be taken into consideration by patients on a low-salt diet.

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

How to use Meropenem Bradex 

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

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

  • 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

Dosing 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 Bradex 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.

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 Bradex 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 (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
  • 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 need to 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 Bradex 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.

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

  • cramps
  • Has been reported (occurs in an unknown number of users):  Severe hypersensitivity reactions 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.

How to store Meropenem Bradex

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 and bottle after EXP. The expiration date is the last day of the specified month. No special storage instructions

Injection

After preparation:

Chemical and physical in-use stability has been demonstrated for 1 hour at 25 ° C or 2 ° C – 8 ° C.

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

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

Infusion

After preparation:

An infusion solution is prepared by dissolving the drug in either 0.9% sodium chloride solution for infusion, or 5% glucose solution for infusion, to a final concentration of 1 to 20 mg/ml. The chemical and physical in-use stability of a reconstituted solution containing either 0.9% sodium chloride or 5% dextrose has been demonstrated for 1 hour at 25 ° C or 2 ° C – 8 ° C.

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

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

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. Each glass bottle contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
  • The other ingredient is anhydrous sodium carbonate.

What the medicine looks like and contents of the pack

Meropenem Bradex 1 g is a white to light yellow powder for solution for injection/infusion in a vial.

There are 10 or 50 vials in each pack.

Marketing Authorization Holder and Manufacturer

Holder of approval

BRADEX SA, 27 Asklipiou str., 145 68 Kryoneri, Greece, Tel .: +30 2106221801, +30 2106220323, Fax: +30 2106221802.

Manufacturer

DEMO SA Pharmaceutical Industry, 21st km National Road Athens-Lamia, 145 68 Krioneri, Greece, .:el .: 210 8161802, Fax: 210 8161587.

Information is provided by

FrostPharma AB

Berga Backe 2

182 53 Dandery

Muhammad Nadeem

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