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Meropenem (Meropenem)

What Meropenem is and what it is used for

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

  • Infection affecting the lungs (pneumonia)
  • Lung and bronchial infections in patients suffering from cystic fibrosis
  • Complicated urinary tract infections
  • Complicated infections in the abdomen
  • Infections that you can catch during or after delivery
  • Complicated skin and soft tissue infections
  • Acute bacterial infection of the brain (meningitis)

Meropenem can be used in the management of neutropenic patients with fever that is suspected to be due to bacterial infection.

Before you use Meropenem

Do not use Meropenem

  • if you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meropenem (listed in Section 6 Further Information)
  • if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem

Take special care with Meropenem

  • if you have health problems, such as liver or kidney problems
  • if you have had severe diarrhoea after taking other antibiotics

You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.

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

Taking/using other medicines

Special care should be taken if you are taking/using other medicines as some could interact with Meropenem. In particular, tell your doctor or nurse if you are taking any of the following medicines:

  • probenecid – a medicine used to treat gout (this may increase the level of meropenem in the blood)
  • sodium valproate – a medicine used to treat epilepsy (meropenem may decrease the level of sodium valproate in the blood)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving Meropenem. It is preferable to avoid the use of meropenem during pregnancy.

Your doctor will decide whether you should use Meropenem.

It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving Meropenem. Small amounts of this medicine may pass into the breast milk and it may affect the baby. Therefore, your doctor will decide whether you should use Meropenem while breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Important information about one of the ingredients of Meropenem

Meropenem contains sodium.

Meropenem 500 mg: This medicinal product contains approximately 2.0 mEq of sodium per vial which should be taken into consideration by patients on a controlled sodium diet.

Meropenem 1 g: This medicinal product contains approximately 4.0 mEq of sodium per vial which should be taken into consideration by patients on a controlled sodium diet.

How to use Meropenem

Meropenem will be given to you as an injection into a vein or a slow injection (infusion) via a drip into a vein. Your doctor or nurse will normally give Meropenem to you. However, in some cases patients, parents or carers are trained to give Meropenem at home. Instructions for doing this are provided in section 6 of this leaflet.

The injection time is about 5 minutes and the infusion time between 15 and 30 minutes. You should normally have your injections at the same times each day.

Dosage

Your doctor will decide on the right dose for you. The dose will depend on the type of infection that you have, where the infection is in the body and how serious the infection is.

The usual dose for adults is between 500 mg and 2 g every 8 hours. The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meropenem for each kilogram (kg) of bodyweight every 8 hours. Children who weigh over 50 kg will be given an adult dose.

If you have kidney problems, you may be given a lower dose of this medicine.

If you miss a dose of Meropenem

If you miss an injection, you should have it as soon as possible. However, if it is almost time for the next injection, skip the missed injection and have the next one as normal. You should never have a double dose to make up for forgotten doses.

If you use more Meropenem than you should

If you accidentally have more than your prescribed dose, contact your doctor or nearest hospital straight away.

If you stop using Meropenem

Do not stop having Meropenem 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, Meropenem can have side effects, although not everybody gets them.

If the following happens, tell your doctor immediately:

  • severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

This is a serious side effect. You will need urgent medical attention. This side effect is rare (affects less than 1 in 1,000 people).

If any of the following happen, tell your doctor immediately:

  • damage to red blood cells (not known. Frequency cannot be estimated from the available data but this is very rare); you may experience breathlessness when you do not expect it, red or brown urine

Other possible side effects. If any of the following happen, tell your doctor as soon as possible:

Common side effects (affect less than 1 in 10 people):

  • abdominal (stomach) pain
  • feeling sick (nausea)
  • being sick (vomiting)
  • diarrhoea
  • headache
  • skin rash, itchy skin
  • pain and inflammation
  • increased number of platelets in your blood (shown in a blood test)
  • changes in blood tests, including tests that show how well your liver is working

Uncommon side effects (affect less than 1 in 100 people):

  • changes in your blood. These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells and increased amounts of a substance called bilirubin’. Your doctor may do blood tests from time to time.
  • changes in blood tests, including those that show how well your kidneys are working
  • a tingling feeling (pins and needles)
  • infections of the mouth or of the vagina that are caused by a fungus (thrush)

Rare side effects (affect less than 1 in 1,000 people):

  • fits (convulsions)

Other possible side effects of unknown frequency:

  • inflammation of the bowel with diarrhoea
  • soreness and redness at the site of injection
  • other changes in your blood. Symptoms include frequent infections, high temperature and sore throat. Your doctor may do blood tests from time to time
  • sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

How to store Meropenem

Before purchase Meropenem, you must read how to store

Keep out of the reach and sight of children

Expiry

Do not use after the expiry date which is stated on the vial label and carton. The expiry date refers to the last day of that month.

Storage

Prior to reconstitution or dilution, this medicinal product does not require any special storage conditions.

After reconstitution: The reconstituted solutions for intravenous injection or infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection or infusion should not exceed one hour.

Do not freeze the reconstituted solution.

Disposal

If you are using Meropenem at home, dispose of any needles in your sharps bin and dispose of infusion lines in an appropriate way (ask your doctor, nurse or pharmacist if you are not sure).

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

Further information

What Meropenem contains

The active ingredient is meropenem. Each vial contains either 500 mg or 1 g of meropenem.

The other ingredient is sodium carbonate, anhydrous.

What Meropenem looks like and contents of the pack

This medicine is a white to pale yellow crystalline powder which comes in glass containers called vials. The powder is made into a solution, which can be given as an injection or further diluted and given as an infusion via a drip. It is supplied in packs containing either 500 mg or 1 g of meropenem. There are 1 or 10 vials per pack.

Meropenem 500 mg and 1 g Powder for Solution for Injection or Infusion

The following information is intended for medical or healthcare professionals only:

Method of administration

To be administered as an intravenous bolus injection over approximately 5 minutes or as an infusion over approximately 15-30 minutes.

Preparation instructions

For intravenous bolus injection, must be dissolved in sterile Water for Injections (5 ml per 250 mg of meropenem). This produces a concentration of approximately 50 mg/ml. Solutions that are ready for use are clear, and colourless or pale yellow.

For infusion the solution can be diluted further (50-200 ml) with any of the following infusion fluids:

0.9% Sodium chloride

5% Glucose

Shake reconstituted solution before use.

Do not mix with other solutions that contain other medicinal products.

In use storage precautions

After reconstitution

The reconstituted solutions for intravenous injection or infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection or infusion should not exceed one hour.

Instructions for giving Meropenem to yourself or someone else at home

Some patients, parents and carers are trained to give Meropenem at home. Warning – You should only give this medicine to yourself or someone else at home after a doctor or nurse has trained you.

The medicine must be mixed with another liquid (the diluent). Your doctor will tell you how much of the diluent to use.

Use the medicine straight after preparing it. Do not freeze it. How to prepare this medicine

1.   Wash your hands and dry them well. Prepare a clean working area.

2.   Remove the Meropenem vial from the packaging. Check the vial and the expiry date. Check that the vial is intact and has not been damaged.

3.   Remove the cap and clean the rubber stopper with an alcohol wipe. Allow the rubber stopper to dry.

4.   Connect a new sterile needle to a new sterile syringe, without touching the ends.

5.   Draw up the recommended amount of sterile Water for Injections into the syringe. The amount of Water for Injections that you need is shown in the table below:

Dose of Meropenem Amount of Water for Injections needed for dilution
500 mg (milligrams) 10 ml (millilitres)
1 g (gram) 20 ml
1.5 g 30 ml
2g 40 ml

Please note: If your prescribed dose of Meropenem is 2 g, you will need to use 2 x 1 g vials of Meropenem. You can then draw the liquid from the vials into the one syringe.

6.   Put the needle of the syringe through the centre of the rubber stopper and inject the recommended amount of Water for Injections into the vial of Meropenem.

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 rubber stopper once more with a new alcohol wipe and allow the rubber stopper to dry.

8.   Wth the plunger of the syringe pushed fully into the syringe, put the needle back through the rubber stopper. You must then hold both the syringe and the vial and turn the vial upside down.

9.   Keeping the end of the needle in the liquid, pull back the plunger and draw all the liquid in the vial into the syringe.

10. Remove the needle and syringe from the vial and throw the empty vial away in a safe place.

11.  Hold the syringe upright, with the needle pointing upwards. Tap the syringe so that any bubbles in the liquid rise to the top of the syringe.

12. Remove any air in the syringe by gently pushing the plunger until all the air has gone.

13. If you are using Meropenem at home, dispose of any needles and infusion lines that you have used in an appropriate way. If your doctor decides to stop treatment, dispose of any unused Meropenem in an appropriate way.

Giving the injection

You can either give this medicine through a short cannula or venflon, or through a port or central line.

Giving Meropenem through a short cannula or venflon

  1. Remove the needle from the syringe and throw the needle away carefully in your sharps bin.
  2. Wipe the end of the short cannula or venflon with an alcohol wipe and allow it to dry. Open the cap on your cannula and connect the syringe.
  3. Slowly push the plunger of the syringe to give the antibiotic steadily over about 5 minutes.
  4. Once you have finished giving the antibiotic and the syringe is empty remove the syringe and use a flush as recommended by your doctor or nurse.
  5. Close the cap of your cannula and carefully throw the syringe away in your sharps bin.

Giving Meropenem through a port or central line

  1. Remove the cap on the port or line, clean the end of the line with an alcohol wipe and allow it to dry.
  2. Connect the syringe and slowly push the plunger on the syringe to give the antibiotic steadily over about 5 minutes.
  3. Once you have finished giving the antibiotic, remove the syringe and use a flush as recommended by your doctor or nurse.
  4. Place a new clean cap on your central line and carefully throw the syringe away in your sharps bin.
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