Consumer medicine information

Merrem 1 g Powder for injection

Meropenem

BRAND INFORMATION

Brand name

Merrem

Active ingredient

Meropenem

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Merrem 1 g Powder for injection.

What is in this leaflet


This leaflet answers some common questions about Merrem. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Merrem against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.

What Merrem is used for


Merrem is an antibiotic used in adults and children to treat certain serious infections.
Merrem belongs to a group of medicines called carbapenem antibiotics. These medicines work by killing the bacteria that are causing your infection.
Merrem will not work against fungal or viral infections (such as colds or flu).
Merrem is given by injection and is usually only used in hospitals. It is available only with a doctor's prescription.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Merrem is not addictive.
Merrem is not recommended for use in children under the age of 3 months.
Safety and effectiveness in children younger than 3 months have not been established.

Before you are given Merrem

When you must not be given it


Do not take Merrem if you have an allergy to:
  • any medicine containing meropenem
  • any other carbopenems, penicillins or other beta-lactam antibiotics
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:
  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

If you are not sure whether you should be given this medicine, talk to your doctor.
Do not breast-feed if you are being given this medicine.
The active ingredient in Merrem passes into breast milk. Your doctor may discuss the risk and benefits if you need this medicine while you are breast feeding.

Before you are given it


Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
  • gastrointestinal or stomach problems, particularly colitis
  • liver problems
  • kidney problems, including dialysis.

Tell your doctor if you have an allergy to any other antibiotics such as other carbapenems, penicillins, cephalosporins or other monobactams.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you are given Merrem.

Taking other medicines


Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Merrem may interfere with each other. These include:
  • probenecid - a medicine used to treat gout
  • sodium valproate - a medicine used to treat epilepsy or mania.

These medicines may be affected by Merrem or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How Merrem is given


Merrem is injected into your vein.
It must always be given by a doctor or nurse.
Many people who get Merrem in hospital will have a drip (intravenous line). Merrem can be given directly into the vein or the drip without any need for an injection through the skin. It is given either as a slow injection over approximately 5 minutes or as a slow drip over 15 to 30 minutes.
Your doctor will decide which is best for you.

How much will you be given


Your doctor will decide what dose of Merrem you will need depending on certain factors such as your type of infection and your age. The usual dose is 500 mg to 1 g injected every 8 hours. If you have meningitis you may require more, while a lower dose may be used for children or if you have kidney problems.

How long you will need to be given Merrem


Merrem needs to be given as a series of injections over a few days. Your doctor will decide how many days you will need to be given Merrem.

If you take too much (overdose)


As Merrem is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.
However, if you experience any severe side effects after being given Merrem, tell your doctor or go to Emergency at your nearest hospital.
You may need urgent medical attention.
In case of overdose, immediately contact the Poisons Information Centre (telephone 13 11 26) for advice.

While you are being given Merrem

Things you must do


If you develop severe diarrhoea, tell your doctor, nurse or pharmacist immediately. Do this even if it occurs several weeks after you have been given Merrem.
It may mean that you have a serious bowel condition and you may need urgent medical attention.
Do not take any medicine for your diarrhoea without checking with your doctor first.
Be careful driving or operating machinery until you know how Merrem affects you.
This medicine may cause headache, tingling or prickling skin and convulsions / seizures (fits) in some people. If you have any of these symptoms, do not drive, operate machinery or do anything that could be dangerous. Children should be careful when undertaking activities requiring attention such as riding bicycles or climbing.
If you are about to have any blood tests, tell your doctor that you are being treated with this medicine.
It may interfere with the results of some tests.

Side effects


Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Merrem.
This medicine helps most people with serious infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • pain, swelling or redness around the injection site
  • nausea and/or vomiting
  • diarrhoea
  • skin problems such as rash or itching
  • headache.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
Tell your doctor or pharmacist immediately if you notice any of the following:
  • severe diarrhoea, even if it occurs several weeks after you have been given Merrem
  • allergic reactions - symptoms may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
  • chest pain or discomfort
  • fast or irregular heartbeat; or changes in the rhythm or rate of the heartbeat
  • convulsions / seizures (fits)
  • unexpected breathlessness and/or red/brown urine – this may indicate damage to your red blood cells.

The above list includes serious side effects that may require medical attention.
Occasionally, Merrem may be associated with changes in your blood that may require your doctor to do certain blood tests.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

After using Merrem

Storage


The hospital staff will store Merrem in a safe place at a temperature below 25°C. They will also check that the expiry date has not passed.

Disposal


The hospital staff will dispose of any unused Merrem.

Product description

What it looks like


Merrem comes as a sterile white powder in 20 and 30 mL glass vials. The hospital staff then makes it into a solution ready for intravenous use. Merrem is available in the following strengths and pack sizes:
  • 500 mg/20 mL vial (AUST R 54675)
  • 1 g/30 mL vial (AUST R 54674).

Ingredients


Active ingredient:
  • meropenem (as the trihydrate form).

Other ingredients:
  • sodium carbonate.

Merrem vials do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier


Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au
This leaflet was prepared in January 2024.
© Pfizer Australia Pty Ltd 2024
® Registered Trademark

BRAND INFORMATION

Brand name

Merrem

Active ingredient

Meropenem

Schedule

S4

 

1 Name of Medicine

Meropenem, as meropenem trihydrate.

2 Qualitative and Quantitative Composition

Merrem I.V. powder for intravenous injection or infusion contains meropenem trihydrate equivalent to meropenem, 500 mg or 1 g, blended with sodium carbonate. Merrem I.V. powder for intravenous injection or infusion contains 208 mg sodium carbonate anhydrous for each gram of meropenem (anhydrous potency). See Table 1.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MERREM01.gif

3 Pharmaceutical Form

White to light yellow powder for injection.

4 Clinical Particulars

4.9 Overdose

The pharmacological properties and mode of administration make it unlikely that intentional overdose will occur. Accidental overdosage could occur during therapy, particularly in patients with renal impairment. Treatment of overdosage should be symptomatic. In normal individuals, rapid renal elimination will occur. In subjects with renal impairment, haemodialysis will remove meropenem and its metabolite.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Meropenem, with and without metabolic activation as appropriate, was not genotoxic in assays for gene mutations (Salmonella typhimurium, E. coli and Chinese hamster ovary cells) and chromosomal damage (mouse micronucleus assay and human lymphocytes in vitro).
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical structural is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMEROPE.gif CAS number. 119478-56-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MERREMST.gif