Meropenem APOTEX

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

MEROPENEM IV APOTEX
Meropenem trihydrate
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about meropenem. 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 using this medicine against the benefits they expect it will have for you.
If you have any concerns about receiving this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.

What this medicine is used for

Meropenem is used to treat many different types of infection, such as:
infections of the lungs
infections of the kidney or bladder (urinary tract infection)
febrile neutropenia
infections around the stomach or bowel
infections of the vagina and womb
serious skin infections
infections in the lining of the brain (meningitis)
infections in the blood stream (septicaemia)
Meropenem is given by injection and is usually only used in hospitals.

How it works

Meropenem belongs to a group of medicines called carbapenem antibiotics. These medicines work by killing the bacteria that are causing your infection.
Meropenem will not work against fungal or viral infections (such as colds or flu).
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor’s prescription.
This medicine is not addictive.
This medicine is not recommended for use in children under the age of 3 months.

Before you are given this medicine

When you must not be given it

Do not use this medicine if you have an allergy to:
meropenem
any other antibiotics such as other carbapenems, penicillins, cephalosporins, or 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, throat or other parts of the body
rash, itching or hives on the skin
Do not use this medicine after the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.
If you are not sure whether you should be given this medicine, talk to your doctor.

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 or kidney problems, including dialysis
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Do not take this medicine until you and your doctor have discussed the risks and benefits involved.
Tell your doctor if you are on a low salt (sodium) diet.
If you have not told your doctor about any of the above, tell them before you are given this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you may get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and meropenem. may interfere with each other. These include:
probenecid, used to treat gout
sodium valproate, valproic acid or valpromide, medicines used to treat epilepsy or mania
oral coagulants (such as warfarin), used to thin the blood
These medicines may be affected by meropenem 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 receiving this medicine.
Other medicines not listed above may also interact with meropenem.

How this medicine is given

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ to the information contained in this leaflet.

How much will you be given

Your doctor will decide what dose of meropenem 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 it is given

Meropenem is injected into your vein. It must always be given by a doctor or nurse.
Many people who get meropenem in hospital will have a drip (intravenous line). Meropenem 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 method is best for you.

How long you will need to be given this medicine

Your doctor will decide how many days you will receive meropenem.

If you take too much (overdose)

Immediately tell your doctor or nurse if you think that you or anyone else may have been given too much of this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are using this medicine

Things you must do

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are receiving this medicine.
Tell any other doctors, dentists and pharmacists who are treating you that you are receiving this medicine.
If you find out that you are pregnant after being given this medicine, tell your doctor immediately.
Tell your doctor if you develop severe diarrhoea, even if it occurs several weeks after you have been given meropenem.
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.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do occasionally do tests to monitor your liver function if you have pre-existing liver disorders.
If you are about to have blood tests, tell your doctor that you are being treated with this medicine.
It may interfere with the results of some tests.

Things to be careful of

Meropenem has been associated with headache, tingling or prickling skin and convulsions (fits).
If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are receiving meropenem.
This medicine helps most people with 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 if you notice any of the following:
pain, swelling or redness around the injection site
nausea and/or vomiting
diarrhoea
abdominal pain
skin rash, itchiness
tingling, ‘pins and needles’ sensation
The above list includes the more common side effects of your medicine.
Tell your doctor or nurse as soon as possible if you notice any of the following:
shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin (signs of an allergic reaction)
severe diarrhoea, even if it occurs several weeks after you have been given meropenem
convulsions / seizures (fits)
unexpected breathlessness and/or red/brown urine – this may indicate damage to your red blood cells
fever, red or purple skin rash that spreads, severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
severe blisters, widespread skin rash, itching, skin reaction which makes the skin look scalded (can also be accompanied by fever and chills)
The above list includes serious side effects and you may need medical attention.
Occasionally, meropenem 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 occur in some patients.

Storage and disposal

Storage

The hospital staff will store meropenem in a safe place at a temperature below 30 degrees C.
They will also check that the expiry date has not passed.

Disposal

The hospital staff will dispose of any unused meropenem.

Product description

What it looks like

500mg:
White to slightly yellow sterile powder in a 20 mL glass vial
AUST R 218843.
1000mg:
White to slightly yellow sterile powder in a 30 mL glass vial
AUST R 218840.
Meropenem vials come in a pack size of 10 vials.
* Not all strengths may be available.

Ingredients

Each vial contains 500 mg or 1000 mg of meropenem trihydrate as the active ingredient.
It also contains sodium carbonate as the inactive ingredient.
This medicine does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Australia
Tel: (02) 8877 8333
Web: www1.apotex.com/au
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was prepared in July 2020.

Source: Read Full Article