meropenem trihydrate powder for injection
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Meropenem Sandoz.
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 using this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT MEROPENEM SANDOZ IS USED FOR
Meropenem Sandoz is an antibiotic used in adults and children to treat certain serious infections caused by bacteria, 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).
It contains the active ingredient meropenem, which belongs to a group of medicines called carbapenem antibiotics
It works by killing the bacteria that are causing your infection.
This medicine will not work against fungal or viral infections (such as colds or flu).
Meropenem Sandoz 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.
This medicine is not addictive.
Meropenem Sandoz 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 MEROPENEM SANDOZ
When you must not be given it
Do not use this medicine if you have an allergy to:
- meropenem, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.
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.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using 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 have an allergy to any other antibiotics such as other carbapenems, penicillins, cephalosporins or monobactams.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you are given Meropenem Sandoz.
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 Meropenem Sandoz 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 Meropenem Sandoz 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 using this medicine.
HOW MEROPENEM SANDOZ IS GIVEN
Meropenem Sandoz is injected into your vein. It must always be given by a doctor or nurse.
Many people who get Meropenem Sandoz in hospital will have a drip (intravenous line). This medicine 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 you will need depending on certain factors such as your type of infection and your age. The usual dose is 500mg to 1g 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 will you need to be given Meropenem Sandoz
This medicine needs to be given as a series of injections over a few days. Your doctor will decide how many days you will need to have Meropenem Sandoz for.
If you have been given too much (overdose)
As Meropenem Sandoz will be given to you under the supervision of your doctor, it is very unlikely that you will receive too much.
However, if you are concerned that you have been given too much, tell your doctor, nurse or pharmacist immediately or go to the Accident and Emergency at your nearest hospital.
You may need urgent medical attention.
WHILE YOU ARE USING MEROPENEM SANDOZ
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 Meropenem Sandoz. 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.
Meropenem Sandoz has been associated with headache, tingling or prickling skin and convulsions/seizures (fits). Any of these could affect your ability to drive or operate machines.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Meropenem Sandoz. 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
- skin rash
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
If any of the following happen, tell your doctor immediately:
- Severe diarrhoea, even if it occurs several weeks after you have been given this medicine.
- 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.
- 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 which may require medical attention. These side effects are rare.
Occasionally, Meropenem Sandoz 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 else 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 MEROPENEM SANDOZ
The hospital staff will store this medicine in a safe place at a temperature below 30 degrees C. They will also check that the expiry date has not passed.
The hospital staff will dispose of any unused Meropenem Sandoz.
What it looks like
Meropenem Sandoz comes in 2 types of vials:
- Meropenem Sandoz 500mg – 20mL clear glass vial with rubber stopper, containing a white to pale yellow powder.
- Meropenem Sandoz 1g – 30mL clear glass vial with rubber stopper, containing a white to pale yellow powder.
Available in packs of 10 vials.
- Meropenem Sandoz 500mg – 500mg meropenem (as trihydrate)
- Meropenem Sandoz 1g – 1g meropenem (as trihydrate).
- sodium carbonate anhydrous.
Meropenem Sandoz is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
19 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500
This leaflet was prepared in September 2011.
Australian Register Numbers
500mg (20mL vial): AUST R 163773
1g (30mL vial): AUST R 163772
Published by MIMS December 2011