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MEROPENEM 1G POWDER FOR SOLUTION FOR INJECTION

Active substance(s): MEROPENEM TRIHYDRATE / MEROPENEM TRIHYDRATE / MEROPENEM TRIHYDRATE

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Package leaflet: Information for the user
Meropenem 1 g, powder for solution for injection/infusion
Meropenem
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.

-

If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1.

What Meropenem is and what it is used for

2.

What you need to know before you use Meropenem

3.

How to use Meropenem

4.

Possible side effects

5.
6.

How to store Meropenem
Contents of the pack and other information

1.

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 the delivery
Complicated skin and soft tissue infections
Acute bacterial infection of the brain (meningitis)

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

2.

What you need to know before you use Meropenem

Do not use Meropenem:



if you are allergic to meropenem or any of the other ingredients of this medicine (listed in
section 6)
if you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems
as you may also be allergic to meropenem

Warnings and precautions
Talk to your doctor before using 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 applies to you, talk to your doctor or nurse before using
Meropenem.

Children
Meropenem should not be used in children below 3 months of age.
Other medicines and Meropenem
Tell your doctor if you are taking, have recently taken or might take any other medicines.
This is because Meropenem can affect the way some medicines work and some medicines can
have an effect on Meropenem.
In particular, tell your doctor or nurse if you are taking any of the following medicines:



Probenecid (used to treat gout)
Sodium valproate (used to treat epilepsy). Meropenem should not be used because it
may decrease the effect of sodium valproate

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine.
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 breastfeed before receiving meropenem. Small amounts of this medicine may pass into the breast
milk. Therefore, your doctor will decide whether you should use meropenem while
breastfeeding.
Ask your doctor 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.

Meropenem contains sodium
This medicinal product contains approximately 4.0 mEq of sodium per 1000 mg dose which
should be taken into consideration by patients on a controlled sodium diet.
If you have a condition which requires you to monitor your sodium intake please inform your
doctor or nurse.

3.

How to use Meropenem

Always use this medicine exactly as your doctor has told you. Check with your doctor if you
are not sure.

Adults




The dose depends on the type of infection that you have, where the infection is in the
body and how serious the infection is. Your doctor will decide on the dose that you
need.
The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). You will
usually receive a dose every 8 hours. However you may receive a dose less often if
your kidneys do not work very well.

Use in children and adolescents










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) that the child weighs. A dose is usually given every
8 hours. Children who weigh over 50 kg will be given an adult dose.
Meropenem will be given to you as an injection or infusion into a large vein.
Your doctor or nurse will normally give Meropenem to you.
However, some patients, parents and carers are trained to give Meropenem at home.
Instructions for doing this are provided in this leaflet (in the section called ‘Instructions
for giving Meropenem to yourself or someone else at home’). Always use Meropenem
exactly as your doctor has told you. You should check with your doctor if you are not
sure.
Your injection should not be mixed with or added to solutions that contain other
medicines.
The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor
will tell you how to give Meropenem.
You should normally have your injections at the same times each day.

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

If you forget to use Meropenem
If you miss an injection, you should have it as soon as possible. However, if it is almost time
for your next injection, skip the missed injection.
Do not take a double dose (two injections at the same time) to make up for a forgotten dose.
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 medicine, ask your doctor or nurse.

4.

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 having Meropenem and see a doctor straight
away. You may need urgent medical treatment. The signs may include a sudden onset of:




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 trouble breathing

Damage to red blood cells (not known)
The signs include:


Being breathless when you do not expect it
Red or brown urine
If you notice any of the above, see a doctor straight away.



Other possible side effects:
Common (affects 1 to 10 users in 100)










Abdominal (stomach) pain
Feeling sick (nausea)
Being sick (vomiting)
Diarrhoea
Headache
Skin rash, itchy skin
Pain and inflammation
Increased numbers 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 (affects 1 to 10 users in 1,000)







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

Rare (affects 1 to 10 users in 10,000)


Fits (convulsions)

Not known (cannot be estimated from the available data)






Inflammation of the bowel with diarrhoea
Sore veins where Meropenem is injected
Other changes in your blood. The 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
Serious hypersensitivity reactions involving fever, skin rash, and changes in the blood
tests that check how the liver is working (increased levels of liver enzymes) and an
increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These
may be signs of a multi-organ sensitivity disorder known as DRESS syndrome

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.

5.

How to store Meropenem

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 container. The expiry
date refers to the last day of that month.
This medicine 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 should not exceed one hour.

Do not freeze the reconstituted solution
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6.

Contents of the pack and other information

What Meropenem contains
-

The active substance is meropenem.
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.

-

The other ingredient is anhydous sodium carbonate.

What Meropenem looks like and contents of the pack
Meropenem is a white to light yellow crystalline powder.
Pack sizes of 1 or 10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ACIC Europe Limited
Leontiou, 163, CLERIMOS BUILIDING, 2nd floor
3022 Limassol
Cyprus
Manufacturer:
Geryon Pharma Limited
18 Owen Drive
Liverpool
L24 1YL
United Kingdom

Distributor:
Creo Pharma Ltd

Felsted Business Centre
Felsted
Essex CM6 3LY

This medicinal product is authorised in the Member States of the EEA under the
following names:
Germany: Meropenem ratiopharm 1 g Pulver zur Herstellung einer Injektionslösung bzw.
Infusionslösung
Italy, Poland: Meropenem ACIC
Spain: Meropenem ACIC 1 g polvo para solución inyectable o para perfusión EFG
United Kingdom: Meropenem 1 g, powder for solution for injection/infusion

This leaflet was last revised in November 2016

Advice/medical education
Antibiotics are used to treat infections caused by bacteria. They have no effect against
infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One
of the commonest reasons for this to occur is because the bacteria causing the infection are
resistant to the antibiotic that is being taken. This means that they can survive and even
multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can
help to reduce the chance of bacteria becoming resistant to them.
When your doctor prescribes a course of an antibiotic it is intended to treat only your current
illness. Paying attention to the following advice will help prevent the emergence of resistant
bacteria that could stop the antibiotic working.
1.

It is very important that you take the antibiotic at the right dose, at the right times and
for the right number of days. Read the instructions on the label and if you do not
understand anything ask your doctor or pharmacist to explain.

2.

You should not take an antibiotic unless it has been prescribed specifically for you and
you should use it only to treat the infection for which it was prescribed.

3.

You should not take antibiotics that have been prescribed for other people even if they
had an infection that was similar to yours.

4.
5.

You should not give antibiotics that were prescribed for you to other people.
If you have any antibiotic left over when you have taken the course as directed by your
doctor you should take the remainder to a pharmacy for appropriate disposal.

The following information is intended for healthcare professionals only:

Instructions for giving Meropenem to yourself or someone else at home
Some patients, parents and carers are trained to give Meropenem at home.


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.
How to prepare this medicine
1.

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

2.

Remove the Meropenem bottle (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 coloured cap and clean the grey 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 liquid 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 more than 1 g, you will need to
use more than 1 vial of Meropenem. You can then draw the liquid in the
vials into the one syringe.

6.

Put the needle of the syringe through the centre of the grey rubber stopper and inject
the recommended amount of Water for Injections into the vial or vials 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 grey rubber stopper once more with a new
alcohol wipe and allow the rubber stopper to dry.

8.

With the plunger of the syringe pushed fully into the syringe, put the needle back
through the grey 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 your 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.
bin.

Close the cap of your cannula and carefully throw the syringe away in your sharps

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.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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