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MEROPENEM 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: MEROPENEM TRIHYDRATE

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Package leaflet: Information for the patient
Meropenem 500 mg, powder for solution for injection or infusion
Meropenem 1 g, powder for solution for injection or infusion
Meropenem
Read all of this leaflet carefully before you start using
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,
pharmacist 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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.

Meropenem 500 mg: This medicinal product contains
approximately 45 mg of sodium per 500 mg dose which
should be taken into consideration by patients on a
controlled sodium diet.

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. How to store Meropenem
6. Contents of the pack and other information

3. HOW TO USE MEROPENEM

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 delivery
Complicated skin and soft tissues 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.
Meropenem may be used to treat bacterial infection of the
blood which might be associated with a type of infection
mentioned above.
2. WHAT YOU NEED TO KNOW 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 Contents of the pack and other information).
• you are allergic (hypersensitive) to other antibiotics such
as penicillins, cephalosporins, or carbapenems as you
may also be allergic to meropenem.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
Meropenem if:
• you have health problems, such as liver or kidney problems.
• 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.
Other medicines and Meropenem
Tell your doctor, pharmacist or nurse if you are taking, have
recently taken or might take any other medicines, including
medicines obtained without a prescription and herbal
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, pharmacist or nurse if you are
taking any of the following medicines:







Probenecid (used to treat gout).
Valproic acid/sodium valproate/valpromide (used to treat
epilepsy). Meropenem should not be used because it
may decrease the effect of sodium valproate.
Oral anti-coagulant agent (used to treat or prevent blood
clots).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or planning to have a baby, ask your doctor or
pharmacist for advice before using 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 breastfeeding 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.
Driving and using machines
No studies on the effect on the ability to drive and use
machines have been performed.
Meropenem contains sodium.

Meropenem 1 g: This medicinal product contains
approximately 90 mg of sodium per 1.0 g 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, pharmacist or
nurse.

Always use this medicine exactly as your doctor,
pharmacist or nurse has told you. Check with your
doctor, pharmacist or nurse if you are not sure.
Use in 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.
How to use Meropenem
• 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 have 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, pharmacist 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 (may affect up to 1 in 10 people)
• 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.

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The following information is intended for medical or 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.

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 very well. Prepare a
clean working area.

Dose of Meropenem

Amount of ‘Water for Injections’
needed for dilution

500 mg (milligrams)

10 ml (milliliters)

1 g (gram)

20 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.

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.

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.

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

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.

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:

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

Uncommon (may affect up to 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, 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 kidney is working.
• A tingling feeling (pins and needles).
• Infections of the mouth or the vagina that are caused by a
fungus (thrush).

Germany :











MEROPENEM MEDIPHA SANTE 500 mg
Pulver zur Herstellung einer
Injektionslösung oder Infusionslösung
MEROPENEM MEDIPHA SANTE
1 g Pulver zur Herstellung einer
Injektionslösung oder Infusionslösung

Rare (may affect up to 1 in 1,000 people)
• Fits (convulsions).

Netherlands:











MEROPENEM MEDIPHA SANTE 500 mg
Poeder voor oplossing voor injectie of
voor intraveneuze infusie
MEROPENEM MEDIPHA SANTE 1 g
Poeder voor oplossing voor injectie of
voor intraveneuze infusie

Ireland:





MEROPENEM MEDIPHA SANTE 500 mg
powder for solution for injection or infusion
MEROPENEM MEDIPHA SANTE 1 g
powder for solution for injection or infusion

Belgium:

















Meropenem Médipha Santé 500 mg
poudre pour solution injectable ou pour
perfusion/poeder voor oplosing voor
injectie of infusie/Pulver zur Herstellung
einer Injektions- oder Infusionslösung
Meropenem Médipha Santé 1 g poudre
pour solution injectable ou pour perfusion/
poeder voor oplosing voor injectie
of infusie/Pulver zur Herstellung einer
Injektions- oder Infusionslösung

Sweden:









Meropenem Medipha Sante 500 mg
Pulver till injektions-/infusionsvätska,
lösning
Meropenem Medipha Sante 1 g Pulver till
injektions-/infusionsvätska, lösning

Denmark:









MEROPENEM MEDIPHA SANTE 500 mg
pulver til injektions- og infusionsvæske,
opløsning
MEROPENEM MEDIPHA SANTE 1 g
pulver til injektions- og infusionsvæske,
opløsning

Norway:








Meropenem Medipha Sante 500 mg
pulver til injeksjons- og infusjonsvæske,
oppløsning
Meropenem Medipha Sante 1 g pulver til
injeksjons- og infusjonsvæske, oppløsning

Finland:







Meropenem Medipha Sante 500 mg
injektio-/infuusiokuiva-aine, liuosta varten
Meropenem Medipha Sante 1 g
injektio-/infuusiokuiva-aine, liuosta varten

Poland:



MEROPENEM MEDIPHA SANTE
MEROPENEM MEDIPHA SANTE

Other possible side effects of unknown frequency
(frequency cannot be estimated from 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.
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 the
Yellow Card Scheme at: 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 after “EXP”. The expiry date refers to
the last day of that month.
This medicinal product does not require any special storage
conditions.
After reconstitution: Chemical and physical in-use stability
has been demonstrated for 1 hour at 25ºC and between
2ºC and 8ºC. From a microbiological point of view, the
product should be used immediately.
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 require. These measures will help
to protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Meropenem contains
Each vial contains 500 mg meropenem anhydrous (as
meropenem trihydrate).
Each vial contains 1 g meropenem anhydrous (as
meropenem trihydrate).
The other ingredient is sodium carbonate, anhydrous.
What Meropenem looks like and contents of the pack
This medicine is a white to light yellow powder for solution
for injection or infusion in vial. Pack sizes of 1 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
United kingdom:
STRAVENCON Ltd
Landmark House
17 Hanover Square
London, W1S 1HU
Belgium, Denmark, Finland, France, Germany, Ireland,
Netherlands, Poland, Norway, Sweden:
MEDIPHA SANTE
Les Fjords – Immeuble Oslo
19 avenue de Norvège
91953 Courtaboeuf, Cedex
France
Manufacturer:
IPG Pharma
Atrium Court
The Ring
Bracknell, RG12 1BW
United Kingdom

This leaflet was last revised in August 2014.
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. You should not give antibiotics that were prescribed for
you to other people.
5. 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.

This medicinal product is authorised in the Member
States of the EEA under the following names:
United Kingdom: Meropenem 500 mg and 1 g

powder for solution for injection or infusion
France:







MEROPENEM MEDIPHA SANTE
500 mg poudre pour solution injectable ou
pour perfusion
MEROPENEM MEDIPHA SANTE 1 g
poudre pour solution injectable ou pour
perfusion
A136/UK/C

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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

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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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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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