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MEROPENEM 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): MEROPENEM TRIHYDRATE / MEROPENEM TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Meropenem 500 mg and 1 g
Powder for solution for injection/infusion
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.
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
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 the following 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 (stomach)
• Infections that you can catch during or after giving birth
• Complicated skin and soft tissue infections
• Acute bacterial infection of the brain (meningitis)
Meropenem may be used to treat bacterial infection of the blood which
might be associated with one of the infections mentioned above.
Meropenem may be used in the management of neutropenic patients
(patients with low levels of white blood cells) 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 (hypersensitive) to meropenem or any of the other
ingredients of this medicine (listed in section 6).
• 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 currently have health problems, such as liver or kidney problems.
• you have previously had severe diarrhoea after taking other antibiotics.
You may develop a positive blood 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 apply 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. This is because Meropenem can affect
the way some medicines work and some medicines can affect the way
Meropenem works.
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.

The following information is intended for medical or healthcare
professionals only:
Intravenous bolus injection administration
A solution for bolus injection is prepared by dissolving the drug product in
water for injection to a final concentration of 50 mg/ml.
Chemical and physical in-use stability for a prepared solution for bolus
injection has been demonstrated for 3 hours at up to 25°C or 12 hours
under refrigerated conditions (2-8°C).
Intravenous infusion administration
A solution for infusion is prepared by dissolving the drug product in either
0.9% sodium chloride solution for infusion or 5% dextrose solution for
infusion to a final concentration of 1 to 20 mg/ml.
Chemical and physical in-use stability for a prepared solution for infusion
using 0.9% sodium chloride solution has been demonstrated for 3 hours at
up to 25°C or 24 hours under refrigerated conditions (2-8°C).
When Meropenem is dissolved in dextrose the solution should be used
immediately
From a microbiological point of view, unless the method of opening/
reconstitution/dilution precludes the risk of microbiological contamination,
the product should be used immediately. If not used immediately in-use
storage times and conditions are the responsibility of the user.
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.

• Anti-coagulants (used to treat or prevent blood clots) taken by mouth.
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 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 breast-feeding 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
Meropenem has been associated with headache; tingling or pricking skin
(paraesthesia); and involuntary muscle movements, leading the person’s
body to shake rapidly and uncontrollably (convulsions), which are usually
accompanied with a loss of consciousness, and any of these could affect
your ability to drive or operate machines.
Meropenem contains sodium
Meropenem 500mg contains approximately 2.0 mEq of sodium per 500 mg dose.
Meropenem 1g contains approximately 4.0 mEq of sodium per 1.0 g dose.
This 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.
3. HOW TO USE MEROPENEM
Always use this medicine exactly as your doctor, pharmacist or nurse has
told you. Check with them 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.

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’ Volume following
needed for reconstitution
reconstitution

500 mg
(milligrams)
1 g (gram)
1.5 g
2g

10 ml

10.5 ml

20 ml
30 ml
40 ml

21 ml
31.3 ml
42 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.

ARTWOR K
SEPARATIONS:

 black

PRODUCT NAME:
Meroepenem 500mg/1g
Villerton
DATE

20/06/17

OPER ATOR

RI006M

DRAFT

03

PHARMACODE: I X I I I I X X X X
MEASURES (mm): 210 x 315
CUTTING PROFILE: ACSI092F00
TECHNICAL SPECIF.: ACSI092F01
g/sq.mt: 60 gr/m2 Thikness: 0,076 mm
FONT: Arial 8 pt

PER UNA CORRETTA VISUALIZZAZIONE DEL L’ARTWORK
IMPOSTARE LA SOVRAST AMPA IN MODO APPROPRI ATO
SOVRASTAMPA SOVRASTAMPA
NON ATTIVA ATTIVA

NO

SI

FACTA
v.04-2015

PRODUCT CODE:
L08GBMERO00

PDF 1. 5

4. POSSIBLE SIDE EFFECTS

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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 (frequency 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.
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 kidneys
are working.
• A tingling feeling (pins and needles).
• Infections of the mouth or the vagina that are caused by a fungus (thrush).
• 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.
Rare (may affect up to 1 in 1,000 people)
• Fits (convulsions).
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. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 to protect the environment.
Your doctor, pharmacist and nurse will know how to store this medicine.

What Meropenem contains
The active substance is meropenem. Each vial contains 500 mg anhydrous
meropenem as meropenem trihydrate.
The active substance is meropenem. Each vial contains 1 g anhydrous
meropenem as meropenem trihydrate.
The other ingredient is anhydrous sodium carbonate.
What Meropenem looks like and contents of the pack
Meropenem is a white to light yellow powder in a vial with grey, bromobutyl
rubber stopper sealed with a violet colour aluminium flip-off cap for the 500
mg and grey colour for 1g strength.
Pack size: 10 vials.
Marketing Authorisation Holder
VILLERTON INVEST S.A.
14, Rue Edward Steichen
L-2540, Luxembourg
Manufacturer
Facta Farmaceutici SpA
Nucleo Industriale S. Atto,
S. Nicolò a Tordino, 64100 Teramo,Italy
This leaflet was last revised in: June 2017
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.

L08GBMERO00

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. 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.

L08GBMERO00

ARTWOR K
SEPARATIONS:

 black

PRODUCT NAME:
Meroepenem 500mg/1g
Villerton
DATE

20/06/17

OPER ATOR

RI006M

DRAFT

03

PHARMACODE: I X I I I I X X X X
MEASURES (mm): 210 x 315
CUTTING PROFILE: ACSI092F00
TECHNICAL SPECIF.: ACSI092F01
g/sq.mt: 60 gr/m2 Thikness: 0,076 mm
FONT: Arial 8 pt

PER UNA CORRETTA VISUALIZZAZIONE DEL L’ARTWORK
IMPOSTARE LA SOVRAST AMPA IN MODO APPROPRI ATO
SOVRASTAMPA SOVRASTAMPA
NON ATTIVA ATTIVA

NO

SI

FACTA
v.04-2015

PRODUCT CODE:
L08GBMERO00

PDF 1. 5

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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