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MEROPENEM 1000 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): MEROPENEM TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Meropenem 500mg powder for solution for injection or infusion
Meropenem 1g powder for solution for injection or infusion
meropenem

Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor, pharmacist or nurse. See section 4.
In this leaflet:
1. What Meropenem 500 mg/1 g powder for solution for injection/infusion is and what it is used
for
2. Before you use Meropenem 500 mg/1 g powder for solution for injection/infusion
3. How to use Meropenem 500 mg/1 g powder for solution for injection/infusion
4. Possible side effects
5. How to store Meropenem 500 mg/1 g powder for solution for injection/infusion
6. Further information

1.

WHAT MEROPENEM 500 MG/1 G POWDER FOR
INJECTION/INFUSION IS AND WHAT IT IS USED FOR

SOLUTION

FOR

Meropenem 500 mg/1 g powder for solution for injection/infusion 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 tissues infections
Acute bacterial infection of the brain (meningitis)

Meropenem 500 mg/1 g powder for solution for injection/infusion may be used in the
management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

2.

BEFORE YOU USE MEROPENEM 500 MG/1 G POWDER FOR SOLUTION FOR
INJECTION/INFUSION

Do not use Meropenem 500 mg/1 g powder for solution for injection/infusion
• If you are allergic (hypersensitive) to meropenem or any of the other ingredients of
Meropenem 500 mg/1 g powder for solution for injection/infusion (listed in Section 6 Futher
information).
• If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or
carbapenems as you may also be allergic to meropenem
Take special care with Meropenem 500 mg/1 g powder for solution for injection/infusion
Check with your doctor before using Meropenem 500 mg/1 g powder for solution for
injection/infusion:
• 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 500 mg/1 g powder for solution for injection/infusion.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription and herbal medicines.
This is because Meropenem 500 mg/1 g powder for solution for injection/infusion can affect the
way some medicines work and some medicines can have an effect on Meropenem 500 mg/1 g
powder for solution for injection/infusion
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 500 mg/1 g powder for solution for
injection/infusion should not be used because it may decrease the effect of sodium valproate.
• Warfarin (medicines that prevent blood clots) blood tests may need to be taken more often.
Pregnancy and breast-feeding
It is important that you tell your doctor if you are pregnant or are planning to become pregnant
before receiving meropenem. 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.

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.
Important information about some of the ingredients of Meropenem 500 mg/1 g powder for
solution for injection/infusion
Meropenem 500 mg/1 g powder for solution for injection/infusion contains sodium.
Meropenem 500 mg/1 g powder for solution for injection/infusion 500 mg: This medicinal
product contains approximately 2.0 mEq of sodium per 500 mg dose which should be taken into
consideration by patients on a controlled sodium diet.
Meropenem 500 mg/1 g powder for solution for injection/infusion 1.0 g: This medicinal product
contains approximately 4.0 mEq 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 or nurse.

3.

HOW TO USE MEROPENEM 500 MG/1 G POWDER FOR SOLUTION FOR
INJECTION/INFUSION

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.
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 500 mg/1 g
powder for solution for injection/infusion 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 500 mg/1 g powder for solution for injection/infusion will be given to you as an
injection or infusion into a large vein.
• Your doctor or nurse will normally give Meropenem 500 mg/1 g powder for solution for
injection/infusion to you.
• However, some patients, parents and carers are trained to give Meropenem 500 mg/1 g powder
for solution for injection/infusion at home. Instructions for doing this are provided in this
leaflet (in the section called ‘Instructions for giving Meropenem 500 mg/1 g powder for
solution for injection/infusion to yourself or someone else at home’). Always use Meropenem
500 mg/1 g powder for solution for injection/infusion 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 500 mg/1 g powder for solution for injection/infusion.

• You should normally have your injections at the same times each day.
If you use more Meropenem 500 mg/1 g powder for solution for injection/infusion 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 500 mg/1 g powder for solution for injection/infusion
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 500 mg/1 g powder for solution for injection/infusion until your
doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Meropenem 500 mg/1 g powder for solution for injection/infusion can cause
side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data but this is rare or very rare).
Severe allergic reactions
If you have a severe allergic reaction, stop having Meropenem 500 mg/1 g powder for solution
for injection/infusion 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
• 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
• 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).
Rare
• Fits (convulsions).
Other possible side effects of unknown frequency
• Inflammation of the bowel with diarrhoea.
• Sore veins where Meropenem 500 mg/1 g powder for solution for injection/infusion 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 500 MG/1 G POWDER FOR SOLUTION FOR
INJECTION/INFUSION

Prior to reconstitution or dilution, this medicinal product does not require any special storage
conditions.
Keep out of the reach and sight of children.
Do not use Meropenem 500 mg/1 g powder for solution for injection/infusion after the expiry
date which is stated on the vial label and carton. The expiry date refers to the last day of that
month.

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 or infusion should not exceed one hour.
Do not freeze the reconstituted solution
The solutions should be inspected visually for particles prior to administration. Only clear pale
yellow solution, free from visible particles should be used.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

6. FURTHER INFORMATION
What Meropenem 500 mg/1 g powder for solution for injection/infusion contains:
Each vial of Meropenem 500 mg/1 g powder for solution for injection/infusion 500mg powder
for solution for injection or infusion contains meropenem trihydrate equivalent to 500 mg
anhydrous meropenem.
Each vial of Meropenem 500 mg/1 g powder for solution for injection/infusion 1g powder for
solution for injection or infusion contains meropenem trihydrate equivalent to 1 g anhydrous
meropenem.
The other ingredient is anhydrous sodium carbonate
What Meropenem 500 mg/1 g powder for solution for injection/infusion looks like and
contents of the pack:
Meropenem 500 mg/1 g powder for solution for injection/infusion is a white to light yellow
crystalline 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
The marketing authorisation holder is:
STADA Arzneimittel AG
Stadastr.2-18
61118 Bad Vibel
Germany
tel: +49 (0)6101 603 0
fax: +49 (0)6101 603 259
e-mail: info@stada.de
The manufacturer is:
Pharmathen S.A.
6, Dervenakion Str., 153 51 Pallini, Attikis
Greece

tel: +30 210 66 65 067
fax: +30 210 66 66 749
e-mail: info@pharmathen.com

STADA Arzneimittel AG
Stadastr.2-18
61118 Bad Vibel
Germany
tel: +49 (0)6101 603 0
fax: +49 (0)6101 603 259
e-mail: info@stada.de

cell pharm GmbH
Feodor-Lynen-Straße 35
30625 Hanover
Germany
tel: +49 (0) 6101 30 42
fax: + 49 (0) 6101 30 42 11
e-mail: info@cellpharm.com

Clonmel Healthcare Ltd
Waterford Road, Clonmel, Co. Tipperary
Ireland
tel: +353-52-617 7777
fax: +353-52-617 7791
e-mail: info@clonmel-health.ie

This medicinal product is authorised in the Member States of the EEA under the following
names:
UK
Meropenem 500 mg/1 g powder for solution for injection/ infusion
Germany: Meropenem STADA 500 mg/1 g Pulver zur Herstellung einer Injektions‐ bzw.
Infusionslösung
Denmark: Meropenem STADA
Finland:
Meropenem STADA
Ireland
Meroponia 500 mg/1000 g powder for solution for injection or infusion
Netherlands Meropenem CF 500 mg/1000 mg, poeder voor oplossing voorinjectie of infusie
Sweden
Meropenem 500 mg/1 g pulver till injektionsvätska eller infusionsvätska, lösning
This leaflet was last approved in

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.

The following information is intended for medical or healthcare professionals only:
Instructions for giving Meropenem 500 mg/1 g powder for solution for injection/infusion to
yourself or someone else at home
Some patients, parents and carers are trained to give Meropenem 500 mg/1 g powder for solution
for injection/infusion 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. The time interval between the beginning of
reconstitution and the end of intravenous injection or infusion should not exceed one hour.
• Do not freeze it.

How to prepare this medicine
1. Wash your hands and dry them very well. Prepare a clean working area.
2. Remove the Meropenem 500 mg/1 g powder for solution for injection/infusion 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 500 mg/1 g powder for solution Amount of ‘Water for
for injection/infusion
Injections’ needed for dilution
500 mg (milligrams)
10 ml (milliliters)
1 g (gram)
20 ml
1.5 g
30 ml
2g
40 ml
Please note: If your prescribed dose of Meropenem 500 mg/1 g powder for solution for
injection/infusion is more than 1g, you will need to use more than 1 vial of
Meropenem 500 mg/1 g powder for solution for injection/infusion. 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 500 mg/1 g
powder for solution for injection/infusion.

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 500 mg/1 g powder for solution for injection/infusion 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 500 mg/1 g powder for
solution for injection/infusion 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 500 mg/1 g powder for solution for injection/infusion 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 500 mg/1 g powder for solution for injection/infusion 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.
Giving Meropenem 500 mg/1 g powder for solution for injection/infusion by intravenous infusion

Meropenem can be given by intravenous infusion over approximately 15 to 30 minutes. For
intravenous infusion, Meropenem 500 mg/1 g powder for solution for injection/infusion vials can
be constituted with sterile water for injection or 0.9 % sodium chloride or 5% glucose solutions
for infusion. The solution formed will be further diluted with 0.9 % sodium chloride or 5%
glucose solutions (concentration ranging from 1 to 20mg/mL).
The solution should be shaken before use. The solutions should be inspected visually for particles
prior to administration. Only clear pale yellow solution, free from visible particles should be used
Each vial is for single use only.

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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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