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MEROPENEM 500MG POWDER FOR SOLUTION FOR INJECTION

Active substance(s): MEROPENEM TRIHYDRATE

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Meropenem

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Meropenem

PACKAGE LEAFLET: INFORMATION FOR THE USER

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Meropenem 500 mg, powder for solution for injection
Meropenem 1 g, powder for solution for injection
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 or nurse.
• 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. How to store Meropenem
6. Contents of the pack and other information
Your doctor will decide whether you should use meropenem.

1

What Meropenem is and what it is used for

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.

Meropenem belongs to a group of medicines called carbapenem antibiotics. It works by killing
bacteria, which can cause serious infections.








Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.

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 contains sodium.
Meropenem, 500 mg powder for solution for injection:
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 may be used in the management of neutropenic patients with fever that is suspected to
be due to a bacterial infection.

Meropenem, 1.0 g powder for solution for injection:
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.

Meropenem may be used to treat bacterial infection of the blood which might be associated with a
type of infection mentioned above.

2

If you have a condition which requires you to monitor your sodium intake please inform your doctor
or nurse

What you need to know before you use Meropenem

3

Do not use Meropenem
• if you are allergic (hypersensitive) to meropenem or any of the other ingredients of this medicine
(listed in section 6).
• if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or
carbapenems as you may also be allergic to meropenem.

Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor 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.

Warnings and precautions Talk to your doctor or nurse before using Meropenem:



How to use 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.

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.

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 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.

How Meropenem will be given to you
• 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.

In particular, tell your doctor 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 are 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.

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.
Continued on the next page >>

-The following information is intended for healthcare professionals only:

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

4.
5.

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.
• The product should be inspected visually after reconstitution for particulate matter, damage of
container or any visible signs of deterioration prior to administration and to discard any solution
where such defects are observed.
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.

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Connect a new sterile needle to a new sterile syringe, without touching the ends.
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 powder for solution for
injection

Amount of ‘Water for 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 is more than 1g, you will need to use more
than 1 vial of Meropenem. You can then draw the liquid in the vials into the one
syringe.

Continued on the next page >>

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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.

6

Contents of the pack and other information

If you stop using Meropenem
Do not stop having Meropenem until your doctor tells you to.

What Meropenem contains
The active substance is meropenem trihydrate.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Meropenem 500 mg, powder for solution for injection:
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.

4

Meropenem 1 g, powder for solution for injection:
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.

Possible side effects

The other ingredient is anhydrous sodium carbonate.
Like all medicines, this medicine can cause side effects, although not everybody gets them.

What Meropenem looks like and contents of the pack
Meropenem is a powder for solution for injection or infusion.

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.

Meropenem, powder for solution for injection is a white to pale yellow crystalline powder. The
ready-for-use solution is a colourless to yellow solution.
Meropenem is supplied in single packs with 1x1 and 10x1 vials.
Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Other possible side effects:

Manufacturer:
Sandoz GmbH,
Biochemiestrasse 10,
6250 Kundl,
Austria.

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.

This leaflet was last revised in 05/2015

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 areworking.
• 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.

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.

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

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can
help to reduce the chance of bacteria becoming resistant to them.

Reporting of side effects
If you get any side effects, talk to your doctor 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:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5

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.

How to store Meropenem

2.
3.

Keep this medicine out of the sight and reach of children.

4.
5.

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.

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

This medicinal product 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 or infusion 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.
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8.

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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.
Remove the needle from the vial and shake the vial well until all the powder has completely
dissolved. Clean the grey rubber stopper once more with a new alcohol wipe and allow the
rubber stopper to dry.
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.
Keeping the end of the needle in the liquid, pull back the plunger and draw all the liquid in the
vial into the syringe.
Remove the needle and syringe from the vial and throw the empty vial away in a safe place.
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.
Remove any air in the syringe by gently pushing the plunger until all the air has gone.
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 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.

Giving the injection
You can either give this medicine through a short cannula or venflon, or through a port or central
line.

draft: 44031782, 44031783
laetus code: 0000
mat.no.: 00000000

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SZ00000LT000

Artwork Proof Box
Ref: N001 - Sandoz logo update (Phase 13)
Proof no.
004.0

Date prepared:
04/09/2015

Colours:
Black
Black 20%

none
none

Dimensions: 340 x 540 mm

Font size:
10 pt
Fonts:
Helvetica

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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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