MEROPENEM 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: MEROPENEM TRIHYDRATE

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

In particular, tell your doctor or nurse if you are taking any of the
following medicines:



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 or nurse.

In this leaflet:
1.
What Meropenem is and what it is used for
2.
Before you use Meropenem
3.
How to use Meropenem
4.
Possible side effects
5.
How to store Meropenem
6.
Further 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 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.
2. 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 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
Check with 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.

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
Meropenem contains sodium.
Meropenem 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 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
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 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.
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 can affect the way some medicines
work and some medicines can have an effect on Meropenem.

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.





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 product, ask
your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Meropenem 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).
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

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 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 highfever and joint pains.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.
5. HOW TO STORE MEROPENEM
Keep out of the reach and sight of children.
Do not use Meropenem after the expiry date which is printed on the
vial label and on the outer carton. The expiry date refers to the last
day of that month.
Do not store above 30°C
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 reconstituted solution
is for single use only. The reconstituted solution should be clear to
slight yellow transparent and should be free of any visible particles.
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 contains
Meropenem 500 mg/ vial powder for solution for injection or infusion
The active substance is meropenem. Each vial contains 500 mg
meropenem (as trihydrate)
The other ingredient is anhydrous sodium carbonate
Meropenem 1g/ vial powder for solution for injection or infusion
The active substance is meropenem. Each vial contains 1000 mg
meropenem (as 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 for solution for injection
or infusion in vial.
Pack size: 10 Vials in a Box.
Marketing Authorisation Holder and Manufacturer
VENUS PHARMA GmbH
Am Bahnhof 1 – 3
Werne D 59368
Germany
This leaflet was last revised in
Aug 2011
Meropenem 500mg : PL 34985/0003
Meropenem 1 g : PL 34985/0004

Tear off area

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THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL
OR HEALTHCARE PROFESSIONALS ONLY:

Dose of Meropenem

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

1 g (gram)

20 ml

1.5 g

30 ml

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.
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 below:
Meropenem 500 mg Powder for Solution for injection or infusion,
vial has a size of 10 ml and can be reconstituted with 10 ml Water
for Injections.
Meropenem 1 g Powder for Solution for injection or infusion, vial has
a size of 20 ml and can be reconstituted with 20 ml Water for
Injections.

500 mg (milligrams)

2g

Amount of ‘Water for Injections’
needed for dilution
10 ml (millilitres)

40 ml

Please note: If your prescribed dose of Meropenem is more than
1g, you will need to use more than 1vial of Meropenem. You can
then draw the liquid in the vials into the one syringe.

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.

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

12. Remove any air in the syringe by gently pushing the plunger
until all the air has gone.

Giving Meropenem through a short cannula or venflon

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.
Please note:

Appearance of Reconstituted Solution: The reconstituted solution
should be clear to slight yellow transparent and should be free of
any visible particles

An Intravenous infusion of meropenem may be prepared by directly
constituting the contents of the vials with 0.9 % sodium chloride or
5% glucose solutions for infusion. Please follow the instructions that
are stated below:

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.

To Meropenem 500 mg add 10 ml of the infusion diluent, then shake
well to reconstitute and then add this to the Diluent infusion bag.

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.

To Meropenem 1 g add 20 ml of the infusion Diluent, then shake
well to reconstitute and then add this to the Diluent infusion bag.
The following concentration is achieved in the infusion bag when the
infusion is prepared:

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.

Dose of Meropenem

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.

500 mg

100 ml 0.9% NaCl

5 mg/ ml

500 mg

100 ml 5% Glucose

5 mg/ ml

1 gram

100 ml 0.9% NaCl

10 mg/ ml

1 gram

100 ml 5% Glucose

10 mg/ ml

10. Remove the needle and syringe from the vial and throw the
empty vial away in a safe place.

Infusion Diluent

Resulting
concentration of
infusion

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.
Ver: 25-08-2011

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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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