PACKAGE LEAFLET: INFORMATION FOR THE USER
Meropenem VENUS 500 mg powder for solution for injection or infusion
Meropenem VENUS 1 g 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 or nurse.
In this leaflet:
1. What Meropenem VENUS is and what it is used for
2. Before you use Meropenem VENUS
3. How to use Meropenem VENUS
4. Possible side effects
5. How to store Meropenem VENUS
6. Further information
1. WHAT MEROPENEM VENUS IS AND WHAT IT IS USED FOR
Meropenem VENUS belongs to a group of medicines called carbapenem antibiot ics. 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 VENUS 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 VENUS
Do not use Meropenem VENUS
• if you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meropenem
VENUS (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 VENUS
Check with your doctor before using Meropenem VENUS:
• 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 VENUS.
Using other medicines
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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 VENUS can affect the way some medicines work and some medicines
can have an effect on Meropenem VENUS.
In particular, t ell 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 VENUS should not be used because it
may decrease the effect of sodium valproate.
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 VENUS
Meropenem VENUS contains sodium.
Meropenem VENUS 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 VENUS 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 VENUS
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.
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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 VENUS 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 VENUS will be given to you as an injection or infusion into a large vein.
• Your doctor or nurse will normally give Meropenem VENUS to you.
• However, some patients, parents and carers are trained to give Meropenem VENUS at home.
Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for
giving Meropenem VENUS to yourself or someone else at home’). Always use Meropenem
VENUS 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 VENUS.
• You should normally have your injections at the same times each day.
If you use more Meropenem VENUS 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 VENUS
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 VENUS 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 VENUS 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 VENUS 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.
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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 VENUS 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.
If any of the side effects gets serious, or if you notice any side effects not list ed in this leaflet, please
tell your doctor or nurse.
5. HOW TO STORE Meropenem VENUS
Keep out of the reach and sight of children.
Do not use Meropenem VENUS 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
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
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.
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6. FURTHER INFORMATION
What Meropenem VENUS contains
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
The other ingredient is anhydrous sodium carbonate
What Meropenem VENUS looks like and contents of the pack
Meropenem VENUS 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
May 2010
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.
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THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE
PROFESSIONALS ONLY:
Instructions for giving Meropenem VENUS to yourself or someone else at home
Some patients, parents and carers are trained to give Meropenem VENUS 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.
2. Remove the Meropenem VENUS 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’ needed for
VENUS dilution
500 mg (milligrams) 10 ml (millilitres)
1 g (gram) 20 ml
1.5 g 30 ml
2g 40 ml
Please note: If your prescribed dose of Meropenem VENUS is more than 1g, you will need to use
more than 1vial of Meropenem VENUS. 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 VENUS.
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.
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13. If you are using Meropenem VENUS 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 VENUS 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 VENUS 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 VENUS 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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