What it is and what it is used for

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

What you need to know before you take it

E MEROPENEM

Do not use Meropenem if : you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meropenem (listed in Section 6 Further information). 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 have health problems, such as liver or kidney problems. + 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. 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 have an effect on Meropenem 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 planning to have a baby, ask your doctor or pharmacist 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. Itis 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 pass into the breast milk. Therefore, your doctor will decide whether you should use Meropenem while breast-feeding, Driving and using machines No studies on the effect on the ability to drive and use machines have been performed. However, Meropenem has been associated with headache, tingling or pricking skin (paraesthesiae) and involuntary muscle movements, leading the person's body to shake rapidly and uncontrollably (convulsions), that are usually accompained with a loss of consciousness and any of these could affect your ability to drive or operate machines. 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 acontrolled sodium diet. If you have a condition which requires you to monitor your sodium intake please inform your doctor, pharmacist or nurse.

How to take it

MEROPENEM

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). Inflammation of the bowel with diarrhoea. Sore veins where Meropenem is injected.

+

Possible side effects

Like all medicines, Meropenem can cause side effects, although not everybody gets them. Tell your doctor immediately or if serious go to your nearest hospital emergency department if you get any of the following side effects. Severe allergic reactions Ifyou 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

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 beclear to slight yellow transparent and should be free of any visible particles. 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. 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.

If you notice any of the above, see a doctor straight away.

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.

Other possible side effects:

Common (may affect up to 1 in 10 people) Abdominal (stomach) pain. Feeling sick (nausea). Being sick (vomiting).

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

What Meropenem looks like and contents of the pack

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! +

The dose for adults is usually between 500 mg (milligrams) and 2 g

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

(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 Meropenemwiill be given to you as an injection or infusion intoa 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.

The other ingredient is anhydrous sodium carbonate.

Diarrhoea. Headache. Skin rash, itchy skin. Pain and inflammation.

How to store it

MEROPENEM Keep this medicine out of the sight and reach of children. Do not use Meropenem after the expiry date which is printed on the vial

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, D59368 GERMANY This leaflet was last revised in Mar. 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 Meropenem 500mg : PL 34985/0003. Meropenem 1 g : PL 34985/0004

(€14n4N41000/5087-05, C14/MMS00/5086-05

Tear

'THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY: ions for giving urselfo ,

Dose of Meropenem

Some patients, parents and carers are trained to give Meropenem at home.

500 mg

'Amount of Water for Injections' needed for dilution 10 mi (millilitres)

1g (gram)

20 ml

15

Warning – You should only give this medicine to yourself or someone else at home after a doctor or nurse has trained you.

29

2

30

=

mi

40 ml

+ 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

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

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

6. Put the needle of the syringe through the center of the grey rubber stopper and inject the recommended amount of Water for Injections into the vial or vials of Meropenem.

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 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.

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 ina 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. Please note:

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: To Meropenem 500 mg add 10 mi of the infusion diluent, then shake well to

reconstitute and then add this to the Diluent infusion bag.

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

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.

concentration of infusion

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.

100 ml 0.9% NaCl

5 mg/ml

a flush as recommended by your doctor or nurse.

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

infusion is prepared:

Dose of Meropenem |

Infusion Diluent

500 mg 500 mg

Resulting

3. Once you have finished giving the antibiotic, remove the syringe and use

4. Place a new clean cap on your central line and carefully throw the syringe away in your sharps bin. Ver: 25-08-2011

Contents of the pack and other information

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 1000 people) + Fits (convulsions). Frequency not known (cannot be estimated from available data) Serious hypersensitivity reactions involving fever, skin rash, and changes in the blood tests that check how the liver is working (increased levels of liver enzymes) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome. Reporting of side effects Ifyou 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 National reporting system listed below. By reporting side effects, you can help provide more information on the safety of this medicine United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard