Meropenem 1g Powder For Solution For Injection
Package leaflet: Information for the user
Meropenem 1 g powder for solution for injection or infusion
Meropenem
Read all of this leaflet carefully before you start taking 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.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- 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
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 tissue 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. What you need to know before you use Meropenem Do not use Meropenem:
- if you are allergic to meropenem or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem
Warnings and precautions
Talk to 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.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meropenem.
^_________
Children
Meropenem should not be used in children below 3 months of age.
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.
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 should not be used because it may decrease the effect of sodium valproate
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
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 breastfeeding.
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.
Meropenem contains sodium
This medicinal product contains approximately 4.0 mEq of sodium per 1 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
Always use this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
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.
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.
- 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 medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 (frequency is 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 (affects 1 to 10 users in 100)
- 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
The following information is intended for healthcare professionals only:
Meropenem 1 g powder for solution for injection or infusion
Meropenem
Instructions for giving Meropenem to yourself or someone else at home
Some patients, parents and carers are trained to give Meropenem at home.
- 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.
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 in the table below:
|
Dose of Meropenem |
Amount of "Water for Injections" needed for 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 is more than 1 g, you will need to use more than 1 vial of Meropenem. 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.
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 at home, dispose of any needles and infusion lines that you have used in an
Uncommon (affects 1 to 10 users in 1,000)
- 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 are working
- A tingling feeling (pins and needles)
- Infections of the mouth or the vagina that are caused by a fungus (thrush)
Rare (affects 1 to 10 users in 10,000)
- Fits (convulsions)
Not known (cannot be estimated from the available data)
- 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
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
Yellow Card Scheme
Website: 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
Keep this medicine out of the sight and reach of children.
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.
This medicine 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 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.
What Meropenem looks like and contents of the pack
Meropenem is a white to light yellow crystalline powder.
Pack sizes of 1 or 10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ACIC Europe Limited
Leontiou, 163, CLERIMOS BUILIDING, 2nd floor
3022 Limassol
Cyprus
Manufacturer:
Geryon Pharma Limited 18 Owen Drive Liverpool L24 1YL
United Kingdom
Distributor:
Creo Pharma Ltd Felsted Business Centre Felsted
Essex CM6 3LY
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Meropenem ratiopharm 1 g Pulverzur
Herstellung einer Injektionslosung bzw. Infusionslosung
Italy, Poland: Meropenem ACIC
Spain: Meropenem ACIC 1 g polvo para
solucion inyectable o para perfusion EFG United Kingdom: Meropenem 1 g powder for solution for injection or infusion
This leaflet was last revised in June 2016
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._
6. Contents of the pack and other information
What Meropenem contains
- The active substance is meropenem.
pharma
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.
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
- The other ingredient is anhydous sodium carbonate.
appropriate way. If your doctor decides to stop your treatment, dispose of any unused Meropenem 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 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.