Meropenem 1g Powder For Solution For Injection Or Infusion
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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
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.
- 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 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.
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 (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to Meropenem.
Warning and precautions
Talk to your doctor or nurse 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 apply 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.
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.
Pregnancy, breast-feeding and fertility
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.
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.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
Meropenem contains sodium.
Meropenem 500 mg powder for solution for injection or infusion contains 1.96 mmol (or 45.13 mg) sodium per dose. Meropenem 1 g powder for solution for injection or infusion contains 3.92 mmol (or 90.25 mg) sodium per dose.
To 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.
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.
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 (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 (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.
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 kidney is working.
- A tingling feeling (pins and needles).
- Infections of the mouth or the vagina that are caused by a fungus (thrush).
Rare (may affect up to 1 in 1,000 people)
- Fits (convulsions)
Other possible side effects of unknown frequency (frequency 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.
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Meropenem 500 mg powder for solution for injection or infusion Meropenem 1 g powder for solution for injection or infusion
Meropenem
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 (see details below).
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
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The following information is intended for healthcare professionals only:
Instructions for giving Meropenem to yourself or someone else at home
Some patients, parents and carers are trained to give Meropenem at home.
Warning - You should only give this medicine to yourself or someone else at home after a doctor or nurse has trained you.
How to prepare this medicine
- 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.
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 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
500 mg (milligrams)
1 g (gram)
1.5 g
2 g
Amount of 'Water for
Injections' needed for dilution 10 ml (milliliters)
20 ml 30 ml 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.
6. Put the needle of the syringe through the centre of the 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 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 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.
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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 after EXP 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.
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. Contents of the pack and other information What Meropenem contains
- The active substance is meropenem trihydrate. Each 20ml vial/100ml bottle of Meropenem 500 mg powder for solution for injection or infusion contains 500 mg Meropenem. Each 20 ml vial, 50/100 ml bottle of Meropenem 1 g solution for injection or infusion contains 1 g Meropenem. The other ingredient is anhydrous sodium carbonate.
What Meropenem looks like and contents of the pack
Meropenem is a white or light yellow powder for solution for injection or infusion in vial or bottle.
Meropenem 500 mg powder for solution for injection or infusion is available in 20 ml glass vials and 100 ml glass bottles. Meropenem 1 g powder for solution for injection or infusion is available in 20 ml glass vials, 50 ml and 100 ml glass bottles.
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Meropenem Kabi 500 mg Pulver zur
Herstellung einer Injektionslosung oder Infusionslosung
Meropenem Kabi 1 g Pulver zur Herstellung einer Injektionslosung oder Infusionslosung
Belgium Meropenem Fresenius Kabi 500 mg poeder
voor oplossing voor injectie of infusie / poudre pour solution injectable ou pour perfusion / Pulver zur Herstellung einer Injektionslosung oder Infusionslosung Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie / poudre pour solution injectable ou pour perfusion / Pulver zur Herstellung einer Injektionslosung oder Infusionslosung
Bulgaria Meropenem Kabi 500 mg
Meropenem Kabi 1 g
Cyprus Meropenem Kabi 500 mg, Kovig Yia eveaipo
SiaAupa g SiaAupa Yia eYXuan Meropenem Kabi 1g, Kovig Yia eveaipo SiaAupa g SiaAupa Yia eYXuan
Czech Meropenem Kabi 500 mg
Republic Meropenem Kabi 1g
Denmark Meropenem Fresenius Kabi
Estonia Meropenem Kabi 500 mg
Meropenem Kabi 1000 mg
Germany Meropenem Kabi 500 mg Pulver zur
Herstellung einer Injektionslosung oder Infusionslosung
Meropenem Kabi 1 g Pulver zur Herstellung einer Injektionslosung oder Infusionslosung
Luxemburg Meropenem Kabi 500 mg Pulver zur
Herstellung einer Injektionslosung oder Infusionslosung
Meropenem Kabi 1 g Pulver zur Herstellung einer Injektionslosung oder Infusionslosung
Netherlands Meropenem Fresenius Kabi 500 mg poeder voor oplossing voor injectie of infusie Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie
Norway Meropenem Fresenius Kabi 500 mg, pulver
til injeksjonsv^ske/ infusjonsv^ske, oppl0sning
Meropenem Fresenius Kabi 1 g, pulver til injeksjonsv^ske/ infusjonsv^ske, oppl0sning
Poland Meropenem Kabi
Portugal Meropenem Kabi 500 mg Po para solugao
injectavel ou para perfusao Meropenem Kabi 1 g Po para solugao injectavel ou para perfusao
Romania Meropenem Kabi 500 mg pulbere pentru solufie injectabila sau perfuzabila Meropenem Kabi 1 g pulbere pentru solufie injectabila sau perfuzabila
Spain Meropenem Kabi 500 mg polvo para
solucion inyectable o para perfusion Meropenem Kabi 1 g polvo para solucion inyectable o para perfusion
Sweden Meropenem Fresenius Kabi 500 mg, pulver
till injektionsvatska eller infusionsvatska, losning
Meropenem Fresenius Kabi 1 g, pulver till injektionsvatska eller infusionsvatska, losning
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.
Pack sizes of 1 or 10 vials or bottles. Greece
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Ltd
Cestrian Court, Finland
Eastgate Way,
Manor Park,
Runcorn,
Cheshire,
United Kingdom Hungary
WA7 1NT
Manufacturer(s) responsible for batch release Ireland
FACTA FARMACEUTICI S.p.A.
Nucleo Industriale S. Atto, S. Nicolo a Tordino, 64100 Teramo Italy
and Latvia
Fresenius Kabi Deutschland GmbH 61346 Bad Homburg v.d.H.
Germany
and Lithuania
LABESFAL - Laboratorios Almiro S.A. (Fresenius Kabi Group)
Lagedo, 3465-157 Santiago de Besteiros Portugal
Meropenem Kabi 500 mg, Kovig Yia napaaKeug SiaAupaTog npog evean g eYXuanMeropenem Kabi 1g, Kovig Yia napaaKeug SiaAupaTog npog evean g eYXuan
Meropenem Fresenius Kabi 500 mg injektio-/infuusiokuiva-aine, liuosta varten Meropenem Fresenius Kabi 1 g injektio-/ infuusiokuiva-aine, liuosta varten
Meropenem Kabi 500 mg Meropenem Kabi 1 g
Meropenem 500 mg powder for solution for
injection or infusion
Meropenem 1 g powder for solution
for injection or infusion
Meropenem Kabi 500 mg pulveris injekciju vai infuziju skfduma pagatavosanai Meropenem Kabi 1000 mg pulveris injekciju vai infuziju skfduma pagatavosanai
Meropenem Kabi 500 mg milteliai injekciniam arba infuziniam tirpalui Meropenem Kabi 1000 mg milteliai injekciniam arba infuziniam tirpalui
Slovenia Meropenem Kabi 500 mg prasek za raztopino za injiciranje ali infundiranje Meropenem Kabi 1 g prasek za raztopino za injiciranje ali infundiranje
Slovakia Meropenem Kabi 500 mg
Meropenem Kabi 1 g
United Meropenem 500 mg powder for solution for
Kingdom injection or infusion
Meropenem 1 g powder for solution for injection or infusion
This leaflet was last revised in September 2015.
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.
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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.
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.
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.
FRESENIUS
KABI
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