500 mg and 1 g powder for solution for injection or infusion
meropenem
What Meronem is and what it is used for
Meronem belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that can cause serious infections.
Meronem is used to treat the following in adults and children aged 3 months and older:
- Lung infection ( pneumonia )
- Infection in the lungs and bronchus in patients with cystic fibrosis
- Complicated urinary tract infections
- Complicated abdominal infections
- Infection you that can occur during or after childbirth
- Complicated infection is in the skin or soft tissues
- Acute bacterial infections in the brain ( meningitis )
Meronem can be used to treat neutropenic patients with fever that is suspected to be caused by a bacterial infection.
Meronem can be used to treat bacterial infections in the blood that may be associated with any of the infections mentioned above.
What you need to know before you use Meronem
Do not use Meronem again
- you are allergic (hypersensitive) to meropenem or any of the other ingredients of this medicine (listed in section 6).
- you are allergic (hypersensitive) to other antibiotics , such as penicillins , cephalosporins or carbapenems, as you may also be allergic to meropenem.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Meronem if:
- you have health problems, such as liver or kidney disease.
- you have severe diarrhea after taking other antibiotics .
You can get a positive result on a blood test (Coombs test) which indicates the presence of antibodies that can destroy your red blood cells. Your doctor will talk to you about this.
You may experience signs and symptoms of severe skin reactions (see section 4). If this happens, talk to a doctor or nurse immediately so you can get treatment for your symptoms.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before receiving Meronem.
Other medicines and Meronem
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is because some medicines may affect or be affected by treatment with Meronem.
In particular, tell your doctor, pharmacist, or nurse if you are taking the following medicines:
- Probenecid (medicine for gout ).
- Valproic acid / sodium valproate / valpromide (antiepileptic medicine ) . Meronem should not be used as it may impair the effect of sodium valproate.
- Blood thinners taken by mouth (used to treat or prevent blood clots).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is desirable to avoid Meronem during pregnancy. Your doctor will decide if you should receive Meronem.
You must tell your doctor if you are breastfeeding or planning to start breastfeeding before receiving Meronem. Small amounts of this medicine may pass into breast milk. Therefore, your doctor will decide if you should be given Meronem while you are breastfeeding.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Meronem has been associated with headaches and tingling and tingling in the skin ( paresthesia ). All of these side effects can affect your ability to drive and use machines.
Meronem can cause involuntary muscle movements, which can cause a person’s body to shake quickly and uncontrollably (cramps). This is usually accompanied by loss of consciousness. You should not drive or use machines if you experience this side effect.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Meronem contains sodium
Meronem 500 mg: This medicine contains 45 mg of sodium (the main ingredient in common table salt/table salt) per 500 mg dose. This corresponds to 2.25% of the maximum recommended daily sodium intake for adults.
Meronem 1 g: This medicine contains 90 mg sodium (the main ingredient in common table salt/table salt) per 1 g dose. This corresponds to 4.5% of the maximum recommended daily sodium intake for adults.
If you have a health problem that requires you to control your sodium intake, tell your doctor, pharmacist, or nurse.
How to use Meronem
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Use for adults
- Dose one depends on the type of infection you have, where in the body infection one is sitting and how serious it is. Your doctor will determine the dose you need
- One dose for adults is usually between 500 mg (milligrams) and 2 g (grams). You are usually given one dose every 8 hours. But you get a dose less often if your kidneys do not work really well.
Use for children and adolescents
- Dose one for children over 3 months and up to 12 years depends on the child’s age and weight. The usual dose is between 10 mg and 40 mg of Meronem for each kilogram (kg) that the child weighs. One dose is usually given every 8 hours. Children weighing over 50 kg will receive an adult dose.
How to use Meronem
- Meronem will be given to you as an injection or infusion into a large vein
- Your doctor or nurse will normally give you Meronem
- Some patients, parents or caregivers are sometimes trained to give Meronem at home. Instructions for doing this can be found in this leaflet (in the section: Instructions for giving Meronem to yourself or someone else in the home). Always use Meronem exactly as your doctor has told you. If you are not sure, talk to your doctor.
- Your injection should not be mixed with or added to solutions containing other medicines
- Injection one can take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meronem
- You should normally get your injections at the same time each day
If you use more Meronem than you should
If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital immediately.
If you forget to use Meronem
If you miss an injection, you should get it as soon as possible. But if it’s almost time for the next injection, skip the missed injection.
You should not be given a double dose (two injections at the same time) to compensate for a missed dose.
If you stop using Meronem
Do not stop using Meronem until your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions
If you get any of these signs or symptoms, talk to a doctor or nurse immediately. You may need urgent medical attention. The symptoms and signs may appear suddenly:
- 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 difficulty breathing
- Signs and symptoms of severe skin reactions, including:
- Severe hypersensitivity reaction with fever, rash and changes in blood tests to check liver function (elevated levels of liver enzymes) and an increase in a type of white blood cell ( eosinophilia ) and enlarged lymph nodes . These can be signs of a hypersensitivity reaction in several organs called DRESS syndrome.
- Severe red and scaly rashes, bulging bumps, blisters or flaky skin that may be associated with high fever and joint pain.
- Severe skin rashes that may appear as reddish round spots, often with blisters in the middle of the torso, flaky skin, sores in the mouth, throat, nose, genitals and eyes, and which may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome ) or a more severe form ( toxic epidermal necrolysis ).
Damage to red blood cells (no known frequency)
Symptoms that may occur:
- Shortness of breath when you do not expect it
- Red or brown urine
If you notice any of the above symptoms, contact a doctor immediately.
Other possible side effects:
Common (may affect up to 1 in 10 people)
- Magont
- Nausea
- Vomiting
- Diarrhea
- Headache
- Skin rash, itching
- Pain and inflammation
- Increased platelet count in the blood (measured 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 the blood. These include decreased platelet count (which makes it easier for you to get bruises), increased number of certain white blood cells , decreased number of other white blood cells and increased amounts of a substance called ‘bilirubin’. Your doctor may take blood samples from time to time
- Changes in values from blood tests, including tests that show how well your kidneys are working
- Tingling and tingling
- Fungal infections of the mouth or abdomen
- Inflammation of the intestine with diarrhea
- Tenderness in the vein where Meronem is injected
- Other changes in the blood. Symptoms may include frequent infections , high fever and sore throat. Your doctor may take blood samples from time to time
Rare ( may affect up to 1 in 1000 people )
- Cramps
- Rapidly disorientation and confusion ( delirium )
How to store Meronem
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 carton. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Injection
Reconstituted solution: The reconstituted solution for intravenous injection should be used immediately. The time between the start of dilution and the end of intravenous injection should not exceed:
- 3 hours when stored at up to 25 ° C).
- 12 hours in cold storage (2-8 ° C).
Infusion
After reconstitution: Prepared intravenous infusion solutions should be used immediately. The time between the start of reconstitution and the end of intravenous infusion should not exceed:
- 3 hours when stored at up to 25 ° C) if Meronem has been dissolved in sodium chloride;
- 24 hours in cold storage (2-8 ° C) if Meronem has been dissolved in sodium chloride.
- If Meronem has been dissolved in glucose (dextrose), the solution should be used immediately.
From a microbiological point of view, the product should be used immediately, unless the method of opening/preparation/dilution excludes the risk of microbial contamination.
If the product is not used immediately, the storage times and conditions of use are the user’s responsibility.
The prepared solution must not be frozen.
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.
Contents of the pack and other information
Content declaration
Meronem 500 mg: The active substance is meropenem. 1 vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem.
Meronem 1 g: The active substance is meropenem. 1 vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
The other ingredient is anhydrous sodium carbonate.
What the medicine looks like and contents of the pack
- Meronem is a white or light yellow powder for solution for injection or infusion in a vial . There are 1 or 10 vials per pack.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer AB
191 90 Sollentuna
Tel: 08 – 550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
Pfizer Service Company BVBA
10 High Way
1930 Zaventem
Belgium