Maxpenem

Meropenem.

The active substance is meropenem.
Each vial contains meropenem trihydrate equivalent to 500mg anhydrous meropenem.
Each vial contains meropenem trihydrate equivalent to 1g anhydrous meropenem.
Excipients/Inactive Ingredients: The other ingredient is sodium carbonate.

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 the patient 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.

Always use this medicine exactly as the doctor has prescribed. Check with the doctor if the patient is not sure.
Adults: The dose depends on the type of infection that the patient has, where the infection is in the body and how serious the infection is. The doctor will decide on the dose that the patient needs.
The dose for adults is usually between 500mg (milligrams) and 2g (grams). The patient will usually receive a dose every 8 hours. However the patient may receive a dose less often if the 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 the patient as an injection or infusion into a large vein.
The doctor or nurse will normally give MEROPENEM to the patient.
However, some patients, parents and carers are trained to give MEROPENEM at home. Instructions for doing this are provided in this monograph (in the section called "Instructions for giving MEROPENEM to yourself or someone else at home" under Patient Counselling Information). Always use MEROPENEM exactly as the doctor has prescribed. The patient should check with the doctor if they are not sure.
The 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. The doctor will tell the patient how to give MEROPENEM.
The patient should normally have the injections at the same times each day.
If the patient uses more MEROPENEM than they should: If the patient accidentally uses more than the prescribed dose, contact the doctor or nearest hospital straight away.
If the patient forgets to use MEROPENEM: If the patient misses an injection, they should have it as soon as possible. However, if it is almost time for the 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 the patient stops using MEROPENEM: Do not stop having MEROPENEM until the doctor tells the patient to. If the patient has any further questions on the use of this medicine, ask the doctor or nurse.

Do not use MEROPENEM: If the patient is allergic to meropenem or any of the other ingredients of this medicine (listed in Description); If the patient is allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems as they may also be allergic to meropenem.

Talk to the doctor before using MEROPENEM: If the patient has health problems, such as liver or kidney problems.
If the patient has had severe diarrhea after taking other antibiotics.
The patient may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. The doctor will discuss this with the patient.
If the patient is not sure if any of the previously mentioned applies to them, talk to the doctor or nurse before using MEROPENEM.
MEROPENEM contains sodium: MEROPENEM 500mg: This medicinal product contains approximately 2 mEq of sodium per 500mg dose which should be taken into consideration by patients on a controlled sodium diet.
MEROPENEM 1 g: This medicinal product contains approximately 4 mEq of sodium per 1g dose which should be taken into consideration by patients on a controlled sodium diet.
If the patient has a condition which requires them to monitor the sodium intake inform the doctor or nurse.
Driving and using machines: No studies on the effect on the ability to drive and use machines have been performed.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor for advice before using this medicine.
It is preferable to avoid the use of meropenem during pregnancy.
The doctor will decide whether the patient should use meropenem.
Small amounts of this medicine may pass into the breast milk and it may affect the baby. Therefore, the doctor will decide whether the patient should use meropenem while breastfeeding.
Ask the doctor for advice before taking any medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed as follows is defined using the following convention:
Very common (may affect more than 1 in 10 people).
Common (may affect up to 1 in 10 people).
Uncommon (may affect up to 1 in 100 people).
Rare (may affect up to 1 in 1,000 people).
Very rare (may affect up to 1 in 10,000 people).
Not known (frequency cannot be estimated from the available data).
Severe allergic reactions: If the patient has a severe allergic reaction, stop having MEROPENEM and see a doctor straight away.
The patient 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 the patient does not expect it.
Red or brown urine.
If the patient notices any of the previously mentioned, see a doctor straight away.
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 the blood (shown in a blood test).
Changes in blood tests, including tests that show how well the liver is working.
Uncommon: Changes in the blood. These include reduced numbers of platelets (which may make the patient bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called "bilirubin". The doctor may do blood tests from time to time.
Changes in blood tests, including tests that show how well the kidneys are 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 diarrhea.
Sore veins where MEROPENEM is injected.
Other changes in the blood. The symptoms included frequent infections, high temperature and sore throat. The 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.

Tell the doctor if the patient is using, has recently used or might use 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 the doctor or nurse if the patient is 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.

This medicinal product does not require any special storage conditions (prior reconstitution).
Injection: After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection should not exceed 2 hours when stored at 25°C or 12 hours when stored at 4°C.
Infusion: After reconstitution: The reconstituted solutions for intravenous infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed: 4 hours when stored at 25°C or 24 hours when stored at 4°C in case MEROPENEM is dissolved in 0.9% sodium chloride solution; 1 hour when stored at 25°C or 4 hours when stored at 4°C in case MEROPENEM is dissolved in 5% glucose solution.
Do not freeze the reconstituted solution.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Additive/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 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.
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.
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 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 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 Injection" into the syringe. The amount of liquid that you need is shown in the table as follows: See table.
MaxpenemT_MM_v1
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 injection 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.
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 plunder 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.
Refer to the Summary of Product Characteristics (SmPC) for further information about MEROPENEM 500mg powder for solution for injection or infusion or MEROPENEM 1g powder for solution for injection or infusion.

Other Beta-Lactams

J01DH02 - meropenem ; Belongs to the class of carbapenems. Used in the systemic treatment of infections.

POM

Powd for soln for inj/infusion (vial) (white to light yellow) 500 mg x 10's. 1,000 mg x 10's.