Description

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Active ingredient present in MEROKEM IV is Meropenem.
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 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.

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BEFORE YOU TAKE MEROKEM IV

Do not use MEROKEM IV if
• you are allergic (hypersensitive) to MEROKEM IV or any of the other ingredients of MEROKEM IV (listed in Section 6 Contents of the pack and other 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 MEROKEM IV 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 MEROKEM IV.

Other medicines and MEROKEM IV
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.

This is because MEROKEM IV can affect the way some medicines work and some medicines can have an effect on MEROKEM IV.

In particular, tell your doctor, pharmacist 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). MEROKEM IV 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 MEROKEM IV during pregnancy.
Your doctor will decide whether you should use MEROKEM IV.
It is important that you tell your doctor if you are breastfeeding or if you intend to breast-feed before receiving MEROKEM IV. 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 MEROKEM IV while breast-feeding

Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
MEROKEM IV contains sodium.

MEROKEM IV 500 mg: This medicinal product contains approximately 45 mg of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.
MEROKEM IV 1 g: This medicinal product contains approximately 90 mg of sodium per 1.0 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, pharmacist or nurse.

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HOW TO TAKE MEROKEM IV

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.
• 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 MEROKEM IV 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.

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HOW TO TAKE MEROKEM IV

• MEROKEM IV will be given to you as an injection or infusion into a large vein.
• Your doctor or nurse will normally give MEROKEM IV to you.
• However, some patients, parents and carers are trained to give MEROKEM IV at home. Instructions for doing this are provided in this leaflet (in the section called
‘Instructions for giving MEROKEM IV to yourself or someone else at home’). Always use MEROKEM IV 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 MEROKEM IV.
• You should normally have your injections at the same times each day.

If you use more MEROKEM IV 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 MEROKEM IV
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 MEROKEM IV
Do not stop having MEROKEM IV until your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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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
MEROKEM IV 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 available data)
• Inflammation of the bowel with diarrhoea.
• Sore veins where MEROKEM IV 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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HOW TO STORE MEROKEM IV

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.
This medicinal product does not require any special storage conditions.
After reconstitution: Chemical and physical in-use stability has been demonstrated for 1 hour at 25ºC and between 2ºC and 8ºC. From a microbiological point of view, the product should be used immediately.
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 require. These measures will help to protect the environment.

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FURTHER INFORMATION

What MEROKEM IV contains
Each vial contains 500 mg Meropenem anhydrous (as Meropenem trihydrate).
Each vial contains 1 g Meropenem anhydrous (as Meropenem trihydrate).
The other ingredient is sodium carbonate, anhydrous.

What MEROKEM IV looks like and contents of the pack
This medicine is a white to light yellow powder for solution for injection or infusion in vial. Pack sizes of 1 or 10 vials.

Not all pack sizes may be marketed.