MEROPENEM 1000 mg. 10 vials
Meropenem belongs to a group of antibiotics called carbapenems. It works by killing the bacteria, which may cause serious infections such as:
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 can get during or after birth;
Complicated infections of skin and soft tissues;
Acute bacterial infection of the brain (meningitis).
Meropenem can be used for the treatment of patients with neutropenia who have a high temperature, which is believed to be due to bacterial infection.
2. Before you use Meropenem
Do not use Meropenem:
if you are allergic (s) (hypersensitive (s)) to meropenem or any of the other ingredients of Meropenem (listed in section 6. Further information);
if you are allergic (s) (hypersensitive (s)) to other antibiotics such as penicillins, cephalosporins or carbapenems as you may be allergic (s) to meropenem.
Take special care with Meropenem:
Consult with your doctor before using Meropenem:
if you have health problems, such as problems with your liver or kidneys;
if you have had severe diarrhea after taking other antibiotics.
When you can develop a positive test (Koombs), indicating 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 things apply to you, talk to your doctor or nurse before taking Meropenem.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, even those who are without a prescription and herbal medicines. This is because Meropenem can affect the way some medicines work and some medicines can affect Meropenem.
In particular, tell your doctor or nurse if you are taking any of the following medications:
Probenecid (used for gout);
Sodium valproate (used to treat epilepsy). Meropenem should not be used because it may decrease the effect of sodium valproate.
Pregnancy and lactation
It is important to tell your doctor if you are pregnant or planning to become pregnant before you are given meropenem. It is preferable to avoid the use of meropenem during pregnancy.
Your doctor will decide whether you should use meropenem.
It is important to tell your doctor if you are breastfeeding or plan to breastfeed before you are given meropenem. Small amounts of this medicine may pass into breast milk and may affect the baby. Therefore, your doctor will decide whether you should use meropenem while breastfeeding.
Ask your doctor before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines.
Important information about some of the ingredients of Meropenem
Meropenem contain sodium.
This medicinal product contains approximately 4.0 mEq of sodium per dose of 1.0 g, which must be taken into consideration by patients on a controlled diet of sodium.
If you have a condition that requires to monitor your sodium intake please inform your doctor or nurse.
3. How to use Meropenem
The dose depends on the type of infection you have, where the infection is in the body and how serious the infection. Your doctor will determine how much 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.
Children and adolescents
The dose for children 3 months to 12 years of age is determined using the age and weight of the child. The usual dose is between 10 mg and 40 mg Meropenem for every kilogram (kg) of weight of the child. Typically one dose is administered every 8 hours. Children who weigh over 50 kg were given an adult dose.
How will be given Meropenem
Meropenem will be given by injection or infusion into a large vein;
Your doctor or nurse will usually apply Meropenem;
Some patients, parents and carers are trained to apply Meropenem home. Instructions for doing this are given in this leaflet (in the point called "Guidelines for the implementation of Meropenem yourself or someone else at home '). Always use Meropenem exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist;
Your injection should not be mixed with or added to solutions containing other drugs;
The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to apply Meropenem;
Usually injections should be administered at the same time each day.
If you take a large amount Meropenem than you should:
If you use more than your prescribed dose, contact your doctor or nearest hospital immediately.
If you forget to take Meropenem:
If you miss an injection, you should be done 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 the missed dose.
If you stop taking Meropenem:
Do not stop taking Meropenem until your doctor tells you.
If you have further questions about the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, Meropenem can cause side effects, although not everybody gets them.
The frequency of possible side effects is given using the following convention:
very common (affects more than 1 in 10 patients);
Common (affects 1 to 10 out of 100 patients);
Uncommon (affects 1 to 10 of 1000 patients);
rare (affects 1 to 10 of 10,000 patients);
very rare (affects less than 1 in 10,000 patients);
not known (can not be estimated from the available data but this is rare or very rare).
Severe allergic reactions
If you have a severe allergic reaction, stop taking Meropenem and immediately go to the doctor. You may need urgent medical attention. The signs may include sudden onset of:
Severe rash, itching or hives on the skin;
Swelling of face, lips, tongue or other parts of the body;
Shortness of breath, wheezing or trouble breathing.
Damage to red blood cells (not known).
Run out of breath when you do not expect it;
Red or brown urine.
If you notice any of the above symptoms, see a doctor immediately.
Other possible side effects:
Abdominal (stomach) pain;
Feeling sick (nausea);
Skin rash, itchy skin;
Pain and inflammation;
Increasing the number of platelets in the blood (shown by blood tests);
Changes in blood tests, including tests that show how well your liver is working.
Changes in the blood. They include a decreased number of platelets (which may make it easier to bruise), increasing the number of certain 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 work;
Infections of the mouth or the vagina, which are caused by a fungus (thrush).
Other possible side effects of unknown frequency:
Inflammation of the bowel with diarrhea;
Inflammation of the veins where it is injected Meropenem;
Other changes in the blood. Symptoms include frequent infections, fever and sore throat. Your doctor may do blood tests from time to time;
Sudden onset of a severe rash or blistering or peeling of the skin. This may be associated with fever and arthralgia.
If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
5. How to store Meropenem
Keep out of reach of children.
Meropenem not use after the expiry date stated on the pack. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After reconstitution: The reconstituted solution for intravenous injection or infusion should be used immediately. The time interval between the beginning and the end of the preparation of an intravenous injection or infusion should not exceed one hour.
Do not freeze the reconstituted solution.
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.
6. Further information
The active substance is meropenem trihydrate.
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem.
The other ingredient is anhydrous sodium carbonate.
Meropenem looks like and contents of the pack
Meropenem is a powder for injection or infusion.
Meropenem is white to pale yellow crystalline powder. The ready to use solution is colorless to yellow solution.
Meropenem powder for injection or infusion is available in single packs with 1x1 and 10x1 vial.
Not all pack sizes may be marketed.