Meropenem 500 mg. 10 vials

SANDOZ
Meropenem 500 mg. 10 vials
€ 159.00
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WHAT MEROPENEM IS AND WHAT IT IS USED FOR
Meropenem Cabi belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that can cause serious infections:
Pulmonary infection (pneumonia);
Pulmonary and bronchial infections in patients suffering from cystic fibrosis;
Complicated urinary tract infections;
Complicated infections in the abdomen;
Infections from which you may become infected during or after birth
Complicated infections of the skin and soft tissues;
Acute bacterial infection of the brain (meningitis).
Meropenem Kabi can be used to treat neutropenic fever patients suspected of being due to a bacterial infection.

2. BEFORE YOU TAKE MEROPENEM
Do not take Meropenem Cabi:
If you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meropenem Cabby (listed in section 6. Further information;
If you are allergic (hypersensitive) to other antibiotics, Penicillins, cephalosporins or carbapenems, as you may also be allergic to meropenem.
Take special care with Meropenem Cabi
Talk to your doctor before taking meropenem:
If you have any health problems, Problems with the liver or kidneys;
If you have had severe diarrhea after taking other antibiotics.
You can develop a positive test (Coombs test) showing the presence of antibodies that can 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 Meropenem Cabi.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines that you can buy without a prescription, and herbal medicines.
This is because Meropenem Cabi can affect the way some medicines work and some medicines can have an effect on Meropenem Cabi.

In particular, tell your doctor or nurse if you are taking any of the following medicines:
Probenecid (used to treat gout);
Sodium vaproate (used to treat epilepsy). Meropenem Cabby should not be used because it may reduce the effect of sodium valproate.
Pregnancy and breastfeeding
Before you receive meropenem, it is important to tell your doctor if you are pregnant or planning a pregnancy. It is advisable to avoid the use of meropenem during pregnancy.
Your doctor will decide if you should use meropenem.
Before you receive meropenem, it is important to tell your doctor if you are breast-feeding or if you intend to breast-feed. Small amounts of this medicine can pass into breast milk and affect the baby. Therefore, your doctor will decide if you should use meropenem while you are breast-feeding.
Ask your doctor for advice before taking any medicine.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.

Important information about some of the ingredients of Meropenem Cabi
Meropenem Cabi contains sodium.
This medicinal product contains 1.96 mmol (or 45.13 mg) / 3.92 mmol (or 90.25 mg) of sodium per dose to be taken into consideration in patients with controlled sodium intake.

If you have a condition that requires your sodium to be monitored, please tell your doctor or nurse.

3. HOW TO TAKE MEROPENEM
Adults
The dose depends on the type of infection, the site of infection in the body and its severity. Your doctor will decide what dose you need;
The adult dose is usually between 500 mg (milligrams) and 2 g (gram). You will usually receive one dose at 8 o'clock. However, you may get the dose less often if your kidneys do not work very well.
Children and adolescents
The dose for children over the age of 3 months and up to 12 years is determined by the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meropenem Kabi per kilogram (kg) of the child's weight. The dose is usually given within 8 hours. Children weighing more than 50 kg will receive an adult dose;
Meropenem Kabi will be given as an injection or infusion into a large vein;
Normally, Meropenem Cabby will be given by your doctor or nurse;
However, some patients, parents and carers are trained to apply Meropenem Cabi home. Instructions for this are given in this leaflet (in the section called "Guidelines for the application of Meropenem Cabi alone or by someone else at home"). Always apply Meropenem Cabi exactly as your doctor has told you. If you are not sure, ask your doctor;
The solution for injection should not be mixed or added to solutions containing other medicines;
Injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to apply Meropenem Cabi;
You should usually inject yourself at the same time each day.
If you take more Meropenem Cabi than you need
If you accidentally take more than the prescribed dose, contact your doctor or nearest hospital immediately.

If you forget to take Meropenem Cabi
If you miss an injection, you should put it as soon as possible. However, if it is almost time for the next injection, skip the forgotten injection.
Do not take a double dose (two injections at the same time) to make up for the missed dose.

If you stop using Meropenem Cabi
Do not stop using Meropenem Cabi 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, Meropenem Cabi can cause side effects, although not everyone gets them.

The incidence of possible side effects listed below is determined using the following convention:
Very common (affecting more than 1 in 10 patients);
Common (affects 1 to 10 users in 100);
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000);
Very rare (affects less than 1 in 10,000 patients);
Frequency (frequency can not be estimated from the available data but these are rare or very rare).
Severe allergic reactions
If you have a severe allergic reaction, stop taking Meropenem Cabi and contact a doctor immediately. You may need urgent treatment. Signs may include the 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 difficulty in breathing;
Red blood cell damage (frequency not known).
Signs include:
I drank when you did not expect it;
Red or brown urine.
If you notice any of the above, contact a doctor immediately.

Other possible side effects:
Common:
Abdominal pain;
Vomiting (nausea);
Vomiting;
Diarrhea;
Headache;
Skin rash, itchy skin;
Pain and inflammation;
Increased blood platelets (proven by blood test);
Changes in blood tests, including tests that show how your liver is working.
Uncommon:
Changes in blood. These include reduced platelet counts (which may lead to easier bruising), increased number of some white blood cells, decreased number of other white blood cells, and an increased amount of a substance called "bilirubin". Your doctor may examine your blood from time to time;
Changes in blood tests including tests that show how your kidneys work;
Tingling sensation;
Infections of the mouth or vagina caused by fungi (thrush).
Rare:
Seizures (seizures).
Other possible side effects not known:
Inflammation of the intestine with diarrhea;
Pain in the veins at the injection site of Meropenem Cabi;
Other blood changes. Symptoms include frequent infections, fever and sore throat. Your doctor may examine your blood from time to time;
Sudden onset of severe rash or blistering or peeling of the skin. This may be accompanied by fever and joint pain.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse

5. HOW TO STORE MEROPENEM
Keep out of the reach and sight of children.
Do not use Meropenem Cabi after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store above 30 ° C.

After reconstitution: Prepared solutions for intravenous injection or infusion should be used immediately. The time interval between initiation of dissolution and end of 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 your unnecessary medicines. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION
What Meropenem Cabi contains
The active substance is meropenem trihydrate.
Each 20 ml vial / 100 ml bottle contains 500 mg meropenem.
Each 20 ml / 50 ml vial, 100 ml bottle contains 1000 mg meropenem.
The other ingredient is: anhydrous sodium carbonate.

What Meropenem Kubi looks like and what the pack contains
Meropenem Kabi is a white or light yellow powder for solution for injection or infusion in vials or bottles.
Meropenem Kabi 500 mg powder for solution for injection or infusion is available in 20 ml glass vials and 100 ml glass bottles.
Meropenem Kabi 1 g powder for solution for injection or infusion is available in glass vials of 20 ml and 50 ml and 100 ml glass bottles.
Packaging dimensions: 1 or 10 vials / bottles.
Not all pack sizes may be marketed.

Advice / medical training
Antibiotics are used to treat infections caused by bacteria. They have no effect against virus-induced infections.
Sometimes, some infection caused by bacteria is unaffected by the course of antibiotic treatment. One of the most common reasons for this is the resistance of the bacteria that caused the infection to the antibiotic administered. This means that they can survive and even multiply despite antibiotics.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria becoming resistant to them.
When your doctor prescribes a course of antibiotic therapy, it is intended to treat only your current illness.

As you pay attention to the following tips, you will help prevent the occurrence of resistant bacteria that may interfere with the action of the antibiotic.
1. It is very important to take the antibiotic at the correct dose, the correct number of times, and the correct number of days. Read the instructions on the label and, if you do not understand, ask your doctor or pharmacist to explain it to you.
2. You should not take an antibiotic unless it is prescribed for you, and you should use it only to treat the infection for which it is prescribed.
3. You should not take antibiotics prescribed to other people, even if they have an infection similar to yours.
4. You should not give other people prescribed antibiotics.
5. If you have a delayed antibiotic after completing the course of treatment as your doctor has told you, you should take the remainder to the pharmacy to dispose of it appropriately.

The following information is intended for medical professionals only:
Guidelines for applying Meropenem Cabi alone or someone else at home
Some patients, parents and carers are trained to apply Meropenem Cabi home.

Warning - this medicine should be used by you or someone else at home only after training by a doctor or nurse.
The drug should be mixed with another liquid (diluent). Your doctor will tell you how much thinner to use;
Apply the medicine as soon as it is ready. Do not freeze it.
How to prepare this medicine
1. Wash your hands and dry them very well. Prepare a clean work surface.
2. Remove Meropenem Cabi Bottle (vial) from the pack. Check the vial and expiration date. Check that the vial is intact and that it is not damaged.
3. Remove the colored cap and clean the rubber stopper with a soaked alcohol swab. Allow the rubber stopper to dry.
4. Attach a new sterile needle to a new sterile syringe without touching the edges.
5. Withdraw the recommended amount of sterile water for injections into the syringe. The amount of liquid you need is shown in the table below:

Dose of Meropenem Cabby Amount of water for injections required for dilution 10 ml (milliliters)
500 mg (milligrams) 10 ml (milliliters)
1 g (gram) 20 ml
1.5 g of 30 ml
2 g 40 ml
Please, have in mind:
If the prescribed Meropenem Cabi dose is more than 1 g, you will need to use more than 1 Meropenem Cabi vial. Then you can withdraw the liquid from the vials in a syringe.

6. Insert the needle of the syringe through the center of the rubber stopper and inject the recommended amount of water for injections into the Meropenem Cabi vial or vial.
7. Remove the needle from the vial and shake well for about 5 seconds or until all the powder has dissolved. Clean the rubber stopper once more with another alcohol pad and let it dry.
8. With the syringe plunger pushed to the end, insert the needle again into the rubber stopper. Then, holding the syringe and the vial, turn the vial upside down.
9. Holding the tip of the needle in the liquid, pull the plunger and withdraw all the liquid from the vial into the syringe.
10. Remove the needle and syringe from the vial and discard the vial in a safe place.
11. Keep the syringe upright with the needle up. Tap the syringe so that the remaining bubbles in the fluid rise to the top of the syringe.
12. Remove the remaining air in the syringe by gently pushing the plunger until all air is released.
13. If you use Meropenem Cabi at home, dispose of all needles and infusion systems appropriately. If your doctor decides to stop your treatment, dispose of the entire amount of unused Meropenem Cabi appropriately.

Putting the injection
You can use this medicine through a short cannula or venous catheter or through a port or central source.

Applying Meropenem Cabi through a short cannula or venous catheter
1. Remove the needle from the syringe and carefully dispose of it in a sharps container.
2. Clean the end of the short cannula or venous catheter with an alcohol swab and let it dry. Open the cannula cap and attach the syringe.
3. Slow press
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