Label: Information for the User

Meropenem Kern Pharma 1000 mg powder for injectable solution and for infusion EFG

Read this label carefully before starting to use this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

The name of this medicine is one of the following:

• Meropenem Kern Pharma 1000 mg powder for injectable solution and for infusion

In the rest of this label, the medicine is referred to as Meropenem Kern Pharma

1. What Meropenem Kern Pharma is and for what it is used

2. What you need to know before starting to use Meropenem Kern Pharma

3. How to use Meropenem Kern Pharma

4. Possible adverse effects

5. Storage of Meropenem Kern Pharma

6. Contents of the package and additional information

Meropenem belongs to a group of medications known as carbapenem antibiotics. It works by destroying bacteria, which can cause severe infections.

This medication is used to treat the following bacterial infections:

• Pneumonia, an infection affecting the lungs
• Respiratory and pulmonary infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated abdominal infections
• Infections you may acquire during and after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial meningitis, a bacterial infection of the brain

Meropenem Kern Pharma may be used to treat neutropenic patients with fever suspected to be caused by a bacterial infection.

Meropenem can be used to treat bacterial blood infections associated with the aforementioned infections.

No use Meropenem Kern Pharma

- If you are allergic to meropenem or any of the other components of this medication (listed in section 6).

- If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems, as you may also be allergic to meropenem.

Warnings and Precautions

Inform your doctor, pharmacist, or nurse before starting to use Meropenem Kern Pharma if:

• You have health problems, such as liver or kidney problems.
• You have had severe diarrhea after taking other antibiotics.

You may develop a positive response to a test (Coombs test) indicating the presence of antibodies that can destroy red blood cells. Your doctor will discuss this with you.

If you are in any of these situations, or if you have doubts, consult your doctor or nurse before using Meropenem Kern Pharma.

Use of Meropenem with other medications

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication.

This is because meropenem may affect the way some medications work, and some of these may affect meropenem.

In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medications:

• Probenecid (used to treat gout).
• Sodium valproate (used to treat epilepsy). Do not use Meropenem, as it may reduce the effect of this medication.
• Anticoagulant agent (used to treat or prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.It is preferable to avoid using meropenem during pregnancy. Your doctor will decide whether to use meropenem.

It is essential to inform your doctor if you are breastfeeding or plan to breastfeed before receiving treatment with meropenem. A small amount of this medication may pass into breast milk. Therefore, your doctor will decide whether to use meropenem during breastfeeding.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. However, meropenem has been associated with headache; tingling or pins and needles in the skin (paresthesia); and involuntary muscle movements, leading to rapid and uncontrolled body agitation (convulsions), which is usually accompanied by loss of consciousness. Any of these effects may affect your ability to drive or operate machinery.

Meropenem Kern Pharma contains sodium

Meropenem Kern Pharma 1000 g: This medication contains approximately 4.0 mEq (90 mg) ofsodiumper dose of 1.0 g, which should be taken into account by patients on a controlled sodium diet.

If you have a condition that requires controlling your sodium intake, inform your doctor, pharmacist, or nurse.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use in adults

• The dose depends on the type of infection you have, the area of the body affected, and its severity. Your doctor will decide what dose you need.
• The usual dose in adults is between 500 mg (milligrams) and 2 g (grams). You will normally receive a dose every 8 hours. However, if your kidneys do not function well, you may receive the dose less frequently.

Use in children and adolescents

• The dose for children over 3 months and up to 12 years is determined using the child's age and weight. The usual dose is between 10 mg and 40 mg of Meropenem Kern Pharma per kilogram (kg) of the child's weight. You will normally receive a dose every 8 hours. Children weighing over 50 kg will receive an adult dose.

How to use Meropenem

• Meropenem Kern Pharma will be administered to you as an injection or infusion into a large vein.
• Meropenem Kern Pharma will normally be administered by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer Meropenem Kern Pharma at home. The instructions for this are found in this leaflet (in the section called "Instructions for administering Meropenem Kern Pharma to yourself or another person at home"). Follow exactly the administration instructions for Meropenem Kern Pharma as indicated by your doctor. Consult your doctor if you have any doubts.
• Your injection should not be mixed with or added to solutions containing other medications.
• The injection may take approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to administer Meropenem Kern Pharma.
• Normally, injections should be administered at the same time each day.

If you use more Meropenem Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Meropenem Kern Pharma

If you forget a dose, you should receive it as soon as possible. However, if it is almost time to administer the next dose, do not receive the missed dose.

Do not use a double dose (two injections at once) to make up for a missed dose.

If you interrupt treatment with Meropenem Kern Pharma

Do not stop Meropenem Kern Pharma until your doctor tells you to. If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe allergic reactions

If you experience a severe allergic reaction,stop taking Meropenem Kern Pharma and seek medical attention immediately. You may need urgent medical treatment. Symptoms can include a sudden onset of:

• Severe skin rash, itching, or hives.
• Swelling of the face, lips, tongue, or other parts of the body.
• Shortness of breath, wheezing, or difficulty breathing.

Damage to red blood cells (unknown)

Symptoms include:

• Shortness of breath when not expected.
• Red or brown urine.

If you notice any of the above,seek medical attention immediately.

Other possible side effects:

Frequent(may affect up to 1 in 10 people)

• Abdominal pain (stomach)
• Unpleasant feeling (nausea)
• Discomfort (vomiting)
• Diarrhea
• Headache
• Skin rash, itching on the skin
• Pain and inflammation
• Increased platelet count in the blood (checked in a blood test)
• Changes in blood tests, including tests that show how the liver works

Rare(may affect up to 1 in 100 people)

• Changes in your blood. These include a decrease in the number of platelets (which may make you bruise more easily), an increase in some white blood cells, a decrease in other white blood cells, and an increase in a substance called "bilirubin". Your doctor may perform blood tests periodically.
• Changes in blood tests, including tests that show how your kidneys work.
• Feeling of tingling (pins and needles).
• Infections of the mouth or vagina caused by a fungus (thrush).

• Inflammation of the intestine with diarrhea.
• Pain in the veins where Meropenem Kern Pharma is injected.
• Other changes in your blood. Symptoms include frequent infections, fever, and sore throat. Your doctor may perform blood tests periodically.
• Sudden onset of a severe skin rash or formation of blisters or peeling of the skin. This may be associated with high fever and joint pain.

Rare(may affect up to 1 in 1,000 people)

• Seizures (convulsions).

Unknown frequency

• Severe hypersensitivity reactions with fever, skin rash, and changes in blood tests that control liver function (elevated liver enzyme values) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be symptoms of a multi-organ sensitivity disorder known as DRESS syndrome.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Injection

After reconstitution: The reconstituted solutions for injection must be used immediately. The time interval between the start of reconstitution and the end of intravenous injection should not exceed:

• 3 hours when stored up to 25°C.
• 12 hours when stored under refrigeration conditions (2°C -8°C).

Infusion

After reconstitution: The reconstituted solutions for infusion must be used immediately. The time interval between the start of reconstitution and the end of infusion should not exceed:

• 6 hours when stored up to 25°C when Meropenem Kern Pharma is dissolved in sodium chloride.
• 24 hours when stored under refrigeration conditions (2°C -8°C) when Meropenem Kern Pharma is dissolved in sodium chloride.
• When Meropenem Kern Pharma is dissolved in glucose, the solution must be used immediately.

From a microbiological point of view, unless the method of opening/reconstitution/dilution eliminates the risk of microbiological contamination, the product must be used immediately.

If not used immediately, the storage times and usage conditions are the responsibility of the user.

Do not refrigerate or freeze the reconstituted solution.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medication. This will help protect the environment.

Composition of Meropenem Kern Pharma

• The active ingredient is meropenem
• The other component is anhydrous sodium carbonate

Meropenem Kern Pharma 1000 mg: Each vial contains meropenem trihydrate equivalent to 1 g of anhydrous meropenem.

Appearance of the product and contents of the package

Meropenem Kern Pharma is a white to light yellow crystalline powder, for solution for injection or for infusion in a glass vial sealed with a rubber stopper and an aluminum flip-off cap. It is presented in packs of 1 or 10 vials.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa (Barcelona)

Spain

Responsible for manufacturing

DEMO S.A.

21st km National Road Athens-Lamia,

14568 Krioneri, Athens

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

United Kingdom:Meropenem 1g Powder for Solution for Injection or Infusion

Austria:Meropenem Noridem 1 g Pulver zur Herstellung einer Injektions- oder Infusionslösung

Germany:Meropenem Noridem 1g Pulver zur Herstellung einer Infusions- oder Injektionslösung

Greece:MeropenemNoridem1g????? ??a e??s?µ? d????µa

Ireland:Meropenem 1g Powderfor Solution for Injection or Infusion

Poland:Meropenem Noridem 1g proszek do sporzadzania roztworu do wstrzykiwan lub wlewów

Last review date of this leaflet: January 2017.

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Instructions for administering Meropenem Kern Pharma to yourself or to another person at home

Some patients, parents, and caregivers are trained to administer Meropenem Kern Pharma at home.

Attention – You should only administer this medication to yourself or to another person at home after a doctor or nurse has trained you.

How to prepare this medication

• The medication must be mixed with another liquid (the diluent). Your doctor will tell you what amount of diluent to use.
• Use the medication just after preparing it. Do not freeze it.

1. Wash your hands and dry them thoroughly. Prepare a clean working area.
2. Remove the vial (vial) of Meropenem Kern Pharma from the pack. Check the vial and the expiration date. Check that the vial is intact and not damaged.
3. Remove the colored cap and clean the rubber stopper with an alcohol-soaked cotton swab. Let the stopper dry.
4. Attach a new sterile needle to a new sterile syringe, without touching the ends.
5. Draw out the recommended amount of "Sterile Water for Injection" with the syringe. The amount of liquid needed is shown in the table below:

Remember:If the amount of Meropenem Kern Pharma prescribed to you is greater than 1 g, you will need to use more than one vial of Meropenem Kern Pharma. You can then draw out the liquid from the vials with a single syringe.

1. Pierce the center of the gray rubber stopper with the needle of the syringe and inject the recommended amount of "Sterile Water for Injection" into the vial(s) of Meropenem Kern Pharma.
2. Remove the needle from the vial and shake the vial well for about 5 seconds, or until all the powder has dissolved. Clean the gray rubber stopper again with a new alcohol-soaked cotton swab and let it dry.
3. With the plunger of the syringe pushed all the way in, pierce the gray rubber stopper again with the needle. You should then hold the syringe and the vial and turn the vial upside down.
4. Keeping the end of the needle in the liquid, pull the plunger and draw out all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and dispose of the empty vial safely.
6. Hold the syringe vertically, with the needle pointing upwards. Gently tap the syringe to allow any bubbles in the liquid to rise to the top of the syringe.
7. Remove the air from the syringe by gently pushing the plunger until the air has come out.
8. If you are using Meropenem Kern Pharma at home, dispose of the needles and infusion sets used safely. If your doctor decides to stop your treatment, dispose of the unused Meropenem Kern Pharma safely.

Administration of the injection

You can administer this medication through a peripheral intravenous catheter, or through a central line or port.

Administration of Meropenem Kern Pharma through a peripheral intravenous catheter

1. Remove the needle from the syringe and dispose of it safely in a sharps container.
2. Wipe the end of the catheter with an alcohol-soaked cotton swab and let it dry. Open the catheter cap and attach the syringe.
3. Slowly push the plunger of the syringe to administer the antibiotic at a steady rate for about 5 minutes.
4. Once you have finished administering the antibiotic and the syringe is empty, remove it and flush the line as recommended by your doctor or nurse.
5. Close the catheter cap and dispose of the syringe safely in a sharps container.

Administration of Meropenem Kern Pharma through a central line or port

1. Remove the cap from the central line or port, wipe the end of the line with an alcohol-soaked cotton swab and let it dry.
2. Attach the syringe and slowly push the plunger to administer the antibiotic at a steady rate for about 5 minutes.
3. Once you have finished administering the antibiotic, remove the syringe and flush the line as recommended by your doctor or nurse.

Replace the cap on the central line and dispose of the syringe safely in a sharps container.