PATIENT INFORMATION LEAFLET

Meropenem Kabi 500 mg powder for injection and infusion EFG

Meropenem

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or nurse.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

1. What Meropenem Kabi 500 mg is and what it is used for

2. What you need to know before using Meropenem Kabi 500 mg

3. How to use Meropenem Kabi 500 mg

4. Possible side effects

5. Storage of Meropenem Kabi 500 mg

6. Contents of the pack and additional information

Meropenem Kabi belongs to a group of medicines called carbapenem antibiotics. It works by destroying bacteria, which can cause serious infections.

Meropenem is used to treat the following infections in adults and children aged 3 months and older:

−Lung infection (pneumonia)

−Respiratory and lung infections in patients with cystic fibrosis

−Complicated urinary tract infections

−Complicated abdominal infections

−Infections you can acquire during or after childbirth

−Complicated skin and soft tissue infections

−Acute bacterial meningitis

Meropenem Kabi 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 that may be associated with one of the aforementioned infections.

No use Meropenem Kabi

− If you are allergic (hypersensitive) to meropenem or to 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

Consult with your doctor or nurse before starting to use Meropenem Kabi:

− If you have health problems, such as liver or kidney problems.

− If 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.

You may develop signs and symptoms of severe skin reactions (see section 4). If this occurs, inform your doctor or nurse immediately so that they can treat the symptoms.

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

Use of Meropenem Kabi with other medications

Inform your doctor of any medications you are using, have recently used, or may need to use.

Meropenem Kabi may affect the way some medications work, and some medications may affect Meropenem Kabi.

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

− Probenecid (used to treat gout).

− Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Do not use Meropenem Kabi, as it may decrease the effect of sodium valproate.

− Oral anticoagulants (used to treat or prevent blood clots).

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication..It is preferable to avoid the use of 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 be, 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 Kabi has been associated with headache, tingling or prickling of the skin (paresthesia), and involuntary muscle movements, leading to rapid and uncontrolled bodily agitation (convulsions), which is usually accompanied by loss of consciousness. Any of these effects may affect your ability to drive or operate machinery. Do not drive or operate machinery if you experience this adverse effect.

Meropenem Kabi contains sodium.

This medication contains 45.13 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 2.3% of the maximum daily sodium intake recommended for an adult.

If you have a situation that requires controlling your sodium intake, inform your doctor 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 decided based on the child's age and weight. The usual dose is between 10 mg and 40 mg of Meropenem Kabi 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 Kabi

-Meropenem Kabi will be administered to you as an injection or infusion into a large vein.

-Meropenem Kabi will normally be administered by your doctor or nurse.

-However, some patients, parents, or caregivers are trained to administer Meropenem Kabi at home. The instructions for this are found in this leaflet (in the section called "Instructions for administering Meropenem Kabi to yourself or another person at home"). Follow exactly the administration instructions for Meropenem Kabi 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 Kabi.

-Injections should normally be administered at the same time every day.

If you use more Meropenem Kabi than you should

If you accidentally use more doses than prescribed, contact your doctor or go to the nearest hospital immediately.

If you forget to use Meropenem Kabi

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 one.

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

If you interrupt treatment with Meropenem Kabi

Do not stop Meropenem Kabi until your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor 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 Kabi 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.

−Severe skin reactions that include:

Blood cell damage (unknown frequency)

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.

−Nausea.

−Vomiting.

−Diarrhea.

−Headache.

−Skin rash, itching.

−Pain and inflammation.

−Increased platelet count in the blood (checked in a blood test).

−Changes in blood test results, including tests that show how well the liver is functioning.

Occasional(may affect up to 1 in 100 people)

− Changes in your blood. These include a decrease in platelet count (which may make you more prone to bruising), increased some white blood cells, decreased other white blood cells, and increased levels of a substance called “bilirubin”. Your doctor may perform blood tests periodically.

− Changes in blood test results, including tests that show how well the kidneys are functioning.

−Tickling sensation (tingling).

−Fungal infections of the mouth or vagina (thrush).

−Intestinal inflammation with diarrhea.

−Pain in the veins where Meropenem Kabi is injected.

−Other changes in your blood. Symptoms include frequent infections, fever, and sore throat. Your doctor may perform blood tests periodically.

Rare(may affect up to 1 in 1000 people)

−Seizures.

− Acute disorientation and confusion (delirium).

Reporting 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

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

Do not store at a temperature above 30°C.

Injection

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

• 3 hours if stored at a temperature of up to 25°C;

• 12 hours when stored under refrigerated conditions (2-8°C).

Infusion

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

• 6 hours if stored at a temperature of up to 25°C when Meropenem Kabi is dissolved in sodium chloride 0.9%;

• 24 hours if stored under refrigerated conditions (2-8°C) when Meropenem Kabi is dissolved in sodium chloride 0.9%;
• 1 hour if stored at a temperature of up to 25°C when Meropenem Kabi is dissolved in 5% dextrose solution;
• 8 hours if stored under refrigerated conditions (2-8°C) when Meropenem Kabi is dissolved in 5% dextrose solution.

From a microbiological point of view, unless the opening/reconstitution/dilution method 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 freeze the reconstituted solution.

Medicines must not be disposed of through the drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of Meropenem Kabi

-The active ingredient is meropenem (trihydrate). Each vial of 20 ml or bottle of 100 ml contains 500 mg of meropenem (anhydrous).

-The other component is sodium carbonate.

Appearance of the product and contents of the pack

Meropenem Kabi is a white or light yellow powder for injectable solution or infusion in vial.

It is available in glass vials of 20 ml and glass bottles of 100 ml.

Container sizes of 1 or 10 vials/bottles.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España, S.A.U.

Marina 16-18, 08005 – Barcelona

Spain

Responsible for manufacturing

ACS Dobfar S.p.A.

Nucleo Industriale S. Atto, S. Nicolò a Tordino, 64020 Teramo

Italy

or

LABESFAL – Laboratórios Almiro S.A. (Fresenius Kabi Group)

Lagedo, 3465-157 Santiago de Besteiros

Portugal

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

Meropenem Kabi 500 mg Powder for the preparation of an injection or infusion solution

Austriainjection or infusion solution

Meropenem Fresenius Kabi 500 mg powder for solution for injection or infusion

Belgiumfor injection or infusion / powder for solution for injection or infusion / Powder for the preparation of an injection or infusion solution

BulgariaMeropenem Kabi 500 mg

CyprusMeropenem Kabi 500 mg, κ?νις για εν?σιμο δι?λυμα ? δι?λυμα για ?γχυση

Czech RepublicMeropenem Kabi

DenmarkMeropenem Fresenius Kabi

EstoniaMeropenem Kabi 500 mg

Meropenem Kabi 500 mg Powder for the preparation of an injection or infusion solution

Germany

Meropenem Kabi 500 mg, κ?νις για δι?λυμαπρος ?νεση ? ?γχυση

Greece

HungaryMeropenem Kabi 50 mg

IrelandMeropenem 500 mg powder for solution for injection or infusion

LatviaMeropenem Kabi 500 mg pulveris injekciju vai infuziju škiduma pagatavošanai

LithuaniaMeropenem Kabi 500 mg milteliai injekciniam arba infuziniam tirpalui

Meropenem Kabi 500 mg Powder for the preparation of an injection or infusion solution

Meropenem Fresenius Kabi 500 mg, pulver til injeksjonsvæske/ infusjonsvæske,

Norwaysolution

PolandMeropenem Kabi

PortugalMeropenem Kabi 500 mg Pó para solução injectável ou para perfusão

RomaniaMeropenem Kabi 500 mg pulbere pentru solutie injectabila sau perfuzabila

SpainMeropenem Kabi 500 mg polvo para solución inyectable o para perfusión

Meropenem Fresenius Kabi 500 mg, pulver till injektionsvätska eller

Swedeninfusionsvätska, solution

Meropenem Kabi 500 mg prašek za raztopino za injiciranje ali infundiranje

Slovenia

Meropenem Kabi 500 mg

Slovakia

United KingdomMeropenem 500 mg powder for solution for injection or infusion

This leaflet was last revised in May 2022.

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/

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This information is intended solely for healthcare professionals:

Instructions for administering Meropenem Kabi to yourself or to another person at home

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

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

Preparing this medicinal product

-The medicinal product must be mixed with another liquid (the diluent). Your doctor will tell you what amount of diluent to use.

-Use the medicinal product just after preparing it. Do not freeze it.

1. Wash your hands and dry them thoroughly. Prepare a clean working area.
2. Remove the bottle (or vial) of Meropenem Kabi from the packaging. Check the vial and the expiration date. Check that the vial is intact and has not been damaged.
3. Remove the colored cap and clean the rubber stopper with an alcohol-impregnated cotton swab. Let the stopper dry.
4. Insert a new sterile needle into a new sterile syringe, without touching the ends.
5. Extract the recommended amount of "Intravenous Infusion Water" with the syringe. The amount of liquid needed is shown in the following table:

Dose of MeropenemAmount of "Intravenous Infusion Water" needed for dilution

Kabi

500 mg (milligrams)10 ml (milliliters)

1 g (gram)20 ml

1.5 g30 ml

2 g40 ml

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

1. Pierce the center of the rubber stopper with the needle of the syringe and inject the recommended amount of "Intravenous Infusion Water" into the vial(s) of Meropenem Kabi.
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 rubber stopper again with a new cotton swab impregnated with alcohol and let it dry.
3. Administering the injection
4. Hold the syringe and vial vertically, with the needle pointing upwards. Gently tap the syringe to remove any air bubbles that may be in the liquid.
5. Remove the air from the syringe by gently pushing the plunger until the air has been removed.
6. Dispose of the used needles and infusion sets properly.

Administering Meropenem Kabi through a peripheral intravenous catheter

1. Remove the needle from the syringe and dispose of it properly in the authorized containers for sharp objects.
2. Clean the end of the peripheral intravenous catheter with an alcohol-impregnated cotton swab and let it dry. Open the cap of the cannula and connect the syringe.
3. Slowly push the plunger of the syringe to administer the antibiotic continuously for about 5 minutes.
4. Once you have finished administering the antibiotic and the syringe is empty, remove it and flush the line as instructed by your doctor or nurse.
5. Close the cap of the cannula and dispose of the syringe properly in the authorized containers for sharp objects.

Administering Meropenem Kabi through a central line or port

1. Remove the cap from the central line or port, clean the end of the line with an alcohol-impregnated cotton swab and let it dry.
2. Connect the syringe and slowly push the plunger to administer the antibiotic continuously for about 5 minutes.
3. Once you have finished administering the antibiotic, remove the syringe and flush the line as instructed by your doctor or nurse.

4.Put a new clean cap on the central line and dispose of the syringe properly in the authorized containers for sharp objects.