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How to use IMIPENEM/CILASTATIN KABI 500 mg/500 mg POWDER FOR SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Imipenem/Cilastatin Kabi 500mg/500mg powder for solution for infusion EFG

Imipenem/cilastatin

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the pack:

What Imipenem/Cilastatin Kabi is and what it is used for
What you need to know before you use Imipenem/Cilastatin Kabi
How to use Imipenem/Cilastatin Kabi
Possible side effects

5 Conservation of Imipenem/Cilastatin Kabi

Additional information

1. What Imipenem/Cilastatin Kabi is and what it is used for

Imipenem/Cilastatin Kabi belongs to a group of medicines called carbapenem antibiotics. It kills a wide variety of bacteria (germs) that cause infections in different parts of the body in adults and children over one year of age.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Treatment

Your doctor has prescribed Imipenem/Cilastatin Kabi because you have one (or more) of the following types of infections:

?? Complicated infections in the abdomen

?? Infection affecting the lungs (pneumonia)

?? Infections that can be acquired during or after childbirth

?? Complicated urinary tract infections

?? Complicated skin and soft tissue infections

Imipenem/Cilastatin Kabi can be used to treat patients with low white blood cell counts who have fever and are suspected of having a bacterial infection.

Imipenem/Cilastatin Kabi can be used to treat bacterial bloodstream infections, which may be associated with one of the aforementioned infections.

2. What you need to know before you use Imipenem/Cilastatin Kabi

Do not use Imipenem/Cilastatin Kabi

?? if you are allergic to imipenem, cilastatin, or any of the other components of this medicine (listed in section 6).

if you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems.

Be cautious with Imipenem/Cilastatin Kabi

Tell your doctor about any problems you have or have had, such as:

allergies to any medication, including antibiotics (unexpected allergic reactions that can be life-threatening require immediate medical attention)
colitis or any other gastrointestinal disease
kidney or urine problems, including reduced renal function (Imipenem/Cilastatin Kabi blood levels increase in patients with reduced renal function. Adverse reactions in the central nervous system may occur if the dose is not adjusted to renal function)
any central nervous system disorder, such as localized tremors or epileptic seizures (attacks)
liver problems

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

Children

Imipenem/Cilastatin Kabi is not recommended for use in children under one year of age or children with kidney problems.

Using Imipenem/Cilastatin Kabi with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Tell your doctor if you are taking ganciclovir, which is used to treat some viral infections.

Also, tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia) or any anticoagulant medication such as warfarin.

Your doctor will decide if you should use Imipenem/Cilastatin Kabi in combination with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is essential that you inform your doctor if you are pregnant or plan to become pregnant before receiving Imipenem/Cilastatin Kabi. Imipenem/cilastatin has not been studied in pregnant women. Imipenem/Cilastatin Kabi should not be used during pregnancy unless your doctor decides that the potential benefit justifies the potential risk to the developing baby.

It is essential that you inform your doctor if you are breastfeeding or plan to breastfeed before receiving Imipenem/Cilastatin Kabi. Small amounts of this medicine may pass into breast milk and may affect the baby. Therefore, your doctor will decide if you should use Imipenem/Cilastatin Kabi while breastfeeding.

Driving and using machines

There are some side effects associated with this product (such as seeing, hearing, or feeling something that is not there, dizziness, drowsiness, and a sensation of objects spinning) that may affect some patients' ability to drive or operate machinery (see section 4).

Imipenem/Cilastatin Kabi contains sodium

Imipenem/Cilastatin Kabi 500 mg/500 mg contains 37.5 mg of sodium (the main component of table salt) per vial. This is equivalent to 1.9% of the maximum recommended daily sodium intake for an adult.

3. How to use Imipenem/Cilastatin Kabi

Imipenem/cilastatin will be prepared and administered by a doctor or other healthcare professional. Your doctor will decide how much Imipenem/Cilastatin Kabi you need.

Use in adults and adolescents

The recommended dose for adults and adolescents is 500 mg/500 mg every 6 hours or 1,000 mg/1,000 mg every 6 or 8 hours. If you have kidney problems, your doctor may reduce your dose.

Use in children

The recommended dose in children over one year of age is 15/15 or 25/25 mg/kg/dose every 6 hours.

Imipenem/Cilastatin Kabi is not recommended for use in children under one year of age and children with kidney problems.

Method of administration

Imipenem/Cilastatin Kabi is administered intravenously (into a vein) over 20-30 minutes for a dose of ≤500 mg/500 mg or 40-60 minutes for doses of >500 mg/500 mg. If you feel nauseous, the infusion rate can be reduced.

If you use more Imipenem/Cilastatin Kabi than you should

Symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood pressure, and slow heart rate. If you are concerned that you may have received too much Imipenem/Cilastatin Kabi, contact your doctor or other healthcare professional immediately.

If you forget to use Imipenem/Cilastatin Kabi

If you are concerned that you may have missed a dose, contact your doctor or other healthcare professional immediately.

Do not take a double dose to make up for missed doses.

If you stop using Imipenem/Cilastatin Kabi

Do not stop using Imipenem/Cilastatin Kabi until your doctor tells you to.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects occur rarely; however, if they occur while you are receiving or after receiving Imipenem/Cilastatin Kabi, the administration of the medicine should be discontinued, and you should contact your doctor immediately:

Allergic reactions such as skin rash, swelling of the face, lips, tongue, and/or throat (with difficulty breathing or swallowing) and/or low blood pressure (hypotension)
Peeling of the skin (toxic epidermal necrolysis)
Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme)
Severe skin rash with loss of skin and hair (exfoliative dermatitis)

Other possible side effects:

Common(may affect up to 1 in 10 people)

?? Nausea, vomiting, diarrhea. Nausea and vomiting seem to occur more frequently in patients with a low white blood cell count.

?? Swelling and redness along a vein, extremely sensitive to touch

?? Skin rash

?? Changes in liver function detected by blood tests

?? Increase in the number of some white blood cells

Uncommon(may affect up to 1 in 100 people)

?? Localized redness of the skin

?? Localized pain and formation of a firm lump at the injection site

?? Itching of the skin

?? Hives

?? Fever

?? Blood disorders that affect cells and are usually detected by a blood test (symptoms may be fatigue, pale skin, and prolonged bruising after injuries)

?? Changes in kidney, liver, and blood function, detected by blood tests

?? Tremors and uncontrolled muscle contractions

?? Seizures (attacks)

?? Mental changes (such as mood changes and deterioration of mental faculties)

?? Seeing, hearing, or feeling something that is not there (hallucinations)

?? Confusion

?? Dizziness, drowsiness

?? Low blood pressure (hypotension)

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

?? Fungal infection (candidiasis)

?? Discoloration of teeth and/or tongue

?? Inflammation of the colon with severe diarrhea

?? Changes in taste

?? The liver cannot perform its normal function

?? Inflammation of the liver

?? The kidney cannot perform its normal function

?? Changes in urine quantity, changes in urine color

?? Brain disease, sensation of tingling (pins and needles), localized tremor

?? Hearing loss (hearing impairment)

Very rare(may affect up to 1 in 10,000 people)

?? Severe liver dysfunction due to inflammation (fulminant hepatitis)

?? Inflammation of the stomach or intestine (gastroenteritis)

?? Inflammation of the intestine with bloody diarrhea (hemorrhagic colitis)

?? Redness and swelling of the tongue, excessive growth of normal tongue projections, giving it a hairy appearance, heartburn, sore throat, increased saliva production

?? Stomach pain

?? Sensation of spinning (vertigo), headache

?? Ringing in the ears (tinnitus)

?? Pain in several joints, weakness

?? Irregular heartbeat, the heart beats strongly or rapidly

?? Chest discomfort, difficulty breathing, abnormally rapid and shallow breathing, pain in the upper back

?? Redness of the face (flushing), bluish discoloration of the face and lips, changes in skin texture, excessive sweating

?? Itching of the vulva in women

?? Changes in blood cell counts

?? Worsening of a rare disease associated with muscle weakness (increased severity of myasthenia gravis)

Frequency not known(frequency cannot be estimated from the available data)

Abnormal movements
Agitation

Reporting of side effects

If you experience any side effects or if you notice any side effects not mentioned in this leaflet, please tell your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Imipenem/Cilastatin Kabi

Keep out of sight and reach of children.

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

Before opening:

Do not store above 25°C.

After opening/reconstitution:

The reconstituted/diluted solutions should be used immediately. The time between the start of reconstitution and the end of intravenous infusion should not exceed two hours.

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. This will help protect the environment.

6. Container Content and Additional Information

Composition of Imipenem/Cilastatine Kabi

The active ingredients are 500 mg of imipenem (in the form of 530 mg of imipenem monohydrate) and 500 mg of cilastatine (in the form of 530 mg of cilastatine in the form of sodium salt).

The other component is sodium bicarbonate.

Appearance of the Product and Container Content

Imipenem/Cilastatine Kabi is a white or almost white or yellow powder, presented in 20 ml glass vials and in 100 ml glass bottles.

Imipenem/Cilastatine Kabi 500 mg/500 mg comes in boxes of 10 glass vials or 10 glass bottles of powder, closed with a rubber stopper, aluminum cap, and flip-off cap.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.

C/ Marina, 16-18,

08005 Barcelona (Spain)

Manufacturer

ACS Dobfar S.p.A Nucleo Industriale S.Atto

Nicolò a Tordino

64020 Teramo (Italy)

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

Austria: Imipenem/Cilastatin Kabi 500 mg/500 mg Pulver zur Herstellung einer Infusionslösung

Belgium: Imipenem/Cilastatine Fresenius Kabi 500 mg/500 mg poeder voor oplossing voor infusie

Bulgaria: ????????/?????????? ???? 500 mg/500 mg ???? ?? ?????????? ???????

Czech Republic: Imipenem/Cilastatin Kabi 500 mg/500 mg, prášek pro přípravu inf. roztoku

Germany: Imipenem/Cilastatin Kabi 500 mg/500 mg Pulver zur Herstellung einer Infusionslösung

Estonia: Imipenem/Cilastatin Kabi

France: Imipenem/Cilastatine Kabi 500 mg/500 mg, poudre pour solution pour perfusion

Greece: Imipenem/Cliastatin 500mg/500mg κ?νις για δι?λυμα προς ?γχυση

Hungary: Imipenem/Cilastatin Kabi 500 mg/500 mg por oldatos infúzióhoz

Italy: Imipenem/Cilastatina Kabi

Ireland: Imipenem/Cilastatin 500 mg/500 mg powder for solution for infusion

Luxembourg: Imipenem/Cilastatin Kabi 500 mg/500 mg, Pulver zur Herstellung einer Infusionslösung

Netherlands: Imipenem/Cilastatine Fresenius Kabi 500 mg/500 mg poeder voor oplossing voor infusie

Norway: Imipenem/Cilastatin Fresenius Kabi 500 mg/500 mg

Poland: Imipenem/Cilastatin Kabi

Portugal: Imipenem/Cilastatina Kabi

Romania: Imipenem/Cilastatin Kabi 500 mg/500 mg pulbere pentru solutie perfuzabila

Slovakia: Imipenem/ Cilastatin Kabi 500 mg/500 mg, prášok na infúzny roztok

Slovenia: Imipenem/cilastatin Kabi 500 mg/500 mg prašek za raztopino za infundiranje

Spain: Imipenem/Cilastatina Kabi 500 mg/500 mg, polvo para solución para perfusión

Sweden: Imipenem/Cilastatin Fresenius Kabi 500 mg/500 mg pulver till infusionsvätska, lösning

United Kingdom: Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion

Date of the last revision of this leaflet: July 2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Each vial is for single use.

Reconstitution

The contents of each container should be transferred to a suitable infusion solution (see Incompatibilityand After Reconstitution): 0.9% sodium chloride to achieve a final volume of 50 ml (for the 250 mg dose) and 100 ml (for the 500 mg dose). In exceptional circumstances where 0.9% sodium chloride cannot be used for clinical reasons, 5% glucose may be used instead.

A suggested procedure is to add approximately 10 ml of the suitable infusion solution to the container. Shake well and transfer the resulting mixture to the infusion solution container.

WARNING: THE MIXTURE IS NOT FOR DIRECT INFUSION.

Repeat with an additional 10 ml of infusion solution to ensure complete transfer of the container contents to the infusion solution. The resulting mixture should be shaken until a clear solution is obtained.

The concentration of the reconstituted solution, following the procedure described above, is approximately 5 mg/ml for both imipenem and cilastatine.

Color variations, from colorless to yellow, do not affect the efficacy of the medicinal product.

Incompatibilities

This medicinal product is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate. However, it may be administered in an I.V. system through which a lactate solution is being infused.

This medicinal product should not be mixed with other medicinal products except those mentioned in the Reconstitutionsection.

After Reconstitution

The diluted solutions should be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion should not exceed two hours.

Disposal of unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations.

IMIPENEM/CILASTATIN KABI 500 mg/500 mg POWDER FOR SOLUTION FOR INFUSION