PATIENT INFORMATION LEAFLET

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

Imipenem /cilastatina

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if they have similar symptoms, as it may harm them.

• If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

2.What you need to know before you start using Imipenem/Cilastatina Kabi

3.How to use Imipenem/Cilastatina Kabi

4.Possible side effects

5Storage of Imipenem/Cilastatina Kabi

6.Further information

Imipenem/Cilastatina 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 one year of age or older.

Treatment

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

??Complicated abdominal infections

??Pulmonary infections (pneumonia)

??Infections that can be acquired during or after childbirth

??Complicated urinary tract infections

??Complicated skin and soft tissue infections

Imipenem/Cilastatina Kabi may be used to treat patients with low white blood cell counts, fever, and suspected bacterial infection.

Imipenem/Cilastatina Kabi may be used to treat bacterial sepsis, which may be associated with one of the infections mentioned above.

Do not use Imipenem/Cilastatina Kabi

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

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

Be careful with Imipenem/Cilastatina Kabi

Inform your doctor about any problem you have or have had, such as:

-allergies to any medicine including antibiotics (life-threatening allergic reactions require immediate medical treatment)

-colitis or any other gastrointestinal disease

-kidney or urinary problems, including reduced kidney function (Imipenem/Cilastatina Kabi levels in the blood increase in patients with reduced kidney function. Central nervous system reactions may occur if the dose is not adjusted for kidney function)

-any central nervous system disorder, such as localized tremors or epileptic seizures (attacks)

-liver problems

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

Children

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

Using Imipenem/Cilastatina Kabi with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

Inform your doctor if you are taking ganciclovir, used to treat some viral infections.

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

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

Pregnancy and breastfeeding

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

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

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

Driving and operating machines

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

Imipenem/Cilastatina Kabi contains sodium

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

Imipenem/cilastatina will be prepared and administered by a doctor or other healthcare professional. Your doctor will decide how much Imipenem/Cilastatina 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 one year of age or older is 15/15 or 25/25 mg/kg/dose every 6 hours.

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

Administration form

Imipenem/Cilastatina 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 may be reduced.

If you use more Imipenem/Cilastatina Kabi than you should

The 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/Cilastatina Kabi, contact your doctor or other healthcare professional immediately.

If you forgot to use Imipenem/Cilastatina Kabi

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

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

If you interrupt treatment with Imipenem/Cilastatina Kabi

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

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

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

The following side effects occur rarely, but if they occur while you are receiving or after receiving Imipenem/Cilastatina Kabi, you should discontinue administration of the medicine and immediately contact your doctor:

• Allergic reactions such as skin rash, facial swelling, lip, tongue, and/or throat swelling (with difficulty breathing or swallowing) and/or low blood pressure (hypotension)
• Skin peeling (toxic epidermal necrolysis)
• Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme)
• Severe skin rash, with skin and hair loss (exfoliative dermatitis)

Other possible side effects:

Frequent(may affect up to 1 in 10 people)

??Nausea, vomiting, diarrhea. Nausea and vomiting appear to occur more frequently in patients with low white blood cell counts.

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

??Skin rash

??Liver function alterations detected by blood tests

??Increased number of certain white blood cells

Poorly frequent(may affect up to 1 in 100 people)

??Local redness

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

??Itching on the skin

??Urticaria

??Fever

??Blood disorders that affect cells and are normally detected by blood tests (symptoms may be fatigue, pale skin, and prolonged bleeding after injuries)

??Liver, kidney, and blood function alterations 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)

??Coloration of the teeth and/or tongue

??Intense diarrhea with inflammation of the colon

??Alterations in the sense of taste

??The liver cannot perform its normal function

??Inflammation of the liver

??The kidney cannot perform its normal function

??Changes in the amount of urine, changes in the color of the urine

??Brain disease, sensation of pins and needles, localized tremor

??Loss of hearing (hearing loss)

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 diarrhea with blood (hemorrhagic colitis)

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

??Stomach pain

??Sensation of spinning objects (vertigo), headache

??Ringing in the ears (tinnitus)

??Pain in multiple joints, weakness

??Irregular heartbeat, the heart beats strongly or quickly

??Discomfort in the chest, difficulty breathing, abnormal breathing, rapid and superficial breathing, pain in the upper back

??Redness of the face (flushing), blue 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 (increase in the severity of myasthenia gravis)

Frequency unknown(the frequency cannot be estimated from the available data)

• Abnormal movements
• Agitation

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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: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 indicated on the packaging and vials after CAD. The expiration date is the last day of the month indicated.

Before opening:

Do not store at a temperature above 25°C.

After opening/reconstitution:

The reconstituted/diluted solutions must be used immediately. The time interval 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 through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Imipenem/Cilastatina Kabi

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

-The other component is sodium bicarbonate.

Appearance of the product and contents of the package

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

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

Only some package 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.

C/ Marina, 16-18,

08005 Barcelona (Spain)

Responsible for manufacturing

ACS Dobfar S.p.ANucleo Industriale S.Atto

S. Nicolò a Tordino

64020 Teramo (Italy)

For more information about this medication, please contact the holder of the marketing authorization.

This medication is authorized in the member states of the European Economic Area with the following names:

Austria:Imipenem/Cilastatin Kabi 500 mg/500 mg Powder for the preparation of an infusion solution

Belgium:Imipenem/Cilastatine Fresenius Kabi 500 mg/500 mg powder for solution for infusion

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

Czech Republic:Imipenem/Cilastatin Kabi500 mg/500 mg,powder for the preparation of an infusion solution

Germany:Imipenem/CilastatinKabi500 mg/500 mg Powder for the preparation of an infusion solution

EstoniaImipenem/Cilastatin Kabi

France:Imipenem/Cilastatine Kabi 500 mg/500 mg, powder for solution for infusion

Greece:Imipenem/Cliastatin 500mg/500mgκ?νιςγιαδι?λυμαπρος?γχυση

Hungary:Imipenem/Cilastatin Kabi 500 mg/500 mg powder for infusion

Italy:Imipenem/Cilastatina Kabi

IrelandImipenem/Cilastatin 500 mg/500 mg powder for solution for infusion

Luxembourg:Imipenem/Cilastatin Kabi 500 mg/500 mg, Powder for the preparation of an infusion solution

Netherlands:Imipenem/Cilastatine Fresenius Kabi 500 mg/500 mg powder for solution for infusion

NorwayImipenem/Cilastatin Fresenius Kabi 500 mg/500 mg

Poland:Imipenem/Cilastatin Kabi

Portugal:Imipenem/Cilastatina Kabi

Romania:Imipenem/Cilastatin Kabi 500 mg/500 mg powder for solution for infusion

Slovakia:Imipenem/ Cilastatin Kabi 500 mg/500 mg, powder for infusion solution

SloveniaImipenem/cilastatin Kabi 500 mg/500 mg powder for infusion solution

Spain:Imipenem/Cilastatina Kabi 500 mg/500 mg, powder for solution for infusion

Sweden:Imipenem/Cilastatin FreseniusKabi500 mg/500 mg powder for infusion solution, solution

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

Last review date of this leaflet: July 2021

The detailed and updated information about this medication 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 only for healthcare professionals:

Each vial is for single use only.

Reconstitution

The contents of each package should be transferred to an appropriate infusion solution (seeIncompatibilityandAfter reconstitution): sodium chloride 0.9% 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 sodium chloride 0.9% cannot be used for clinical reasons, 5% glucose may be used instead.

A suggested procedure is to add approximately 10 ml of the appropriate infusion solution to the vial. 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 the complete transfer of the contents of the vial to the infusion solution. The resulting mixture should be shaken until a transparent solution is obtained.

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

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

Incompatibilities

This medication is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate.However, it may be administered through an IV system where a lactate solution is being infused.

This medication should not be mixed with any other except those mentioned in theReconstitutionsection.

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.

The elimination of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.