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

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Imipenem /cilastatin

Read the entire leaflet carefully before you start using this 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 give it to other people, even if they have the same symptoms as you, as it may harm them.

• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

3. How to use Imipenem/Cilastatin Kabi

4. Possible side effects

5. How to store Imipenem/Cilastatin Kabi

6. Further 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 one year of age or older.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, timing, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via the sink or in household waste.

Treatment

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

?? Complicated abdominal infections

?? Infection affecting the lungs (pneumonia)

?? Infections that can occur 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 suspected to be due to a bacterial infection.

Imipenem/Cilastatin Kabi can be used to treat bloodstream infections caused by bacteria, which may be associated with one of the types of infection mentioned above.

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

Do not use Imipenem/Cilastatin Kabi

?? if you are allergic to imipenem, cilastatin, 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.

Take special care with Imipenem/Cilastatin Kabi

Tell your doctor about any medical conditions you currently have or have had in the past, such as:

• allergies to any medicines, including antibiotics (unexpected allergic reactions that are life-threatening require immediate medical treatment)
• colitis or any other gastrointestinal disease
• kidney or urinary problems, including reduced renal function (blood levels of Imipenem/Cilastatin Kabi increase in patients with reduced kidney function. Adverse reactions in the central nervous system may occur if the dose is not adjusted according to renal function)
• any disorders of the central nervous system, such as localized tremors or epileptic seizures (fits)
• liver problems

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

Children

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

Using Imipenem/Cilastatin Kabi with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor if you are taking ganciclovir, which is used to treat certain 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 medicines such as warfarin.

Your doctor will decide whether 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is important 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 important 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 whether you should use Imipenem/Cilastatin Kabi while breastfeeding.

Driving and using machines

Some side effects associated with this medicine (such as seeing, hearing, or sensing things that are not real, dizziness, drowsiness, and sensation of spinning) may affect the ability of some patients 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/cooking salt) per vial. This corresponds to 1.9% of the maximum recommended daily intake of sodium 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 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 for children aged one year and older is 15/15 or 25/25 mg/kg/dose every 6 hours.

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

Method of administration

Imipenem/Cilastatin Kabi is administered intravenously (into the vein) over 20–30 minutes for a dose of ≤500 mg/500 mg or over 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/Cilastatin Kabi than you should

Symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood pressure, and slow heartbeat. 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 treatment with Imipenem/Cilastatin Kabi

Do not stop using Imipenem/Cilastatin Kabi unless instructed by your doctor.

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

4. Possible adverse effects

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

The following adverse effects occur rarely; however, if they occur while receiving or after receiving Imipenem/Cilastatin Kabi, administration of the medicine must 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)
• Skin peeling (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 adverse effects:

Frequent (may affect up to 1 in 10 people)

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

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

?? Skin rash

?? Changes in liver function detected by blood tests

?? Increase in the number of certain white blood cells

Uncommon (may affect up to 1 in 100 people)

?? Localized skin redness

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

?? Itching of the skin

?? Hives (urticaria)

?? Fever

?? Blood disorders affecting blood cells, usually detected by blood tests (symptoms may include fatigue, pale skin, and prolonged bruising after injury)

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

?? Tremors and uncontrolled muscle contractions

?? Seizures (fits)

?? Psychiatric disturbances (such as changes in mood and impaired mental function)

?? Seeing, hearing, or feeling things that are 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 the teeth and/or tongue

?? Inflammation of the colon with severe diarrhoea

?? Changes in taste sensation

?? Liver unable to perform its normal function

?? Inflammation of the liver

?? Kidney unable to perform its normal function

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

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

?? Hearing loss

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

?? Severe loss of liver function due to inflammation (fulminant hepatitis)

?? Inflammation of the stomach or intestine (gastroenteritis)

?? Inflammation of the intestine with bloody diarrhoea (haemorrhagic colitis)

?? Redness and swelling of the tongue, excessive growth of the normal projections on the tongue 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, heart beating forcefully or rapidly

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

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

?? Itching of the vulva in women

?? Changes in the number of blood cells

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

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

• Abnormal movements
• Agitation

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Imipenem/Cilastatin Kabi

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the vials after EXP. The expiry date refers to the last day of the month indicated.

Before opening:

Do not store above 25°C.

After opening/reconstitution:

Reconstituted/diluted solutions should be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion must 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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Imipenem/Cilastatin Kabi

• The active substances are 500 mg of imipenem (as 530 mg of imipenem monohydrate) and 500 mg of cilastatin (as 530 mg of cilastatin in the form of the sodium salt).

• The other component is sodium bicarbonate.

Appearance of the product and contents of the pack

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

Imipenem/Cilastatin Kabi 500 mg/500 mg is supplied in packs of 10 glass vials or 10 glass bottles of powder, closed with a rubber stopper, aluminium cap, and flip-off cap.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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)

For further information about this medicinal product, please contact the Marketing Authorisation Holder.

This medicinal product is authorised 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 most recent revision of this leaflet: July 2021

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

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This information is intended for healthcare professionals only:

Each vial is for single use only.

Reconstitution

The contents of each container should be transferred into an appropriate infusion solution (see Incompatibilities and 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, for clinical reasons, 0.9% sodium chloride cannot be used, 5% glucose may be used instead.

A recommended procedure is to add approximately 10 ml of the appropriate infusion solution to the container. Shake well and transfer the resulting mixture to the infusion 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's contents into 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 cilastatin.

Variations in colour, from colourless to yellow, do not affect the efficacy of the medicinal product.

Incompatibilities

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

This medicinal product must not be mixed with other medicinal products except those mentioned in the Reconstitution section.

After reconstitution

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

Any unused medicinal product and all materials that have been in contact with it must be disposed of in accordance with local regulations.