Imipenem/cilastatin Kabi

Leaflet attached to the packaging: information for the user

Imipenem/Cilastatin Kabi, 500 mg + 500 mg, powder for solution for infusion

Imipenem+ Cilastatin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Imipenem/Cilastatin Kabi and what is it used for
• 2. Important information before using Imipenem/Cilastatin Kabi
• 3. How to use Imipenem/Cilastatin Kabi
• 4. Possible side effects
• 5. How to store Imipenem/Cilastatin Kabi
• 6. Contents of the packaging and other information

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

Imipenem/Cilastatin Kabi belongs to a group of medicines called carbapenem antibiotics. This medicine destroys a wide range of bacteria (microorganisms) that cause infections in different parts of the body in adults and children over 1 year of age.

Treatment

Your doctor has prescribed Imipenem/Cilastatin Kabi because you have at least one of the following infections:

• complicated infections of the abdominal cavity;
• lung infection (pneumonia);
• infections acquired during childbirth or after birth;
• complicated urinary tract infections;
• complicated skin and soft tissue infections.

Imipenem/Cilastatin Kabi may be used to treat patients with a low white blood cell count and fever, which is likely to be caused by a bacterial infection. Imipenem/Cilastatin Kabi may be used to treat bacterial blood infections that may be associated with one of the types of infections listed above.

2. Important information before using Imipenem/Cilastatin Kabi

When not to use Imipenem/Cilastatin Kabi

Warnings and precautions

Before starting treatment with Imipenem/Cilastatin Kabi, discuss with your doctor or nurse if:

• you are allergic to any medicines, including antibiotics (sudden, life-threatening allergic reactions require immediate medical attention);
• you have colitis or any other gastrointestinal disease;
• you have kidney or urinary tract disease, including impaired kidney function (in patients with impaired kidney function, increased levels of Imipenem/Cilastatin Kabi are observed in the blood; if the dose is not adjusted to kidney function, side effects from the central nervous system may occur);
• you have central nervous system diseases, such as local tremors or seizures (convulsions);
• you have liver disease.

The result of the test detecting antibodies in the blood that can destroy red blood cells (Coombs test) may be positive. Your doctor will discuss this with you.
Children
Imipenem/Cilastatin Kabi is not recommended for use in children under 1 year of age and in children with kidney disease.

Imipenem/Cilastatin Kabi and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or plan to take.
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 (medicines used in epilepsy, bipolar affective disorders, migraine or schizophrenia), or any "blood-thinning" medicines, such as warfarin.
Your doctor will decide whether you can receive Imipenem/Cilastatin Kabi with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant or plan to become pregnant, tell your doctor before starting treatment with Imipenem/Cilastatin Kabi. The use of imipenem with cilastatin has not been studied in pregnant women. Imipenem/Cilastatin Kabi should not be used in pregnant women unless the doctor decides that the potential benefits of using the medicine outweigh the risk to the fetus.
If you are breastfeeding or plan to breastfeed, tell your doctor before starting treatment with Imipenem/Cilastatin Kabi. The medicine may pass into breast milk and affect the breastfed child. Therefore, the doctor will decide whether Imipenem/Cilastatin Kabi can be used during breastfeeding.

Driving and using machines

Some side effects associated with the use of this medicine (such as hallucinations, dizziness, drowsiness and a feeling of spinning) may affect some patients' ability to drive or operate machinery (see section 4).

Imipenem/Cilastatin Kabi contains sodium

This medicine contains 37.5 mg of sodium (the main component of common salt) in each vial. This corresponds to 1.9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Imipenem/Cilastatin Kabi

Imipenem/Cilastatin Kabi is prepared and administered to the patient by a doctor or other qualified medical staff. The doctor will decide how much Imipenem/Cilastatin Kabi to administer to the patient.
Use in adult patients and adolescents
The recommended dose in adult patients and adolescents is 500 mg + 500 mg every 6 hours or 1000 mg + 1000 mg every 6 or 8 hours. In patients with kidney disease, the doctor may reduce the dose of the medicine.
Use in children
The recommended dose in children over 1 year of age is (15 mg + 15 mg)/kg body weight or (25 mg + 25 mg)/kg body weight every 6 hours. Imipenem/Cilastatin Kabi is not recommended for use in children under 1 year of age or in children with kidney disease.
Method of administration
Imipenem/Cilastatin Kabi is administered intravenously; a dose of ≤(500 mg + 500 mg) is administered over 20-30 minutes, and a dose of >(500 mg + 500 mg) over 40-60 minutes. If the patient feels nauseous, the infusion rate can be reduced.

Using a higher than recommended dose of Imipenem/Cilastatin Kabi

Symptoms of overdose may include: seizures, confusion, tremors, nausea, vomiting, low blood pressure and slow heart rate. If you think you have received too much Imipenem/Cilastatin Kabi, contact your doctor or other qualified medical staff immediately.

Missing a dose of Imipenem/Cilastatin Kabi

If you think you have missed a dose of Imipenem/Cilastatin Kabi, contact your doctor or other qualified medical staff immediately.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Imipenem/Cilastatin Kabi

Do not stop treatment with Imipenem/Cilastatin Kabi without your doctor's advice.
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During or after administration of Imipenem/Cilastatin Kabi, the following side effects have occurred rarely, but if they occur, treatment with the medicine should be discontinued and medical attention should be sought immediately.

• Allergic reactions, including rash, face, lip, tongue and/or throat swelling (causing breathing or swallowing difficulties) and/or low blood pressure.
• Peeling of the skin (toxic epidermal necrolysis).
• Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme).
• Severe rash with skin peeling and hair loss (exfoliative dermatitis).

Other possible side effects:
Common(may affect up to 1 in 10 people):

• nausea, vomiting, diarrhea; it seems that nausea and vomiting occur more frequently in patients with a low white blood cell count;
• swelling and redness along the vein, which is extremely sensitive to the touch;
• rash;
• abnormal liver function detected by blood tests;
• increased levels of certain types of white blood cells.
• Uncommon(may affect up to 1 in 100 people):
• local redness of the skin;
• pain and hardening at the injection site;
• itching of the skin;
• hives;
• fever;
• blood disorders affecting blood cells, usually detected by blood tests (symptoms may include fatigue, pale skin and prolonged bruising after injury);
• abnormal kidney, liver and blood function detected by blood tests;
• tremors and uncontrolled muscle twitching;
• seizures;
• mental disorders (such as mood swings and impaired judgment);
• seeing, hearing or feeling things that do not exist (hallucinations);
• disorientation;
• dizziness, drowsiness;
• low blood pressure.

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

• fungal infection (candidiasis);
• discoloration of teeth and/or tongue;
• colitis (severe diarrhea);
• taste disorders;
• liver function disorders;
• hepatitis;
• kidney function disorders;
• changes in urine output and urine color;
• brain function disorders, tingling sensation, local tremors;
• hearing loss.

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

• severe liver function disorders due to hepatitis (fulminant hepatitis);
• gastritis or enteritis;
• enteritis with bloody diarrhea (hemorrhagic colitis);
• redness and swelling of the tongue, hypertrophy of the tongue papillae giving it a "hairy" appearance, heartburn, throat pain, increased salivation;
• stomach pain;
• feeling of spinning (dizziness), headaches;
• ringing in the ears (tinnitus);
• pain in several joints, weakness;
• irregular heart rhythm, rapid or strong heartbeat (palpitations);
• discomfort in the chest, breathing difficulties, rapid or shallow breathing, pain in the upper back;
• hot flashes with facial flushing, cyanosis of the face and lips, skin structure changes, excessive sweating;
• vulvar itching in women;
• changes in blood cell count;
• worsening of symptoms of a rare disease in which muscle weakness occurs (worsening of myasthenia symptoms).

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

• abnormal movements;
• agitation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49-21-301
fax: +48 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Imipenem/Cilastatin Kabi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial (bottle) after EXP. The expiry date refers to the last day of the month.
Before opening:
Do not store above 25°C.
After first opening/reconstitution:
The reconstituted/diluted solution should be used immediately. The time from the start of dissolution to the end of intravenous infusion should not exceed two hours.
The prepared solution should not be frozen.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Imipenem/Cilastatin Kabi contains

• The active substances are: 500 mg of imipenem (in the form of 530 mg of imipenem monohydrate) and 500 mg of cilastatin (in the form of 530 mg of cilastatin sodium).
• The other ingredient is: sodium bicarbonate.

What Imipenem/Cilastatin Kabi looks like and contents of the pack

Imipenem/Cilastatin Kabi is a white to almost white or pale yellow powder, supplied in 20 ml or 100 ml glass vials.
Imipenem/Cilastatin Kabi is available in packs containing 10 glass vials or 10 glass bottles with powder, closed with a rubber stopper and an aluminum flip-off cap, in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

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

• S. Nicolò a Tordino, 64100 Teramo Italy

For more information about this medicine, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

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
Czech Republic
Imipenem/Cilastatin Kabi 500 mg/500 mg, prášek pro přípravu inf. roztoku
France
Imipenem/Cilastatine Kabi 500 mg/500 mg, poudre pour solution pour perfusion
Greece
Imipenem/Cliastatin 500 mg/500 mg κόνις για διάλυμα προς έγχυση
Spain
Imipenem/Cilastatina Kabi 500 mg/500 mg, polvo para solución para perfusión
Netherlands
Imipenem/Cilastatine Fresenius Kabi 500 mg/500 mg poeder voor oplossing voor infusie
Luxembourg
Imipenem/Cilastatin Kabi 500 mg/500 mg, Pulver zur Herstellung einer Infusionslösung
Germany
Poland
Imipenem/Cilastatin Kabi 500 mg/500 mg Pulver zur Herstellung einer Infusionslösung
Imipenem/Cilastatin Kabi
Portugal
Imipenem/Cilastatina Kabi
Romania
Imipenem/Cilastatină Kabi 500 mg/500 mg pulbere pentru soluţie perfuzabilă
Slovakia
Imipenem/Cilastatin Kabi 500 mg/500 mg, prášok na infúzny roztok
Sweden
Imipenem/Cilastatin Fresenius Kabi 500 mg/500 mg pulver till infusionsvätska, lösning
Hungary
Imipenem/Cilastatin Kabi 500 mg/500 mg por oldatos infúzióhoz
United Kingdom
Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion
Italy
Imipenem/Cilastatina Kabi 500 mg/500 mg, polvere per soluzione per infusione
Date of last revision of the leaflet:09.07.2021
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Information intended for healthcare professionals only:

Each pack is intended for single use only.

Reconstitution of the solution

The contents of each pack should be transferred to 100 ml of a suitable infusion solution (see section Incompatibility): 0.9% sodium chloride solution.
In exceptional circumstances, if 0.9% sodium chloride solution cannot be used for clinical reasons, 5% glucose solution can be used.
According to the recommended procedure, about 10 ml of the infusion solution should be added to the pack. The pack should be shaken vigorously, and the resulting mixture should be transferred to the infusion solution container.
NOTE: THE MIXTURE IS NOT INTENDED FOR DIRECT INFUSION.
The procedure should be repeated, adding another 10 ml of infusion solution to ensure that the entire contents of the pack are transferred to the infusion solution. The resulting mixture should be shaken until it becomes clear.
The concentration of imipenem and cilastatin in the solution prepared according to the above procedure is approximately 5 mg/ml.
Color differences (from a colorless solution to a yellow solution) do not affect the potency of the medicine.

Incompatibility

This medicine is chemically incompatible with lactates and should not be dissolved or diluted in solvents containing lactates. However, the medicine can be administered through an infusion set through which a lactate-containing solution is administered.
Do not mix the medicine with other medicines, except those mentioned in the section Reconstitution of the solution.

Reconstituted solution

The reconstituted/diluted solution should be used immediately. The time from the start of dissolution to the end of intravenous infusion should not exceed two hours.
Any unused medicine or waste material should be disposed of in accordance with local regulations.