Imipenem + Cilastatina Ranbaxi

1. What is Imipenem + Cilastatin Ranbaxy and what is it used for

Imipenem + Cilastatin Ranbaxy belongs to a group of medicines called carbapenem antibiotics.
This medicine destroys a wide range of bacteria that cause infections in different parts of the body in children (aged one year and older) and adults.

Treatment

Your doctor has prescribed Imipenem + Cilastatin Ranbaxy because you have been diagnosed with at least one of the following infections:

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

Imipenem + Cilastatin Ranbaxy may be used to treat patients with a reduced number of white blood cells, who have a fever that is likely to be caused by a bacterial infection.
Imipenem + Cilastatin Ranbaxy may be used to treat bacterial blood infections, which may be associated with one of the infections listed above.

2. Important information before using Imipenem + Cilastatin Ranbaxy

When not to use Imipenem + Cilastatin Ranbaxy

• If you are allergic to imipenem, cilastatin, or any of the excipients (listed in section 6);
• If you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems.

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Warnings and precautions

Before starting treatment with Imipenem + Cilastatin Ranbaxy, you should discuss this with your doctor,

pharmacist, or nurse.
You should inform your doctor if you have experienced:

• allergies (sudden, life-threatening allergic reactions that require immediate medical attention) to any medicines, including antibiotics;
• colitis or any other gastrointestinal disease;
• kidney or urinary tract diseases, including impaired kidney function (in patients with impaired kidney function, the blood level of the medicine is increased. If the dose is not adjusted, side effects from the central nervous system may occur).
• any central nervous system disorders, such as tremors or seizures;
• liver disease.

The result of a test that detects antibodies in the blood that can destroy red blood cells (Coombs test)
may be positive. Your doctor will discuss this with you.
If you are taking medicines such as valproic acid or sodium valproate, you should inform your doctor (see Imipenem + Cilastatin Ranbaxy and other medicinesbelow).
Children
Imipenem + Cilastatin Ranbaxy is not recommended for children under one year of age or for children with kidney disease.

Imipenem + Cilastatin Ranbaxy and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
If you are taking ganciclovir, which is used to treat certain viral infections, you should inform your doctor.
You should also inform your doctor if you are taking valproic acid or sodium valproate (medicines used for epilepsy, bipolar disorder, migraine, or schizophrenia)
or blood-thinning medicines such as warfarin.
Your doctor will decide whether you can receive Imipenem + Cilastatin Ranbaxy with these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
This medicine has not been studied in pregnant women, so it should not be used unless your doctor decides that the potential benefits to the mother outweigh the risks to the baby.
If you plan to breastfeed or are breastfeeding, you should tell your doctor before starting treatment with Imipenem + Cilastatin Ranbaxy. It may pass into breast milk in small amounts and affect the baby.
Therefore, your doctor will decide whether you can use it.
Before using any medicine, you should consult your doctor or pharmacist.
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Driving and using machines

Some side effects associated with the use of this medicine (such as hallucinations, i.e., seeing, hearing, or feeling things that do not exist; balance disorders, drowsiness, and dizziness) may affect some patients' ability to drive or operate machinery (see section 4).

Imipenem + Cilastatin Ranbaxy contains sodium

This medicine contains approximately 1.63 mmol (approximately 37.5 mg) of sodium, which should be taken into account for patients controlling their sodium intake.

3. How to use Imipenem + Cilastatin Ranbaxy

Imipenem + Cilastatin Ranbaxy will be prepared and administered to you by your doctor or other qualified medical staff. Your doctor will decide how much medicine to give you.
Use in adults and adolescents
The usual dose of Imipenem + Cilastatin Ranbaxy in adults 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, your doctor may reduce the dose of the medicine.
Use in children
Children aged one year or older are usually given a dose of (15 mg + 15 mg) or (25 mg + 25 mg)/kg body weight every 6 hours. Imipenem + Cilastatin Ranbaxy is not recommended for children under one year of age or for children with kidney disease.
Method of administration
Imipenem + Cilastatin Ranbaxy is administered intravenously; doses of 500 mg + 500 mg or less are administered over 20-30 minutes, and doses greater than 500 mg + 500 mg are administered over 40-60 minutes.
If the patient feels nauseous, the infusion rate can be reduced.

Using a higher dose of Imipenem + Cilastatin Ranbaxy than recommended

Symptoms of overdose may include: seizures, confusion, tremors, nausea, vomiting, low blood pressure, and slow heart rate. If there is a concern that too much Imipenem + Cilastatin Ranbaxy has been administered, you should contact your doctor or other qualified medical staff immediately.

Missing a dose of Imipenem + Cilastatin Ranbaxy

If there is a concern that a dose of Imipenem + Cilastatin Ranbaxy has been missed, you should contact your doctor or other qualified medical staff immediately.
In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist. You should not take a double dose to make up for a missed dose.

Stopping treatment with Imipenem + Cilastatin Ranbaxy

You should not stop treatment with Imipenem + Cilastatin Ranbaxy without your doctor's advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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The frequency of the following possible side effects is defined as follows:

• very common: may occur in more than 1 in 10 people
• common: may occur in less than 1 in 10 people
• uncommon: may occur in less than 1 in 100 people
• rare: may occur in less than 1 in 1,000 people
• very rare: may occur in less than 1 in 10,000 people
• frequency not known: cannot be estimated from the available data

During or after administration of Imipenem + Cilastatin Ranbaxy, the following side effects have rarely occurred. If these effects occur, you should stop taking the medicine and contact your doctor immediately.

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

Other possible side effects:

Common

• Nausea, vomiting, diarrhea. It seems that nausea and vomiting occur more frequently in patients with a reduced number of white blood cells.
• Swelling and redness along the vein, which is extremely sensitive to the touch.
• Rash.
• Abnormal liver function detected by blood tests.
• Increased number of certain types of white blood cells.

Uncommon

• Local redness of the skin.
• Pain and formation of a hard lump at the injection site.
• Itching of the skin.
• Hives.
• Fever.
• Blood cell disorders, usually detected by blood analysis (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 (epileptic fits).
• Psychiatric disorders (such as mood swings and impaired judgment).
• Hallucinations, i.e., seeing, hearing, and feeling things that do not exist.
• Disorientation.
• Dizziness, drowsiness.
• Low blood pressure.

Rare

• Discoloration of teeth and/or tongue.
• Colitis (inflammation of the large intestine) with 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.

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Very rare

• Severe liver function disorder due to hepatitis (fulminant hepatitis).
• Gastritis or enteritis.
• Colitis with bloody diarrhea (hemorrhagic colitis).
• Redness and swelling of the tongue, hypertrophy of the papillae on the tongue giving it a "hairy" appearance, heartburn, sore throat, increased salivation.
• Stomach pain.
• Dizziness (balance disorders), headaches.
• Ringing in the ears (tinnitus).
• Joint pain, weakness.
• Irregular heart rhythm, accelerated or strong heartbeat (palpitations).
• Discomfort in the chest, breathing difficulties, excessive acceleration or shallowness of breathing, pain in the upper back.
• Hot flashes with facial flushing, cyanosis of the face and lips, skin structure changes, excessive sweating.
• Vulvar itching.
• Changes in blood cell count.
• Worsening of symptoms of a rare disease in which there is muscle weakness (worsening of myasthenia symptoms).

Frequency not known

• Abnormal movements.
• Agitation.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Ranbaxy

The medicine should be stored in a place inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Imipenem + Cilastatin Ranbaxy powder should be stored at a temperature below 25°C.
Store the vial or infusion bottle in the carton until use.
Imipenem + Cilastatin Ranbaxy should be used immediately after preparation.
Do not freeze the prepared solution.
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Medicines should not be disposed of via wastewater or household waste. You should 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 Ranbaxy contains

Each vial and bottle of Imipenem + Cilastatin Ranbaxy contains:

• 500 mg of imipenem in the form of imipenem monohydrate;
• 500 mg of cilastatin in the form of cilastatin sodium salt.
• 20 mg of sodium bicarbonate as an excipient.

What Imipenem + Cilastatin Ranbaxy looks like and what the packaging contains

Imipenem + Cilastatin Ranbaxy is a white to light yellow sterile powder.
1 vial and bottle of Imipenem + Cilastatin Ranbaxy contain 37.5 mg (1.63 mmol) of sodium.
Imipenem + Cilastatin Ranbaxy is available in the following packaging:

• vials with a capacity of 22 ml with a built-in needle that allows the medicine to be prepared directly in an infusion bag. Package size: 1 vial containing 500 mg of imipenem and 500 mg of cilastatin, in a carton.
• vials with a capacity of 30 ml. Package size: 1 vial containing 500 mg of imipenem and 500 mg of cilastatin, in a carton.
• infusion bottles with a capacity of 100 ml. Package size: 1 bottle containing 500 mg of imipenem and 500 mg of cilastatin, in a carton, and 10 bottles containing 500 mg of imipenem and 500 mg of cilastatin, in a carton.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16,
00-710 Warsaw

Manufacturer

Terapia S.A.
Str. Fabricii Nr. 124, Cluj-Napoca 400632
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
To obtain more detailed information, you should contact the marketing authorization holder:
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16,
00-710 Warsaw
Date of leaflet approval:02.05.2023
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Information intended for healthcare professionals only

Imipenem + Cilastatin Ranbaxy, 500 mg + 500 mg, powder for solution for infusion

(Imipenem+ Cilastatin)
Preparation of the solution for intravenous administration
The following table provides information useful for dissolving Imipenem + Cilastatin Ranbaxy to prepare a solution for intravenous administration. 0.9% sodium chloride solution for intravenous infusion is recommended as a solvent.

Adding Imipenem + Cilastatin Ranbaxy from a vial to an infusion bag
Before use, ensure that there are no foreign particles in the powder and that the seal between the stopper and the vial is intact.
Remove the stopper by twisting and pulling until the seal is broken.
Insert the cannula into the injection port of the infusion bag. Press the cannula shield against the vial until you hear a click.
Hold the vial upright and squeeze the infusion bag several times to fill 2/3 of the vial with solvent (0.9% sodium chloride solution). Shake the vial until the powder is completely dissolved.
Invert the vial and, squeezing the infusion bag, pour the contents of the vial back into the infusion bag.
Repeat steps 4 and 5 until the vial is completely empty.
A part of the label on the vial can be removed and attached to the infusion bag.
The bottle can be removed or left on the infusion bag.
Preparation of the solution for intravenous administration (30 ml vial)
The following table provides information useful for dissolving the medicine. 0.9% sodium chloride solution for intravenous infusion is recommended as a solvent.

Preparation of the solution for intravenous administration should be performed under appropriate conditions and in an appropriate environment.
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The contents of the vial should be dissolved and transferred to 100 ml of an appropriate infusion solution. The recommended procedure is as follows:

• 1. Before use, ensure that there are no foreign particles in the powder and that the seal between the stopper and the vial is intact.
• 2. Remove the stopper by twisting and pulling until the seal is broken.
• 3. Add approximately 10 ml of an appropriate infusion solution to the vial. Shake the vial vigorously.
• 4. Transfer the resulting mixture to an infusion container.
• 5. Repeat steps 3 and 4. NOTE: THE MIXTURE IS NOT INTENDED FOR DIRECT INFUSION.
• 6. Shake the resulting mixture until it becomes clear.

Before administration, the prepared solution should be inspected for particles or discoloration.
Changes in color from colorless to yellow do not affect the efficacy of the medicine.
Pharmaceutical incompatibilities
There is a chemical incompatibility of Imipenem + Cilastatin Ranbaxy with lactates, and therefore, solutions containing lactates should not be used to prepare the solution. However, Imipenem + Cilastatin Ranbaxy can be administered through an intravenous administration set that is also used to administer a solution containing lactates. Imipenem + Cilastatin Ranbaxy should not be mixed with other antibiotics or added to other antibiotics.
The medicine should not be mixed with other medicines except those specified in the section Preparation of the solution for intravenous administration.
After preparation
The medicine should be used immediately.
Any unused solution and the vial should be disposed of in accordance with local regulations.