Imipenem + cilastatin ranbaxy

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Patient Information Leaflet

Imipenem + Cilastatin Ranbaxy, 500 mg + 500 mg,
powder for solution for infusion
(Imipenemum + Cilastatinum)
Please read all of this leaflet carefully before you are given this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Imipenem + Cilastatin Ranbaxy is and what it is used for
2. What you need to know before you are given Imipenem + Cilastatin Ranbaxy
3. How you will be given Imipenem + Cilastatin Ranbaxy
4. Possible side effects
5. How to store Imipenem + Cilastatin Ranbaxy
6. Contents of the pack and other information

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

Imipenem + Cilastatin Ranbaxy belongs to a group of medicines called carbapenem antibiotics.
This medicine kills 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 at least one of the following infections:

• Complicated intra-abdominal infections;
• Lung infection (pneumonia);
• Infections occurring during or after childbirth;
• Complicated urinary tract infections;
• Complicated skin and soft tissue infections.

Imipenem + Cilastatin Ranbaxy may be used to treat patients with low white blood cell counts who have fever likely caused by a bacterial infection.
Imipenem + Cilastatin Ranbaxy may also be used to treat bacterial blood infections, which may be associated with one of the above-mentioned infections.

2. Important information before using Imipenem + Cylastatyna Ranbaxy

When not to use Imipenem + Cylastatyna Ranbaxy

• If the patient is allergic to imipenem, cilastatin, or any excipient (listed in section 6);
• If the patient is allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems.

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Warnings and precautions
Before starting Imipenem + Cylastatyna Ranbaxy, discuss this with your doctor,
pharmacist, or nurse.
Inform your doctor if the patient has had:

• allergies (sudden, life-threatening allergic reactions requiring immediate medical attention) to any medicines, including antibiotics;
• colitis or any other gastrointestinal disorder;
• kidney or urinary tract disorders, including impaired renal function (in patients with reduced kidney function, blood levels of the drug may increase. If the dose is not adjusted, adverse effects on the central nervous system may occur);
• any disorders of the central nervous system, such as tremors or seizures;
• 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.
If the patient is taking medicines such as valproic acid or sodium valproate, inform the
doctor (see Imipenem + Cylastatyna Ranbaxy and other medicines below).
Children
Imipenem + Cylastatyna Ranbaxy is not recommended for children under one year of age,
or for children with kidney disease.
Imipenem + Cylastatyna Ranbaxy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking ganciclovir, used to treat certain viral infections, inform the doctor.
Also inform the doctor if the patient is taking valproic acid or sodium valproate
(medicines used for epilepsy, bipolar affective disorder, migraine, or schizophrenia),
or medicines that reduce blood clotting, such as warfarin.
The doctor will decide whether the patient can receive Imipenem + Cylastatyna Ranbaxy together
with these medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The use of this medicine in pregnant women has not been studied, so it should not be used unless the doctor decides that the potential benefits to the mother outweigh the risks to the unborn child.
If the patient is planning to breastfeed or is already breastfeeding, she should inform the doctor before starting Imipenem + Cylastatyna Ranbaxy. The medicine may pass into breast milk in small amounts and may affect the breastfed infant. Therefore, the doctor will decide whether the patient may use this medicine.
Before taking any medicine, consult your doctor or pharmacist.
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Driving and operating machinery
Some adverse effects associated with this medicine (such as hallucinations - seeing, feeling, or hearing things that are not real; disturbances in balance, drowsiness, and dizziness) may affect some patients' ability to drive or operate machinery (see section 4).
Imipenem + Cylastatyna Ranbaxy contains sodium
This medicine contains approximately 1.63 mmol (about 37.5 mg) of sodium, which should be taken into account for patients controlling sodium intake in their diet.

3. How to use Imipenem + Cilastatin Ranbaxy

Imipenem + Cilastatin Ranbaxy will be prepared and administered to the patient by a doctor or
another healthcare professional. The doctor will decide the dose to be given to the patient.

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, the doctor may reduce the dose of the medicine.

Use in children
Children aged one year and 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 equal to or less than 500 mg + 500 mg should be given over 20–30 minutes, and doses exceeding 500 mg + 500 mg over 40–60 minutes.
If the patient experiences nausea, the infusion rate may be reduced.

Overdose of Imipenem + Cilastatin Ranbaxy
Symptoms of overdose may include seizures, confusion, tremor, nausea, vomiting, low blood pressure, and slow heart rate. If an overdose of Imipenem + Cilastatin Ranbaxy is suspected, contact a doctor or another healthcare professional immediately.

Missed dose of Imipenem + Cilastatin Ranbaxy
If a dose of Imipenem + Cilastatin Ranbaxy has been missed, contact your doctor or a healthcare professional immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist. Do not take a double dose to make up for a missed dose.

Stopping Imipenem + Cilastatin Ranbaxy
Do not stop using Imipenem + Cilastatin Ranbaxy without your doctor's instruction.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
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The frequency of occurrence of the possible side effects listed below is defined as follows:

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

The following side effects have rarely occurred during or after administration of Imipenem + Cilastatin Ranbaxy. If any of these side effects occur, 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 difficulties), and/or low blood pressure.
• Skin peeling (toxic epidermal necrolysis)
• Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme)
• Severe form of rash with skin peeling and hair loss (exfoliative dermatitis)

Other possible side effects:
Common

• Nausea, vomiting, diarrhoea. Nausea and vomiting appear to occur more frequently in patients who have a reduced white blood cell count
• Swelling and redness along the vein, which is exceptionally sensitive to 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
• Urticaria (hives)
• Fever
• Blood cell disorders, usually detected during blood analysis (symptoms may include fatigue, pale skin, and prolonged bruising after injury)
• Abnormal kidney, liver and blood function detected by blood tests
• Tremor and uncontrolled muscle jerking
• Seizures (fits)
• Psychiatric disturbances (such as mood swings and impaired judgment)
• Hallucinations, i.e. seeing, hearing or feeling things that do not exist
• State of disorientation
• Dizziness, drowsiness
• Low blood pressure

Rare

• Discoloration of teeth and/or tongue
• Colitis (inflammation of the large intestine) with severe diarrhoea
• Taste disturbances
• Liver function disorders
• Hepatitis (liver inflammation)
• Kidney function disorders
• Changes in the amount of urine passed and changes in urine colour
• Brain function disorders, tingling sensation, localised tremor
• Hearing loss

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Very rare

• Severe liver dysfunction due to hepatitis (fulminant hepatitis)
• Inflammation of the stomach or intestines
• Inflammation of the intestine with bloody diarrhoea (haemorrhagic colitis)
• Redness and swelling of the tongue, overgrowth of tongue papillae giving it a "hairy" appearance, heartburn, sore throat, increased salivation
• Stomach pain
• Dizziness (disturbances of balance), headache
• Ringing in the ears (tinnitus)
• Joint pain, weakness
• Irregular heartbeat, rapid heartbeat or strong heart palpitations
• Chest discomfort, breathing difficulties, abnormally fast or shallow breathing, pain in the upper spine
• Hot flushes with facial redness, bluish discoloration of the face and lips, skin texture changes, excessive sweating
• Itching of the genital area
• Changes in blood cell counts
• Worsening of symptoms of a rare disease causing muscle weakness (exacerbation of myasthenia gravis symptoms)

Frequency not known

• Abnormal movements
• Restlessness

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Imipenem + Cilastatina Ranbaxy

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the immediate packaging and
the cardboard box.
The expiry date refers to the last day of the stated month.
The powder form of the medicine Imipenem + Cilastatina Ranbaxy should be stored at a temperature
below 25°C.
Keep the vial or infusion bottle in the cardboard box until the time of use.
The medicine Imipenem + Cilastatina 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. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Imipenem + Cylastatyn Ranbaxy contains
Each vial and bottle of Imipenem + Cylastatyn Ranbaxy contains:

• 500 mg imipenem as imipenem monohydrate;
• 500 mg cilastatin as cilastatin sodium;
• 20 mg sodium hydrogen carbonate as an excipient.

What Imipenem + Cylastatyn Ranbaxy looks like and contents of the pack
Imipenem + Cylastatyn Ranbaxy is a sterile white to pale yellow powder.
Each vial and bottle of Imipenem + Cylastatyn Ranbaxy contains 37.5 mg (1.63 mmol) of sodium.
Imipenem + Cylastatyn Ranbaxy is available in the following pack sizes:

• 22 ml vials with a built-in needle enabling direct preparation of the solution into an infusion bag. Pack size: 1 vial containing 500 mg imipenem and 500 mg cilastatin, in a cardboard box.
• 30 ml vials. Pack size: 1 vial containing 500 mg imipenem and 500 mg cilastatin, in a cardboard box.
• 100 ml infusion bottles. Pack sizes: 1 bottle containing 500 mg imipenem and 500 mg cilastatin, in a cardboard box; and 10 bottles, each containing 500 mg imipenem and 500 mg cilastatin, in a cardboard box.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16,
00-710 Warsaw, Poland

Manufacturer
Terapia S.A.
Fabriciei Street No. 124, Cluj-Napoca 400632
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

For further information, please contact the Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16,
00-710 Warsaw, Poland
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Information intended exclusively for medical personnel

Imipenem + Cilastatin Ranbaxy, 500 mg + 500 mg, powder for solution for infusion
(Imipenemum + Cilastatinum)
Preparation of solution for intravenous administration
The table below provides information useful when reconstituting Imipenem + Cilastatin Ranbaxy to prepare a solution for intravenous administration. As a solvent, 0.9% sodium chloride infusion solution is recommended.

Adding Imipenem + Cilastatin Ranbaxy vial to an infusion bag
Before use, ensure that there are no foreign particles in the powder and that the seal between the cap and the vial is intact.
Remove the cap by twisting and pulling until the seal breaks.
Insert the cannula into the infusion bag port. Press the cannula protector onto the vial until a click is heard.
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, by squeezing the infusion bag, transfer the contents of the vial back into the infusion bag.
Repeat steps 4 and 5 until the vial is completely emptied.
The label portion on the vial may be removed and attached to the infusion bag.
The vial may be removed or left attached to the infusion bag.
Preparation of solution for intravenous administration (30 ml vial)
The table below provides useful information for reconstituting the medicinal product. The recommended solvent is 0.9% sodium chloride solution for intravenous infusion.

The preparation of the solution for intravenous administration must be carried out under appropriate conditions and in a suitable environment.
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The contents of the vial should be dissolved and transferred into 100 ml of a suitable 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 cap and the vial is intact.
2. Remove the cap by twisting and pulling until the seal breaks.
3. Add approximately 10 ml of a suitable infusion solution to the vial. Shake the vial vigorously.
4. Transfer the resulting mixture to the infusion container.
5. Repeat steps 3 and 4. WARNING: THE MIXTURE IS NOT INTENDED FOR DIRECT INFUSION.
6. Shake the resulting mixture until it becomes clear.

Before administration, inspect the prepared solution for the presence of particles or discoloration.
A change in color from colourless to yellow does not affect the efficacy of the medicinal product.
Incompatibilities
Imipenem + Cilastatin Ranbaxy is chemically incompatible with lactates; therefore, infusion solutions containing lactate should not be used for reconstitution. However, Imipenem + Cilastatin Ranbaxy may be administered through an intravenous administration set through which a lactate-containing solution is being infused. Imipenem + Cilastatin Ranbaxy must not be mixed with other antibiotics or added to other antibiotics.
The medicinal product must not be mixed with other medicinal products except as specified in the section Preparation of the solution for intravenous administration.
After preparation
The medicinal product should be used immediately.
Any unused solution and the vial must be disposed of in accordance with local regulations.