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

Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• 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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Imipenem/Cilastatin Aurovitas is and what it is used for
2. What you need to know before using Imipenem/Cilastatin Aurovitas
3. How to use Imipenem/Cilastatin Aurovitas
4. Possible adverse effects
5. How to store Imipenem/Cilastatin Aurovitas
6. Contents of the pack and other information

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

Imipenem/cilastatin belongs to a group of medicines called carbapenem antibiotics. It kills a wide range of bacteria (germs) that cause infections in various 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 flu or colds.

It is important that you follow your doctor's instructions regarding dosage, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Treatment

Your doctor has prescribed imipenem/cilastatin because you have one (or more) of the following types of infection:

• Complicated abdominal infections
• Lung infection (pneumonia)
• Infections that may occur during or after childbirth
• Complicated urinary tract infections
• Complicated skin and soft tissue infections

Imipenem/cilastatin may be used to treat patients with low white blood cell counts who have fever suspected to be due to a bacterial infection.

Imipenem/cilastatin may 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 Aurovitas

Do not use Imipenem/Cilastatin Aurovitas

• 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.

Warnings and precautions

Inform your doctor about any medical conditions you currently have or have had in the past, including:

• allergies to any medicines, including antibiotics (unexpected allergic reactions that are life-threatening require immediate medical treatment)
• colitis or any other gastrointestinal disease
• any disorders of the central nervous system, such as localized tremors or epileptic seizures
• liver, kidney, or urinary problems

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

Inform your doctor if you are taking valproic acid or sodium valproate (see Use of Imipenem/Cilastatin Aurovitas with other medicines below).

Children

The administration of imipenem/cilastatin is not recommended in children under one year of age or in children with kidney problems.

Use of Imipenem/Cilastatin Aurovitas with other medicines

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

Inform 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 in combination with these medicines.

Pregnancy, breastfeeding, and fertility

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

Imipenem/cilastatin has not been studied in pregnant women. Imipenem/cilastatin should not be used during pregnancy unless your doctor decides that the potential benefit justifies the potential risk to the fetus.

Small amounts of this medicine may pass into breast milk and could affect the baby. Therefore, your doctor will decide whether you should use imipenem/cilastatin during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some side effects associated with this product (such as seeing, hearing, or feeling things that are not there, dizziness, drowsiness, and sensation of spinning) may affect the ability of some patients to drive or operate machinery (see section 4).

Imipenem/Cilastatin Aurovitas contains sodium

Patients on low-sodium diets should be aware that this medicine contains 37.6 mg (1.6 mmol) of sodium per dose.

3. How to use Imipenem/Cilastatin Aurovitas

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 usual dose of imipenem/cilastatin 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 usual dose in children aged one year or older is 15/15 or 25/25 mg/kg/dose every 6 hours. Imipenem/cilastatin is not recommended in children under one year of age and in children with kidney problems.

Method of administration

Imipenem/cilastatin is administered intravenously (into a vein) over 20–30 minutes for a dose of ≤500 mg/500 mg or 40–60 minutes for a dose of >500 mg/500 mg.

If you use more Imipenem/Cilastatin Aurovitas 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, contact your doctor or another healthcare professional immediately.

If you forget to use Imipenem/Cilastatin Aurovitas

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

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

If you stop using Imipenem/Cilastatin Aurovitas

Do not stop using imipenem/cilastatin unless instructed to do so 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 experiences them.

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 redness of the skin
• Localized pain and formation of a firm lump at the injection site
• Itching of the skin
• Urticaria
• Fever
• Blood disorders affecting blood cells, usually detected by blood tests (symptoms may include fatigue, pale skin, and prolonged bruising after injuries)
• Changes in kidney, liver, and blood function, detected by blood tests
• Tremors and uncontrolled muscle contractions
• Seizures
• Psychiatric disturbances (such as mood changes 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):

• 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). If these side effects occur while receiving or after receiving imipenem/cilastatin, administration of the medicine must be stopped and you should contact your doctor immediately.
• 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)
• Fungal infection (candidiasis)
• Discoloration of 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 urine volume, changes in urine colour
• Brain disease, tingling sensation (pins and needles), localized tremor
• Hearing loss (hearing impairment)

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 salivation
• Stomach pain
• Sensation of spinning (vertigo), headache
• Ringing in the ears (tinnitus)
• Pain in several joints, weakness
• Irregular heartbeat, heart beating strongly or rapidly
• Chest discomfort, difficulty breathing, abnormally rapid and shallow breathing, pain in the upper spine
• Facial redness (flushing), bluish discolouration 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 (increased severity of myasthenia gravis)

Frequency not known (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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Imipenem/Cilastatin Aurovitas

Keep this medicine 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.

Imipenem/Cilastatin Aurovitas dry vials: no special storage conditions are required.

After reconstitution:

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 must not be disposed of via wastewater or household waste. If you are uncertain, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Imipenem/Cilastatin Aurovitas

• The active substances are imipenem (as monohydrate) and cilastatin (as sodium salt).

Each vial of Imipenem/Cilastatin Aurovitas 500 mg/500 mg powder for solution for infusion contains 500 mg of imipenem (as 530 mg of imipenem monohydrate) and 500 mg of cilastatin (as 530 mg of cilastatin sodium salt).

• The other component is sodium hydrogen carbonate.

Presentation of the product and contents of the pack

Imipenem/Cilastatin 500 mg is presented in colourless type III glass vials with a capacity of 20 ml, closed with a 20 mm diameter bromobutyl rubber stopper and an aluminium flip-off cap.

Pack sizes:

1 vial of 500 mg

10 vials of 500 mg

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer

ACS Dobfar S.p.A.

Nucleo Industriale S.Atto, S. Nicolò a Tordino

64100 Teramo

Italy

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Date of the most recent revision of this summary: January 2018

Detailed 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/).

This information is intended for healthcare professionals only:

Each vial is for single use only.

Preparation of intravenous solution

The following table is provided to facilitate the reconstitution of Imipenem/Cilastatin Aurovitas for intravenous infusion.

Reconstitution of Imipenem/Cilastatin Aurovitas 500 mg:

The contents of the vials must be dissolved and transferred into an appropriate infusion solution to achieve a final volume of 100 ml.

A recommended procedure is to add approximately 10 ml of infusion solution (see “Compatibility and stability”) to the vial. Shake well and transfer the resulting suspension to the infusion bottle.

PRECAUTION: THE SUSPENSION IS NOT FOR DIRECT INFUSION.

Repeat with an additional 10 ml of the solution to ensure complete transfer of the vial contents into the infusion bottle. Adjust the volume to 100.0 ml with the same infusion solution. Mix thoroughly until a clear solution is obtained.

The concentration of the reconstituted solution, prepared as described above, is approximately 5 mg/ml for both imipenem and cilastatin.

The reconstituted solution must be inspected visually for particulate matter and/or discoloration prior to administration. Once reconstituted, the imipenem/cilastatin solution ranges from colorless to yellow. Color variation within this range does not affect the potency of the product.

Compatibility and stability

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

Imipenem/Cilastatin Aurovitas may be reconstituted with water for injections or with a 9 mg/ml (0.9%) sodium chloride infusion solution.

Do not freeze the reconstituted solution.

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