Document: leaflet MAH GENERIC_PL 04515-0237 change

• leaflet MAH GENERIC_PL 04515-0237
• leaflet MAH GENERIC_PL 15413-0021
• leaflet MAH GENERIC_PL 30306-0112

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Package leaflet: Information for the user

Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion

imipenem/cilastatin

What is in this leaflet:

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

2. What you need to know before you use Imipenem/Cilastatin

3.    How to use Imipenem/Cilastatin

4.    Possible side effects

5.    How to store Imipenem/Cilastatin

6. Contents of the pack and other information

1. What Imipenem/Cilastatin 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 and above.

Treatment

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

•    Complicated infections in the abdomen

• Infection affecting the lungs (pneumonia)

• Infections that you can catch during or after the delivery

•    Complicated urinary tract infections

• Complicated skin and soft tissue infections

Imipenem/Cilastatin may be used in the management of patients with low white blood cell counts, who have fever that is suspected to be due to a bacterial infection.

Imipenem/Cilastatin may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.

2. What you need to know before you use Imipenem/Cilastatin

Do not use Imipenem/Cilastatin

• if you are allergic (hypersensitive) to imipenem, cilastatin or any of the other ingredients of this medicine (listed in section 6)

• if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems

Warnings and precautions

Talk to your doctor before using Imipenem/Cilastatin. Tell your doctor about any medical condition you have or have had including:

•    allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require immediate medical treatment)

•    colitis or any other gastrointestinal disease

•    any central nervous system disorders such as localized tremors or epileptic seizures

•    liver, kidney or urinary problems

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

Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Other medicines and Imipenem/Cilastatin below).

Children

Imipenem/Cilastatin is not recommended in children less than one year of age or children with kidney problems.

Other medicines and Imipenem/Cilastatin

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

Tell your doctor if you are taking ganciclovir which is used to treat some viral infections.

Also, tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia) or any blood thinners such as warfarin.

Your doctor will decide whether you should use Imipenem/Cilastatin in combination with these medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Small amounts of this medicine may pass into breast milk and it may affect the baby. Therefore, your doctor will decide whether you should use Imipenem/Cilastatin while breast-feeding.

Driving and using machines

There are some side effects associated with this product (such as seeing, hearing, or feeling something that is not there, dizziness, sleepiness, and a spinning sensation) that may affect some patients’ ability to drive or operate machinery (see section 4).

Imipenem/Cilastatin contains 1.6 mmol (or 37.5 mg) sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.

3. How to use Imipenem/Cilastatin

Imipenem/Cilastatin will be prepared and given to you by a doctor or another health care professional. Your doctor will decide how much Imipenem/Cilastatin you need.

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 or weigh less than 70 kg, your doctor may lower your dose.

Method of administration

Imipenem/Cilastatin is given 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.

Use in children

The usual dose for children one year of age 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 children with kidney problems.

If you use more Imipenem/Cilastatin than you should

Symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood pressure and slow heart rate. If you are concerned that you may have been given too much Imipenem/Cilastatin, contact your doctor or another healthcare professional immediately.

If you forget to use Imipenem/Cilastatin

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 a forgotten dose.

If you stop using Imipenem/Cilastatin

Do not stop using Imipenem/Cilastatin until your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergic reactions

If you have a severe allergic reaction, stop using Imipenem/Cilastatin and see a doctor immediately. You may need urgent medical treatment. The signs may include a sudden onset of:

The following information is intended for healthcare professionals only: Reconstitution of the intravenous solution

The product is supplied as dry sterile powder in vials containing the equivalent of 500 mg of imipenem and 500 mg of cilastatin.

The product is buffered with sodium hydrogen carbonate, in order to obtain pH solutions between 6.5 and 8.5. There is no significant modification of the pH when the solutions are prepared and used as indicated. The product contains 37.5 mg of sodium (1.6 mmol).

For single use only. Discard any unused solution.

The reconstitution of powder is to be made under aseptic conditions using the diluents mentioned below. The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if it is clear and free from particles.

Reconstituted solution stability has been established for 0.9% sodium chloride injection and sterile Water for Injections.

Reconstituted and diluted solutions should be used immediately.

Reconstitution of the 100 ml vial

The sterile powder must be reconstituted as directed below. It must be shaken until a clear solution is obtained allowing 3-4 minutes to reconstitute the powder. The variations in colour, from colourless to yellow, do not affect the potency of the product.

H0401B

•    Severe rash, itching or hives on the skin.

• Swelling of the face, lips, tongue or other parts of the body.

•    Shortness of breath, wheezing or trouble breathing.

Other side effects:

Common (may affect up to 1 in 10 people):

•    Nausea, vomiting, diarrhoea. Nausea and vomiting appear to occur more frequently in patients with low number of white blood cells

•    Swelling and redness along a vein which is extremely tender when touched

•    Rash

• Abnormal liver function detected by blood tests

•    Increase in some white blood cells

Uncommon (may affect up to 1 in 100 people):

•    Local skin redness

• Local pain and formation of a firm lump at the injection site

•    Skin itchiness

•    Hives

•    Fever

• Blood disorders affecting the cell components of the blood and usually detected by blood tests (symptoms may be tiredness, paleness of skin, and prolonged bruising after injury)

• Abnormal kidney, liver and blood function detected by blood tests

•    Tremors and uncontrolled twitching of muscles

•    Seizures

• Psychic disturbances (such as mood swings and impaired judgment)

• Seeing, hearing or feeling something that is not there (hallucinations)

•    Confusion

•    Dizziness, sleepiness

•    Low blood pressure

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

•    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)

•    Staining of the teeth and/or tongue

• Inflammation of the colon with severe diarrhoea

•    Disturbances in taste

• Inability of the liver to perform normal function

•    Inflammation of the liver

• Inability of the kidney to perform normal function

• Changes in the amount of urine, changes in urine colour

• Disease of the brain, tingling sensation (pins and needles), localised 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 stomach or intestine (gastro-enteritis)

• Inflammation of intestine with bloody diarrhoea (haemorrhagic colitis)

• Red swollen tongue, overgrowth of the normal projections on the tongue giving it a hairy appearance, heartburn, sore throat, increase in the production of saliva

•    Stomach pain

• A spinning sensation (vertigo), headache

•    Ringing in the ears (tinnitus)

• Pain in several joints, weakness

• Irregular heartbeat, the heart beating forcefully or rapidly

• Chest discomfort, difficulty breathing, abnormally fast and superficial breathing, pain in the upper spine

• Flushing, bluish discoloration of the face and lips, skin texture changes, excessive sweating

•    Itching of the vulva in women

• Changes in the amounts of blood cells

• Worsening of a rare disease associated with muscle weakness (aggravation of myasthenia gravis)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Imipenem/Cilastatin

Keep this medicine out of the reach and sight of children

Do not use this medicine after the expiry date which is stated on the vial label and carton. The expiry date refers to the last day of that month.

Prior to reconstitution, this medicinal product does not require any special storage conditions.

Prepared solutions should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed two hours. Prepared solutions should not be frozen.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Imipenem/Cilastatin contains

•    The active substances are imipenem and cilastatin. Each vial contains 530 mg of imipenem monohydrate and 530 mg of cilastatin sodium corresponding to 500 mg of imipenem and 500 mg of cilastatin.

•    The other ingredient is sodium hydrogen carbonate.

What Imipenem/Cilastatin looks like and contents of the pack

This medicine is an off white to yellowish white hygroscopic powder for solution for infusion in a glass vial. Packs of the 20 ml vials contain 5 vials per carton. Packs of the 100 ml vials contain 1 vial per carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations for Imipenem/Cilastatin are held by Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK.

The manufacturer (responsible for batch release of the product in the EEA) is Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead,

SL6 6RJ, UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria:    Imipenem/Cilastatin Hospira 500 mg/500 mg Pulver zur

Herstellung einer Infusionslosung

Cyprus:    Imipenem/Cilastatin Hospira 500 mg/500 mg Kovi£ yia

SiaAupa npo£ £yxuar|

Czech Republic: Imipenem/Cilastatin Hospira 500 mg/500 mg Prasek pro pripravu infuzniho roztoku

Germany:    Imipenem/Cilastatin Hospira 500 mg/500 mg Pulver zur

Herstellung einer Infusionslosung

Greece:    Imipenem/Cilastatin Hospira 500 mg/500 mg Kovi£ yia

SiaAupa npo£ £yxuar|

Hungary:    Imipenem/Cilastatin Hospira 500 mg/500 mg por oldatos

infuziohoz

Italy:    Imipenem/Cilastatina Hospira 500 mg/500 mg polvere

per soluzione per infusione

Latvia:    Imipenem/Cilastatin Hospira 500 mg/500 mg pulveris

infuziju skTduma pagatavosanai

Lithuania:    Imipenem/Cilastatin Hospira 500 mg/500 mg miltelaia

infuziniam tirpalui

Malta:    Imipenem/Cilastatin Hospira 500 mg/500 mg Powder for

Solution for Infusion

Poland:    Imipenemum/Cilastatinum Hospira, 500 mg + 500 mg,

proszek do sporzqdzania roztworu do infuzji Portugal:    Imipenem + Cilastatina Hospira, 500 mg + 500 mg po

para solupao para perfusao

Romania:    Imipenem/Cilastatin Hospira 500 mg/500 mg, pulbere

pentru solujie perfuzabila

Spain:    Imipenem/Cilastatina Hospira 500 mg/500 mg polvo para

solucion para perfusion EFG

United Kingdom: Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion

This leaflet was last revised in 04/2016.

Dose (imipenem in mg)	Volume of solvent to be added (ml)	Mean approximate concentration of product (mg/ml of imipenem)
500	100	5

Reconstitution of the 20 ml vial

The contents of the vial must be suspended and transferred to 100 ml of an appropriate solution for infusion. A suggested procedure is to add approximately 10 ml of appropriate infusion solution to the vial. Shake well and transfer the resulting suspension to the infusion solution container.

Caution: The suspension is not for direct infusion.

Repeat with an additional 10 ml of infusion solution to ensure complete transfer of the vial contents to the infusion solution. The resulting mixture must be shaken until clear.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Incompatibility

The product is chemically incompatible with lactate and must not be reconstituted in solutions that contain it. However, it can be administered into an IV tubing, through which a lactate solution is to be infused.

The product must not be mixed or physically added to other antibiotics.

After reconstitution and dilution

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

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