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IMIPENEM-CILASTATIN 250 MG - 250 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): CILASTATIN SODIUM / IMIPENEM MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Imipenem/Cilastatin 250 mg/250 mg
Powder for Solution for Infusion

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

imipenem cilastatin
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours. If any of the side effects gets serious, or if
you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Imipenem/Cilastatin is and what it is used for
- 2. Before you use Imipenem/Cilastatin
- 3. How to use Imipenem/Cilastatin
- 4. Possible side effects
- 5. How to store Imipenem/Cilastatin
- 6. Further 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. BEFORE YOU USE IMIPENEM/CILASTATIN

It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed
before receiving Imipenem/Cilastatin. 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.
Ask your doctor or pharmacist for advice before taking any medicine.
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).
Important information about some of the ingredients of Imipenem/Cilastatin
Imipenem/Cilastatin 250 mg/250 mg contains 0.8 mmol (18.8 mg) sodium per container and
Imipenem/Cilastatin 500 mg/500 mg contains 1.6 mmol (37.5 mg) sodium per container, wich
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 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.
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.
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 does of >500 mg/500 mg.
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 forgot 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 use Imipenem/Cilastatin
· if you are allergic (hypersensitive) to imipenem, cilastatin or any of the other ingredients of
Imipenem/Cilastatin
· if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or
carbapenems

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

Take special care with 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

Like all medicines Imipenem/Cilastatin can cause side effects, although not everybody gets them. .

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 Using
other medicines below).
Children
Imipenem/Cilastatin is not recommended in children less than one year of age or children with
kidney problems.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those obtained without a prescription.
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
It is important that you tell your doctor if you are pregnant or are planning to become pregnant
before receiving Imipenem/Cilastatin. 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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
The frequency of possible side effects listed below is defined using the following convention:
· very common: affects more than 1 user in 10
· common: affects 1 to 10 users in 100
· uncommon: affects 1 to 10 users in 1,000
· rare: affects 1 to 10 users in 10,000
· very rare: affects less than 1 user in 10,000
· not known: frequency cannot be estimated from the available data
Common
· 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
· 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

The following information is intended for medical or healthcare professionals only:

CAUTION: THE SUSPENSION IS NOT FOR DIRECT INFUSION.

Each vial is for single use only.

Repeat with an additional 10 ml of infusion solution to ensure complete transfer of container
contents to the infusion solution. The resulting mixture should be agitated until clear.

Reconstitution
Contents of each container must be transferred to 50 ml (for 250mg strength) and 100 ml
(for 500mg strength) of an appropriate infusion solution (see Incompatibility and After
reconstitution): 0.9% sodium chloride. In exceptional circumstances where 0.9% sodium chloride
cannot be used for clinical reasons, 5% glucose may be used instead.
A suggested procedure is to add approximately 10 ml from the appropriate infusion solution to
the container. Shake well and transfer the resulting suspension to the infusion solution container.

The concentration of the reconstituted solution following the above procedure is approximately
5 mg/ml for both imipenem and cilastatin.
Variations of colour, from colourless to yellow, do not affect the potency of the product.

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Rare
· Allergic reactions including rash, swelling of the face, lips, tongue and/or throat (with difficulty
in breathing or swallowing), and/or low blood pressure. If these side-effects occur while
receiving or after receiving Imipenem/Cilastatin, the medicine must be stopped and your
doctor contacted 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)
· 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
· 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)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

For further information about this medicinal product, please contact the Marketing Authorization
Holder.


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


Imipenem/Cilastatin Kabi 250 mg/250 mg, 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 250 mg/250 mg, 500 mg/500 mg, prášek pro

přípravu inf. roztoku
Germany
Imipenem/Cilastatin Kabi 250 mg/250 mg, 500 mg/500 mg Pulver zur

Herstellung einer Infusionslösung
Finland
Imipenem/Cilastatin Fresenius Kabi 500 mg/500 mg Infuusiokuiva-aine, liuosta
varten
France
Imipenem/Cilastatine Kabi 250 mg/250 mg, 500 mg/500 mg, poudre pour

solution pour perfusion
Greece
Imipenem/Cliastatin Kabi 500mg/500mg
Hungary
Imipenem/Cilastatin Kabi 500 mg/500 mg por oldatos infúzióhoz
Italy
Imipenem/Cilastatina Kabi 500 mg/500 mg, polvere per soluzione per
infusione
Luxembourg
Imipenem/Cilastatin Kabi 250 mg/250 mg Pulver zur Herstellung einer
Infusionslösung
Netherlands
Imipenem/Cilastatine Fresenius Kabi 500 mg/500 mg poeder voor oplossing
voor
infusie
Poland
Imipenem/Cilastatin Kabi
Portugal
Imipenem/Cilastatina Kabi
Romania
Imipenem/Cilastatin Kabi 500 mg/500 mg pulbere pentru solutie perfuzabilă
Slovakia
Imipenem/ Cilastatin Kabi 250 mg/250 mg, prášok na infúzny roztok,

Imipenem/ Cilastatin Kabi 500 mg/500 mg, prášok na infúzny roztok,
Spain
Imipenem/Cilastatina Kabi 250/250 mg, 500/500 mg, polvo para solución
para
perfusión
Sweden
Imipenem/Cilastatin Fresenius Kabi 500 mg/500 mg pulver till infusionsvätska,
lösning
United Kingdom Imipenem/Cilastatin 250 mg/250 mg, 500 mg/500 mg Powder for Solution for
Infusion
This leaflet was last approved in 03/2012.

5. HOW TO STORE IMIPENEM/CILASTATIN
Keep out of the reach and sight of children.
Do not use Imipenem/Cilastatin after the expiry date stated on the container. The expiry date
refers to the last day of that month.
Before opening:
The vials should be kept in the outer carton until immediately before use in the outer carton until
immediately before use in order to protect from light.
Do not store above 25ºC.
After first opening/reconstitution:
Reconstituted/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.
Do not freeze the reconstituted solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Imipenem/Cilastatin contains
The active substances are either:
• 250 mg imipenem (as 265mg imipenem monohydrate) and 250 mg cilastatin (as 265 mg
cilastatin sodium salt)
• or 500 mg imipenem (as 530mg imipenem monohydrate) and 500 mg cilastatin (as 530 mg
cilastatin sodium salt)
The other ingredient is sodium hydrogen carbonate
What Imipenem/Cilastatin looks like and contents of the pack
Imipenem/Cilastatin 250 mg imipenem and 250 mg cilastatin is a white to almost white or yellow
powder delivered in 20 ml glass vials.
Imipenem/Cilastatin 500 mg imipenem and 500 mg cilastatin is a white to almost white or yellow
powder delivered in 20 ml glass vials and 100 ml glass bottles.
Imipenem/Cilastatin 250 mg/250 mg and 500 mg/500 mg comes in packs containing 10 glass or
10 glass bottles of powder, closed with a rubber stopper, aluminium cap and flip-off cap.
Marketing Authorisation Holder and Manufacturer


Marketing Authorisation Holder:


Fresenius Kabi Ltd.,
Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT, United Kingdom


Manufacturer:
Facta Faramaceutici, Nucleo Industriale S. atto, S. Nicolo a Tordino, Teramo, Italy


Incompatibility
This medicinal product is chemically incompatible with lactate and should not be reconstituted
in diluents containing lactate.However, it can be administered into an IV system through which a
lactate solution is being infused.

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

This medicinal product should not be mixed with other medicinal products except those mentioned
under Reconstitution.
After reconstitution
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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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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