IMIPENEM 500 mg/500 mg Powder For Intravenous Infusion Solution

Зміст інструкції

1. Imipenem e Cilastatina Hikma 500 mg/500 mg powder for solution for infusion
2. Imipenem e Cilastatina
   1. What is Imipenem and Cilastatina Hikma and what is it used for
   2. What you need to know before you take Imipenem and Cilastatina Hikma
   3. How to take Imipenem and Cilastatin Hikma
   4. Possible side effects
   5. How to store Imipenem and Cilastatina Hikma
   6. Package Contents and Other Information

Imipenem e Cilastatina Hikma 500 mg/500 mg powder for solution for infusion

Generic medicine

Imipenem e Cilastatina

Read this leaflet carefully before you start to use this medicineas it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Imipenem e Cilastatina Hikma is and what it is used for
• 2. What you need to know before you use Imipenem e Cilastatina Hikma
• 3. How to use Imipenem e Cilastatina Hikma
• 4. Possible side effects
• 5. How to store Imipenem e Cilastatina Hikma
• 6. Contents of the pack and other information

1. What is Imipenem and Cilastatina Hikma and what is it used for

Imipenem and Cilastatina Hikma belongs to a group of medicines called carbapenem antibiotics.
It fights a wide spectrum of bacteria (germs) that cause infections in various
parts of the body in adults and in children over one year of age.
Treatment
Your doctor has prescribed Imipenem and Cilastatina Hikma because you have (or more) of the
following types of infection:

• Complicated intra-abdominal infections
• An infection affecting the lungs (pneumonia)
• Infections that you may contract during and after childbirth
• Complicated urinary tract infections
• Complicated skin and soft tissue infections

Imipenem and Cilastatina Hikma can be used in the treatment of patients with low
white blood cell counts, who have a fever suspected to be due to bacterial infection.
Imipenem and Cilastatina Hikma can be used for the treatment of bacterial infections of the
blood that may be associated with one of the above-mentioned infections.

2. What you need to know before you take Imipenem and Cilastatina Hikma

Do not take Imipenem and Cilastatina Hikma

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

Warnings and precautions
Before using Imipenem/cilastatin, tell your doctor or pharmacist about any medical condition
you have or have had, including:

• Allergies to any medicine including antibiotics (sudden, life-threatening allergic reactions require immediate medical treatment)
• colitis or other gastrointestinal problems
• kidney or urinary problems, including reduced kidney function (the levels in the blood of Imipenem and Cilastatina Hikma increase in patients with reduced kidney function. Adverse reactions affecting the central nervous system may occur if the dose is not adjusted to kidney function)
• any central nervous system disorder such as localized tremors or seizures (convulsions)
• liver problems

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

Children
Imipenem and Cilastatina Hikma is not recommended for use in children who are less than one
year old or children with kidney problems.

Other medicines and Imipenem and Cilastatin Hikma
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
Tell your doctor if you are taking ganciclovir, which is used to treat some
viral infections.
Tell your doctor if you are taking valproic acid or sodium valproate (used to
treat epilepsy, bipolar disorder, migraine or schizophrenia) or any blood thinner such as warfarin.
The doctor will decide whether you should take Imipenem and Cilastatina Hikmain combination with
these medicines.

Pregnancy and breastfeeding
It is important that you tell your doctor if you are pregnant or if you are planning a
pregnancy before taking Imipenem and Cilastatina Hikma. Imipenem and Cilastatina Hikma
has not been tested on pregnant women. Imipenem and Cilastatina Hikma should not be
used during pregnancy unless your doctor considers that the potential benefits
justify the risk to the fetus.
It is important that you tell your doctor if you are breastfeeding or if you intend to breastfeed before taking Imipenem and Cilastatina Hikma. Small amounts of this medicine
can pass into breast milk and harm the baby. Consequently, your doctor
will decide whether you can use Imipenem and Cilastatina Hikma while breastfeeding.
Ask your doctor or pharmacist for information 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, drowsiness and a sensation of pins and needles) that may impair
the ability of some patients to drive or operate machinery (see section 4)

Imipenem and Cilastatina Hikma contains sodium
The medicine contains 37.5 mg of sodium (the main component of table salt/cooking salt)
per vial. This is equivalent to 1.88% of the maximum recommended daily intake of sodium for an adult.

3. How to take Imipenem and Cilastatin Hikma

Imipenem and Cilastatin Hikma will be prepared and administered to you by a doctor or a
healthcare professional. Your doctor will decide how much Imipenem and Cilastatin Hikma you
need.

Use in adults and adolescents
The recommended dose of Imipenem and Cilastatin Hikma for adults and adolescents is
500mg/500mg every 6 hours or 1000mg/1000mg every 6 or 8 hours. If you have kidney problems your
doctor may reduce the dose.

Use in children
The recommended dose for children one year or older is 15/15 or 25/25 mg/kg/dose every 6 hours.
Imipenem and Cilastatin Hikma is not recommended for children under one year of age or with
kidney problems.
Method of administration
Imipenem and Cilastatin Hikma is administered intravenously (into a vein) in approximately
20-30 minutes for a dosage < 500mg/500mg or in 40-60 minutes for a dosage >
500mg/500mg. The infusion rate may be reduced if you do not feel well.

If you take more Imipenem and Cilastatin Hikma than you should
Symptoms of overdose may include convulsions (seizures), confusion, tremor, nausea, vomiting,
low blood pressure and slowed heartbeat. If you think that you have been given
too much medicine, inform your doctor or another healthcare professional immediately

If you forget to take Imipenem and Cilastatin Hikma
If you believe you have forgotten to take a dose, contact your doctor or
another healthcare professional immediately.
If you have any questions about the use of this product, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Imipenem and Cilastatina Hikma can cause side effects, although
not everyone gets them.
The following side effects occur rarely, in any case if they occur
while you are receiving or after you have received Imipenem and Cilastatina Hikma, the
administration of the medicine must be interrupted and your doctor must be contacted
immediately:

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

Other possible side effects:
Common (may affect up to 1 in 10 people)

• increased number of specific white blood cells
• swelling and redness of the veins that become particularly painful when touched
• rash
• abnormal liver function detected by blood tests
• nausea, vomiting, diarrhea. Nausea and vomiting appear to affect more frequently patients with a low number of white blood cells

Not common (may affect up to 1 in 100 people)

• local redness of the skin
• local pain and formation of wheals at the injection site
• skin itching
• urticaria
• fever
• alterations of the blood that affect blood cells and are generally detected by blood tests (symptoms may be fatigue, pallor of the skin and prolonged clotting time following an injury)
• abnormalities in kidney, liver and blood function detected by blood tests
• tremors and uncontrolled muscle movements
• convulsions (seizures)
• psychiatric disorders (such as mood swings and impaired judgment)
• seeing, hearing or perceiving something that is not there (hallucinations)
• confusion
• dizziness, drowsiness
• low blood pressure

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

• Fungal infections (candidiasis)
• discoloration of the teeth and/or tongue
• inflammation of the colon with severe diarrhea
• altered taste
• inability of the liver to perform its normal functions
• liver inflammation
• inability of the kidneys to perform their normal functions
• change in the amount of urine, change in urine color
• brain disorders, tingling sensation (pins and needles), localized tremors
• 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 the stomach or intestine (gastroenteritis)
• inflammation of the intestine with diarrhea and blood (hemorrhagic colitis)
• red and swollen tongue, excessive growth of the normal papillae of the tongue giving it a hairy appearance, sweating, sore throat, increased saliva production
• stomach pain
• feeling of dizziness (vertigo), headache
• ringing in the ears (tinnitus)
• joint pain, weakness
• irregular heartbeat, the heart beats stronger or faster
• chest discomfort, difficulty breathing, rapid and shallow breathing, pain in the upper back
• redness, bluish discoloration of the face and lips, change in skin texture, excessive sweating
• vulvar itching in women
• changes in the number of blood cells
• worsening of a rare condition associated with muscle weakness (worsening of myasthenia gravis)

Not known (frequency cannot be estimated from the available data)

• abnormal movements
• agitation

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting
system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Imipenem and Cilastatina Hikma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the
vials (Exp.). The expiry date refers to the last day of that month.
Do not store at a temperature above 25 C
Keep the vials in the outer packaging.
After reconstitution:
The diluted solutions must be used immediately. The time interval between the start of
reconstitution and the end of the intravenous infusion must not exceed two hours.
Do not freeze the reconstituted solution.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Imipenem and Cilastatina Hikma Contains

• The active ingredients are imipenem and cilastatin. Each vial of Imipenem and Cilastatina Hikma 500 mg/500 mg contains 530 mg of imipenem monohydrate equivalent to 500 mg of imipenem and 530 mg of cilastatin sodium salt equivalent to 500 mg of cilastatin.
• The excipient is 20 mg sodium bicarbonate.

Description of the Appearance of Imipenem and Cilastatina Hikma and Package Contents
Imipenem and Cilastatina Hikma in the dosage of 500 mg/500 mg is a powder from white to almost
white or pale yellow for solution for infusion available in 20 ml
vials made of colorless type III glass, sealed with 20 mm diameter bromobutyl rubber stoppers.

Pack Sizes
1 vial/box (20 ml vial)
10 vials/box (20 ml vial)

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, 8, 8A e 8B, Fervença
2705-906 Terrugem SNT
Portugal
Tel.: 351-21-960 84 10 / Fax: 351-21-961 51 02
E-mail: [email protected]
Manufacturer
ACS Dobfar S.p.A.
Nucleo Industriale S. Atto

• S. Nicolò a Tordino 64020 TERAMO Italy

Distributor for Italy
Hikma Italia SpA
Viale Certosa 10, 27100 Pavia

This medicinal product is authorised in the Member States of the European Economic Area with
the following designations:
Austria: Imipenem/Cilastatin Hikma 500 mg/500 mg Pulver zur Herstellung

einer Infusionslösung
Ireland: Imipenem/Cilastatin 500 mg/500 mg Powder for solution for infusion
Italy: Imipenem e Cilastatina Hikma 500 mg/500 mg Polvere per soluzione

infusione
Germany: Imipenem/Cilastatin Hikma 500 mg/500 mg Pulver zur Herstellung

einer Infusionslösung
Portugal: Imipenem/Cilastatina Hikma 500 mg/500 mg g Pό para solução para

perfusão
Netherlands: Imipenem/Cilastatin Hikma 500 mg/500 mg
United Kingdom: Imipenem/Cilastatin 500 mg/500 mg Powder for solution for infusion
France: Imipenem/Cilastatine Hikma 500 mg/500 mg Poudre pour

solution pour perfusion
Spain: Imipenem /Cilastatina Hikma 500 mg/500 mg Polvo para

solución para perfusión

The following information is intended exclusively for doctors or healthcare professionals:
Each vial is for single use only
Reconstitution
The contents of each vial must be transferred into 100 ml of appropriate solution for infusion
sodium chloride 0.9% (see Incompatibilitiesand After reconstitution). In exceptional
circumstances where sodium chloride 0.9% cannot be used for clinical reasons, glucose 5% must be
used instead.

A recommended procedure is to add approximately 10 ml of the appropriate infusion solution
to the vial. Shake well and transfer the resulting mixture into the container of the
infusion solution.
WARNING: THE MIXTURE IS NOT SUITABLE FOR DIRECT INFUSION.
Repeat with further 10 ml of infusion solution to ensure complete transfer of the vial contents into the infusion solution container. The resulting
mixture must be shaken until a clear solution is obtained.
The concentration of the reconstituted solution following the above procedure is approximately 5
mg/ml for both imipenem and cilastatin.
Colour variations, from colourless to yellow, do not affect the potency of the product

Compatibility and stability
Administer Imipenem/Cilastatina Hikmain accordance with good clinical and
pharmaceutical practice, using freshly prepared solutions with the following solvent: sodium chloride 0.9% injection.

Incompatibilities

This medicinal productis chemically incompatible with lactate and must not be
reconstituted with diluents containing lactate, however, it may be administered in an
intravenous infusion system in which a lactate solution has already been administered.
This medicinal product must not be mixed with other products except those mentioned in the
“Reconstitution” paragraph.

After reconstitution
Diluted solutions must be used immediately. The time interval between the start of
reconstitution and the end of intravenous infusion must not exceed 2 hours.
Unused medicine and waste materials derived from such medicine must be disposed of in
accordance with local regulations.