Imipenem/Cilastatin 500 mg/500 mg powder for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Imipenem; Cilastatin

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

J01DH51

INN (International Name):

Imipenem; Cilastatin

Dosage:

500 mg/500 milligram(s)

Pharmaceutical form:

Powder for solution for infusion

Therapeutic area:

imipenem and enzyme inhibitor

Authorization status:

Not marketed

Authorization date:

2020-12-18

Patient Information leaflet

Page 1 of 8
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 USING 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 or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible
side effects not listed in this leaflet. See section 4.
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 of your
baby

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
Page 2 of 8
DO NOT USE IMIPENEM/CILASTATIN

if you are allergic to imipenem, cilastatin or any of the other
ingredients of this
medicine

Summary of Product characteristics

Health Products Regulatory Authority
21 July 2021
CRN00C0SF
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imipenem/Cilastatin 500 mg/500 mg powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial/bottle contains imipenem monohydrate equivalent to 500 mg
imipenem anhydrate and cilastatin sodium equivalent
to 500 mg cilastatin.
Excipient(s) with known effect:
Each vial/bottle contains sodium bicarbonate equivalent to
approximately 1.6 mEq of sodium (approximately 37.5 mg)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White to almost white or light yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imipenem/Cilastatin is indicated for the treatment of the following
infections in adults and children 1 year of age and above
(see section 4.4 and 5.1):

complicated intra-abdominal infections

severe pneumonia including hospital and ventilator-associated
pneumonia

intra- and post-partum infections

complicated urinary tract infections

complicated skin and soft-tissue infections
Imipenem/Cilastatin may be used in the management of neutropenic
patients with fever that is suspected to be due to a
bacterial infection.
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of the
infections listed above.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose recommendations for Imipenem/Cilastatin represent the
quantity of imipenem/cilastatin to be administered.
The daily dose of Imipenem/Cilastatin should be based on the type of
infection and given in equally divided doses based on
consideration of degree of susceptibility of the pathogen(s) and the
patient's renal function (see also section 4.4 and 5.1).
Adults and adolescents
For patients with normal renal function (creatinine clearance of > 90
ml/min), the r