Imipenem/Cilastatin Hospira Pdr for Soln for Infusion 500mg/500mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CILASTATIN, IMIPENEM

Available from:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC code:

J01DH51

INN (International Name):

CILASTATIN 500 mg IMIPENEM 500 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

CILASTATIN 500 mg IMIPENEM 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2010-09-02

Patient Information leaflet

Page
1
of
8
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIPENEM/CILASTATIN HOSPIRA 500 MG/500 MG POWDER FOR SOLUTION FOR
INFUSION
Imipenem/Cilastatin Hospira
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 further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
:
1.
What Imipenem/Cilastatin Hospira is and what it is used for
2.
What you need to know before you use Imipenem/Cilastatin Hospira
3.
How to use Imipenem/Cilastatin Hospira
4.
Possible side effects
5.
How to store Imipenem/Cilastatin Hospira
6.
Contents of the pack and other information
1.
WHAT IMIPENEM/CILASTATIN HOSPIRA IS AND WHAT IT IS USED FOR
Imipenem/Cilastatin Hospira 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 Hospira 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 Hospira 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 Hospira may be used to treat bacterial infection
of the blood which might be
associated with a type of infection mentioned above.
Page
2
of
8
2.
WHAT YOU NEED TO

Summary of Product characteristics

Page
1
of
17
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Imipenem/Cilastatin Hospira 500 mg/500 mg Powder for Solution for
Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Excipient(s) with known effect:
Each vial contains 1.6 mmol (37.5 mg) of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for solution for infusion.
Off white to yellowish white hygroscopic powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imipenem/Cilastatin Hospira is indicated for the treatment of the
following infections in
adults and children 1 year of age and above (see sections 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 Hospira 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 Hospira represent the
quantity of
Imipenem/Cilastatin Hospira to be administered.
Page
2
of
17
The daily dose of Imipenem/Cilastatin Hospira 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
≥90ml/min), the
recommended dose regimens are:
500 mg/500 mg every 6 hour