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

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Imipenem; Cilastatin

Dostępny od:

Hikma Farmacêutica (Portugal) S.A.

Kod ATC:

J01DH; J01DH51

INN (International Nazwa):

Imipenem; Cilastatin

Dawkowanie:

500 mg/500 milligram(s)

Forma farmaceutyczna:

Powder for solution for infusion

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Carbapenems; imipenem and enzyme inhibitor

Status autoryzacji:

Not marketed

Data autoryzacji:

2010-12-03

Ulotka dla pacjenta

Compatibility and stability
In keeping with good clinical and pharmaceutical practice,
IMIPENEM/CILASTATIN should
be administered as a freshly prepared solution with the following
diluent: 0.9% Sodium
Chloride Injection.
INCOMPATIBILITY
This medicinal product is chemically incompatible with lactate and
should not be
reconstituted with diluents containing lactate, however, can be
administered into an IV
system through which a lactate solution is being infused.
This medicinal product must 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.
Any unused product or waste material should be disposed of
in accordance with local requirements.
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 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 bo

Charakterystyka produktu

Health Products Regulatory Authority
14 February 2020
CRN0093Y3
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imipenem/Cilastatin 500mg/500mg powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 530 mg imipenem monohydrate equivalent to 500 mg
imipenem and 530 mg cilastatin sodium salt
equivalent to 500mg cilastatin.
Excipient(s) with known effect:
Each vial contains 20 mg of sodium bicarbonate. The total amount in
the vial is 37.5 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion
White to almost white or light (pale) 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 sections 4.4 and 5.1):
- Complicated intra-abdominal infection
- 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 local 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 recommen