Imipenem/Cilastatine Stravencon 500mg/500mg, poeder voor oplossing voor infusie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

CILASTATINE NATRIUM SAMENSTELLING overeenkomend met ; CILASTATINE ; IMIPENEM 1-WATER SAMENSTELLING overeenkomend met ; IMIPENEM 0-WATER

Beschikbaar vanaf:

Stravencon Limited Landmark House 17 Hanover Square W1S 1HU LONDEN (VERENIGD KONINKRIJK)

ATC-code:

J01DH51

INN (Algemene Internationale Benaming):

CILASTATINE SODIUM COMPOSITION corresponding to ; CILASTATINE ; IMIPENEM 1-WATER COMPOSITION corresponding to ; IMIPENEM 0-WATER

farmaceutische vorm:

Poeder voor oplossing voor infusie

Samenstelling:

NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; STIKSTOF (HEAD SPACE) (E 941),

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Imipenem and cilastatin

Product samenvatting:

Hulpstoffen: NATRIUMWATERSTOFCARBONAAT (E 500 (II)); STIKSTOF (HEAD SPACE) (E 941);

Autorisatie datum:

2014-12-04

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIPENEM/CILASTATINE STRAVENCON 500MG/500MG, POEDER VOOR OPLOSSING
VOOR INFUSIE
Imipenem/Cilastatin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or nurse.
-
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, or if you notice any side effects not
listed in this leaflet,
please tell your doctor, pharmacist or nurse. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Imipenem/Cilastatin Stravencon is and what it is used for
2.
What you need to know before you are given Imipenem/Cilastatin
Stravencon
3.
How to administer Imipenem/Cilastatin Stravencon
4.
Possible side effects
5.
How to store Imipenem/Cilastatin Stravencon
6.
Contents of the pack and other information
1.
WHAT IMIPENEM/CILASTATIN STRAVENCON IS AND WHAT IT IS USED FOR
Imipenem/Cilastatin Stravencon 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.
Your doctor has prescribed Imipenem/Cilastatin Stravencon 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 Stravencon 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. This
product 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 AR

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Imipenem/Cilastatine Stravencon 500mg/500mg, poeder voor oplossing
voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imipenem/Cilastatin
Each vial contains imipenem monohydrate equivalent to 500 mg imipenem
anhydrate and
cilastatin sodium equivalent to 500 mg cilastatin.
Excipients with known effect:
Each vial contains 1.6mmol (37.6mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to light yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imipenem/Cilastatin Stravencon is indicated 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 Stravencon 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 Stravencon represent
the quantity of
Imipenem/Cilastatin to be administered.
The daily dose of Imipenem/Cilastatin should be based on the type and
severity of infection,
the pathogen(s) isolated, the patient's renal function and body weight
(see also section 4.4 and
5.1).
2
_Adults and adolescents _
For patients with normal renal function (creatinine clearance of >70
ml/min/1.73 m
2
), the
recommended dose regimens are:
500 mg/500 mg every 6 hours
_OR_
1000 mg/1000 mg every 8 hours OR every 6 hours
It is recommended that infections suspected or proven to be due to
less susceptible bacterial
species (