Imipenem/Cilastatine Stravencon 250mg/250mg, poeder voor oplossing voor infusie

国家: 荷兰

语言: 荷兰文

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

有效成分:

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

可用日期:

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

ATC代码:

J01DH51

INN（国际名称）:

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

药物剂型:

Poeder voor oplossing voor infusie

组成:

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

给药途径:

Intraveneus gebruik

治疗领域:

Imipenem and cilastatin

產品總結:

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

授权日期:

2014-12-04

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIPENEM/CILASTATINE STRAVENCON 250MG/250MG, 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

产品特点

1
1.
NAME OF THE MEDICINAL PRODUCT
Imipenem/Cilastatine Stravencon 250mg/250mg, poeder voor oplossing
voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imipenem/Cilastatin
Each vial contains imipenem monohydrate equivalent to 250 mg imipenem
anhydrate and
cilastatin sodium equivalent to 250 mg cilastatin.
Excipients with known effect:
Each vial contains less than 1mmol (~18.8 mg) 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