IMIPENEM CILASTATIN Kabi 500 mg 500 mg Powder for solution for infusion

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

CILASTATIN SODIUM; IMIPENEM MONOHYDRATE

Tillgänglig från:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (International namn):

CILASTATIN SODIUM; IMIPENEM MONOHYDRATE

Enheter i paketet:

500mg/500mg X 10vial Vials

Tillverkad av:

ACS Dobfar S.p.A.

Produktens egenskaper

ACSI079F01
FRONT
COMPOSITION
Each vial contains 500mg imipenem (as 530mg imipenem monohydrate) and
500mg cilastatin (as 530mg cilastatin sodium salt).
Each vial contains sodium bicarbonate equivalent to approximately 1.6
mEq of
sodium (approximately 37.6 mg) and sodium hydrogen carbonate.
PHARMACEUTICAL FORM
Sterile powder for solution for infusion.
White to almost white or light yellow powder.
Imipenem / Cilastatin Kabi is compatible with the following solution:
-
0.9% Sodium Chloride Injection
-
5% Dextrose Injection
After dilution, the solution should be clear after agitated
THERAPEUTIC INDICATIONS
The activity of Imipenem/Cilastatin Kabi against an unusual broad
spectrum of
pathogens makes it particularly useful in the treatment of
polymicrobic and mixed
aerobic/anaroebic infections, as well as initial therapy prior to the
identification of
the causative organisms.
Imipenem/Cilastatin Kabi is indicated for the treatment of the
following infections
due to susceptible organisms:
•
intra-abdominal infections
•
lower respiratory tract infections
•
gynaecological infections
•
septicaemia
•
genitourinary tract infections
•
bone and join infections
•
skin and soft tissue infections
•
endocarditis
Imipenem/Cilastatin Kabi is indicated for the treatment of mixed
infections caused by
susceptible strains of aerobic and anaerobic bacteria. The majority of
these mixed
infections are associated with contamination by faecal flora and fauna
originating
from the vagina, skin and mouth. In these mixed infections,
Bacteroides fragilis is
the most commonly encountered anaerobic pathogen and is usually
resistant to
aminoglycosides, cephalosporins and penicillins. However, Bacteroides
fragilis is
usually susceptible to Imipenem/Cilastatin Kabi.
Imipenem/Cilastatin
Kabi
has
demonstrated
efficacy
against
many
infections
caused
by
aerobic
and
anaroebic
gram-positive
and
gram-negative
bacteria
resistant to the cephalosporins, including cefazolin, cefoperazone,
cephalothin,
cefoxitin,
cefotaxime,
moxalactam,
cefamandole