CLAFORAN INJECTION 0.5G

Country: Malaysia

Language: English

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

Active ingredient:

CEFOTAXIME SODIUM

Available from:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International Name):

CEFOTAXIME SODIUM

Units in package:

1Units Units

Manufactured by:

Zentiva Saglik Ürünleri Sanayi ve Ticaret Anonim Sirketi

Summary of Product characteristics

_ _
_cefotaxime_
_ _
COMPOSITION
CLAFORAN® 0.5 G : Each vial of dry powder contains 0.524 g cefotaxime
sodium, corresponding to
0.5 g cefotaxime.
CLAFORAN® 1 G : Each vial of dry powder contains 1.048 g cefotaxime
sodium, corresponding to
1.0 g cefotaxime.
PROPERTIES
Claforan is a broad-spectrum bactericidal cephalosporin antibiotic.
Claforan is exceptionally active _in _
_vitro_ against Gram-negative organisms sensitive or resistant to
first or second generation
cephalosporins. It is similar to other cephalosporins in activity
against Gram-positive organisms.
INDICATIONS
Severe infections caused by cefotaxime-susceptible pathogens:
Infections
-
of the respiratory tract, including nose and throat,
-
of the ear,
-
of the kidneys and urinary tract,
-
of the skin and soft tissues,
-
of the bones and joints,
-
of the genital organs including gonorrhoea,
-
of the abdominal region.
Sepsis, endocarditis, meningitis; for perioperative prophylaxis in
patients who are at increased risk
from infection, and for the prophylaxis of infections in patients with
reduced resistance.
_Cefotaxime is generally effective against the following pathogens:
_Staphylococci, aerobic and
anaerobic streptococci, Streptococcus pneumoniae, Neisseria spp.,
Haemophilus influenzae,
Escherichia coli, Citrobacter spp., Salmonella spp., Klebsiella spp.,
Enterobacter aerogenes, Serratia
spp., indole-positive and indole-negative Proteus spp., Yersinia
enterocolitica, Clostridium spp., and
Bacteroides spp.
_Pathogens with varying susceptibility are: _Streptococcus faecalis,
Enterobacter cloacae,
Pseudomonas aeruginosa, and Bacteroides fragilis.
There is not yet sufficient clinical experience with Salmonella typhi
and paratyphi A and B
infections.
_Cefotaxime is not effective against _Treponema pallidum and
Clostridium difficile.
_Combination therapy: _In severe, life-threatening infections, the
combination of Claforan with
aminoglycosides is indicated without awaiting the results of
sensitivity tests. The two preparations
must be administered separate