CLAFORAN INJECTION 1.0G

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

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 separately.
Infections with Pse