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CEFAZOLIN AJS, CEFAZOLIN RMB, CEFAZOLIN SXP (Southern Cross Pharma Pty Ltd)

Product name
CEFAZOLIN AJS, CEFAZOLIN RMB, CEFAZOLIN SXP
Date registered
Evaluation commenced
Decision date
Approval time
159 (255 working days)
Active ingredients
cefazolin sodium
Registration type
New generic medicine
Indication

CEFAZOLIN AJS, CEFAZOLIN RMB, CEFAZOLIN SXP (powder for injection) is indicated in the treatment of the following serious infections due to susceptible organisms:

  • Respiratory tract infections due to S. pneumoniae, Klebsiella species, H. influenzae, Staph. aureus (penicillin-sensitive and penicillin-resistant), and Group A beta-haemolytic streptococci.

    Injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.

    Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present.

  • Genitourinary tract infections due to E. coli, Pr. mirabilis, Klebsiella species, and some strains of Enterobacter and enterococci.
  • Skin and skin structure infections due to Staph. aureus (penicillin-sensitive and penicillin- resistant), and Group A beta-haemolytic streptococci and other strains of streptococci.
  • Bone and joint infections due to Staph. aureus.
  • Septicaemia due to S. pneumoniae, Staph. aureus (penicillin-sensitive and penicillin-resistant), Pr.mirabilis, E. coli and Klebsiella species.
  • Endocarditis due to Staph. aureus (penicillin-sensitive and penicillin- resistant), and Group A betahaemolytic streptococci.

    Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

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