CEFAZOLIN-AFT (AFT Pharmaceuticals Pty Ltd)
Product name
CEFAZOLIN-AFT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days)
Active ingredients
cefazolin sodium
Registration type
New generic medicine
Indication
CEFAZOLIN-AFT (powder for injection) is indicated for treatment of the following serious infections due to susceptible organisms:
- Respiratory tract infections due to Strep. pneumoniae, Klebsiella sp., 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, P. mirabilis, Klebsiella sp. 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 Strep. pneumoniae, Staph. aureus (penicillin sensitive and penicillin resistant), P. mirabilis, E. coli and Klebsiella sp.
- Endocarditis due to Staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic streptococci.
- Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.