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VANCOMYCIN JUNO (Juno Pharmaceuticals Pty Ltd)
Product name
VANCOMYCIN JUNO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
147 (255 working days)
Active ingredients
vancomycin hydrochloride
Registration type
New generic medicine
Indication
VANCOMYCIN JUNO (powder for injection) is indicated in potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins.
VANCOMYCIN JUNO is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. Once sensitivity data are available, therapy should be adjusted accordingly.
VANCOMYCIN JUNO is effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g. E. faecalis), VANCOMYCIN JUNO is effective only in combination with an aminoglycoside. VANCOMYCIN JUNO is effective for the treatment of diphtheroid endocarditis. VANCOMYCIN JUNO is used in combination with rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
The effectiveness of VANCOMYCIN JUNO has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia, and soft tissue infections. When staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to VANCOMYCIN JUNO.
VANCOMYCIN JUNO should be administered orally for the treatment of Staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis produced by C. difficile. Parenteral administration of VANCOMYCIN JUNO alone is inappropriate for this indication. Vancomycin is not effective by the oral route for other types of infections. For oral administration the parenteral formulation may be used. Some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.