Pfizer VANCOMYCIN vancomycin (as hydrochloride) 1000 mg powder for injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
11-07-2022

유효 성분:

vancomycin, Quantity: 1000 mg

제공처:

Pfizer Australia Pty Ltd

약제 형태:

Injection, powder for

구성:

Excipient Ingredients: hydrochloric acid; sodium hydroxide

관리 경로:

Intravenous, Oral

패키지 단위:

1 X 20mL

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. Severe staphylococcal (including methicillin resistant staphylococcal) infections in patients who cannot receive or who have 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. Alone or in combination with an aminoglycoside for endocarditis caused by Strep. viridans or Strep. bovis. For endocarditis caused by enterococci (eg Strep. faecalis), effective only in combination with an aminoglycoside. Diphtheroid endocarditis. In combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by Staph. epidermidis or diphtheroids. Other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia, and soft itssue infections. When staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to Vancomycin injections. Should be administered orally for the treatment of Staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by C difficile). Parenteral administration alone is inappropriate for this indication. Vancomycin is not effective by the oral route for other types of infections. For oral adminsitration, the parenteral formulation may be used. Some systemic absorption may occur following oral administration in patients with pseudo-membranous colitis.

제품 요약:

Visual Identification: white to light brown powder or plug in a 20 mL or 25 mLType I clear glass vial, with a rubber stopper closure and aluminium crimp with plastic "filp-off" top.; Container Type: Vial; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2022-05-11