Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
vancomycin, Quantity: 1000 mg
Pfizer Australia Pty Ltd
Injection, powder for
Excipient Ingredients: hydrochloric acid; sodium hydroxide
Intravenous, Oral
1 X 20mL
(S4) Prescription Only Medicine
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.
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
Licence status A
1998-03-26
DBL™ VANCOMYCIN _Vancomycin Hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Vancomycin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given vancomycin against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT DBL VANCOMYCIN IS USED FOR This medicine is used to treat severe infections caused by bacteria, such as: • staphylococcal infections (including methicillin resistant staphylococci ) • endocarditis (an infection of the lining of the heart) • osteomyelitis (bone infection) • pneumonia (lung infection) • septicaemia (infection of the blood) • infections of the skin or the skin structure • enterocolitis (infection in the intestines). This medicine belongs to a group of medicines called glycopeptide antibiotics. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL VANCOMYCIN _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN DBL VANCOMYCIN IF YOU HAVE AN ALLERGY TO: • any medicine containing vancomycin and similar antibiotics e.g. teicoplanin You may need to check with your doctor • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU ARE GIVEN IT_ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOO Přečtěte si celý dokument
Version: pfpvanci11121 Supercedes: hhpvanci20721 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION – DBL ™ VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1. NAME OF THE MEDICINE Vancomycin hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of DBL Vancomycin contains 500 mg or 1000 mg of vancomycin (as the hydrochloride). For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Powder for injection is a white to light brown powder or plug. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Vancomycin is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. DBL Vancomycin is useful in therapy of 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. DBL Vancomycin 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., _S. faecalis_ ), vancomycin is effective only in combination with an aminoglycoside. Vancomycin is effective for the treatment of diphtheroid endocarditis. DBL Vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by _S_ . _epidermidis_ or diphtheroids. The effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure 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 d Přečtěte si celý dokument