Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
vancomycin hydrochloride, Quantity: 1025.2 mg
Baxter Healthcare Pty Ltd
Injection, powder for
Excipient Ingredients: hydrochloric acid; sodium hydroxide
Oral, Intravenous
10 vials
(S4) Prescription Only Medicine
VANCOMYCIN BAXTER is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins.,VANCOMYCIN BAXTER 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.,VANCOMYCIN BAXTER 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. VANCOMYCIN BAXTER 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 determine their susceptibilities to vancomycin.,Vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by C. difficile). Parenteral administration of vancomycin 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.
Visual Identification: white to tan powder or porous cake.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2023-06-16
VANCOMYCIN BAXTER 1 VANCOMYCIN BAXTER CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING VANCOMYCIN BAXTER? VANCOMYCIN BAXTER contains the active ingredient Vancomycin hydrochloride. Vancomycin is an antibiotic used to treat serious infections caused by bacteria (germs). For more information, see Section 1. Why am I using VANCOMYCIN BAXTER? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE VANCOMYCIN BAXTER? Do not use if you have ever had an allergic reaction to VANCOMYCIN BAXTER, to other similar medicines or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use VANCOMYCIN BAXTER? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with vancomycin and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE VANCOMYCIN BAXTER? • Your doctor will decide the appropriate dose for you. • A doctor or nurse will usually prepare and administer the injection or infusion. • Follow all instructions given to you by your doctor and pharmacist. More instructions can be found in Section 4. How do I use VANCOMYCIN BAXTER? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING VANCOMYCIN BAXTER? THINGS YOU SHOULD DO • Tell your doctor if you experience any problems with this medicine. • Remind any doctor, dentist or pharmacist you visit that you are using vancomycin. DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how vancomycin affects you. LOOKING AFTER YOUR MEDICINE • This medicine will generally be stored in the pharmacy or on the ward (below 25°C and protected from light). For more information, Aqra d-dokument sħiħ
Version: 2.0 Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION – VANCOMYCIN BAXTER (VANCOMYCIN HYDROCHLORIDE) 1. NAME OF THE MEDICINE Vancomycin hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of VANCOMYCIN BAXTER 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 tan powder or porous cake. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VANCOMYCIN BAXTER is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. VANCOMYCIN BAXTER 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. VANCOMYCIN BAXTER 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. VANCOMYCIN BAXTER 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 determine their susce Aqra d-dokument sħiħ