देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
daptomycin, Quantity: 500 mg
Wockhardt Bio Pty Ltd
Injection, powder for
Excipient Ingredients: sodium hydroxide
Intravenous
1 vial
(S4) Prescription Only Medicine
Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,Consideration should be given to official guidance on the appropriate use of antibacterial agents. Daptomycin is not indicated for the treatment of pneumonia.,Adult patients (?18 years of age),Complicated Skin and Skin Structure Infections,DAPTOMYCIN WKT is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,Staphylococcus aureus Bloodstream Infections (Bacteraemia),DAPTOMYCIN WKT is indicated in adults (?18 years of age) for Staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (RIE), caused by methicillin-susceptible and methicillin-resistant isolates.,The efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to Staphylococcus aureus has not been demonstrated. In the setting of Staphylococcus aureus bacteraemia (SAB), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).,Paediatric patients (1 to 17 years of age),Daptomycin is not indicated for treatment of patients less than 1 year of age (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, Paediatric use).,Daptomycin has not been studied in treatment of infective endocarditis in children (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).,Complicated Skin and Skin Structure Infections,DAPTOMYCIN WKT is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,Staphylococcus aureus Bloodstream Infections (Bacteraemia),DAPTOMYCIN WKT is indicated in paediatric patients (1 to 17 years of age) with Staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. Empiric treatment should be reviewed based on the results of susceptibility testing. Prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of Staphylococcus aureus bacteraemia.
Visual Identification: pale yellow to light brown freeze dried powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2023-02-20
DAPTOMYCIN WKT POWDER FOR INJECTION CMI V 1.3 ( Nov 2022) Page 1 of 6 DAPTOMYCIN WKT 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 BEING GIVEN DAPTOMYCIN WKT? DAPTOMYCIN WKT contains the active ingredient daptomycin which is used to treat complicated infections of the skin and the tissues under the skin in adults and children (1 to 17 years of age). It is also used to treat blood infections and infections of the tissues that line the inside of the heart (including heart valves). For more information, see Section 1. Why am I being given DAPTOMYCIN WKT? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN DAPTOMYCIN WKT? Do not use if you have ever had an allergic reaction to daptomycin or any of the ingredients listed at the end of the CMI. You should not be given daptomycin if you have or have had any kidney problems, are suffering from diarrhoea. 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 am given DAPTOMYCIN WKT? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Daptomycin 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 IS DAPTOMYCIN WKT GIVEN? DAPTOMYCIN WKT will be given to you by a doctor or a nurse as it needs to be given as an injection or infusion into a vein. The dose will depend on how much you weigh and the type of infection being treated. More instructions can be found in Section 4. How is DAPTOMYCIN WKT given? in the full CMI. 5. WHAT SHOULD I KNOW WHILE BEING GIVEN DAPTOMYCIN WKT? THINGS YOU SHOULD DO Remind any doctor, dentist or pharmacist you visit that you are using DAPTOMYCIN WKT Tell your doctor if any of the following occur:- • the symptoms of your infection पूरा दस्तावेज़ पढ़ें
DAPTOMYCIN WKT V1.5 Feb 2023 Page 1 of 31 AUSTRALIAN PRODUCT INFORMATION – DAPTOMYCIN WKT (DAPTOMYCIN) 1 NAME OF THE MEDICINE Daptomycin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DAPTOMYCIN WKT 350 mg powder for injection DAPTOMYCIN WKT 500 mg powder for injection DAPTOMYCIN WKT is supplied in a single-dose 15 mL capacity vial, as a sterile, preservative- free, pale yellow to light brown, lyophilised cake or powder containing 350 mg or 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9 % sodium chloride for injection. Daptomycin has a high aqueous solubility (> 1 g/mL). The only inactive ingredient is sodium hydroxide, which is used in minimal quantities for pH adjustment. 3 PHARMACEUTICAL FORM Powder for injection. Sterile, preservative-free, pale yellow to light brown, lyophilised cake or powder. 4 CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co- administered with appropriate antibacterial agent(s). Consideration should be given to official guidance on the appropriate use of antibacterial agents. Daptomycin is not indicated for the treatment of pneumonia. Adult patients (≥18 years of age) _Complicated Skin and Skin Structure Infections _ DAPTOMYCIN WKT is indicated for the treatment of adults (≥ 18 years of age) with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin. _Staphylococcus aureus Bloodstream Infections (Bacteraemia) _ DAPTOMYCIN WKT is indicated in adults (≥18 years of age) for _Staphylococcus aureus _ bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (RIE), caused by methicillin-susceptible and methicillin-resistant isolates. DAP पूरा दस्तावेज़ पढ़ें