Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
daptomycin
Panpharma Australia Pty Ltd
Registered
Daptomycin Panpharma Version 1.4 1 DAPTOMYCIN PANPHARMA DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION 350 MG AND 500 MG_ _ _Daptomycin (pronounced DAP-toe-My-sin) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Daptomycin Panpharma. 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 taking this medicine against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DAPTOMYCIN PANPHARMA IS USED FOR _WHAT IT IS USED FOR _ Daptomycin Panpharma is used in adults and children (1 to 17 years of age) to treat complicated infections of the skin and the tissues under the skin. It is also used in adults to treat blood infections. It is also used in adults to treat infections of the tissues that line the inside of the heart (including heart valves) - that are caused by Staphylococcus aureus bacteria. Daptomycin Panpharma will not work against infections that cause pneumonia (a serious infection or inflammation in the lung tissue). _ _ _ _ _HOW DAPTOMYCIN PANPHARMA _ _WORKS _ Daptomycin Panpharma is an antibiotic that belongs to a group of medicines called cyclic lipopeptides. These antibiotics work by killing the Gram-positive bacteria that are causing your infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DAPTOMYCIN PANPHARMA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. This medicine is available only with a doctor's prescription. Daptomycin Panpharma is not addictive. BEFORE YOU HAVE DAPTOMYCIN PANPHARMA _WHEN YOU MUST NOT HAVE IT _ YOU MUST NOT HAVE DAPTOMYCIN PANPHARMA IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO DAPTOMYCIN, THE ACTIVE INGREDIENT, OR TO ANY OF THE OTHER INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symptom Read the complete document
Product Information Page 1 Daptomycin Panpharma (350 mg & 500 mg) Version 1.0 AUSTRALIAN PRODUCT INFORMATION – DAPTOMYCIN PANPHARMA (DAPTOMYCIN) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Daptomycin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Daptomycin 350 mg powder for injection. Daptomycin Panpharma 350 mg contains 350 mg daptomycin. One mL provides 50 mg of daptomycin after reconstitution with 7 mL of sodium chloride 9 mg/mL (0.9%) solution. Daptomycin 500 mg powder for injection. Daptomycin Panpharma 500 mg contains 500 mg daptomycin. One mL provides 50 mg of daptomycin after reconstitution with 10 mL of sodium chloride 9 mg/mL (0.9%) solution. Daptomycin is the active ingredient in Daptomycin Panpharma. It is a cyclic lipopeptide antibacterial agent derived from the fermentation of _Streptomyces roseosporus_ . Active ingredient: daptomycin Chemical names: _N_ -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L- ornithyl-L-aspartyl-D-alanyl-L- aspartylglycyl-D-seryl- _threo_ -3- methyl-L- glutamyl-3- anthraniloyl-L-alanine Ɛ1 -lactone Molecular weight: 1620.67 Molecular formula C 72 H 101 N 17 O 26 Daptomycin Panpharma is supplied in a single-use 15 mL vial, as a sterile, preservative-free, pale yellow to light brown, lyophilised cake or powder containing at least 900 mg/g of daptomycin for intravenous (IV) use following reconstitution with 0.9 % sodium chloride 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. Product Information Page 2 Daptomycin Panpharma (350 mg & 500 mg) Version 1.0 4 CLINICAL PARTICULARS 4.1 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 ant Read the complete document