Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
micafungin sodium, Quantity: 101.73 mg (Equivalent: micafungin, Qty 100 mg)
Astellas Pharma Australia Pty Ltd
Micafungin sodium
Injection, powder for
Excipient Ingredients: citric acid; sodium hydroxide; lactose monohydrate
Intravenous Infusion
1 vial, 10 vials
(S4) Prescription Only Medicine
MYCAMINE is indicated for: ? treatment of invasive candidiasis in children and adults ? treatment of oesophageal candidiasis in adults, adolescents greater than or equal to 16 years of age and the elderly patients for whom intravenous therapy is appropriate ? prophylaxis of Candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/?L) for 10 or more days.
Visual Identification: White coloured powder for injection; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2013-05-08
MYCAMINE ® M y c a m i n e ® 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 MYCAMINE? Mycamine contains the active ingredient micafungin (as sodium). Mycamine is used to treat a number of different conditions and illnesses (see Section 1. Why am I using MYCAMINE? in the CMI for full detail). The most common uses are to treat a serious fungal infection called invasive candidiasis; fungal infection in the food pipe (oesophagus); Candida (yeast) infection while undergoing a certain type of stem cell transplant or if you are expected to have white blood cell counts below a certain level. 2. WHAT SHOULD I KNOW BEFORE I USE MYCAMINE? Do not use if you have ever had an allergic reaction to Mycamine or any of the ingredients listed at the end of the CMI. There are a number of circumstances in which a person should not use this medicine or may need to use caution. It is important to understand if these apply to you before taking Mycamine (see Section 2. What should I know before I use MYCAMINE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with MYCAMINE 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 MYCAMINE? Mycamine must be prepared and given to you by a nurse or another health care professional. Your doctor will decide how much Mycamine you will receive each day. More instructions can be found in Section 4. How do I use MYCAMINE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING MYCAMINE? THINGS YOU SHOULD DO • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are receiving Mycamine. • Tell any other doctors, dentists, and pharmacists who treat you that you are having this medicine. • If you are going to have surgery, tell the surgeon or anaesthetist that you are having this medicine. It may aff Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION MYCAMINE ® (MICAFUNGIN) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Micafungin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MYCAMINE 50 mg contains 50.86 mg micafungin sodium, corresponding to 50 mg micafungin. MYCAMINE 100 mg contains 101.73 mg micafungin sodium, corresponding to 100 mg micafungin. For the full list of excipients, refer to Section 6.1 – LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM Powder for injection vial. MYCAMINE 50 mg and 100mg is a white coloured powder for injection. The powder must be diluted with either sodium chloride 0.9% or glucose 5% solution prior to use (refer to Section 4.2 - DOSE AND METHOD OF ADMINISTRATION). 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS MYCAMINE is indicated for: • Treatment of invasive candidiasis in children and adults • Treatment of oesophageal candidiasis in adults, adolescents ≥ 16 years of age and the elderly patients for whom intravenous therapy is appropriate • Prophylaxis of Candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µL) for 10 or more days 4.2 D OSE AND METHOD OF ADMINISTRATION MYCAMINE must be diluted with either sodium chloride 0.9% or glucose 5% solution prior to use. MYCAMINE should be administered once daily by intravenous infusion. The dosage depends on the indication and body weight of the patient as shown in Tables 1, 2 and 3 below. TABLE 1. DOSAGE FOR ADULTS, ADOLESCENTS ≥ 16 YEARS OF AGE AND THE ELDERLY INDICATION BODY WEIGHT > 40 KG BODY WEIGHT ≤ 40 KG Treatment of invasive candidiasis 100 mg/day* 2 mg/kg/day* Treatment of oesophageal 150 mg/day 3 mg/kg/day 2 candidiasis Prophylaxis of Candida infection 50 mg/day 1 mg/kg/day * If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weig Prečítajte si celý dokument