Country: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
amphotericin B, Quantity: 50 mg
Gilead Sciences Pty Ltd
amphotericin B (amphotericin)
Injection, powder for
Excipient Ingredients: hydrogenated soy phosphatidylcholine; sucrose; dl-alpha-tocopherol; distearoylphosphatidylglycerol; sodium succinate; cholesterol
Intravenous
10 x 50mg + 10 x 5 micrometre filters, single vial and a single 5um filter
(S4) Prescription Only Medicine
INDICATIONS: Ambisome is indicated for: prophylaxis in liver transplant patients at risk of systemic Candida, Aspergillus and Cryptococcus infections, and for the treatment of systemic fungal infections caused by organisms susceptible to Amphotericin B (see Clinical Trials). Ambisome is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to Leishmania infantum. INDICATED AS AT 8 SEPTEMBER 2003 :AmBisome is indicated for: prophylaxis in liver transplant patients at risk of systemic Candida, Aspergillus and Cryptococcus infections, and for the treatment of systemic fungal infections caused by organisms susceptible to Amphotericin B (see Clinical Trials). AmBisome is indicated for empirical treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment. AmBisome is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to Leishmania infantum.
Visual Identification: A yellow lyophilised cake or powder.; Container Type: Vial; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1996-01-30
AmBisome CMI v2.0 (30 March 2017) Page 1 of 2 AMBISOME POWDER FOR INJECTION VIAL _Liposomal amphotericin B (amphotericin) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AmBisome. The medicine your doctor has prescribed for you is called AmBisome for Injection. This is the brand name of a drug called liposomal amphotericin B (amphotericin). All medicines have risks and benefits. Your doctor has weighed the risks of you having AmBisome against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS AMBISOME USED FOR AmBisome contains amphotericin B (amphotericin) which belongs to a group of medicines called antifungals. It is used to help the body overcome serious fungal infections by either killing the fungus or stopping it spreading. Amphotericin B (amphotericin) is also used to treat a disease which is rare in Australia called leishmaniasis. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AMBISOME HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed AmBisome for another reason. AmBisome is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN AMBISOME _WHEN YOU MUST NOT HAVE IT_ : DO NOT HAVE AMBISOME IF YOU ARE ALLERGIC TO: • amphotericin B (amphotericin) or • any of the other ingredients in AmBisome listed at the end of this leaflet. _BEFORE YOU ARE GIVEN IT _ Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have, or have had, any of the following medical conditions: • kidney disease • liver disease • diabetes TELL YOUR DOCTOR IF YOU ARE PREGNANT, OR LIKELY TO BECOME PREGNANT DURING YOUR COURSE OF MEDICATION. Your doctor can discuss with you the benefits and risks of having AmBisome. TELL YOUR DOCTOR IF YOU ARE BREASTFEEDING, OR LIKELY TO BREASTFEED DURING YOUR COURSE O Lestu allt skjalið
1 AUSTRALIAN PRODUCT INFORMATION – AMBISOME ® (LIPOSOMAL AMPHOTERICIN) INJECTION 1 NAME OF THE MEDICINE AmBisome (liposomal amphotericin). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AmBisome is available in vials as powder for injection. Each vial contains amphotericin B.P. equivalent to 50 mg of amphotericin B encapsulated in the bilayer of liposomes consisting of approximately 213 mg hydrogenated soy phosphatidylcholine, 52 mg cholesterol, 84 mg distearoylphosphatidylglycerol (as the sodium salt), 0.64 mg alpha-tocopherol together with 900 mg sucrose, and 27 mg sodium succinate hexahydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM AmBisome is a sterile, lyophilised product for intravenous infusion. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS AmBisome is indicated for: • prophylaxis in liver transplant patients at risk of systemic Candida, Aspergillus and Cryptococcus infections, and for • the treatment of systemic fungal infections caused by organisms susceptible to Amphotericin B (See 5.1 Pharmacodynamic Properties, Clinical Trials). AmBisome is indicated for empirical treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment. AmBisome is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to _Leishmania infantum_ . 4.2 D OSE AND METHOD OF ADMINISTRATION AmBisome should be administered by intravenous infusion over 30 to 60 minutes. The recommended concentration for intravenous infusion is 0.20 mg/mL to 2.00 mg/mL amphotericin as AmBisome. Dosage of amphotericin as AmBisome must be adjusted to the specific requirements of each patient. a) For systemic mycoses, therapy is usually instituted at a daily dose of 1.0 mg/kg/day of body weight, and increased stepwise to 5.0 mg/kg/day, as required. 2 Data are presently insufficient to define total dosage requirements and duration of treatment necessa Lestu allt skjalið