AMPHOTERICIN LIPOSOMAL SUN amphotericin B (amphotericin) 50mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amphotericin B, Quantity: 50 mg

Available from:

Sun Pharma ANZ Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: hydrogenated soy phosphatidylcholine; cholesterol; 1,2-distearoyl-sn-glycero-3-phospho-(1'-rac-glycerol) sodium; sodium succinate hexahydrate; sucrose; sodium hydroxide; dl-alpha-tocopherol; hydrochloric acid

Administration route:

Intravenous Infusion

Units in package:

10 x vials + 10x 5 micrometre sterile filters, Single vial and single 5 micrometre sterile filter

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AMPHOTERICIN LIPOSOMAL SUN 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 section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).,AMPHOTERICIN LIPOSOMAL SUN is indicated for empirical treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment.,AMPHOTERICIN LIPOSOMAL SUN is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to Leishmania infantum.

Product summary:

Visual Identification: Yellow coloured lyophilized mass or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2023-03-15