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

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

amphotericin B, Quantity: 50 mg

MAH:

Sun Pharma ANZ Pty Ltd

pharmaceutical_form:

Injection, powder for

composition:

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

administration_route:

Intravenous Infusion

units_in_package:

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

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

AMPHOTERICIN LIPOSOMAL RBX 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 RBX 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 RBX is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to Leishmania infantum.

leaflet_short:

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