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

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

amphotericin B, Quantity: 50 mg

Disponível em:

Sun Pharma ANZ Pty Ltd

Forma farmacêutica:

Injection, powder for

Composição:

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

Via de administração:

Intravenous Infusion

Unidades em pacote:

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

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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

Resumo do produto:

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

Status de autorização:

Registered

Data de autorização:

2023-03-15