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

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

amphotericin B, Quantity: 50 mg

Beschikbaar vanaf:

Sun Pharma ANZ Pty Ltd

farmaceutische vorm:

Injection, powder for

Samenstelling:

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

Toedieningsweg:

Intravenous Infusion

Eenheden in pakket:

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

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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.

Product samenvatting:

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

Autorisatie-status:

Registered

Autorisatie datum:

2023-03-15