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

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
15-03-2023

Toimeaine:

amphotericin B, Quantity: 50 mg

Saadav alates:

Sun Pharma ANZ Pty Ltd

Ravimvorm:

Injection, powder for

Koostis:

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

Manustamisviis:

Intravenous Infusion

Ühikuid pakis:

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

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

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.

Toote kokkuvõte:

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

Volitamisolek:

Registered

Loa andmise kuupäev:

2023-03-15