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

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
15-03-2023

Aktivna sestavina:

amphotericin B, Quantity: 50 mg

Dostopno od:

Sun Pharma ANZ Pty Ltd

Farmacevtska oblika:

Injection, powder for

Sestava:

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

Pot uporabe:

Intravenous Infusion

Enote v paketu:

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

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

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 dovoljenje:

Registered

Datum dovoljenje:

2023-03-15