AMBISOME- amphotericin b injection, powder, lyophilized, for solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

AMPHOTERICIN B (UNII: 7XU7A7DROE) (AMPHOTERICIN B - UNII:7XU7A7DROE)

Prieinama:

Astellas Pharma US, Inc.

INN (Tarptautinis Pavadinimas):

AMPHOTERICIN B

Sudėtis:

AMPHOTERICIN B 50 mg in 12.5 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

AmB isome is indicated for the following: See DOSAGE AND ADMINISTRATION for recommended doses by indication. AmB isome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.

Produkto santrauka:

AmB isome for Injection is available as an individual carton (NDC 0469-3051-30). Each carton contains one pre-packaged, disposable sterile 5 micron filter.

Autorizacija statusas:

New Drug Application

Prekės savybės

AMBISOME- AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ASTELLAS PHARMA US, INC.
----------
AMBISOME
(AMPHOTERICIN B) LIPOSOME FOR INJECTION
DESCRIPTION
AmBisome
for Injection is a sterile, non-pyrogenic lyophilized product for
intravenous infusion. Each
vial contains 50 mg of amphotericin B, USP, intercalated into a
liposomal membrane consisting of
approximately 0.64 mg alpha tocopherol, USP; 52 mg cholesterol, NF; 84
mg distearoyl
phosphatidylglycerol, sodium salt; 213 mg hydrogenated soy
phosphatidylcholine. In addition, 27 mg
disodium succinate hexahydrate and 900 mg sucrose, NF are used as a
buffer. AmBisome may contain
hydrochloric acid and/or sodium hydroxide as pH adjusters. Following
reconstitution with Sterile
Water for Injection, USP, the resulting pH of the suspension is
between 5-6.
AmBisome is a true single bilayer liposomal drug delivery system.
Liposomes are closed, spherical
vesicles created by mixing specific proportions of amphophilic
substances such as phospholipids and
cholesterol so that they arrange themselves into multiple concentric
bilayer membranes when hydrated
in aqueous solutions. Single bilayer liposomes are then formed by
microemulsification of multilamellar
vesicles using a homogenizer. AmBisome consists of these unilamellar
bilayer liposomes with
amphotericin B intercalated within the membrane. Due to the nature and
quantity of amphophilic
substances used, and the lipophilic moiety in the amphotericin B
molecule, the drug is an integral part of
the overall structure of the AmBisome liposomes. AmBisome contains
true liposomes that are less than
100 nm in diameter. A schematic depiction of the liposome is presented
below.
Note: Liposomal encapsulation or incorporation into a lipid complex
can substantially affect a drug’s
®
®
functional properties relative to those of the unencapsulated drug or
non-lipid associated drug. In
addition, different liposomal or lipid-complex products with a common
active ingredient may vary from
one another in the chemical composition