AMBISOME POWDER FOR SOLUTION

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

AMPHOTERICIN B

Հասանելի է:

ASTELLAS PHARMA CANADA INC

ATC կոդը:

J02AA01

INN (Միջազգային անվանումը):

AMPHOTERICIN B

Դոզան:

50MG

Դեղագործական ձեւ:

POWDER FOR SOLUTION

Կազմը:

AMPHOTERICIN B 50MG

Կառավարման երթուղին:

INTRAVENOUS

Միավորները փաթեթում:

1/10 VIALS (20 OR 30 ML VIALS)

Ռեկվիզորի տեսակը:

Prescription

Թերապեւտիկ տարածք:

POLYENES

Ապրանքի ամփոփագիր:

Active ingredient group (AIG) number: 0105864001; AHFS:

Լիազորման կարգավիճակը:

APPROVED

Հաստատման ամսաթիվը:

2011-03-01

Ապրանքի հատկությունները

PRODUCT MONOGRAPH
PR
AMBISOME
®
liposomal amphotericin B for injection
50 mg Amphotericin B per vial
ANTIFUNGAL
Distributed by:
Astellas Pharma Canada, Inc.
Markham, Ontario L3R 0B8
Date of Revision: January 13, 2020
Manufactured by:
Gilead Sciences
San Dimas, CA USA.
CONTROL NUMBER 232288
243633-AMB-CAN
AmBisome Product Monograph
Page 2 of 33
PRODUCT MONOGRAPH
PR
AMBISOME
®
liposomal amphotericin B for injection
50 mg Amphotericin B per vial
THERAPEUTIC CLASSIFICATION
ANTIFUNGAL
ACTION AND CLINICAL PHARMACOLOGY
The active component of AmBisome
®
(liposomal amphotericin B for injection) is amphotericin B, which
acts by binding to the ergosterol component in the cell membrane of
susceptible fungi. This results in a
change in membrane permeability allowing leakage of cell components.
While amphotericin B has a
higher affinity for the ergosterol component of the fungal cell
membrane, it can also bind to the
cholesterol component of the mammalian cell membrane and the damage to
human cells and fungal cells
may share a common mechanism.
AmBisome is a true single bilayer liposomal drug delivery system.
Liposomes are closed, spherical
vesicles created by mixing specific proportions of amphiphilic
substances such as phospholipids and
cholesterol so that they arrange themselves into multiple concentric
bilayer membranes when hydrated in
aqueous solutions. AmBisome consists of these unilamellar bilayer
liposomes with amphotericin B
intercalated within the membrane, forming a charge transfer complex
with the distearoyl
phosphatidylglycerol. Due to the nature and quantity of amphiphilic
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. The
unique size of the AmBisome liposomes results in therapeutic levels at
diverse sites of fungal infections
within the body. A schematic depiction of the liposome is presented in
Figure 1.
FIGURE 1: SCHEMATIC CROS