AMPHOTERICIN B FOR INJECTION, USP POWDER FOR SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

AMPHOTERICIN B

Доступно од:

STERIMAX INC

АТЦ код:

J02AA01

INN (Међународно име):

AMPHOTERICIN B

Дозирање:

50MG

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

AMPHOTERICIN B 50MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

50MG

Тип рецептора:

Prescription

Терапеутска област:

POLYENES

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2013-04-22

Карактеристике производа

1
PRODUCT MONOGRAPH
PR
AMPHOTERICIN B FOR INJECTION, USP
AMPHOTERICIN B FOR INJECTION, USP
50 MG OF AMPHOTERICIN B PER VIAL
FOR INTRAVENOUS INFUSION
ANTIFUNGAL AGENT
STERIMAX INC.
SUITE 1, MATHESON BLVD. E
MISSISSAUGA, ON L4W 4M8
DATE OF PREPARATION: APRIL 15, 2013
CONTROL NO. 141661
2
PRODUCT MONOGRAPH
PR
AMPHOTERICIN B FOR INJECTION, USP
For intravenous infusion
THERAPEUTIC CLASSIFICATION
Antifungal Agent
ACTION AND CLINICAL PHARMACOLOGY
Amphotericin B is fungistatic or fungicidal depending on the
concentration obtained in body fluids and
the susceptibility of the fungus. It has been shown to exhibit a high
order of
_in vitro_
activity against a
broad spectrum of yeast and fungi.
The drug probably acts by binding to sterols present in the membrane
of sensitive fungi, with the resultant
change in permeability allowing leakage of a variety of small
molecules. Since mammalian cell
membranes also contain sterols, it has been suggested that the damage
to human cells and fungal cells
may share common mechanisms.
Following intravenous infusion, the antibiotic is slowly excreted by
the kidneys, and demonstrable blood
levels persist for at least 18 hours after the infusion is
discontinued.
INDICATIONS AND CLINICAL USE
Amphotericin B for Injection, USP is specifically intended for the
treatment of disseminated mycotic
infections, including coccidioidomycosis; cryptococcosis (torulosis);
disseminated candidiasis,
histoplasmosis, South American leishmaniasis, North and South American
blastomycosis; mucormycosis
(phycomycosis) caused by species of the genera Mucor, Rhizopus,
Absidia, Entomophthora, and
Basidiobolus, sporotrichosis (
_Sporotrichum schenckii_
), and aspergillosis (
_Aspergillus fumigatus_
).
OTHER CLINICAL USES
Limited studies have shown that amphotericin B powder for injection
may be useful when administered
by routes other than intravenous for the treatment of certain types of
fungal infections.
1. Administration by Bladder Irrigation
The effective use of amphotericin B for fungal infections of the
bladder