ABELCET SUSPENSION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

AMPHOTERICIN B

Dostupné s:

LEADIANT BIOSCIENCES, INC

ATC kód:

J02AA01

INN (Mezinárodní Name):

AMPHOTERICIN B

Dávkování:

5MG

Léková forma:

SUSPENSION

Složení:

AMPHOTERICIN B 5MG

Podání:

INTRAVENOUS

Jednotky v balení:

20ML

Druh předpisu:

Prescription

Terapeutické oblasti:

POLYENES

Přehled produktů:

Active ingredient group (AIG) number: 0105864002; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2002-10-04

Charakteristika produktu

PRODUCT MONOGRAPH
PR
ABELCET
®
(Amphotericin B Lipid Complex Injection)
5 mg Amphotericin B/mL: 20 mL Vial
Injectable Suspension
Antifungal
Leadiant Biosciences, Inc. Date of Revision:
2000 Ellesmere Road, Unit 16
July 20, 2017
Scarborough, Ontario
M1H 2W4
Control#: 206278
2
PRODUCT MONOGRAPH
PR
ABELCET
®
(Amphotericin B Lipid Complex Injection)
5 mg Amphotericin B/mL: 20 mL Vial
Injectable Suspension
THERAPEUTIC CLASSIFICATION
Antifungal
ACTION AND CLINICAL PHARMACOLOGY
The active component in Amphotericin B Lipid Complex Injection is
amphotericin B which
acts by binding to sterols in the cell membrane of susceptible fungi,
with a resultant change in
permeability of the membrane. Mammalian cell membranes also contain
sterols, and damage
to human cells is believed to occur through the same mechanism of
action.
PHARMACOKINETICS: The pharmacokinetics of amphotericin B after the
administration of
ABELCET
®
are nonlinear. Volume of distribution and clearance from blood
increase with
increasing dose of ABELCET
®
, resulting in less than proportional increases in blood
concentrations of amphotericin B over a dose range of 0.6-5 mg/kg/day.
The
pharmacokinetics of amphotericin B in whole blood after the
administration of ABELCET
®
and amphotericin B desoxycholate are shown in Table 1.
3
TABLE 1. PHARMACOKINETIC PARAMETERS OF AMPHOTERICIN B IN WHOLE BLOOD
IN PATIENTS
ADMINISTERED MULTIPLE DOSES OF ABELCET
® OR AMPHOTERICIN B DESOXYCHOLATE
PHARMACOKINETIC PARAMETER
ABELCET
®
5 MG/KG/DAY FOR 5-7 DAYS
MEAN ± SD
AMPHOTERICIN B
0.6 MG/KG/DAY FOR 42 DAYS
A
MEAN ± SD
Peak Concentration (µg/mL)
1.7 ± 0.8 (n=10)
b
1.1 ± 0.2 (n=5)
Concentration at End of Dosing Interval
(µg/mL)
0.6 ± 0.3 (n=10)
b
0.4 ± 0.2 (n=5)
Area Under Blood Concentration-Time
Curve (AUC
0-24h
) (µg*h/mL)
14 ± 7 (n=14)
b,c
17.1 ± 5 (n=5)
Clearance (mL/h*kg)
436 ± 188.5 (n=14)
b,c
38 ± 15 (n=5)
Apparent Volume of Distribution
(Vd
area
) (L/kg)
131 ± 57.7 (n=8)
c
5 ± 2.8 (n=5)
Terminal Elimination Half-Life (h)
173.4 ± 78 (n=8)
c
91.1 ± 40