ABELCET- amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl- injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

AMPHOTERICIN B (UNII: 7XU7A7DROE) (AMPHOTERICIN B - UNII:7XU7A7DROE), DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- (UNII: U86ZGC74V5) (DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- - UNII:U86ZGC74V5), DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- (UNII: BI71WT9P3R) (DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- - UNII:BI71WT9P3R)

Tilgjengelig fra:

Leadiant Biosciences, Inc.

INN (International Name):

AMPHOTERICIN B

Sammensetning:

AMPHOTERICIN B 5 mg in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

ABELCET ® is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin B therapy (See DESCRIPTION OF CLINICAL STUDIES). DESCRIPTION OF CLINICAL STUDIES Fungal Infections Data from 473 patients were pooled from three open-label studies in which ABELCET ® was provided for the treatment of patients with invasive fungal infections who were judged by their physicians to be refractory to or intolerant of conventional amphotericin B, or who had preexisting nephrotoxicity. Results of these studies demonstrated effectiveness of ABELCET ® in the treatment of invasive fungal infections as a second line therapy. Patients were defined by their individual physician as being refractory to or failing conventional amphotericin B therapy based on overall clinical judgement after receiving a minimu

Produkt oppsummering:

Single-use vials along with 5-micron filter needles are individually packaged. 100 mg of ABELCET ® in 20 mL of suspension NDC 57665-101-41 Prior to admixture, ABELCET ® should be stored at 2° to 8°C (36° to 46°F) and protected from exposure to light. Do not freeze. ABELCET ® should be retained in the carton until time of use. The admixed ABELCET ® and 5% Dextrose Injection may be stored for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature. Do not freeze. Any unused material should be discarded. U.S. Patent Nos. 4,973,465 5,616,334 6,406,713 I-101-41-US-Q Manufactured by Exelead, Inc., Indianapolis, IN 46268 Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878 Revised 11/2018

Autorisasjon status:

New Drug Application

Preparatomtale

ABELCET- AMPHOTERICIN B, DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- AND
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- INJECTION
LEADIANT BIOSCIENCES, INC.
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ABELCET® (AMPHOTERICIN B LIPID COMPLEX INJECTION) 100 MG
DESCRIPTION
ABELCET
is a sterile, pyrogen-free suspension for intravenous infusion.
ABELCET
consists of amphotericin B complexed with two phospholipids in a 1:1
drug-to-lipid
molar ratio. The two phospholipids,
l-α-dimyristoylphosphatidylcholine (DMPC) and l-α-
dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar
ratio. ABELCET
is
yellow and opaque in appearance, with a pH of 5 - 7.
NOTE: LIPOSOMAL ENCAPSULATION OR INCORPORATION IN A LIPID COMPLEX
CAN
SUBSTANTIALLY AFFECT A DRUG’S FUNCTIONAL PROPERTIES RELATIVE TO
THOSE OF THE
UNENCAPSULATED OR NONLIPID-ASSOCIATED DRUG. IN ADDITION, DIFFERENT
LIPOSOMAL
OR LIPID-COMPLEXED PRODUCTS WITH A COMMON ACTIVE INGREDIENT MAY VARY
FROM
ONE ANOTHER IN THE CHEMICAL COMPOSITION AND PHYSICAL FORM OF THE LIPID
COMPONENT. SUCH DIFFERENCES MAY AFFECT FUNCTIONAL PROPERTIES OF THESE
DRUG
PRODUCTS.
Amphotericin B is a polyene, antifungal antibiotic produced from a
strain of
_Streptomyces nodosus_. Amphotericin B is designated chemically as
[1R-(1R*, 3S*, 5R*,
6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E,
31E, 33R*,
35S*, 36R*, 37S*)]-33-[(3-Amino-3, 6-dideoxy- β-D-mannopyranosyl)
oxy]-
1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]
nonatriaconta-19, 21, 23, 25, 27, 29, 31-heptaene-36-carboxylic acid.
It has a molecular weight of 924.09 and a molecular formula of C
H
NO
. The
structural formula is:
ABELCET
is provided as a sterile, opaque suspension in 20 mL glass, single-use
vials.
Each 20 mL vial contains 100 mg of amphotericin B in 20 mL of
suspension (see
DOSAGE AND ADMINISTRATION), and each mL of ABELCET
contains:
Amphotericin B USP 5.0 mg
l-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg
l-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg
®
®
®
47
73
17
®
®
Sodium Chloride USP 9.0 mg
Water