amphotec- Amphotericin B injection, lipid complex

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

InterMune, Inc.

INN (Միջազգային անվանումը):

Amphotericin B

Դեղագործական ձեւ:

INJECTION, LIPID COMPLEX

Կազմը:

50 mg in 10 mL

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

AMPHOTEC is indicated for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate in effective doses, and in patients with invasive aspergillosis where prior amphotericin B deoxycholate therapy has failed. AMPHOTEC should not be administered to patients who have documented hypersensitivity to any of its components, unless, in the opinion of the physician, the advantages of using AMPHOTEC outweigh the risks of hypersensitivity.

Ապրանքի ամփոփագիր:

AMPHOTEC® (Amphotericin B) Cholesteryl Sulfate Complex for Injection is a sterile lyophilized powder supplied in single use glass vials. Each vial is individually packaged. AMPHOTEC 50 mg in 20 mL vial (NDC 64116-025-01) AMPHOTEC 100 mg in 50 mL vial (NDC 64116-021-01) STORAGE Store unopened vials of AMPHOTEC at 15-30°C (59-86°F). AMPHOTEC should be retained in the carton until time of use. Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH  44146, USA Distributed by: InterMune, Inc., Brisbane, CA  94005 U.S. Patent Numbers 4,822,777; 5,032,582; 5,194,266; 5,077,057. Rx Only

Ապրանքի հատկությունները

AMPHOTEC- AMPHOTERICIN B INJECTION, LIPID COMPLEX
INTERMUNE, INC.
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AMPHOTEC®
AMPHOTERICIN B CHOLESTERYL SULFATE
COMPLEX FOR INJECTION
DESCRIPTION
AMPHOTEC® is a sterile, pyrogen-free, lyophilized powder for
reconstitution and intravenous (IV)
administration. AMPHOTEC consists of a 1:1 (molar ratio) complex of
amphotericin B and cholesteryl
sulfate. Upon reconstitution, AMPHOTEC forms a colloidal dispersion of
microscopic disc-shaped
particles.
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 AND PHYSICAL
FORM OF THE LIPID
COMPONENT. SUCH DIFFERENCES MAY AFFECT THE FUNCTIONAL PROPERTIES OF
THESE DRUG PRODUCTS.
Amphotericin B is an antifungal polyene antibiotic produced by a
strain of _Streptomyces nodosus._
Amphotericin B, which is the established name for [1R
(1_R_*,3_S_*,5_R_*,6_R_*,9_R_*,11_R_*,
15_S_*,16_R_*,17_R_*,18_S_*,19_E_,21_E_,23_E_,25_E_,27_E_,29_E_,31_E_,33_R_*,35_S_*,36_R_*,37_S_*)]-33-[(3-Amino-3,6-
dideoxy-_ß_-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, has the
following structure:
The molecular formula of the drug is C
H NO ; its molecular weight is 924.10.
AMPHOTEC is available in 50 mg and 100 mg single dose vials. Each 50
mg single dose vial contains
amphotericin B, 50 mg; sodium cholesteryl sulfate, 26.4 mg;
tromethamine, 5.64 mg; disodium edetate
dihydrate, 0.372 mg; lactose monohydrate, 950 mg; and hydrochloric
acid, qs, as a sterile,
nonpyrogenic, lyophilized powder. Each 100 mg single dose vial
contains amphotericin B, 100 mg;
sodium cholesteryl sulfate, 52.8 mg; tromethamine, 11.28 mg; disodium
edetate dihydrate, 0.744 mg;
lactose monohydrate, 1900 mg; and hy