Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
amphotericin B (UNII: 7XU7A7DROE) (amphotericin B - UNII:7XU7A7DROE)
InterMune, Inc.
Amphotericin B
INJECTION, LIPID COMPLEX
50 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
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
AMPHOTEC- AMPHOTERICIN B INJECTION, LIPID COMPLEX INTERMUNE, INC. ---------- 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 Prečítajte si celý dokument