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GLIADEL® Wafer(十)
2013-09-20 17:38:34 来源: 作者: 【 】 浏览:6861次 评论:0
2.
AMA Council Report, Guidelines for Handling Parenteral Antineoplastics. JAMA, 1985; 253(11):1590-1592.
National Study Commission on Cytotoxic Exposure -- Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia, 1983; 1:426-428.
Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA -- A Cancer Journal for Clinicians, 1983; (Sept/Oct) 258-263.
American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J. Hosp Pharm, 1990; 47:1033-1049.
OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm, 1986; 43:1193-1204.
NDC: 62856-177-08

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

Manufactured by

Eisai Inc.
Woodcliff Lake, NJ 07677

Rev. 04/2010

201241
PRINCIPAL DISPLAY PANEL
NDC 62856-177-08

Caution Card:


Pouch Label:


Box Label:

 

GLIADEL 
polifeprosan 20 with carmustine implant wafer
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62856-177
Route of Administration INTRACAVITARY DEA Schedule      
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARMUSTINE (CARMUSTINE)  CARMUSTINE 7.7 mg
Inactive Ingredients
Ingredient Name Strength
POLIFEPROSAN 20  
Product Characteristics
Color white (white)  Score no score
Shape ROUND (ROUND)  Size 15mm
Flavor  Imprint Code 
Contains     
Packaging
# Item Code Package Description
1 NDC:62856-177-08 8 in 1 BOX
1  1 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020637 09/24/1996 
Labeler - Eisai Inc. (831600833) 
Registrant - Eisai Inc. (831600833)
Establishment
Name Address ID/FEI Business Operations
Eisai Inc.  624009093 MANUFACTURE

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