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ELITEK- rasburicase kit


  1. Patient Information
  2. Revised: 11/2018document Id:

Patient Information 

Hypersensitivity Reactions

Instruct patients to notify their physician immediately if any of the following occur: allergic reaction, bronchospasm, chest pain or tightness, dyspnea, hypoxia, hypotension, shock or urticaria [seeBoxed Warning,Warnings and Precautions (5.1)].

Manufactured by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
U.S. License No. 1752

Revised: 09/2017

2017 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - 1.5 mg Kit Carton

NDC0024-5150-10

ELITEK
rasburicase

1.5 mg

Three single-use vials
Three diluent ampules

FOR INTRAVENOUS INFUSION

Sterile Contains No Preservatives Single Use Vials

Rx only

Sanofi

PRINCIPAL DISPLAY PANEL - 1.5 mg Kit Carton

PRINCIPAL DISPLAY PANEL - 7.5 mg Kit Carton

NDC0024-5151-75

ELITEK
rasburicase

7.5 mg

One single-use vial
One diluent ampule

FOR INTRAVENOUS INFUSION

Sterile Contains No Preservatives Single Use Vial

Rx only

Sanofi

PRINCIPAL DISPLAY PANEL - 7.5 mg Kit Carton
ELITEK
rasburicase kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0024-5150
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0024-5150-103 in 1 CARTON07/12/2002
11 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, SINGLE-USE1 mL
Part 21 AMPULE1 mL
Part 1 of 2
ELITEK
rasburicase injection, powder, lyophilized, for solution
Product Information
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RASBURICASE(UNII: 08GY9K1EUO) (RASBURICASE - UNII:08GY9K1EUO)RASBURICASE1.5 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL(UNII: 3OWL53L36A)10.6 mg in 1 mL
ALANINE(UNII: OF5P57N2ZX)15.9 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)13.45 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10394607/12/2002
Part 2 of 2
DILUENT
diluent injection, solution
Product Information
Route of AdministrationINTRAVENOUS
Inactive Ingredients
Ingredient NameStrength
WATER(UNII: 059QF0KO0R)
POLOXAMER 188(UNII: LQA7B6G8JG)1 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10394607/12/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10394607/12/2002
ELITEK
rasburicase kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0024-5151
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0024-5151-751 in 1 CARTON06/01/2006
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, SINGLE-USE5 mL
Part 21 AMPULE5 mL
Part 1 of 2
ELITEK
rasburicase injection, powder, lyophilized, for solution
Product Information
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RASBURICASE(UNII: 08GY9K1EUO) (RASBURICASE - UNII:08GY9K1EUO)RASBURICASE7.5 mg in 5 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL(UNII: 3OWL53L36A)53 mg in 5 mL
ALANINE(UNII: OF5P57N2ZX)79.9 mg in 5 mL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)67.25 mg in 5 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10394606/01/2006
Part 2 of 2
DILUENT
diluent injection, solution
Product Information
Route of AdministrationINTRAVENOUS
Inactive Ingredients
Ingredient NameStrength
WATER(UNII: 059QF0KO0R)
POLOXAMER 188(UNII: LQA7B6G8JG)5 mg in 5 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10394606/01/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10394606/01/2006
Labeler -Sanofi-Aventis U.S. LLC (824676584)
Establishment
NameAddressID/FEIBusiness Operations
Sanofi Chimie262699775ANALYSIS(0024-5150, 0024-5151) , API MANUFACTURE(0024-5150, 0024-5151)
Establishment
NameAddressID/FEIBusiness Operations
Sanofi S.p.A338454274ANALYSIS(0024-5150, 0024-5151) , LABEL(0024-5150, 0024-5151) , MANUFACTURE(0024-5150, 0024-5151) , PACK(0024-5150, 0024-5151)

Revised: 11/2018document Id: 

7fe684f0-3823-46ad-b6a2-37ab919220a4Set id: 0ae10bc4-6b65-402f-9db5-2d7753054922Version: 18Effective Time: 20181104Sanofi-Aventis U.S. LLC



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