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ERWINAZE- asparaginase injection, powder, lyophilized, for solution


  1. Patient Information
  2. Revised: 3/2016document Id:

Patient Information 

Instruct patients on the risk of allergic reactions, including anaphylaxis. Describe the symptoms of allergic reactions, including anaphylaxis, and instruct the patient to seek medical advice immediately if they experience such symptoms.
Instruct patients on the risk of pancreatitis and to seek medical advice immediately if they experience abdominal pain.
Instruct patients on the risk of hyperglycemia and glucose intolerance. Advise patients to seek medical advice if they experience excessive thirst or any increase in the volume or frequency of urination.
Instruct patients on the risk of thrombosis and hemorrhage and to seek medical advice immediately if they experience headache, arm or leg swelling, shortness of breath, and chest pain.

Manufactured by:
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304
U.S. License No. 1901

Erwinazeis a registered trademark of Porton Biopharma Limited used under license by Jazz Pharmaceuticals.

PRINCIPAL DISPLAY PANEL
5 Vials NDC 57902-249-05
asparaginaseErwinia chrysanthemi
Erwinaze
For injection, Intramuscular or Intravenous Use
10,000 International Units per Vial

Rx Only Single Use Vial. Discard unused portion.

carton
ERWINAZE
asparaginase injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57902-249
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPARAGINASE ERWINIA CHRYSANTHEMI(UNII: D733ET3F9O) (ASPARAGINASE - UNII:G4FQ3CKY5R)ASPARAGINASE ERWINIA CHRYSANTHEMI10000 [iU] in 1 mL
Inactive Ingredients
Ingredient NameStrength
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)5 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)0.5 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57902-249-055 in 1 CARTON11/18/2011
1NDC:57902-249-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12535911/18/2011
Labeler -Jazz Pharmaceuticals, Inc. (135926363)
Registrant -Jazz Pharmaceuticals, Inc. (135926363)

Revised: 3/2016document Id: 

4da45931-b925-4f47-9cf1-4fcfb12c5b29Set id: 30bdf2ea-008b-4cbb-81e4-c3474f2ad286Version: 15Effective Time: 20160330Jazz Pharmaceuticals, Inc.



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