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DOSAGE AND ADMINISTRATION
The recommended dose of Elspar (asparaginase) is 6, 000 International Units/m² intramuscularly (IM) or intravenously (IV) three times a week.
Instructions for Administration
When Elspar (asparaginase) is administered IM, the volume at a single injection site should be limited to 2 mL. If a volume greater than 2 ml is to be administered, two injection sites should be used.
Preparation and Handling Precautions
For IM administration, reconstitute Elspar (asparaginase) by adding 2 ml Sodium Chloride Injection to the 10, 000 unit vial. Withdraw volume of reconstituted Elspar (asparaginase) containing calculated dose into sterile syringe. For IV administration, reconstitute Elspar (asparaginase) by adding 5 ml Sterile Water for Injection or Sodium Chloride Injection to the 10, 000 unit vial. Withdraw volume of reconstituted Elspar (asparaginase) containing calculated dose into sterile syringe.
Use reconstituted Elspar (asparaginase) within eight hours.
Parenteral drug products should be inspected visually for particulate matter, cloudiness or discoloration prior to administration, whenever solution and container permit. If any of these are present, discard the solution. However, occasionally, a very small number of gelatinous fiber-like particles may develop on standing. Filtration through a 5.0 micron filter during administration will remove the particles with no resultant loss in potency.
Dosage Forms And Strengths
10, 000 International Units as lyophilized powder in single-use vial.
Storage And Handling
10, 000 International Units as lyophilized powder in single dose vial individually packaged in a carton.
Storage and Handling
Keep vials refrigerated at 2-8°C (36-46°F).
Elspar (asparaginase) does not contain a preservative. Store unused, reconstituted solution at 2-8°C (36-46°F) and discard after eight hours, or sooner if it becomes cloudy.
Ovation Pharmaceuticals, Inc., Deerfield, IL 60015, U.S.A. Revised: 3/2007. FDA revision date: 3/30/2007
Last reviewed on RxList: 10/10/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Elspar Information
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