Label: BICISATE injection, powder, lyophilized, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 51808-217-01 - Packager: AnazaoHealth Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 23, 2012
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- Official Label (Printer Friendly)
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DESCRIPTION
AnazaoHealth supplies ECD as a compounded kit for preparing Tc99m ECD. Each Reaction vial contains 1.35 mg of ECD, 0.54 edetate disodium, 36mg mannitol and 0.125 mg stannous chloride dehydrate. The vial is back filled with inert gas and may contain a partial vacuum.
Each ECD buffer vial contains a total volume of 1 mL that includes 6.15 mg sodium phosphate dibasic and 0.69 mg sodium phosphate monobasic
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- HALF-LIFE
- CONTRAINDICATIONS
- DOSAGE AND ADMINISTRATION
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PREPARATION
For best results, use tc99m from a generator eluted within 24 hours. The eluate should be used within 2 hours of elution.
Reconstitution Instructions:
- Snap off the plastic lid and place in appropriate lead shielding. Wipe the septum with 70% isopropyl alcohol and allow it to dry.
- Using a 10 mL syringe, draw up 100 mCi of tc99m (in approximately 2 mL) and inject into the ECD Buffer, being sure to withdraw an equal amount of gas from the vial to neutralize pressure.
- With a sterile syringe, inject 3 mL of 0.9% sodium chloride into the reaction vial to dissolve the contents. Remove an equal volume of air to maintain pressure within the vial. Shake the contents of the vial for a few seconds.
- With another sterile syringe, immediately (within 30 seconds) withdraw 1 mL out of the reaction vial and inject it into the buffer vial. Discard the reaction vial
- Swirl the contents of the buffer vial for a few seconds and allow this mixture to stand for 30 minutes at room temperature.
- Examine the vial contents for particulates and discoloration prior to patient administration. It should be clear of any particulates.
It is recommended that the kit be stored refrigerated until use; at such time the product should be aseptically withdrawn
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BICISATE
bicisate injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-217 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BICISATE (UNII: 3JXF0Z0XOI) (BICISATE - UNII:3JXF0Z0XOI) BICISATE 1.35 mg Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) 0.54 mg MANNITOL (UNII: 3OWL53L36A) 36 mg STANNOUS CHLORIDE (UNII: 1BQV3749L5) 0.125 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51808-217-01 1 in 1 KIT Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/23/2012 Labeler - AnazaoHealth Corporation (011038762) Establishment Name Address ID/FEI Business Operations AnazaoHealth Corporation 011038762 MANUFACTURE(51808-217)
