Label: MEBROFENIN injection, powder, lyophilized, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 51808-216-01 - Packager: AnazaoHealth Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated June 19, 2012
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- Official Label (Printer Friendly)
- DESCRIPTION
- INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is:
Nonjaundiced patient: 74 - 185 MBq (2-5 mCi)
Patient with serum bilirubin level greater than 1.5 mg/dL: 111-370 MBq (3-10 mCi)
The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.
An interval of at least 24 hours should be allowed before repeat examination
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PREPARATION
To prepare injection, follow this aseptic procedure:
- Waterproof gloves should be worn during the preparation procedure.
- Snap off the plastic lid and place room temperature reaction vial in an appropriate lead shield.
- Swab the rubber closure of the vial with a germicide.
- Inject 1 – 3 ml Sterile additive free sodium pertechnetate Tc-99m injection containing up to 740 MBq (20 mCi) into the vial. Be sure to maintain inert atmosphere in vial by introducing as little air as possible during reconstitution. NOTE: If sodium pertechnetate Tc-99m injection must be diluted, use only preservative free Sodium Chloride Injection USP.
- Secure the lead shield cover. Swirl the vial gently to mix contents and let stand 3 to 5 minutes prior to use.
- Record the date and time of preparation on a pressure-sensitive label.
- Affix pressure-sensitive label to shield.
- Examine vial contents; if the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used.
- Measure the radioactivity by suitable calibration system and record prior to patient administration.
- Appropriate quality control is recommended.
- Use within 12 hours of preparation
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEBROFENIN
mebrofenin injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-216 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEBROFENIN (UNII: 7PV0B6ED98) (MEBROFENIN - UNII:7PV0B6ED98) MEBROFENIN 10 mg Inactive Ingredients Ingredient Name Strength STANNOUS CHLORIDE (UNII: 1BQV3749L5) 0.2 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51808-216-01 1 in 1 KIT Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/19/2012 Labeler - AnazaoHealth Corporation (011038762) Establishment Name Address ID/FEI Business Operations AnazaoHealth Corporation 011038762 MANUFACTURE(51808-216)
