Label: MEBROFENIN injection, powder, lyophilized, for solution
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Updated June 19, 2012
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- INDICATIONS AND USAGE
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
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
INGREDIENTS AND APPEARANCE
mebrofenin injection, powder, lyophilized, for solution
Product 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)