Indications and uses
Technetium Tc-99m Mebrofenin by intravenous administration is indicated as a hepatic imaging agent, used in the diagnosis of liver disease
Mebrofenin
- Manufacturer
- AnazaoHealth Corporation
- Effective date
- 2012-06-19
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 20:15:31
Label at a glance#
ProductMebrofenin
Active ingredientMEBROFENIN
Label structure6 sections
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 a...
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Dear Medical Professional,
Per your order, we have compounded Mebrofenin as a sterile solution. The characteristics of this preparation are
DESCRIPTION
AnazaoHealth supplies compounded Mebrofenin for the preparation of Tc-99m Mebrofenin. Each reaction vial contains 10 mg Mebrofenin and 0.2 mg tin as stannous chloride. The vial is back filled with nitrogen gas after lyophilization. The vial may contain a partial vacuum.
INDICATIONS AND USAGE
Technetium Tc-99m Mebrofenin by intravenous administration is indicated as a hepatic imaging agent, used in the diagnosis of liver disease
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
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
Figure 1
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51808-216-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c809-f6ea-e053-dbdaa90aa703 | Mebrofenin |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51808-216-01 | Mebrofenin | 1 in 1 KIT | INJECTION, POWDER, LYOPHILIZED, | 1 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MEBROFENIN | ACTIVE INGREDIENT | 7PV0B6ED98 | 3 | |
| MEBROFENIN | ACTIVE MOIETY | 7PV0B6ED98 | 3 | |
| STANNOUS CHLORIDE | INACTIVE INGREDIENT | 1BQV3749L5 | 3 |
Products#
Every source-derived product name is available through these pages.
- Mebrofenin
- STANNOUS CHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51808-216 | 51808-216-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MEBROFENIN | 7PV0B6ED98 | ACTIB |
| STANNOUS CHLORIDE | 1BQV3749L5 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STANNOUS CHLORIDE | STANNOUS CHLORIDE | 1BQV3749L5 | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 0.08 mg | ||
| STANNOUS CHLORIDE | STANNOUS CHLORIDE | 1BQV3749L5 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 0.42 mg | ||
| STANNOUS CHLORIDE | STANNOUS CHLORIDE | 1BQV3749L5 | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.25 mg | ||
| STANNOUS CHLORIDE | STANNOUS CHLORIDE | 1BQV3749L5 | INJECTION / INTRAVENOUS | 3.4 mg | ||
| STANNOUS CHLORIDE | STANNOUS CHLORIDE | 1BQV3749L5 | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | 0.08 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4d7406b4-8bcd-40f0-a31f-975f5b811da7 | aeefa6ee-f45c-49fe-b38e-6cfd99a33030 | 2012-06-19 | 4d7406b4-8bcd-40f0-a31f-975f5b811da7 aeefa6ee-f45c-49fe-b38e-6cfd99a33030 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.