SODIUM FLUORIDE F 18- sodium fluoride f-18 injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM FLUORIDE F-18 (UNII: 9L75099X6R) (FLUORIDE ION F-18 - UNII:4M4WE5N2GE)

Available from:

Precision Nuclear LLC

INN (International Name):

SODIUM FLUORIDE F-18

Composition:

FLUORIDE ION F-18 200 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Fluoride F 18 Injection USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. None Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F 18 Injection has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. Animal reproductive and developmental toxicity studies have not been conducted with Sodium Fluoride F 18 Injection. Prior to the administration of Sodium Fluoride F 18 Injection to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F 18 Injection should be given to a pregnant woman only if clearly needed. It is not known whether Sodium Fluoride F 18 Injection is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of Sodium F

Product summary:

Sodium Fluoride F 18 Injection is supplied in a multiple-dose Type I glass vial with elastomeric stopper and aluminum crimp seal containing between 370 and 7,400 MBq/mL (10 to 200 mCi/mL) of no carrier-added sodium fluoride FI8, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume and total radioactivity per vial are variable. Each vial is enclosed in a shielded container of appropriate thickness. The product is available in a 30 mL and 50 mL vial configuration with a variable fill volume. The NDC numbers are: Store upright in a shielded container at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). Use the solution within 12 hours of the EOS reference time. Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM FLUORIDE F 18- SODIUM FLUORIDE F-18 INJECTION
PRECISION NUCLEAR LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM FLUORIDE F 18
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SODIUM FLUORIDE F 18
INJECTION.
SODIUM FLOURIDE F 18 INJECTION USP, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1/2011
INDICATIONS AND USAGE
Sodium Fluoride F I8 Injection USP is a radioactive diagnostic agent
for positron emission tomography
(PET) indicated for imaging of bone to define areas of altered
osteogenic activity (1).
DOSAGE AND ADMINISTRATION
Sodium Fluoride F I8 Injection emits radiation and must be handled
with appropriate safety measures
(2.1).
Administer 300 to 450 MBq (8 to 12 mCi) as an intravenous injection in
adults (2.4).
Administer approximately 2.1 MBq/kg in children with a minimum of 19
MBq (0.5 mCi) and a maximum
of 148 MBq (4 mCi) as an intravenous injection (2.5).
Imaging can begin 1 to 2 hours after administration; optimally at one
hour post administration (2.7).
Encourage patients to void immediately prior to imaging the lumbar
spine and bony pelvis (2.7).
DOSAGE FORMS AND STRENGTHS
Multiple-dose vial containing 370 to 7,400 MBq/mL (10 to 200 mCi/mL)
of no-carrier-added sodium fluoride
F 18 at the end of synthesis (EOS) reference time in aqueous 0.9%
sodium chloride solution (3). Sodium
Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free
and preservative-free solution for
intravenous administration.
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Allergic Reactions: As with any injectable drug product, allergic
reactions and anaphylaxis may occur.
Emergency resuscitation equipment and personnel should be immediately
available (5.1).
Cancer Risk: Sodium Fluoride F 18 Injection may increase the risk of
cancer. Use the smallest dose
necessary for imaging and ensure safe handling to protect the patient
and health care worker (5.2).
ADVERSE REACTIONS
No adverse reactions have been reported for