SODIUM FLUORIDE F 18- sodium fluoride f 18 injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUORIDE ION F-18 (UNII: 4M4WE5N2GE) (FLUORIDE ION F-18 - UNII:4M4WE5N2GE)

Available from:

Global Isotopes, LLC d/b/a Zevacor Molecular

INN (International Name):

FLUORIDE ION F-18

Composition:

FLUORIDE ION F-18 10 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Fluoride F18 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

Product summary:

Sodium Fluoride F 18 Injection, USP is supplied in a multiple-dose Type I glass vial with elastomeric stopper and aluminum crimp seal containing between 370 MBq/mL and 7,400 MBq/mL (10 mCi/mL-200 mCi/mL) of no carrier-added sodium fluoride F18, 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 vial configuration with a variable fill volume. The NDC number is: 69126-002-01 (30 mL) Storage Store at 25°C (77°F) in a shielded container; excursions permitted to 15–30°C (59–86°F).  Use the solution within 12 hours of the EOS reference time. Handling 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
GLOBAL ISOTOPES, LLC D/B/A ZEVACOR MOLECULAR
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM FLUORIDE F18 INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SODIUM FLUORIDE F18
INJECTION.
SODIUM FLUORIDE F18 INJECTION, USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
Sodium Fluoride F18 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 F18 Injection emits radiation and must be handled with
appropriate safety measures ( 2.1).
Administer 8 mCi—12 mCi (0.3 GBq—0.45 GBq) as an intravenous
injection in adults ( 2.4).
Administer approximately 2.1 MBq/kg in children with a minimum of 0.5
mCi (0.019 GBq) and a maximum of 4 mCi
(0.148 GBq) as an intravenous injection ( 2.5).
Imaging can begin 1–2 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 MBq/mL-7,400 MBq/mL (10 mCi/mL—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 REA