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:

NukeMed, Inc. dba SpectronRx

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:

1 INDICATIONS AND USAGE Sodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. 4 CONTRAINDICATIONS None. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F18 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 reproduction 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. 8.3 Nursing Mothers 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 reac

Product summary:

16 HOW SUPPLIED Sodium Fluoride F 18 Injection is supplied in a multiple-dose glass vial with (elastomeric) stopper and aluminum crimp seal containing between 370-7,400 MBq/mL (10 to 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 shielding container of appropriate thickness. The product is available in a 10-50 mL vial configuration with a variable fill volume. The NDC number is: 13108-211-10 (10 mL) 13108-211-25 (25 mL) 13108-211-30 (30 mL) 13108-211-50 (50 mL) Storage Store at 25°C (77°F); 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
NUKEMED, INC. DBA SPECTRONRX
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HIGHLIGHTS OF PRESCRIBING INFORMATION
SODIUM FLUORIDE F 18 INJECTION
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.
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection is a radioactive diagnostic agent for
positron emission tomography (PET) indicated for
imaging of bone to define areas of altered osteogenic activity(1). (1)
DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION
• Sodium Fluoride F18 Injection emits radiation and must be handled
with appropriate safety measures(2.1).
• Administer 300-450 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 1–2 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). (2)
DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS AND STRENGTHS
Multiple-dose vial containing 370–7,400 MBq/mL (10–200 mCi/mL) at
EOS reference time of no-carrier-added sodium
fluoride F18 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. (3)
CONTRAINDICATIONS
None(4). (4)
WARNINGS AND PRECAUTIONS
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 handl