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:

Houston Cyclotron Partners LP dba Cyclotope

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:

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 Fluoride F 18 Injection or not to administer Sodium Fluoride F 18 Injection, taking into account the importance of the drug to the mother. The body of scientific inform

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 370-7,400 MBq/mL (10-200 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 30 mL vial configuration with a variable fill volume. The NDC number is: 47584-002-01 (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
HOUSTON CYCLOTRON PARTNERS LP DBA CYCLOTOPE
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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 FLUORIDE F 18 INJECTION
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2011
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).
DOSAGE FORMS AND STRENGTHS
Multiple-dose vial containing 370–7,400 MBq/mL (10–200 mCi/mL) of
no-carrier-added sodium fluoride F18 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.
ADVERSE REACTIONS
No adverse reactions have been reported for Sodium Fluoride F 18
Injection based on a review of the published literature,
publicly available reference sources, and adverse drug reaction
reporting systems. (3)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CYCLOTOPE AT
1-713-747-5686 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH. (3)
USE IN SPECIFIC POPULATIONS
Pregnancy: No human or animal data. Any radiopharmaceutical, including
Sodium Fluoride F18 injection, may cause
fetal harm. Use only if clearly needed (8.1)
Nursing: A decision should be made whether to interrupt nursing after
Sodium Fluoride F 18 Injection administration or
not to administer Sodium Fluoride F 18 Injecti