SODIUM FLUORIDE F 18 injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

NCM USA Bronx LLC

DCI (Denominação Comum Internacional):

SODIUM FLUORIDE F-18

Composição:

FLUORIDE ION F-18 200 mCi in 1 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 F18 Injection, USP 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, USP. Prior to the administration of Sodium Fluoride F 18 Injection, USP to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F 18 Injection, USP should be given to a pregnant woman only if clearly needed. It is not known whether Sodium Fluoride F 18 Injection, USP 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 Sodiu

Resumo do produto:

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 370-7,400 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 shielded container of appropriate thickness. The product is available in a 30 mL vial configuration with a variable fill volume. The NDC number is: 24445-623-30 (30 mL) 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. This radiopharmaceutical is licensed by the State of New York, Department Of Health, Bureau of Environmental Radiation Protection, for distribution to persons licensed pursuant to New York's Regulatory Code for Radioactive material specified in Chapter 1-Part 16 of the State Sanitary Code, as appropriate, or under equivalent licenses of an Agreement State or Licensing State..

Status de autorização:

Abbreviated New Drug Application

Características técnicas

SODIUM FLUORIDE F 18- SODIUM FLUORIDE F 18 INJECTION
NCM USA BRONX 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, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR SODIUM FLUORIDE F
18 INJECTION.
SODIUM FLUORIDE F 18 INJECTION, USP
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2011
INDICATIONS AND USAGE
Sodium Fluoride F 18 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, USP 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 (20–200 mCi/mL) at
End of Synthesis (EOS) reference
time of no-carrier-added Sodium Fluoride F18, USP in aqueous 0.9%
sodium chloride solution (3). Sodium
Fluoride F 18 Injection, USP 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, USP 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 fo