SODIUM FLUORIDE F 18- sodium fluoride f-18 injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Biomedical Research Foundation of Northwest Louisiana

INN (International Name):

SODIUM FLUORIDE F-18

Sammensætning:

FLUORIDE ION F-18 200 mCi in 1 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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. 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

Produkt oversigt:

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 to 200 mCi/mL) of no-carrier-added sodium fluoride F 18, 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: 24562-002-30 (30mL) Store at 20° to 25°C (68° to 77°F) in a shielded container; excursions permitted to 15° to 30°C (59°–86°F) [See USP Controlled Room Temperature]. 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

SODIUM FLUORIDE F 18- SODIUM FLUORIDE F-18 INJECTION, SOLUTION
BIOMEDICAL RESEARCH FOUNDATION OF NORTHWEST LOUISIANA
----------
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, USP.
SODIUM FLUORIDE F 18 INJECTION, USP
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: JANUARY 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 F 18 Injection, USP emits radiation and must be
handled with appropriate safety
measures(2.1).
Administer 300 MBq to 450 MBq (8 mCi 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 MBq/mL to 7,400 MBq/mL (10 mCi/mL to
200 mCi/mL) at EOS reference
time of no-carrier-added sodium fluoride F 18 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).
(5).
AD