SODIUM FLUORIDE F 18 injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH

INN (International Adı):

SODIUM FLUORIDE F-18

Kompozisyon:

FLUORIDE ION F-18 600 mCi in 1 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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, 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 reproductive and developmental toxicity 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 af

Ürün özeti:

Sodium Fluoride F 18 Injection, USP is supplied in a multiple-dose Type 1 glass vial with elastomeric stopper and aluminum crimp seal containing between 740 and 22,200 MBq/mL (20-600 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 shielded container of appropriate thickness. The product is available in a 25 mL vial configuration with a variable fill volume. The NDC number is: 13267-542-42. 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.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SODIUM FLUORIDE F 18- SODIUM FLUORIDE F 18 INJECTION
THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
----------
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: 2014
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 296-444 MBq (8-12 mCi) as an intravenous injection in
adults. (2.4)
• Administer approximately 2.1 MBq/kg in children with a minimum of
18.5 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 740-22,200 MBq/mL (20-600 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. Sodium Fluoride F 18 Injection, USP is a clear,
colorless, sterile, pyrogen-free, and preservative-free solution for
intravenous administration. (3)
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 Risks: 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.