Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
SODIUM FLUORIDE F-18 (UNII: 9L75099X6R) (FLUORIDE ION F-18 - UNII:4M4WE5N2GE)
NukeMed, Inc. dba SpectronRx
SODIUM FLUORIDE F-18
FLUORIDE ION F-18 200 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
SODIUM FLUORIDE F 18- SODIUM FLUORIDE F 18 INJECTION NUKEMED, INC. DBA SPECTRONRX ---------- 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 read_full_document