SODIUM FLUORIDE F 18- sodium fluoride f-18 injection

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Essential Isotopes LLC

INN (Rahvusvaheline Nimetus):

SODIUM FLUORIDE F-18

Koostis:

FLUORIDE ION F-18 200 mCi in 1 mL

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 Sodium Fluo

Toote kokkuvõte:

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 and 7,400 MBq/mL (10-200 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: 51760-002-30 (30 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.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

SODIUM FLUORIDE F 18- SODIUM FLUORIDE F-18 INJECTION
ESSENTIAL ISOTOPES 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 USP.
SODIUM FLUORIDE F 18 INJECTION USP
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1/2011
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 (10–200 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
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 for Sodium