SODIUM FLUORIDE F18 injection

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Cardinal Health 414, LLC

INN (Международно Name):

SODIUM FLUORIDE F-18

Композиция:

FLUORIDE ION F-18 200 mCi in 1 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 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 after administration o

Каталог на резюме:

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 shielded container of appropriate thickness. The product is available in a 30 mL vial configuration with a variable fill volume. The NDC number is: NDC 65857-300-30 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

SODIUM FLUORIDE F18- SODIUM FLUORIDE F18 INJECTION
CARDINAL HEALTH 414, 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: 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
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DOSAGE FORMS AND STRENGTHS
Multiple-dose vial containing 370–7,400 MBq/mL (10–200 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 (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
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ADVERSE REACTIONS
No adverse reactions have been reported for Sodium Fluoride F-18
Injection, USP, based on a review of the published
literature, publicly available reference sources, and adverse drug
reaction reporting systems (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CARDINAL HEALTH AT
1-800-618-2768 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2016
Sodium Fluoride F-18 Injection, USP, emits radiation and must be
handled with appropriate safety measures (2.1).
Administer 300-450 MBq (8–12 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 immediate