SODIUM FLUORIDE F-18 injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

UIHC-P E T IMAGING CENTER

ИНН (Международная Имя):

SODIUM FLUORIDE F-18

состав:

FLUORIDE ION F-18 200 mCi in 1 mL

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

SODIUM FLUORIDE F-18- SODIUM FLUORIDE F-18 INJECTION
UIHC-P E T IMAGING CENTER
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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, 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).
(1)
DOSAGE AND ADMINISTRATION
Sodium Fluoride F18 Injection emits radiation and must be handled with
appropriate safety measures (2.1).
Administer 300-450 MB q
(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 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) of
no-carrier-added sodium fluoride F18 at the end of
synthesis (EOS) reference time 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
Allergic Reactions: As with any injectable drug product, allergic
reactions and anaphylaxis may occur. Emergency
resuscitation equipment and personal 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).
ADVERSE REACTIONS
No adverse reactions have been reported