FLUDEOXYGLUCOSE F18- fludeoxyglucose f18 injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)

Available from:

Houston Cyclotron Partners LP dba Cyclotope

INN (International Name):

FLUDEOXYGLUCOSE F-18

Composition:

FLUDEOXYGLUCOSE F-18 500 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient 2-deoxy-2-[ 18 F]fluoro-D-glucose has the molecular formula of C 6 H 11 18 FO 5 with a molecular weight of 181.26, and has the following chemical structure: Fludeoxyglucose F 18 Injection is provided as a ready to use sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.740 to 18.5 GBq (20.0-500 mCi) of 2-deoxy-2-[ 18 F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative. Fluorine F 18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV "annihilation" gamma photons, that are produced and emitted simultaneously in

Product summary:

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 – 18.5 GBq/mL (20 - 500 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 16 - 17 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 47584-001-01 Store the Fludeoxyglucose F 18 Injection vial upright in a lead shielded container at 20º to 25°C (68º to 77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distribute, store and dispose of Fludeoxyglucose F 18 Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State. The expiration date and time are provided on the container label. Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS time.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDEOXYGLUCOSE F18- FLUDEOXYGLUCOSE F18 INJECTION
HOUSTON CYCLOTRON PARTNERS LP DBA CYCLOTOPE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F18 INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUDEOXYGLUCOSE F18
INJECTION.
FLUDEOXYGLUCOSE F18 INJECTION
INITIAL U.S. APPROVAL: 2005
DOSAGE FORMS AND STRENGTHS
Multiple-dose glass vial containing 0.74-18.5 GBq/mL (20-500 mCi/mL)
of Fludeoxyglucose F18 Injection and 4.5 mg of
sodium chloride in citrate buffer (approximately 16 – 17 mL volume),
for intravenous administration (3).
ADVERSE REACTIONS
Hypersensitivity reactions have occurred; have emergency resuscitation
equipment and personnel immediately available
(6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CYCLOTOPE AT
1-713-747-5686 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
REVISED: 8/2012
FULL PRESCRIBING INFORMATION: CONTENTS*
3 DOSAGE FORMS AND STRENGTHS
6 ADVERSE REACTIONS
11 DESCRIPTION
11.1 Chemical Characteristics
11.2 Physical Characteristics
16 HOW SUPPLIED / STORAGE AND DRUG HANDLING
*
FULL PRESCRIBING INFORMATION
3 DOSAGE FORMS AND STRENGTHS
Multiple-dose glass vial containing 0.74-18.5 GBq/mL (20-500 mCi/mL)
of Fludeoxyglucose F 18
Injection and 4.5 mg of sodium chloride in citrate buffer
(approximately 16 - 17 mL volume) for
intravenous administration.
6 ADVERSE REACTIONS
Hypersensitivity reactions with pruritus, edema and rash have been
reported in the post-marketing
setting. Have emergency resuscitation equipment and personnel
immediately available.
11 DESCRIPTION
Sections or subsections omitted from the full prescribing information
are not listed.
11.1 CHEMICAL CHARACTERISTICS
Fludeoxyglucose F 18 Injection is a positron emitting
radiopharmaceutical that is used for diagnostic
purposes in conjunction with positron emission tomography (PET)
imaging. The active ingredient 2-
deoxy-2-[
F]fluoro-D-glucose has the molecular formula of C
H
FO
with a molecular weight
of 181.26, and has