RUBY-FILL- rubidium rb 82 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RUBIDIUM CHLORIDE RB-82 (UNII: F0Z746KRKQ) (RUBIDIUM CATION RB-82 - UNII:550Z839889)

Available from:

Jubilant DraxImage Inc., dba Jubilant Radiopharma

INN (International Name):

RUBIDIUM CHLORIDE RB-82

Composition:

RUBIDIUM CATION RB-82 100 mCi

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. RUBY-FILL is contraindicated for use if a solution other than additive-free 0.9% Sodium Chloride Injection USP has been used to elute the generator at any time. Immediately stop the patient infusion and permanently discontinue the use of the affected RUBY-FILL generator whenever the incorrect eluent is used [see Boxed Warning, Contraindications (4), Warnings and Precautions (5.1) ]. Risk Summary There are no data available on the use of rubidium Rb 82 in pregnant women. Animal reproduction studies with rubidium Rb 82 chloride have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending

Product summary:

RUBY-FILL Rubidium Rb 82 Generator consists of Sr 82 adsorbed on a hydrous stannic oxide column with an activity of 3145 to 4255 MBq (85 to 115 mCi) Sr 82 at calibration time. A lead shield encases the generator. The container label provides complete assay data for each generator. Use RUBY-FILL Rubidium Rb 82 Generator only with an appropriate, properly calibrated Elution System (RUBY Rubidium Elution System) labeled for use with the generator.

Authorization status:

New Drug Application

Summary of Product characteristics

RUBY-FILL- RUBIDIUM RB 82 INJECTION, SOLUTION
JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RUBY-FILL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RUBY-FILL.
RUBY-FILL (RUBIDIUM RB 82 GENERATOR)
TO PRODUCE RUBIDIUM RB 82 CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1989
WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT
AND FAILURE
TO FOLLOW QUALITY CONTROL TESTING PROCEDURE
_PLEASE SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT
USING THE INCORRECT ELUENT CAN CAUSE HIGH STRONTIUM (SR 82) AND (SR
85) BREAKTHROUGH LEVELS (5.1)
USE ONLY ADDITIVE-FREE 0.9% SODIUM CHLORIDE INJECTION USP TO ELUTE THE
GENERATOR (2.5)
IMMEDIATELY STOP THE PATIENT INFUSION AND DISCONTINUE THE USE OF THE
AFFECTED RUBY-FILL GENERATOR IF
THE INCORRECT SOLUTION IS USED TO ELUTE THE GENERATOR (4)
EVALUATE THE PATIENT’S RADIATION ABSORBED DOSE AND MONITOR FOR THE
EFFECTS OF RADIATION TO CRITICAL
ORGANS SUCH AS BONE MARROW (2.9)
EXCESS RADIATION EXPOSURE WITH FAILURE TO FOLLOW THE QUALITY CONTROL
TESTING PROCEDURE
EXCESS-RADIATION EXPOSURE OCCURS WHEN THE LEVELS OF SR 82 OR SR 85 IN
THE RUBIDIUM RB 82 CHLORIDE
INJECTION EXCEED SPECIFIC LIMITS. (5.2)
STRICTLY ADHERE TO THE GENERATOR QUALITY CONTROL TESTING PROCEDURE
(2.6)
STOP USING THE GENERATOR IF IT REACHES ANY OF ITS EXPIRATION LIMIT
(2.7)
INDICATIONS AND USAGE
RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride
injection for intravenous use. Rubidium Rb 82
chloride injection is a radioactive diagnostic agent indicated for
Positron Emission Tomography (PET) imaging of the
myocardium under rest or pharmacologic stress conditions to evaluate
regional myocardial perfusion in adult patients with
suspected or existing coronary artery disease. (1)
DOSAGE AND ADMINISTRATION
Use RUBY-FILL with a specific Elution System. (2.4)
• Use only addi