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CHROMIUM(51CR)EDETATE INJECTION
CODE: CJ13P
TECHNICAL LEAFLET
PRESENTATION
A sterile solution, in water for injection, of
chromium(51Cr)edetate for intravenous injection. The
radioactive concentration is 3.7 MBq/ml (100 µCi/ml).
The formulation contains chromium edetate at a
concentration of 0.64 mg/ml, disodium edetate (1.9 mg/ml)
and benzyl alcohol (10 mg/ml) as preservative. The pH of
the injection is 3.5 - 5.0.
The product is a diagnostic radiopharmaceutical supplied
as a multidose vial containing 37 MBq (1 mCi).
All activities quoted are to the activity reference date
stated on the label.
MANUFACTURER AND HOLDER OF MARKETING AUTHORISATION
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire
United Kingdom
INDICATION
Chromium [
51
Cr] edetate is indicated for the determination of
glomerular filtration rate in the assessment of renal function.
CONTRA-INDICATIONS
Must not be given to premature babies or neonates.
PRECAUTIONS FOR USE
This medicinal product contains benzyl alcohol (10mg/ml).
Benzyl alcohol may cause toxic reactions in infants and
children up to 3 years old.
The possibility of hypersensitivity including serious
anaphylactoid reactions should always be considered.
Advanced life support facilities should be readily available.
To reduce the radiation dose to the bladder and an
accumulation of radioactivity in it, the patient should be asked
to drink additional fluids and to void the bladder as often as
possible in the hours following administration.
Radiopharmaceutical agents should only be used by qualified
personnel with the appropriate government authorisation for
the use and manipulation of radionuclides. They m
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