Chromium(51Cr) edetate 3.7MBq/mL injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

chromium(51Cr) edetate

Available from:

GE Healthcare Australia Pty Ltd

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

CHROMIUM(51CR) EDETATE INJECTION
CJ13P
PATIENT INFORMATION LEAFLET
IDENTIFICATION OF THE MEDICINAL
PRODUCT
N
AME OF THE
M
EDICINAL
P
RODUCT
Chromium(51Cr) edetate Injection
Q
UALITATIVE
C
OMPOSITION
-
Active ingredient :
Chromium [
51
Cr] edetate
-
Other ingredients :
Disodium EDTA Ph.Eur.
Benzyl alcohol Ph.Eur.
Water for Injections Ph.Eur
Q
UANTITATIVE
C
OMPOSITION
Each vial contains 6.4 mg and 37 MBq
(Megabecquerel - the unit in which radioactivity is
measured) of chromium [
51
Cr] edetate.
P
HARMACEUTICAL
F
ORM
Solution for injection
P
HARMACO
-T
HERAPEUTIC
G
ROUP
Chromium [
51
Cr] EDTA is a radiopharmaceutical
product which is used to help to make a
diagnosis. When injected, a radiopharmaceutical_ _
circulates in the bloodstream and may temporarily
collect in some organs of the body. Because the
substance contains a small amount of
radioactivity it can be detected from outside the
body using special cameras. Blood and urine
samples can be collected and measured for
radioactivity. This can give the physician valuable
information about the functioning of particular
organs
N
N
AME AND
A
DDRESS OF THE
M
ANUFACTURER AND
H
OLDER OF THE
M
ARKETING
A
UTHORISATION
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
WHEN
IS
THE
PRODUCT
USED
?
After being injected into a vein, the rate of
removal of chromium [
51
Cr] EDTA from your body
can be determined. This is normally done by
measuring the amount in blood or urine samples.
This rate can give your physician valuable
information about the functioning of your kidneys.
WARNINGS
W
HEN SHOULD THIS
P
RODUCT NOT BE USED
?
You should tell your physician if you are allergic to
the active ingredient or any other ingredient
You should tell your physician if there is any
possibility that you are pregnant, or if you are
breast-feeding.
Premature babies or newborn babies (neonates)
must not be given Chromium EDTA.
_IN CASE OF DOUBT IT IS ESSENTIAL TO _
_CONSULT YOUR PHYSICIAN BEFORE YOU _
_RECEIVE THIS PRODUCT _
S
PECIAL
W
ARNINGS
CHROMIUM E

Summary of Product characteristics

_ _
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 may be
received, used and administered only by authorised persons
in designated clinical settings. Their receipt, storage, use,
transfer and disposal are subject to the regulations and/or
appropriate licences of the local competent official
organisations.
The normal precautions for handling radioactive materials
should also be observed. A separate leaflet specifying
inf