Chromium [51Cr] EDTA Injection GE Healthcare 3.7 MBq/ ml

Pays: Norvège

Langue: norvégien

Source: Statens legemiddelverk

Ingrédients actifs:

Krom (51Cr) edetat

Disponible depuis:

GE Healthcare Ltd

Code ATC:

V09CX04

DCI (Dénomination commune internationale):

Chromium (51 Cr) edetate

Dosage:

3.7 MBq/ ml

forme pharmaceutique:

Injeksjonsvæske, oppløsning

Unités en paquet:

Hetteglass 10 ml

Type d'ordonnance:

C

Statut de autorisation:

Markedsført

Date de l'autorisation:

1999-09-20

Résumé des caractéristiques du produit

GE HEALTHCARE LIMITED
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Chromium[
51
Cr] EDTA Injection GE Healthcare
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chromium[
51
Cr]edetate, 37MBq/vial (3.7MBq/ml) at the activity reference date
The formulation contains 0.64mg/ml chromium edetate.
Chromium-51 has a physical half-life of approximately 28 days and
decays by gamma
emission with a principal energy of 0.32MeV.
Excipients with known effect:
Benzyl alcohol: 10 mg/ml
Sodium: 0.23 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, violet solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Chromium [
51
Cr] edetate is indicated for the determination of glomerular
filtration rate
in the assessment of renal function.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and elderly:
The
normally
recommended
dose
for
adults
and
the
elderly
is
1.1-6.0MBq
by
intravenous injection or continuous infusion based on the average
patient weight of
70kg. The actual activity administered will depend on the technique
used to determine
the renal clearance and on that used for radioactivity detection.
Higher activities up to
a maximum of 11MBq may be appropriate for use in conjunction with
external counting
techniques.
Paediatric population:
The maximal activity to be used in children must not exceed 3.7 MBq.
The use in children and adolescents has to be considered carefully,
based upon
clinical needs and assessing the risk/benefit ratio in this patient
group. The activity to
be administered to children may be calculated approximately by
correcting on a weight,
body surface area or age basis the activity to adults. For children
under about one year
of age, the target organ size in relation to the whole body must also
be taken into
consideration.
Chromium (
51
Cr) EDTA Injection contains benzyl alcohol. It must not be given to
premature babies or neonates.
Method of administration
The following