Indium [In111] Chloride 370 MBq/ ml

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Indium (111In) klorid

Tilgjengelig fra:

Curium Netherlands B.V.

ATC-kode:

V09IB

INN (International Name):

Indium (111In) chloride

Dosering :

370 MBq/ ml

Legemiddelform:

Oppløsning

Enheter i pakken:

Hetteglass 0.5 ml

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

1999-11-01

Preparatomtale

1
1.
NAME OF THE MEDICINAL PRODUCT
Indium (In111) Chloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per ml at activity reference date:
Indium-111
370 MBq
111
In disintegrates by electron capture with a half-life of approximately
67 hours (2.8 days) and emits gamma
radiation with principal energies of 172 keV (91%) and 246 keV (94%).
By internal conversion X radiations
of 23 and 26 keV are also emitted.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Radiopharmaceutical precursor.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Indium (
111
In) chloride is used as an ingredient for the radiolabelling of
certain suitably derivatised proteins
which are subsequently administered intravenously for a variety of
investigative purposes using appropriate
imaging procedures.
Indium (
111
In) chloride is used extensively for the radiolabelling of monoclonal
antibodies. The nature of the
disease state to be investigated will be determined by the particular
monoclonal antibody to be labelled.
Indium (
111
In) chloride has also been used as the radiolabelling ingredient in
injectable preparations such as
Indium (
111
In)-labelled proteins.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The vial contains a sterile aqueous solution for the in-vitro
radiolabelling of suitable conjugated proteins
such as monoclonal antibodies, which are subsequently administered
intravenously.
The quantity of Indium (
111
In) chloride required for radiolabelling and the quantity of Indium (
111
In)-labelled
pharmaceutical that is subsequently administered will depend on the
pharmaceutical being labelled and its
intended use. Information on recommended dosage and administration
will be provided by the manufacturer
of the pharmaceutical to be radiolabelled.
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 the newborn and
children under