Indium [111In] Oxinate 37 MBq/ ml

Land: Noorwegen

Taal: Noors

Bron: Statens legemiddelverk

Werkstoffen:

Indium (111In) oksin

Beschikbaar vanaf:

Curium Netherlands B.V.

ATC-code:

V09HB01

INN (Algemene Internationale Benaming):

Indium (111In) oxide

Dosering:

37 MBq/ ml

farmaceutische vorm:

Oppløsning

Eenheden in pakket:

1 sett

Prescription-type:

C

Autorisatie-status:

Markedsført

Autorisatie datum:

1999-11-01

Productkenmerken

20 APP 4908 Norway SPC 15052019_tc
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
INDIUM (IN-111) OXINATE, RADIOPHARMACEUTICAL PRECURSOR
1.
NAME OF THE MEDICINAL PRODUCT
Indium (In-111) Oxinate
(Curium Netherlands catalogue no.: DRN 4908)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Indium (In-111)chloride
37 MBq (1 mCi)
Oxine
0.025 mg
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.
pH = 2.5-3.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Indium (
111
In) oxine is used as an ingredient for the in-vitro radiolabelling of
separated
blood cells which are subsequently administered intravenously for a
variety of
investigative purposes using appropriate imaging/counting procedures.
Investigative procedures using indium (
111
In)-labelled blood cells include:

111
In-labelled leucocytes or granulocytes: Investigation of sites of
inflammatory
processes and abscesses, complementary with other imaging
investigations; for
example, localisation of sites of focal infection, such as abdominal
abscess,
confirmation of bone infection after prosthesis, investigation of
pyrexia of unknown
origin and evaluation of inflammatory conditions not associated with
infection such as
inflammatory bowel disease. In red marrow bearing regions of the
skeleton,
osteomyelitis may present as sites of reduced uptake of
111
In-labelled leucocytes.
Diffuse or local pulmonary uptake of
111
In-labelled leucocytes should be interpreted
with caution, as this can be due to physiological marginal location.

111
In-labelled platelets (thrombocytes): Determination of platelet
survival and
biodistribution, particularly spleen and liver uptake in cases of
thrombocytopenia,
20 APP 4908 Norway SPC 15052