TechneScan PYP 20 mg

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Natriumpyrofosfat

Tilgjengelig fra:

Curium Netherlands B.V.

ATC-kode:

V09BA03

INN (International Name):

Natriumpyrofosfat

Dosering :

20 mg

Legemiddelform:

Preparasjonssett til radioaktive legemidler

Enheter i pakken:

Hetteglass 5x20 mg

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

2005-06-08

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
TechneScan PYP 20 mg kit for radiopharmaceutical preparation
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20 mg sodium pyrophosphate decahydrate and 4 mg
stannous chloride dihydrate
(corresponding to 2.1 mg stannous).
The radionuclide is not part of the kit.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation
Powder for solution for injection.
Off-white to slightly yellow lyophilisate.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
a)
Red blood cell labelling for blood pool scintigraphy.
Major indications are:
- Angiocardioscintigraphy for:
* evaluation of ventricular ejection fraction,
* evaluation of global and regional cardiac wall motion,
* myocardial phase imaging.
- Organ perfusion and vascular abnormalities imaging for the detection
of hemangioma.
- Diagnosis and localization of occult gastro intestinal bleeding.
b)
Determination of blood volume.
c)
Spleen scintigraphy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
_ _
a)
_Blood pool scintigraphy_
:
The average activity administered by intravenous injection for
_in vivo_
or after
_in vitro_
labelling is
890 MBq (740-925 MBq).
b)
_Determination of blood volume:_
The average activity administered by intravenous injection after
_in vitro_
labelling is 3 MBq
(1-5 MBq).
c)
_Spleen scintigraphy:_
The average activity administered by intravenous injection after
_in vitro_
labelling of denaturated
erythrocytes is 50 MBq (20-70 MBq).
The optimal amount of non-radioactive stannous tin for preparation of
red blood cells (RBCs)
_in vivo_
or
_in vitro_
is 10 to 20 µg/kg body weight in adults. Especially in cases of
_in vitro_
labelling this dose should
not be exceeded. Sodium pertechnetate (
99m
Tc) should be injected (
_in vivo_
) or added to the incubation
mixture (
_in vitro_
) after 30 minutes.
Renal impairment
_Careful consideration of the activity to be a