TechneScan HDP -

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Natriumoksidronat

Tilgjengelig fra:

Curium Netherlands B.V.

ATC-kode:

V09BA01

INN (International Name):

Natriumoksidronat

Legemiddelform:

Preparasjonssett til radioaktive legemidler

Enheter i pakken:

Hetteglass 5x3 mg

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

1999-11-01

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Technescan HDP Kit for radiopharmaceutical preparation
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Oxidronate
3.0 mg
The radionuclide is not part of the kit.
Excipients:
Sodium 12 mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution, the agent may be used for bone
scintigraphy, where it delineates areas of altered osteogenesis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The average activity administered by single intravenous injection is
500 MBq (300 - 740 MBq) in a
70 kg adult. Other activities may be justifiable. It should be noted
that in each country physicians
should follow the Diagnostic Reference Levels and the rules set out by
local law.
_Elderly population _
There is no special dosage regimen for the elderly patient.
_Paediatric population _
The use in paediatric children and adolescents has to be considered
carefully, based upon clinical
needs and assessing the risk/benefit ratio in this patient group. The
activities to be administered to
children and to adolescents were calculated according to the EANM
dosage card (2008) by using the
following Formula:
_A_[_MBq_]
Administered = _Baseline Activity _
x
_Multiple_
(with a baseline activity of 35.0)
The resulting activities to be administered may be found in the
following table:
Weight (kg)
Activity
(MBq)
Weight (kg)
Activity
(MBq)
Weight (kg)
Activity
(MBq)
3
40
22
185
42
320
4
40
24
200
44
335
6
60
26
215
46
350
8
75
28
225
48
360
10
95
30
240
50
375
12
110
32
255
52 - 54
395
14
125
34
270
56 - 58
420
16
140
36
280
60 - 62
445
18
155
38
295
64 - 66
470
20
170
40
310
68
490
In very young children (up to 1 year) a minimum dose of 40 MBq is
necessary in order to obtain
images of sufficient quality.
Method of administration
According to the fol