Thallous (201TI) Chloride 37 MBq/ ml

País: Noruega

Língua: norueguês

Origem: Statens legemiddelverk

Ingredientes ativos:

Talliumklorid (201Tl)

Disponível em:

Curium Netherlands B.V.

Código ATC:

V09GX01

DCI (Denominação Comum Internacional):

Talliumklorid (201Tl)

Dosagem:

37 MBq/ ml

Forma farmacêutica:

Injeksjonsvæske, oppløsning

Unidades em pacote:

Hetteglass 10 ml

Tipo de prescrição:

C

Status de autorização:

Markedsført

Data de autorização:

1999-11-01

Características técnicas

S U M M A R Y O F P R O D U C T C H A R A C T E R I S T I C S
1
NAME OF THE MEDICINAL PRODUCT
Trade name: Thallous (Tl201) Chloride Injection
(Curium Netherlands catalogue number: DRN 8103)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
201
Tl-Thallium as thallous chloride 37 MBq
The specific activity is more than 18.5 GBq (500 mCi)/mg thallium.
201
Tl
decays to
201
Hg by electron capture with an half-life of 73.1 hours.
Most important radiation emitted
Energy level
Abundance (%)
69 keV-X-rays
27.4
80 keV-X-rays
20.5
135 keV-

-rays
2.7
166 keV-

-rays
1.6
167 keV-

-rays
10.0
For excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for injections.
4
CLINICAL INFORMATION
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.

Myocardial scintigraphy in the evaluation of coronary perfusion and
cellular
viability: ischemic heart disease, cardiomyopathies, myocarditis,
myocardial
contusions and secondary cardiac lesions.

Scintigraphy of the muscles: muscle perfusion in peripheral vascular
disorders.

Parathyroid scintigraphy.

Thallium-avid tumour visualisation in different organs, especially for
the
brain tumours and thyroid tumours and metastases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION

Injection of 0.74 to 1.11 MBq/kg in adults and the elderly of Thallous
(Tl201) chloride solution via the intravenous route. This activity can
be
increased by 50 % if SPECT-imaging is considered until a maximum
activity of 110 MBq.

The dose to be administered to a child should be a fraction of the
adult
dose calculated from the body weight according to the following table.
3 kg = 0.1
22 kg = 0.50
42 kg = 0.78
4 kg = 0.14
24 kg = 0.53
44 kg = 0.80
6 kg = 0.19
26 kg = 0.56
46 kg = 0.82
8 kg = 0.23
28 kg = 0.58
48 kg = 0.85
10 kg = 0.27
30 kg = 0.62
50 kg = 0.88
12 kg = 0.32
32 kg = 0.65
52-54 kg = 0.90
14 kg = 0.36
34 kg = 0.68
56-58 kg = 0.92
16 kg = 0.40
36 kg = 0.71
60-62 kg = 0.96
18 kg = 0.44
38 kg = 0.73
64-66 kg = 0.98
20 kg = 0.46
40 kg = 0.76
68 kg = 0.99
In very young