UltraTechneKow FM Generator

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Sodium Molybdate (99Mo); Sodium pertechnetate (99mTc)

Available from:

QT INSTRUMENTS (S) PTE LTD

ATC code:

V09FX01

Dosage:

2.15, 4.3, 6.45, 8.6, 10.75, 12.9, 17.2, 21.5, 25.8, 30.1, 34.4, 43 (GBq)

Pharmaceutical form:

SOLUTION

Composition:

Sodium Molybdate (99Mo) 2.15, 4.3, 6.45, 8.6, 10.75, 12.9, 17.2, 21.5, 25.8, 30.1, 34.4, 43 (GBq); Sodium pertechnetate (99mTc) 2.08,4.16,6.24,8.32,10.4,12.47,16.63,20.79,24.95,29.11,33.26,41.58 (Gbq)

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Curium Netherlands B.V.

Authorization status:

ACTIVE

Authorization date:

2012-01-19

Summary of Product characteristics

DRN 4329
ULTRA-TECHNEKOW FM SINGAPORE
PAGE 1 OF 5
04329706BYS04a / 10 CON 4329 Singapore SPC 01112023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ultra-Technekow FM
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Technetium (
99m
Tc) is produced by means of a (
99
Mo/
99m
Tc) generator
and decays with the emission of gamma radiation with a mean energy
of 140 keV and a half-life of 6 hours to technetium (
99
Tc) which, in view
of its long half-life of 2.13 x 10
5
years can be regarded as quasi stable.
A sterile generator containing the parent isotope
99
Mo, adsorbed to an
aluminium oxide column. The
99
Mo on the column is in equilibrium with
the formed daughter isotope
99m
Tc. The generators are supplied with
the following
99
Mo activity amounts at activity reference time:
GBQ
(MCI)
GBQ (MCI)
2.15
(58)
17.20
(465)
4.30
(116)
21.50
(581)
6.45
(174)
25.80
(697)
8.60
(232)
30.10
(814)
10.75
(291)
34.40
(930)
12.90
(349)
43.00
(1162)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Radionuclide generator.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
The eluate from the generator (Sodium Pertechnetate (
99m
Tc) Injection
Ph. Eur.) may be used as a reagent for labelling of various carrier
compounds supplied as kits or administered directly in-vivo.
A.
When administered intravenously, the sterile sodium
pertechnetate (
99m
Tc) solution is used as a diagnostic aid in the
following:
•
THYROID SCINTIGRAPHY: direct imaging and measurement of
thyroid uptake to give information on the size, position,
nodularity and function of the gland in thyroid disease.
•
SALIVARY GLAND SCINTIGRAPHY: to assess salivary gland
function and duct patency.
•
LOCATION OF ECTOPIC GASTRIC MUCOSA: Meckel's diverticulum.
•
CEREBRAL SCINTIGRAPHY: to identify breaches in the blood-
brain barrier caused by tumour, infarction, haemorrhage and
oedema, when no other methods are available.
B.
When used in conjunction with pre-treatment with a reducing