Teceos 13 mg

Land: Norge

Språk: norska

Källa: Statens legemiddelverk

Aktiva substanser:

Butedronatetetranatrium

Tillgänglig från:

Cis bio international

ATC-kod:

V09BA04

INN (International namn):

Butedronatetetranatrium

Dos:

13 mg

Läkemedelsform:

Preparasjonssett til radioaktive legemidler

Enheter i paketet:

Hetteglass 5x13 mg

Receptbelagda typ:

C

Bemyndigande status:

Markedsført

Tillstånd datum:

2007-09-01

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TECEOS 13 mg kit for radiopharmaceutical preparation.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One
vial
contains
13
mg
of
butedronate
tetrasodium
(or
3,3-diphosphono-1,2-
propanedicarboxylic acid, tetrasodium salt, DPD).
The radionuclide is not part of the kit.
Excipient with known effect:
Each vial contains 3.2 mg of sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
White lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After
radiolabelling
with
sodium
pertechnetate
(
99m
Tc)
solution,
the
solution
of
technetium (
99m
Tc)-butedronate obtained is indicated for:

bone scintigraphy, where it delineates areas of altered osteogenesis.

cardiac scintigraphy in patients with clinical suspicion of cardiac
amyloidosis, in
order to detect transthyretin cardiac amyloidosis (ATTR).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product is intended for use in designated nuclear
medicine facilities
only, and should only be handled by authorised personnel.
Posology
_Adults and elderly population _
BONE SCINTIGRAPHY
The average activity administered by intravenous injection is 500 MBq
for an average
patient weight of 70 kg and can be adjusted to patient weight (300-700
MBq).
CARDIAC SCINTIGRAPHY
The recommended activity administered by a single intravenous
injection is 700 MBq.
_Renal impairment _
Careful consideration of the activity to be administered is required
since an increased
radiation exposure is possible in these patients.
_ _
Patients with high bone uptake and/or severe renal impairment: a dose
adjustment can
be required.
_Paediatric population _
The use in 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 may be calculated
according