Neurolite -

País: Noruega

Idioma: noruego

Fuente: Statens legemiddelverk

Ingredientes activos:

Bicisatdihydroklorid ad Tc-99m Bicisate

Disponible desde:

Lantheus MI UK Ltd.

Código ATC:

V09AA02

Designación común internacional (DCI):

Bicisate dihydrochloride by Tc-99m Bicisate

formulario farmacéutico:

Pulver og væske til injeksjonsvæske, oppløsning

Unidades en paquete:

1 sett

tipo de receta:

C

Estado de Autorización:

Markedsført

Fecha de autorización:

1995-02-01

Ficha técnica

1. LEGEMIDLETS NAVN
NEUROLITE®
2. KVALITATIV OG KVANTITATIV SAMMENSETNING
Vial A contains 900 μg Bicisate dihydrochloride and 72 microg
Stannous Chloride dihydrate.
Vial B contains the solvent.
After reconstitution of the Neurolite kit with sterile nonpyrogenic,
oxidant free Sodium Pertechnetate Tc-
99m, the complex Tc-99m N,N’ (1,2-ethylenediyl) bis-L-cysteine
diethyl ester (Tc-99m Bicisate) is
formed.
For a full list of excipients, see section 6.1.
3. LEGEMIDDELFORM
Powder and solvent for solution for injection, kit for
radiopharmaceutical preparation of Technetium Tc-
99m Bicisate injection.
4. KLINISKE OPPLYSNINGER
4.1 INDIKASJONER
This medicinal product is for diagnostic use only.
Tc-99m Bicisate scintigraphy is indicated in the evaluation of
regional cerebral perfusion abnormalities in
adult patients with central nervous system disorders.
4.2 DOSERING OG ADMINISTRASJONSMÅTE
The recommended dose for intravenous administration after preparation
with Sodium Pertechnetate Tc-
99m Injection, Ph. Eur., in the average patient (70 kg) is 740 MBq (20
mCi).
Scintigraphy should be carried out within 6 hours of administration.
If necessary, high activity up to 1700 Mbq can be injected provided
that the patient is able to void at least
every two hours.
The patient dose should be measured by a suitable radioactivity
calibration system prior to patient
administration. It is recommended to check the radiochemical purity
prior to patient administration.
4.3 KONTRAINDIKASJONER
Hypersensitivity to the active substance or to any of the excipients.
4.4 ADVARSLER OG FORSIKTIGHETSREGLER
Radiopharmaceuticals should be used only by physicians who are
qualified by training and experience in
the safe handling of radionuclides and whose experience and training
have been approved by the
appropriate government agency authorised to license the use of
radionuclides where appropriate.
Contents of the vials are intended only for use in the preparation of
Technetium Tc-99m Bicisate and are
not to be administered directly to the adult pa