Nanocis 0.15 mg

Krajina: Nórsko

Jazyk: nórčina

Zdroj: Statens legemiddelverk

Aktívna zložka:

Rheniumsulfid

Dostupné z:

Cis bio international

ATC kód:

V10AX05

INN (Medzinárodný Name):

Rheniumsulfid

Dávkovanie:

0.15 mg

Forma lieku:

Injeksjonsvæske, oppløsning

Počet v balení:

5 sett

Typ predpisu:

C

Stav Autorizácia:

Markedsført

Dátum Autorizácia:

2005-12-21

Súhrn charakteristických

spcT1732D
12/2015
1
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
NANOCIS,
KIT FOR THE PREPARATION OF TECHNETIUM (
99M
TC) COLLOIDAL RHENIUM SULPHIDE INJECTION
(NANOCOLLOID)
1.
NAME OF THE MEDICINAL PRODUCT
NANOCIS
Kit for the preparation of technetium (
99m
Tc) colloidal rhenium sulphide injection
(Nanocolloid)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial A contains 0.24 mg of rhenium sulphide, corresponding to
0.15 mg of elemental
rhenium.
The radionuclide is not part of the kit.
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Powder and solvent for solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After labelling with sodium pertechnetate (
99m
Tc) solution for injection:
-
Lymphoscintigraphy for the purpose of visualising the regional
lymphatic system:
spcT1732D
12/2015
2
•
IMAGING
AND
INTRAOPERATIVE
DETECTION
OF
SENTINEL
LYMPH
NODE
(SLN)
in
the
following
tumours:
breast
cancer,
malignant
melanoma,
vulvar
carcinoma,
penile
carcinoma, prostate cancer and head and neck squamous cell carcinoma.
• IMAGING OF REGIONAL LYMPHATIC FLOW for individualised radiation
therapy.
• LYMPHATIC FLOW SCINTIGRAPHY for diagnosing lymphatic oedema in the
limbs.
- Digestive exploration (gastroesophageal scintigraphy).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be reconstituted before administration
to the patient.
LYMPHOSCINTIGRAPHY:
IMAGING AND DETECTION OF SENTINEL LYMPH NODE
The activity of technetium (
99m
Tc) colloidal rhenium sulphide in adults depends upon the
indication, the anatomical region that is to be investigated and the
time between the
injection and imaging.
The injection site is selected according to the anatomical area to be
investigated. The
injection is made without pressure into loose connective tissue, which
should not be poorly
vascularised. Before the injection, an aspiration test should
ascertain that no blood vessel
was inadvertently punct