Nanocoll -

Χώρα: Νορβηγία

Γλώσσα: Νορβηγικά

Πηγή: Statens legemiddelverk

Δραστική ουσία:

Albumin humant kolloidale partikler ad Tc-99m albumin nanokolloid

Διαθέσιμο από:

GE Healthcare AS

Φαρμακολογική κατηγορία (ATC):

V09DB01

INN (Διεθνής Όνομα):

Albumin human colloidal particles by Tc-99m albumin nanocolloid

Φαρμακοτεχνική μορφή:

Pulver til injeksjonsvæske, suspensjon

Μονάδες σε πακέτο:

Hetteglass 5x0.5 mg

Τρόπος διάθεσης:

C

Καθεστώς αδειοδότησης:

Markedsført

Ημερομηνία της άδειας:

2000-03-03

Αρχείο Π.Χ.Π.

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
NANOCOLL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin colloidal particles 500 micrograms/vial.
At least 95% of human albumin colloidal particles have a diameter

80 nm.
NANOCOLL is prepared from human serum albumin derived from human blood
donations tested
according to the EEC Regulations and found non reactive for :
- Hepatitis B surface antigen (HBsAg)
- Antibodies to human immunodeficiency virus (anti-HIV 1/2)
- Antibodies to hepatitis C virus (anti-HCV)
NANOCOLL is reconstituted with Sodium Pertechnetate (
99m
Tc) Injection (not included in this kit) to
prepare technetium-99m
albumin nanocolloid injection.
Technetium-99m decays with the emission of gamma radiation with an
energy of 140 keV and a half
life of 6 hours to technetium-99 which can be regarded as quasi
stable.
Excipients with known effect:
The reconstituted injection contains 0.24 mg/ml sodium.
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Powder for solution for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with Sodium Pertechnetate (
99m
Tc) solution the product is indicated in adults,
neonates and children aged 1 to 18 years for:
_ _
_Intravenous administration: _
- Bone marrow scanning. (The product is not suitable to study the
haematopoietic activity of the
bone marrow).
- Inflammation scanning in areas other than the abdomen.
2
_ _
_Subcutaneous administration: _
Lymphoscintigraphy to demonstrate integrity of the lymphatic system,
also to identify the sentinel node
in malignant diseases such as melanoma, breast , prostate, penile,
head and neck, female pelvic (cervix
and vulvar) cancer and to differentiate between venous and lymphatic
obstruction.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Recommended activities in adults are as follows:
- Bone marrow scanning: 185-500 MBq.
- Inflammation