Gallium (Ga67) Citrate 37 MBq/ ml

Krajina: Nórsko

Jazyk: nórčina

Zdroj: Statens legemiddelverk

Aktívna zložka:

Gallium (67Ga) sitrat

Dostupné z:

Mallinckrodt Medical B.V.

ATC kód:

V09HX01

INN (Medzinárodný Name):

Gallium (67Ga) citrate

Dávkovanie:

37 MBq/ ml

Forma lieku:

Injeksjonsvæske, oppløsning

Počet v balení:

Hetteglass i blyemballasje 5.5 ml

Typ predpisu:

C

Stav Autorizácia:

Markedsført

Dátum Autorizácia:

1999-11-01

Súhrn charakteristických

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gallium (Ga67) Citrate Injection
(Mallinckrodt Medical catalogue number: DRN 3103)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per ml at activity reference date and time
67
Ga as gallium citrate
37 MBq
The qualitative composition is in conformity with the monograph 555 of
the
European Pharmacopoeia. Gallium (
67
Ga) is a radionuclide (Atomic number
31; atomic weight 67) and has a physical half-life of 3.3 days (78.3
hours). It
decays to stable zinc by electron capture emitting gamma energies of
93 keV
(38%), 185 keV (21%) and 300 keV (16.8%). A small but clinically
insignificant amount of
66
Ga is present as a natural contaminant (see
dosimetry).
For excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This product is for diagnostic use only
4.1.1
Non-specific tumour imaging and/or localising agent
Gallium may be used in conjunction with other imaging modalities in
the
diagnosis, staging and subsequent management of malignant lymphomas
such
as Hodgkin and non-Hodgkin lymphoma. It may also be of subsequent use
in
establishing response to chemotherapy.
67
Ga imaging can be helpful in the
diagnosis of bronchial neoplasm by establishing the extent of
mediastinal
spread. It has also been used to ascertain the degree of dissemination
of other
malignant primaries with varying reliability.
4.1.2
Localisation of inflammatory lesions
Gallium may be used in establishing a diagnosis in specific
inflammatory
disorders, particularly those affecting the lung such as sarcoidosis
and
opportunistic infections due to Pneumocystis carinii. In sarcoidosis
and
interstitial lung disease uptake is influenced by disease activity.
Gallium
(
67
Ga) may be useful in characterising and/or localising extrapulmonary
inflammatory lesions e.g. tuberculous lymphadenopathy or in the
investigation of fever of unknown origin. It provides only
non-specific
evidence of inflammatory sites within the body