GLUCOVISION (PHOSPHATE) SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

FLUDEOXYGLUCOSE 18F

Prieinama:

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

ATC kodas:

V09IX04

INN (Tarptautinis Pavadinimas):

FLUDEOXYGLUCOSE (18F)

Dozė:

540GBQ

Vaisto forma:

SOLUTION

Sudėtis:

FLUDEOXYGLUCOSE 18F 540GBQ

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

100

Recepto tipas:

Schedule C

Gydymo sritis:

ROENTGENOGRAPHY

Produkto santrauka:

Active ingredient group (AIG) number: 0152591021; AHFS:

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2020-11-30

Prekės savybės

SULPHIDE COLLOID KIT
for the preparation of
99m
Tc Sulphide Colloid Injection
PRODUCT MONOGRAPH
DESCRIPTION
The kit consists of 30 mL vials, which contain the sterile,
non-pyrogenic, non-radioactive ingredients necessary to produce
Technetium
99m
Tc Sulphide
Colloid for intravenous use.
The following ingredients are present in each vial
1.
Sulphide Colloid Solution 'A' (The total volume of kit component is
adjusted to meet the needs of the individu al customer)
PER ML
Sodium Thiosulfate Pentahydrate
3 mg
Potassium Perrhenate
0.5 mg
Gelatin
4 mg
Sterile Water for Injection
qs 1 mL
2.
Sulphide Colloid Solution 'B' (The total volume of kit component is
adjusted to meet the needs of the individu al customer)
PER ML
Sodium Phosphate Dibasic Heptahydrate
93 mg
Sodium Phosphate Monobasic Monohydrate
8 mg
Sterile Water for Injection
qs 1 mL
3.
1N HCI
When prepared according to the directions, the labeling is greater
than 95% and remains stable throughout the useful life of preparation.
No bacteriostatic
agent is present.
ACTION
When colloidal particles of 0.1 µ or 1 µ size are injected
intravenously, their distribution in the body such that 80% or 90% is
captured by the phagocytic
(Kupffer) cells of the liver 5 to 10% is captured by the phagocytic
cells of the spleen and the remainder by the reticuloendothelium of
the bone marrow.
Nearly all of the colloid particles are too small to lodge in the
capillary bed of the lungs. The gall bladder, GI tract, urinary
bladder are likewise not visualized
and therefore no organ interference occurs on the scan.
INDICATIONS
Technetium
99m
Tc Sulphide Colloid Injection may be used to perform: i) liver and
spleen imaging; ii) bone marrow imaging; and iii) lymphoscintigraphy.
CONTRAINDICATIONS
None known.
WARNINGS
The contents of the kit are NOT radioactive before preparation and are
NOT to be administered directly to the patient. After the addition of
Sodium
Pertechnetate
99m
Tc, adequate shielding of the final preparation must be maintained.
Adequate studies have not yet been perform