GLUCOVISION (PHOSPHATE) SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

FLUDEOXYGLUCOSE 18F

Disponible des:

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

Codi ATC:

V09IX04

Designació comuna internacional (DCI):

FLUDEOXYGLUCOSE (18F)

Dosis:

540GBQ

formulario farmacéutico:

SOLUTION

Composición:

FLUDEOXYGLUCOSE 18F 540GBQ

Vía de administración:

INTRAVENOUS

Unidades en paquete:

100

tipo de receta:

Schedule C

Área terapéutica:

ROENTGENOGRAPHY

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2020-11-30

Fitxa tècnica

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