GLUCOVISION (PHOSPHATE) SOLUTION

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

FLUDEOXYGLUCOSE 18F

थमां उपलब्ध:

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

ए.टी.सी कोड:

V09IX04

INN (इंटरनेशनल नाम):

FLUDEOXYGLUCOSE (18F)

डोज़:

540GBQ

फार्मास्यूटिकल फॉर्म:

SOLUTION

रचना:

FLUDEOXYGLUCOSE 18F 540GBQ

प्रशासन का मार्ग:

INTRAVENOUS

पैकेज में यूनिट:

100

प्रिस्क्रिप्शन प्रकार:

Schedule C

चिकित्सीय क्षेत्र:

ROENTGENOGRAPHY

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

CANCELLED POST MARKET

प्राधिकरण की तारीख:

2020-11-30

उत्पाद विशेषताएं

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