GALLIUM CITRATE (Ga 67) INJECTION 37 MBqml

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

GALLIUM CITRATE EQV Ga67

متاح من:

QT INSTRUMENTS (S) PTE LTD

ATC رمز:

V09HX01

جرعة:

37 MBq/ml at ART

الشكل الصيدلاني:

INJECTION

تركيب:

GALLIUM CITRATE EQV Ga67 37 MBq/ml at ART

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

Curium Netherlands B.V.

الوضع إذن:

ACTIVE

تاريخ الترخيص:

1998-07-28

خصائص المنتج

DRN 3103 GALLIUM CITRATE (GA-67) INJECTION
DESCRIPTION
Gallium Citrate (Ga-67) Injection is a clear, colourless, sterile,
isotonic, aqueous solution with pH of 5.0-
8.0. At activity reference time the product has the following
composition:
- gallium-67 (as gallium citrate)
37
MBq (1 mCi)
- sodium chloride
6.9
mg
- sodium citrate
2.0
mg
- benzyl alcohol
9.0
mg
- sodium hydroxide (pH adjustment)
q.s
- hydrochloric acid 37% (pH adjustment)
q.s
- water for injections
.
q.s
Gallium-67 is carrier free. It contains at reference time less than
0.2% of gallium-66.
STORAGE
Store below 25°C. If multi-dose use is intended, each aliquot should
be removed under aseptic
conditions. Store below 30°C after removal of the first aliquot.
STABILITY
Gallium (Ga-67) Citrate Injection expires 16 days after production.
The expiry date and time is provided
on the outer packaging and on each vial.
After opening of the vial, the shelf-life of the product is 8 hours.
ACTION
Upon intravenous injection carrier-free gallium-67 initially binds to
serum proteins. The mechanism of
concentration in various tissues is unknown, but intracellular
accumulation in lysosomes has been
reported. In the first day 10-15% of the administered dose is excreted
by the kidneys, thereafter the liver
becomes the main route of excretuibm resyktubg ub ekunubatuib if
another 15-20% with the faeces.
The normal non-pathological pattern of distribution always shows
uptake in the liver and spleen and in
parts of the skeleton, including marrow. Further accumulation with a
variable degree of intensity may be
observed in the orbita, the nasopharynx and the salivary glands, the
sternum and the sternoclavicular
joints and in the large joints of the body. Accumulation in mammary
tissue nearly always occurs in
lactation but is also occasionally found in apparently normal breasts.
This non-pathological distribution
distinguishes itself from pathological accumulation by its symmetry.
In children the thymus or remnants
of thymic tissue may accumulate considerable amounts of gall