LYMPH-FLO injection composite pack

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

antimony trisulfide, Quantity: 1.1 mg/mL

থেকে পাওয়া:

Royal Adelaide Hospital Radiopharmacy

ফার্মাসিউটিকাল ফর্ম:

Injection, solution

রচনা:

Excipient Ingredients: water for injections; monobasic sodium phosphate dihydrate; dibasic sodium phosphate

প্রশাসন রুট:

Intradermal

প্যাকেজ ইউনিট:

1x1mL vial Antimony Trisulfide solution, 1x1mL vial Phosphate Buffer solution, 1x1mL vial Hydrochloric Acid solution

প্রেসক্রিপশন টাইপ:

Not scheduled. Not considered by committee

থেরাপিউটিক ইঙ্গিত:

Technetium [99mTc] Colloidal Antimony Sulphide Injection is used for visualisation of lymphatic drainage following intradermal administration in the following conditions: lymphoedema, primary melanoma and breast carcinoma.

পণ্য সারাংশ:

Visual Identification: A colourless solution; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

অনুমোদন অবস্থা:

Licence status A

অনুমোদন তারিখ:

1999-05-25

পণ্য বৈশিষ্ট্য

PRODUCT INFORMATION LEAFLET: LYMPH-FLO
KIT FOR THE PREPARATION OF TECHNETIUM[
99M
TC] COLLOIDAL ANTIMONY SULPHIDE
INJECTION - A DIAGNOSTIC RADIOPHARMACEUTICAL FOR INTRADERMAL USE
DESCRIPTION
Lymph-Flo is a sterile, non-pyrogenic diagnostic kit for the in vitro
preparation of
Technetium[
99m
Tc] Colloidal Antimony Sulphide Injection - a colloidal dispersion of
antimony sulphide, the micelles of which are labelled with Technetium[
99m
Tc] and
stabilised with Povidone. The final pH of the injection is between 5.5
and 6.5. Lymph-
Flo does not comply with the BP 93 monograph for Technetium[
99m
Tc] Colloidal
Antimony
Sulphide
Injection
because
the
concentration
of
antimony
in
the
reconstituted injection (0.29 mg/mL)
exceeds
the
maximum
concentration
allowed
by
the
BP
(0.20 mg/mL).
Each kit consists of five separate non-radioactive components together
with a user
label:
1.
Antimony Trisulfide - A 10 mL reaction vial containing 1.1 mg of
antimony trisulfide
and 3.5 mg of povidone in 1 mL of water for injection. This solution
should not be
used in the preparation of the final product if flocculation or
precipitate is
observed.
2.
Phosphate Buffer
- A 10 mL vial containing 49.0 mg of sodium phosphate dibasic
anhydrous and 6.1 mg of sodium phosphate monobasic dihydrate in 1 mL
of water
for injection. The pH range of the solution is between 7 and 8.
3.
Hydrochloric Acid - A 10 mL vial containing 1 mL of 1.0 M hydrochloric
acid
solution.
4.
An empty sterile 10 mL vial.
5.
A sterile, pyrogen-free 0.2
µ
m filter.
PHYSICAL CHARACTERISTICS
Technetium[
99m
Tc] decays by isomeric transition with a physical half-life of 6.0
hours.
The
principal
photon
that
is
useful
for
detection
and
imaging
is
listed
in
Table
1.
TABLE 1. PRINCIPAL RADIATION EMISSION DATA
Principal
Radiation
Mean % per
Disintegration
Mean Energy
(keV)
Gamma-2
87.2
140.5
Reference: Browne, E., Firestone, R.B. and Shirley, V.S. (Ed):
Table of Radioactive Isotopes
, 1986, J. Wiley.
TABLE 2. PHYSICAL DECAY CHART FOR TECHNETIUM[
99M
TC]
Hours
Fraction remaining
Hours
F