FROSSTIMAGEDRAXIMAGE KIT FOR PREPARATION OF TC99M (MAA)

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

HUMAN SERUM ALBUMIN

Available from:

ISORAD LTD, ISRAEL

ATC code:

V09GA04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

HUMAN SERUM ALBUMIN 2.5 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

JUBILANT DRAXIMAGE INC., CANADA

Therapeutic group:

TECHNETIUM (99MTC) HUMAN ALBUMIN

Therapeutic area:

TECHNETIUM (99MTC) HUMAN ALBUMIN

Therapeutic indications:

Lung imaging evaluation of pulmonary perfusion.

Authorization date:

2021-06-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
FROSSTIMAGE/DRAXIMAGE KIT FOR THE
PREPARATION OF TC99M (MAA)
FOR INTRAVENOUS USE
Solution for Injection containing
Human Serum Albumin 2.5 mg/vial
INDICATIONS AND USAGE
Lung imaging evaluation of pulmonary perfusion.
Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent
which may be used as
an adjunct in the evaluation of pulmonary perfusion in adults and
paediatric patients.
Technetium Tc 99m Albumin Aggregated Injection may be used in adults
as an imaging agent to
aid in the evaluation of peritoneovenous (LeVeen) shunt patency.
DESCRIPTION
The kit consists of reaction vials which contain the sterile,
non-pyrogenic, non-radioactive
ingredients
necessary
to
produce
Technetium
Tc
99m
Albumin
Aggregated
Injection
for
diagnostic use by intravenous injection.
Each 10 mL reaction vial contains 2.5 mg of albumin aggregated, 5.0 mg
of albumin human,
0.1 mg of stannous chloride dihydrate and 1.2 mg of sodium chloride;
the contents are in a
lyophilized form under an atmosphere of nitrogen. Sodium hydroxide
and/or hydrochloric acid is
used
for
pH
adjustment
prior
to
lyophilization
so
that
the
pH
of
the
reconstituted
radiopharmaceutical is 5.2 to 6.0.
No bacteriostatic preservative is present.
The human serum albumin was non-reactive when tested for Hepatitis B
Surface Antigen
(HBsAg), antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2),
antibody to Hepatitis C
Virus (anti-HCV) and Antigen to Human Immunodeficiency Virus (HIV-1).
The aggregated
particles are formed by denaturation of human albumin in a heating and
aggregation process. Each
vial contains 3 to 8 million particles. By light microscopy, more than
90% of the particles are
between 10 and 70 micrometers, while the typical average size is 20 to
40 micrometers; none is
greater than 150 micrometers.
Technetium Tc 99m Albumin Aggregated Injection for intravenous use is
in its final dosage form
when sterile isotonic sodium pertechnetate solution is added to each
vial. Not less than 90% of the
pertechnetate Tc 99m