DRAXIMAGE MAA kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

aggregated albumin, Quantity: 2.5 mg; stannous chloride dihydrate, Quantity: 0.1 mg; sodium chloride, Quantity: 1.2 mg; Albumin, Quantity: 5 mg

Disponível em:

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

DCI (Denominação Comum Internacional):

aggregated albumin,Albumin,sodium chloride,Stannous chloride dihydrate

Forma farmacêutica:

Powder

Composição:

Excipient Ingredients: nitrogen; water for injections

Via de administração:

Intravenous

Unidades em pacote:

box of 10 vials

Tipo de prescrição:

Not scheduled. Not considered by committee

Indicações terapêuticas:

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.

Resumo do produto:

Visual Identification: powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store between 2 - 25 degrees celsius

Status de autorização:

Licence status A

Data de autorização:

2016-10-07

Folheto informativo - Bula

DRAXIMAGE
®
MAA
KIT FOR THE PREPARATION OF
TECHNETIUM TC 99MALBUMIN
AGGREGATED INJECTION
DIAGNOSTIC
FOR INTRAVENOUS USE
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 4to 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 added to a reaction vial is bound to
aggregates at preparation time and
remains bound throughout the 8-hour lifetime of the preparation.
ACTION
Immediately following intravenous injection, more than 80% of the
aggregated albumin is
trapped in the pulmonary alveolar capillary bed. The imaging procedure
can thus be started as
soon as the injection is complete. Assuming that a sufficient number
of radioactive particles has
been used, the distribution of radioactive

Características técnicas

PRODUCT INFORMATION
DRAXIMAGE
® MAA
KIT FOR THE PREPARATION OF
TECHNETIUM TC 99M ALBUMIN
AGGREGATED INJECTION
DIAGNOSTIC
ATC CODE: V09EB01
FOR INTRAVENOUS USE
Date of Preparation:
March 23, 2017
PRODUCT INFORMATION
DRAXIMAGE
® MAA
KIT FOR THE PREPARATION OF
TECHNETIUM TC 99MALBUMIN
AGGREGATED INJECTION
DIAGNOSTIC
FOR INTRAVENOUS USE
NAME OF THE MEDICINE
Albumin Aggregated
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 added to a reaction vial is bound to
aggregates at preparation time and
remains bound throughout the 8-hour lifetime of the preparation.
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Registered Trademark of Jubilant DraxImage Inc.
PHARMACOLOGY
Immed