TechneScan LyoMAA -

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Albumin humant serum makroaggregater ad Tc-99m makroalbumin

Tilgjengelig fra:

Curium Netherlands B.V.

ATC-kode:

V09EB01

INN (International Name):

Albumin human serum macro aggregates by Tc-99m macroalbumin

Legemiddelform:

Pulver til injeksjonsvæske, oppløsning

Enheter i pakken:

Hetteglass 5x2 mg

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

1999-11-01

Preparatomtale

18 APP 4378 Norway SPC 15052019_tc
1 NAME OF THE MEDICINAL PRODUCT
TechneScan LyoMAA, Powder for suspension for injection/kit for
radiopharmaceutical
preparation.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per vial:
Macroaggregates of human serum albumin: 2.0 mg
In the labelled product the distribution of particle size (largest
dimension) is as follows:
95 % of the particles is between 10 and 100 µm, of which the large
majority is between 10
and 90 µm and less than 0.2 % of the particles is between 100-150
µm.
No particles are larger than 150 µm. The number of particles per vial
is 4.5 x 10
6
.
The product is prepared from batches of human albumin but has been
screened for hepatitis
B surface antigen (HBsAg), antibodies for human immunodeficiency virus
(anti-HIV) and
antibodies for hepatitis C virus (anti-HCV).
The radioisotope is not part of the kit.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation
Powder for solution for injection
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
-
Pulmonary perfusion scintigraphy
-
As secondary indication
99m
Tc-albumin macroaggregates may be used for
venoscintigraphy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended activities to be administered intravenously to an adult
weighing 70 kg vary
between 37-185 MBq (1-5 mCi). The number of particles per administered
dose must be in
a range of 60 x 10
3
-700 x 10
3
. The lung test may start immediately after injection.
The activity to be administered in children should be a fraction of
the adult activity and
should be calculated according to the following equation:
Paediatric dosage (MBq) = Adult dosage (MBq) x Child weight (kg)
70
Although body weight is the more used factor on which to base the
adjustment of the
activity administered, in a limited number of cases the body surface
area may be
considered to be more appropriate.
Paediatric dosage (MBq) = Adult dosage (MBq) x Child body surface (m
2
)
1.73
18 APP 4