Maasol -

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Albumin humant serum makroaggregater ad Tc-99m makroalbumin

Tilgjengelig fra:

GE Healthcare AS

ATC-kode:

V09EB01

INN (International Name):

Albumin human serum macro aggregates by Tc-99m macroalbumin

Legemiddelform:

Pulver til injeksjonsvæske, suspensjon

Enheter i pakken:

Hetteglass 5x1.75 mg

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

1999-09-20

Preparatomtale

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161010 Maasol RFI response-no-spc-tracked.doc
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
MAASOL, KIT FOR RADIOPHARMACEUTICAL PREPARATION
1. NAME OF THE MEDICINAL PRODUCT
MAASOL kit for radiopharmaceutical preparation
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin macroaggregates, 1.75 milligrams / vial
Particles number
2.0 x 10
6

15% / vial
Distribution of aggregates
10 - 100

m
The product is prepared from human serum albumin derived from human
blood donations
tested according to the EEC REGULATIONS and found non reactive for:
- Hepatitis B surface antigen (HBsAg)
- Antibodies to human immunodeficiency virus (anti HIV 1/2)
- Antibodies to hepatitis C virus (anti HCV)
MAASOL is reconstituted with Sodium Pertechnetate (
99m
Tc) Injection (not included in
this kit) to prepare technetium-99m human albumin macroaggregates
injection.
Excipient(s) with known effect:
Before reconstitution, this medicinal product contains: Sodium: 0.30
mg/vial
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Powder for suspension for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After reconstitution with Sodium Pertechnetate (
99m
Tc) injection, the solution obtained is
indicated for:
Side 2 av 13
161010 Maasol RFI response-no-spc-tracked.doc
- Pulmonary perfusion scintigraphy.
- As secondary indication
99m
Tc-albumin macroaggregates injections may be used for
venoscintigraphy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology_ _
Adults
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.
Renal/Hepatic impairment
Careful consideration of the activity to be administered is required
since an increased
radiation exposure is possible in these patients.
Paediatric population