Macrosalb 2.5 mg kit for radiopharmaceutical preparation

País: Malta

Língua: inglês

Origem: Malta Medicines Authority

Disponível em:

Medi-Radiopharma Ltd 2030 Erd Szamos st. 10-12, Hungary

Código ATC:

V09EB01

DCI (Denominação Comum Internacional):

MACROAGGREGATED HUMAN ALBUMIN 2.5 mg

Forma farmacêutica:

KIT FOR RADIOPHARMACEUTICAL PREPARATION

Composição:

MACROAGGREGATED HUMAN ALBUMIN 2.5 mg

Tipo de prescrição:

POM

Área terapêutica:

DIAGNOSTIC RADIOPHARMACEUTICALS

Status de autorização:

Authorised

Data de autorização:

2023-01-19

Folheto informativo - Bula

Page: 1/7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MACROSALB 2.5 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION
macroaggregated human albumin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your nuclear medicine doctor
who will supervise
the procedure.
-
If you get any side effects, talk to your nuclear medicine doctor.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Macrosalb
is and what it is used for
2.
What you need to know before Macrosalb
is used
3.
How Macrosalb
is used
4.
Possible side effects
5.
How Macrosalb
is stored
6.
Contents of the pack and other information
1.
WHAT MACROSALB
IS AND WHAT IT IS USED FOR
Macrosalb
contains the active substance macroaggregated human albumin which is a
natural
protein from human blood.
This medicine is a radiopharmaceutical product for diagnostic use
only.
Macrosalb
should be radiolabelled with ‘technetium-99m’ and obtained product
is used for
scintigraphic imaging in adults and children.
WHEN IT IS INJECTED,
the product is temporarily taken up by certain organs. Since the
product
contains a small amount of radioactivity, it can be detected outside
the body using special
cameras, and pictures, known as scans, can be taken. This scan shows
the distribution of the
radioactivity in the organ and how that organ is functioning.
Macrosalb
is mainly used for lung scans. These scans provide information about
the structure
of the lungs and the blood flow through the lung tissue.
Macrosalb
is also used to show how the blood flows through the veins.
The use of Macrosalb
does involve exposure to small amounts of radioactivity. Your doctor
and the nuclear medicine doctor have considered that the clinical
benefit that you will obtain
from the procedure with the radiopharmaceutical outweighs the risk due
to radiation.
Page: 2/7
2.
WHAT YOU NE

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
MACROSALB 2.5 MG, KIT FOR RADIOPHARMACEUTICAL PREPARATION
1.
NAME OF THE MEDICINAL PRODUCT
Macrosalb
2.5 mg
kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2.5 mg macroaggregated human albumin (macrosalb).
The macroaggregates number per vial is ranging between 3×10
6
and 8×10
6
. In the labelled
product the particle size distribution is as follows: More than 90 %
of the particles are
between 10 and 100 micrometers.
Produced from human serum albumin of human donors.
The radionuclide is not part of the kit.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation
White to off white freeze-dried plug, pellets, or powder, clean and
free from foreign matter
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (
99m
Tc) solution, the suspension of
technetium(
99m
Tc)-albumin macroaggregates obtained is indicated in adults and
paediatric
population for:
Pulmonary perfusion scintigraphy
For the diagnosis or exclusion of pulmonary embolism in patients with
symptoms of
pulmonary embolism and for monitoring the evolution of a pulmonary
embolism.
For examinations concomitant to therapies that result in a significant
reduction in the
regional lung perfusion, as preoperative investigation of local
pulmonary perfusion prior to
(partial) lung resection, preoperative examination and progress
monitoring of lung
transplants and for pre-therapeutic examinations for assisting
radiation therapy planning.
In combination with ventilation scintigraphy for the initial
evaluation and the follow-up of
patients with severe obstructive and/or restrictive pulmonary
diseases.
For the diagnosis and quantification of pulmonary right-to-left
shunts.
Radionuclide venography
As an alternative to Doppler ultrasound, for radionuclide venography
of the lower limbs, in
combination with pulmonary perfusion scintig