Pulmocis 2 mg kit for radiopharmaceutical preparation

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MACROSALB

Available from:

CIS Bio International Route Nationale 306-Saclay, BP 32, 91192, Gif-sur-Yvette Cedex, France

ATC code:

V09EB01

INN (International Name):

MACROSALB 2 mg

Pharmaceutical form:

KIT FOR RADIOPHARMACEUTICAL PREPARATION

Composition:

MACROSALB 2 mg

Prescription type:

POM

Therapeutic area:

DIAGNOSTIC RADIOPHARMACEUTICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-04-22

Patient Information leaflet

Page 1 of 5
Package leaflet: Information for the patient
Pulmocis 2 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 Pulmocis is and what it is used for
2.
What you need to know before you are given Pulmocis
3.
How Pulmocis is given
4.
Possible side effects
5.
How Pulmocis is stored
6.
Contents of the pack and other information
1.
What Pulmocis is and what it is used for
Pulmocis 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.
Pulmocis should be radiolabelled with ‘technetium-99m’ and
obtained product is used for
scintigraphic imaging in adults and children.
When it is injected, this medicine is temporarily taken up by certain
organs.Since it 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 the
body and can give your doctor valuable information about the structure
and the functioning of this
organ.
Pulmocis is mainly used for lung scans. These scans provide
information about the structure of the
lungs and the blood flow through the lung tissue.
This medicine is also used to show how the blood flows through the
veins.
The use of Pulmocis 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

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pulmocis 2 mg kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2 mg macroaggregated human albumin (macrosalb).
The macroaggregates number per vial is ranging between 2 x 10
6
and 4 x 10
6
. In the labelled product
the particle size distribution is as follows: more than 95% 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 pellet
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 scintigraphy in patients with
both suspected lower limb deep
vein thrombosis and pulmonary embolism.
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4.2
Posology an