PULMOCIS 2 mg kit for radiopharmaceutical preparation

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Human albumin macro aggregated

Доступно од:

CIS bio International

АТЦ код:

B05AA; B05AA01

INN (Међународно име):

Human albumin macro aggregated

Дозирање:

2.0 milligram(s)

Фармацеутски облик:

Kit for radiopharmaceutical preparation

Тип рецептора:

Product subject to prescription which may not be renewed (A)

Терапеутска област:

Blood substitutes and plasma protein fractions; albumin

Статус ауторизације:

Marketed

Датум одобрења:

2001-10-19

Карактеристике производа

Health Products Regulatory Authority
18 December 2019
CRN008R54
Page 1 of 16
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. No macroaggregates has a size
larger than 150 micrometer.
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 powder in pellet form.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medical 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 p