Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: CIS bio international, R.N.306 Saclay B.P. 32, F 91192, Gif-sur-Yvette, Cedex, France
PULMOCIS 2 mg kit for radiopharmaceutical preparation.
| Pharmaceutical Form |
|---|
|
Kit for radiopharmaceutical preparation. White powder in pellet form. |
Each vial contains 2 mg macroaggregated human albumin (macrosalb).
The macroaggregates number per vial is ranging between 2 × 106 and 4 × 106. 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.
| Active Ingredient | Description | |
|---|---|---|
| Technetium ⁹⁹ᵐTc macrosalb |
Technetium ⁹⁹ᵐTc macrosalb is for diagnostic use only. It is used for pulmonary perfusion scintigraphy and radionuclide venography. When administered in usual doses, technetium [99mTc] macrosalb injection shows no pharmacodynamic effects detectable clinically or/and analytically. |
| List of Excipients |
|---|
|
Human albumin |
15mL, colourless, Ph. Eur. type I, drawn glass vials, closed with rubber stoppers and aluminium capsules.
Pack size: 5 multidose vials.
CIS bio international, R.N.306 Saclay B.P. 32, F 91192, Gif-sur-Yvette, Cedex, France
PA0677/003/001
Date of first authorisation: 19 October 2001
Date of last renewal: 19 October 2006
| Drug | Countries | |
|---|---|---|
| PULMOCIS | Austria, Estonia, France, Hong Kong, Croatia, Ireland, Malta, United Kingdom |
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