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RESPREEZA Powder and solvent for solution (2019)

Active ingredients: Alfa1 antitrypsin

Product Name and Form

Respreeza 1,000 mg powder and solvent for solution for infusion.

Respreeza 4,000 mg powder and solvent for solution for infusion.

Respreeza 5,000 mg powder and solvent for solution for infusion.

Pharmaceutical form

Powder and solvent for solution for infusion.

The powder is white to off-white. The solvent is a clear and colourless solution.

The reconstituted solution has an approximate osmolality of 279 mOsmol/kg and a pH of 7.0.

Qualitative and Quantitative Composition

Respreeza 1,000 mg powder and solvent for solution for infusion: One vial contains approximately 1,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase.

After reconstitution with 20 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor.

The total protein content is approximately 1,100 mg per vial.

Respreeza 4,000 mg powder and solvent for solution for infusion: One vial contains approximately 4,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase.

After reconstitution with 76 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor.

The total protein content is approximately 4,400 mg per vial.

Respreeza 5,000 mg powder and solvent for solution for infusion: One vial contains approximately 5,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase.

After reconstitution with 95 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor.

The total protein content is approximately 5,500 mg per vial.

* Produced from the plasma of human donors.

Excipients with known effect: Respreeza contains approximately 1.9 mg sodium per ml of reconstituted solution (81 mmol/l).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Alfa1 antitrypsin

Human alpha1-proteinase inhibitor is understood to be the primary anti-protease in the lower respiratory tract, where it inhibits neutrophil elastase (NE). Normal healthy individuals produce sufficient alpha1-proteinase inhibitor to control the NE produced by activated neutrophils and are thus able to prevent inappropriate proteolysis of lung tissue by NE.

List of excipients

Powder:

Sodium chloride
Sodium dihydrogen phosphate monohydrate
Mannitol

Solvent:

Water for injections

Pack sizes and Marketing

Respreeza 1,000 mg powder and solvent for solution for infusion: Respreeza 1,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap. 20 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.

Respreeza 4,000 mg powder and solvent for solution for infusion: Respreeza 4,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap. 76 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.

Respreeza 5,000 mg powder and solvent for solution for infusion: Respreeza 5,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap. 95 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap.

Presentations

Each pack contains:

Respreeza 1,000 mg powder and solvent for solution for infusion:

One single-use powder vial.

One solvent vial of 20°ml water for injections.

One transfer set 20/20 (Mix2Vial set) for reconstitution.

Respreeza 4,000 mg powder and solvent for solution for infusion:

One single-use powder vial.

One solvent vial of 76°ml water for injections.

One transfer set 20/20 (Mix2Vial set) for reconstitution.

Respreeza 5,000 mg powder and solvent for solution for infusion:

One single-use powder vial.

One solvent vial of 95°ml water for injections.

One transfer set 20/20 (Mix2Vial set) for reconstitution.

Marketing authorization holder
Authorization dates

CSL Behring GmbH, Emil-von-Behring-Strasse 76, D-35041, Marburg, Germany

Date of first authorisation: 20 August 2015

Marketing authorization number:

EU/1/15/1006/001

EU/1/15/1006/002

EU/1/15/1006/003