Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: PAION Deutschland GmbH, Heussstraße 25, 52078 Aachen, Germany
GIAPREZA 2.5 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear and colourless solution. pH: 5.0 to 6.0. Osmolarity: 130 to 170 mOsm/kg. |
Each ml of concentrate contains angiotensin II acetate equivalent to 2.5 mg angiotensin II.
One vial of 1 ml concentrate for solution for infusion contains 2.5 mg of angiotensin II.
One vial of 2 ml concentrate for solution for infusion contains 5 mg of angiotensin II.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Angiotensin II |
Angiotensin II raises blood pressure by vasoconstriction; increased aldosterone release via direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein-coupled angiotensin II receptor type 1 on vascular smooth muscle cells which stimulates Ca2+/calmodulindependent phosphorylation of myosin and causes smooth muscle contraction. |
| List of Excipients |
|---|
|
Mannitol |
1 ml vial: 1 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap. Pack size of 1 or 10 vials per carton.
2 ml vial: 2 ml solution in a Type I glass vial with an aluminium over-seal, stopper (elastomeric), and plastic cap. Pack size of 1 vial per carton.
Not all pack sizes may be marketed.
PAION Deutschland GmbH, Heussstraße 25, 52078 Aachen, Germany
EU/1/19/1384/001
EU/1/19/1384/002
EU/1/19/1384/003
Date of first authorisation: 23 August 2019
| Drug | Countries | |
|---|---|---|
| GIAPREZA | Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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