Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, D-35041 Marburg, Germany
Hizentra 200 mg/ml solution for subcutaneous injection.
Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for subcutaneous injection. The solution is clear and pale-yellow or light-brown. Hizentra has an approximate osmolality of 380 mOsmol/kg. |
Human normal immunoglobulin (SCIg).
One ml contains:
Human normal immunoglobulin 200 mg.
(purity: at least 98% is immunoglobulin type G (IgG))
Each vial of 5 ml solution contains: 1 g of human normal immunoglobulin.
Each vial of 10 ml solution contains: 2 g of human normal immunoglobulin.
Each vial of 20 ml solution contains: 4 g of human normal immunoglobulin.
Each vial of 50 ml solution contains: 10 g of human normal immunoglobulin.
Each pre-filled syringe of 5 ml solution contains: 1 g human normal immunoglobulin.
Each pre-filled syringe of 10 ml solution contains: 2 g human normal immunoglobulin.
Each pre-filled syringe of 20 ml solution contains: 4 g human normal immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG1 69%
IgG2 26%
IgG3 3%
IgG4 2%
The maximum IgA content is 50 micrograms/ml.
Produced from the plasma of human donors.
Hizentra contains approximately 250 mmol/L (range: 210 to 290) of L-proline.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Human normal immunoglobulin G |
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donors. |
| List of Excipients |
|---|
|
L-proline |
5, 10 or 20 ml of solution in a vial (type I glass) and 50 ml of solution in a vial (type II glass), with a stopper (halobutyl), a cap (aluminium crimp) and a flip off disc (plastic).
Pack sizes of 1, 10 or 20 vials:
1 g / 5 ml
2 g / 10 ml
4 g / 20 ml
10 g / 50 ml
5, 10 or 20 ml of solution in a pre-filled syringe (cyclo-olefin-copolymer (COC)) blistered with an oxygen absorber pack.
Pack sizes of 1 or 10 pre-filled syringes:
1 g / 5 ml
2 g / 10 ml
4 g / 20 ml
Alcohol swabs, needles and other supplies or equipment are not contained in the pack.
Not all pack sizes may be marketed.
CSL Behring GmbH, Emil-von-Behring-Strasse 76, D-35041 Marburg, Germany
Vials:
EU/1/11/687/001
EU/1/11/687/002
EU/1/11/687/003
EU/1/11/687/004
EU/1/11/687/005
EU/1/11/687/006
EU/1/11/687/010
EU/1/11/687/011
EU/1/11/687/012
EU/1/11/687/013
EU/1/11/687/014
Pre-filled syringes:
EU/1/11/687/015
EU/1/11/687/016
EU/1/11/687/017
EU/1/11/687/018
EU/1/11/687/019
EU/1/11/687/020
Date of first authorisation: 14 April 2011
Date of first renewal: 18 February 2016
| Drug | Countries | |
|---|---|---|
| HIZENTRA | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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