Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pharming Group N.V., Darwinweg 24, 2333 CR Leiden, The Netherlands
Ruconest 2100 Units powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection. White to off-white powder. |
One vial contains 2100 units of conestat alfa, corresponding to 2100 units per 14 ml after reconstitution, or a concentration of 150 units/ml.
Conestat alfa is a recombinant analogue of the human C1 esterase inhibitor (rhC1-INH) produced by recombinant DNA technology in the milk of transgenic rabbits.
1 unit of conestat alfa activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 ml of pooled normal plasma.
Excipient with known effect: Each vial contains approximately 19.5 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Conestat alfa |
Conestat alfa, a recombinant human complement component 1 (C1) esterase inhibitor (rhC1-INH), is an analogue of human C1-INH and is obtained from the milk of rabbits expressing the gene coding for human C1-INH. C1-INH exerts an inhibitory effect on several proteases (target proteases) of the contact and complement systems. |
| List of Excipients |
|---|
|
Sucrose |
2100 units of conestat alfa powder in a 25 ml vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic).
Pack size of 1.
Pharming Group N.V., Darwinweg 24, 2333 CR Leiden, The Netherlands
EU/1/10/641/001
Date of first authorisation: 28 October 2010
Date of latest renewal: 18 September 2015
| Drug | Countries | |
|---|---|---|
| RUCONEST | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
