Posology : מינונים

4.2   Posology and method of administration
Ruconest should be initiated under the guidance and supervision of a physician experienced in the diagnosis and treatment of hereditary angioedema.


Posology in adults and adolescents aged 12 years and above
- Body weight up to 84 kg
One intravenous injection of 50 U/kg body weight.
- Body weight of 84 kg or greater
One intravenous injection of 4200 U (2 vials).
In the majority of cases a single dose of Ruconest is sufficient to treat an acute angioedema attack.
- In case of an insufficient clinical response, an additional dose (50 U/kg body weight up to     4200 U) can be administered at the discretion of the physician (see section 5.1).

Not more than two doses should be administered within 24 hours.

Dose calculation
Determine the patient’s body weight.
- Body weight up to 84 kg
For patients up to 84 kg calculate the volume required to be administered according to the formula below:


Volume to be                  body weight (kg) times 50 (U/kg)             body weight (kg) =                                            = administered (ml)                       150 (U/ml)                               3 
- Body weight of 84 kg or greater
For patients of 84 kg or above the volume required to be administered is 28 ml, corresponding to 4200 U (2 vials).

Paediatric population
The safety and efficacy of Ruconest in children (age 0 to 12 years) have not yet been established.

Elderly (≥65 years old)
Data in patients older than 65 years are limited.
There is no rationale for patients older than 65 years to respond differently to Ruconest.

Renal impairment
No dose adjustment is necessary in patients with renal impairment since conestat alfa does not undergo renal clearance.

Hepatic impairment
There is no clinical experience with Ruconest in patients with hepatic impairment. Hepatic impairment may prolong the plasma half-life of conestat alfa, but this is not thought to be a clinical concern. No recommendation on a dose adjustment can be made.

Method of administration

For intravenous use.
Ruconest should be administered by a healthcare professional.
For instructions on reconstitution of Ruconest before administration, see section 6.6.
The required volume of the reconstituted solution should be administered as a slow intravenous injection over approximately 5 minutes.