RUCONEST Powder for solution for injection Ref.[10970] Active ingredients: Conestat alfa

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

Posology in adults, adolescents and children aged 2 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).

• In adults and adolescents an additional dose may be administered if the patient has not responded adequately after 120 minutes.
• In children an additional dose may be administered if the patient has not responded adequately after 60 minutes. 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 administered (ml) = body weight (kg) times 50 (U/kg) / 150 (U/ml) = body weight (kg) / 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

Ruconest may be used in paediatric patients (2 years and older) at the same dose as in adults (50 U/kg body weight).

The safety and efficacy of Ruconest in children less than 2 years old have not been established. No clinical data are available.

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.

No clinical information on overdose is available.

4 years.

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 48 hours between 5˚C and 25˚C. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8˚C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Do not store above 25°C.

Store in the original package in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

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.

Each vial of Ruconest is for single use only.

An aseptic technique should be used for reconstitution, combining and mixing the solutions.

Reconstitution

Each vial of Ruconest (2100 U) should be reconstituted with 14 ml water for injections. Water for injections should be added slowly to avoid forceful impact on the powder and mixed gently to minimise foaming of the solution. The reconstituted solution contains 150 U/ml conestat alfa and appears as a clear colourless solution.

The reconstituted solution in each vial should be visually inspected for particulate matter and discoloration. A solution exhibiting particulates or discoloration should not be used. The medicinal product should be used immediately (see section 6.3).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.