Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered products should be clearly recorded.


Conestat alfa is derived from milk of transgenic rabbits and contains traces of rabbit protein.
Before initiating treatment with Ruconest, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction.

Hypersensitivity reactions cannot be excluded and may have symptoms similar to angioedema attacks. All patients must be closely monitored and carefully observed for any symptoms of hypersensitivity during and after the administration period. Patients should be informed of the early signs of hypersensitivity reactions e.g., hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur after administration, they should alert their physician.
In case of anaphylactic reactions or shock, emergency medical treatment should be administered.
Although cross-reactivity between cow milk and rabbit milk is considered unlikely, the possibility of such a cross-reactivity in a patient who has evidence of clinical allergy to cow milk cannot be excluded and the patient should be observed for signs and symptoms of hypersensitivity following Ruconest administration.

Thromboembolic events
Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with known risk factors (e.g., indwelling catheters, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, immobility). Patients with known risk factors should be monitored closely.

Sodium
Each vial of Ruconest contains 19.5 mg of sodium. To be taken into consideration by patients on a controlled sodium diet.

Effects on Driving

4.7   Effects on ability to drive and use machines
Based on the known pharmacology and adverse reaction profile of Ruconest, effects on the ability to drive and use machines are not expected. However, headache, vertigo and dizziness have been reported following the use of Ruconest, but may also occur as a result of an attack of HAE. Patients should be advised not to drive and use machines if they experience headache, vertigo or dizziness.