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 medicinal product should be clearly recorded.

Blood pressure effects

Patients with significant cardiac or vascular disease and patients on anti-hypertensive medicinal products were excluded from participation in premarketing clinical trials, see section 4.8.

To reduce the risk of a potential decrease in blood pressure and associated symptoms (dizziness, fatigue and/or nausea), patients should be well hydrated and have adequate food intake at the time of injection (see sections 4.2 and 4.8).

Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per unit volume, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7    Effects on ability to drive and use machines

Voxzogo has moderate influence on the ability to drive, cycle and use machines. Vosoritide may cause transient decreases in blood pressure that are usually mild but syncope, pre-syncope, and dizziness, as well as other signs and symptoms of decreased blood pressure have been reported as adverse reactions with Voxzogo. The patient’s response to treatment should be considered and if appropriate, advised not to drive, cycle or use machines for at least 60 minutes after injection.