Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

Over suppression of parathyroid hormone may result in elevations of serum calcium levels and may lead to metabolic bone disease. Patient monitoring and individualized dose titration is required to reach appropriate physiological endpoints.

If clinically significant hypercalcaemia develops, and the patient is receiving a calcium-based phosphate binder, the dose of the calcium-based phosphate binder should be reduced or interrupted.

Chronic hypercalcaemia may be associated with generalized vascular calcification and other soft-tissue calcification.

Phosphate or vitamin D-related medicinal products should not be taken concomitantly with paricalcitol due to an increased risk of hypercalcaemia and Ca x P product elevation (see section 4.5).

Digitalis toxicity is potentiated by hypercalcaemia of any cause, so caution should be applied when digitalis is prescribed concomitantly with paricalcitol (see section 4.5).

Caution should be exercised if co-administering paricalcitol with ketoconazole (see section 4.5).

Warning for excipients
This medicinal product contains 11% v/v of ethanol (alcohol). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, and high- risk groups such as patients with liver disease or epilepsy.

Effects on Driving

4.7     Effects on ability to drive and use machines

Dizziness may occur following administration of paricalcitol, which may have a minor influence on the ability to drive and use machines (see section 4.8).