Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Oversuppression of parathyroid hormone may result in elevations of serum calcium levels and may lead to metabolic bone disease. Patient monitoring and individualized dose titration are required to reach appropriate physiological endpoints.
If clinically significant hypercalcemia 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
A dose of 40 micrograms of this medicine administered to an adult weighing 70 kg would result in exposure to approximately 18 mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about 3 mg/100 ml.
For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.

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).