Posology : מינונים

2         DOSAGE AND ADMINISTRATION
2.1       Dosing Recommendations
Before starting or resuming NOQDIRNA assess the sodium concentration and only start or resume NOQDIRNA in patients with a normal serum sodium concentration [see Warnings and Precautions (5.1), Contraindications (4)].
The recommended NOQDIRNA dosage in:
•    Women is Noqdirna 25, one tablet once daily, one hour before bedtime, administered sublingually without water.
•    Men is Noqdirna 50, one tablet once daily, one hour before bedtime, administered sublingually 
without water.
Keep the tablet under the tongue until it has fully dissolved.
The recommended dose for women is lower than for men because women are more sensitive to the effects of NOQDIRNA and had a higher risk of hyponatremia with the 50 mcg dose in clinical trials.
Instruct patients to empty their bladder immediately before bedtime. Limit fluid intake to a minimum from 1 hour before until 8 hours after administration [see Warnings and Precautions (5.1) and Patient Counseling Information (17)].
Pediatric Use:
NOQDIRNA is not indicated for pediatric use.
The safety and effectiveness of NOQDIRNA have not been established in pediatric patients.
2.2       Sodium Monitoring
Ensure serum sodium concentration is normal prior to initiating or resuming NOQDIRNA. NOQDIRNA is contraindicated in patients with hyponatremia or a history of hyponatremia [see Contraindications (4)].
Check the serum sodium concentration within the first week and again at one month after initiating or resuming therapy.
Periodically monitor serum sodium during NOQDIRNA therapy, as clinically appropriate. More frequent serum sodium monitoring is recommended for patients 65 years and older and for those at risk of hyponatremia.
If the patient develops hyponatremia, NOQDIRNA must be temporarily or permanently discontinued, and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia [see Warnings and Precautions (5.1)].