Posology : מינונים

4.2    Posology and method of administration

Therapy should be initiated by a physician experienced in the management of CHB.
Posology

Adults and adolescents (aged 12 years and older with body weight at least 35 kg): one tablet once daily.

Treatment discontinuation
Treatment discontinuation may be considered as follows (see section 4.4): 
•      In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or until there is loss of efficacy (see section 4.4). Regular reassessment is recommended after treatment discontinuation to detect virological relapse.


•     In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy. With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.

Missed dose
If a dose is missed and less than 18 hours have passed from the time it is usually taken, the patient should take this medicinal product as soon as possible and then resume their normal dosing schedule.
If more than 18 hours have passed from the time it is usually taken, the patient should not take the missed dose and should simply resume the normal dosing schedule.

If the patient vomits within 1 hour of taking the treatment, the patient should take another tablet. If the patient vomits more than 1 hour after taking the treatment, the patient does not need to take another tablet.

Special populations

Elderly
No dose adjustment of this medicinal product is required in patients aged 65 years and older (see section 5.2).

Renal impairment
No dose adjustment of this medicinal product is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 15 mL/min or in patients with CrCl < 15 mL/min who are receiving haemodialysis.

On days of haemodialysis, this medicinal product should be administered after completion of haemodialysis treatment (see section 5.2).

No dosing recommendations can be given for patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.4).

Hepatic impairment
No dose adjustment of this medicinal product is required in patients with hepatic impairment (see sections 4.4 and 5.2).

Paediatric population
The safety and efficacy of Vemlidy in children younger than 12 years of age, and weighing < 35 kg, have not yet been established. No data are available.

Method of administration

Oral use. Vemlidy film-coated tablets should be taken with food (see section 5.2). There is no information available regarding the crushing/splitting of the product. It is recommended that the film-coated tablet is not chewed, split or crushed.