Posology : מינונים

4.2   Posology and method of administration

Posology
Recommended dose and duration of treatment for adults
The recommended dose of dalbavancin in adult patients with ABSSSI is 1,500 mg administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg (see sections 5.1 and 5.2).

Elderly
No dose adjustment is necessary (see section 5.2).
Renal impairment
Dose adjustments are not required for patients with mild or moderate renal impairment (creatinine clearance  30 to 79 ml/min). Dose adjustments are not required for patients receiving regularly scheduled haemodialysis (3 times/week), and dalbavancin may be administered without regard to the timing of haemodialysis.

In patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regularly scheduled haemodialysis, the recommended dose is reduced to either 1,000 mg administered as a single infusion or 750 mg followed one week later by 375 mg (see section 5.2).

Hepatic impairment
No dose adjustment of dalbavancin is recommended for patients with mild hepatic impairment (Child-Pugh A). Caution should be exercised when prescribing dalbavancin to patients with moderate or severe hepatic impairment (Child-Pugh B & C) as no data are available to determine appropriate dosing (see sections 5.2).

Paediatric population
Xydalba is not indicated for children and adolescents under 18 years old.
The safety and efficacy of dalbavancin in children aged from birth to < 18 years has not yet been established.

Method of administration

Intravenous use
Xydalba must be reconstituted and then further diluted prior to administration by intravenous infusion over a 30 - minute period. For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.