Posology : מינונים

4.2   Posology and method of administration

Posology
ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1).

ZINPLAVA should be administered as a single intravenous infusion of 10 mg/kg (see below and section 6.6).

The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4).

Special populations

Elderly
No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2).
Renal impairment
No dose adjustment is necessary for patients with renal impairment (see section 5.2).


Hepatic impairment
No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Paediatric population
The safety and efficacy of ZINPLAVA in patients below 18 years of age have not been established.
No data are available.

Method of administration

•     Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. ZINPLAVA should not be administered as an intravenous push or bolus.
•     The diluted solution can be infused via a central line or peripheral catheter.
•     ZINPLAVA must not be co-administered with other medicinal products simultaneously through the same infusion line.

For instructions on dilution of the medicinal product before administration, see section 6.6.