Posology : מינונים

4.2 Posology and method of administration

Posology:
The rate at which Hemosol B0 is administered depends on the blood concentration of electrolytes, acid-base balance, fluid balance and overall clinical condition of the patient. The volume of replacement solution and/or dialysate to be administered will also depend on the desired intensity (dose) of the treatment. The solution, should be prescribed and administration (dose, infusion rate, and cumulative volume) should be established only by a physician experienced in critical care medicine and CRRT (Continuous Renal Replacement Therapy).

Commonly used flow rates for the substitution solution in haemofiltration and haemodiafiltration are:
Adult:    500 - 3000 mL/hour

Commonly used flow rates for the dialysis solution (dialysate) in continuous haemodialysis are: Adult:       500 - 2500 mL/hour

Commonly used flow rates in adults are approximately 2000 to 2500 ml/h which correspond to a daily fluid volume of approximately 48 to 60 L.


Special population:
Elderly population
Evidence from clinical studies and experience suggests that use in the elderly population is not associated with differences in safety or effectiveness.


Paediatric population:
The range of flow rates for the substitution solution in haemofiltration and haemodiafiltration and for the dialysis solution (dialysate) in continuous haemodialysis are: Children (from neonates to adolescents to 18 years): 1000 to 2000 mL/h/1.73 m2.
Flow rates up to 4,000 mL/h/1.73 m2 may be needed, especially in younger children (≤10 kg).
The absolute flow rate (in mL/h) in the paediatric population should generally not exceed the maximum adult flow rate.


Method of administration:
For use with Hemodialysis machines. HEMOSOL B0, when used as a substitution solution is administered into the extracorporeal circuit before (pre-dilution) or after the haemofilter or haemodiafilter (post-dilution).

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