HEMOSOL B0

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CALCIUM CHLORIDE DIHYDRATE; LACTIC ACID; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM CARBONATE HYDROGEN; SODIUM CHLORIDE

Available from:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

ATC code:

B05XA30

Pharmaceutical form:

SOLUTION FOR HAEMOFILTRATION

Composition:

CALCIUM CHLORIDE DIHYDRATE 5.145 G / 1000 ML; MAGNESIUM CHLORIDE HEXAHYDRATE 2.033 G / 1000 ML; LACTIC ACID 5.400 G / 1000 ML; SODIUM CHLORIDE 6.45 G / 1000 ML; SODIUM CARBONATE HYDROGEN 3.090 G / 1000 ML

Administration route:

FOR USE WITH HEMODIALYSIS MACHINES

Prescription type:

Required

Manufactured by:

BIEFFE MEDITAL S.P.A., ITALY

Therapeutic group:

COMBINATIONS OF ELECTROLYTES

Therapeutic area:

COMBINATIONS OF ELECTROLYTES

Therapeutic indications:

As substitution solution in continuous haemofiltration and haemodiafiltration and as dialysis solution in continuous haemodialysis for acute renal failure.

Authorization date:

2013-10-31

Summary of Product characteristics

Page 1 of 7
PRESCRIBING INFORMATION
1 NAME OF THE MEDICINAL PRODUCT
HEMOSOL B0
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
HEMOSOL B0 consists of a two compartment polyolefin bag containing the
electrolyte
solution in the small compartment (compartment A) and the buffer
solution in the large
compartment (compartment B).
BEFORE RECONSTITUTION
1000 ml of electrolyte solution (small compartment A) contains:
active substances:
Calcium chloride, 2H
2
O
Magnesium chloride, 6H
2
O
Lactic acid
5,145 g
2,033 g
5,4 g
1000 ml of buffer solution (large compartment B) contains:
active substances:
Sodium hydrogen carbonate
Sodium chloride
3,09 g
6,45 g
AFTER RECONSTITUTION
The small and the large compartments are mixed to give one
reconstituted solution whose
ionic composition is:
IN MMOL/L
IN MEQ/L
Calcium
Magnesium
Sodium
Chloride
Lactate
Hydrogen carbonate
Ca
2+
Mg
2+
Na
+
Cl
-
HCO
3
-
1,75
0,5
140
109,5
3
32
3,50
1,0
140
109,5
3
32
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for haemofiltration and haemodialysis
Clear and colourless reconstituted solution.
Theoretical Osmolarity: 287 mOsm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As substitution solution in continuous haemofiltration and
haemodiafiltration and as dialysis
solution in continuous haemodialysis for acute renal failure.
Page 2 of 7
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