Hemosol B0

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Calcium chloride dihydrate 5.145 g;  ; Lactic acid 5.4 g equivalent to lactic acid solution 90% w/w 6 g; Magnesium chloride hexahydrate 2.033 g;  ; Sodium bicarbonate 3.09 g; Sodium chloride 6.45 g;  

Available from:

Vantive Limited

INN (International Name):

Calcium chloride dihydrate 5.145 g

Pharmaceutical form:

Dialysis solution

Composition:

Active: Calcium chloride dihydrate 5.145 g   Lactic acid 5.4 g equivalent to lactic acid solution 90% w/w 6 g Magnesium chloride hexahydrate 2.033 g   Excipient: Water for injection Active: Sodium bicarbonate 3.09 g Sodium chloride 6.45 g   Excipient: Carbon dioxide Water for injection

Units in package:

Bag, plastic, ,two compartment bags: small bag (250 mL) electrolyte solution : large bag (4750 mL) buffer, 5 L

Class:

General sale

Prescription type:

General sale

Manufactured by:

Macco Organiques sro

Product summary:

Package - Contents - Shelf Life: Bag, plastic, ,two compartment bags: small bag (250 mL) electrolyte solution : large bag (4750 mL) buffer - 5 L - 12 months from date of manufacture stored PVC pack, store between 4°C to 30°C 18 months from date of manufacture stored Polyolefin pack, store between 4°C to 30°C 24 hours reconstituted stored PVC and Polyolefin packs, store between 4°C to 30°C

Authorization date:

2010-04-06

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Hemosol B0 Data Sheet 14 August 2018
Page 1 of 11
Baxter Healthcare Ltd
1 HEMOSOL B0 (solution, dialysis)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hemosol B0, is a solution for haemodialysis and haemofiltration
consisting of a mixture of the
following five active ingredients: Calcium chloride dihydrate,
Magnesium chloride hexahydrate,
(_S_)‐Lactic acid, Sodium bicarbonate and Sodium chloride.
Hemosol B0 is contained in a two‐compartment polyolefin bag
containing an electrolyte solution in
the small compartment (compartment A) and the buffer solution in the
large compartment
(compartment B).
The quantities of these active ingredients are provided in the
following tables.
_ _
_Before reconstitution _
_1000mL of electrolyte solution (small compartment A) contains: _
_Active substances _
Calcium chloride dihydrate
Magnesium chloride hexahydrate
(S)‐Lactic acid
5.145g
2.033g
5.4g
_1000mL of buffer solution (large compartment B) contains: _
_Active substances_
Sodium bicarbonate
Sodium chloride
3.09g
6.45g
_After reconstitution _
The small and the large compartments are mixed to give one
reconstituted solution with the following
ionic composition:
_1000mL of the reconstituted solution contains: _
_Active substances _
_mmol/L _
_mEq/L _
Sodium
Na
+
Calcium
Ca
2+
Magnesium
Mg
2+
Chloride
Cl
─
Hydrogen carbonate
HCO
3
─
Lactate
140
1.75
0.5
109.5
32
3
140
3.5
1.0
109.5
32
3
Theoretical osmolarity:
287mOsm/L.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution, dialysis.
Hemosol B0 solution is clear and colourless when reconstituted as a
solution.
NEW ZEALAND DATA SHEET
Hemosol B0 Data Sheet 14 August 2018
Page 2 of 11
Baxter Healthcare Ltd
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Hemosol B0 is used in the treatment of renal failure, as substitution
solution in haemofiltration and
haemodiafiltration and as dialysis solution in continuous
haemodialysis or continuous
haemodiafiltration.
Hemosol B0 may also be used in case of drug poisoning with dialysa