BICAVERA 2.3% %w/v Soln for Peritoneal Dialysis

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE SODIUM BICARBONATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE MONOHYDRATE

Available from:

Fresenius Medical Care Deutschland GmbH

INN (International Name):

SODIUM CHLORIDE SODIUM BICARBONATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE MONOHYDRATE

Dosage:

2.3% %w/v

Pharmaceutical form:

Soln for Peritoneal Dialysis

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Withdrawn

Authorization date:

2010-02-16

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
bica_Vera _2.3% Glucose, Solution for peritoneal dialysis
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
bica_Vera _2.3% glucose is delivered in a double-chamber bag. One chamber contains the alkaline hydrogen carbonate
carbonate solution; the other chamber contains the acidic glucose-based electrolyte solution. Mixing of both solutions
by opening the median seam between the two chambers resulting in the ready-to-use solution.
BEFORE RECONSTITUTION
1 litre of acidic glucose based electrolyte solution contains:
active substances:
Sodium chloride
11.57
g
Calcium chloride dihydrate
0.5145 g
Magnesium chloride hexahydrate
0.2033 g
Glucose monohydrate
50.0
g
(equivalent to glucose)
45.46
g
Na
+
198.0
mmol/l
Ca
2+
3.5
mmol/l
Mg
2+
1.0
mmol/l
Chloride
209.0
mmol/l
1 litre of alkaline hydrogen carbonate solution contains:
active substances:
Sodium hydrogen carbonate
5.88
g
Na
+
70.0
mmol/l
HCO
3
-
70.0
mmol/l
AFTER RECONSTITUTION
1 litre of the ready-to-use solution contains
active solution:
Sodium chloride
5.786
g
Sodium hydrogen carbonate
2.940
g
Calcium chloride dihydrate
0.2573 g
Magnesium chloride hexahydrate
0.1017 g
Glucose monohydrate
25.0
g
(equivalent to glucose)
22.73
g
Na
+
134.0
mmol/l
Ca
2+
1.75
mmol/l
Mg
2+
0.5
mmol/l
Chloride
104.5
mmol/l
Hydrogen Carbonate
34.0
mmol/l
Glucose
126.1
mmol/l
For excipients see, 6.1
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/09/2007_
_CRN 2041678_
_page number: 1_
3 PHARMACEUTICAL FORM
Solution for peritoneal dialysis
Clear and colourless solution.
Theoretical osmolarity: 401 mosm/l
pH
≈ 7.40
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
End-stage (decompensated) chronic renal failure of any origin treated with peritoneal dialysis.
4.2 POSOLOG