BICAVERA Soln for Peritoneal Dialysis 1.5% %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-05-2024
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Active ingredient:
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE MONOHYDRATE SODIUM CHLORIDE SODIUM BICARBONATE
Available from:
Fresenius Medical Care Deutschland GmbH
Dosage:
1.5% %w/v
Pharmaceutical form:
Soln for Peritoneal Dialysis
Authorization date:
2003-11-28
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
bica_Vera _1.5% Glucose, Solution for peritoneal dialysis
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
bica_Vera _1.5% glucose is delivered in a double chamber bag. One chamber contains the alkaline hydrogen 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 results 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
33.0
g
(equivalent to glucose)
30.0
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 substances:
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
16.5
g
(equivalent to glucose)
15.0
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
83.25
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: 358 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 POSOLOGY AND METHOD O
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