ACCUSOL 35 POTASSIUM 2MMOL/L
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS SODIUM BICARBONATE POTASSIUM CHLORIDE GLUCOSE ANHYDROUS
Available from:
Baxter Healthcare Limited
Dosage:
2 mMol.
Pharmaceutical form:
Solution for Haemofiltration
Authorization date:
2006-04-28
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Accusol 35 Potassium 2 mmol/l
Solution for haemofiltration, haemodialysis and haemodiafiltration
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Equivalent to the following ionic composition:
The 5000 ml of final solution results from mixing 3750 ml of solution ‘A’ with 1250 ml of solution ‘B’.
The pH of the final solution is between 7.0 - 7.5.
For a full list of excipients, see section 6.1.
The number “35” in the name specifies the buffer concentration of the solution (bicarbonate = 35mmol/l.)
3 PHARMACEUTICAL FORM
Solution for haemofiltration, haemodialysis and haemodiafiltration.
COMPOSITION
PER 1000 ML
ACCUSOL 35
LARGE CHAMBER ‘A’
Calcium chloride dihydrate
0.343 g
Magnesium chloride hexahydrate
0.136 g
Sodium chloride
7.66 g
Potassium chloride
0.199 g
Glucose monohydrate
1.47 g
SMALL CHAMBER ‘B’
Sodium bicarbonate
12.9 g
FINAL SOLUTION AFTER MIXING
PER 1000 ML
ACCUSOL 35
Calcium chloride dihydrate
0.257 g
Magnesium chloride hexahydrate
0.102 g
Sodium chloride
6.14 g
Potassium chloride
0.149 g
Glucose anhydrous
1.0 g
Sodium bicarbonate
2.94 g
IONIC COMPOSITION OF FINAL SOLUTION
PER 1000 ML
ACCUSOL 35
Calcium (Ca
++
)
1.75 mmol
Magnesium (Mg
++
)
0.5 mmol
Sodium (Na
+
)
140 mmol
Potassium (K
+
)
2 mmol
Chloride (Cl
-
)
111.5 mmol
Glucose Anhydrous
5.55 mmol
Bicarbonate (HCO
3
-
)
35 mmol
Theoretical Osmolarity
296 MOSM/L
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/04/2011_
_CRN 2099091_
_page number: 1_
Accusol 35 is a sterile, non pyrogenic, clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Accusol 35 is indicated for the treatment of acute and chronic renal failure, as substitution solution in haemofiltrat
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