PHYSIONEAL 40 GLUCOSE 2.27% W/V 22.7 MG/ML CLEAR-FLEX SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; SODIUM LACTATE

Available from:

BAXTER CORPORATION

ATC code:

B05ZA

INN (International Name):

HEMODIALYTICS, CONCENTRATES

Dosage:

30.3G; 0.245G; 0.068G; 19.95G; 9.29G; 6.73G

Pharmaceutical form:

SOLUTION

Composition:

DEXTROSE 30.3G; CALCIUM CHLORIDE 0.245G; MAGNESIUM CHLORIDE 0.068G; SODIUM CHLORIDE 19.95G; SODIUM BICARBONATE 9.29G; SODIUM LACTATE 6.73G

Administration route:

HAEMODIALYSIS (INTRAPERITONEAL)

Units in package:

3.75L(A)-1.25L(B)

Prescription type:

Ethical

Therapeutic area:

HEMODIALYSIS SOLUTION

Product summary:

Active ingredient group (AIG) number: 0649302009; AHFS:

Authorization status:

MARKETED

Authorization date:

2013-02-06

Summary of Product characteristics

Page 1 of 19
PRESCRIBING INFORMATION
PHYSIONEAL 40 GLUCOSE 1.36%
PHYSIONEAL 40 GLUCOSE 2.27%
PHYSIONEAL 40 GLUCOSE 3.86%
IN CLEAR-FLEX PLASTIC CONTAINER
Solution for Peritoneal Dialysis
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
August 23, 2016
Submission Control No: 195541
Baxter and Physioneal are trademarks of Baxter International Inc.
Page 2 of 19
PRESCRIBING INFORMATION
DIRECTIONS FOR USE FOR HEALTH PROFESSIONALS
NAME OF THE MEDICINAL PRODUCT
PHYSIONEAL 40 Glucose 1.36% w/v/13.6 mg/mL, CLEAR-FLEX,
Solution for Peritoneal Dialysis, Mfr. Std
.
PHYSIONEAL 40 Glucose 2.27% w/v/22.7 mg/mL, CLEAR-FLEX,
Solution for Peritoneal Dialysis, Mfr. Std.
PHYSIONEAL 40 Glucose 3.86% w/v/38.6 mg/mL, CLEAR-FLEX,
Solution for Peritoneal Dialysis, Mfr. Std.
Page 3 of 19
QUALITATIVE AND QUANTITATIVE COMPOSITION
FORMULA BEFORE MIXING:
PHYSIONEAL 40 GLUCOSE
CHAMBER “A”(GLUCOSE BAG) CONTAINS:
1.36%
2.27%
3.86%
Glucose Monohydrate
20.0 g/L
33.3 g/L
56.6 g/L
Equivalent to Anhydrous
Glucose
18.2 g/L
30.3 g/L
51.5 g/L
Calcium Chloride Dihydrate
0.245 g/L
0.245 g/L
0.245 g/L
Magnesium Chloride
Hexahydrate
0.068 g/L
0.068 g/L
0.068 g/L
CHAMBER “B”(BUFFER BAG) CONTAINS:
1.36%
2.27%
3.86%
Sodium Chloride
19.95 g/L
19.95 g/L
19.95 g/L
Sodium Bicarbonate
9.29 g/L
9.29 g/L
9.29 g/L
Sodium (S)-Lactate
6.73 g/L
6.73 g/L
6.73 g/L
FORMULA AFTER MIXING:
THE MIXED SOLUTION CONTAINS:
1.36%
2.27%
3.86%
Glucose monohydrate
15.0 g/L
25.0 g/L
42.5 g/L
Equivalent to Anhydrous
Glucose
13.6 g/L
22.7 g/L
38.6 g/L
Sodium Chloride
5.38 g/L
5.38 g/L
5.38 g/L
Calcium Chloride Dihydrate
0.184 g/L
0.184 g/L
0.184 g/L
Magnesium Chloride
Hexahydrate
0.051 g/L
0.051 g/L
0.051 g/L
Sodium Bicarbonate
2.10 g/L
2.10 g/L
2.10 g/L
Sodium (S)-Lactate
1.68 g/L
1.68 g/L
1.68 g/L
1000 mL of final solution after mixing corresponds to 750 mL of
chamber A and
250 mL of chamber B.
COMPOSITION OF THE FINAL SOLUTION (MMOL/L) AFTER MIXING:
1.36%
2.27%
3.86%
Anhydrous Glucose
(C
6
H
12
O
6
)
75.5
126
214
Sodium (Na
+
)
132
132
132
Calcium (Ca
++