PHYSIONEAL 40 GLUCOSE 1.36% W/V 13.6MG/ML SOLUTION FOR PERITONEAL DIALYSIS

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:

37.5G; 0.507G; 0.14G; 8.43G; 3.29G; 2.63G

Pharmaceutical form:

SOLUTION

Composition:

DEXTROSE 37.5G; CALCIUM CHLORIDE 0.507G; MAGNESIUM CHLORIDE 0.14G; SODIUM CHLORIDE 8.43G; SODIUM BICARBONATE 3.29G; SODIUM LACTATE 2.63G

Administration route:

HAEMODIALYSIS (INTRAPERITONEAL)

Units in package:

2L/2.5L

Prescription type:

Ethical

Therapeutic area:

HEMODIALYSIS SOLUTION

Product summary:

Active ingredient group (AIG) number: 0649302004; AHFS:

Authorization status:

MARKETED

Authorization date:

2003-08-05

Summary of Product characteristics

Page 1 of 17
PRESCRIBING INFORMATION
PHYSIONEAL 40 GLUCOSE 1.36%
PHYSIONEAL 40 GLUCOSE 2.27%
PHYSIONEAL 40 GLUCOSE 3.86%
IN VIAFLEX PLASTIC CONTAINER
Solution for Peritoneal Dialysis
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
August 23, 2016
Submission Control No: 195541
Baxter, Physioneal, and Viaflex are trademarks of Baxter International
Inc.
Page 2 of 17
PRESCRIBING INFORMATION
DIRECTIONS FOR USE FOR HEALTH PROFESSIONALS
NAME OF THE MEDICINAL PRODUCT
PHYSIONEAL 40 GLUCOSE 1.36% W/V / 13.6 MG/ML, SOLUTION FOR PERITONEAL
DIALYSIS, MFR. STD.
PHYSIONEAL 40 GLUCOSE 2.27% W/V / 22.7 MG/ML, SOLUTION FOR PERITONEAL
DIALYSIS, MFR. STD.
PHYSIONEAL 40 GLUCOSE 3.86% W/V / 38.6 MG/ML, SOLUTION FOR PERITONEAL
DIALYSIS, MFR. STD.
Page 3 of 17
QUALITATIVE AND QUANTITATIVE COMPOSITION
FORMULA BEFORE MIXING:
PHYSIONEAL 40 GLUCOSE
CHAMBER “A” (GLUCOSE BAG) CONTAINS:
1.36%
2.27%
3.86%
Glucose Monohydrate
41.25 g/L
68.85 g/L
117.4 g/L
Equivalent to Anhydrous
Glucose
37.5 g/L
62.6 g/L
106.5 g/L
Calcium Chloride
Dihydrate
0.507 g/L
0.507 g/L
0.507 g/L
Magnesium Chloride
Hexahydrate
0.140 g/L
0.140 g/L
0.140 g/L
CHAMBER “B” (BUFFER BAG) CONTAINS:
1.36%
2.27%
3.86%
Sodium Chloride
8.43 g/L
8.43 g/L
8.43 g/L
Sodium Bicarbonate
3.29 g/L
3.29 g/L
3.29 g/L
Sodium (S)-Lactate
2.63 g/L
2.63 g/L
2.63 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 362.5 mL of
chamber A and 637.5 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
++
)
1.25
1.25
1.25