Baxter Dianeal Low Calcium (2.5 mEql) Peritoneal Dialysis Solution with 2.5% Dextrose

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Sodium Lactate USP; Dextrous Hydrous USP; Calcium chloride USP; Sodium Chloride USP; Magnesium Chloride USP

Available from:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (International Name):

Sodium Lactate USP; Dextrous Hydrous USP; Calcium chloride USP; Sodium Chloride USP; Magnesium Chloride USP

Units in package:

2500ml mL; 2500ml mL; 2000ml mL; 5000ml mL

Manufactured by:

BAXTER HEALTHCARE SA, SINGAPORE BRANCH

Patient Information leaflet

Not Applicable

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Baxter Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
Baxter Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose
Baxter Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose
Baxter Dianeal Low Calcium (2.5 mEq/l) Peritoneal Dialysis Solution
with 1.5% Dextrose
Baxter Dianeal Low Calcium (2.5 mEq/l) Peritoneal Dialysis Solution
with 2.5% Dextrose
Baxter Dianeal Low Calcium (2.5 mEq/l) Peritoneal Dialysis Solution
with 4.25% Dextrose
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition/100 mL
Osmolarlty
(mOsmollL) (calc)
pH
Ionic Concentration (mEq/L)
Dextrose, Hydrous, USP
Sodium Chloride, USP (NaCI)
Sodium Lactate
(C
3
1-1,11a0
0
)
Calcium Chloride, USP (CaCl
2
2H
2
0)
Magnesium Chloride. USP
(MgC1
2
6H
2
0)
Sodium
Calcium
Magnesium
Chloride
Lactate
DIANEAL PD-2
Peritoneal
Dialy sis Solution with
1.5% Dextrose
1.5
g
538 mg 448 mg 25.7 mg 5.08 mg
346
5.2
(4.0 to
6.5)
132
3.5
0.5
96
40
DIANEAL PD-2
Peritoneal
Dialysis Solution with
2.5% Dextrose
2.5
g
538 mg 448 mg
25.7
mg
5.08
mg
396
5.2
14.0 to
6.5)
132
3.5
0.5
96
40
DIANEAL PD-2
Peritoneal
Dialysis Solution with
4.25% Dextrose
4.25
g
538 mg 448 mg 25.7 mg 5.08 mg
485
5.2
(4.0 to
6.5)
132
3.5
0.5
96
40
DIANEAL Low Calcium
12.5 mEq/L) Peritoneal
Dialysis
Solution with 1.5%
Dextrose
1.5
g
538 mg
448 mg
18.3 mg
5.08 mg
344
5.2
(4,010
6.5)
132
2.5
0.5
95
40
DIANEAL Low Calcium
12.5 mEett) Peritoneal
Dialysis
Solution with 2.5%
Dextrose
2.5
g
538 mg
448 mg
18.3 mg
5.08 mg
395
5.2
(4.0 to
6.5)
132
2.5
0.5
95
40
DIANEAL Low Calcium
12.5 mEqIL) Peritoneal
Dialysis
Solution with 4.25%
Dextrose
4.25
g
538 mg
448 mg
18.3 mg
5.08 mg
483
5.2
(4.0 to
6.5)
132
2.5
0.5
95
40
3. PHARMACEUTICAL FORM AND PRODUCT DESCRIPTION
Solution for peritoneal dialysis.
Baxter DIANEAL peritoneal dialysis solutions are sterile, clear,
colourless and nonpyrogenic.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AMBUFLEX:
Peritoneal dialysis is indicated for patients in acute or chronic
renal failure when nondialytic medical
th