Baxter Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose

국가: 말레이시아

언어: 영어

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

유효 성분:

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

제공처:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (International Name):

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

패키지 단위:

2500ml mL; 5000ml mL; 2000ml mL

Manufactured by:

BAXTER HEALTHCARE SA, SINGAPORE BRANCH

제품 특성 요약

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