Baxter Dianeal Low Calcium (2.5 mEql) Peritoneal Dialysis Solution with 1.5% Dextrose

국가: 말레이시아

언어: 영어

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

유효 성분:

Sodium Lactate; Dextrose Anhydrous IP; Sodium Chloride IP; Calcium Chloride IP; Magnesium Chloride IP

제공처:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (국제 이름):

Sodium Lactate; Dextrose Anhydrous IP; Sodium Chloride IP; Calcium Chloride IP; Magnesium Chloride IP

패키지 단위:

2000 ml

Manufactured by:

Baxter Manufacturing (Thailand) Co., Ltd.

제품 특성 요약

DIANEAL
® LOW CALCIUM (2.5 MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 1.5% AND
2.5% DEXTROSE
For Peritoneal Dialysis
For Intraperitoneal administration only
DESCRIPTION
Dianeal peritoneal dialysis solutions are sterile, nonpyrogenic
solutions for intraperitoneal administration only.
They contain no bacteriostatic or antimicrobial agents.
Composition, calculated osmolarity, pH, and ionic concentrations are
shown in the following table.
Composition/ 100 mL
Osmolarity
(mOsmol/L) (calc)
pH
Ionic Concentration (mEq/L)
How Supplied
Dextrose Hydrous, USP
Sodium Chloride, USP
(NaCl)
Sodium Lactate,
(C
3
H
5
NaO
3
)
Calcium Chloride, USP
(CaCl
2
· 2H
2
O)
Magnesium Chloride,USP
(MgCl
2
· 6H
2
O)
Sodium
Calcium
Magnesium
Chloride
Lactate
Fill
Volume
(mL)
Container
Size (mL)
Code
Dianeal
PD4
Peritoneal
Dialysis
Solution with
1.5%
Dextrose
1.5 g
538
mg
448
mg
18.3
mg
5.08
mg
344
5.2
(4.0
to
6.5)
132
2.5
0.5
96
40
2000
2000
THB9766
5000
5000
THB4826
Dianeal
PD4
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
96
40
2000
2000
THB9776
5000
5000
THB5202
Dianeal
PD4
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
96
40
2000
2000
THB9796
5000
5000
THB5203
* Note: not all pack sizes are marketed.
(D-Glucopyranose monohydrate)
Dextrose Hydrous, USP
Sodium Lactate
The plastic container is fabricated from polyvinyl chloride (PL146
Plastic). Exposure to temperatures above
25°C/77°F during transport and storage will lead to minor losses in
moisture content. Higher temperatures lead
to greater losses. It is unlikely that these minor losses will lead to
clinically significant changes within the
expiration period. The amount of water that can permeate from inside
the solution container into the overpouch
is insufficient to affect the solution significantly. Solutions in
contact with the plastic container may leach out
certain chemical components from the plastic in very small amounts;
however, biolog