Renasol200 Low Calcium (2.5 mEqL) Peritoneal Dialysis Solution with 2.5% Dextrose

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

SODIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE; CALCIUM CHLORIDE DIHYDRATE; Dextrose Monohydrate; Sodium Lactate

Inapatikana kutoka:

Bluecross Healthcare Sdn Bhd

INN (Jina la Kimataifa):

SODIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE; CALCIUM CHLORIDE DIHYDRATE; Dextrose Monohydrate; Sodium Lactate

Vitengo katika mfuko:

2000 ml

Viwandani na:

CHI SHENG PHARMA & BIOTECH CO. LTD.

Taarifa za kipeperushi

Consumer Medication Information Leaflet (RiMUP)
1
RENASOL
Renasol100 Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with
1.5%w/v Dextrose
Renasol200 Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with
2.5%w/v Dextrose
Renasol300 Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with
4.25%w/v Dextrose
ACTIVE INGREDIENTS:
ELECTROLYTES
RENASOL100
LOW
CALCIUM
(2.5MEQ/L)
PERITONEAL
DIALYSIS
SOLUTION
WITH
1.5%W/V DEXTROSE
RENASOL200
LOW
CALCIUM
(2.5MEQ/L)
PERITONEAL
DIALYSIS
SOLUTION
WITH
2.5%W/V DEXTROSE
RENASOL300
LOW
CALCIUM
(2.5MEQ/L)
PERITONEAL
DIALYSIS
SOLUTION
WITH
4.25%W/V DEXTROSE
COMPOSITION/L
Dextrose Monohydrate
15 g
25 g
42.5 g
Sodium Chloride (NaCl)
5.38 g
5.38 g
5.38 g
Sodium
Lactate
(C
3
H
5
NaO
3
)
4.48 g
4.48 g
4.48 g
Calcium chloride
dihydrate (CaCl
2
·2H
2
O)
0.183 g
0.183 g
0.183 g
Magnesium chloride
hexahydrate,
(MgCl
2
·6H
2
O)
0.0508 g
0.0508 g
0.0508 g
IONIC CONCENTRATION
(MEQ/L)
Sodium
132
132
132
Calcium
2.5
2.5
2.5
Magnesium
0.5
0.5
0.5
Chloride
95
95
95
Lactate
40
40
40
OSMOLALITY (MOSMOL/L) (CALC.)
344
395
483
PH
5.0 – 6.5
5.0 – 6.5
5.0 – 6.5
WHAT IS IN THIS LEAFLET?
1.
What RENASOL is used for
2.
How RENASOL works
3.
Before you use RENASOL
4.
How to use RENASOL
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
RENASOL
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT RENASOL_ _IS USED FOR?
RENASOL in Continuous
Ambulatory Peritoneal Dialysis
(CAPD) system container are
indicated for use in chronic renal
failure patients being maintained
on CAPD when nondialytic
medical therapy is judged to be
inadequate.
Peritoneal dialysis uses the body's
own peritoneal or abdominal
membrane as a filter to cleanse the
blood. The peritoneal membrane
lines the peritoneal cavity.
HOW RENASOL WORKS?
RENASOL is a peritoneal dialysis
procedure for removing toxic
substances and metabolites
normally excreted by the kidneys,
and for aiding in the regulation of
fluid and electrolyte balance. The
procedure is accomplished by
insti

Tabia za bidhaa

RENASOL100 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH
1.5%W/V DEXTROSE
RENASOL200 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH
2.5%W/V DEXTROSE
RENASOL300 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH
4.25%W/V DEXTROSE
For Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated
Peritoneal Dialysis (APD)
For intraperitoneal administration only
1.0) PRODUCT DESCRIPTION
Renasol Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with with
1.5% Dextrose/2.5% Dextrose/4.25% Dextrose is clear sterile,
nonpyrogenic solution in
CAPD system container for intraperitoneal administration only.
2.0) QUALITATIVE AND QUANTITATIVE COMPOSITION
ELECTROLYTES
RENASOL100
LOW
CALCIUM
(2.5MEQ/L) PERITONEAL DIALYSIS
SOLUTION
WITH
1.5%W/V
DEXTROSE
RENASOL200
LOW
CALCIUM
(2.5MEQ/L) PERITONEAL DIALYSIS
SOLUTION
WITH
2.5%W/V
DEXTROSE
RENASOL300
LOW
CALCIUM
(2.5MEQ/L) PERITONEAL DIALYSIS
SOLUTION
WITH
4.25%W/V
DEXTROSE
COMPOSITION/L
Dextrose Monohydrate
15 g
25 g
42.5 g
Sodium Chloride (NaCl)
5.38 g
5.38 g
5.38 g
Sodium Lactate (C
3
H
5
NaO
3
)
4.48 g
4.48 g
4.48 g
Calcium Chloride
(CaCl
2
·2H
2
O)
0.183 g
0.183 g
0.183 g
Magnesium Chloride,
(MgCl
2
·6H
2
O)
0.0508 g
0.0508 g
0.0508 g
IONIC CONCENTRATION
(MEQ/L)
Sodium
132
132
132
Calcium
2.5
2.5
2.5
Magnesium
0.5
0.5
0.5
Chloride
95
95
95
Lactate
40
40
40
OSMOLALITY (MOSMOL/L) (CALC.)
344
395
483
PH
5.0 – 6.5
5.0 – 6.5
5.0 – 6.5
3.0) PHARMACOLOGICAL PROPERTIES
3.1) PHARMACODYNAMICS
Pharmacotherapeutic group: Peritoneal Dialytics, Hypertonic solutions
ATC code: B05DB
Peritoneal dialysis is a procedure for removing toxic substances and
metabolites normally excreted by the kidneys, and for aiding in the
regulation of fluid and electrolyte
balance. The procedure is accomplished by instilling peritoneal
dialysis fluid through a conduit into the peritoneal cavity. Toxic
substances and metabolites, present in
high concentration in the blood, cross the peritoneal membrane into
the dialyzing fluid. Dextrose in the dialyzing fluid is used to
produce