PHYSIONEAL 40 DEXTROSE SOLUTION 4.25% wv 42.5 mgml

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

CALCIUM CHLORIDE DIHYDRATE (in small Bag A); DEXTROSE MONOHYDRATE (in small Bag A); MAGNESIUM CHLORIDE HEXAHYDRATE (in small Bag A); SODIUM BICARBONATE (in large Bag B); SODIUM CHLORIDE (in large Bag B); SODIUM LACTATE (in large Bag B)

Dostępny od:

VANTIVE PTE. LTD.

Kod ATC:

B05DB

Dawkowanie:

0.507 g/l

Forma farmaceutyczna:

SOLUTION, STERILE

Skład:

CALCIUM CHLORIDE DIHYDRATE (in small Bag A) 0.507 g/l; DEXTROSE MONOHYDRATE (in small Bag A) 117.14 g/l; MAGNESIUM CHLORIDE HEXAHYDRATE (in small Bag A) 0.140 g/l; SODIUM BICARBONATE (in large Bag B) 3.29 g/l; SODIUM CHLORIDE (in large Bag B) 8.43 g/l; SODIUM LACTATE (in large Bag B) 2.63 g/l

Droga podania:

INTRAPERITONEAL

Typ recepty:

General Sale List

Wyprodukowano przez:

BAXTER HEALTHCARE SA

Status autoryzacji:

ACTIVE

Data autoryzacji:

2003-10-07

Ulotka dla pacjenta

PHYSIONEAL 40 DEXTROSE 1.5% OR 2.5% OR 4.25% W/V_ _
1. TRADE NAME OF THE MEDICINAL PRODUCT
PHYSIONEAL 40 DEXTROSE
 1.5% or 2.5% or 4.25% w/v Solution for Peritoneal Dialysis 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PHYSIONEAL 40 DEXTROSE
 1.5% w/v _/ _15.0 mg/ml, Solution for Peritoneal Dialysis 
PHYSIONEAL 40 DEXTROSE
 2.5% w/v _/ _25.0 mg/ml, Solution for Peritoneal Dialysis  
PHYSIONEAL 40 DEXTROSE
 4.25% w/v / 42.5 mg/ml, Solution for Peritoneal Dialysis 
THE ACTIVE SUBSTANCES ARE:

PHYSIONEAL 40 DEXTROSE 
1.5%
2.5%
4.25% 
SMALL CHAMBER “A” 
Dextrose monohydrate 
41.25 g/l 
68.85 g/l 
117.14 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 
LARGE CHAMBER, “B” 
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 Lactate 
2.63  g/l 
2.63  g/l 
2.63  g/l 
FINAL SOLUTION AFTER MIXING 
Dextrose monohydrate 
15.0  g/l 
25.0  g/l 
42.5  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 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
solution A and 637.5 ml of solution B. 
The pH of the final solution is 7.4. 
COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L 
Dextrose (C
6
H
12
0
6
H
2
0) 
75.7  mmol/l 
126  mmol/l 
214  mmol/l 
Sodium (Na+) 
132   mmol/l 
132  mmol/l 
132  mmol/l 
Calcium (Ca
++
) 
1.25  mmol/l 
1.25 mmol/l 
1.25 mmol/l 
Magnesium (Mg
++
) 
0.25  mmol/l 
0.25 mmol/l 
0.25 mmol/l 
Chloride (Cl
-
) 
95     mmol/l 
95    mmol/l 
95    mmol/l 
Bicarbonate (HCO
3
-
) 
25     mmol/l 
25    mmol/l 
25    mmol/l 
Lactate (C
3
H
5
O

Charakterystyka produktu

PHYSIONEAL 40 DEXTROSE 1.5% OR 2.5% OR 4.25% W/V_ _
1.
TRADE NAME OF THE MEDICINAL PRODUCT
PHYSIONEAL 40 DEXTROSE 1.5% or 2.5% or 4.25% w/v Solution for
Peritoneal Dialysis
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PHYSIONEAL 40 DEXTROSE 1.5% w/v _/ _15.0 mg/ml, Solution for
Peritoneal Dialysis
PHYSIONEAL 40 DEXTROSE 2.5% w/v _/ _25.0 mg/ml, Solution for
Peritoneal Dialysis
PHYSIONEAL 40 DEXTROSE 4.25% w/v / 42.5 mg/ml, Solution for Peritoneal
Dialysis
THE ACTIVE SUBSTANCES ARE:
PHYSIONEAL 40 DEXTROSE
1.5%
2.5%
4.25%
SMALL CHAMBER “A”
Dextrose monohydrate
41.25 g/l
68.85 g/l
117.14 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
LARGE CHAMBER, “B”
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 Lactate
2.63 g/l
2.63 g/l
2.63 g/l
FINAL SOLUTION AFTER MIXING
Dextrose monohydrate
15.0 g/l
25.0 g/l
42.5 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 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
solution A and 637.5 ml of solution B.
The pH of the final solution is 7.4.
COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L
Dextrose (C
6
H
12
0
6
H
2
0)
75.7 mmol/l
126 mmol/l
214 mmol/l
Sodium (Na+)
132 mmol/l
132 mmol/l
132 mmol/l
Calcium (Ca
++
)
1.25 mmol/l
1.25 mmol/l
1.25 mmol/l
Magnesium (Mg
++
)
0.25 mmol/l
0.25 mmol/l
0.25 mmol/l
Chloride (Cl
-
)
95 mmol/l
95 mmol/l
95 mmol/l
Bicarbonate (HCO
3
-
)
25 mmol/l
25 mmol/l
25 mmol/l
Lactate (C
3
H
5
O
3
-
)
15 mmol/l
15 mmol/l
15 mmol/l
Osmolarity
344 mOsmol/I
395 mOsmol/I
483 mOsmol/l
OTHER INGREDIENTS:
Water for Injection
PHYSIONEAL 40 is the new name of the medicinal product formerly known
as PHYSIONEAL. The
number '40' has been added to the name to specify the buffer
concentration of the solution (15 mmol/l