MultiBic potassium-free solution for haemofiltration

Țară: Malta

Limbă: engleză

Sursă: Malta Medicines Authority

Ingredient activ:

CALCIUM CHLORIDE, DIHYDRATE, GLUCOSE, GLUCOSE MONOHYDRATE, MAGNESIUM, MAGNESIUM CHLORIDE, HEXAHYDRATE

Disponibil de la:

Fresenius Medical Care Deutschland GmbH D-61346 Bad Homburg, Germany

Codul ATC:

B05ZB

INN (nume internaţional):

CALCIUM CHLORIDE DIHYDRATE 2.033 g/l CHLORIDE 111 mmol/l CALCIUM 10 mmol/l GLUCOSE 2.982 mmol/l GLUCOSE MONOHYDRATE 30 g/l MAGNESIUM 82 mmol/l MAGNESIUM CHLORIDE HEXAHYDRATE 22 g/l

Forma farmaceutică:

SOLUTION FOR HAEMOFILTRATION

Compoziție:

CALCIUM CHLORIDE DIHYDRATE 2.033 g/l CHLORIDE 111 mmol/l CALCIUM 10 mmol/l GLUCOSE 2.982 mmol/l GLUCOSE MONOHYDRATE 30 g/l MAGNESIUM 82 mmol/l MAGNESIUM CHLORIDE HEXAHYDRATE 22 g/l

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2005-12-16

Prospect

Module 1: Package Leaflet 
MULTIBIC POTASSIUM-FREE  

PACKAGE LEAFLET 

MULTIBIC POTASSIUM-FREE SOLUTION FOR HAEMOFILTRATION 

-         READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS SOLUTION. 
- 
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. 
- 
IF YOU HAVE FURTHER QUESTIONS PLEASE ASK YOUR DOCTOR OR PHARMACIST. 

IN THIS LEAFLET:  
1. 
What multiBic potassium-free solution for haemofiltration is and what
it is used for.  
2. 
Before you use multiBic potassium-free solution
for haemofiltration. 
3. 
How to use multiBic potassium-free solution for haemofiltration.  
4. 
Possible side effects  
5. 
Storing multiBic potassium-free solution for haemofiltration
.

 MULTIBIC POTASSIUM-FREE SOLUTION FOR HAEMOFILTRATION 

- 
The active substances are sodium chloride, sodium hydrogen
carbonate, calcium chloride, 
magnesium chloride hexahydrate and glucose (as monohydrate). 

 multiBic potassium-free is delivered in a double-chamber bag
(two-compartment). The large 
chamber contains the alkaline hydrogen carbonate solution
(sodium 146.93 mmol/L, hydrogen 
carbonate 46.93 mmol/L, chloride 100.00 mmol/L), the small chamber
contains the acidic 
glucose-based electrolyte solution (sodium

115.75 mmol/L, calcium 6.75 mmol/L, magnesium 
2.25 mmol/L, chloride 140.5 mmol/L, glucose 25.0 mmol/L). Mixing
of both solutions by 
opening the seam between the two chambers results in the
ready-to-use solution. 

1000 mL of multiBic potassium-free ready-to-use solution contains:
sodium chloride 6.048 g, 
sodium hydrogen carbonate 3.066 g, calcium chloride 0.2205
g, magnesium chloride 
hexahydrate 0.1016 g and anhydrous glucose 1.0 g, equivalent
to the electrolyte content: sodium 
140 mmol/L, calcium 1.5 mmol/L, magnesium 0.5 mmol/L, chloride
109.0 mmol/L, hydrogen 
carbonate 35 mmol/L, glucose 5.55 mmol/L. 

- 
The other ingredients are water for injections, hydrochloric acid
(25%) and carbon dioxid

Caracteristicilor produsului

Page 1of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT MULTIBIC POTASSIUM-FREE SOLUTION FOR HAEMOFILTRATION
MULTIBIC 2 MMOL/L POTASSIUM SOLUTION FOR HAEMOFILTRATION
MULTIBIC 3 MMOL/L POTASSIUM SOLUTION FOR HAEMOFILTRATION
MULTIBIC 4 MMOL/L POTASSIUM SOLUTION FOR HAEMOFILTRATION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MULTIBIC potassium-free/2/3/4 mmol/l potassium is provided in a
two-compartment bag
with 4.75 l of an alkaline hydrogen carbonate solution in one
compartment and 0.25 l of an
acidic electrolyte, glucose solution in the other compartment.
BEFORE MIXING:
each 1000 ml solution contains:
Acidic electrolyte, glucose solution (small compartment)
MULTIBIC
potassium-
free
MULTIBIC
2 mmol/l
potassium
MULTIBIC
3 mmol/l
potassium
MULTIBIC
4 mmol/l
potassium
Unit
Potassium chloride
0
2.982
4.473
5.964
g
Calcium chloride
dihydrate
4.410
4.410
g
4.410
4.410
g
Magnesium chloride
hexahydrate
2.033
2.033
2.033
2.033
g
Glucose anhydrous
20.00
20.00
20.00
20.00
g
as Glucose
monohydrate
22.00
22.00
22.00
22.00
K
+
0
40
60
80
mmol
Ca
2+
30
30
30
30
mmol
Mg
2+
10
10
10
10
mmol
Cl
-
82
122
142
162
mmol
Glucose
111
111
111
111
mmol
Alkaline hydrogen carbonate solution (large compartment)
MULTIBIC
potassium-
free
MULTIBIC
2 mmol/l
potassium
MULTIBIC
3 mmol/l
potassium
MULTIBIC
4 mmol/l
potassium
Unit
Sodium chloride
6.453
6.453
6.453
6.453
g
Sodium hydrogen
carbonate
3.104
3.104
3.104
3.104
g
Na
+
147.37
147.37
147.37
147.37
mmol
Cl
-
110.42
110.42
110.42
110.42
mmol
HCO
3
-
36.95
36.95
36.95
36.95
mmol
Page 2of 8
AFTER MIXING:
1000 ml of the ready-to-use solution MULTIBIC potassium-free/2/3/4
mmol/l potassium
contains:
MULTIBIC
potassium-
free
MULTIBIC
2 mmol/l
potassium
MULTIBIC
3 mmol/l
potassium
MULTIBIC
4 mmol/l
potassium
Unit
Sodium chloride
6.136
6.136
6.136
6.136
g
Potassium chloride
0
0.1491
0.2237
0.2982
g
Sodium hydrogen
carbonate
2.940
2.940
2.940
2.940
g
Calcium chloride
dihydrate
0.2205
0.2205
g
0.2205 g 0.2205
g
0.2205
0.2205
0.2205
g
Magnesium
chloride
hexahydrate
0.1017
0.1017
0.1