MultiBic 4mmol/L Potassium solution for haemofiltration

Страна: Малта

Език: английски

Източник: Malta Medicines Authority

Купи го сега

Листовка (PIL)

17-06-2024

Данни за продукта (SPC)

26-06-2023

Активна съставка:

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

Предлага се от:

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

АТС код:

B05ZB

INN (Международно Name):

CHLORIDE 111 mmol/l POTASSIUM 30 mmol/l POTASSIUM CHLORIDE 4.41 g/l CALCIUM 10 mmol/l GLUCOSE 5.961 mmol/l GLUCOSE MONOHYDRATE 80 g/l MAGNESIUM 162 mmol/l MAGNESIUM CHLORIDE HEXAHYDRATE 22 g/l CALCIUM CHLORIDE DIHYDRATE 2.033 g/l

Лекарствена форма:

SOLUTION FOR HAEMOFILTRATION

Композиция:

Вид предписание :

POM

Терапевтична област:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Статус Оторизация:

Withdrawn

Дата Оторизация:

2005-12-16

Листовка

Module 1: Package Leaflet
MULTIBIC 4 MMOL/L POTASSIUM

PL51400104
Page 1 of 5

PACKAGE LEAFLET

MULTIBIC 4 MMOL/L POTASSIUM 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 4 mmol/L potassium solution for haemofiltration
is and what it is used for.
2.
Before you use multiBic 4
mmol/L potassium solution for haemofiltration.
3.
How to use multiBic 4 mmol/L potassium solution for
haemofiltration.
4. Possible
side
effects.

5.
Storing multiBic 4 mmol/L potassium solution for haemofiltration
.

MULTIBIC 4 MMOL/L POTASSIUM SOLUTION FOR HAEMOFILTRATION

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

multiBic 4 mmol/L potassium 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, potassium 18.0 mmol/L,
calcium 6.75 mmol/L, magnesium 2.25 mmol/L, chloride
158.5 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 4 mmol/L potassium ready-to-use
solution contains sodium chloride 6.048
g, potassium chloride 0.298 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 1

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Данни за продукта

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

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