Prismasol 2 mmol/l Potassium solution for haemodialysis/haemofiltration

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glucose (as monohydrate); Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium chloride ph.eur.; Potassium chloride; Sodium hydrogen carbonate; Calcium; Magnesium; Sodium; Lactate; Hydrogen carbonate; Chloride; Potassium; Glucose

Available from:

Gambro Lundia AB

ATC code:

B05ZB

INN (International Name):

Glucose (as monohydrate); Magnesium chloride hexahydrate; Calcium chloride dihydrate; Lactic acid; Sodium chloride ph.eur.; Potassium chloride; Sodium hydrogen carbonate; Calcium; Magnesium; Sodium; Lactate; Hydrogen carbonate; Chloride; Potassium; Glucose

Dosage:

2 millimole(s)/litre

Pharmaceutical form:

Solution for haemodialysis/haemofiltration

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Hemofiltrates

Authorization status:

Not marketed

Authorization date:

2003-12-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRISMASOL 2 MMOL/L POTASSIUM SOLUTION FOR
HAEMODIALYSIS/HAEMOFILTRATION
CALCIUM CHLORIDE DIHYDRATE/ MAGNESIUM CHLORIDE HEXAHYDRATE/ GLUCOSE
MONOHYDRATE/ LACTIC ACID
SOLUTION 90% W/W / SODIUM CHLORIDE/ POTASSIUM CHLORIDE/ SODIUM
HYDROGEN CARBONATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Prismasol is and what it is used for
2.
What you need to know before you use Prismasol
3.
How to use Prismasol
4.
Possible side effects
5.
How to store Prismasol
6.
Contents of the pack and other information
1. WHAT PRISMASOL IS AND WHAT IT IS USED FOR
Prismasol contains the active substances calcium chloride dihydrate,
magnesium chloride
hexahydrate, glucose monohydrate, lactic acid solution 90% w/w, sodium
chloride, potassium
chloride and sodium hydrogen carbonate.
Prismasol is used in the treatment of renal failure as a solution for
continuous haemofiltration or
haemodiafiltration (as a replacement for fluid lost from the blood
passing through a filter) and
continuous haemodialysis or haemodiafiltration (the blood flows on one
side of a dialysis membrane
while a haemodialysis solution flows on the other side of the
membrane).
Prismasol solution may also be used in case of drug poisoning with
dialysable or filterable substances.
Prismasol 2 mmol/l Potassium is indicated particularly in patients who
have tendency to
hyperkalaemia (a high concentration of potassium in the blood).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PRISMASOL
DO NOT USE PRISMASOL 2 MMOL/L POTASSIUM IN CASE OF:
•
allergy to one of the active substances or any of the other
ingredients (listed in section 6),
•
a low concen

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prismasol 2 mmol/l Potassium solution for
haemodialysis/haemofiltration
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Prismasol 2 mmol/l Potassium is presented in a two-compartment bag
containing in the smaller compartment A, the
electrolyte solution, and in the larger compartment B, the buffer
solution. The final reconstituted solution is obtained
after breaking the frangible pin and mixing both solutions.
BEFORE RECONSTITUTION
1 000 ml of electrolyte solution (small compartment A) contains:
active substances:
Calcium chloride dihydrate
5.145 g
Magnesium chloride hexahydrate
2.033 g
Glucose
22.00 g
(as glucose monohydrate)
(S)-Lactic acid
5.400 g
(as lactic acid solution 90 %w/w)
1 000 ml of buffer solution (large compartment B) contains:
active substances:
Sodium chloride
6.45 g
Potassium chloride
0.157 g
Sodium hydrogen carbonate
3.090 g
A+B
Calcium chloride, 2 H
2
O
0.257 g
Magnesium chloride, 6 H
2
O
0.102 g
Glucose
1.100 g
Lactic acid
0.270 g
Sodium chloride
6.128 g
Potassium chloride
0.149 g
Sodium hydrogen carbonate
2.936 g
AFTER RECONSTITUTION
1 000 ml of the reconstituted solution contains:
EACH LITRE OF THE FINAL RECONSTITUTED SOLUTION CORRESPONDS TO 50 ML OF
ELECTROLYTE SOLUTION A AND 950 ML OF BUFFER
SOLUTION B.
For the full list of excipients, see section 6.1.
Active substances
mmol/l
mEq/l
Calcium
Ca
2+
1.75
3.50
Magnesium
Mg
2+
0.5
1.0
Sodium
Na
+
140
140
Chloride
Cl
-
111.5
111.5
Lactate
3
3
Hydrogen carbonate
HCO
3
-
32
32
Potassium
K
+
2
2
Glucose
6.1
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___