Prismasol 4 mmol/l Potassium solution for haemofiltration and haemodialysis

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, GLUCOSE ANHYDROUS, LACTIC ACID, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE

Saatavilla:

Gambro Lundia AB

ATC-koodi:

B05ZB

INN (Kansainvälinen yleisnimi):

CALCIUM CHLORIDE, DIHYDRATE, POTASSIUM CHLORIDE, GLUCOSE ANHYDROUS, LACTIC ACID, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE

Lääkemuoto:

SOLUTION FOR HAEMOFILTRATION

Koostumus:

CALCIUM CHLORIDE DIHYDRATE 0.257 millimole(s)/litre ; POTASSIUM CHLORIDE 0.298 millimole(s)/litre ; GLUCOSE ANHYDROUS 1.1 millimole(s)/litre ; LACTIC ACID 0.27 millimole(s)/litre ; MAGNESIUM CHLORIDE HEXAHYDRATE 0.102 millimole(s)/litre ; SODIUM CHLORIDE 6.128 millimole(s)/litre ; SODIUM HYDROGEN CARBONATE 2.936 millimole(s)/litre

Prescription tyyppi:

POM

Terapeuttinen alue:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-03-23

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRISMASOL 4 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 4 mmol/l Potassium is indicated particularly in patients who
are normokalaemic (a
normal concentration of potassium in the blood).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PRISMASOL
DO NOT USE PRISMASOL 4 MMOL/L POTASSIUM IN CASE OF:
•
allergy to one of the active substances or any of the other
ingredients (listed in section 6),
•
a high concentration

Valmisteyhteenveto

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S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Prismasol 4 mmol/l Potassium solution for
haemodialysis/haemofiltration
2
Q
UALITATIVE AND QUANTITATIVE COMPOSITION
Prismasol 4 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 or peel seal 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
0.314 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
0.298 g
Sodium hydrogen carbonate 2.936 g
AFTER RECONSTITUTION
1 000 ml of the reconstituted solution contains:
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
-
113.5
113.5
Lactate
3
3
Hydrogen carbonate
HCO
3
-
32
32
Potassium
K
+
4
4
Glucose
6.1
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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.
3
P
HARMACEUTICAL FORM
Solution for haemodialysis/haemofiltration
Clear reconstituted solution with a slightly yellow colour.
Theoretical Osmolarity:
301 mOsm/l
pH of the reconstituted solution: 7.0–8.5
4
C
LINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prismasol 4 mmol/l Potassium is used in the treatment of renal
failure, as substitution solution in
haemofiltration and haemodiafiltration and as dialysis solution in
continuous haemodia