Prismasol 4 mmol/l Potassium solution for haemofiltration and haemodialysis

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

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

Dostupné z:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC kód:

B05ZB

INN (Medzinárodný Name):

CALCIUM CHLORIDE DIHYDRATE 0.257 mmol/l POTASSIUM CHLORIDE 0.298 mmol/l GLUCOSE ANHYDROUS 1.1 mmol/l LACTIC ACID 0.27 mmol/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.102 mmol/l SODIUM CHLORIDE 6.128 mmol/l SODIUM HYDROGEN CARBONATE 2.936 mmol/l

Forma lieku:

SOLUTION FOR HAEMOFILTRATION

Zloženie:

CALCIUM CHLORIDE DIHYDRATE 0.257 mmol/l POTASSIUM CHLORIDE 0.298 mmol/l GLUCOSE ANHYDROUS 1.1 mmol/l LACTIC ACID 0.27 mmol/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.102 mmol/l SODIUM CHLORIDE 6.128 mmol/l SODIUM HYDROGEN CARBONATE 2.936 mmol/l

Typ predpisu:

POM

Terapeutické oblasti:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2010-03-23

Súhrn charakteristických

1 of 9
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
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.
2 of 9
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 haemodialysis or
con