Prismasol 2 mmoll Potassium

Nazione: Malesia

Lingua: inglese

Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Principio attivo:

POTASSIUM CHLORIDE; Sodium Chloride Ph Eur; glucose monohydrate, Ph Eur; Magnesium Chloride.6H2O Ph. Eur.; Calcium Chloride 2H2O; Lactic Acid.; Sodium Hydrogen Carbonate Ph. Eur.

Commercializzato da:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (Nome Internazionale):

POTASSIUM CHLORIDE; Sodium Chloride Ph Eur; glucose monohydrate, Ph Eur; Magnesium Chloride.6H2O Ph. Eur.; Calcium Chloride 2H2O; Lactic Acid.; Sodium Hydrogen Carbonate Ph. Eur.

Confezione:

5000ml mL; 5000 ml mL

Prodotto da:

BIEFEE MEDITAL S.P.A.

Scheda tecnica

1
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Prismasol 2 mmol/l Potassium
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, 2 H
2
O
5.145 g
Magnesium chloride, 6 H
2
O
2.033 g
Glucose anhydrous
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
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
-
111.5
111.5
Lactate
3
3
Hydrogen carbonate
HCO
3
-
32
32
Potassium
K
+
2
2
Glucose
6.1
EACH LITRE OF THE FINAL RECONSTITUTED SOLUTION CORRESPONDS TO 50 ML OF
SOLUTION A AND 950
ML OF SOLUTION B.
Theoretical Osmolarity:
297 mOsm/l
pH of the reconstituted solution: 7.0 – 8.5
For the full list of excipients, see section 6.1.
2
3.
PHARMACEUTICAL FORM
Solution for haemodialysis and/or haemofiltration
Clear reconstituted solution with a slightly yellow colour.
4.CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prismasol 2 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 continuous haemodiafiltration.
Prismasol 2 mmol/l Potassium solution may also be used in case of drug
poisoning with
dialysable or filterable substances.
Prismasol 2 mmol/l Potassium solution is indicated in patients who
have tendency to
hyperkalaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION