PRISMASOL BO SOLUTION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CALCIUM CHLORIDE DIHYDRATE; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM CHLORIDE; SODIUM HYDROGEN CARBONATE; SODIUM LACTATE

Available from:

VANTIVE PTE. LTD.

ATC code:

B05ZB

Dosage:

0.257g/l

Pharmaceutical form:

SOLUTION

Composition:

CALCIUM CHLORIDE DIHYDRATE 0.257g/l; MAGNESIUM CHLORIDE HEXAHYDRATE 0.103 g/l; SODIUM CHLORIDE 6.14g/l; SODIUM HYDROGEN CARBONATE 2.69g/l; SODIUM LACTATE 0.336 g/l

Administration route:

HEMODIALYSIS

Prescription type:

General Sale List

Manufactured by:

Bieffe Medital S.p.A

Authorization status:

ACTIVE

Authorization date:

2001-08-16

Summary of Product characteristics

Prismasol B0
07-19-00-6364
SG, HK, BN
Patient information leaflet
.......................................................2
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 0719006364
Date: 15MAY2023
Proofread No.: 01
Designer: SC
Page: 1 of 4
Colour Reference:
Black
DRAFT FOR SUBMISSION
2
07-19-00-6364
PATIENT INFORMATION LEAFLET
HK BN
SG
SOLUTION FOR HAEMOFILTRATION AND
HAEMODIALYSIS.
_READ ALL OF THIS LEAFLET CAREFULLY _
_BEFORE YOU START USING THIS MEDICINE._
•
Keep this leaflet. You may need to
read it again.
•
If you have further questions, ask
your doctor or pharmacist.
•
This medicine has been prescribed
for you personally and you should
not pass it on to others. It may harm
them, even if their symptoms are the
same as yours.
PRISMASOL B0
Solution for haemofiltration and
haemodialysis.
1. WHAT DOES
PRISMASOL B0
CONTAIN?
PRISMASOL B0 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 peel seal and mixing both
solutions.
BEFORE RECONSTITUTION:
1000 ml of electrolyte solution (SMALL
COMPARTMENT A) contains:
Calcium chloride, 2 H
2
O
5.145 g
Magnesium chloride, 6 H
2
O
2.033 g
Lactic acid
5.4 g
Water for injections
to 1000 ml
1000 ml of buffer solution
(LARGE COMPARTMENT B) contains:
Sodium bicarbonate
3.09 g
Sodium chloride
6.45 g
Water for injections
to 1000 ml
AFTER RECONSTITUTION:
The solution in the small and the large
compartments are mixed to give one
reconstituted solution whose
composition is:
mmol/l
mEq/l
Calcium, Ca
2+
1.75
3.50
Magnesium, Mg
2+
0.5
1.0
Sodium, Na
+
140
140
Chloride, Cl
−
109.5
109.5
Lactate, C
3
H
5
O
3
−
3
3
Bicarbonate, HCO
3
−
32
32
Theoretical Osmolarity: 287 mOsm/l
PACKAGING:
2 bags (5000 ml) per carton
MARKETING AUTHORISATION
HOLDER:
SG:
Baxter Healthcare (Asia) Pte Ltd.,
150 Beach Road,
#30-01/08, Gateway West,
Singapore 189720
MANUFACTURER:
Bieffe Medital S.p.A.
Via Stelvio 94
23035 Sondal