HAEMODIALYSIS CONCENTRATE NKFS-03 (ACID) FOR BICARBONATE DIALYSIS

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

ACETIC ACID (GLACIAL); CALCIUM CHLORIDE DIHYDRATE; GLUCOSE MONOHYDRATE; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Dostupno od:

B. BRAUN SINGAPORE PTE LTD

ATC koda:

B05ZA

Doziranje:

8.46 g/l

Farmaceutski oblik:

SOLUTION

Sastav:

ACETIC ACID (GLACIAL) 8.46 g/l; CALCIUM CHLORIDE DIHYDRATE 7.77 g/l; GLUCOSE MONOHYDRATE 77.50 g/l; MAGNESIUM CHLORIDE HEXAHYDRATE 3.58 g/l; POTASSIUM CHLORIDE 5.25 g/l; SODIUM CHLORIDE 216.19 g/l

Administracija rute:

HEMODIALYSIS

Tip recepta:

General Sale List

Proizveden od:

B BRAUN MEDICAL INDUSTRIES SDN BHD

Status autorizacije:

ACTIVE

Datum autorizacije:

1999-07-19

Svojstava lijeka

COMPOSITION OF THE READY-TO-USE BICARBONATE HAEMODIALY-
SIS SOLUTION
Sodium Bicarbonate 8.4% (bicarbonate concentrate) + water
+ NKFS-0x (acid concentrate) yield a ready-to-use bicarbonate
haemodialysis solution.
For the electrolyte concentration and theoretical osmolarity of
this ready-to-use solution, please refer to the product label of
the acid concentrate used.
Water for the dilution of haemodialysis concentrates has to
comply with European Pharmacopoeia monograph 1167 re-
quirements.
NOTE: Drinking water is not suitable for the preparation of
bicarbonate haemodialysis solutions.
INDICATIONS
The indications below apply exclusively to the ready-to-use
bicarbonate haemodialysis solution prepared from acid con-
centrate and bicarbonate concentrate following the specified
dilution procedure:
–
Acute renal failure
–
Chronic renal failure
–
Hyperhydration
–
Intoxications
–
Compensation of acid-base and electrolyte balances
–
Adjustment of the blood / plasma / body temperature
CONTRAINDICATIONS
–
Hyperkalaemia with the use of a potassium-containing
acidic bicarbonate haemodialysis concentrate
–
Hypokalaemia with the use of a potassium-free acidic bi-
carbonate haemodialysis concentrate
–
Intractable coagulopathy
In patients with unstable circulation and/or unstable blood
pressure, a different extracorporeal method of treatment
may be indicated.
USAGE IN PREGNANCY
Safety of NKFS-0x (acid concentrate) for haemodialysis treat-
ment has not been determined in pregnant women.
The products should be used only when clearly needed as pre-
scribed by the physician.
ADVERSE REACTIONS
During
haemodialysis,
hypotension,
nausea,
vomiting
and
muscle cramps may occur.
DOSAGE
Unless otherwise directed, mix 1.000 l NKFS-0x (acid concen-
trate) and 1.225 l Sodium Bicarbonate 8.4% with 32.775 l wa-
ter of suitable quality. Please refer to the product label of the
acid concentrate used for details of the mixing ratio.
MODE AND DURATION OF ADMINISTRATION
For extracorporeal bicarbonate haemodialysis or bicarbonate
haem