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HSA Approval

HAEMODIALYSIS CONCENTRATE NKFS-01 (ACID) FOR BICARBONATE DIALYSIS

SIN09474P

HAEMODIALYSIS CONCENTRATE NKFS-01 (ACID) FOR BICARBONATE DIALYSIS

HAEMODIALYSIS CONCENTRATE NKFS-01 (ACID) FOR BICARBONATE DIALYSIS

August 21, 1997

B. BRAUN SINGAPORE PTE LTD

B. BRAUN SINGAPORE PTE LTD

Regulatory Information

B. BRAUN SINGAPORE PTE LTD

B. BRAUN SINGAPORE PTE LTD

Therapeutic

General Sale List

Formulation Information

SOLUTION

**Dosage** Unless otherwise directed, mix 1.000 l NKFS-0x (acid concentrate) and 1.225 l Sodium Bicarbonate 8.4% with 32.775 l water 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 haemodiafiltration. The duration of administration must be determined on an individual basis.

HEMODIALYSIS

Medical Information

**Indications** The indications below apply exclusively to the ready-to-use bicarbonate haemodialysis solution prepared from acid concentrate 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 bicarbonate haemodialysis concentrate - Intractable coagulopathy In patients with unstable circulation and/or unstable blood pressure, a different extracorporeal method of treatment may be indicated.

B05ZA

血液透析

Manufacturer Information

B. Braun Singapore Pte Ltd.

B BRAUN MEDICAL INDUSTRIES SDN BHD

Active Ingredients

CALCIUM CHLORIDE DIHYDRATE

7.77 g/l

Calcium chloride

POTASSIUM CHLORIDE

5.25 g/l

Potassium chloride

MAGNESIUM CHLORIDE

3.58 g/l

Magnesium chloride

SODIUM CHLORIDE

216.19 g/l

Sodium chloride

GLACIAL ACETIC ACID

8.46 g/l

Acetic acid

Documents

Package Inserts

Haemodialysis_PI.pdf

Approved: September 17, 2021

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