Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
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
Documents
Package Inserts
Haemodialysis_PI.pdf
Approved: September 17, 2021