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HSA Approval

DUOSOL WITH 4 MMOL/L POTASSIUM SOLUTION FOR HAEMOFILTRATION

SIN15785P

DUOSOL WITH 4 MMOL/L POTASSIUM SOLUTION FOR HAEMOFILTRATION

DUOSOL WITH 4 MMOL/L POTASSIUM SOLUTION FOR HAEMOFILTRATION

August 20, 2019

B. BRAUN SINGAPORE PTE LTD

B. BRAUN SINGAPORE PTE LTD

Regulatory Information

B. BRAUN SINGAPORE PTE LTD

B. BRAUN SINGAPORE PTE LTD

Therapeutic

Prescription Only

Formulation Information

SOLUTION, STERILE

**4.2 Posology and method of administration** The use of solutions for haemofiltration in patients with acute renal failure should be under the direction of a physician with experience in using such treatment. In acute renal failure, treatment is carried out for a limited period and is discontinued when renal function is restored. Posology The filtration rate prescribed is dependent on the clinical status and the body weight of the patient. Unless otherwise prescribed, a filtration rate of 20–25 ml/kg body weight per hour is recommended for the removal of metabolic waste products normally excreted in the urine, depending on the metabolic condition of the patient. A maximum filtration rate of 75 litre per day is recommended. The dose-volume is at the discretion of the physician because the volume of substitution solution depends on the intensity of treatment performed and on the amount of fluid to be replaced in order to achieve fluid balance. Method of administration Intravenous use. The ready-to-use solution for haemofiltration has to be prepared by opening the peel seam. The mixing is performed by twisting the bag five times. For further instructions, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. The ready-to-use solution for haemofiltration is infused into the extracorporeal circulation by means of an infusion pump. During haemofiltration the solution for haemofiltration replaces the ultrafiltrate removed from the blood taking into account overall fluid balance. In acute renal failure, treatment is carried out for a limited time period and is discontinued when renal function is fully restored.

INTRAVENOUS

Medical Information

**4.1 Therapeutic indications** The ready-to-use solution is indicated for use in patients with acute renal failure requiring continuous haemofiltration.

**4.3 Contraindications** Specific to the ready-to-use solution for haemofiltration: - Hyperkalaemia - Metabolic alkalosis For haemofiltration in general: - Acute renal failure with a marked hypercatabolic state when uraemic symptoms can no longer be corrected by haemofiltration - Inadequate blood flow from the vascular access - All states of increased risk of haemorrhage due to systemic anticoagulation

B05ZB

血液过滤

Manufacturer Information

B. Braun Singapore Pte Ltd.

B. Braun Avitum AG

Active Ingredients

Magnesium chloride hexahydrate (Electrolyte solution)

0.91g/1000ml

Magnesium chloride

Potassium chloride (Electrolyte solution)

2.68g/1000ml

Potassium chloride

Sodium chloride (Sodium bicarbonate solution)

6.18g/1000ml

Sodium chloride

Sodium hydrogen carbonate (Sodium bicarbonate solution)

3.59g/1000ml

Sodium bicarbonate

Sodium chloride (Electrolyte solution)

4.21g/1000ml

Sodium chloride

Calcium chloride dihydrate (Electrolyte solution)

1.98g/1000ml

Calcium chloride

Glucose monohydrate (Electrolyte solution)

9.90g/1000ml

Glucose

Documents

Package Inserts

Duosol with 4mmol per L Potassium Solution for Haemofiltration PI.pdf

Approved: December 2, 2022

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