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HSA Approval

MULTIBIC POTASSIUM-FREE SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION

SIN14061P

MULTIBIC POTASSIUM-FREE SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION

MULTIBIC POTASSIUM-FREE SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION

December 7, 2011

FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.
Licence HolderFRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore Classification

Formulation Information

SOLUTION, STERILE

**3\. How to use multiBic® potassium-free** multiBic® potassium-free will be given in a hospital or clinic. Your doctor will know how to use this medicine. If you have any further questions on the use of this medicine, ask your doctor.

HEMODIALYSIS

Medical Information

**1\. What multiBic® potassium-free is and what it is used for** multiBic® potassium-free is a continuous renal replacement therapy solution for removal of waste products from the body in people with kidney disease. It is used in patients with kidney injury and also for the treatment of poisoning. The type of solution you are given depends on the amount of potassium (a salt) in your blood. Your doctor will check your potassium levels regularly.

**2\. What you need to know before you use multiBic® potassium-free** **Do not use multiBic® potassium-free if** - you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - you have hypokalaemia (your potassium level is very low) - you have metabolic alkalosis (a condition where there is too much bicarbonate in the blood) - you cannot achieve a sufficient blood flow through the haemofilter (filter used in the blood filtration) - you have a high risk of bleeding related to medications required to prevent clotting in the haemofilter.

B05ZB

血液过滤

Manufacturer Information

FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Fresenius Medical Care Deutschland GmbH

Active Ingredients

(solution B) Sodium chloride

6.453g/L

Sodium chloride

(solution B) Sodium hydrogen carbonate

3.104g/L

Sodium bicarbonate

(solution A) Magnesium chloride hexahydrate

2.033g/L

Magnesium chloride

(solution A) Calcium chloride dihydrate

4.410g/L

Calcium chloride

(solution A) Anhydrous glucose 20 g/L eqv glucose monohydrate

22.00g/L

Perboric acid

Documents

Patient Information Leaflets

MULTIBIC POTASSIUM-FREE SOLUTION FOR HAEMODIALYSIS HAEMOFILTRATION PIL.pdf

Approved: August 14, 2020

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