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HSA Approval

SODIUM BICARBONATE INTRAVENOUS INFUSION 8.4% w/v

SIN09226P

SODIUM BICARBONATE INTRAVENOUS INFUSION 8.4% w/v

SODIUM BICARBONATE INTRAVENOUS INFUSION 8.4% w/v

February 20, 1997

B. BRAUN SINGAPORE PTE LTD

B. BRAUN SINGAPORE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantB. BRAUN SINGAPORE PTE LTD
Licence HolderB. BRAUN SINGAPORE PTE LTD

Product Classification

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

Formulation Information

INJECTION

**Dosage** The quantity of Sodium Bicarbonate Intravenous Infusion BP to be infused is determined by the blood gas values and is calculated according to the following formulae: mL of 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP = negative base excess x kg b.w. x 0.3 (The factor 0.3 corresponds to the proportion of the extracellular fluid in relation to total body fluid). The maximum daily dose is determined according to the correction requirements. Correction of metabolic acidosis should not be affected too rapidly. It is advisable to start administering only half of the calculated dose and adjust further doses according to the actual results of blood gas analysis. Blind buffer therapy is not advisable. It should only be performed in life-threatening situations. _Flow rate_ Up to 1.5 mmol of sodium bicarbonate per kg body weight per hour, corresponding to 1.5 ml of 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP/kg bw/h. _Route of administration_ Strictly intravenously! 8.4% w/v Sodium Bicarbonate Intravenous Infusion BP has an osmolarity of about 2000 mOsm/l and, when infused undiluted, it should be administered via central venous catheter, preferably inserted into the vena cava.

INTRAVENOUS

Medical Information

**Indications** Correction of metabolic acidosis; Urine alkalinisation in the case of intoxication with weak organic acids, e.g. barbiturates or acetylsalicylic acid; Urine alkalinisation in order to improve the solubility of drug substances which are poorly soluble in neutral or acid medium, e.g. methotrexate, sulphonamides; Urine alkalinisation in the case of haemolysis.

**Contraindications** Respiratory and metabolic alkalosis, Hypernatremia, Hypokalemia.

B05XA02

sodium bicarbonate

Manufacturer Information

B. Braun Singapore Pte Ltd.

B BRAUN MELSUNGEN AG

Active Ingredients

SODIUM BICARBONATE

8.4% w/v

Sodium bicarbonate

Documents

Package Inserts

Package insert Dec 2021.pdf

Approved: December 13, 2021

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