Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product 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
Documents
Package Inserts
Package insert Dec 2021.pdf
Approved: December 13, 2021