Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use
General

Sodium Bicarbonate 8.4% should only be administered with particular caution in presence of the following conditions:
• respiratory acidosis
• hypocalcaemia
• increased serum osmolarity
• further in all situations where sodium intake must be restricted, like cardiac insufficiency, oedema, hypertension, eclampsia, severe kidney insufficiency.
When respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be adequately supported to ensure adequate elimination of excess CO2.

Administration of Sodium Bicarbonate 8.4% may lead to sodium and fluid overload.

Accidental paravenous administration may lead to tissue necrosis.
It must be made absolutely sure that the solution is infused intravenously; accidental intra- arterial infusion may cause shock or loss of an extremity.

If infused undiluted or too rapidly into peripheral veins, Sodium Bicarbonate 8.4% may cause vein irritation and consecutively phlebitis or thrombosis on account of its alkalinity and its high osmolarity.

Patient monitoring should include regular checks of the acid-base balance, the serum electrolyte concentrations and the water balance.

Correction of the acid-base status is always associated with shifts of the electrolyte balance. In particular, the potassium balance is affected. Alkalisation or correction of acidosis promote the potassium influx into cells and may therefore lead to hypokalaemia.

Potassium or calcium deficiencies should be corrected before beginning of the alkalinising therapy.

The effects of bicarbonate on organ function, complication rates and survival in diabetic ketoacidosis, cardiac arrest and lactic acidosis have not been investigated sufficiently.
Caution is advised when using sodium bicarbonate in these conditions.

Paediatric population
Newborns and children under 2 years: rapid infusion (10 ml/min) of hypertonic sodium bicarbonate solutions may produce hypernatraemia, a decrease in cerebrospinal fluid pressure and (in preterm infants) possible intracranial haemorrhage. Therefore, do not administer > 8 mmol per kg body weight per day (see also section 4.2).

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