PHARMACOLOGICAL CLASSIFICATION: A 24 Mineral substitutes, electrolytes.
PHARMACOLOGICAL ACTION: Electrolyte solution for intravenous use, after dilution, especially for restoring the balance of the bicarbonate-carbonic acid systems. The bicarbonate-carbonic acid system is the major buffer system in the body that is subject to compensatory physiological regulation. Following any alteration in this system, every other buffer pair defines and in turn is defined by the pH. Thus, any alteration in the bicarbonate-carbonic acid system achieved by the lungs and kidneys brings into play the buffer systems in the body fluids. The ratio of the bicarbonate-carbonic acid system at a pH of 7,4 is 20:1
INDICATIONS: For the correction of metabolic acidosis.
CONTRA-INDICATIONS: Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary oedema, in toxaemia of pregnancy, and in impaired renal function.
WARNINGS: Sodium bicarbonate is incompatible with acids, acidic salts, many alkaloidal salts, aspirin and with bismuth salicylate.
DOSAGE AND DIRECTIONS FOR USE: Dilute before use:
The dose must be found in an empirical fashion. If possible, small doses should be used initially so as not to overtreat. Sodium bicarbonate is incompatible with acids, acidic salts, many alkaloidal salts, aspirin and with bismuth salicylate. Solutions up to 4,2% (0,5 mmol/ per mL) of sodium bicarbonate are administrated intravenously for the rapid correction of acidosis. Solutions containing up to 8,4% (1 mmol per mL) are used for the initial treatment of metabolic acidosis caused by cardiac arrest.
When used in the treatment of persistent metabolic acidosis in neonates the sodium bicarbonate should be given slowly as a dilute (M/4) Solution, to prevent intraventricular haemorrhage.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: There is a danger of inducing a metabolic alkalosis, especially if the patient has any element of coexistent potassium depletion, and of causing frank carpopedal spasm, if the patient has coincidental hypocalcaemia. This danger can be avoided if potassium depletion and hypocalcaemia are treated appropriately.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Symptoms of hypernatraemia may include, hypotension, oliguria, restlessness, weakness, thirst, reduced salivation and lachrimation, swollen tongue, tachycardia, flushing of the skin, pyrexia, dizziness, headache, delirium, hyperpnoea and respiratory arrest. Retention of sodium leads to the accumulation of fluid with cerebral oedema and peripheral and pulmonary oedema. Treatment is symptomatic and supportive.
IDENTIFICATION: Clear, colourless, sterile sodium bicarbonate solution in Water for Injections.
PRESENTATION: 50 mL clear glass ampoules.
STORAGE INSTRUCTIONS Store below between 15°C and 30°C.
KEEP OUT OF REACH OF CHILDREN.
Intramed Sodium bicarbonate Injection 4% m/v
Intramed Sodium bicarbonate Injection 8,5 m/v
NAME AND BUSINESS ADDRESS OF APPLICANT: INTRAMED (PTY) LTD
6 Gibaud Road
Port Elizabeth, 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT: Jan. 1988