STERILE SODIUM CHLORIDE

When concentrations of 3 and 5% w/v are indicated, the solution should be administered into a large vein, at a rate not exceeding 100 mL per hour. Adults, children and the elderly Concentration and sodium chloride dosage for intravenous use are determined by several factors, including age, weight and clinical condition of the patient.

9% w/v daily. 9% w/v) solution. An isotonic solution can be prepared by diluting 30 mL Sodium Chloride 30% w/v Concentrate for Solution for Infusion to 1 litre with a non-electrolyte solution or water for injections. 9% w/v solutions of sodium chloride are widely used for sterile irrigation and dilution purposes.

The following general adverse effects may occur due to excess sodium chloride in the body: nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation and lachrymation, sweating, fever, hypotension, tachycardia, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death.

Excess chloride in the body may cause a loss of bicarbonate with an acidifying effect. Infants may appear not to be severely dehydrated, but coma and convulsions may persist due to vascular injury. They may show respiratory distress with tachypnoea and flaring nostrils.

Intra-amniotic injection of hypertonic solutions of sodium chloride can lead to serious adverse effects such as disseminated intravascular coagulation, renal necrosis, cervical and uterine lesions, haemorrhage, pulmonary embolism, pneumonia and death.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Sodium chloride should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function or pre- eclampsia. Care should also be taken when administering sodium chloride intravenously to very young or elderly patients.

Excessive administration may result in hypokalaemia and should be avoided. Pseudohyponatraemia, a condition where spuriously low concentrations of sodium are found, occurs when a high concentration of solid matter (such as lipids and protein) are present in the plasma.

This condition has been reported in patients with diabetes mellitus. False reading for plasma concentrations may be obtained as sodium is present only in the aqueous phase of plasma. Correct values are obtained by referring the concentration to plasma water, in order to avoid unnecessary, and possibly dangerous, treatment with sodium chloride.

Only use the solution if it is particle free.

Caution:

Sodium Chloride 30% w/v Concentrate for Solution for Infusion is a hypertonic solution, and should be diluted before use.