Indications

1.For use in prophylactic and replacement therapy, requiring the use of isotonic saline solution.

2.As a vehicle or diluent for compatible drugs for parenteral administration.

3.As a saline irrigant.

4.As a priming fluid for haemodialysis procedures and to initiate and terminate blood transfusions.

Dosage and Administration

Sodium Chloride Injection BP 0.9% w/v may be administered via intravenous, intramuscular or subcutaneous injection or via intravenous infusion.

When Sodium Chloride Injection BP 0.9% w/v is used for the preparation of other medicinal products, the method of administration will be determined by the prescribing information of the medicinal product being diluted.

Contraindications

Sodium Chloride Injection BP 0.9% w/v is contraindicated in patients presenting hypernatraemia or hyperchloraemia.

The contra-indications related to the added medicinal product should be considered.

Precautions & Warning:

1.Fluid balance/renal function

2.Use in patients with (severe) renal impairment

3.Risk of fluid and/or solute overload and electrolyte disturbances

4.Hyponatraemia

5.Use in patients at risk for sodium retention, fluid overload and oedema

Sodium chloride 0.9% should be used with particular caution, if at all, in patients with or at risk for: Hypervolaemia Iatrogenic hyperchloraemic metabolic acidosis (e.g., during intravenous volume resuscitation),Conditions that may cause sodium retention, fluid overload and oedema (central and peripheral), such as patients with:primary hyperaldosteronism,secondary hyperaldosteronism, associated with, for example: hypertension,congestive heart failure,liver disease (including cirrhosis),renal disease (including renal artery stenosis, nephrosclerosis) or pre-eclampsia.

Adverse Reactions:

The following adverse reactions have not been reported with this product but may occur:

1.Hypernatraemia (e.g. when administered to patients with nephrogenic diabetes insipidus or high nasogastric output)

2.Hyperchloraemic metabolic acidosis

3.Hyponatraemia, which may be symptomatic. Hyponatraemia may occur when normal free water excretion is impaired.

Drug interactions:

Drugs leading to an increased vasopressin effect

The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and may increase the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with intravenous fluids

1.Drugs stimulating vasopressin release include: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics

2.Drugs potentiating vasopressin action include: Chlorpropamide, NSAIDs, cyclophosphamide

3.Vasopressin analogues include: Desmopressin, oxytocin, terlipressin

Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as oxcarbazepine.

Storage instructions:

Do not store above 25°C