INFORMATION FOR HEALTH PROFESSIONALS
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Sodium Chloride Injection 0.9% is a sterile isotonic solution of sodium chloride in Water for Injections, pH 4.5 - 7.0, containing no preservatives (normal saline).
Normal saline can be used as the vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. It can also be used as a sterile irrigation medium.
The dosage of sodium chloride as a vehicle for parenteral drugs and as an electrolyte replenisher must be calculated after consideration of clinical and laboratory data.
Congestive heart failure
Severe renal impairment
Conditions of sodium retention and oedema
Liver cirrhosis
Irrigation during electrosurgical procedures
Do not use unless the solution is clear. The entire contents of the Polyamp Duofit® should be used promptly.
When used as a vehicle for intravenous drug deliver, the product information document of such drugs should be checked prior to use to ensure compatibility with the sodium chloride solution. Reconstitution instructions should be read carefully.
Excessive administration of sodium chloride causes hypernatremia, resulting in dehydration of internal organs, hypokalaemia and acidosis. Monitoring of fluid, electrolyte and acid-base balance may be necessary. Congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease or those receiving corticosteroids, corticotrophin or other drugs that may give rise to sodium retention. Sodium chloride should be administered with care to patients with congestive heart failure, hypertension, peripheral or pulmonary oedema, impaired renal function, urinary tract obstruction, pre-eclampsia and very young or elderly patients.
Intravenous infusion during or immediately after surgery may result in sodium retention.
Given that there is a possibility of systemic absorption of irrigation solutions, the same precautions apply.
Safety in pregnancy has not been established. Use is recommended only when clearly indicated.
Safety in lactation has not yet been established. Use of this product whilst breastfeeding is recommended only when potential benefits outweigh potential risks to the newborn.
Additives may be incompatible with sodium chloride.
Co medication of drugs inducing sodium retention may exacerbate any systemic effects.
Excessive amounts of sodium chloride may cause hypernatraemia, hypokalaemia and acidosis. Proper use of normal saline as a vehicle for parenteral drugs or as an electrolyte replacement therapy is unlikely to result in adverse effects.
Hypernatraemia rarely occurs with therapeutic doses of sodium chloride, but may occur in excessive administration. A serious complication of this is dehydration of the brain causing somnolence and confusion, which may progress to convulsions, coma and ultimately respiratory failure and death. Pulmonary embolism or pneumonia may also result. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, weakness and irritability.
If any adverse effects are observed during administration, discontinue infusion , evaluate the patient and institute appropriate supportive treatment.
Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may result in distension or disruption of tissues. Inadvertent contamination from careless technique may transmit infection. Adverse effects resulting from irrigation of body cavities, tissues or indwelling catheters and tubes are usually avoidable when appropriate procedures are followed.
Excessive sodium chloride in the body produces general gastrointestinal effects of nausea, vomiting, diarrhoea and cramps. Salivation and lacrimation are reduced, while thirst and sweating are increased. Hypotension, tachycardia, renal failure, peripheral and pulmonary oedema and respiratory arrest may occur. CNS symptoms include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death.
Normal plasma sodium concentrations should be carefully restored at a rate not greater than 10-15 mmol/day using IV hypotonic saline. Dialysis may be necessary if there is significant renal impairment, the patient is moribund or plasma sodium levels are greater than 200 mmol/L. Convulsions are to be treated with IV diazepam.
5 mL Polyamp Duofit® presentation: Store below 25°C
10 mL Polyamp Duofit® presentation: Store below 30°C
5 & 10 mL Polyamp Duofit®: 24 months
General Sales Medicine
Polyamp Duofit® 50 x 5 mL
Polyamp Duofit® 50 x 10 mL
AstraZeneca Limited
303 Manukau Road
Epsom, Auckland
New Zealand
Telephone: (09) 623-6300
1 December 2004
(API 160204)
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