Sodium Chloride 0.45 % Solution for Infusion

/ Teva

Dosage depends upon the age, weight and clinical condition of the patient, as well as laboratory determinations.

Supply of water and electrolytes.

-Hypersensitivity to the active substance or to any of the excipients
– Hyponatraemia, hypochloraemia,
– Extracellular hyperhydration or hypervolaemia,
– Severe renal insufficiency (with oliguria/anuria),
– Fluid and sodium retention,
– Uncompensated cardiac failure,
– General oedema and ascitic cirrhosis.
The contra-indications related to the added medicinal product should be considered.

Electrolyte balance: Hyponatraemia/Hypernatraemia
Fluid balance/renal function Use in patients with moderate renal impairment
The product should be administered with particular caution to patients with moderate renal
impairment. In such patients administration may result in sodium retention.
Risk of fluid and/or solute overload and electrolyte disturbances
Depending on the volume and rate of infusion, intravenous administration of Sodium Chloride can cause:
• Fluid and/or solute overload resulting in over hydration/hypervolemia and, for example,
congested states, including central and peripheral oedema.
• Clinically relevant electrolyte disturbances and acid-base imbalance.
In general; the risk of dilutional states is inversely proportional to the electrolyte concentrations in the solution and additions. The risk of solute overload causing congested states is directly proportional to the electrolyte concentration in the solution and its additions.
Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.
Use in patients at risk for sodium retention, fluid overload and oedema
Product should be used with particular caution, in patients with or at risk for:
• Hypervolemia
• 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.
Medications that may increase the risk of sodium and fluid retention, such as corticosteroids.
Infusion reaction: Symptoms of unknown aetiology which can appear to be hypersensitivity reactions have been reported very rarely in association with parenteral infusion of Sodium Chloride. These have been characterized as hypotension, pyrexia, tremor, chills, urticaria, rash and pruritus. Stop the infusion immediately if signs or symptoms of these reactions develop.
Specific patient groups: Pediatrics and elderly
The consulting physician should be experienced in this product’s use and safety in these special populations that are especially sensitive to rapid changes in serum sodium levels.
Administration with blood products
Do not mix or administer Sodium Chloride 0.45% through the same administration set with whole blood or cellular blood components.
Please refer to the license holder for further details.

Overhydration, hyponatremia, injection site pain. Please refer to the license holder for further details.

Interaction related to the presence of sodium:
Corticoids/Steroids and carbenoxolone, which are associated with the retention of sodium and water (with oedema and hypertension).
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 i.v. fluids:
• Drugs stimulating vasopressin release include: Chlorpropamide, clofibrate, carbamazepine,
vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine,
ifosfamide, antipsychotics, narcotics
• Drugs potentiating vasopressin action include: Chlorpropamide, NSAIDs, cyclophosphamide
• Vasopressin analogues include: Desmopressin, oxytocin, terlipressin.
Other medicinal products increasing the risk of hyponatraemia also include diuretics in general andantiepileptics such as oxcarbazepine.
Caution is advised in patients treated with lithium. Renal sodium and lithium clearance may be
decreased in the presence of hyponatraemia. Administration of Sodium Chloride 0.45% Solution may result in increased lithium levels.

Sodium Chloride 0.45% should be administrated with special caution for pregnant women during labour particularly as to serum-sodium if administered in combination with oxytocin.

An excessive volume of Sodium Chloride 0.45% may lead to:
-Hypo- and hypernatremia (which can lead to CNS manifestations, including seizures, coma, cerebral oedema and death) and
-Sodium overload (which can lead to central and/or peripheral oedema).
Excessive administration of chloride salts may cause a loss of bicarbonate with an acidifying effect.
When Sodium Chloride 0.45% Solution is used as a diluent for injectable preparations of other medicinal products, the signs and symptoms of over infusion will be related to the nature of the additives being used.
In the event of accidental over infusion, treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the drug administered.

Storage: Store below 25°C