IMPORTANT: CONTAINS NO PRESERVATIVE. SINGLE DOSE. DISPOSE OF UNUSED CONTENTS.
Protect from freezing and excessive heat (any temperature above 40°C / 104°F). Store at controlled room temperature (15°C to 30°C / 59°F to 86°F).
Solutions containing sodium ions should be used with great care,if at all in patients with congestive heart failure,severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
Solutions which contain potassium should be used with great care if at all in patients with hyperkalemia severe renal failure and in conditions in which potassium retention is present.
In patients with diminished renal function administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.
Solutions containing acetate or gluconate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate or gluconate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of these ions such as severe hepatic insufficiency.
The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations overhydration congested states or pulmonary edema.
The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
NORMOSOL®-R should be used with caution in severe renal impairment because of the danger of hyperkalemia. As with all intravenous solutions care should be taken to avoid circulatory overload especially in patients with cardiac or pulmonary disorders. NORMOSOL®-R is not intended to correct acidosis or large deficits of individual electrolytes nor to replace blood or plasma expanders when these are indicated.
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
Caution must be exercised in the administration of parenteral fluids especially those containing sodium ions to patients receiving corticosteroids or corticotropin.
Solutions containing acetate or gluconate ions should be used with caution as excess administration may result in metabolic alkalosis.
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection,venous thrombosis, or phlebitis extending from the site of injection,extravasation and hypervolemia.
If an adverse reaction does occur discontinue the infusion evaluate the patient institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
In the event of overhydration or solute overload re-evaluate the patient and institute appropriate corrective measures. See WARNINGS PRECAUTIONS and ADVERSE REACTIONS.