Normosol-M and Dextrose

Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic, hypertonic solution of balanced maintenance electrolytes and 5% dextrose injection in water for injection.

The solution is administered by intravenous infusion for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories.

Each 100 mL contains dextrose, hydrous 5 g, sodium chloride, 234 mg, potassium acetate, 128 mg and magnesium acetate, anhydrous 21 mg. May contain hydrochloric acid for pH adjustment. The electrolyte content (not including hydrochloric acid) and other characteristics are as follows:

The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.

Normosol-M and 5% Dextrose Injection is a parenteral fluid, electrolyte and nutrient replenisher.

Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula:

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Potassium Acetate, USP is chemically designated CH3COOK, colorless crystals or white crystalline powder very soluble in water.

Magnesium acetate is chemically designated Mg (C2H3O2)2, colorless or white crystals very soluble in water.

Water for Injection, USP is chemically designated H2O.

™Normosolmultiple electrolyte solutions, Hospira.

The flexible plastic container is fabricated from a clear multilayer polyolefin plastic film. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

None known.

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 should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.

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.

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.)

Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication

(Use aseptic technique)

1. Remove blue cap from BLU-MED™ sterile medication additive port at bottom of container.

2. With a needle of appropriate length, puncture resealable additive port and inject. Withdraw needle after injecting medication.

3. Mix container contents thoroughly.

4. The additive port may be protected by an appropriate cover.

Preparation for Administration

(Use aseptic technique)

NOTE: See appropriate IV administration set Instructions for Use.

1. Close flow control clamp of administration set.

2. Remove cap from sterile administration set port at bottom of container.

3. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.

4. Suspend container.

5. Squeeze and release drip chamber to establish proper fluid level in chamber.

6. Open clamp. Eliminate air from remainder of set.

7. Attach set to patient access device.

8. Begin infusion.

WARNING: Do not use flexible container in series connections.