Normosol-R

This page contains information on Normosol-R for veterinary use.
The information provided typically includes the following:
  • Normosol-R Indications
  • Warnings and cautions for Normosol-R
  • Direction and dosage information for Normosol-R

Normosol-r

This treatment applies to the following species:
Manufacturer: Abbott

Veterinary

REPLACEMENT ELECTROLYTES AND WATER

For Replacing Acute Losses Of Extracellular Fluid

Flexible Plastic Container

For Animal Use Only

Single Dose. Contains No Preservative.

DESCRIPTION

NORMOSOL®-R is a sterile, nonpyrogenic isotonic solution of balanced electrolytes in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid.

Each 100 mL of NORMOSOL®-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg. May contain HCl and/or NaOH for pH adjustment. (pH 6.6 (5.5 - 8.0): 294 mOsmol/liter (calc.).)

Electrolytes per 1000 mL (not including pH adjustment): Sodium 140 mEq; potassium 5 mEq; magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq.

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®-R is a parenteral fluid and electrolyte replenisher.

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

Potassium Chloride, USP is chemically designated KCI, a white granular powder freely soluble in water.

Magnesium Chloride, USP is chemically designated magnesium chloride hexahydrate (MgCl2 • 6H20) deliquescent crystals very soluble in water.

Sodium Acetate, USP, is chemically designated sodium acetate anhydrous (C2H3NaO2), a hygroscopic powder soluble in water. It has the following structural formula:

Sodium gluconate is chemically designated C6H11NaO7, the normal sodium salt of gluconic acid soluble in water. It has the following structural formula:

Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

CLINICAL PHARMACOLOGY

When administered intravenously, NORMOSOL®-R provides water and electrolytes for replacement of acute extracellular fluid losses without disturbing normal electrolyte relationships. The electrolyte composition approaches that of the principal ions of normal plasma (extracellular fluid). The electrolyte concentration is approximately isotonic in relation to the extracellular fluid (approx. 280 mOsmol/liter) and provides a physiologic sodium to chloride ratio, normal plasma concentrations of potassium and magnesium and two bicarbonate alternates, acetate and gluconate.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl-) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl-) are largely under the control of the kidney which maintains a balance between intake and output.

Potassium chloride in water dissociates to provide potassium (K+) and chloride (Cl-) ions. Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). Potassium plays an important role in electrolyte balance.

Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion.

Magnesium chloride in water dissociates to provide magnesium (Mg++) and chloride (Cl-) ions. Magnesium is the second most plentiful cation of the intracellular fluids. It is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability. Normal plasma concentration ranges from 1.5 to 2.5 or 3.0 mEq/liter. Magnesium is excreted solely by the kidney at a rate proportional to the plasma concentration and glomerular filtration.

Sodium acetate provides sodium (Na+) and acetate (CH3C00-) ions, the latter anion (a source of hydrogen ion acceptors) serving as an alternate source of bicarbonate (HC03-) by metabolic conversion. This has been shown to proceed readily even in the presence of severe liver disease. Thus, acetate anion exerts a mild systemic antiacidotic action that may be advantageous during fluid and electrolyte replacement therapy.

Sodium gluconate provides sodium (Na+) and gluconate (C6H11O7-) ions. Gluconate is a theoretical alternate metabolic source of bicarbonate (HCO3-) anion.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE

NORMOSOL®-R is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. NORMOSOL®-R also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. NORMOSOL®-R is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume.

CONTRAINDICATIONS

None known.

WARNINGS

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.

PRECAUTIONS

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.

ADVERSE REACTIONS

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.

OVERDOSAGE

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

DOSAGE AND ADMINISTRATION

Normosol®-r Is Administered By Intravenous Infusion. It May Also Be Administered Subcutaneously. The Amount To Be Infused Is Based On Replacement Of Losses Of Extracellular Fluid Volume In The Individual Patient. Up To 3 Times The Volume Of Estimated Blood Loss During And After Surgery Can Be Given To Correct Circulatory Volume When There Is Only A Moderate Loss Of Blood.

Drug Interactions

Additives may be incompatible. Consult with Additive Manufacturer. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

NORMOSOL®-R does not contain calcium to avoid precipitation of calcium salts that may occur when certain drugs are added. Solutions which contain calcium in amounts exceeding the normal plasma concentration may enhance clotting on contact with citrated blood. Hence, NORMOSOL®-R can be used for starting blood transfusion.

INSTRUCTIONS FOR USE

To Open

Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

To Add Medication

1. Prepare additive port.

2. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.

3. The additive port may be protected by covering with an additive cap.

4. Mix container contents thoroughly.

Preparation For Administration (use Aseptic Technique)

1. Close flow control clamp of administration set.

2. Remove cover from outlet port at bottom of container.

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

Note

See full directions on administration set carton.

4. Suspend container from hanger.

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

6. Open flow control clamp and clear air from set. Close clamp.

7. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

8. Regulate rate of administration with flow control clamp.

Important: Contains No Preservative. Single Dose. Dispose Of Unused Contents.

How Supplied

This solution is supplied in a single-dose flexible plastic container as follows:

List No.

Product Name

Container Size (ml)

 

2107-01

Normosol®-R

3000

EN-1067

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).

Normosol-R Caution: Federal Law Restricts This Drug To Use By Or On The Order Of A Licensed Veterinarian.

Revised: October, 2005

Manufactured for: Abbott Laboratories, North Chicago, IL 60064, USA

NORMOSOL®-R is a registered trademark of Hospira, Inc.

©2005 Abbott Laboratories

Nac No.

10240064

ABBOTT
Abbott Animal Health
200 ABBOTT PARK ROAD, ABBOTT PARK, IL, 60064-6375
Telephone:   888-299-7416
Order Desk:   888-299-7416
Technical Information:   888-299-7416
Fax:   847-938-0659
Website:   www.abbottanimalhealth.com
Every effort has been made to ensure the accuracy of the Normosol-R information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-09-05

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