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Animal NDC 86136-008-05 Osmosol-r

Multiple Electrolyte Injection Type 1

Animal Product Information

Field Name Field Value
Animal NDC Code 86136-008-05
Proprietary Name Osmosol-r What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Multiple Electrolyte Injection Type 1 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Mwi (vetone)
Product Type Prescription Animal Drug
Usage Information
    For animal use only Sterile nonpyrogenic solution
Active Ingredient(s)
  • Potassium Chloride
  • Magnesium Chloride
  • Sodium Acetate Anhydrous
  • Sodium Chloride
  • Sodium Gluconate
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Osmosol-r Images

Osmosol-r Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Information For Owners/Caregivers



Assembled in U.S.A.

Manufactured for:

MWI, Boise, ID 83705
www.VetOne.net

NDC 86136-008-05

V1 501206

5000 mL (169.07 fl oz)

18-827

RMS# 92-2123

Iss. 08/21

Manufactured by: Nova-Tech, Inc.

RMS#92-2126

Iss. 08/21


Veterinary Indications



For animal use only

Sterile nonpyrogenic solution


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

RX Only


Caution:



Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Sterile nonpyrogenic solution. Use only if solution is clear and container is undamaged. This is a single dose unit. For Intravenous or subcutaneous use. It contains no preservatives. Use promptly upon initial entry. If entire contents are not used, discard unused portion. Must not be used in series connections. Additives may be incompatible. Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found or if the solution contains visible solid particles.


Active Ingredients:



Each 100 mL contains Sodium Chloride 526 mg; Sodium Acetate 222 mg; Sodium Gluconate 502 mg; Potassium Chloride 37 mg; Magnesium Chloride 30 mg in water for Injection. May contain HCl or NaOH for pH adjustment.

mEq/liter: Sodium 140; Potassium 5; Magnesium 3; Chloride 98; Acetate 27; Gluconate 23.

Osmolarity: 294 mOsmol/liter (calc).

pH: 7.4 (6.5 - 8.0).


Usual Dose:



SEE INSERT.


Storage:



Store between 15°C - 30°C. Keep from freezing.


Description:



OsmoSol-R 7.4 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 OsmoSol-R 7.4 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride, 30 mg. May contain HCL and/or NaOH for pH adjustment. pH 7.4 (6.5 - 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. OsmoSol-R 7.4 is a parenteral fluid and electrolyte replenisher. 


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 deeemed necessary.


Indications:



OsmoSol-R 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. OsmoSol-R 7.4 can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. OsmoSol-R 7.4 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.


Precautions:



OsmoSol-R 7.4 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. OsmoSol-R 7.4 is not intended to correct acidosis or large deficits of individual electrolytes, nor to replace blood or plasma expanders when these are indicated. Do not administer unless solution is clear and container is undamaged. Discard unused portion. 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.


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 initialization 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 if solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Do Not Use flexible container in series connections.


Dosage And Administration:



Administer 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 ciruculatory volume when there is only a moderate loss of blood.


Overdosage:



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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.