NDC 0990-7965 Normosol-m And Dextrose

Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate

NDC Product Code 0990-7965

NDC CODE: 0990-7965

Proprietary Name: Normosol-m And Dextrose 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: Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.
  • Drug uses not available

NDC Code Structure

  • 0990 - Icu Medical Inc.

NDC 0990-7965-09

Package Description: 12 POUCH in 1 CASE > 1 BAG in 1 POUCH > 1000 mL in 1 BAG

NDC Product Information

Normosol-m And Dextrose with NDC 0990-7965 is a a human prescription drug product labeled by Icu Medical Inc.. The generic name of Normosol-m And Dextrose is dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: Icu Medical Inc.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Normosol-m And Dextrose Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DEXTROSE MONOHYDRATE 5 g/100mL
  • SODIUM CHLORIDE 234 mg/100mL
  • POTASSIUM ACETATE 128 mg/100mL
  • MAGNESIUM ACETATE 21 mg/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Icu Medical Inc.
Labeler Code: 0990
FDA Application Number: NDA017610 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 02-08-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Normosol-m And Dextrose Product Label Images

Normosol-m And Dextrose 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.

Product Labeling Index

Description

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:Sodium (Na+) 40 mEq/literPotassium (K+) 13 mEq/literMagnesium (Mg++)3 mEq/literChloride (Cl−) 40 mEq/literBicarbonate (HCO3−) as acetate16 mEq/literCaloric value (dextrose) 170 Calories/literTonicity HypertonicOsmolarity 363 mOsmol/liter (calc.)pH (range) 5.0 (4.0 to 6.5)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.The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. 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.——————————————————————™Normosol −−multiple electrolyte solutions, ICU Medical, Inc.

Clinical Pharmacology

When administered intravenously, Normosol-M and 5% Dextrose Injection provides water and electrolytes (with dextrose as a readily available source of carbohydrate) for maintenance of daily fluid and electrolyte requirements, plus minimal carbohydrate calories. The electrolyte composition approaches that of the principal ions of normal plasma (extracellular fluid). The electrolyte concentration is hypotonic (112 mOsmol/liter) in relation to the extracellular fluid (280 mOsmol/liter). One liter provides approximately one-third of the average adult daily requirement for water and principal electrolytes in balanced proportions, with acetate as a bicarbonate alternate, plus 170 calories from dextrose.Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and supply calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide in water.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 acetate in water dissociates to provide potassium (K+) and acetate (CH3COO−) 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 and child over 10 days old; 3.5 to 6.0 mEq/liter in a child less than 10 days old. 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 acetate in water dissociates to provide magnesium (Mg++) and acetate (CH3COO−) 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 per liter. Magnesium is excreted solely by the kidney at a rate proportional to the plasma concentration and glomerular filtration.Acetate anion (CH3COO−), a source of hydrogen ion acceptors, serves as an alternate source of bicarbonate (HCO3−) by metabolic conversion in the liver. 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.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). Average normal pediatric daily requirements are based on the child’s weight as described in the table below:WeightFluid RequirementsUp to 10 kg100 mL/kg11 to 20 kg1,000 mL + 50 mL/kg for each kg above 10 kgAbove 20 kg1,500 mL + 20 mL/kg for each kg above 20 kgWater 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-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories from dextrose. Magnesium in the formula may help to prevent iatrogenic magnesium deficiency in patients receiving prolonged parenteral therapy.

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 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.

Precautions

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 should be used with caution, as excess administration may result in metabolic alkalosis.Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.Do not administer unless solution is clear and container is undamaged. Discard unused portion.In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.

Pregnancy Category C.

Animal reproduction studies have not been conducted with Normosol-M and 5% Dextrose Injection. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed.

Pediatric Use.

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates and very small infants the volume of fluid may affect fluid and electrolyte balance.Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.

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-M and 5% Dextrose Injection is administered by intravenous infusion. The dose is dependent upon the age, weight and clinical condition of the patient. A daily total amount of 1500 mL/M2 of body surface will meet the usual adult daily requirements for water and principal electrolytes in patients unable to take anything by mouth. The usual daily maintenance amount for an average adult (70 kg and 1.8 square meters of body surface) is approximately three liters.As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.Drug InteractionsAdditives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.To avoid precipitation of calcium salts that may occur when certain drugs are added, Normosol-M and 5% Dextrose Injection does not contain calcium.Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.INSTRUCTIONS FOR USETo OpenTear outer wrap at notch and remove solution container. 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.If supplemental medication is desired, follow directions below before preparing for administration.To Add MedicationPrepare additive port.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.The additive port may be protected by covering with an additive cap.Mix container contents thoroughly.To AdministerAttach administration set per manufacturer’s instructions.Regulate rate of administration per institutional policy.WARNING: Do not use flexible container in series connections.

How Supplied

Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in single-dose flexible plastic containers. NDC No.     Product Container Size (mL)0409-7965-03Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP) 5000990-7965-03Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP) 5000409-7965-09 Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP)10000990-7965-09 Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Inj., Type 1, USP)1000ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time.Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2018EN-5755Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

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