Normosol-m And Dextrose

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


Icu Medical Inc.
Human Prescription Drug
NDC 0990-7965
Normosol-m And Dextrose also known as Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate is a human prescription drug labeled by 'Icu Medical Inc.'. National Drug Code (NDC) number for Normosol-m And Dextrose is 0990-7965. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Normosol-m And Dextrose drug includes Dextrose Monohydrate - 5 g/100mL Magnesium Acetate - 21 mg/100mL Potassium Acetate - 128 mg/100mL Sodium Chloride - 234 mg/100mL . The currest status of Normosol-m And Dextrose drug is Active.

Drug Information:

Drug NDC: 0990-7965
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Normosol-m And Dextrose
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Icu Medical Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:DEXTROSE MONOHYDRATE - 5 g/100mL
MAGNESIUM ACETATE - 21 mg/100mL
POTASSIUM ACETATE - 128 mg/100mL
SODIUM CHLORIDE - 234 mg/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 08 Feb, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: NDA017610
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:ICU Medical Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:801005
801009
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:LX22YL083G
0E95JZY48K
M911911U02
451W47IQ8X
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Calculi Dissolution Agent [EPC]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0990-7965-0912 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG08 Feb, 2021N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Normosol-m and dextrose dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate dextrose monohydrate anhydrous dextrose sodium chloride sodium cation chloride ion potassium acetate potassium cation magnesium acetate magnesium cation water hydrochloric acid

Indications and Usage:

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.

Warnings:

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 e
dema. 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.

Dosage and Administration:

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/m 2 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 interactions additives 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 dr
ugs 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 use to open tear 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 medication prepare 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 administer attach administration set per manufacturer’s instructions. regulate rate of administration per institutional policy. warning: do not use flexible container in series connections.

Contraindications:

Contraindications none known.

Adverse Reactions:

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.

Use in Pregnancy:

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:

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.

Overdosage:

Overdosage in the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. see warnings , precautions and adverse reactions .

Description:

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/liter potassium (k + ) 13 meq/liter magnesium (mg ++ ) 3 meq/liter chloride (cl − ) 40 meq/liter bicarbonate (hco 3 − ) as acetate 16 meq/liter caloric value (dextrose) 170 calories/liter tonicity hypertonic osmolarity 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 (c 6 h 12 o 6 • h 2 o), 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 ch 3 cook, colorless crystals or white crystalline powder very soluble in water. magnesium acetate is chemically designated mg (c 2 h 3 o 2 ) 2 , colorless or white crystals very soluble in water. water for injection, usp is chemically designated h 2 o. 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. structural formula dextrose

Clinical Pharmacology:

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 ox
idation 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 (ch 3 coo − ) 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 (ch 3 coo − ) 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 (ch 3 coo − ), a source of hydrogen ion acceptors, serves as an alternate source of bicarbonate (hco 3 − ) 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: weight fluid requirements up to 10 kg 100 ml/kg 11 to 20 kg 1,000 ml + 50 ml/kg for each kg above 10 kg above 20 kg 1,500 ml + 20 ml/kg for each kg above 20 kg 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.

How Supplied:

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) 0409-7965-03 normosol-m and 5% dextrose injection (multiple electrolytes and 5% dextrose inj., type 1, usp) 500 0990-7965-03 normosol-m and 5% dextrose injection (multiple electrolytes and 5% dextrose inj., type 1, usp) 500 0409-7965-09 normosol-m and 5% dextrose injection (multiple electrolytes and 5% dextrose inj., type 1, usp) 1000 0990-7965-09 normosol-m and 5% dextrose injection (multiple electrolytes and 5% dextrose inj., type 1, usp) 1000 icu 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: march, 2020 ifu0000171 icu medical, inc., lake forest, illinois, 60045, usa

Package Label Principal Display Panel:

Principal display panel - 1000 ml bag label 1000 ml ndc 0990-7965-09 normosol ® -m and 5% dextrose injection multiple electrolytes and 5% dextrose injection type 1, usp each 100 ml contains dextrose, hydrous 5 g; sodium chloride 234 mg; potassium acetate 128 mg; magnesium acetate, anhydrous 21 mg in water for injection. may contain hydrochloric acid for ph adjustment. electrolytes per 1000 ml (not including ph adjustment); sodium 40 meq; potassium 13 meq; magnesium 3 meq; chloride 40 meq; acetate 16 meq. 363 mosmol/liter (calc). ph 5.0 (4.0 to 6.5) additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. single-dose container. usual dosage: see insert. for i.v. use. sterile, nonpyrogenic. use only if solution is clear and container is undamaged. must not be used in series connections. rx only 3 v contains dehp imp0000054 icu medical, inc., lake forest, illinois, 60045, usa icumedical principal display panel - 1000 ml bag label


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