Multiple Electrolytes Ph 7.4

Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride

Fresenius Kabi Usa, Llc
Human Prescription Drug
NDC 65219-389

Multiple Electrolytes Ph 7.4 also known as Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride is a human prescription drug labeled by 'Fresenius Kabi Usa, Llc'. National Drug Code (NDC) number for Multiple Electrolytes Ph 7.4 is 65219-389. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Multiple Electrolytes Ph 7.4 drug includes Magnesium Chloride - 30 mg/100mL Potassium Chloride - 37 mg/100mL Sodium Acetate - 368 mg/100mL Sodium Chloride - 526 mg/100mL Sodium Gluconate - 502 mg/100mL . The currest status of Multiple Electrolytes Ph 7.4 drug is Active.

Drug Information:

Drug NDC:	65219-389
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:	Multiple Electrolytes Ph 7.4
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:	Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride And Magnesium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Fresenius Kabi Usa, Llc
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:	MAGNESIUM CHLORIDE - 30 mg/100mL POTASSIUM CHLORIDE - 37 mg/100mL SODIUM ACETATE - 368 mg/100mL SODIUM CHLORIDE - 526 mg/100mL SODIUM GLUCONATE - 502 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:	ANDA
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:	17 Jun, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 2025
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:	ANDA215371
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:	Fresenius Kabi USA, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	801109
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:	02F3473H9O 660YQ98I10 4550K0SC9B 451W47IQ8X R6Q3791S76
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 NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
65219-389-05	20 BAG in 1 CASE (65219-389-05) / 500 mL in 1 BAG (65219-389-00)	21 Oct, 2022	N/A	No
65219-389-10	10 BAG in 1 CASE (65219-389-10) / 1000 mL in 1 BAG (65219-389-02)	21 Oct, 2022	N/A	No
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.

Other medicines with the same generic name

Plasma-lyte A

Sodium Chloride & more..

Injection, Solution
Baxter Healthcare Corporation
NDC: 0338-0221

Multiple Electrolytes Ph 7.4

Sodium Chloride & more..

Injection, Solution
Fresenius Kabi USA, LLC
NDC: 65219-389

Multiple Electrolytes Ph 5.5

Sodium Chloride & more..

Injection, Solution
Fresenius Kabi USA, LLC
NDC: 65219-387

Product Elements:

Multiple electrolytes ph 7.4 sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride sodium chloride sodium cation chloride ion sodium gluconate gluconic acid sodium cation sodium acetate sodium cation acetate ion potassium chloride potassium cation chloride ion magnesium chloride magnesium cation chloride ion sodium hydroxide

Drug Interactions:

Drug interactions other products that affect fluid and/or electrolyte balance administration of multiple electrolytes injection, type 1, usp to patients treated concomitantly with drugs associated with sodium and fluid retention, may increase the risk of hypernatremia and volume overload. avoid use of multiple electrolytes injection, type 1, usp in patients receiving such products, such as corticosteroids or corticotropin. if use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance. other drugs that increase the risk of hyponatremia administration of multiple electrolytes injection, type 1, usp in patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia. avoid use of multiple electrolytes injection, type 1, usp in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. drugs that increase the vasopressin effect reduce renal electrolyte free Read more...

water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. if use cannot be avoided, monitor serum sodium concentrations. lithium renal clearance of lithium may be increased during administration of multiple electrolytes injection, type 1, usp. monitor serum lithium concentrations during concomitant use. other products that increase the risk of hyperkalemia because of its potassium content, avoid use of multiple electrolytes injection, type 1, usp in patients receiving products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics, ace inhibitors, angiotensin ii receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. if use cannot be avoided, monitor serum potassium concentrations. drugs with ph dependent renal elimination due to its alkalinizing effect (formation of bicarbonate), multiple electrolytes injection, type 1, usp may interfere with the elimination of drugs with ph dependent renal elimination. renal clearance of acidic drugs may be increased. renal clearance of alkaline drugs may be decreased.

Indications and Usage:

Indications and usage multiple electrolytes injection, type 1, usp, ph 7.4 is indicated as a source of water and electrolytes or as an alkalinizing agent.

Warnings:

Warnings hypersensitivity reactions hypersensitivity and infusion reactions have been reported with multiple electrolytes injection, type 1, usp. see adverse reactions . stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. appropriate therapeutic countermeasures must be instituted as clinically indicated. electrolyte imbalances fluid overload depending on the volume and rate of infusion, the intravenous administration of multiple electrolytes injection, type 1, usp can cause electrolyte disturbances such as overhydration, and congested states, including pulmonary congestion and edema. avoid multiple electrolytes injection, type 1, usp in patients with or at risk for fluid and/or solute overloading. if use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. hyponatremia multiple electrolytes injection, type 1 Read more...

, usp may cause hyponatremia. hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. the risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including siadh) treated with high volume of hypotonic multiple electrolytes injection, type 1, usp. avoid multiple electrolytes injection, type 1, usp in hypervolemic or overhydrated patients. if use cannot be avoided, monitor serum sodium concentrations. hypernatremia hypernatremia may occur with multiple electrolytes injection, type 1, usp. conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see precautions . avoid multiple electrolytes injection, type 1, usp in patients with, or at risk for, hypernatremia. if use cannot be avoided, monitor serum sodium concentrations. hypermagnesemia avoid solutions containing magnesium including multiple electrolytes injection, type 1, usp in patients with or predisposed to hypermagnesemia, including patients with severe renal impairment and those patients receiving magnesium therapy (e.g., treatment of eclampsia and myasthenia gravis). multiple electrolytes injection, type 1, usp is not indicated for the treatment of hypomagnesemia. acidosis multiple electrolytes injection, type 1, usp is not for use for the treatment of lactic acidosis or severe metabolic acidosis in patients with severe liver and/or renal impairment. alkalosis excess administration of multiple electrolytes injection, type 1, usp can result in metabolic alkalosis. avoid multiple electrolytes injection, type 1, usp in patients with alkalosis or at risk for alkalosis. multiple electrolytes injection, type 1, usp is not indicated for the treatment of hypochloremic hypokalemic alkalosis. avoid use in patients with hypochloremic hypokalemic alkalosis. hypocalcemia multiple electrolytes injection, type 1, usp contains no calcium, and an increase in plasma ph due to its alkalinizing effect may lower the concentration of ionized (not protein-bound) calcium. avoid multiple electrolytes injection, type 1, usp in patients with hypocalcemia. hyperkalemia potassium-containing solutions, including multiple electrolytes injection, type 1, usp may increase the risk of hyperkalemia. patient's at increased risk of developing hyperkalemia include those: with conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury or burns, certain cardiac disorders such as congestive heart failure. treated concurrently or recently with agents or products that cause or increase the risk of hyperkalemia (see precautions ). avoid multiple electrolytes injection, type 1, usp in patients with, or at risk for hyperkalemia. if use cannot be avoided, monitor serum potassium concentrations. although multiple electrolytes injection, type 1, usp has a potassium concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency; therefore, it is not indicated for correction of severe potassium deficiency.

Dosage and Administration:

Dosage and administration important administration instructions multiple electrolytes injection, type 1, usp, ph 7.4 is intended for intravenous administration using sterile equipment. do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. set the vent to the closed position on a vented intravenous administration set to prevent air embolism. use a dedicated line without any connections to avoid air embolism. do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. prior to infusion, visually inspect the solution for particulate matter and discoloration. the solution should be clear and there should be no precipitates. do not administer unless solution is clear, and container is undamaged. multiple electrolytes injection, type 1, usp, ph 7.4 is compatible Read more...

with blood or blood components. it may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes. multiple electrolytes injection, type 1, usp, ph 7.4 and 0.9% sodium chloride injection, usp are equally compatible with blood or blood components. dosing information the choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. introduction of additives additives may be incompatible. evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. consult with a pharmacist, if available. if, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. mix thoroughly when additives have been introduced. after addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. do not store solutions containing additives. discard any unused portion.

Contraindications:

Contraindications multiple electrolytes injection, type 1, usp, ph 7.4 is contraindicated in patients with a known hypersensitivity to the product. see warnings .

Adverse Reactions:

Adverse reactions post-marketing adverse reactions the following adverse reactions associated with the use of multiple electrolytes injection, type 1, usp were identified in clinical trials or postmarketing reports. because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. hypersensitivity and infusion reactions : tachycardia, chest pain, chest discomfort, dyspnea, flushing, hyperemia, asthenia, pyrexia, hypotension, wheezing, urticaria, cold sweat, chills. general disorders and administration site conditions : infusion site pain, burning sensation. metabolism and nutrition disorders : hyperkalemia, hyponatremia. nervous system disorders : hyponatremic encephalopathy. to report suspected adverse reactions, contact fresenius kabi usa, llc at 1-800-551-7176 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Drug Interactions:

Use in Pregnancy:

Pregnancy teratogenic effects animal reproduction studies have not been conducted with multiple electrolytes injection, type 1, usp. it is also not known whether multiple electrolytes injection, type 1, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. multiple electrolytes injection, type 1, usp should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use the use of multiple electrolytes injection, type 1, usp in pediatric patients is based on clinical practice.

Geriatric Use:

Geriatric use geriatric patients are at increased risk of developing electrolyte imbalances. multiple electrolytes injection, type 1, usp is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. consider monitoring renal function in elderly patients.

Overdosage:

Overdosage excessive administration of multiple electrolytes injection, type 1, usp, ph 7.4 can cause: fluid overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired. hypernatremia and hyperkalemia, especially in patients with severe renal impairment. hypermagnesemia. see warnings and adverse reactions metabolic alkalosis with or without hypokalemia and decreased ionized serum calcium and magnesium concentrations. when assessing an overdose, any additives in the solution must also be considered. the effects of an overdose may require immediate medical attention and treatment. interventions include discontinuation of multiple electrolytes injection, type 1, usp, ph 7.4, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).

Description:

Description multiple electrolytes injection, type 1, usp, ph 7.4 is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. each 100 ml contains 526 mg of sodium chloride, usp (nacl); 502 mg of sodium gluconate (c 6 h 11 nao 7 ); 368 mg of sodium acetate trihydrate, usp (c 2 h 3 nao 2 â¢3h 2 o); 37 mg of potassium chloride, usp (kcl); and 30 mg of magnesium chloride, usp (mgcl 2 â¢6h 2 o). it contains no antimicrobial agents. the ph is adjusted with sodium hydroxide. the ph is 7.4 (6.5 to 8.0). multiple electrolytes injection, type 1, usp, ph 7.4 administered intravenously has value as a source of water, electrolytes, and calories. one liter has an ionic concentration of 140 meq sodium, 5 meq potassium, 3 meq magnesium, 98 meq chloride, 27 meq acetate, and 23 meq gluconate. the osmolarity is 294 mosmol/l (calc). normal physiologic osmolarity range is 280 to 310 mosmol/l. the caloric content is 21 kcal/l. the flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex Â® bag). the amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. however, the safety of the plastic has been confirmed in tests in animals according to usp biological tests for plastic containers as well as by tissue culture toxicity studies.

Clinical Pharmacology:

Clinical pharmacology multiple electrolytes injection, type 1, usp, ph 7.4 has value as a source of water and electrolytes. it is capable of inducing diuresis depending on the clinical condition of the patient. multiple electrolytes injection, type 1, usp, ph 7.4 produces a metabolic alkalinizing effect. acetate and gluconate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility studies with multiple electrolytes injection, type 1, usp have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

How Supplied:

How supplied multiple electrolytes injection, type 1, usp, ph 7.4 in free flex Â® plastic containers is available as shown below: product code unit of use unit of sale 389150 ndc 65219-389-00 one 500 ml free flex Â® bag ndc 65219-389-05 package of 20 free flex Â® bags 389100 ndc 65219-389-02 one 1000 ml free flex Â® bag ndc 65219-389-10 package of 10 free flex Â® bags exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. store at 20Â° to 25Â°c (68Â° to 77Â°f). [see usp controlled room temperature.]. brief exposure up to 40Â°c does not adversely affect the product. the container closure is not made with natural rubber latex. non-pvc, non-dehp, sterile.

Package Label Principal Display Panel:

Package label - principal display â multiple electrolytes injection, type 1, usp ph 7.4 500 ml bag label 500 ml ndc 65219-389-00 multiple electrolytes injection, type 1, usp ph 7.4 rx only each 100 ml contains : 526 mg sodium chloride, usp; 502 mg sodium gluconate, usp; 368 mg sodium acetate trihydrate, usp; 37 mg potassium chloride, usp; 30 mg magnesium chloride, usp ph adjusted with sodium hydroxide. electrolytes per 1,000 ml: sodium 140 meq; potassium 5 meq; magnesium 3 meq; chloride 98 meq; acetate 27 meq; gluconate 23 meq 294 mosmol/liter (calc.) ph 7.4 (6.5 to 8.0) package label - principal display â multiple electrolytes injection, type 1, usp ph 7.4 500 ml bag label

Package label â principal display â multiple electrolytes injection, type 1, usp ph 7.4 500 ml shipper label ndc 65219-389-05 389150 multiple electrolytes injection, type 1, usp ph 7.4 500 ml x 20 store at: 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature] until ready to use. avoid excessive heat. package label â principal display â multiple electrolytes injection, type 1, usp ph 7.4 500 ml shipper label

Package label - principal display â multiple electrolytes injection, type 1, usp ph 7.4 1000 ml bag label 1000 ml ndc 65219-389-02 multiple electrolytes injection, type 1, usp ph 7.4 rx only each 100 ml contains : 526 mg sodium chloride, usp; 502 mg sodium gluconate, usp; 368 mg sodium acetate trihydrate, usp; 37 mg potassium chloride, usp; 30 mg magnesium chloride, usp ph adjusted with sodium hydroxide. electrolytes per 1,000 ml: sodium 140 meq; potassium 5 meq; magnesium 3 meq; chloride 98 meq; acetate 27 meq; gluconate 23 meq 294 mosmol/liter (calc.) ph 7.4 (6.5 to 8.0) package label - principal display â multiple electrolytes injection, type 1, usp ph 7.4 1000 ml bag label

Package label â principal display â multiple electrolytes injection, type 1, usp ph 7.4 1000 ml shipper label ndc 65219-389-10 389100 multiple electrolytes injection, type 1, usp ph 7.4 1000 ml x 10 store at: 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature] until ready to use. avoid excessive heat. package label â principal display â multiple electrolytes injection, type 1, usp ph 7.4 1000 ml shipper label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.