Ringers

Sodium Chloride, Potassium Chloride, And Calcium Chloride


Icu Medical Inc.
Human Prescription Drug
NDC 0990-7982
Ringers also known as Sodium Chloride, Potassium Chloride, And Calcium Chloride is a human prescription drug labeled by 'Icu Medical Inc.'. National Drug Code (NDC) number for Ringers is 0990-7982. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Ringers drug includes Calcium Chloride - 33 mg/100mL Potassium Chloride - 30 mg/100mL Sodium Chloride - 860 mg/100mL . The currest status of Ringers drug is Active.

Drug Information:

Drug NDC: 0990-7982
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: Ringers
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, Potassium Chloride, And Calcium Chloride
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:CALCIUM CHLORIDE - 33 mg/100mL
POTASSIUM CHLORIDE - 30 mg/100mL
SODIUM CHLORIDE - 860 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: 01 Jan, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 19 Jan, 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: NDA018251
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:847617
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:M4I0D6VV5M
660YQ98I10
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:Blood Coagulation Factor [EPC]
Calcium [CS]
Cations
Divalent [CS]
Increased Coagulation Factor Activity [PE]
Increased Large Intestinal Motility [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Potassium Compounds [CS]
Potassium Salt [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0990-7982-0912 POUCH in 1 CASE (0990-7982-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG24 Feb, 2020N/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:

Ringers sodium chloride, potassium chloride, and calcium chloride potassium chloride potassium cation chloride ion calcium chloride calcium cation chloride ion sodium chloride sodium cation chloride ion hydrochloric acid sodium hydroxide water

Drug Interactions:

Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. the presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .

Indications and Usage:

Indications and usage this solution is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.

Warnings:

Warnings solutions containing calcium ions should not be administered simultaneously through the same administration set as blood because of the likelihood of coagulation. 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. 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. in patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. solutions containing lactate ions should be used with great care in patients with metabolic or respiratory alkalosis. the administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in
severe hepatic insufficiency. the intravenous administration of these solutions 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.

Dosage and Administration:

Dosage and administration the dose is dependent upon the age, weight and clinical condition of the patient. drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. the presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .

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.

Drug Interactions:

Drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. the presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. see precautions .

Use in Pregnancy:

Pregnancy category c animal reproduction studies have not been conducted with ringer's injection, usp,. it is also not known whether this injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. this injection 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 or very small infants the volume of fluid may affect fluid and electrolyte balance.

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 this product is a sterile, nonpyrogenic solutions containing isotonic concentrations of electrolytes in water for injection. the solution is isotonic. the solution is administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. each 100 ml of ringer's injection, usp contains sodium chloride 860 mg, potassium chloride 30 mg and calcium chloride, dihydrate 33 mg. may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. a liter provides 147 meq sodium (na + ), 4 meq potassium (k + ), 4 meq calcium (ca ++ ) and 155 meq chloride (cl − ). the electrolyte content is isotonic (309 mosmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mosmol/liter). the ph of the solution is 5.4 (5.0 − 7.5). 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. the solution is a parenteral fluid, nutrient and/or electrolyte 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: calcium chloride, usp is chemically designated calcium chloride, dihydrate (cacl 2 ∙ 2 h 2 o), white fragments or granules freely soluble in water. potassium chloride, usp is chemically designated kcl, a white granular powder freely soluble in water. sodium chloride, usp is chemically designated naci, a white crystalline powder freely soluble in water. water for injection, usp is chemically designated h 2 o. 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. solution inside the plastic container also can leach out certain 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. structural formula dextrose

Clinical Pharmacology:

Clinical pharmacology when administered intravenously, this solution provides a source of water and electrolytes with or without minimal carbohydrate calories. the electrolyte content resembles that of the principal ionic constituents of normal plasma and the solution therefore is suitable for parenteral replacement of extracellular losses of fluid and electrolytes, with or without carbohydrate calories. calcium chloride in water dissociates to provide calcium (ca ++ ) and chloride (cl − ) ions. they are normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%. potassium chloride in water dissociates to provide potassium (k + ) and chloride (cl − ) ions. potassium is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 meq/liter in a healthy a
dult). it is the chief cation of body cells (160 meq/liter of intracellular water). 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. 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. 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.

How Supplied:

How supplied this solution is supplied in a single-dose flexible plastic container as follows: ndc no. product name container size (ml) 0409–7982–09 ringer's inj., usp 1000 0990-7982-09 ringer's inj., 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. protect from freezing. store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] revised: march, 2020 ifu0000173 icu medical, inc., lake forest, illinois, 60045, usa

Package Label Principal Display Panel:

Principal display panel - 1000 ml bag label 1000 ml ndc 0990-7982-09 ringer's injection, usp each 100 ml contains sodium chloride 860 mg; potassium chloride 30 mg; calcium chloride, dihydrate 33 mg in water for injection. may contain hcl or naoh for ph adjustment. electrolytes per 1000 ml: sodium 147 meq; potassium 4 meq; calcium 4 meq; chloride 155 meq. 309 mosmol/liter (calc.). ph 5.4 (5.0 to 7.5). do not administer calcium containing solutions concurrently with stored blood. additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. single-dose container. for intravenous or subcutaneous use. usual dosage: see insert. 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 imp0000056 icu medical, inc., lake forest, illinois, 60045, usa icumedical principal display panel - 1000 ml bag label

Principal display panel - 1000 ml bag overwrap to open tear at notch 2 hdpe do not remove from overwrap until ready for use. after removing the overwrap, check for minute leaks by squeezing container firmly. if leaks are found, discard solution as sterility may be impaired. recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see insert. 98-4321-r14-3/98 principal display panel - 1000 ml bag overwrap


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