Lactated Ringers
Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride
B. Braun Medical Inc.
Human Prescription Drug
NDC 0264-2203Lactated Ringers also known as Sodium Chloride, Sodium Lactate, Potassium Chloride, And Calcium Chloride is a human prescription drug labeled by 'B. Braun Medical Inc.'. National Drug Code (NDC) number for Lactated Ringers is 0264-2203. This drug is available in dosage form of Irrigant. The names of the active, medicinal ingredients in Lactated Ringers drug includes Calcium Chloride - .02 g/100mL Potassium Chloride - .03 g/100mL Sodium Chloride - .6 g/100mL Sodium Lactate - .31 g/100mL . The currest status of Lactated Ringers drug is Active.
Drug Information:
| Drug NDC: | 0264-2203 |
| 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: | Lactated 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, Sodium Lactate, Potassium Chloride, And Calcium Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | B. Braun Medical Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Irrigant |
| 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 - .02 g/100mL
POTASSIUM CHLORIDE - .03 g/100mL
SODIUM CHLORIDE - .6 g/100mL
SODIUM LACTATE - .31 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | IRRIGATION
|
| 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: | 27 Dec, 1982 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 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: | NDA018681 |
| 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: | B. Braun Medical Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 847628
|
| 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. |
| UPC: | 0302642203000
0302642203505
|
| UPC stands for Universal Product Code. |
| UNII: | M4I0D6VV5M
660YQ98I10
451W47IQ8X
TU7HW0W0QT
|
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0264-2203-00 | 16 CONTAINER in 1 CASE (0264-2203-00) / 1000 mL in 1 CONTAINER | 27 Dec, 1982 | N/A | No |
| 0264-2203-50 | 8 CONTAINER in 1 CASE (0264-2203-50) / 2000 mL in 1 CONTAINER | 27 Dec, 1982 | N/A | No |
| 0264-2203-70 | 4 CONTAINER in 1 CASE (0264-2203-70) / 4000 mL in 1 CONTAINER | 27 Dec, 1982 | 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. |
Product Elements:
Lactated ringers sodium chloride, sodium lactate, potassium chloride, and calcium chloride sodium chloride sodium cation chloride ion sodium lactate sodium cation lactic acid potassium chloride potassium cation chloride ion calcium chloride calcium cation chloride ion water
Indications and Usage:
Indications and usage lactated ringer's irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Warnings:
Warnings for irrigation only. not for injection. irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus this irrigation must be regarded as a systemic drug. absorption of large amounts 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. do not warm container over 150°f (66°c).
General Precautions:
General do not use for irrigation that may result in absorption into the blood. caution should be observed when the solution is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of circulatory overload. aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues. when used as a "pour" irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the plastic irrigation container. when used for irrigation via irrigation equipment, the administration set should be attached promptly. unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. for repeated irrigations of urethral catheters, a separate container should be used for each pat
Read more...ient use only if solution is clear and container and seal are intact.
Dosage and Administration:
Dosage and administration the dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. when used as a vehicle for other drugs, the manufacturer's recommendations should be followed. drug interactions additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. see precautions .
Contraindications:
Contraindications not for injection by usual parenteral routes. an electrolyte solution should not be used for irrigation during electrosurgical procedures.
Adverse Reactions:
Adverse reactions possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. accidental contamination from careless technique may transmit infection. should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Use in Pregnancy:
Pregnancy teratogenic effects category c animal reproduction studies have not been conducted with lactated ringer's irrigation. it is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. it should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use the safety and effectiveness of lactated ringer's irrigation have not been established. its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
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 lactated ringer's irrigation is a sterile, nonpyrogenic, solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. the composition is based on a modification of the injectable formula originally known as hartmann's solution. each 100 ml contains: sodium chloride usp 0.6 g, sodium lactate 0.31 g, potassium chloride usp 0.03 g, calcium chloride dihydrate usp 0.02 g, water for injection usp qs. ph adjusted with hydrochloric acid nf ph: 6.75 (6.0â7.5) calculated osmolarity: 275 mosmol/liter concentration of electrolytes (meq/liter): sodium 130, potassium 4, calcium 3, chloride 110, lactate (ch 3 ch(oh)coo â ) 28 the solution contains no bacteriostat, antimicrobial agent or added buffer (except for ph adjustment) and is intended only for use as a single-dose or short procedure irrigation. when smaller volumes are required the unused portions should be discarded. lactated ringer's irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. the formulas of the active ingredients are: ingredients molecular formula molecular weight sodium chloride usp nacl 58.44 sodium lactate ch 3 ch(oh)coona 112.06 potassium chloride usp kcl 74.55 calcium chloride dihydrate usp cacl 2 â¢2h 2 o 147.01 the plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. the copolymer contains no plasticizers and exhibits virtually no leachability. the plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. the safety of the plastic container has been confirmed by biological evaluation procedures. the material passes class vl testing as specified in the u.s. pharmacopeia for biological tests â plastic containers. these tests have shown that the container is nontoxic and biologically inert. the pic⢠container is pvc-free and dehp-free.
Clinical Pharmacology:
Clinical pharmacology lactated ringer's irrigation exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. it also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations. lactated ringer's irrigation provides an isotonic irrigation with the same ionic constituents as lactated ringer's injection, usp, a modification of hartmann's solution.lactated ringer's irrigation is considered generally compatible with living tissues and organs. calcium chloride in water dissociates to provide calcium (ca ++ ) and chloride (cl â ) 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
Read more... excretion accounts for the remaining 20%. potassium chloride in water dissociates to provide potassium (k + ) and chloride (cl â ) 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 meq/liter in a healthy adult). 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 â ) 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 â ) 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 â ) are largely under the control of the kidney which maintains a balance between intake and output. sodium lactate in water dissociates to provide sodium (na + ) and lactate (c 3 h 5 o â 3 ) ions. the lactate anion provides an alkalizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. in the liver, the lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism. the lactate anion acts as a source (alternate) of bicarbonate when normal production and utilization of lactic acid is not impaired as a result of disordered lactate metabolism. since metabolic conversion is dependent on the integrity of cellular oxidative processes, lactate may be inadequate or ineffective as a source of bicarbonate in patients suffering from acidosis associated with shock or other disorders involving reduced perfusion of body tissues. when oxidative activity is intact, one to two hours time is required for metabolism of lactate. 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 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 lactated ringer's irrigation is supplied sterile and nonpyrogenic in pic⢠(plastic irrigation container). the 1000 ml containers are packaged 16 per case, the 2000 ml containers are packaged 8 per case, and the 4000 ml containers are packaged 4 per case. ndc cat. no. size lactated ringer's irrigation (canada din 01974076) 0264-2203-00 r5410-01 1000 ml 0264-2203-50 r5415-01 2000 ml 0264-2203-70 r5417 4000 ml exposure of pharmaceutical products to heat should be minimized. avoid excessive heat. protect from freezing. store at 20°â25°c (68°â77°f) [see usp controlled room temperature]; however, brief exposure up to 40°c does not adversely affect the product. do not warm above 150°f (66°c).
Spl Patient Package Insert:
Directions for use of pic⢠(plastic irrigation container) not for injection. aseptic technique is required. caution â before use, perform the following checks: (a) read the label. ensure solution is the one ordered and is within the expiration date. (b) invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the container for leakage or damage. any container which is suspect should not be used. use only if solution is clear and container and seal are intact. single unit container. discard unused portion. outer closure removal â grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off. (figure 1) connect the administration set through the sterile set port according to set instructions (figure 2) or remove
Read more... screw cap and pour. do not warm above 150°f (66°c) to assure minimal bottle distortion. keep bottles upright. figure 1 figure 2
Package Label Principal Display Panel:
Principal display panel - 1000 ml label lactated ringer's irrigation isotonic solution for irrigation ref r5410-01 din 01974076 ndc 0264-2203-00 hk 22614 1000 ml pic⢠container lot exp. each 100 ml contains: sodium chloride usp 0.6 g sodium lactate 0.31 g potassium chloride usp 0.03 g calcium chlorideâ¢2h 2 o usp 0.02 g water for injection usp qs ph adjusted with hcl nf ph: 6.75 (6.0 â 7.5) calc. osmolarity: 275 mosmol/liter electrolytes (meq/liter): na + 130 k + 4 ca ++ 3 cl â 110 lactate 28 sterile, nonpyrogenic. single unit container. discard unused portion. not for injection. use only if solution is clear and container and seal are intact. warning: do not warm above 150°f (66°c). store at 20°â25°c (68°â77°f) [see usp controlled room temperature]. avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free pic is a trademark of b. braun medical inc. b|braun b. braun medical inc. irvine, ca 92614-5895 usa made in usa in canada, distributed by: b. braun medical inc. scarborough, ontario m1h 2w4 y37-002-320 principal display panel - 1000 ml label
Principal display panel - 2000 ml label lactated ringer's irrigation isotonic solution for irrigation ref r5415-01 din 01974076 ndc 0264-2203-50 hk 22614 2000 ml pic⢠container lot exp. each 100 ml contains: sodium chloride usp 0.6 g sodium lactate 0.31 g potassium chloride usp 0.03 g calcium chlorideâ¢2h 2 o usp 0.02 g water for injection usp qs ph adjusted with hcl nf ph: 6.75 (6.0 â 7.5) calc. osmolarity: 275 mosmol/liter electrolytes (meq/liter): na + 130 k + 4 ca ++ 3 cl â 110 lactate 28 sterile, nonpyrogenic. single unit container. discard unused portion. not for injection. use only if solution is clear and container and seal are intact. warning: do not warm above 150°f (66°c). store at 20°â25°c (68°â77°f) [see usp controlled room temperature]. avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free pic is a trademark of b. braun medical inc. b. braun medical inc. irvine, ca 92614-5895 usa made in usa in canada, distributed by: b. braun medical inc. scarborough, ontario m1h 2w4 y37-002-331 principal display panel - 2000 ml label
Principal display panel - 4000 ml label lactated ringer's irrigation isotonic solution for irrigation ref r5417 din 01974076 ndc 0264-2203-70 hk 22614 4000 ml pic⢠container lot exp. each 100 ml contains: sodium chloride usp 0.6 g sodium lactate 0.31 g potassium chloride usp 0.03 g calcium chlorideâ¢2h 2 o usp 0.02 g water for injection usp qs ph adjusted with hcl nf ph: 6.75 (6.0 â 7.5) calc. osmolarity: 275 mosmol/liter electrolytes (meq/liter): na + 130 k + 4 ca ++ 3 cl â 110 lactate 28 sterile, nonpyrogenic. single unit container. discard unused portion. not for injection. use only if solution is clear and container and seal are intact. warning: do not warm above 150°f (66°c). store at 20°â25°c (68°â77°f) [see usp controlled room temperature]. avoid excessive heat. protect from freezing. see package insert. rx only pvc-free and dehp-free pic is a trademark of b. braun medical inc. b. braun medical inc. irvine, ca 92614-5895 usa made in usa in canada, distributed by: b. braun medical inc. scarborough, ontario m1h 2w4 y37-002-332 principal display panel - 4000 ml label