Elliotts B
Sodium Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate
Lukare Medical, Llc
Human Prescription Drug
NDC 55792-007Elliotts B also known as Sodium Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate is a human prescription drug labeled by 'Lukare Medical, Llc'. National Drug Code (NDC) number for Elliotts B is 55792-007. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Elliotts B drug includes Anhydrous Dextrose - 8 mg/10mL Calcium Chloride - 2 mg/10mL Magnesium Sulfate, Unspecified - 3 mg/10mL Potassium Chloride - 3 mg/10mL Sodium Bicarbonate - 19 mg/10mL Sodium Chloride - 73 mg/10mL Sodium Phosphate - 2 mg/10mL . The currest status of Elliotts B drug is Active.
Drug Information:
| Drug NDC: | 55792-007 |
| 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: | Elliotts B |
| 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 Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lukare Medical, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| 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: | ANHYDROUS DEXTROSE - 8 mg/10mL
CALCIUM CHLORIDE - 2 mg/10mL
MAGNESIUM SULFATE, UNSPECIFIED - 3 mg/10mL
POTASSIUM CHLORIDE - 3 mg/10mL
SODIUM BICARBONATE - 19 mg/10mL
SODIUM CHLORIDE - 73 mg/10mL
SODIUM PHOSPHATE - 2 mg/10mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRATHECAL
|
| 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: | 04 Jun, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | NDA020577 |
| 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: | Lukare Medical, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 5SL0G7R0OK
M4I0D6VV5M
DE08037SAB
660YQ98I10
8MDF5V39QO
451W47IQ8X
SE337SVY37
|
| 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]
Calculi Dissolution Agent [EPC]
Cations
Divalent [CS]
Increased Coagulation Factor Activity [PE]
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 |
|---|
| 55792-007-10 | 10 AMPULE in 1 BOX (55792-007-10) / 10 mL in 1 AMPULE (55792-007-01) | 04 Jun, 2013 | 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:
Elliotts b sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate sodium chloride sodium cation chloride ion sodium bicarbonate bicarbonate ion anhydrous dextrose anhydrous dextrose magnesium sulfate, unspecified magnesium cation potassium chloride potassium cation calcium chloride calcium cation sodium phosphate phosphate ion water
Indications and Usage:
Indications and usage elliotts b solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.
Warnings:
Warnings intrathecal administration of drugs such as methotrexate sodium and cytarabine should be performed by perÂsonnel skilled in the technique of lumbar puncture under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. the labeling for methotrexate sodium and cytarabine should be consulted.
General Precautions:
General particular attention should be taken to assure the maintenance of sterile technique throughout the procedure. (see dosage and administration .)
Dosage and Administration:
Dosage and administration see product labeling for methotrexate sodium and cytarabine. elliotts b solution is intended for intrathecal administration only. elliotts b solution does not contain antibacÂterial preservatives and introduction of contaminated solutions into the cerebrospinal fluid may have extremely serious consequences. therefore, administration of intrathecal solutions should be accomplished as soon as possible after preparation. a sterile filter-needle should be used to withdraw the contents of the ampule. intrathecal drug products should be inspected visually for particulate matter and discoloration prior to adminÂistration. preparation and administration precautions elliotts b solution is a diluent for the cytotoxic anticancer agents, methotrexate sodium and cytarabine. care should be exercised in the handling and preparation of infusion solutions with these products. (see product labeling for methotrexate sodium and cytarabine.)
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions adverse reactions may occur with any given intrathecal injection due to the chemotherapy or the technique of intrathecal administration. (see product labeling for methotrexate sodium and cytarabine.) preservative-free methotrexate sodium and cytarabine should be used to minimize adverse reactions due to preservatives. if an adverse reaction does occur, discontinue the administration, evaluate the patient, institute appropriate therapeutic countermeasures and, if possible, save the remainder of the unused solution(s) for examination.
Use in Pregnancy:
Usage in pregnancy all components of elliotts b solution are normal body constituents. animal reproduction studies have not been conducted with elliotts b solution.
Overdosage:
Overdosage elliotts b solution is a diluent. in the event of a drug, fluid or solute overload following administration, evaluÂate the patient's condition, and institute appropriate corrective treatment. (see product labeling for methotrexate sodium and cytarabine.)
Description:
Description elliotts b ® solution is a sterile, nonpyrogenic, isotonic solution containing no bacteriostatic preservatives. elliotts b solution is a diluent for intrathecal administration of methotrexate sodium and cytarabine. each 10 ml of elliotts b solution contains: sodium chloride, usp 73 mg sodium bicarbonate, usp 19 mg dextrose, usp 8 mg magnesium sulfate ⢠7h 2 o, usp 3 mg potassium chloride, usp 3 mg calcium chloride ⢠2h 2 o, usp 2 mg sodium phosphate, dibasic ⢠7h 2 o, usp 2 mg water for injection, usp qs 10 ml concentration of electrolytes: sodium 149 meq/liter bicarbonate 22.6 meq/liter potassium 4.0 meq/liter chloride 132 meq/liter calcium 2.7 meq/liter sulfate 2.4 meq/liter magnesium 2.4 meq/liter phosphate 1.5 meq/liter the formulae and molecular weights of the ingredients are: ingredient molecular formula molecular weight sodium chloride nacl 58.44 sodium bicarbonate nahco 3 84.01 dextrose c 6 h 12 o 6 180.16 magnesium sulfate ⢠7h 2 o mg 2 so 4 ⢠7h 2 o 246.48 potassium chloride kcl 74.55 calcium chloride ⢠2h 2 o cacl 2 ⢠2h 2 o 147.01 sodium phosphate, dibasic ⢠7h 2 o na 2 hpo 4 ⢠7h 2 o 268.07 the ph of elliotts b solution is 6.0-7.5, and the osmolarity is 288 mosmol per liter (calculated).
Clinical Pharmacology:
Clinical pharmacology elliotts b solution provides a buffered salt solution for use as a diluent for the intrathecal administration of methotrexate sodium and cytarabine. it has been demonstrated that elliotts b solution is comparable to cereÂbrospinal fluid in ph, electrolyte composition, glucose content, and osmolarity: comparison of electrolyte composition, ph and nonelectrolytic constituents of elliotts b solution and csf solution na + meq/l k + meq/l ca ++ meq/l mg ++ meq/l hco 3 - meq/l cl - meq/l ph phosphorus mg/dl glucose mg/dl cerebrospinal fluid 117-137 2.3-4.6 2.2 2.2 22.9 113-127 7.31 1.2-2.1 45-80 elliotts b solution 149 4.0 2.7 2.4 22.6 132 6.0-7.5 2.3 80 the approximate buffer capacity of elliotts b solution is 1.1 x 10 -2 equivalents when the challenge solution is 0.01 n hcl and 7.8 x 10 -3 equivalents when the challenge solution is 0.01 n naoh. 1 compatibility studies with methotrexate sodium and cytarabine indicate these drugs are physically compatiÂble with el
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Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no standard mutagenicity or carcinogenicity studies have been conducted with elliotts b solution.
How Supplied:
How supplied ndc size 55792-007-10 10 ml ampule elliotts b solution is available in single-use clear glass ampules, packaged 10 ampules per box. store at controlled room temperature, 20º-25ºc (68º-77ºf) [see usp]. preservative free. discard unused portion. use only if solution is clear and ampule is intact. distributed by: lukare medical, llc scotch plains, nj 07076 1-855-752-9317 www.elliottsbsolution.com
Package Label Principal Display Panel:
Packaging ampule labeling: box labeling: ampule labeling box labeling