ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS Adverse reactions may occur with any given intrathecalinjection due to the chemotherapy or the technique of intrathecaladministration. (See product labelingfor methotrexate sodium and cytarabine.)Preservative-free methotrexate sodium and cytarabine shouldbe used to minimize adverse reactions due to preservatives.If an adverse reaction does occur, discontinue theadministration, evaluate the patient, institute appropriate therapeuticcountermeasures and, if possible, save the remainder of the unused solution(s) for examination.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility. No standard mutagenicity or carcinogenicity studieshave been conducted with Elliotts Solution.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Elliotts Solution provides buffered salt solution for use as diluent for the intrathecaladministration of methotrexate sodium and cytarabine. It has been demonstratedthat Elliotts Solution is comparable to cere-brospinal fluid in pH,electrolyte composition, glucose content, and osmolarity:Comparison of Electrolyte Composition, pH and Nonelectrolytic Constituents of Elliotts Solution and CSFSolutionNa+ mEq/L K+ mEq/L Ca++ mEq/L Mg++ mEq/L HCO3 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 Solution 149 4.0 2.7 2.4 22.6 132 6.0-7.5 2.3 80 The approximate buffer capacity of Elliotts BSolution is 1.1 10-2 equivalents when the challenge solution is0.01 HCl and 7.8 10-3 equivalents when the challenge solution is0.01 NaOH.1 Compatibility studies with methotrexate sodiumand cytarabine indicate these drugs are physically compati-ble with Elliotts BSolution.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. None known.

DESCRIPTION SECTION.

DESCRIPTION. Elliotts B(R) Solution is sterile, nonpyrogenic, isotonic solution containing no bacteriostatic preservatives. Elliotts Solution is diluent for intrathecal administration of methotrexate sodium and cytarabine.Each 10 mL of Elliotts Solution contains:Sodium Chloride, USP73 mgSodium Bicarbonate, USP19 mgDextrose, USP8 mgMagnesium Sulfate 7H2O, USP3 mgPotassium Chloride, USP3 mgCalcium Chloride 2H2O, USP2 mgSodium Phosphate, dibasic 7H2O, USP2 mgWater for Injection, USPqs 10 mLConcentration of Electrolytes:Sodium149 mEq/literBicarbonate22.6 mEq/literPotassium4.0 mEq/literChloride132 mEq/literCalcium2.7 mEq/literSulfate2.4 mEq/literMagnesium2.4 mEq/literPhosphate1.5 mEq/literThe formulae and molecular weights of the ingredients are:INGREDIENTMOLECULARFORMULAMOLECULARWEIGHTSodium ChlorideNaCl58.44Sodium BicarbonateNaHCO3 84.01DextroseC6H12O6 180.16Magnesium Sulfate 7H2OMg2SO4 7H2O246.48Potassium ChlorideKCl74.55Calcium Chloride 2H2OCaCl2 2H2O147.01Sodium Phosphate, dibasic 7H2ONa2HPO4 7H2O268.07The pH of Elliotts Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. See product labeling formethotrexate sodium and cytarabine.Elliotts Solution is intended for intrathecaladministration only. Elliotts Solutiondoes not contain antibac-terial preservatives and introduction of contaminatedsolutions into the cerebrospinal fluid may have extremely serious consequences.Therefore, administration of intrathecal solutions should be accomplished assoon as possible after preparation.A sterile filter-needle should be used to withdraw thecontents of the ampule.Intrathecal drug products should be inspected visuallyfor particulate matter and discoloration prior to admin-istration.. Preparation and Administration Precautions. Elliotts Solution is diluent for the cytotoxicanticancer agents, methotrexate sodium and cytarabine. Care should be exercisedin the handling and preparation of infusion solutions with these products. (Seeproduct labeling for methotrexate sodium and cytarabine.).

DRUG ABUSE AND DEPENDENCE SECTION.

DRUG ABUSE AND DEPENDENCE. There is no potential for drug abuse or drug dependence.

GENERAL PRECAUTIONS SECTION.

General. Particular attention should be taken to assurethe maintenance of sterile technique throughout the procedure. (See DOSAGE ANDADMINISTRATION.).

HOW SUPPLIED SECTION.

HOW SUPPLIED. NDCSIZE55792-007-1010 mL ampuleElliotts 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, LLCScotch Plains, NJ 070761-855-752-9317www.elliottsbsolution.com.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Elliotts Solution is indicated as diluent for the intrathecal administrationof methotrexate sodium and cytarabine for the prevention or treatment ofmeningeal leukemia or lymphocytic lymphoma.

OVERDOSAGE SECTION.

OVERDOSAGE. Elliotts Solution is diluent. In the event of drug,fluid or solute overload following administration, evalu-ate the patientscondition, and institute appropriate corrective treatment. (See productlabeling for methotrexate sodium and cytarabine.).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGING. Ampule labeling:Box labeling:. Ampule Labeling. Box Labeling.

PRECAUTIONS SECTION.

PRECAUTIONS. General. Particular attention should be taken to assurethe maintenance of sterile technique throughout the procedure. (See DOSAGE ANDADMINISTRATION.). Carcinogenesis, Mutagenesis, Impairment of Fertility. No standard mutagenicity or carcinogenicity studieshave been conducted with Elliotts Solution. Usage in Pregnancy. All components of Elliotts Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts Solution.

PREGNANCY SECTION.

Usage in Pregnancy. All components of Elliotts Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts Solution.

REFERENCES SECTION.

REFERENCES:. 1. Cradock JC, et al. Evaluation of some pharmaceutical aspects of intrathecal methotrexate sodium, cytara-bine and hydrocortisone sodium succinate. American Journal of Hospital Pharmacy (1978); 35:402.Rev. 10/2015.

SPL UNCLASSIFIED SECTION.

Preparation and Administration Precautions. Elliotts Solution is diluent for the cytotoxicanticancer agents, methotrexate sodium and cytarabine. Care should be exercisedin the handling and preparation of infusion solutions with these products. (Seeproduct labeling for methotrexate sodium and cytarabine.).

WARNINGS SECTION.

WARNINGS. Intrathecal administration of drugs such as methotrexatesodium and cytarabine should be performed by per-sonnel skilled in thetechnique of lumbar puncture under the supervision of physician who isexperienced in the use of cancer chemotherapeutic agents. The labeling formethotrexate sodium and cytarabine should be consulted.