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  5. Label Information: Elliotts B

FDA Label for Elliotts B

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. CLINICAL PHARMACOLOGY
    3. INDICATIONS AND USAGE
    4. CONTRAINDICATIONS
    5. WARNINGS
    6. PRECAUTIONS
    7. GENERAL
    8. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    9. USAGE IN PREGNANCY
    10. ADVERSE REACTIONS
    11. DRUG ABUSE AND DEPENDENCE
    12. OVERDOSAGE
    13. DOSAGE AND ADMINISTRATION
    14. PREPARATION AND ADMINISTRATION PRECAUTIONS
    15. HOW SUPPLIED
    16. REFERENCES:
    17. PACKAGING

Elliotts B Product Label

The following document was submitted to the FDA by the labeler of this product Qol Medical, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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, USP73 mg
Sodium Bicarbonate, USP19 mg
Dextrose, USP8 mg
Magnesium Sulfate • 7H2O, USP3 mg
Potassium Chloride, USP3 mg
Calcium Chloride • 2H2O, USP2 mg
Sodium Phosphate, dibasic • 7H2O, USP2 mg
Water for Injection, USPqs 10 mL

Concentration of Electrolytes:
Sodium149 mEq/literBicarbonate22.6 mEq/liter
Potassium4.0 mEq/literChloride132 mEq/liter
Calcium2.7 mEq/literSulfate2.4 mEq/liter
Magnesium2.4 mEq/literPhosphate1.5 mEq/liter


The formulae and molecular weights of the ingredients are:


INGREDIENTMOLECULAR
FORMULA		MOLECULAR
WEIGHT
Sodium Chloride
NaCl
58.44
Sodium Bicarbonate
NaHCO3
84.01
Dextrose
C6H12O6
180.16
Magnesium Sulfate • 7H2O
Mg2SO4 • 7H2O
246.48
Potassium Chloride
KCl
74.55
Calcium Chloride • 2H2O
CaCl2 • 2H2O
147.01
Sodium Phosphate, dibasic • 7H2O
Na2HPO4 • 7H2O
268.07


The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).


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 cere­brospinal 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

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 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 compati­ble with Elliotts B Solution.



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.


Contraindications



None known.


Warnings



Intrathecal administration of drugs such as methotrexate sodium and cytarabine should be performed by per­sonnel 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.


Precautions





General



Particular attention should be taken to assure the maintenance of sterile technique throughout the procedure. (See DOSAGE AND ADMINISTRATION.)


Carcinogenesis, Mutagenesis, Impairment Of Fertility



No standard mutagenicity or carcinogenicity studies have been conducted with Elliotts B Solution.


Usage In Pregnancy



Pregnancy Category C



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


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.


Drug Abuse And Dependence



There is no potential for drug abuse or drug dependence.


Overdosage



Elliotts B Solution is a diluent. In the event of a drug, fluid or solute overload following administration, evalu­ate the patient's condition, and institute appropriate corrective treatment. (See product labeling for methotrexate sodium and cytarabine.)


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 antibac­terial 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 admin­istration.


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.)


How Supplied



NDCSIZE
67871-007-10
10 mL ampule
Elliotts B Solution is available in single-use clear glass ampules, packaged 10 ampules per box.

Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP].

Preservative Free.  Discard unused portion.  Use only if solution is clear and ampule is intact.

Distributed by:
QOL Medical, LLC
Vero Beach, FL 32963
1-866-528-4750
www.elliottsbsolution.com

References:



1. Cradock JC, et al. Evaluation of some pharmaceutical aspects of intrathecal methotrexate sodium, cytara­bine and hydrocortisone sodium succinate.  American Journal of Hospital Pharmacy (1978); 35:402.

Rev. 12/11
Part No. 210



Packaging



Ampule labeling:

Ampule Labeling - ampule

Ampule Labeling - ampule


Box labeling:


* Please review the disclaimer below.