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ELLIOTTS B® SOLUTION (buffered intrathecal electrolyte/dextrose injection)

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软件介绍

Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection) is indicated in the patients suffering from meningeal leukemia, especially in children. It is also recommended for the lymphocytic lymphoma. These two diseases are the two most common forms of cancer that occur in childhood. The adults may also end up with them. It is used both to treat the diseases and to prevent them, once the first signs are diagnosed. It acts by maintaining the pH of cytarabine and methotrexate sodium in normal limits.

Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection) requires a medical prescription and a wide variety of initial tests, especially when it is administered on children. They have sensitive organisms, not to mention the disease has already weakened them a lot.

Administration
Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection) can be taken by intrathecal administration. It is very important to know precisely how to do it. Although this technique was introduced in the 70s, it is one of the latest and less popular ones in the medicine world. If you think you are not experienced enough or you might have problems with the administration, then see your doctor whenever you need a dose.

The medicine must be prepared. It is a diluent after all, so you will need to be careful with preparing the final infusion. Also, it doesn't contain any preservatives at all. As soon as you open the product and start preparing it, it starts losing its efficiency. It must be taken immediately after preparation.

It comes in a 10mL ampule. In order to take it out, you will have to use a sterile needle. Store it at the room temperature.

The dose depends on each patient, therefore the treatment is individualized. Diagnosing the disease soon is a big step in curing it. The duration of the treatment also depends on these aspects. Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection) may be used in associated therapies as well. Such combinations are indicated when the disease is too evolved.

Contraindications
There aren't any known contraindications for Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection). However, there are some warnings you need to take in consideration. For instance, the pregnant and nursing women require caution and constant checks. Although the medicine is not known to be harmful for the unborn or nursed babies, there are some risks, since many tests are still ongoing or not conclusive enough.

Side effects
The side effects of Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection) are common for most drugs with intrathecal administration. Chemotherapy may also have a word to say, therefore you might experience nausea or vomiting. If anything unusual occurs, don't hesitate to talk to your doctor.

ELLIOTTS B - sodium chloride, sodium bicarbonate, dextrose, magnesium sulfate, unspecified, potassium chloride, calcium chloride and sodium phosphate injection, solution
QOL Medical LLC

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ELLIOTTS B® SOLUTION (buffered intrathecal electrolyte/dextrose injection)
Rx Only

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 • 7H2O, USP	3 mg
Potassium Chloride, USP	3 mg
Calcium Chloride • 2H2O, USP	2 mg
Sodium Phosphate, dibasic • 7H2O, 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	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.

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.

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

NDC	SIZE
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, 20º-25ºC (68º-77ºF) [See USP].

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

Manufactured by: Ben Venue Laboratories, Inc.
                            Bedford, Ohio 44146

Distributed by: QOL Medical LLC
                         Kirkland, WA 98033
                         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. 09/06
Part No. 210

PACKAGING

Ampule labeling:

通用名称:钠钾镁钙葡葡糖注射液

　　英文名称:Sodium Potassium Magnesium Calcium and Glucose Injection

　　【成份】

　　本品为复方制剂，其主要组份为每 1000ml中含:氯化钠 6.372g，氯化钾 0.30g，氯化镁(MgCl2·6H2O)0.204g，醋酸钠 (NaC2H3O2)2.052g，枸橼酸钠(C6H5Na3O7·2H2O)0.588g,葡萄糖酸钙 (C12H22CaO14·H2O)0.672g，葡萄糖l0g。与人体细胞外液基本相同。

　　【性状】

　　本品为无色至淡黄色澄明液体。

ELLIOTTS B® SOLUTION (buffered intrathecal electrolyte/dextrose injection)

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