ELLIOTTS B- sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodi

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

sodium chloride (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37, chloride ion - UNII:Q32ZN48698), sodium bicarbonate (UNII: 8MDF5V39QO) (bicarbonate ion - UNII:HN1ZRA3Q20), anhydrous dextrose (UNII: 5SL0G7R0OK) (anhydrous dextrose - UNII:5SL0G7R0OK), MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838), potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152), calcium chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB), sodium phosphat

Tilgjengelig fra:

Lukare Medical, LLC

INN (International Name):

sodium chloride

Sammensetning:

sodium chloride 73 mg in 10 mL

Administreringsrute:

INTRATHECAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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. None known. There is no potential for drug abuse or drug dependence.

Produkt oppsummering:

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

Autorisasjon status:

New Drug Application

Preparatomtale

ELLIOTTS B- SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE,
MAGNESIUM SULFATE,
POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE INJECTION
LUKARE 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 • 7H O, USP
3 mg
Potassium Chloride, USP
3 mg
Calcium Chloride • 2H O, USP
2 mg
Sodium Phosphate, dibasic • 7H 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
84.01
Dextrose
C H O
180.16
Magnesium Sulfate • 7H O
Mg SO • 7H O
246.48
Potassium Chloride
KCl
74.55
Calcium Chloride • 2H O
CaCl
• 2H O
147.01
Sodium Phosphate, dibasic • 7H O
Na HPO • 7H O
268.07
The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288
mOsmol per liter (calculated).
®
®
2
2
2
3
6
12
6
2
2
4
2
2
2
2
2
2
4
2
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
HCO
MEQ/L
CL
MEQ/L
PH PHOS PHORUS
MG/DL
GLUCOSE
MG/DL
Cer