Elliotts B (Page 2 of 2)

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
67871-007-1010 mL ampule

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:
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
(click image for full-size original)

Box labeling:

Box Labeling
(click image for full-size original)
ELLIOTTS B sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67871-007
Route of Administration INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium chloride (sodium cation and chloride ion) sodium chloride 73 mg in 10 mL
sodium bicarbonate (bicarbonate ion) sodium bicarbonate 19 mg in 10 mL
anhydrous dextrose (anhydrous dextrose) anhydrous dextrose 8 mg in 10 mL
magnesium sulfate (magnesium cation) magnesium sulfate 3 mg in 10 mL
potassium chloride (potassium cation) potassium chloride 3 mg in 10 mL
calcium chloride (calcium cation) calcium chloride 2 mg in 10 mL
sodium phosphate (phosphate ion) sodium phosphate 2 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
Water 10 mL in 10 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67871-007-10 10 AMPULE (AMPULE) in 1 BOX contains a AMPULE (67871-007-01)
1 NDC:67871-007-01 10 mL in 1 AMPULE This package is contained within the BOX (67871-007-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020577 09/27/2006
Labeler — QOL Medical, LLC (140026258)

Revised: 08/2012 QOL Medical, LLC

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