QUABIC-100- hemodialysis grade sodium bicarbonate solution solution, concentrate

QUABIC-100 by

Drug Labeling and Warnings

QUABIC-100 by is a Otc medication manufactured, distributed, or labeled by Aqua Medica, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a Hemodialyhsis-Grade Sodium Bicarbonate Solution.

This solution already diluted 1.27:57 with purified water (standard 13959:2014), provides:

Sodium: 35.0 mEq/L

Each 1000 mL of this solution conteins:

Sodium bicarbonate USP, hemodialysis grade: 84.0 g

Purified water (standard iso 13959:2014), csp: 1000 mL

ACTIVE INGREDIENT

Sodium Bicarbonate: Antiseptic

PURPOSE

For use only with 3-pump hemodialysis machines.

INDICATIONS & USAGE

Use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standar ISO 13959:2014) IN A RATIO 1:1

WARNINGS

This solution should be transparent and colorless. Do not use if cloudy or with broken seal. If not all of the contents are used, discard the excess. Keep at room temperature.

DOSAGE & ADMINISTRATION

For use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water.

DO NOT USE

If cloudy or with borken seal.

WHEN USING

If not all the contents are used, discard the excess.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STORAGE AND HANDLING

Keep at room temperature.

INACTIVE INGREDIENT

Purified water (standard ISO 13959:2014)

PRINCIPAL DISPLAY PANEL

81943-503-03

INGREDIENTS AND APPEARANCE

QUABIC-100 
hemodialysis grade sodium bicarbonate solution solution, concentrate

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81943-503
Route of Administration	HEMODIALYSIS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	8.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81943-503-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/30/2024

Labeler - Aqua Medica, S.A. de C.V. (589696442)

Establishment
Name	Address	ID/FEI	Business Operations
Aqua Medica, S.A. de C.V.		589696442	manufacture(81943-503)