QUABIC-300- hemodialysis grade sodium bicarbonate solution solution, concentrate 
AQUA MEDICA, S.A. DE C.V.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

This is a Hemodialysis-Grade Sodium Bicarbonate Solution.

This solution already diluted 1:27:57 with purified water (standard 13959:2014), provides:

Sodium: 35.0 mEq/l

Bicarbonate: 35.0 mEq/l

Each 1000 mL of this solution contains:

Sodium bicarbonate USP, hemodialysis grade: 84.0 g

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

Active Ingredient(s)

Sodium Bicarbonate: Antiseptic

Purpose

For use only with 3-pump hemodialysis machines.

Use

Use oly with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standard ISO 13959:2014) IN A RATIO 1:1.23:32.77.

Warnings

The 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.

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

Do not use

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

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

Other information

Inactive ingredients

Purified water (standard ISO 13959:2014)

Package Label - Principal Display Panel

3785 mL NDC: 81943-502-01 3785 mL Label

QUABIC-300 
hemodialysis grade sodium bicarbonate solution solution, concentrate
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81943-502
Route of AdministrationHEMODIALYSIS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE8.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81943-502-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/30/2020
Labeler - AQUA MEDICA, S.A. DE C.V. (816672224)
Establishment
NameAddressID/FEIBusiness Operations
AQUA MEDICA, S.A. DE C.V.816672224manufacture(81943-502)

Revised: 10/2023
Document Id: 090c1d7f-2888-23a3-e063-6394a90a8eff
Set id: c3cd7f0f-8d70-23af-e053-2a95a90a569b
Version: 6
Effective Time: 20231031
 
AQUA MEDICA, S.A. DE C.V.